Journal — diary_prequel
1,240 entries over 18 years, 8 months, 2001-01-06 – 2019-09-09.
Showing the first 500 of 1,240. The rest are reachable individually — search within this package or browse the page text.
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September 17, 1985, the President was asked about the issue of AIDS in schools. Instead of affirming the conclusions reached by the nation's top scientists, the President undermined th The President stated that he was glad not to be faced with the decision of whether or not to s a child to school with a child who had AIDS. He added: I can understand the problem of the parents. It is true that some medical sources hav said that this cannot be communicated in any way other than the ones we already knc and which would not involve a child being in the school. And yet, medicine has not come forth unequivocally and said, "This we know for a fact, that it is safe." And un they do, I think we just have to do the best we can with this problem. I can understan both sides of it.'° The President's failure to support the science on AIDS transmission exacerbated fear prejudice, and discrimination against children with AIDS. After the press conference, one pediatrician told the Los Angeles Times that he expected parents to "quote the President and 'Gee, even the President doesn't come out and support the medical experts -- how can he ex us to send our children to school?'" The expert added, "Given the current information and th circumstances, he could have been much more definite.""! Questions for Mr. Roberts It is important for the Senate and the public to understand Judge Roberts's role in thi deplorable chapter in the history of public health in the United States. Judge Roberts should " Id. '© Close to Home, Washington Post (Sept. 22, 1985). Senator Arlen Specter Senator Patrick Leahy
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Jan. 11, 2103 - Did morning CNN and Soledad O'Brien on CNN and further discussed the flu situation. Much, much press interest. As expected, Bill Hall (HHS Press office) wrote a note to Courtney Billet, Greg Folkers and John Burklow saying that from now on the CDC should handle press on the flu and I should only do local media and national media only when they want to talk about research associated with flu like universal flu vaccine. This has shades of Jenny Backus. Almost certainly a result of a complaint from CDC. We (NIH/NIAID) are trying not to clash with them, but this is really insulting and we will have to see how this plays out and how we should push back on this.
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Jan. 6 - 22, 2001 - Clearly, it is unclear what is going on with the White House and my nomination. Secretary Thompson keeps pushing the President to appoint me and the President defers to Clay Johnson, Director of White House Personnel, who has actually never interviewed me. I get word indirectly from Scott Whitaker, Bob Charrow and others that there really is a political battle going on in the WH with a strong antiThompson faction led by Clay Johnson who does not want to appoint me because he wants to put down Thompson who is pushing me. On the other hand, there are those who clearly want me, but are less aggressive in pushing any agenda since they are assuming that I will get appointed. It is unclear what role Sen Brownback is playing in influencing Clay Johnson. I hear from Rick Klausner that the issue is just that they are reluctant for me to do two jobs simultaneously. I doubt this and believe that there is something else going on. Jan.22, 2001 - Finally, I get called to the West Wing of the WH to meet with Clay Johnson and Ed Moy (Johnson's deputy) to discuss the job. Johnson was cold and abrupt. He said that the President was getting confused messages about my "conditions" for the job and the POTUS had asked Johnson to clarify things. Johnson coldly and abruptly asked how I can do 2 jobs simultaneously. I explained about the extraordinary overlap in what the NIH Director must know and do with what the Institute Directors must know and do and tell him that I feel that I will have no problem doing this. He clearly was not convinced. Then he wanted to know why I wanted 2 full salaries, i.e. the NIH Director's salary and the NIAID Director's salary. I explained that this was not the case, and that I merely did not want to lose money by relinquishing my retention bonus that I could not take as NIH Director as well as several outside activities that I could not do as NIH Director. He acted (coldly) like he understood that. As soon as I answered these 2 questions, he abruptly said: "Well, you answered my questions and told me what I 'sident Bush to need to know. Thanks a lot and have a nice day", whereupon he ended the meeting. Never did he even approach asking what my vision for the NIH was or other related substantive questions. Clearly he had made up his mind before the meeting and was only meeting because the President had asked him to.
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Jan 24, 2001 - Tommy Thompson calls me at home at 9:30 PM (he was sequestered in "the bunker" for security reasons) and tells me that he spoke with Clay Johnson today and Johnson told him that he was going to recommend someone else and not me to the President. Thompson was clearly very angry and sad. I am more convinced now that this is a Clay Johnson agenda working here.
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Jan. 26, 2001 - I go to the Annual Alphalfa Dinner at the Capitol Hilton as a Guest of Robert Wood ("Woody") Johnson IV.. Amazing scene! Virtually every important government official (the entire Cabinet, military leaders, etc) was there. At the reception, I met Barbara Bush who was very warm with a hug and kiss and told me that she is "pulling for me". I did not pursue this since this is not my style. I then met former President Bush who was his usual wonderful self with me, hugging me and telling guests who were standing around that I had won the 1988 election for him when he told the world that I was his hero. I mentioned that we had just received the President's Budget for FY2003 this week and that the President has fulfilled the promise to double the NIH budget and had given NIAID and additional $1.5 billion for bioterrorism research. I told Bush that this was similar to what he, himself, had done with me in the 1980s when he increased my AIDS budget, but that this was on a much larger scale. I told him how much I appreciated this. He told me to make sure that I tell the POTUS this. I also saw Tommy Thompson at the dinner and walked into the ballroom with him. He seemed very sad and troubled. He again said that he was going to see the POTUS next week and will tell him that I am not only the best person, but the "only" person for the NIH Director's job, regardless of what Clay Johnson will tell him. At the dinner Woody Johnson brought me over to the head table to say hello to the POTUS. Bush greeted me warmly (he clearly knew who I was). I thanked him for the BT money and he asked about our efforts; I briefly told him. He then surprised me by asking whether I had seen Clay Johnson yet, and so he knows that the meeting was set up. I told him that I did see him a couple of days ago. The POTUS said "Good, I will touch bases with Clay next week". Later on I met Laura Bush and she too complimented me on my work and we had a very nice conversation. In none of these encounters did I mentioned the NIH Director's job. My feeling at this time is confirmed that the President really does not know the situation except that he has heard a lot about me, but this is confounded by the fact that it is clear that Clay Johnson does not want me. Is it really because he is against 2 jobs, or is there some hidden agenda. I feel strongly that it is the latter. We shall see....maybe.
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March 2, 2001 - meet with Anne Phelps at White House to discuss global AIDS and other issues.
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April 3, 2001 - Extensive briefing of Secr. Thompson's staff (Halaska, Steiger, Ann Agnew) regarding International AIDS. Secretary Thompson dropped by and spent most of the hour. After the meeting he called me into his office to speak in private (Bob Woods (Chief of Staff) and Brett Davis (Special Assistant to the Secretary) were there. Thompson said he wanted me to be his point man on AIDS and to spearhead our international endeavors. Stated that he and Colin Powell would lead a Task Force on International AIDS and he wanted me to be the "go-to person".
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April 4, 2001 - I was asked to prepare talking points on AIDS for Secretary. Thompson for his upcoming plane trip with Pres, Bush to (?). I did so. Thompson's staff was so impressed with 3ome comments. the talking points that they mentioned that Thompson wanted me to accompany his staff to the White House the next day to develop a white paper for Powel and Thompson to use in upcoming meeting with the POTUS.
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April 5, 2001 - Several hour meeting in the Situation Room of the White House chaired by Gary Edson (Condoleeza Rice's Deputy) of NSC. Meeting attended by..... Bill Steiger charged with developing paper.
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April 8 - 10, 2001 - I exchanged several drafts of white paper with Steiger and make significant changes and input. It was clear that much of the paper included material from my talking points for Thompson (see above).
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April 11, 2001) and will state some events \IDS and other HISTORICAL RECORD OF HIV/AIDS Anthony S. Fauci, M.D. Director National Institute of Allergy and Infectious Diseases National Institutes of Health This written record will start today (April 11, 2001) and will state some events retrospectively. I have other records including 2 dictated tapes that should be noted. The event that precipitated this written record, which I hope that I can regularly contribute to is the tidal wave of activity concerning the possibility of treating HIV-infected individuals in developing nations and in sub-Saharan Africa specifically. Towards to end of the Clinton Administration, Leon Fuerth who was the National Security Advisor to VP Al Gore had set into motion a Task Force on which I was included (see other records) to develop a plan to "treat infected Africans and provide some infrastructure, prevention, etc. The group involved USAID, CDC, NIH, White House, State Department and others. After the election, obviously, this dissolved. However, with the new George W. Bush administration, Secr. of State Colin Powell and Secr of DHHS, Tommy G. Thompson became very interested. Starting from the end of March I began intensive briefings of Secretary. Thompson and members of his staff, particularly Terrell Halaska (Deputy Chief of Staff, DHHS) and William Steiger (Special Assistant for International Affairs at DHHS) trying to convince them of the need for USA involvement in the rapidly growing international interest in developing a forum for treating Africans with HIV. Also, I had several interactions with Anne Phelps of the Domestic Policy Council at the White House. During all of this, I had turned down the offer to be Director of NIH. I was asked by Ed. Moy (Director of Presidential Personnel at the White House) and by Secr. Thompson. My reason was that I wanted to concentrate of Global Health problems, particularly HIV/AIDS in developing nations such as sub-Saharan Africa. They regretted my not taking the job, but were enthusiastic and quite flattering about my work on AIDS and encouraged to take a leadership role in pushing the AIDS (as well as TB and malaria) global agenda. This was especially true of Secr. Thompson with whom I was rapidly developing an excellent relationship.
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April 11, 2001 - Attached below is the document and some comments. ---------------------- Forwarded by Millicent H. Schwenk/NSC/EOP on 04/11/2001 11:16 AM --------------------------- Gary R. Edson 04/10/2001 09:00:45 PM Record Type: Record To: Millicent H. Schwenk/NSC/EOP@EOP cc: Subject: Millie: I haven't reviewed this to see what;'s changed, but you should look at it. ---------------------- Forwarded by Gary R. Edson/NSC/EOP on 04/10/2001 09:01 PM --------------------------- (Embedded image moved steigerw@usa.net to file: 04/10/2001 07:05:59 PM PIC07622.PCX) Record Type: Record To: Gary R. Edson/NSC/EOP cc: terrell.halaska@hhs.gov Subject: my hhs dial-up e-mail is down tonight. i wanted to send you a slightly modified version after receiving additional comments from dr. fauci. i am sending in the body of the e-mail because i am not certain the attachment will go through. let me know if you have any questions or need me to do anything else. thanks, steiger Draft Privileged and Confidential For Official Use Only Infectious diseases, including HIV/AIDS, malaria, and tuberculosis, are ravaging developing nations, causing 25 percent of all deaths worldwide and eroding recent gains in economic growth, education, and life expectancy. Tuberculosis accounted for 1.7 million deaths last year, while malaria killed more than one million, mostly children in Africa. At the same time, the spread of HIV/AIDS is triggering a crisis in international public health, the full scope of which we are only beginning to recognize. The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates that 36 million people are now living with HIV or AIDS, 70 percent of them in sub-Saharan Africa, where the disease is now the leading cause of death. Nearly 60 million people have become infected with HIV since the beginning of the epidemic in the 1970's and over 22 million of them have already died from AIDS. The U.S. has been the leader in research and assistance to battle these diseases, and the President?s recent proposed budget increase for the National Institutes of Health (NIH) reaffirms that commitment. NIH spent an estimated $90 million on international HIV/AIDS research in FY 2000, a number that is expected to rise to $130 million by the end of FY 2001. The U.S. is the largest single donor to UNAIDS and the largest contributor to international HIV/AIDS treatment and prevention programs, a total of more than $460 million in FY2001. The Centers for Disease Control and Prevention (CDC) spent over $100 million on HIV/AIDS prevention in FY 2001. The U.S. Government has also dramatically increased its investment in international malaria and tuberculosis efforts to $110 million in FY 2001. Our programs for taking care of our own population affected by HIV/AIDS and tuberculosis are also world leaders. HHS is providing over $10 billion in FY 2001 for HIV/AIDS-related assistance. This includes $795 million for prevention services through the CDC and other agencies, $1.8 billion for Ryan White medical and related support services for individuals and families with HIV/AIDS, including the AIDS Drug Assistance Program; $2.2 billion for NIH-funded HIV/AIDS research, including $280 million in vaccine research; $4.3 billion for HIV/AIDS-related coverage for Medicare and Medicaid beneficiaries. Over the last several years the scope of the infectious disease crisis in the developing world has led the U.S and other industrialized nations to make international public health an important item on their foreign policy agendas. In Okinawa in July of 2000, the U.S. and our G-8 partners committed to promoting investments and partnership to prevent and control HIV/AIDS, tuberculosis and malaria and to accelerate the development of new vaccines. More recently, wider public attention has turned to the challenges posed by these diseases as pharmaceutical manufacturers have announced price reductions in developing countries for their main anti-retroviral drugs. These price cuts are a significant step forward and have sharpened debate on the question of how best to provide treatment to the populations most affected by the HIV/AIDS epidemic, malaria, and tuberculosis. As Senator Bill Frist (R-TN) has recently suggested, the U.S. has a moral obligation to provide leadership in mobilizing additional resources for international health. Stopping the spread of infectious diseases is also in our own enlightened self-interest, given the threats HIV/AIDS and other maladies now pose to the political and economic stability of Africa and other important regions of the world. It is in our public health interest to address tuberculosis as well, since 43 percent of U.S. TB cases are among foreign-born persons. We also believe the U.S. has a duty to ensure that those resources go to efforts that are medically and scientifically sound and will contribute to the development of a sustainable health infrastructure in the most affected countries so that they can meet their challenges themselves over time. Providing drugs at or below cost is only part of the solution. It is estimated that approximately 50 percent of HIV-infected people in the U.S. meet the HHS treatment guidelines for beginning antiretroviral therapy. What this percentage might be in developing nations is unclear. However, perhaps as important as providing antiretroviral drugs in some circumstances is treating opportunistic infections and providing nutrition and clean water. Yet even if enough drugs to treat every single infected person were sent, free of charge, to the African continent, an adequate surveillance infrastructure for testing for HIV infection and an adequate health care delivery system for administering the drugs do not exist in many countries. Furthermore, the capability of monitoring patients to insure they are taking these complex regimens of drugs properly and to determine the spectrum of toxicity and the effect of treatment on the spread of the disease There is no existing surveillance capability to ensure that patients follow extremely complicated drug regimens accurately, or to monitor what effect the treatment has on the spread of the disease is sorely lacking in many places. We should begin to help create the basic system to provide needed medications for opportunistic infections and symptomatic care, while also building the more complex systems needed to provide antiretrovirals and other medicines safely and effectively to avoid creating resistant strains, a lesson we have learned from efforts to control tuberculosis. At the same time, we must continue to focus our efforts on prevention ? a proven strategy that is cost-effective. Government accountability, individual behavior change and abstinence-based approaches (where they are culturally appropriate) must be part of prevention efforts. We have found that working with local organizations, such as missionary hospitals and clinics, is an effective way to lessen the impact of the epidemic on individuals, families and communities. We should also encourage countries to adopt comprehensive, evidence-based national strategies to ensure the resources we devote to this challenge are well-managed to produce the results we seek. This is not, however, an issue that the U.S. Government can -- or should -- solve single handedly. We must reach out to a number of partners: our allies, the international community, pharmaceutical manufacturers, non-profits like the Gates Foundation, and the faith-based community that has infrastructure on the ground in the developing world. A successful strategy to reduce the impact of infectious disease requires close donor cooperation to achieve maximum efficiency and avoid competition and duplication of efforts. The Bush Administration stands ready to contribute to a comprehensive plan to improve the public health delivery system in Africa and other parts of the world where HIV is rapidly expanding, an effort that should include prevention of new infections, care for the sick, provision of drugs, and training of medical professionals. To this end, we appeal to the world to join us in establishing a new, multi-lateral Global Fund to Fight Infectious Diseases, an international public-private partnership to provide grants for prevention and health infrastructure development focused on fighting HIV/AIDS, malaria, and tuberculosis. We believe the fund should operate under the following series of core principles: ? Our goals are to prevent new HIV infections and treat those already afflicted, to build the infrastructure for health care and disease control, and to develop and train human resources. ? We seek to support a community-driven process that identifies the needs of affected areas and allows communities themselves to develop an appropriate, comprehensive set of medical, social and support services. ? We must build on already established institutions and networks in local areas, including research relationships, to ensure we are creating human and physical capacity that is sustainable over the long run. ? We support an integrated approach focusing on prevention, delivery, care and treatment. We also wish to include components for health infrastructure improvement, surveillance of epidemics and care for orphans. ? We will outline and agree to fund a core menu of ?best practice? programs, according to certain quality standards and experience with evidence-based models proven to work in developing countries. ? We will solicit letters of intent from governments and non-governmental organizations (NGOs), especially faith-based groups, that describe plans to implement one of more of our core models in local areas. ? We will require demonstration of local leadership and adherence to international standards of financial accountability and transparency. We will give preference to comprehensive plans that involve governments and civil society working together. ? We will link our efforts in health to expanded programs in the areas of education and nutrition in an international parallel to the Administration?s campaign to ?Leave No Child Behind.? ? We are committed to a policy of promoting intellectual property protection, including for pharmaceutical patents, because of its critical role in the rapid innovation, development, and commercialization of effective and safe drug therapies and vaccines. Financial incentives are needed to develop new medications. No one benefits if research on such products is discouraged. With more than 50 years of experience with health projects and a proven institutional capacity to manage large financial transactions, the World Bank should serve as the fiscal agent for the Fund. As trustee, the Bank would not be involved in matters of policy, but would serve as the repository for contributions from both governments and private donors and ensure the prompt disbursement of grants. A small Executive Secretariat housed at the Bank and jointly staffed by the Bank, UNAIDS and the World Health Organization would undertake the day-to-day management of the trust fund, including soliciting grant proposals. A high-level Governing Council would provide the overall strategic direction for the fund. Donors that contribute at least $xx million and representatives of the developing world (serving in their own personal capacity and not as the emissaries of any particular state) would form the membership of this board. The Council would fully control all fund decisions, including determining programmatic allocations, operational rules and procedures, policies and strategies, approving financial plans and work programs, and attracting additional donations. In addition, the Council would make the final determination of the list of ?best practice? models the fund would underwrite and the criteria necessary to win approval of letters of intent. The president of the World Bank, the Director General of UNAIDS and the Director General of WHO would be ex officio, non-voting members of the Council. Much like a university endowment, the fund would have a two-tiered financial structure. The "core fund" would comprise a pool of resources that could be support any activity falling within the work program and eligibility criteria approved by the Governing Council (except for limited restrictions by donors). At the same time, however, the fund would permit donors to earmark contributions for use on their particular priorities, as long as they fell within the overall purposes and priorities of the trust fund. Both ?core? and dedicated resources would be combined in each grant in a way transparent to the recipient. Composed of international scientific, medical, public health and development experts, a Scientific and Public Health Review Committee would perform a rigorous technical peer review process to assess the grant applications. Drawn from developing and developed countries and international organizations, with experience in the affected countries, such as UNAIDS and WHO, the Committee will make final decisions about the feasibility and sustainability of proposed programs according to criteria for each ?best practice? model prescribed by the Governing Council. The Committee will also operate under broad guidelines that spell out the recommended ratio of expenditures on prevention, treatment, and research the Council would prefer projects follow. The models we might support could cover primary prevention and education programs up to more sophisticated, comprehensive efforts that could involve basic care and treatment, controlled delivery of antiretroviral therapy, medical training, and clinical trials. Applicants will determine which one of the approved packages would be most appropriate and useful for the local final document: context. Some might ask for resources to upgrade or build health centers to deliver basic HIV/AIDS or tuberculosis care and prevention programs. Others might want help with such programs plus training for physicians, lab workers, nurses, community health volunteers, and pharmacists. Still others might integrate both models with the provision of complex drug treatment. Every funded model will also include localized monitoring to assure the efficacy of the grant and to help inform the selection of proposals in the future. We will also emphasize technical assistance to those countries and organizations that are unable to satisfy our criteria in their letters of intent, so that over time they might also be able to participate. The Administration is committed to making the fight against the global HIV/AIDS epidemic and other killers a priority, and we ask our friends and partners to join with us in a single, worldwide effort. ____________________________________________________________________ Get free email and a permanent address at http://www.amexmail.com/?A=1
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April 11, 2001 - Attached below is what is to be the final document: Draft Privileged and Confidential For Official Use Only Infectious diseases, including HIV/AIDS, malaria, and tuberculosis, are ravaging developing nations, causing 25 percent of all deaths worldwide and eroding recent gains in economic growth, education, and life expectancy. Tuberculosis accounted for 1.7 million deaths last year, while malaria killed more than one million, mostly children in Africa. At the same time, the spread of HIV/AIDS is triggering a crisis in international public health, the full scope of which we are only beginning to recognize. The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates that 36 million people are now living with HIV or AIDS, 70 percent of them in sub-Saharan Africa, where the disease is now the leading cause of death. Nearly 60 million people have become infected with HIV since the beginning of the epidemic in the 1970's and over 22 million of them have already died from AIDS. The U.S. has been the leader in research and assistance to battle these diseases, and the President's recent proposed budget increase for the National Institutes of Health (NIH) reaffirms that commitment. NIH spent an estimated $90 million on international HIV/AIDS research in FY 2000, a number that is expected to rise to $130 million by the end of FY 2001. The U.S. is the largest single donor to UNAIDS and the largest contributor to international HIV/AIDS treatment and prevention programs, a total of more than $460 million in FY2001. The Centers for Disease Control and Prevention (CDC) spent over $100 million on HIV/AIDS prevention in FY 2001. The U.S. Government has also dramatically increased its investment in international malaria and tuberculosis efforts to $110 million in FY 2001. Our programs for taking care of our own population affected by HIV/AIDS and tuberculosis are also world leaders. HHS is providing over $10 billion in FY 2001 for HIV/AIDS-related assistance. This includes $795 million for prevention services through the CDC and other agencies, $1.8 billion for Ryan White medical and related support services for individuals and families with HIV/AIDS, including the AIDS Drug Assistance Program; $2.2 billion for NIHfunded HIV/AIDS research, including $280 million in vaccine research; $4.3 billion for HIV/AIDS-related coverage for Medicare and Medicaid beneficiaries. Over the last several years the scope of the infectious disease crisis in the developing world has led the U.S and other industrialized nations to make international public health an important item on their foreign policy agendas. In Okinawa in July of 2000, the U.S. and our G-8 partners committed to promoting investments and partnership to prevent and control HIV/AIDS, tuberculosis and malaria and to accelerate the development of new vaccines. More recently, wider public attention has turned to the challenges posed by these diseases as pharmaceutical manufacturers have recently announced price reductions in developing countries for their main anti-retroviral drugs. These price cuts are a significant step forward and have sharpened debate on the question of how best to provide treatment to the populations most affected by the HIV/AIDS epidemic, malaria, and tuberculosis. As Senator Bill Frist (R-TN) has recently suggested, the U.S. has a moral obligation to provide leadership in mobilizing additional resources for international health. Stopping the spread of infectious diseases is also in our own enlightened self-interest, given the threats HIV/AIDS and other maladies now pose to the political and economic stability of Africa and other important regions of the world. It is in our public health interest to address tuberculosis as well, since 43 percent of U.S. TB cases are among foreign-born persons. We also believe the U.S. has a duty to ensure that those resources go to efforts that are medically and scientifically sound and will contribute to the development of a sustainable health infrastructure in the most affected countries so that they can meet their challenges themselves over time. Providing drugs at or below cost is only part of the solution. Only a portion of the total HIVinfected population will meet criteria for beginning antiretroviral therapy. Far more need community support and basic care for opportunistic infections, such as tuberculosis, and for prevention, care and treatment of sexually transmitted diseases. Yet even if enough drugs to treat every single infected person were sent, free of charge, to the African continent, an adequate infrastructure to deliver them does not exist. There is no existing surveillance capability to ensure that patients follow extremely complicated drug regimens accurately, or to monitor what effect the treatment has on the spread of the disease. We should begin to help create the basic system to provide needed medications for opportunistic infections and symptomatic care, while also building the more complex systems needed to provide antiretrovirals and other medicines safely and effectively to avoid creating resistant strains, a lesson we have learned from efforts to control tuberculosis. At the same time, we must continue to focus our efforts on prevention - a proven strategy that is cost-effective. Individual and government accountability, behavior change and abstinence-based approaches that are culturally appropriate must be part of prevention efforts. We have found that working with local organizations, such as missionary hospitals and clinics, is an effective way to lessen the impact of the epidemic on individuals, families and communities. We should also encourage countries to adopt comprehensive, evidence-based national strategies to ensure the resources we devote to this challenge are well-managed to produce the results we seek. This is not, however, an issue that the U.S. Government can -- or should -- solve single handedly. We must reach out to a number of partners: our allies, the international community, pharmaceutical manufacturers, non-profits like the Gates Foundation, and the faith-based community that has infrastructure on the ground in the developing world. A successful strategy to reduce the impact of infectious disease requires close donor cooperation to achieve maximum efficiency and avoid competition and duplication of efforts. The Bush Administration stands ready to contribute to a comprehensive plan to begin building a public health delivery system in Africa and other parts of the world where HIV is rapidly expanding, an effort that should include prevention of new infections, care for the sick, provision of drugs, and training of medical professionals. To this end, we appeal to the world to join us in establishing a new, multi-lateral Global Fund to Fight Infectious Diseases, an international public-private partnership to provide grants for prevention and health infrastructure development focused on fighting HIV/AIDS, malaria, and tuberculosis. We believe the fund should operate under the following series of core principles: • Our goals are to prevent new infections and treat those already afflicted, to build the infrastructure for health care and disease control, and to develop and train human resources. • We seek to support a community-driven process that identifies the needs of affected areas and allows communities themselves to develop an appropriate, comprehensive set of medical, social and support services. • We must build on already established institutions and networks in local areas, including research relationships, to ensure we are creating human and physical capacity that is sustainable over the long run. • We support an integrated approach focusing on prevention, delivery, care and treatment. We also wish to include components for health infrastructure improvement, surveillance of epidemics and care for orphans. • Our intent is to start with a relatively limited number of projects, to research which approaches work best and are adaptable to local conditions, before scaling up over the next few years. • We will outline and agree to fund a core menu of "best practice" programs, according to certain quality standards and experience with evidence-based models proven to work in developing countries. • We will solicit letters of intent from governments and non-governmental organizations (NGOs), especially faith-based groups, that describe plans to implement one of more of our core models in local areas. • We will require demonstration of local leadership and adherence to international standards of financial accountability and transparency. We will give preference to comprehensive plans that involve governments and civil society working together. • We will link our efforts in health to expanded programs in the areas of education and nutrition in an international parallel to the Administration's campaign to "Leave No Child Behind." • We are committed to a policy of promoting intellectual property protection, including for pharmaceutical patents, because of its critical role in the rapid innovation, development, and commercialization of effective and safe drug therapies and vaccines. Financial incentives are needed to develop new medications. No one benefits if research on such products is discouraged. With more than 50 years of experience with health projects and a proven institutional capacity to manage large financial transactions, the World Bank should serve as the fiscal agent for the Fund. As trustee, the Bank would not be involved in matters of policy, but would serve as the repository for contributions from both governments and private donors and ensure the prompt disbursement of grants. A small Executive Secretariat housed at the Bank and jointly staffed by the Bank, UNAIDS and the World Health Organization would undertake the day-to-day management of the trust fund, including soliciting grant proposals. A high-level Governing Council would provide the overall strategic direction for the fund. Donors that contribute at least $xx million and representatives of the developing world (serving in their own personal capacity and not as the emissaries of any particular state) would form the membership of this board. The Council would fully control all fund decisions, including determining programmatic allocations, operational rules and procedures, policies and strategies, approving financial plans and work programs, and attracting additional donations. In addition, the Council would make the final determination of the list of "best practice" models the fund would underwrite and the criteria necessary to win approval of letters of intent. The president of the World Bank, the Director General of UNAIDS and the Director General of WHO would be ex officio, non-voting members of the Council. Much like a university endowment, the fund would have a two-tiered financial structure. The "core fund" would comprise a pool of resources that could be support any activity falling within the work program and eligibility criteria approved by the Governing Council (except for limited restrictions by donors). At the same time, however, the fund would permit donors to earmark contributions for use on their particular priorities, as long as they fell within the overall purposes and priorities of the trust fund. Both "core" and dedicated resources would be combined in each grant in a way transparent to the recipient. Composed of international scientific, medical, public health and development experts, a Scientific and Public Health Review Committee would perform a rigorous technical peer review process to assess the grant applications. Drawn from developing and developed countries and international organizations, with experience in the affected countries, such as UNAIDS and WHO, the Committee will make final decisions about the feasibility and sustainability of proposed programs according to criteria for each "best practice" model prescribed by the Governing Council. The Committee will also operate under broad guidelines that spell out the recommended ratio of expenditures on prevention, treatment, and research the Council would prefer projects follow. The models we might support could cover primary prevention and education programs up to more sophisticated, comprehensive efforts that could involve basic care and treatment, controlled delivery of antiretroviral therapy, medical training, and clinical trials. Applicants will determine which one of the approved packages would be most appropriate and useful for the local context. Some might ask for resources to upgrade or build health centers to deliver basic HIV/AIDS or tuberculosis care and prevention programs. Others might want help with such programs plus training for physicians, lab workers, nurses, community health volunteers, and pharmacists. Still others might integrate both models with the provision of complex drug treatment. Every funded model will also include localized monitoring to assure the efficacy of the grant and to help inform the selection of proposals in the future. We will also emphasize technical assistance to those countries and organizations that are unable to satisfy our criteria in their letters of intent, so that over time they might also be able to participate. We believe the nearly complete drive to eliminate polio offers us a model to develop a strategy to control HIV/AIDS and the other major killer infectious diseases. The Administration is committed to making the fight against the global HIV/AIDS epidemic and other killers a priority, and we ask our friends and partners to join with us in a single, worldwide effort. Bullets for above document are listed below: Draft--For Official Use Only Global Fund to Fight Infectious Diseases Bush Administration response to the crisis HIV/AIDS and other diseases have triggered in international public health. Multi-lateral, international public-private partnership to provide grants for prevention and health infrastructure development focused on fighting HIV/AIDS, malaria, and tuberculosis. Comprehensive plan to begin building a public health delivery system in Africa and elsewhere, an effort that should include prevention of new infections, care for the sick, provision of drugs, and training of medical professionals. Cooperation by many partners: our G-8 allies, the international community, pharmaceutical manufacturers, non-profits like the Gates Foundation, and the faith-based community that has a presence on the ground in the developing world. Goals • Prevent new infections, treat those already afflicted, build infrastructure for health care and disease control, and develop and train medical personnel. • Identify the needs of affected areas and allow communities themselves to develop an appropriate, comprehensive set of medical, social and support services. • Build on already established institutions and networks in local areas, including research relationships to ensure countries can sustain the fight on their own over time. Approach • Integrated approach focusing on prevention, delivery, care and treatment, along with components for health infrastructure improvement, surveillance of epidemics and care for orphans. • Start with a relatively limited number of projects, to research which approaches work best and are adaptable to local conditions, before scaling up over the next few years. • Link our efforts in health to expanded programs in the areas of education and nutrition in an international parallel to the Administration's campaign to "Leave No Child Behind." • Work cooperatively with major pharmaceutical companies to ensure greater availability of access to key drug treatments. • Continue to promote intellectual property protection, including for pharmaceutical patents, because of its critical role in the rapid innovation, development, and commercialization of effective and safe drug therapies. Structure • World Bank as trustee-- not involved in matters of policy, but repository for contributions from both governments and private donors • Small Executive Secretariat jointly staffed by the Bank, UNAIDS and the World Health Organization to undertake day-to-day management of the trust fund, including soliciting grant proposals. • Two-tiered financial structure like a university endowment: • "core fund" of resources to support any activity falling within the work program and eligibility criteria nembers. • donors could also earmark contributions for use on their particular priorities, as long as they fell within the overall purposes and priorities of the trust fund. • Both "core" and dedicated resources combined in each grant in a way transparent to the recipient. Governance • High-level Governing Council to provide overall strategic direction. • Donors and representatives of the developing world (serving in their own personal capacity); • President of the World Bank, Director General of UNAIDS and Director General of WHO as ex officio, non-voting members. • Council to fully control all fund decisions, including determining programmatic allocations, operational rules and procedures, policies and strategies, approving financial plans and work programs, and attracting additional donations. Grant-Making • Governing Council to outline and agree to fund core menu of "best practice" programs, according to certain quality standards and experience with evidence-based models proven to work in developing countries. • Fund to solicit letters of intent from governments and non-governmental organizations (NGOs), especially faith-based groups, that describe plans to implement one of more of core models in local areas. • Applicants to determine which approved packages most appropriate and useful for local context. • Models could range from simple prevention and education programs to more sophisticated, comprehensive efforts that could involve basic care and treatment, controlled delivery of anti-HIV therapy, medical training, and clinical trials. • Emphasis on individual and government accountability, behavior change and abstinence-based approaches. • Technical assistance to countries and organizations unable to satisfy our criteria in their letters of intent, so that over time they might also be able to participate. • Scientific and Public Health Review Committee to perform rigorous technical peer review process to assess letters of intent. • International scientific, medical, and development experts drawn from developing and developed countries and international organizations • Empowered to make final decisions about feasibility and sustainability of proposed programs according to criteria for each "best practice" model prescribed by the Governing Council. • Broad guidelines that spell out the recommended ratio of expenditures on prevention, treatment, and research the Governing Council would prefer projects follow. • Demonstration of local leadership and adherence to international standards of financial accountability and transparency required. • Preference given to comprehensive plans that involve governments and NGOs working together.
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April 13, 2001 -- There is a variable degree of hysteria going around with regard to the apparent dichotomy between those who are pushing for treatment for HIV infection in Africa and those who are pushing for treatment. I see no need for conflict. Obviously, we need to do both. Below is an e-mail sent from Laurie Garrett (Pulitzer Prize winning reported for Newsday) to AIDS activist Gregg Gonsalves. To me, it just shows the hysteria of Garrett. I (as well as other of my colleagues) have always felt that she was a lousy reporter...a good book writer, but a lousy reporter since she came to every sto: with her own agenda. Great for a book, but not for reporting. any event, the e-mail frames the ongoing feeling at the time. Greetings. Tam writing to you because I have leammed over the years that you are very smart, insightful, and deeply concerned about the global HIV pandemic. I need your help. I'm trying to understand what the hell is going on with the treatment Vv prevention momentum now unfolding. Two enormously significant dates are approaching, which will merit huge media attention paid to AIDS: the 20th Anniversary of the original MMWR "gay plague" report, and the June special session of the UN on HIV. As we near those dates, literally thousands of people -- all, as far as I can tell, well intended --- are argueing over how best to direct energies and as yet uncommitted billions of dollars for themajority of the HIV+ people of the world, namely, those too poor to currently afford HAART. Ihave received many Emails and phone calls, heard heated debates, and watched tensions rise dramatically in recent weeks. Many of you are deeply upset. Some of you have grasped onto the treatment access issue for Africa as fervently as you once protested the Vietnam War, or fought the Reagan administration for AIDS research funds and human rights. As the observer --- the journalist --- I find the rancor distressing, but genuine. I hear various sides claiming that others have ulterior motives, are poor scientists, etc. But I don't think these charges are accurate or fair. My sense is that all sides in these squabbles --- even many people working inside the drug industry --- want to do the right thing. You just don't seem to agree about what, exactly, the right thing is. Today I got a particular angst-wrought message from Gregg Gonsavles, a long time American HIV activist who has, of late, focused his considerable energies on the global treatment access question. I wrote back to him, at length, and then realized that the questions I was raising actually ought to be sent to you, as well. If you have a few moments, please take a look below. Do you have answers for my questions? Feelings about these issues? I welcome responses......Hey, I'm a reporter: I ask questions and hope to get thoughtful answers. Thanks very very much for your time and thoughtful attention. Laurie Garrett lgarrett@newsday.com *************************************************************** Gregg, Did you see Newsday's editorial two days ago? Total support for your position regarding treatment access. Last night I was in a screaming match with a doc who does work in South Africa. An American. He actually said, "I don't give a fuck about microbicides! I don't give a fuck about prevention! Fuck all you public health assholes! This is about what is morally right --- treating. Fuck everything else! Bitch!" Unbelievable. It is absolutely amazing to me that the classic Public Health v Organized Medicine dichotomy has so deeply divided the AIDS community all of a sudden. Correction: the do-gooder community of Westerners. I haven't heard many African voices chiming in on this one. Why the hell is there any dichotomy? Haven't we learned anything from all the mistakes made with TB, drug resistant bacteria, vaccine campaigns......? Jesus! I have never seen a moment so desperately in need of leadership. Somebody needs ---- IMMEDIATELY --- to call an emergency scientific meeting, with a very very focused agenda, super-fast. We need: - Assessment of the validity of the Harvard model. And of other HAART treatment models. With emphasis on AFRICAN reactions and desires to said model (and not just five African academics who have been collaborating with Americans or Europeans for years. REAL people, who toil in thankless jobs in horrible clinics all over the continent.) - Assessment of the questionable validity of a few assumptions in that report, including: - HAART is a public health measure because is lowers transmissability (oh really? ALL studies of the matter at the Human Retrovirus meeting showed that there was no clear correlation between blood viral load and semen or vaginal viral loads. Do we really know this is true? We have ONE study --- The Rakai survey. That's it.) - HAART will, to quote Sachs, "save millions of lives". Really? But we now have 3 studies on large patient pops. showing the life expectancy benefit of HAART in USA and Europe is perhaps as little, on average, as 1.5 years, no more than 5 years. That's not even a "saved life" in cancer terms, as in "5 year survival rates". When grim data came out a year ago critics charged that the high failure rates were due to large populations of Americans who were getting diagnosed and treated in late stage HIV infection. Well, now we have changed the treatment reccommendations to specifically say that later stage treatment is preferable --- so much for that explanation, no? What really, truely, is the statistically valid efficacy of HAART? - In terms of the pentultimate concern that I believe (I hope) is the bottom line for all sides --- SAVING LIVES --- what would be the impact of a massive spending commitment aimed at: - cleaning up the blood supply (less than 10% of which globally, according to WHO, is currently screened for Hep B, C and HIV) - global large scale distribution of autodestruct nonreuseable syringes and MANDATORY coupling of all injectable drug and vaccine products with such syringes. In other words, if a vial of measles vaccine contains 10 child doses, if should be vaccum sealed to a slab of cardboard on which are 10 autodestruct syringes. Talk about immorality! How in the world can ANY humanitarian, medical or UN agency POSSIBLY justify distributing vaccines in countries with greater than 5% HIV rates without attaching enough autodestruct syringes to ensure that EVERY SINGLE CHILD receives a sterile injection? I have seen this with my own eyes ---nobody can BS this one. I have been in African villages where 20 kids were vaccinated with the same "single use" plastic syringe. And I have been in Ukarianian hospitals where syrgines were passed from child to child like candy. Consider these points: - Russia estimates that by 2006 12% of her population will be HIV+, and nearly all the infected will be under 29 years of age, IVDUs. It's not a sexual epidemic --- YET --- in Eastern Europe and ex-USSR. The opportunity to stop that part of the pandemic COLD is there. It's easy. It's mass access to autodestruct syringes. And it's this question: which societal concern should guide HIV policy --- hatred of narcontics users, or fear of the virus? Am I wrong about this? - CDC just released a report indicating there were 19 BILLION (yup) medical injections last year globally, some 90% of which were unnescessary. And 80% in Asia were nonsterile, 75% in SS Africa and 70% in ex-USSR. PHYSICIAN DO NO HARM: why the hell hasn't anybody asked what %age of this pandemic is nosocomial, iatragenic????? - creating a prize --- say, $10 million --- as incentive to the first scientific team that develops a truely safe and effective vaginal microbicide that can be affordably mass produced. (Total global current microbicide R&D is now less than $50 million, as far as I can tell.) Would that work? Just how large an intellectual problem is anti-HIV microbicides? Isn't it a helluva lot easier than coming up with a 90+% effective preventive vaccine? So, we're working on that vaccine --- FINALLY. Why not a serious commitment to the microbicides, too? (Is it the word "vaginal"?) - linking treatment tightly with prevention education, in a quid pro quo manner (tax payers are subsidizing your HAART, and you are free to live without prejudice or discrimination, stay healthy and continue to have a rich, full life. BUT, you must in return understand you have a social responsibility, and cannot knowingly do anything that might spread your virus to others. This includes females, who, you African males disdain and consider subhuman. This includes male & female prostitutes who you pay to accept risk.) I know of no rigorous case controlled study done anywhere in the world that asks whether or not this will work. Have I missed them? But clearly, in the USA and Europe, a very significant %age of HAART recipients feel NO social obligation ---- why else would we have resurgent syphilis, gonorrhea, HIV and a national 14% DRUG RESISTANT HIV rate? What I'm really asking here is whether the fine difference between "treatment" and "cure" can be fully understood, and integrated into behavior, without intense counseling, etc. Obviously we have problems with comprehension here in the richest country in the world, especially among college educated white middle class males. - reassessing the results of the Levine Report and the seeming tendency for everything at NIH to revert. Would a serious recommittment to addressing long unanswered basic science questions be in order right now? - before we start mass distributing HAART, do we know: - which of the drugs are heat sensitive? What is the half life of a protease inihibitor that is stored under a tin roof in 90% humidity at consistent ambient temperatures above 90 degrees F? Are there Cold Chain issues with any aspects of HAART or OIs treatment? - which of the drugs have interactions with antimalarials? With antiparasitics? With rotgut booze? with other drugs that have undergone chemical change due to storage in above conditions? - what percentage of the target populations have TB, and what %age of deaths in the local HIV pop are due to TB? Do we know everything we need to know to guide co-treatment of TB and HIV with TB-DOTS and HIV_DOTS? - why TB DOTs has largely failed globally, resulting in MDR-TB strains surfacing in 112 nations over the last 6 years (when it was limited to less than 10 countries before then)? Do we really know how much of that failure is due to insufficient monetary support, how much to infrastructural failure and how much to the DOTs model, itself, in varying cultural and political settings? - which HAART combos are least likely to lead to multiple drug resistance, or cross resist- ance and how that compares with the cheap combos proposed by CIPLA and MSF, etc? - what key factors have, for the last decade, prevented distribution of the Essential Drugs lists in most African countries? (Hint: it aint got crap to do with the cost of the drugs, prices set by manufacturers or WHO policies. It has everything to do with corruption, black markets, Russian mob, bad roads, lack of ship off-loading capacity at ports, warehousing in high heat, etc etc.) - WHY AFRICA? OK, I'm asking a rhetorical question here. But if global distribution of HAART makes sense for ssAfrica, why not also for Vietnam? Ukraine? Cambodia? Russia? Estonia? Is it a question of a certain cut-off, such as "societies with greater than 10% HIV+ rates?" Or 5%? Who has the right to make that decision? What are the moral issues here? Do white doctors from America and Europe get to choose which HIV poor populations on earth get to have freebie drugs? Does WHO decide? MSF? YOU?????? (If I were an AIDS doc in Bombay or Kiev right now I would be mighty pissed off....). - If, indeed, Senegal, Uganda, Thailand and Brazil have not only lowered their mass HIV rates, but sustained lowered levels, what worked? (From my observations in Uganda I would say the lowering was transient, and it is now resurging in much of the country. It was not sustained. Senegal never did have a high rate: why? All of west Africa has lower rates....why? Many believe it has little to do with prevention programs or drug access, and everything to do with male/female power balance issues and female access to the cash economy.) Jon Mann for ages had a mantra: if a prevention effort works, why? and why isn't it immediately replicated elsewhere? - Why were all the questions raised in opposition to phase 3 vaccine trials not raised for largescale HAART? Remember when NIAID decided to can Phase 3 vaccine studies? The reasons were not so much about the likelihood the vaccines would work (nobody thought they would), but concerns that people who received the vaccines would then put themselves and their partners at higher risk, based on the assumption that they were at least somewhat protected. That was shouted from the rafters, and continues to be a huge issue. NIH and CDC have spent loads of money trying to figure out how to counsel vaccine volunteers, what to say about safe sex, etc. It has been an ENORMOUS concern in the vaccine arena --- well in advance of actually having a product worth testing. But with HAART? Bupkiss. Nada. Zilcho. This seems a glaring contradiction bordering on mass hypocrisy. 'rip to Uganda zton, DC 7:00 PM LS OK, that's my venting for the day. I try to report the truth. I strive for balance. It's getting harder because everybody is fudging the truth now. Everybody is letting their agendas guide policy ---NOT the science. For the most part, as far as I can tell, the science has never really been done. Please, prove to me that I've merely missed it. Laurie April 15 - 20 - Trip to Uganda TRIP TO UGANDA
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April 15 - 20, 2001 April 15 - Leave Washington, DC April 16 - Arrive Entebbe/Kampala at 7:00 PM April 17 - Spent the day touring medical facilities and making patient rounds at various hospitals and facilities in Kampala. Jack Killen (Director, Division of AIDS, NIAID) was my traveling partner. Started the day off by meeting with Nelson K. Sewankambo (Dean, University of Makerere School of Medicine. Went off to the Mulago Hospital Antenatal Clinic escorted by Professor F. Mmiro, a charming and enthusiastic 50-ish OB-GYN doc and Laura Guay, a pediatrician. This was a most extraordinary experience. I witnessed and interacted with large numbers of Ugandan women who come to the clinic for antenatal care. If they request, they are screened for HIV infection and counseled. Most of them, although they come to the antenatal clinic, deliver at home unless there are complications such as twinning or toxemia. The percentage of HIV-positivity among them used to be >40 percent. Now it is approximately 20 percent. The physical nature of the clinic was that of open rooms connected to outside virandas. The clinic was packed. Many women looked healthy, but several clearly had HIV disease. Since no treatment is available, no one from among the clinic patients gets treated for HIV. If they can pay something, they get treatment for OIs and many get prophylactic Bactrim. Patients who can pay fully will get reasonable care. I had to hold back my tears. Next we went on to the Makerere University (MU)-Johns Hopkins University (JHU) Project that is heavily funded by NIAID. We were shown around by Laura Guay and Phillip Musoke Mudido, a Ugandan physician. Laura is extraordinary. She is an American woman who has been in Uganda for 13 years. She is single and has adopted (or at least supports) a few Ugandan children who are AIDS orphans. They showed me around their clinical research projects. Next went to the U.S. Embassy to meet with Ambassador Martin Brennan, a 40ish man who appeared extremely interested and knowledgeable about HIV in Uganda. I discussed with him the NIAID initiatives as well as my recent interactions with Secretary Thompson, the State Department, NSC, Domestic Policy Council, and the White House concerning the development and implementation of a White House and US Government policy and plan of action for treatment of HIV in Africa and AIDS care in Africa. At the meeting was Ms. Dawn Liberi, USAID Chief for Uganda and Jonathan Mermin, a CDC person assigned to the US Embassy. Excellent meeting. Extraordinary security related to the terrorist attack on the Nairobi Embassy last year. We could not even take cell phones into the ambassador's office. Next went on to the Joint Clinical Research Center (JCRC) escorted by Peter Mugenyi and Cissy Kityo. Like Nelson Sewankambo, Peter is clearly an important physician in Uganda and the JCRC does much clinical research on HIV/AIDS. It was unclear how patients get put on a protocol and are followed at JCRC versus getting admitted as a regular patient to Mulago Hospital. The JCRC is the source of many of the important clinical studies that have come out of Kampala. I was impressed by the sophisication of their operation. Many Africans and some expatriots (mostly Americans) work here and also at other facilities that I visited including the Rakai Project (see below). Most Staff (PH.Ds, MDs, MPHs and even technicians have spent some time learning techniques and theory in the USA. Next went on to make Ward Rounds in the Department of Medicine at Mulago Hospital with Roy Mugerwa and Harriet Mayanja. This was clearly one of the defining moments of the trip for me and changed the way I think about the reality and potential of AIDS care and health care in general in Uganda and Africa since Uganda is considered one of the best. The wards were packed; people were lying in hallways, in open air virandas, and some were waiting with their families to gain admission. Most looked extremely ill and cachectic. Others were reasonable fit, but obviously acutely ill. I have rounded on thousands of patients over the years, but I have never seen anything like this except maybe when I made rounds at the King Edward Hospital at the University of Natal in Durban, South Africa in July, 2000. The difference here is that virtually no one gets treated specifically for their disease because of lack of anti-retrovirals and inability to pay even for drugs for OIs, TB and malaria. The rule (with few exceptions is that if the patients cannot pay something (even a dollar or 2), then they get no specific treatment. If they can pay, but are poor, they do "cost sharing" whereby they pay for part of what is to be done (i.e. chest x-ray, medications, etc.); however, it is severely limited by the amount which they cost share. If you are relatively wealthy and can pay, you go to a different ward and anything is possible diagnostically (chest x-ray, CT, blood work) and therapeutically (ARV, OI treatment, etc.). I saw patient after patient with HIV disease (mostly diagnosed not by serology since ELISA was too expensive - $4.00) and OIs. Overwhelmingly, patients had active TB. Here again, diagnosis was made clinically without chest x-ray and frequently without sputum smear and culture. Certainly, no CTs, bronchoscopies etc. I remember specifically a 17 year girl who had HIV disease (diagnosed by wasting and oral thrush) and likely cryptococcal meningitis (dx made clinically); they were considering doing an India ink stain on CSF, but decided not to since they could not do anything for her anyway since she could not afford amphotericin or fluconazole. The plan for the patient was hydration, analgesia and discharge home to her mother. It was tragic! Again, I could barely hold back tears. A similar case was that of a man in his 30s with obvious HIV disease and likely disseminated TB. Again, no specific therapy. It hit me like a truck! We were here in Uganda talking about the possibility of AIDS care now that drugs would likely be available at markedly reduced prices for Africa (see other discussion regarding tidal wave of movement to provide drugs). The problem that was clear to me was that even in the Mulago Hospital, which is one of the best in Africa there was not even basic health care! Imagine (see below) in the rural areas where there are hardly any doctors. In addition, what kind of training were the house staff getting when they could not definitively diagnose and certainly only rarely treat anyone? It became clear to me that we must use the enthusiasm about providing AIDS drugs to Africans to catalyze an effort to address fundamental health care in Africa. Even in the best of places (Uganda), there is hardly any health care infrastructure. April 18 - Visit to Rakai. Went with Jack Killen (who was with me throughout the entire trip). Leading the trip was Nelson Sewankambo, David Serwadda, T Lutalo, and F. Wabwire. This was one of the highlights of the trip. NIAID funds, in collaboration with Makerere University, Columbia University, and Johns Hopkins, a project in the Rakai district of Uganda (southwest of Kampala towards the border with Tanzania and Rwanda). The project has been going on for about 13 years and has been the source of many major papers including most of Tom Quinn's work on the role of STDs in HIV transmission, the relationship between viral load and transmission in discordant couples, and the protective effect of circumcision on transmission of HIV, among other studies. The site was inspiring, particularly the dedication of the staff who were mostly young Ugandan MDs, PH.Ds, technicians, nurses, etc. Also included among them were a few dedicated American expatriots who were either permanent or doing a fellowship (usually out of Hopkins). Of note, were Noah Kiwanuka, a Ugandan, born in Rakai, who went to medical school in Kampala and received his MPH from Hopkins. He was as good as they get and clearly was in command of the project. Also of note was Mary Meehan, an American wife, mother of 3, and a scientist who had been living with her journalist husband in Uganda and working at both the Uganda Virus Institute in Entebbe and the Rakai project. Of particular note on the trip was the level of available care in this district, which made Mulago look modern. I visited the Kalisizo hospital as well as a "subdistrict" antinatal and general medical clinic. There was almost no physical access. The best of the roads were almost impassable. There were large ruts and gigantic potholes in the unpaved road. Even with a four-wheel drive van, we barely made it since it was the rainy season and segments of the road were partially washed away. I will never forget the patients that I saw at Kalisizo and the rural clinic. There were benches full of patients waiting to be registered and hallways full of people waiting to be seen. Some patients were tended to by their families and were lying on the walkways and hallways or on the lawn without a bed. The pediatric ward had 2 children per bed. I was told that among their other diseases such as HIV and TB, the majority of the people in the wards, especially the children, had malaria. I say several children being transfused for malariainduced anemia. Now in 2001, the blood supply is well-screened. I can only imagine how many children got HIV-infected years ago before blood screening by these transfusions given for malaria. The faces of the patients were haunting. They were very quiet; no one made a sound, even the most ill. The Kalisizo hospital was staffed by 3 MDs whose training was medical school and 1 to 2 years of house staff training. These people did everything that did not absolutely require secondary and tertiary care. They performed deliveries, Caesarean sections, abdominal surgery (including bowel resection and anastomosis), fractures and other trauma as well as some types of chest surgery. With all due respect to their dedication, I thought at the time and still do now that despite the fact that on-the spot training is critical, these people could not be highly skilled surgeons since the only formal training that they had before they came to this place was a course in "surgical techniques" in medical school. This involved resecting bowels of sheep and other animals. There was no senior attending here supervising them. An important point about the visit was the extraordinary sophistication and dedication of the staff of the Rakai Project. They were amazingly organized in their system of following patients on study. They had a large number of counselors and field workers who went out into the field and tracked and counseled their patients. They went out by truck, motorcycle or on foot. They were mostly young Ugandans who were clearly dedicated. The success of the projects clearly depended on them. April 19 - The meeting entitled "AIDS Care in Africa" started today and I gave a brief opening address that I had carefully prepared with a written statement and slides that I had asked Greg Folkers to immediately post on the NIAID Website after the talk (please see copy of speech). Given the tidal wave of enthusiasm of getting antiretroviral drugs to Africans, there was in the global community immediately prior to this meeting a major dichotomy between those who were concerned that providing treatment would suck off resources from prevention and other activities and those who felt that we should proceed vigorously towards treating African with anti-retrovirals now that the prices of drugs were markedly decreased. It was clear to me from my reflections before the meeting (see my speech) and from my 2 days of observing first-hand the situation in Kampala that there needed to be a balance between treating Africans and accelerating the prevention measures. Also, and extremely important was the fact that as mentioned above, there was hardly any health care infrastructure in Uganda (which was better than most African countries). I stressed that we must act in a comprehensive manner by building sustainable health care and research infrastructure and by also considering other basic health care issues such as clean water; treatment and prophylaxis for malaria, TB; vaccinations against childhood diseases; treatment of diarrheal and acute respiratory diseases. My remarks were extremely well received and clearly the meeting organizers and participants were pleased that I was there and were looking to me for sober leadership in this difficult problem. An interesting event transpired at the morning session. Ugandan President Museveni was scheduled to speak immediately before my talk. He was late and so I gave my talk and chaired the session for about 1 1⁄2 hours. Just at the end of the question period, the President walked into the Ballroom of the Sheraton Hotel where the meeting was held. He was accompanied by his Chief Deputy Dr. Ruhakana Rugunda. Everyone including myself left the stage to make way for the President. I took a seat in the first row of the audience. Just then, Dr. Rugunda stepped down from the stage, grabbed my arm and led me to the stage saying that the President very much wanted me to sit down next to him during his speech. I was told that the President has long been an admirer of me and respected all that I had done for AIDS. The President greeted me with a handshake and began his speech by recognizing me to the audience. After his speech, Dr. Rugunda asked me to say some words. I extemporaneously spoke into the microphone directly to the President and told him that he was a model of African leadership and that he was highly respected in the USA and throughout the world for his sensitivity, insight and leadership in the fight against AIDS, and that we often refer to the "Uganda Model". I told him that when I returned to the USA part of my responsibility was to report back to my Minister of Health, Secretary of DHHS, Gov. Tommy Thompson and the staff of the White House. I said that I would tell them that what we have heard about President Museveni was true and that you were indeed an inspired leader and that we look forward to continuing to work with him. He was obviously very pleased with my remarks and gave me a hearty handshake and a very warm smile. At dinner that night, The Rockefeller Foundation hosted a working dinner for several of the participants to discuss the meeting. I was asked to serve as rappateur for my table and we had lively discussions about where we go next in this process.
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April 20, 2001 - Last day of meeting and my day of departure. Discussions continued and we all realized how difficult it would be to accomplish this lofty goal of providing antiretroviral therapy for Africans. There was good news during the meeting that the consortium of drug companies had withdrawn their ill-advised lawsuit against South Africa for trying to distribute drugs outside of patent restrictions. Now the South African government (which has been extremely problematic at best with President Mabeki showing bizarre behavior regarding whether HIV causes AIDS) would have to move to start treating their people since the drug companies could no longer be considered the obstacles. Lincoln Chen of the Rockefeller Foundation gave a very nice summary of the meeting as the last speaker and used many of my direct quotes from my talk and my discussions to make important points. One in particular was my warning to beware of the "ethical police" who would only want us to do studies in Africa that would be acceptable and relevant in the USA. This centers around the issue of the Declaration of Helsinki which states that the control arm of any trial in a developed country (or anywhere) would have to be the best possible therapy for the disorder. By "best possible therapy", they mean best anywhere. This would make research to answer questions that are relevant to Africa virtually impossible. We all agree that high ethical standards are necessary; but to demand the best therapy anywhere as the control arm in a nation where there is virtually no health care and which would not be relevant to Africa is unrealistic. Everyone in the audience agreed and gave me a long applause. After the meeting, we drove to the Uganda Virus Institute in Entebbe on the way to the airport to visit Dr. Sylester Sempala, a well known Ugandan virologist whom I had met previously at a meeting in Naples, and Mary Meehan. It was a nice facility (by African standards) and the view was magnificent. It was perched overlooking the shores of Lake Victoria. This was an extremely important trip for me in that it gave me a first-hand appreciation of the dire situation in Africa, not only with regard to HIV/AIDS, but also with regard to heath care in Africa in general. I believe that this trip will change me dramatically towards a direction that I have already been heading for the past couple of years. This direction is towards a greater effort and interest on my part in global health.
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April 24, 2001 - Spent 30 minutes on the phone with Secretary Tommy Thompson briefing him on my trip to Uganda. Thompson is getting ready to brief the Cabinet and convince them that the USA should take a leadership role in the AIDS in Africa initiative. He mentioned that he will rely very heavily on me to help him accomplish this important goal.
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May 5, 2001 - Important conference call with DHHS. On call was Art Lawrence (Acting ASH), Eric Goosby, Helene Gayle, ASH-Designate Claude Allen, Jeff Copeland, Terrell Halaska, Bill Steiger. We (Me, Jeff Copeland, Terrell Halaska, Bill Steiger) had been working for weeks on putting together a position paper for Secretary Thompson on the response to the challenge of AIDS in Africa. UN Secretary General Kofi Annan will come out with a proposal for a Global Trust Fund for AIDS in Africa in June at a Special Session of the UN General Assembly. The White House used our White paper as background to get out front on the issue and announce that the USA would contribute to the Global Trust Fund. We were told on the call that the Cabinet Council met with Pres. Bush. The Cabinet Council consisted of Secr. Thompson, Secretary Colin Powell, Carl Rove, OMB Director Mitch Daniels, Domestic Policy Council Margaret La Montagne, Pres. Counsel Rodriguez and members of VP Cheney's office. The decision was made for Pres. Bush to announce on May 9, 2001 that the USA would contribute in FY 2002 $200 million to the Trust Fund. However, of great relevance to me and NIH, there would be no new money. It would all be budgetary offsets. Of the $200 million, HHS would give $100 million, Dept. of State would give $60 million and $40 million would come from the existing AIDS trust fund. Of the $100 million from HHS $95 million would come from NIH as a transfer. $65 million would come from B & F, $25 million from NIAID, $5 million from NIH OD and $5 million from cyber security. Of considerable note is that Bill Steiger mentioned on the call that he was very "grateful for the generosity of Tony Fauci who has offered to provide the $25 million from his FY 2002 appropriation. Since NIAID will get a 14.2% increase, when you subtract the $25 million, this means we would still get a $260 million increase in our >$2 billion budget. It would not be taken out of the base, but would be a one time transfer.". The fact is that I had offered to help a few weeks earlier in my conversation with Terrell Halsaka. By "help" I was not referring to the Trust fund; I was referring to putting more research money into the AIDS effort in Africa. There was no way that I offered $25 million for the trust fund. However, I did not object over the phone since it was obviously a done deal and the President was going to announce it. It would look very bad if I objected. There was nothing that I could do but turn this "challenge" into an "opportunity". In the end, it really is the right thing to do since it shows leadership in an important cause and our base was not impacted. I will probably take some heat from our constituencies. However, who can cogently argue against my doing something for dying Africa babies? At the end of the day, I am not unhappy at the outcome since we need to get the ball rolling on the African AIDS issue and Tommy Thompson and J are leading the way.
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May 10, 2001 -- Met with Ambassador-Designate to the UN John Negroponte at the State Department. Also at the meeting was his aide Joe Marty. Secretary Thompson had suggested to him that I brief him on the international AIDS crises in preparation for his assuming the position as US Ambassador to the UN. It was a good meeting and John recalled with pleasure that I had briefed him on AIDS in 1985 (more than 15 years ago). I mentioned to him that the situation in Africa is much more of a health care infrastructure/nation building problem than it is a scientific problem. We renewed friendship and promised to work closely together.
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May 11, 2001 -- HVIN in Crystal city in the AM of Friday 5/11/01; but then went to Atlanta on Sunday to deliver Commencement Address at Emory Medical School. I know.... I am nuts!
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May 18, 2001 -- Had important meeting with Adel Mahmoud in my Conference room regarding future collaborations with Merck on an HIV Vaccine. Present -- Jack Killen, John La Montagne, Peggy Johnston, Gary Nabel. Meeting triggered by my concern that Merck was leading Gary Nabel on regarding collaborations with NIH (in the form of Emilio Emini), but really did not want to collaborate for obvious and understandable reasons. Ed Scolnick and I spoke by phone and decided that we needed to get Adel M. involved. My feeling is that although the parties are friends (me, Adel Mahmoud, Ed Scolnick), Merck does not feel that it is in their best interest to get seriously involved in a collaboration with the US government (i.e. NIH) for the obvious reason that they want control given they have invested so much and are aimed directly at approval of product. I believe that they are acting like they want to collaborate for public relations purposes. I actually do not blame them since I would probably do the same thing if I were in private industry.
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May 21, 2001 -- Had dinner at home of William Haseltine (CEO of Human Genome Sciences). Bill is an old and good friend who frequently includes me in social events. The event was the meeting of the Board of Trustees of the Brookings Institution. Bill is a Board member. It was a politically star-studded gust list including most of the Trustees. Present were James Johnson (Chair), Larry Summers (former Secr. of Treasury and recently appointed President of Harvard), Dennis Ross (Middle East peace negotiator who gave a great after dinner talk on Middle East conflict), Joan Spero (DDCF), Donna Shalala, Leonard Shaeffer. Michael Armacost (President of The Brookings), Lee Hamilton (former Congressman and President of the Woodrow Wilson Institute), Zoe Baird, etc. etc. Excellent conversation at dinner regarding a wide range of world and. domestic topics.
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May 24, 2001 -- Went with Christine to the Sons of Italy dinner at the National Building Museum. Met and had warm conversations with old friends Sam Donaldson (MC for the event), Tony Lo Bianco, Connie Stevens, John Podesta, etc. Seated at my table was Connie and Tony Morella, and Geraldine Ferraro.
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May 25, 2001 -- Briefed the Staff of Sen. Thomas Daschle on global health down at the Senator's office. Main person was Dennis McDonough. It was coincidental that Sen. Jim Jeffords had just turned from Republican to Independent and will vote with the Democrats and so Daschle will be the new Senate Majority Leader. Big excitement about this in Washington.
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June 24-25, 2001 -- Attended the United Nations General Assembly Special Session (UNGASS) on HIV/AIDS in NYC as part of the U.S. Delegation headed by Secretary of State Colin Powell and Secretary of DHHS Tommy Thompson. This was an historic event in which Heads of State, Ambassadors, and Ministers of Health gathered and pledged a new attitude towards the catastrophic epidemic. A Declaration was agreed. upon (with some objections from Moslem countries to the use of words such as sexworkers, homosexuality, etc.). A United National Global Trust Fund was agreed upon. As mentioned above, US contributed $200 million to the fund. Other countries are following such as UK with $200 million over 5 years, France with $120 over 5 years. There is some concern as to how the fund would be managed and administered. Kofi Annan gave a magnificent speech. Colin Powell also was superb; much of material from his speech reflected material that I had put together for the joint meeting in the White House (see above) in preparation for the "fund". I spent much time with Secretary Thompson negotiating with the French Minister of Health Bernard Kouchner and Brazilian Minister of Health Jose Serra. We discussed the establishment of Hospitals for AIDS in Africa with the French and the patent situation re: US made drugs used in Brazil.
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July 20, 2001 -- Meeting at the White House. Was asked and went to White House to present an "AIDS Update" to the Cabinet Task Force on HIV/AIDS that is chaired by Secretaries Tommy Thompson and Colin Powell. Present was Secretary of Education and Deputy Secretaries of Treasury, OMB, etc. I was very well received and Powell asked many questions.
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July 25, 2001 -- Met with former Speaker of the House Newt Gingrich. He is interested in diabetes and brought people from the American Diabetes Association with him. He had previously helped in getting us (NIAID) an additional $40 million dollars a couple of years ago for autoimmune diseases and wanted to know how he might continue to help us in our work on the immunological nature of Type 1 diabetes. He also wanted and got a general briefing on what NIAID is doing in diabetes research from me and Dan Rotrosen (Director, DAIT, NIAID).
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August 2, 2001 - Had meeting at NIH (Building 31, 7A-24 Conference room called by Richard Falkenrath of the National Security Council who is Ambassador to the Biological Weapons Convention. Present at the meeting were: John La Montagne, Thomas Monath (Acambis Co.- Vice Pres. For Research and Med. Affairs), Stuart Nightingale (DHHS), Robert Mikulak (Director, Office of Chemical & Biological Weapons Convention, Dept. of State), Carole Heilman (DMID/NIAID), George Poste, Matthew Meselson (Harvard), Margaret Hamburg, Joshua Lederberg. Purpose of meeting was to review a White Paper that had been put together as an internal document for President Bush. The President had just rejected signing the renewal of the Biological Weapons Convention (BWC) on the basis that it was unenforceable. Falkenrath was tasked with putting together a briefing document that was an expression of our interest in the problem, but was an alternative approach to the BWC. We crafted something that was a "high road" approach indicating that since we cannot enforce restrictions among committed users and abusers, then at least we can support biomedical research to provide better diagnostics, therapeutics and vaccines. At worst, even if it does not help with bioterrorism, it would be useful for mankind.
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August 9, 2001 - After much deliberation and soul searching, President Bush decided and announced that Federal funding would be allowed for research on embryo-derived stem cells. However, funding would be restricted to work on embryonic stem cell lines that had either already been established or were in the process of being established (i.e. the stem cells had already been removed from the embryo as of August 9, 2001). NIH (mostly in the form of Lana Skirboll) had canvassed the world and found that 60 such lines were in existence, many in the private sector. The lines were growing robustly and were established according to the 4 points that President Bush mentioned in his speech, i.e. they had to be in vitro fertilized embryos that fulfilled the following criteria: 1) informed consent; 2) in excess of clinical need; 3) not done as a result of financial inducement; 4) embryos not established for the purpose of research. The public response was that the far right felt that the President had betrayed his pledge not to fund research on embryonic stem cells. Several scientists felt that he had not gone far enough since he restricted granting of Federal funds for further (after August 9) use of embryos to derive stem cells. I felt that Bush went as far as he could go politically since on the one hand, if he disallowed any work on embryonic stem cells, the far right would have been happy, but it would not be a sustainable position for the general public. On the other hand, if he allowed the unrestricted use of embryos that had been established for in vitro fertilization (even though this was what I hoped he would do), the conservatives would have damaged him politically. In other words, I believe that he went as far as he could go.
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August 10, 2001 - Secretary Tommy Thompson came to NIH to hold a press conference to discuss the embryonic stem cell decision. He requested that I be with him on stage along with Claude Lenfant, Lana Skirboll, Ruth Kirschstein, and Audrey Penn (acting Director of NINDS). When he asked me to speak, I made a statement thanking him for his leadership (since he favored allowing funding all along) and also thanked the President for his courage in making a difficult choice, but one that will allow us to go 1 told him exactly NIH. forward and do some good for mankind. I also pointed out the important fact that now we can do head-to-head comparisons of stem cells derived from embryos versus adults versus fetal tissue. My comments appeared on the front page of the New York Times on August 11 and a clip of my comments was shown on the Lehr Newshour on the evening of August 10. I am sure that some scientists will criticize me for saying that the decision was a positive thing. However, it is clear to me that these types of people are clueless when it comes to the world of Washington, D.C. Furthermore, the far right will also be upset since I favored the use of embryonic stem cells at all. I care even less about what they think of my position. All in all, I believe that this was a good day for biomedical research. Lana Skirboll deserves much create for turning the President around.
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August 12, 2001 - CNN in association with Time Magazine ran a special program on "America's Best in Science and Medicine". I was featured in an 11 minute segment along with 4 other scientists. This was in association with Time Magazine naming me one of 18 scientists as "America's Best in Science and Medicine". This feature appeared in the August 26 edition of Time that reached the newsstands on August 13.
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August 13, 2001 - Bob Wood (Chief of Staff for HHS Secretary Thompson) phoned and said that Secr. Thompson and President Bush have been discussing my turning down of the NIH Director's job and they want me to reconsider and to name my own conditions including maintaining my Directorship of NIAID and virtually anything else I wanted.
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August 14, 2001 - Terrell Halaska (Deputy Chief of Staff to Secr. Thompson) called with almost identical pleas as that of Bob Wood (see above). She mentioned that I am frequently mentioned at the White House and that the President wanted very much for me to be NIH Director. I told Terrell that I did not want to do this and explained to her that my reasons were similar to those 12 years ago when I said no to President Bush (the elder), i.e. I wanted to work fulltime on the AIDS epidemic and on Global Health and Infectious Diseases. She was very understanding and was quite complimentary to me, saying what an honor it was to work with me. Clearly, the phone call went well.
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August 15, 2001 - As I had promised, I called back Bob Wood and told him exactly what I had told Terrell Halaska. Bob also was very understanding.
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August 20, 2001 - Secr. Thompson spends entire day at NIH as part of his week at NIH. I presented to him on Global Health and Vaccine Development at NIH. Also, Gary Nabel and I gave him a tour of the NIAID Vaccine Research Center.
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August 21, 2001 - Attended a meeting at the White House of the Policy Coordinating Committee of the Biological Weapons Conference group. Chaired by Robert Joseph (Special asst. to the President) and Richard Falkenrath (Deputy to Condolezza Rice). Present at meeting was Ambassador Donald Mahley, Special Negotiator at State Department for Chemical/Biological Weapons, as well as representatives from Justice Dept., State, DOD, DHHS (me, John La Montagne, William Steiger), etc. Purpose was to review document that the group put together (White Paper) as a policy that the President will articulate in association with the USA refusing to re-certify the Biological he Weapons Conference. The paper takes a high road approach about how to handle this problem, while recognizing that much of what was contained in previous agreements was unenforcible. John La Montagne and I had contributed to the scientific components of the white paper.
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August 23, 2001 - Secr.Thompson on a visit to NIH again offered me the position as NIH Director and said that the President wanted me and that I could indeed be NIH Director, NIAID Director, and keep my Lab. I told him that I wanted to remain doing what I was doing at full speed and so refused his offer. He was extremely gracious and quite complimentary to me. He said that I was the most outstanding person that he had ever met ....really. He said that he would not ask me again unless I brought it up.
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Sept. 11, 2001 - Day of infamy. I was in New York City at the time of the attack on the World Trade Center. Below is a note that I sent to Andy Saxon (in response to his concern for the safety of me and my family) after returning to Washington, D.C. that explains what happened: Dear Andy: Thanks for the note. I was actually in New York City about 30 blocks from the World Trade Center in a taxi cab getting ready to go to a meeting of the Doris Duke Charitable Foundation at the precise time that the first plane hit. By the time I got to the meeting in mid-town Manhattan and went into the building, I saw on TV the second plane hit. It was the most horrible day of my life. I was not hurt nor was I ever in any danger; however, it is an experience that I will never forget. As you know, my father lives alone in New York, but his apartment is about 70 blocks uptown from the WTC and he is fine. Also, as you know, my girls go to school in Washington, D.C; however, they are reasonably far from the Pentagon. They saw the smoke from their classrooms on the grounds of the National Cathedral and as expected were emotionally traumatized. All DC schools were immediately dismissed and the children went home. However, Jenny, Megan, and Alison (not to mention Chris) were very frightened since they knew that I had just left for New York City that morning. I could not phone to tell them that I was OK since all of the cell phones and fixed phones were jammed. Finally, I got through to them and they were obviously very relieved. I feel very fortunate. I was stranded in NYC for a while, but finally caught a late night train out to DC. Washington is an eerie town right now. Military police are all over downtown, National Airport is closed INDEFINITELY, and F-16 jets are flying in combat formation all day and night over the city. The NIH has concrete barricades at every entrance and if your car does not have an NIH sticker and you do not have an NIH ID, you could be the Pope and you will not get on campus. This is true of all Federal Buildings. As you probably know from the News, the FBI now knows that there are several cells of terrorists still in the USA with plans to execute terrorist attacks, and Washington, D.C. is the prime target. I do not think that things will be the same around here. What a terrible situation for us and the world. Again, thank you for your concern. Best regards, Tony September 17 - 20 , 2001 - I have been called to several top secret meetings over a 4 days period at the White House with the National Security Council (NSC) in a group chaired by Richard Falkenrath (see other notes) to discuss short and long range plans for how to handle a bioterrorism attack, particularly one of smallpox. Also, several meeting in top secret format were held at DHHS in the Humphrey Building. People at the DHHS meetings include Stewart Simonson (Chief of Staff to Claude Allan), Scott Lillibridge, Claude Allan (deputy Secretary), Tom Month of Acambis company that is making smallpox vaccine, D.A. Henderson (Hopkins), Kathy Zoon (FDA), Ann Agnew (Exec Sec. OD/DHHS, John La Montagne (NIAID), James Meegan (NIAID), Bill Raub (DHHS), and others. Check files. At the White House (Chaired by Richard Falkenrath, Deputy to Condi Rice) there was Avis Bohlen (State), J.D. Crouch (Defense), Kenneth Justice )Commerce, Kathy Zoon (FDA), John La Montagne (NIAID), Bill Steiger (DHHS), Don Mahley (State), Michael Chertoff (Justice), General John Parker (Defense), Peter Jahrlin (Defense) and others. Check with John La Montagne and other notes. We discussed and provided 'White Papers" a) to justify our not agreeing to the renewal of the 1992 Bioweapons Convention because it is un enforcible and would also hinder our legitimate scientists workiing on biomedical research on these organisms. b) justification for not destroying the smallpox stores since we need them to do research to counter effects of a smallpox terrorism attack with diagnostics, vaccines, and therapy.c) Short and long range plans for countering an immediate or distant bioterrorism attack.
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September 17, 2001 - While I was at DHHS for the smallpox meetings, Secretary Thompson called me in his office and said that although he had said that he would not ask me again to be NIH Director unless I brought it up, he said that he had to do so now since "...the country needs me, particularly during these stressful times. I want you very much and President Bush wants me very much". Although I had been resisting this for months (and years) (see above), I felt that I could not refuse this call to duty. Thompson said to name my conditions. I wrote them down and deliver them to him the next day on Sept. 18. The conditions were: 1) Dual roles as NIH Director and NIAID Director; 2) Additional staff; 3) Direct access to him; 4) Good faith discussions regarding plans that he has to do administrative restructuring (centralizing) at NIH OD and away from the individual institutes such as budget, human resources, etc. I felt that particularly budget and to a lesser extent HR centralization would not work; 5) $300,000.00 salary ; 6) Continue to do editing with royalties (especially HPIM) and remain on Board of Trustees of the Doris Duke Charitable Foundation. The Secretary agreed on all of these except he decreased the salary number to $295,000.00. I told him that I accept the offer. He will send all of this to the White House to clear that they also accept these conditions. I do not expect anything to happen soon given that we are headed to war and likely additional terrorist attacks.
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September 24, 2001 - Yet another visit to the White House, this time to review the final document on Biological Weapons Convention (BWC) Alternative Concepts. We agreed on the document to be sent forward to Condoleezza White and Colin Powell.(see hard copy files). Attending the meeting were: Robert Joseph (WH), Avis Bohlen (State), J,D, Crouch (DOD), Kenneth Juster (Commerce), Claude Allen (DHHS), Tony Fauci (NIH), Bill Steiger (DHHS), John La Montagne (NIH), Kevin Chilton (Joint Staff), Ken Baker (DOE), Alan Foley (CIA), Don Mohley (State), Michael Chertoff (Justice) September 24 - Oct.10 - Multiple meetings at White House and DHHS regarding response to Bioterrorism. Anthrax cases (3 thus far) identified in Florida. USA on "heightened alert".
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October 8-21, 2001 - Historic, breaking news every day. New York City, Washington, D.C., Florida are targets of mail-related anthrax cases. As of Oct. 21 there have been 9 cases of anthrax - 1 death from inhalation, 2 serious inhalation anthrx and 6 cutaneous anthrax with about 40 documented "exposures:. Check news clips for accuracy. Secretary Thompson appointed me Chair of the Vaccine Technology Team to determine the scientific and technical feasibility of upscaling the production of smallpox vaccine - see Memo of October 17 (Wednesday) from ASF to Claude Alan (Deputy Secretary, DHHS). Within this period of time there has been major inconsistencies regarding the "grade" of the anthrax involved in the above exposures. I have spoken with USAMRIID current and former scientists, particularly Co. Peter Jahrling. He has examined the material from Sen. Daschle's office and finds that it clearly is finely milled and what he would consider "weapon grade". He told me that it was better than any bioweapon of anthrax that the USA has ever made. He believes that it was from Iraq. To my amazement, Gov. Ridge (Penn) was recently appointed to the Cabinet-level post of Director of the Office of Homeland Security and he went on television stating that he was told by scientists (likely CD and/or Army people that this was "garden-variety" anthrax; that is was sensitive to all antibiotics and that it was definitely not weapon grade. I was floored. I called back Peter Jahrling and he said that he looked at under low power and it looked like a clump, which would suggest that is was crude and not weapon grade. However, when he looked under electron microscope he saw pure spores that were finely milled. He hydrated the system and the spores became totally suspended and remained so which is the definition of weaponized. Clearly, someone is intentionally not telling Gov. Ridge the truth or he is masking the truth. The obvious potential reason is that the USA does not want to deal right now with the obvious conclusion that the material came from Iraq. I have been trying to cry the warning. I mentioned this to Terrell Halaska (Deputy Chief of Staff to Tommy Thompson) as well as to Stuart Simonson of OGC/OS/DHHS. I also hinted to Tim Russert, Sen Lieberman and Sen John McCain who were my co-guests on "Meet the Press" on Sunday, Oct. 21, 2001. I believe that there will be hell to pay when the American public realizes that they have not been dealt with in a totally open manner. Lew
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Oct. 8 - 17, 2001 - Thompson asks me to chair a "Vaccine Technology Team" to provide scientific and technical feasibility with pros, cons, and recommendations on how to expand the existing smallpox vaccine stores and develop new, additional stores. See my Oct. 17 memo to Thompson.
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Oct. 10, 2001 - Met at St Regis Hotel in Washington, D.C. with Secretary Thompson; Secretary of State for Health, UK Mr. Alan Milburn; Minister of Health of Canada, Mr. Allan Rock; Secretary of Health of Mexico, Julio Frenk to discuss international collaborations in Public Health related particularly to the response to bioterrorism. Claude Allen and Tommy Thompson appoint me chair of a committee to advice on technical matters related to smallpox vaccine manufacture, testing and application.
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Oct. 21 - 22, 2001 - More cases of inhalation anthrax, most recently in a DC Postal worker who did not touch the Daschle letter, but who was only in the central Post Office Building where the letter was initially sorted. I am convinced that this is very high grade material. I in good conscience cannot refrain from bringing this to the attention of DHHS forcefully. I spoke to Stu Simonson (Oct. 21) and told him that he must tell Secretary Thompson of my concerns. I also mentioned this to Frank Sesno (CNN) who has called me at home because of the concern that there may have been an exposure at CNN since they have contracted a private environmental firm to monitor their offices. They received a tentative positive ID for anthrax in the environment and called me. I told Frank that he must report this to the CDC and gave him the appropriate number. He did so and is now working with the CDC. On Oct. 22 at a CNN morning appearance, I saw Frank Sesno again and he wanted to pursue our conversation. I strongly urged him to explicitly ask Gov. Ridge just from whom he is getting information that this is not weaponized material. I believe that it is of weapons grade given my conversations with Peter Jahrling at USAMRIID. Also, I received a phone call from Sen. Bill Frist who was in NYC. We had both been on the Diane Rehm Show this AM and he called to ask advice on how to get the correct message out. I also implored Sen. Frist to look into the weaponizing situation in the same manner that I did with Frank Sesno. Hopefully this will get straightened out before all credibility is lost. See New York Times article of October 22, 2001 by Judith Miiler and Sheryl Stolberg.
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Oct. 23, 2001 - Major problem in that DC Postal workers are enraged that they were not given CIPRO. They feel that there was not enough care in surveying their Brentwood mail facility. See news accounts around this time. I directly and forcefully told Sec. Thompson that Gov. Ridge had either been mislead or was misleading the American people (which I doubt) regarding the quality of the anthrax spores that had been obtained from the Daschle letter (see above). I strongly suggested to him that he meet with the President and with Gov Ridge to emphasize that we cannot serve the public well with regard to the Public Health if we are not given correct information. Someone at that meeting leaked this to the NY Times and Sheryl Stolberg called me and heard that I had "angrily confronted the FBI for withholding information". I refused to comment; however, off the record I mentioned that the FBI was not in the room at that meeting and that I was trying to get Sec. Thompson to demand the truth.
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Oct. 24, 2001 - Called to emergency meeting at DHHS. Thompson in a very concerned state of mind; asked for my help and counsel. We now have reliable intelligence that the USA will be hit with a major bioterrorism attack within the next several days (from present to Oct. 31). He appointed me in charge of all vaccines. It was clear that the CDC was not responding adequately. I was amazed at the disconnect between that CDC and DHHS and the lack of responsiveness of the CDC to the Secretary. I have lost confidence in their capability of responding to any bioterrorism attack, much less a major one that is being predicted. Thompson wants to move all responsibilities away from CDC and put them in DHHS office with me in charge of vaccines. I encourage him not to dismantle the CDC, but to try and fix it. If Jeff Koplan does not cooperate, then fire him. I will prepare a vaccine report for anthrax similar to the one that I prepared for smallpox (see above).
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Oct. 25, 2001 -- The Miller/Stolberg article appears in the NY Times. I come out looking good. All stories break that the Daschle letter anthrax is of the highest grade and almost certainly was made by and/or stolen from a country and not made in someone's backroom lab.
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Oct. 25-28, 2001 -- More cases of inhalation anthrax (5 in Washington, D.C. among postal workers.). Media frenzy. I appear on every major network show including Meet the Press on Oct. 21 and This Week with Sam Donaldson and Cokie Roberts on Oct. 28. Several newpaper editorials in L.A. Times, NY Times and Washington Post (Charles Krauthammer) calling for me to be put in charge of the Bioterrorism effort and response. Major concern is still the clash of the CDC style of doing things without letting DHHS or anyone else know about it and then having mixed messages get out with the style of Tommy Thompson who reverts to the Governor of Wisconsin mode which is to trust a small group of inner circle people and run things from his office. I have become one of these inner circle people. However, I am very concemed that this clash of styles between the CDC and DHHS is very destructive. I am working with Stewart Simonson (Thompson's confidante) and Mike Osterholm to try to get the CDC and the rest of the DHHS to work in harmony so that we can be effective and so that we do not look like a bunch of disorganized incompetents to the rest of the world. It is very frustrating for me.
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Oct 29, 2001 -- More calls by the Press and others for me to be by Gov. Ridge's side for White House Press briefings. Received call from White House that Ridge wants me at the press conference at WH tomorrow. First case in New Jersey of cutaneous anthrax in woman who had no direct connection with postal service. Possibility of contaminated letter from Hamilton Township post office going to her home or place of employment. The plot is thickening!
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Oct. 30, 2001 -- Give press conference at White House. After conference, met at the office of the Nuclear Threat Initiative with former members of the USA Army bioterrorist team and others. Frank and frightening discussion about the nature of the material (anthrax) that was used in the Daschle letter. For some reason, the CIA and the FBI are not making public (probably for forensic reasons in tracking the perpetrators) the true nature of the threat. In short, this material is of the highest grade even better than our bioterrorist experts have made. They feel that only a highly skilled person could do this. That person could get material in small quantities and do the work here. If the person has large amounts, he would have to have special facilities or would have to have gotten it from a rogue state or covertly from USA . People at the meeting were: Richard Spertzel, ay others; also on sm. No new cases. Stewart Simonson, Michael Osterholm, Margaret Hamburg, C.J. Peters, William Patrick, James LeDuc, Phil Russell, Les Caudell, Co. Edward Eitzen.
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Oct. 31, 2001 - NYC "outlier" women dies of inhalation anthrax. Still no connection with postal cases. Could this be an outlier of the existing paradigm or the sentinel case of an entirely new paradigm? Did major media today with The Today Show with Katie Couric, Grand Rounds at NIH covered by all networks, CBS Evening News, Jim Lehr Newshour, etc.
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Nov. 1, 2001 - Had extraordinary briefing of Democratic Senate Caucus on bioterrorism. Present among others were Sens. Lieberman, Daschle, Boxer, Mikulski, Cleland, Hollings, Wellstone, Jeffords, Biden, Wydan, Levin, etc. In all there were about 30 senators. They were extraordinarily complimentary to me for my public leadership on bioterrorism, calling me an "American hero", a national treasure, etc. I thoroughly briefed them. They felt strongly that I should lead the nation's efforts. I politely suggested that I prefer my present job.
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Nov. 2, 2001 - Important Senate Hearing of the Labor, HHS Subcommittee chaired by Tom Harkin. Also present were Sens. Spector, Byrd, and Stevens. Hearing on smallpox. I was able to communicate to Specter that NIAID was not allowed to put in a request in the $1.6 billion supplement of DHHS for bioterrorism. In other words we needed $153.7 million additional to the PB, but we were not allowed to submit for the supplement by OMB. I "busted" the budget by telling Specter after the Hearing what we needed. He promised to put it into our appropriation.
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Nov. 3, 2001 - There was a spoof on me and Attorney General Aschroft on "Saturday Night Live". No new cases of anthrax. Kathy Nguyen case in NYC still a mystery.
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Nov. 4, 2001 - I appear on "Face the Nation" with Sen. Ted Kennedy and others; also on CSPAN's Washington Journal and CNN Special. No new issues.
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Nov. 5-12, 2001 - relatively quiet re: bioterrorism. No new cases.
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Nov. 9, 2001 - Still no information on why the WH ordered me to recall my Op-Ed. Have e-mailed Gayle Smith (NSS). I will explain situation to her tomorrow and see if she has any insight. Meeting did not occur at 8:30 AM because of scheduling issues. Will try to do a call tomorrow Nov.10, 2011 - Got some insight from Gayle, but am afraid she is not telling me everything. She claims that she heard discussion about my Op-Ed at the WH, but not by WHCOMS. Issue was whether it was a good idea to put it out right after HRC's speech since it already got great PR and so why waste a Fauci Op-ED. Perhaps better to wait until the POTUS does World AIDS Day. This could be true, but who knows? Gayle did say that the OMB people might have been concerned by the couple of words that said we need significant increases in resources, including from other donor countries. This implies needing more USG resources, which would obviously bother OMB. However, I could easily have changed this to say we need significant new resources FROM other donor countries. In any event, Gayle assured me that the Op-Ed was not "off message" in the substance of its content. We will hold onto it for now. Having said this, here is another example of the ridiculous need to control the "message" on the part of this White House. AIDS Conference Back to the Raj Shah intrigue. On Raj's suggestion, Yesterday's scheduled meeting now a phone call among me, Eric, Raj, Tom Frieden. Raj wanted to again bring up the possibility of doing something "big" since he feels that the POTUS will not have another opportunity. After much discussion we explained to Raj again that "Blue Sky", i.e. $2.5 billion will never get by OMB or the Congress and even so, the best way forward according to the models is not to just pick out a few countries and full-court-press. Raj goes along and we think it is over. Apparently, immediately after the call, Raj calls Rick Klausner asking him to convince me to not give in and adopt his plan. Rick calls me on my way to The Inn at Little Washington for my delayed 70th birthday present from Denise from last December. We are in the limo (rented by Denise) and Rick tries to convince me to re-convene the group. He says that Raj feels that I am the only one who could do this. Raj just does not want to give up. However, out of want to go the extra mile, I will call up Eric and Tom.
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Nov. 13, 2001 - Went to an extraordinary dinner at the home of the Saudi Ambassador to the USA (Prince Bandar bin Sultan bin Abdul Aziz) Sat at table with his wife Princess Haifa Al Faisal (Late King Faisal's daughter). Also at the table was CIA Director George Tenet and Sen. Ted Stevens. Dinner in honor of Nelson Mandela. The Princess specifically mentioned me as a very honored guest when she introduced the program. Nov. 13- Dec.1, 2001 - At first no connection with spores in mail However, careful detective work has indicated that this might be a tertiary mail contamination that gave inhalational anthrax, which is not supposed to happen. Letter that passed through Trenton with the Leahy letter got contaminated and went to a post office in CT. may have gotten a letter that was next to the secondary contaminated letter. Check news stories for details. I appeared an Magazine choses in virtually every newspaper and TV with statements. Washingtonian Magazine choses me as one of Washington's "Best and Brightest" - Dec, 2001 issue. Secretary Thompson told me that over the past week and 1⁄2 he has spoken to Pres. Bush about appointing me Director, NIH. Apparently, there is some resistance by Sen. Brownback who is a born-again Christian and right winger. He is pushing Bob Redfield and other strict conservatives. Apparently, he believes that I am too liberal because of my association with gays in the AIDS work and because of my statements about the scientific need for embryonic stem cell research. Thompson re-iterates my conditions for taking the job. Science advisor Jack Marburger is against my doing dual job. On Nov. 27 and 29 I appeared before 2 Senate committees. On Nov. 29, I testified that we needed $200 Million (professional judgment) more than the PB. Jeff Koplan (CDC Director) testified with me that CDC needed an additional $2 Billion for bioterrorism research. We both made big NY Times and Washington Post coverage. My picture in NY Times on Nov. 30. Weekend of Dec. 1 & 2 - Thompson asked me to prepare talking points for him in his visit to the Pres. To argue against reneging on the promise to give NIH $4 Billion in FY2003 to complete the doubling trajectory.
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Dec. 4, 2001 - Probably one of the most significant days for NIH and me regarding the budget of the institution. Word was that the "pass back" for NIH would be $0.5 billion, which would be devastating for NIH (no new initiatives and $275 shortfall on Type 5s). I entered into intensive negiations with Tommy Thompson over a 2-3 hour period in his office during which time he frequently called the White House discussing our negotiations. The bottom line is that Tommy and the President wanted to give the NIH a pass back that I would be able to publicly defend to the constituents, the Press, and the Congress. I laid down some strict conditions of this support. It was $2.0 billion for NIH excluding bioterrorism. I calculated that it would take $1.3 billion to reach current services, $200 million for maintenance of campus (including security). This would leave about $500 for new initiatives. On top of that I needed 1.0 billion for bioterrorism. They wanted to know my opinion of whether the constituents would accept this "almost" meeting the doubling trajectory. I told Tommy to tell the President that I would definitely defend this pass back since it actually was a great deal given the constraints on budget due to the demands of the war and the bioterrorism (BT) defense. I gave him my word that I would support him and the President. Tommy also informed me that a few people in OMB were very pissed off at me because I testified at the 2 Senate Hearings (especially the Specter Appropriations Hearing) that we needed $200 million more in FY2002 for BT. He also re-affirmed that Sen. Brownback was not in favor of my nomination for NIH Director because he felt that I was too liberal and he wanted his candidate who is Bob Redfield, a born-again Christian. Tommy said that the President wanted me , but was getting pressure from the far right. I am perfectly comfortable with this situation. I am what I am. Take me or leave me. I am happy with what I am doing now.
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Dec. 7, 2001 - Negotiated with Ed Sontag (Asst Secr. For Management at DHHS) regarding restructuring and consolidation of the NIH from an administrative standpoint, i.e. Budget, HR, Legislation, Procurement, Public Affairs, Grants Management, IT, etc. I had an agreement with Tommy Thompson that Budget should be sacrosanct and should stay in the ICDs as opposed to consolidating at the level of NIH. Ruth Kirschstein (Acting Director, NIH) almost gave away the farm in the negotiations. I stepped in and took over the meeting for NIH. Ruth was about to agree to give up 850 FTEs. I insisted that we could not cut down by any more than 200. Sontag came down to 275; we agreed upon 250. Also, Sontag was concerned that the new Clinical Research Center was projected to be $142 million over. Ed asked how we were going to handle it and Ruth said that this did not happen on her watch and that it was someone else's fault at NIH and she would see that this person (Steve Ficca) would be held responsible (?fired). She gave no indication how she would handle the real problem except to say that she would take it out of the IRP. I insisted that we would need major flexibility from the Department regarding how we could make up this money and that we could not hurt the IRP so abruptly and severely. Sontag agreed to help. Poor Ruth is in way over her head. I will have to make some difficult decisions if I become NIH Director about keeping her on as Deputy. I may need to appoint another Deputy and have her keep her title, but not her responsibilities.
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Dec. 8, 2001 - Thompson tried to call me at home last night (Friday), but I was out. He called me on Saturday in my office and told me that President Bush has agreed to appoint me NIH Director. Thompson wants me to speak with Sen. Brownback to try and alleviate his concerns about my position on stem cells, embryos, etc. I will set up to meet him next week. Thompson wants to make announcement before Christmas.
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Dec. 12, 2001 - Met with Sen. Brownback and his aide Rob Wassinger. Brownback was concerned about statements that I made 13 years ago! Concerning the then new SCID mouse that could be reconstituted with fetal tissue to regenerate a human immune system in a mouse. I stated at an ACT-UP meeting in NYC that this was a promising area of research and that it would require the use of fetal tissue. At the time there was the beginning of a moratorium by President Reagan and later Bush on the use of fetal tissue for transplantation into humans. I apparently (reported in the press) urged the ACT-UP people to make their concerns known so that this could be taken into consideration by the administration and lawmakers. Brownback and Wassinger said that several "right-tolifers" had called them very concerned that I was being considered for NIH Director when I had been a vocal advocate for the use of fetal tissue. I had a lengthy (1 1⁄2 hour) discussion with Sen. Brownback about embryonic stem cells, fetal tissue, etc. I believe that the conversation went as well as could be expected. He was very cordial, but concerned about "how I would advise the President if I were NIH Director". I told him that I do not advise the President on Ethical or Moral issues since I trust that the President has his own strong moral compass. I mentioned that I am a scientists and that I merely give him accurate scientific facts and he can make up his own mind within the framework of his own values. I think that Brownback respected that answer. We left with his still being concerned about me, but I do not think that he will try to block me.
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Dec. 14, 2001 - Spoke with Rick Klausner about his perception about NIH Director. Rick feels that the WH is not leveling with Thompson since he has heard that they think that doing both jobs (NIH and NIAID) is a "non-starter" and they are against it. There is a disconnect here since Thompson feels that they (WH) will accept this, and he merely needs to get the Brownback issue out of the way. Something is strange here since Thompson is talking about getting the President to announce me before Christmas and Rick says the "rest of the WH" is against this. Stay tuned. Dec.15, 2001 - Sat. meeting at NAS regarding recommendations of giving anthrax vaccine to people who were exposed to anthrax and who are just finishing their 60 course of antibiotics. I, Jeff Koplan, D.A. Henderson, and Kathy Zoon (FDA) playing major role of setting policy and advising the Secretary.
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Dec. 16-19, 2001 - Much controversy and last minute scrambling in getting the consent form and the protocol out for the discretionary use of anthrax vaccine in exposed people who had been receiving antibiotics, but who are coming off their 60 day course. The CDC is really relinquishing their responsibility of doing a good job with the informed consent. They handed us a piece of junk as a draft. Stewart Simonson (Counsel to Secr. Thompson) has asked me to help get it right. I had been working all day and into the night on Dec.16-19 revising the consent forms and helping people get straight why DHHS is offering the vaccine to people. The Press are very suspicious and as usual critical of the Administration. I have exhaustively reviewed the data (with Cliff Lane as a great help) and come to the conclusion that vaccine + antibiotics is no better than antibiotics alone for post-exposure. Yet, Dr. John Eisold (the Navy physician who takes care of Capitol Hill people) is insisting that the Senate staffers also get the vaccine. We are in a dilemma. It is true that there is a "theoretical" reason to make the vaccine available in that animal studies show persistence of spores weeks after antibiotics and there is a fear that after antibiotics are discontinued the disease will occur. I would not take antibiotics. However, Eisold and the Senate Staffers are demanding that they get the anthrax vaccine. In fact, I received a phone call from Ms. Laura Petrou from Senator Daschle's staff on Dec. 19, 2001 enraged that we were taking so long in getting the vaccine to the staffers. Apparently, D.A. Henderson and Tommy Thompson had told Daschle that the vaccine would be available 2 days ago. They were insistent. The blacks in the postal service are quite skeptical. I have insisted that if I am going to help we must not "recommend" the vaccine since the data in animals show that it is not better than antibiotics alone. The difficult situation is that politically we essentially have to give it to the Senate staffers since they are demanding it. If we give it to them and do not offer it to the postal workers, we will be accused of racism and not treating the postal workers equally. Remember that they were outraged that the Senate staffers got antibiotics right away and the postal workers only got antibiotics after 2 people at Brentwood died. Therefore, we are offering, but not recommending the vaccine for any of the 9000 people who were put on 60 antibiotic course. We are not explicitly telling the public that this is really the rationale for what is going on. There is some confusion as to why we are not recommending it and if we are not recommending it, why are we even offering it. I have tried to articulate this to the public as I did on a Dec. 19 appearance on Jim Lehr's News Hour.
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Dec. 19-24, 2001 - As expected, publicity went bad for HHS on the anthrax vaccine story. Washington Post writer Ceci Connelly keeps blasting HHS and particularly Tommy Thompson and the CDC for lack of clear guidelines. The mostly black postal workers for the most part refuse the vaccine, saying that they do not trust the government and do not want to be "guinea pigs". They completely miss the point that no one really is telling them that they should take the vaccine. In contrast, the staffers from Daschle's office have a high % of people who are taking the vaccine.
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Dec. 27, 2001 - Receive a letter from Sen Brownback dated Dec. 19, 2001 in which he states that he is "deeply concerned by your inability to define the entity created after the successful procedure referred to by some as human somatic cell nuclear transfer (SCNT)..." He wants me to respond. I do not want to put anything in writing and so I call his office and ask to speak with the Senator. His unbelievably right wing staffer, Rob Wassinger, answers and says that they will not put the call through to the Senator and that I should answer the questions in writing. Clearly, they are trying to trap me and clearly Wassinger is an asshole.
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Feb. 4, 2002 - An editorial in the Washington Post calls for President Bush to appointment me as the NIH Director.
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Feb. 5, 2002 - Spectacular day! I traveled on Air Force One with President Bush to Pittsburgh to spin his FY2003 budget on Bioterrorism and to visit scientists at Univ. of hould appoint announced Elias Pittsburgh who are working on a novel early warning system for BT. I met the group at Andrews Air Force Base and flew up at 11:00 AM. Did not see the President on the flight up; however, spent considerable time with him in Pittsburgh. The motorcade trip to and from the Pittsburgh airport was exciting. I was in a van about 4 cars behind the President and the motorcade was heavy with Secret Service and Police. The President was extremely complimentary to me during the visit as he spoke to other people about me in front of me. He specifically thanked me for my great work in his speech that was covered by CNN. During the flight back to DC he called me to his state room and spent the entire flight back speaking with me!!! In the room were Gov. Ridge, Secretary Thompson, and D.A. Henderson. Thompson mentioned to me in Pittsburgh that they spent much of the trip going up to Pittsburgh talking about me and the work that I have been doing. Tommy is pushing hard with the President to appoint me.
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Feb. 8, 2002 - Sheryl Stolberg suggests in the New York Times that Bush should appoint me. She mentions that the sticking point is my requirement to do both jobs.
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Feb. 15, 2002 - Laura Meckler wrote a piece for AP on the right wing Family Research Council opposing my nomination for NIH Director based on my philosophy on fetal tissue and stem cells. They refer to my comments in 1988 about the utility of the SCIDhu mouse model.
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Feb. 23, 2002 - Article in New York Times by Sheryl Gay Stolberg telling the story as it happened saying that I am no longer a candidate for NIH Director's job. She states that the White House says that the reason is the objection to the 2 jobs, while the social conservatives say that my views on abortion and stem cells make me unacceptable to them. Also, mentions the Sen. Brownback story. Key article since it is factually correct.
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Mar. 5, 2002 - Secretary Thompson called me today and said that he was very upset, but I will not be asked to be NIH Director. He said that he was being forced by the White House to submit Dr. Elias Zerhouni's name and that he was not happy at all about this. He stated that as far as he was concerned, I was his number one person at the NIH and he was looking forward to working with me in the future.
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Mar. 9, 2002 - Attended Gridiron Club dinner in Washington, D.C. Spent time speaking with President Bush, Karl Rove, Clay Johnson, Donna Shalala, Tim Russert, Sam Donaldson, John Neroponte, Cokie Roberts, etc. The topic was often concern and dismay on the part of people (non-White House) that Bush was not going to offer me the NIH job. Most felt that it really was the litmus test issue and not the 2 jobs issue. Clay Johnson, who I believe is behind all of this, actually volunteered to me that "Dr. Zerhouni is no Tony Fauci, but then again, there really is only 1 Tony Fauci". It is tough for me to figure out just how much the Social Conservative/Sen. Sam Borwnback issue played in Clay Johnson's insistence to the president that I not be NIH Director.
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Mar. 26, 2002 - I went to White House ceremony where Pres. Bush announced Elias Zerhouni as nominee for NIH Director.
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Mar. 27, 2002 - Went to NYC for Press Conference for the announcement of my receiving the Albany Medical Center Prize in Medicine, which is the largest prize in Medicine in America and the second largest in the world to the Nobel Prize. Amount = $500,000.00.
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Mar. 28, 2002 - Big press conference at DHHS for the announcement of the publication in NEJM of the dilution studies for smallpox vaccine. Also, in same issue of NEJM was my editorial calling for an open dialogue as to whether there should be pre-emptive vaccination of "first responders" or even of the enitre population on a voluntary basis. D.A. Henderson is not particularly happy about my editorial since he continually has trouble admitting that a smallpox attack is a danger. Clearly this is related to the fact that he has devoted much of his professional life to trying to eliminate smallpox. Mar. 31 - April 6, 2002 - Went on a terrific trip to Africa with Sec. Thompson and a delegation listed below. We visited Mozambique, South Africa, Botswana, and Cote D'Ivoire. The trip was designated a Presidential Mission and so we received the royal treatment. Flew over on an Air Force jet and were received at each country with Secret Service protection and local military and police escourts via motorcades etc. Visited CDC and NIH funded facilities. Met with President Joaquim Chissano of Mozambique. Long conversation with South African Health Minister Manto Tshabalala-Msimang regarding reluctance of South African government to provide nevirapine to prevent mother to child transmission (MTCT). I disagree with her stance, but respect the difficult situation that she is in. She is driven by a need to decide things for herself since she was one of the original ANC members who were in exile during apartheid and she does not trust anyone but her own people. She, however, told me that President Tabo Mbeki respected me greatly and frequently speaks highly of me, During the Stay in South Africa the Supreme Court of SA ruled that the government must supply nevirapine to pregnant infected mothers and their newborns according to ACTG protocol 012. Met with President Festus Mogae of Botswana. He too had heard about me. Met with Prime Minister of Cote D'Ivoire. Representative people on the trip that I developed good friendships with in addition to Sec. Thompson and his staff of Bill Steiger, Terrell Halaska, Dave Boyer, Corina Gardner, Matt Bluhm and others were: Former Congressmen Ronald Dellums and Ray McGrath, Scott Evertz of the White House, Congresswomen Barbara Lee (D-CA) and EB Johnson (D-TX), Michael Miller of NSC, Anne Peterson of USAID, Bill Roper and others.
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April 25-30, 2002 - During the trip to South Africa, I spent about 1 1⁄2 hours at dinner trying to convince her to help President Mbeki change his stance on treatment of HIVinfected people including pregnant women (see above). Of note, just this week the South African government has made a major change in their stance. They now allow treatment for rape victims and soon will start treating infected pregnant women. It is entirely conceivable that my discussions played some role in this turnaround.
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May 23, 2002 - For the past 2 weeks, Mark Dybul, Terrell Halaska and I have been working on a proposal for prevention of mother-to-child-transmission (MCTC) in developing nations to present to president Bush who wants to use this as an announcement of a major initiative at the G-8 Conference this summer in Ottawa. Terrell asked me to put it together for her and I enlisted Mark Dybul who did a great job with me. I and Terrell had several pre-meetings at the White House Conference Center on Jackson Place during early May and then today Mark, Terrell and I met with Gary Edson and Jay Lefkowitz of the WH. To present our plan to save 146,000 babies from being infected per year for a cost of about $100,000,000 per year. Gary and Jay loved the plan and will present it to the President within a couple of days. It was a great meeting and they were very impressed at how we organized the data and the presentation.
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May 29, 2002 - I briefed President Bush in the Hamilton Room of the West Wing on the MCTC plan. Present were Josh Bolton (Deputy Chief of Staff), Andrew Card (Chief of Staff), Karl Rove, Mr Calio, Gary Edson, Secretary Thompson, Andrew Natsios (USAID), Terrell Halaska, Christen Silverberg, Jay Lefkowitz and others. The President liked very much our plan, which I presented to him succinctly, but completely. The background of the initiative is that Sens. Frist/Kerry are trying to get through a supplemental Bill on adding more money to the Global AIDS Fund. The President is against this since he feels that the Fund has no plan and the money will be wasted. This is the reason that he wants to seize the opportunity of the Congress throwing more money at us to put forth his own initiative on a concrete proposal as opposed to the vagaries of the Fund. He accepted my proposal. Interesting dynamics at the meeting in that Andrew Natsios was upset that this was an HHS proposal and started (quite inappropriately in front of the President) getting into a turf war where he pointed out that he has an MOU with the CDC that with regard to AIDS in Africa, USAID has the lead. The President picked up on this discord and said that the only thing that he knows is that he likes "Tony's plan" and that HHS and USAID should work out (with Gary Edson as referree) how it is going to be implemented. He stated, however, that he wants "a person" to be held accountable for the success or failure of the project. To say the least, Sec. Thompson was angry with Natsios. From my standpoint, the meeting was a great success since our plan was accepted by the President and he was extremely friendly to me.
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June 6, 2002 - I found out at National Airport that President Bush was establishing a Department of Homeland Security (DHS) that would encompass 160,000 employees with a budget of >$30 billion by consolidating all activities related to terrorism, including bioterrorism in one Department. This would mean that $1.748 billion of NIAID money for FY 2003 would go to DHS.
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June 6 - 12, 2002 - Spending a lot of time working with the DHHS and th White House in trying to hash out the details of legislation that would create the DHS. Everyone seems to agree that the research would still be done at NIAID under my direction; however, the money likely will first go to DHS and thenn be passed through or contracted to me to perform the research. Also, the President is planning to announce the MTCT program that I helped to put together in a few days. the
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June 10, 2002 - Had breakfast with Treasury Sec. Paul O'Neill this AM to discuss the entire concept of AIDS in Africa. We related very well and he received my advice, consultation very enthusiastically.
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June 13, 2002 - Received a call from Richard Falkenrath at the White House who said that he had heard that I was concerned about the $1.748 Billion going to Department of Homeland Security (DHS). We wanted to assure me that the money would come directly to me from DHS and the research would be directed by me. He agreed that the research should be incorporated completely into the emerging diseases research agenda of NIAID and not fragmented out. He said that Sen. Kennedy mentioned to the WH that I was concerned and they wanted to alleviate my concerns. Interesting intrigue going on. I just got a call from Sue Hardesty of Sen. Richard Durbin's office who said that the Senator had heard from Bono (of U2 fame) that I was against the global AIDS fund and had convinced President Bush not to support it. The Sen. wanted to know if this were true. In addition, Sue told me that Sen. Frist had said that he changed his mind and decided not to support the Global AIDS Fund because he had heard that I was against it. I believe that if this is true about Frist, then he is covering his ass since he backed down on his promise to support the extra money for the fund. I know that he backed down because Bush told him to. Now he is trying to make it look like I am the one against it. It is interesting that rumors are forming that I am involved in convincing the Pres. that we should not invest in the Fund. I believe that this results from my being involved in putting together the MTCT plan, which some feel that the Pres. actually wants to substitute for the increase in the Fund. Of note, Jeff Sachs called me from Rome last night asking about the same issue. Welcome to Washington!!!
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June 13 - 18, 2002 - Extremely busy with putting the finishing touches on the MTCT proposal that the Pres. is planning to annouce soon. I am trying and succeeding (I believe) in having them do it correctly, i.e. this is not a substitute for the Global Trust Fund, but as a comlement to it. Have been working very hard with Terrell Halaska and Mark Dybul in getting the Pres. speech written and his talking points arranged for the announcement. Simultaneously with this going on, I have been working with Stewart Simonson in trying to get the correct authorization language written for the proposed bill for the new Department of Homeland Security (DHS). The WH wants me to be comfortable with it; however, they seem inflexible in that they clearly want the $1.748 billion of NIH money to go to the new DHS and they want the perogative to set the research agenda. Richard Falkenrath of DHS assures me that despite this, they want me to run the program from NIH.
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June 19, 2002 - Most extraordinary day!! The POTUS requested that I join him and Secs, Thompson, O'Neill, and Powell and Sen. Frist and Andrew Natsios at the Rose Garden Ceremony to announce the MCTC plan that Mark and I essentialy created. I met with the Pres for about 10-15 minutes in the Oval Office before the announcement. He was extremely gracious and complimentary. During the announcement, he specifically thanked me for all that I have done with the project. After the annoucnement, I went with Ari Fleischer and gave a press briefing in the WH press room on the program. Importantly, the Pres. asked Josh Bolten to meet with me and get my feel for the big picture of what the Adminsitration should be doing with AIDS (domestic and global). Present at the meeting were me, Josh, Margaret La Montagne Spellings, Robin Cleveland, Jay Lefkowitz, Gary Edson, Kristen Silverberg, Allen Gilbert. Josh asked whether we should do a Manhattan Project for a vaccine and not invest in international prevention and treatment. He said that I should assume that money was not an issues and I should tell them what is "the right thing to do". I gave details about the importance of building a sustainable (low tech) infrastructure of clinics and trained Africans. This infrastructure could then be used for HIV prevention and ulitmately treatment, but could also be used for approaching malaria, TBC, and other important diseases. I said that the USA needs to be the world leader in making international health a driving force in our foreign policy. If we lead, other countries will follow. Josh seemed genuinely moved and agreed with me. He even stated that it is his feeling that years from now, this Administration will be judged by how it handled the International HIV/AIDS Pandemic. He stated that the Pres. was very sympathetic to me and what he has heard me say on various occasions, but there is a skepticism that money will be wasted if there is no accountability. This is also fed by Paul O'Neill and Mitch Daniels. I said that I agree that we should not do it unless there was strict accountability. We need to have someone to run the program who could "kick ass". Josh and I resonated very well. I believe that the WH will be calling upon me soon to help with such a strategic plan. In fact, I am going to proceed to put one together and present to them pre-emptively. It was a great day!!! I may have accomplished more for global health on this day than on many, many others put together.
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July 7-12, 2002 - XIVth International AIDS conference in Barcelona. - Very important conference. The science was completely overshadowed by the policy, which in turn was dominated by the discussion of the incredible numbers and projections for the developing world. Latest figures are that approximately 40 million additional infections will occur worldwide by 2010 and up to 70 million dealths will occur by 2020 if serious intervention (prevention and therapy) are not implemented. I gave a highly scientific talk and used it to come to the conclusion that we must implement treatment and prevention for the North and the South. Please see records on my speeches for the full text of the talk. It was a Plenary Lecture on July 10. I spent much time with Secretary Thompson and his team (Terrell Halaska, Tony Jewell, Bill Steiger et al). There was an aggressive demonstration against Secretary Thompson during his address on Tuesday, July 9. I was with him and predicted to him exactly what would happen. I had heard from Gregg Gonsalves that ACTUP would demonstrate for awhile and then allow him to speak provided that he would meet with them afterwards. He agreed to meet, but they shouted him down and although (as per my suggestion) he calmly finished his speech, the audience could not hear what he said. This was unlike Secretary Sullivan in San Francisco when the TV and microphones allowed audiences (TV and present ) to at least here what he said. I helped Secretary Thompson with the Press (backstage)immediately after the shout-down. There was an issue that I handled. During the conference 2 days before the demonstration, at a Press Briefing during which I sat next to the President, the Press asked about needle exchange. Tommy G. Thompson (TGT) was not briefed on this issue and I told him briefly that we (Fauci, Jeff Koplan of CDC, David Satcher - Surgeon General, Alan Leschner - Director NIDA and others) had recommended to Donna Shalala upon review of the scientific data that the Clinton Adm. allow Federal funding of needle exchange. However, based on objections of Gen. McAffrie (Drug Czar) and certain Black leaders, Clinton would not allow it. (Of note Clinton was at the AIDS Conference in Barcelona and publicly stated that he regretted that decision and wished that he had allowed needle exchange). In essence, I told TGT that Clinton did not allow it and we (current administration) are not allowing it. This created a bit of a stir in the press since when asked at the press event (backstage) after the demonstration, he seemed confused about the dichotomy between scientific data and policy. I had to come in and explain the issue. I made it very clear that based on the scientific data, I had recommended that Clinton allow exchange. TGT said that he would ask Dr. Fauci to go over the data again, which the Press did not buy since they know the data are absolutely conclusive. It was a little awkward for TGT, but he is going to have to face the issue that the Bush Adminstration will likely do (and is doing) exactly what the Clinton Administration did and follow a policy that contradicts the scientific data. An important event at the meeting was a meeting that I arranged in my hotel (Fira de Palace) among myself, Mark Dybul, Cissy (?last name) and Peter Mugyenyi from Uganda. Peter is the Director of the Joint Clinical Research Center (JCRC) in Kampala. He is successfully treating many Ugandans with antiretroviral therapy (ART). We (Mark and I) want to use his model to try to implement the plan that Josh Bolten asked me about (see above and below). Peter showed us his plan of a main center with regional satelites and subgroups out of the satelites. These are low-tech clinics and each cost about $30,000.00 which is much less that the proposals that we have heard. I was very impressed with this and plan to use this as a model to put together a program to present to the WH (see below) It was a great meeting for me in that I became even closer (if that is possible) to TGT. He implicitly and explicitly trusts me and my opinion. I appeared on the Aaron Brown Show on CNN during the conference and this went extremely well.
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July 14, 2002 - C-SPAN's Washington Journal - I appeared for 45 minutes on the show the morning after returning from the AIDS conference. I had spent July 7-10 at the conference and July 11-12 in Genoa as Chair of the International Scientific Committee that is reviewing the Gaslini Institute for Lorenzo Moretta (its Scientific Director)
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July 16, 2002 - Diane Rehm Show - Spent a terrific 1 hour alone on the show with Diane. I went over the AIDS Conference highlights. I explained about and defended Secretary Thomspon vis-a-vis the demonstration against him. Also, I defended the Administration in that I related that they actually are willing to greatly support international AIDS efforts, but that they require developing nations and others involved to put forth a strategic plan with accountability, endpoints, projected deliverables, etc. I received excellent reviews for the show. I have it on tape as a reference.
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July 17, 2002 - Meeting at the White House with Gary Edson and Jay Lefkowitz. We discussed the details and implementation of the MTCT project. Obviously, there will be difficulties with USAID. They are resentful that DHHS is getting involved in international AIDS issues. Anne Peterson was at today's meeting. I have no confidence that she or her staff are capable of successfully pulling off this program. Mark Dybul alone can do better than their whole group. Sorry for being so direct, but it is true. Of note is that I brought up to Gary Edson and Jay Lefkowitz the issue that I had discussed with Josh Bolten regarding the more Global plan of therapy, prevention for HIV and other diseases in a "low-tech" manner. I discussed my meeting with Peter Mugyenyi and Cissy (?last name) from Uganda (see above). I told Jay and Gary that I believe that we could pull off a program based on the "Mugyenyi model". He told me to put together a proposal in a very short time frame (before the WH leaves for August break ( i.e. <2 weeks). They want to determine if the POTUS could bring this initiative with him on his upcoming trip to Africa in January, 2003. I will work with Mark Dybul to do this.
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July 21, 2002 - Over the past few weeks important issues have evolved regarding Biodefense. There is a major struggle going on in the Congress about the formation of the new Department of Homeland Security (DHS). At issue (among other important issues) is whether the $1.748 billion that is in the President's budget for FY2003 will be transferred over to the new DHS and who will actually be responsible for the strategic plan and prioritization for biodefense. DHS people (Gov. Ridge and Richard Falkenrath) clearly state that they want the money and the responsibility, but that they will work very closely with me. The Congress and all of the scientific Societies (FASEB. ASM. Etc.) say that they want the money and prioritization with me. As usual, I must publicly defend the President's position, but I work behind the scenes with people like Sens. Lieberman, Kennedy, and Frist to get language in the new authorizing Bill that will not transfer the money or responsibility (let us see what actually happens). Meanwhile, VP Dick Cheney is pushing for a Manhattan Project approach to Biodefense. He mentioned this at his visit to CDC and told Julie Gerberding that he would mention this to me also. Of note, I was quite influential in supporting Julie for the CDC job. We have CIA intelligence that Iraq has smallpox and everyone in DHHS and the WH are scrambling to get together an immunization plan that will go well beyond what the ACIP is recommending (i.e. pre-emptively vaccinate only about 10,000 - 20,000 health workers and rely on ring vaccination in the event of an attack). Cheney is pushing for a much wider vaccine plan. TGT will present our plan to Cheney within a few days, which recommends a staged (1,2,3) process that vaccinates about 500,000 health workers from Oct. 02, to December 02 and then from Jan. 03 through the end of 03 vaccinate up to 10 million responders (phsyicians, nurses, police, firefighters, EM people, primary care personnel). After that and depending on the adverse event rate and the perception of threat, we will make vaccine available for the entire USA population on a voluntary basis. One of the reasons for the push by Cheney is that he knows that Iraq has smallpox and he is planning to push out Sadam Hussein either by direct invasion of Iraq or by funding the opposition. He is afraid that Sadam will strike Israel or even us if his back is against the wall. There will be very intense discussions over the next couple of weeks with the WH and DHHS that involve me regarding smallpox vaccine policy. Things are obviously very busy with my being involved simultaneously with Biodefense and International response to HIV/AIDS. Both of these involve my direct interaction with the White House.
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July 22-24, 2002 - Went to the beach (Beach Haven) to link up with family. In the car on the way up and while I was there, I spent considerable time on the phone trying to work out with Sen. Spector's staff (Bettylou Taylor et al) language in the Lieberman Bill on authorization of DHS that Spector could support. They want to make sure that I am comfortable with the language. I am trying to get language that give DHS ultimate lead in the overall prioritization of the research on biodefense, but the money stays in DHHS and the research is executed by NIH, but the development of the research agenda in done by DHHS in consultation with DHS. Finally we had a conference call (I took it in the kitchen of the beach house) among me, the White House (Richard Falkenrath) and the Senate staff that are marking up the bill. Richard and I agreed upon what I listed above. Hopefully, the bill will get through with that language. It was important to have the WH on the phone since I was getting concerned that they might think that I was undermining their efforts to get the DHS going. By hashing it out with them, we are doing it up front and honestly.
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July 25, 2002 - Had top secret conference call with Jerry Hauer (HHS), Phil Russell (HHS), Stewart Simonson (HHS), and Lester Crawford (FDA). Subject - VP Cheney has indicated that we will hit Iraq soon and we expect retaliation with a smallpox attack on us or on Israel. Cheney wants us to greatly accelerate the process of getting vaccine available to vaccinate everyone if necessary. I offered to accelerate studies to determine if we can dilute the Dryvax even more than 1:5 and whether we can also dilute the 77 million doses of Aventis Pasteur WetVax. Stay tuned. The House and the Senate Committees have adapted the language that I had suggested to Richard Falkenrath. Therefore, at this time it appears that the money will go to DHHS, the overall prioritization will rest with DHS, the strategic plan and specific priorities will be the responsibility of DHHS in consultation with DHS and the research will be executed by and through the NIH. If this holds, I will have won a big victory.
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July 26, 2002 - Got an e-mail from Gary Edson at the WH asking if I had completed the Global AIDS Treatment plan to present to him in order to determine if it is worth presenting to the President for him to announce in his upcoming (January) visit to Africa. Mark and I are finished and we set up a meeting at the WH for Wednesday, July 31. Let us see what happens. Had an unusual meeting at the Rayburn Building with Chairman Kolbe (R-AZ) of the House Foreign Relations Committee and his chief staffer Charlie Flichner. I accompanied Claude Allen (Deputy Secretary, DHHS). They are very upset at the White House, particularly Gary Edson, for having the President announce the MTCT initiative without first consulting with them. They made disparaging remarks about Gary ("Emperor Edson", "President Edson"). They were cautious about being disrespectful about the President; however, they were pissed. They also disparaged Tommy Thompson about getting involved in International issues when this is not the purvue of DHHS. Actually, it is becoming the purvue of DHHS with the CDC's GAP (Global AIDS Program). This clearly was a turf issue. They are a powerful Committee and they are pissed that the President made an announcement without consulting them. Wait until they hear about the Global AIDS Treatment package that we are presenting to Gary Edson and Jay Lefkowitz on Wednesday, July 31. I am going to have to relate to Gary the essence of my meeting with Kolbe and Flichner.
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August 1, 2002 - Met at the White House with Gary Edson, Jay Lefkowitz, and Margaret La Montagne Spellings to present the Dybul/Fauci plan for comprehensive treatment and prevention of HIV in African countries. This was in response to the original request by Josh Bolten and then the specific request by Gary Edson to put together a plan based on the "Mugyenyi Model " of Uganda (see July 17 above). Also present at the meeting was Terrell Halaska, Joe O'Neill, Mark Dybul, and Allen Gilbert. Gary, Jay and Margaret was extremely pleased and excited about the plan. They mentioned that we had done a "fabulous" job. They asked us to respond to about 5-6 questions in writing. Clearly they are going to run it by the President when he returns from his August vacation in Crawford, Texas. He may well want to make this a Presidential initiative similar to the MTCT proposal that we had put together for him.
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August 16, 2002 - Went back to White House to present the revised Global AIDS Plan to Gary Edson. Also present were Terrell Halaska, Mark Dybul and Joe O'Neill, Director of Office of National AIDS Policy (ONAP). Gary again liked the revised plan and liked how we answered the questions that he and Margaret Spellings posed to us at the last meeting concerning: a) impact on Domestic AIDS issues; b) development of a sharp sound bite for the State of the Union Address in case it comes to that; c) relationship to Global AIDS Trust Fund; d) Inclusion of Russia, India, and China; e) reason why the Gates/Merck/Harvard/Univ of Penn initiative in Botswana has failed; f) administrative structure of the program. He asked me to revise the document by tightening it up to an Exec Summary, 5 pages of text and a group of tables. He wants us present it to Josh Bolten when Josh gets back from vacation next week. Mark and I can quickly make this revision.
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August 26, 2002 - Meeting at the White House with Gary Edson, Jay Lefkowitz, Margaret Spellings, Ken Thomas (ONAP), Jim Capretta, Robin Cleveland (OMB) and Mark Dybul. We presented the condensed version (see above) to Gary , Margaret, and Jay. Several minutes into the meeting Robin and Jim showed up and in a somewhat offhand manner without evening knowing the details of what we were presenting, Robin became very critical of the idea and the project. She actually parroted words that we had heard weeks ago from the Kolbe Committee (Charlie Flichner) about how they were very skeptical that we could actually get "twin pairs" of hospitals. Also, she questioned whether the Uganda model would work even though she knew virtually nothing about it. I kept my cool, was subliminally sharp in response to her, but was very pissed inside. Gary intervened and defended what we had done and indicated that we would come back to Robin with more details about the Uganda model etc. (which we had already done among us previously). Afterwards, Gary, Ken, Mark and I met for about 45 minutes in The Situation Room and discussed further revising of the documents. I would not be surprised if Robin leaked all of this to USAID and the House Foreign Ops Committee. I did not like the way she acted at the meeting and I do not trust her. She acted a bit disrespectful to us in my mind; however, I believe that this was not her intent and she was reflecting the questions that the House Foreign Ops Committee was asking her. te House today: August 26 - Sept. 5 - Much discussion about pre-emptively attacking Iraq to neutralize them before they use or get capacity for "weapons" of mass desctruction. This is pushing our HHS team to be ready to vaccinate the USA population. Our plan for "staged" smallpox vaccination of immediate first responders to broad first responders to voluntary vaccination of general public is ready to go. We are waiting for word from the White House to roll out the plan.
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Sept. 6, 2002 - Two meetings at the White House today: 1) Meeting in Executive Office Building (EOB_ in OMB's Robin Cleveland's office with Robin, Gary Edson, Joe O'Neill, and Mark Dybul. We presented our reenforced implementation with a beautiful computer model of accessibility to central medical centers (CMCs), primary, secondary and tertiary clinics in Uganda as a prototype. Robin was still not entirely satisfied with the presentation since she was hung up on quarantees that this plan would work given failures in previous endeavors in these countries. She and Gary also wanted to flesh out the computer model on India, Mozambique and Guyana. We will go back and try again. Next meeting likely will be with Josh Bolten. 2) Meeting in EOB with General Bruce Lawlor (deputy to Gov. Ridge of OHS), Col Kadlac (OHS), and Col Gerald Parker of Ft. Detrick for me to present to Lawlor the NIAID plan for research including collaborations with DoD and facilities at Ft. Detrick. I presented the NIAID Strategic Plan and Research Agenda. It was a great meeting. Lawlor was extremely impressed and highly supportive. We promised to work together and he offered to help in any way possible. He is a tough, nice , straight shooter. His background is that he commanded a tank battalion in the Gulf War.
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Sept. 17, 2002 - Another meeting at the White House on the President's AIDS initiative. This time I presented the program to Josh Bolten in his office in the West Wing. Also present were Gary Edson, Jay Lefkowitz, Terrell Halaska, Mark Dybul, Joe O'Neill, Robin Cleveland, Kristen Silverberg, Carol Thompson. We are definitely moving along. Clearly Josh wants to do it. He thoroughly liked my presentation. The problem will be OMB and the question of where we are going to get the money. Issue also is if the President accepts it, when can we announce since the budget for 2002 has not even been settled and 2003 has virtually decided. We want to announce soon since WHO and other organizations are dancing around the question of an implementation strategy and we do not want to President to lose the leadership edge. Josh asked OMB (Robin) to work out a budget scenario and get back to him. They also will elevate it up one more notch to Andy Card, Condolezza Rice and Mitch Daniels. We will meet again soon.
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Sept. 18, 2002 - Briefed Secretary Thompson about the upcoming smallpox vaccination policy and role-out. Also present were Julie Gerberding, Stewart Simonson, Michael Osterholm, Jerry Hauer, Les Crawford, Ann Agnew, Terrell Halaska, etc. We are advancing towards the 3 stage policy that ultimately would allow voluntary vaccination for anyone who wants it. Had briefing at the White House on the fact that West Nile Virus can now be spread via blood transfusions (and transplants). We are in the midst of a major epidemic with about 1641 cases and 80 deaths. It has been clearly documentd now that blood transfusions can transmit WNV. We discussed how we would handle the press, etc. I strongly suggested that we avoid the mistakes of the early 1980s regarding HIV and the blood supply. I suggested that we obviously try to avoid panic, but that we make it clear that transfusions are NOT entirely risk free with regard to WNV as well as several other pathogens. It is a question of relative risk of the transfusion versus not getting the transfusion. INCREDIBLE evening - Bono the lead singer of U-2 and the best selling musician in history had called my office yesterday (his chief-of-staff) to say that he wanted to talk to me by phone or preferably in person to discuss how we could partner and how he could help me in my work on trying to get AIDS treament and care and prevention to subSaharan Africa. He had, this past year, gone to Africa in a much-publicized trip with Treasury Secretary Paul O'Neill. At mid-day we got a call that Bono wanted to fly from Chicago to speak with me in person that evening. He did and we met at my house. We had wine, Chris cooked pasta and we had an amazing evening, talking for hours. He is alsolutely fantastic, passionate and very intelligent. He will try to help by supporting me and President Bush in the evolution of our implementation plan for Africa. Also visiting was his staff Jamie Drummond, Lucy Matthew, and Katrina...... We promised to stay in close touch and work together. I did not tell Jenny, Megan and Alison that Bono was coming to the house for dinner. When he walked in the door, they were speechless; however, he was wonderful with them. They (and I) will never forget this extraordinary night.
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Sept. 24, 2002 - Had CIA briefing and overall review of smallpox plan in Secr. Thompson's office with Gov. Ridge, Col. Bob Kadlac, Julie Gerberding, Jerry Hauer, and a Ridge person . Clearly Russia had modified smallpox and very likely Iraq has smallpox. We reviewed the pre-emptive plan for vaccination that will be presented to Pres. Bush tomorrow by TGT in anticipation that he will make the policy decision soon. We will recommend the 3 stage proceedure of 500,000 to 10 million to the general population. Word in the meeting is that we will definitely attack Iraq by January.
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Sept. 26, 2002 - White House briefing with Carol Kuntz (Assistant to VP Cheney), Kristen Silverberg, Stewart Simonson, Jerry Hauer, Bob Kadlac and others regarding smallpox vaccination policy. Carol was concerned that she was getting different signals from different people about varying toxicities among children versus adults, primary vaccinees versus re-vaccinees. Apparently, D.A. Henderson has been very dogmatic with her (what else is new?). I told her that one can go to the literature and analyze the information in many ways. Since she questioned my numbers, I just kept quite and promised myself to get back to her.
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Sept. 27, 2002 - Spoke with Carol Kuntz over the phone and explained some calculations that I had done (see attachment). She apologized for questioning me the day before and even made the comment that "Who is she to go mano-a mano with Tony Fauci" since I am "a legend" in the White House. I had a great conversation with her and sent the document shown below to her.
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September 27, 2002 NOTE TO CAROL KUNTZ From: Anthony S. Fauci, M.D. Director National Institute of Allergy and Infectious Diseases National Institutes of Health Carol: As per your request, I will summarize below the information that I discussed with you over the phone and will provide as attachments (1 through 5) some data sheets: 1) The question arises whether the rate of serious complications due to primary vaccinia vaccination is greater in children versus adults and whether, because children will be obviously excluded from the cohort of health worker and first responder vaccinees, this will result in a lower than anticipated rate of complications for the first 2 stages of the vaccine program, i.e. up to 10,000,000 people. My reference is Lane JM et al: Complications of smallpox vaccination, 1968. National surveillance in the United States. N Engl J Med 281:1201, 1969. I worked from Table 1 of the paper (attachment #1) and analyzed the "Primary vaccinations". I divided the cohort into 2 groups of <1 yr to 9 yrs old and 10 through 20+ yrs old in order to compare the actual rate per million complications in each group. I found the following: There were 4,900,000 individuals in the <1 to 9 yr olds and 694,000 individuals in the 10 to 20+ yr olds. The rate of complications in the 2 groups were as follows: <1 - 9 y.o. 10 - 20+ y.o. per million Postvaccinial encephalitis 3 1 Vaccinia necrosum 0.4 4.0 Eczema vaccinatum 10 14 Generalized vaccinia 22 26 Accidental inoculation 26 10 Deaths 1 1.44 Therefore, one can conclude from this analysis that the younger group has a higher incidence of encephalitis, but the older group is similar, if not slightly worse off, when compared to the younger group with regard to the other complications of primary vaccination. HOWEVER, the critical issue as I see it is the major difference between previously unvaccinated and previously vaccinated individuals with regard to the frequency of vaccine-related complications. Whether you look at the figures from the 1969 paper referred to above (attachment #2) or the 2001 MMWR (attachment #3), the rate of complications in the previously unvaccinated group is considerably higher than that in the previously vaccinated group. For example, in the Table 6 of the 1969 New England Journal of Medicine paper (attachment #2), the complications per million are as follows comparing previously unvaccinated versus previously vaccinated: Encephalitis - 2.9 versus 0; vaccinia necrosum - 0.9 versus 0.7; eczema vaccinatum 10.4 versus 0.9; generalized vaccinia - 23.4 versus 1.2. The differences are even more impressive in the Table from the 2001 MMWR (attachment #3) 2) Since the differences are so striking between previously unvaccinated and previously vaccinated individuals with regard to the incidence of serious adverse events associated with smallpox vaccination, I calculated the percent of people in the work force that we could predict would be previously vaccinated or not. I used the most recent US Census (2000) (attachment #4). I consider the work force to be individuals from 20 through 64 years old (this corresponded to natural breaks in the census data). In 2000, there were 281,421,906 people in the USA. I found that there were 59 million people or 21% of the total population and 36% of the work force between the ages of 20 and 34 years. These people will have not been previously vaccinated. Routine vaccinations stopped in 1972 and most children would not have been vaccinated before age 5 and so 34 years old is the cut off point. I further found that 107 million people between the ages of 35 and 64, i.e. 38% of the population and 64% of the work force were likely vaccinated. Thus, 64% of the people that we would be vaccinating in the first responder/health care worker category would fall into a group that historically has a much lower rate of serious adverse events than the previously unvaccinated group. I believe that this must at least be taken into consideration in our policy decisions. 3) You asked a question about residual immunity in people vaccinated decades ago. If you look at laboratory immunity (i.e. antibody levels and cell-mediated immune function), there is no question that the vast majority of studies indicate that there are variable levels of residual laboratory immunity in people who were immunized even decades ago. The question remains whether the laboratory immunity is totally reflective and correlated with clinical immunity to an actual exposure. There are several studies that indicate that previous immunization, even decades ago, provides real, but variable, degrees of protection against death (i.e. lower case fatality rates) compared to unimmunized individuals. It is impossible to determine the effect on actual infection without death. Some of these studies such as the 1902-1903 Liverpool outbreak study is partially flawed in that there was some smallpox circulating in the community that might have boosted immunity. However, several studies that are summarized in a paper by Mack TM et al: Smallpox in Europe 1950-1971. J. Infect. Dis. Vol.125, number 2, Feb. 1972 (attachment #5) indicate that case fatality rates are significantly less in individuals vaccinated even more than 2 decades before. I personally do not believe that all of these people were protected because that were intermittently boosted by naturally occurring San smallpox. There just were not that many widespread smallpox outbreaks to boost the population of Europe consistently during that time frame. In fact, from 1950 through 1971, there were only 680 cases of smallpox in the countries in question. Therefore, I would have to conclude (not definitively, but likely) that previously immunized people do have a variable, but significant, degree of residual protective immunity against death from smallpox. I hope that you find this information useful. Please give me a call if you have any questions at (301) 496-2263. Thank you and best regards. Sincerely, Anthony S. Fauci, M.D.
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Sept. 29, 2002 - Received ICAAC Award and gave the ICAAC Award lecture in San Diego on "Bioterrorism in the spectrum of emerging and re-emerging diseases". Audience was 10,000 people and received rave reviews for the lecture.
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Sept. 30, 2002 - Got another top secret briefing from the CIA. Apparently Russia is still making genetically modified microbes for offensive use. Also, was briefed on Iraq's capabilities. It is my impression that the CIA information is really very soft. They have sources, but they are difficult to validate.
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Oct. 4, 2002 - Engaged with Julie Gerberding, Jerry Hauer, Kevin Keane in a briefing of State and local Public Health officials on the likely roll out plan of smallpox vaccination in3 stages (500,000 smallpox response teams and emergency personnel, then 10,000,000 health care workers, primary care people, police and fireman, etc. followed by making vaccine available to general public after the Acambis product is licensed in early 2004. This was followed by a press conference, which did not go well since Jerry Hauer said that we were not going to make any "announcements". Note that there have been many leaks about the 3 stage plan and the press was clearly annoyed that the press conference started with a statement that we were not going to tell them anything important. However, Julie proceeded to get up and say that we recommended the above plan. She left the stage for a few minutes and I corrected her (politely) by saying that we are not "recommending" anything, we are merely giving a likely option. The Secretary recommends something to the President and that is confidential. The reason for this is that we do not want to put the President in the position of possibly going against his top health advisors, i.e. boxing in the President. Julie returned and confirmed my correction. The press rightfully thought that we were sloppy (not me, but DHHS). We called the main players - Larry Altman, Laura Mackler of AP, Ceci Connolly of Washington Post and Sheryl Stolberg of NY Times to clarify the situation. All of this is happening because the WH is taking so long to come out with a policy and we are compromised because if we do not say that we favor a certain plan, then it looks like we do not know what we are doing. How can we not favor a certain plan if we have been working on this problem for months???
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Oct. 8 - 22, 2002 - Washington, D.C. area being terrorized by a sniper who has already shot 12 people and killed 9.
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Oct. 10, 2002 - Had 2 important meetings at the White House today: First - meeting with Gary Edson, Jay Lefkowitz and Robin Cleveland about the comprehensive AIDS implementation plan for prevention, treatment, and care for developing nations for possible consideration by the President. This was in response to a call from Jay about 1 week ago asking to spread out the plan from 5 years to 7 years and to calculate how much money would be spent for each prevention intervention, i.e. condom distribution versus sex worker education versus needle exchange versus family counseling. The point is that they feel that the request might be too much for the 5 years (Total = $9.987 billion over 5 years, including up to $1.0 billion for the Global Fund). They want us to spread it out so that the early years will be less. Also, they want us to assume that countries other than Russia, China, and India (which will contribute 50%) would be contributing some proportion. We figured Botswana and South Africa could contribute 30% each Namibia and Guyana 20% and Uganda 10%. Furthermore, they anticipate that the President is going to ask just what the money is going for and if it is for Condoms, sex workers and IV drug users, he should at least know that. Obviously, the right wing in the WH would be against this. We crunched the number and I presented this. Right off Robin mentioned that Jim Capretta (OMB PAD) had mentioned to Mitch Daniels that something was cooking vis-à-vis international AIDS and that this would require new money. Mitch immediately said no chance and that no matter what we give, we will be criticized. Robin then left for another meeting. I suggested to Jay and Gary that another alternative would be to do this through the Global fund with the stipulation that they work from our plan with suggestions from them. My reason was as follows. The WHO group just met in Geneva with Bernard Schwartlander to try to galvanize a plan and support for a global program. Mark Dybul went to that meeting. It appears that they will ask for a 3 year plan to treat 3 million people at a cost of $10-15 billion with $4.6 billion from USA. They want to announce this on World AIDS Day (Dec. 1). This could pre-empt the President. In other words, we will be pressured to give $4.6 billion to do someone else's plan. This would be less that our 5 year and 7 year plan. Why not announce that we will give $4.6 million to the global fund if they coordinate their activities through our plan? The President could announce this and get credit for leadership as well as for contributing to the Global AIDS Fund. Also, it would avoid the impression that we Americans are going off on our own. Gary and Jay liked the plan very much and asked me to put together a 3-pager for Josh Bolten. They made me swear to tell no one about this, not even Mark, Terrell or TGT. I finally convinced them that I really needed to tell Mark since he is necessary to put these things together. I am very uncomfortable about not telling Terrell. Second meeting was a briefing of Vice President Cheney's Staff on the NIAID efforts on biodefense, i.e. what is our "vision" for spending the $1.75 billion as well as our longterm vision. At the meeting were Carol Kuntz, Seth Carus and Noreen Hynes (all from Cheney's senior staff) and Jerry Hauer (from the DHHS). The meeting went extremely well. I wowed them with a passionately delivered presentation. I told them that we at NIAID could transform the way the country deals with bioterrorism threat from a 1 document (see yer who has already research and public health standpoint. They loved it and asked what powers I needed that I do not have to execute this. I mentioned that we should have a fund to purchase vaccines and drugs so that the pharmaceutical industry would have an incentive to get involved. Also, I said the FDA needed to be more flexible.
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Oct. 17, 2002 - Sent down the 3-pager that Jay and Gary wanted (see above). It calls for the USG taking the lead and committing a considerable amount of money THROUGH the Global Trust Fund, but under the stipulation that other countries join us and implement our plan. The plan would cost approximately $18.8 billion of new money over 5 years. In the covering memo to Jay and Gary, I mentioned that I was uncomfortable about not telling Terrell what we are doing since I am supposed to me representing her and TGT at these meetings. Of note, Gary and Jay usually respond almost immediately to me when I send material such as this. However, over the subsequent 2 days (Oct 18,19), I have heard nothing from them. I suspect that they are put aback by my mentioned my discomfort about not telling Terrell about this. We shall see what happens. Also, received a call from Stewart Simonson who said that Vice-President Cheney wants a meeting with me about my Biodefence Research Vision on Wednesday, Oct . 23. The White House has set up the meeting.
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Oct. 20, 2002 - Gary Edson contacted me and likes very much the revised document (see above). We are closing in on it and he will soon show it to Josh Bolten.
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Oct. 22, 2002 - Had a terrific visit and briefing of Vice President Cheney in the West Wing of the WH. Present were the VP, "Scooter" Libby, Carol Kuntz, Noreen Hynes, Seth Carus, (Gen.) Phil Russell, and Stewart Simonson. I went over our NIAID Research Agenda and Strategic plan for biodefense. As I did in my briefing of Carol Kuntz (see above), I stressed that we can and will do the job. I stressed that we needed help in getting greater regulatory flexibility, having the power to sole source contracts, and we need to provide major incentives for industry. We must work more closely with industry the same way that the automobile industry made our planes and tanks during World War II. It was a very easy and enjoyable interaction with the VP. Of note, when we discussed briefly the policy for smallpox vaccination, it was clear that Libby is the driving force for mass vaccination sooner rather than later. The VP seemed rather measured on the subject. On the way out of the WH, I ran into Gary Edson in Josh Bolten's office (Josh's assistant had seen me walking by and asked me to come in to say hello to Josh). Josh and Gary were actually working on the plan that Mark and I had just sent to them. They like it very much and I think that something is going to happen with it.
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Oct. 23, 2002 - Met with Bono again at the Jefferson Hotel for breakfast. Also present were Jamie Drummond, Lucy Matthew, Katrina and Erin Chapman. We spent almost 2 hours going over options for how we can drive the agenda for universal care, prevention that Victoria and treatment for HIV infected people worldwide. I emphasized the importance of engaging Russia, India, and China because of the large populations in these countries in which a mere increase in prevalence from 1% to 2% in countries like India and China (I billion people in each country) could quickly create a pool of infected people that would equal all of Africa. He will be meeting with Condolezza Rice this afternoon to push for the USA getting involved in a major way with money (billions) and leadership. I am impressed with Bono's good intentions and his intelligence and energy. I am disappointed that I cannot tell him about the program that Mark Dybul and I have been working on for the "comprehensive implementation" plan. Hopefully, we can make this public soon so that we can engage Bono's assistance with his bully pulpit.
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Oct. 29, 2002 - Received today the written version of the oral history that Victoria Harden collected from me a few months ago. See attached document. Fauci on biodefense 8-9-02.doc Oct. 30 - Nov. 1 - Multiple conversations and e-mail exchanges with Gary Edson regarding the AIDS Project (see above). I believe that finally we are getting this straight. Historically (see above), every time that we try to calculate the needed resources for a comprehensive program, Robin Cleveland (OMB) or someone else says that it will not fly (see note of Oct. 10, 2002). Now Gary calls me and says that our most recent package might be low-balling it since he recently read an article by Jeff Sachs in The Economist that we need $25 billion per year. I finally told Gary that I had had enough. The world is calling for $10 billion per year for 5 years with an increase to $15 billion per year by 2007. They all say that the USA commitment should be 35% of this or $3.5 billion per years for 5 years. I told Gary that this is what we should propose as the President's initiative provided that the other countries put in the remaining 65% and that they use our implementation plan. I told Gary that he and Robin need to figure out how much of $3.5 billion per year we (USA) will have already been spending in order to determine the amount (% of $3.5 billion) that really would have to be new money. Finally, he agreed and now we can stop all of this ridiculous back and forth with Robin and him. We may be getting close to presenting this to the President. We just need to convince Josh Bolten
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Nov. 1, 2002 - Had a great meeting with Carol Kuntz, Noreen Hynes, and Seth Carus regarding the request of the Vice President for me to list what added powers that I would need to make the BioD program work at NIAID. Stewart Simonson and Phil Russell also present I listed a group of these and Carol et al liked and agreed with them. They were mostly sole source contracting authority, rapid grants, DARPA-like powers, etc. Next step is arranging a meeting with me, TGT, and Cheney.
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Nov. 12, 2002 - See note of Oct. 30 - Nov. 1 above. Gary Edson called me last week and said that they were on the verge of making the decision regarding whether we will go for the major implementation plan. However, there is skepticism on the part of OMB (and likely others that he did not mention) concerning whether this can be done. They need to do due diligence and get some outside opinions and so they Gary has asked me to gather for a meeting at the WH a group of people who have actually done developing country implementation. They want to speak with these people without my being there, i.e. to check up on me. I suggested and they agreed to bring in the following: Peter Mugyenyi (Uganda), Jean (Bill) Pape (Haiti), Paul Farmer (Harvard-Haiti), Eric Goosby (Pangea Foundation and Rwanda). Gary asked me on a Friday and I needed to contact these people who were scattered all over the world to come to DC to see me and then have a visit to the WH. Gary insisted that I not reveal the plan to them and so I had to convince them to travel within a 72 hours period merely on faith as a favor to me. They all agreed and came: Mugyenyi from Uganda, Goosby from Rwanda, Farmer from Germany, and Pape from Haiti. Still Gary insists (despite my asking him again and again) that I cannot tell Terrell Halaska about any of this. I pushed Gary and he checked with Josh Bolten who said that this week we indeed will be able to tell Secretary Thompson. On another issue, things are heating up regarding possible war with Iraq. This makes compelling the imminent decision of policy regarding smallpox vaccination of civilians. The Pentagon will imminently announce that 250,000 to 500,000 troops will be vaccination with vaccinia (Dryvax). The question of the availability and recommendations for civilians remains. I am pushing for "recommending" that the 500,000 and then the up to 10,000,000 health workers and first responders get vaccinating. However, I feel that although we should make available the vaccine for the general public, given that the threat assessment is very soft, we should recommend that they not take the vaccine unless they feel very strongly that they do not want to take any chances. This is different from the situation with the anthrax vaccine where the DHHS said that had no recommendation either way; they just made the vaccine available if people wanted it. Went down to the White House to pre-brief Gary Edson and Jay Lefkowitz on Mugyenyi, Goosby, Pape, and Farmer. They both inquired as to what pretense I used to get these people to come to the USA. I said that I asked them to come and advise me about clinical trials in developing nations. Had dinner at the Trattoria Sorrento in Bethesda (Cordell Street) with the 4 visitors and told them exactly why I called them in and explained what type of questions would be asked of them at the WH. They look upon me as a hero for what I am doing.
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Nov. 13, 2002 - Multiple meetings in the DHHS to plan roll out of smallpox vaccination plan. It is imminent. The President is planning on having to start bombing Iraq in the 2nd week of January and wants to start vaccinating the 500,000 people smallpox response teams by December 1 and the 10,000,000 first responders by January in order to prepare for a release of smallpox by Iraq. Much discussion about timing the announcement of vaccinating the military with the announcement about the general population. Concern is that if we do not link the 2, the people will react to vaccinating the military by saying "what about us?" It looked like we were going to make the announcement on Friday, Nov. 16. However, at the WH, the President told the cabinet (including TGT) that he now wants to wait until he comes back from a foreign trip (Nov. 27) since Osama bin Laden just released a tape yesterday indicating that he is still alive and threatened the USA, UK, and Russia. Bush does not want it to appear that we are panicking in response to the tape. I am relieved that we decided to wait since I would have had to cancel my going to Los Angeles to receive the RAND Prize ($10,000.00) in order to remain in DC for the Press. Heard that the WH meeting with the 4 visitors on the global AIDS plan went extremely well. I believe that we are convincing the skeptics that we can effectively treat HIV in developing nations. Of note, Robin Cleveland asked to have Nils Daulaire there for his opinion. It is my impressions that she is resentful of the NIH and me. This is likely due to the fact that her OMB account for which she is responsible includes USAID and there is obviously some competition in her mind given that NIH always does so well with the budget.
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November 19, 2002 - Another meeting at the White House with Jay Lefkowitz, Gary Edson, Joe O'Neill, Mark Dybul and me to further discuss the potential for getting the President to accept our proposal for a comprehensive $50 billion over 5 year plan. Gary and Jay want me to further refine the presentation and actually start finalizing it for presentation first to Mitch Daniels and then ultimately to President. Jay had shown me a memo that Nils Daulaire had sent to Robin after the meeting with Mugyemnyi et al and it was clear that Robin and Nils are working together. Nils is a fine former public servant and is now in the private sector. However, judging from his memo, he is dead wrong on certain issues, i.e. he does not believe that Russia, China and India will surpass Africa within the next 5 years in AIDS impact. Also, I am not happy that Robin previously told Nils about the plan at the same time that Gary and Jay will not allow me to tell Terrell Halaska or Secretary Thompson about it. Strange situation in this WH regarding secrecy - they are almost pathologic about it. At the meeting, Jay and Gary asked me and Mark to prepare again even more material for an upcoming meeting with Mitch Daniels (see above). We got it to them within 1 day.
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November 21, 2002 - Another pre-roll out meeting at the Department to prepare for the upcoming announcement by the President on the Smallpox vaccination policy. Meeting was with Kevin Keane, Bill Hall, Jerry Hauer, and on teleconference - Michael Osterholm, Julie Gerberding and an assortment of CDC public affairs people. I have convinced them that we should not recommend to the general public that they take the vaccine give the non-quantifiable risk. I am also convincing them that for the Stage 2 (10,000,000 first repsonders), we also should not make a blanket recommendation that they get vaccinated. Rather, we should say that as a group the vaccine should be offered to them, but since this is a heterogenous group, the actual recommendation to take it or not should rely on discussions between the CDC and the State and local public health officials in light of the particular needs and situation within a given jurisdiction. Clearly, the Stage 1 group (500,000 smallpox response teams) should have a recommendation to take the vaccine voluntarily. -ourt
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Nov. 22, 2002 - Gave keynote address at the Holy Cross function at The Supreme Court for "Lift the Cross High". Justice Clarence Thomas was our host and was the other speaker. My remarks were very well received by all. It was a very elegant evening aimed ultimately at fund-raising for Holy Cross. Thomas is also an alumnus.
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Nov. 26, 2002 - Briefing of Vice President Cheney at the White House regarding Project Bioshield (I made up the name) which is requesting his help in getting me special authorities for Countermeasure Advanced Development. Meeting included VP Cheney, "Scooter" Libby (both on teleconference from secret location), Secretary Thompson, Stewart Simonson, Bill Raub, Carol Kuntz, Noreen Hynes, Seth Carus. Bill Raub presented the need for a $1-2$ billion Vaccine Trust Fund. Meeting went extremely well. VP was very supportive of my proposals and told Carol to set up a meeting between me, TGT, Stewart and Josh Bolten. Also met later in the day with Richard Danzig (former Secretary of the Navy under Clinton). He is a private consultant under contract to the DoD for Biodefense and wanted to get to know me since he has "heard so much about me". He wants to start an informal group of people linked by common interest in biodefense.
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Dec. 3, 2002 - Still waiting for the President to decide on the announcement of the smallpox vaccine policy. Should be tomorrow or next day. Also, a lot of back and forth between me, Jay Lefkowitz and Gary Edson. I believe that we are moving towards a Global AIDS Initiative. Jay will present our plan and budget to Mitch Daniels today. Phone call with Jay Lefkowitz and Keith Hennessey and Doug Badger called wanting to know why we needed a vaccine trust fund as opposed to other mechanisms to guarantee purchase of vaccines. This is what Bill Raub presented to the VP (see above); however, they are asking me about it because of "my credibility" (according to Carol Kuntz. Carol was on the phone with Kristen Silverberg. There is some concern as this passes through the WH that there is not enough justification for a "Trust Fund". Carol Kuntz wants to set up a meeting at the WH for me to help explain this sometime later this week or next week.
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Dec. 4, 2002 - Amazing day. I was at one time on 3 different lines with 3 different people at the White House - Gary Edson, Jay Lefkowitz, Carol Kuntz. There was an intense and critical issue with Gary and Jay. Gary was getting ready to meet with Mitch Daniels regarding our AIDS plan and he heard through his WH grapevine that Mitch was going to try to "Steamroller" him by bringing up the Washington Post article from a couple of days ago about the program in Botswana being a failure. In other words, if Botswana failed, why did we believe that our program would succeed. I explained to Gary that the Botswana Program was "Top Down" government as opposed to local network. They were using high tech., approach instead of grass roots. Gary asked me to contact our African friends and get their opinion (in one half hour!!!!). I contacted Peter Mugyenyi, Sam Kibende, and Eric Goosby and they all agreed with me. Peter mentioned that the big mistake that the Gates Foundation and Merck went directly to the Botswana Government and asked them to put together a plan. Botswana then employed the Harvard AIDS Institute who developed a high-tech USA Harvard like plan with CDReleased by Chairman Rand Paul ROMs for developing voluntary Counseling and Testing. Peter said that it was doomed to failure. I relayed this to Gary and he was satisfied. Also, more delays in the announcement of the smallpox vaccine policy. It will not be this week and so I will be able to go to Albany to give a talk associated with my Albany Prize from last Spring.
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Dec. 4 - 10, 2002 - Incredible amount of action going on. Many calls and interactions with VP Cheney's staff (Carol Kuntz, Noreen Hynes, Seth Carus) regarding Project BioShield. The VP wants to come to NIH and have me show him around the Vaccine Research Center (VRC) in the context of the "Advanced Project Development" of Project Bioshield. Project Bioshield has caught on with the VP and his staff. Scooter Libby is becoming a strong ally and fan of mine. At the same time there is a lot of buzz as to when the President is going to announce his vaccine policy. Many leaks, interestingly most from the WH itself. We are busily preparing our Qs and As for the announcement. Elias Zerhouni feeling a bit out of the loop. I am trying to keep him informed, but the WH and DHHS wants to deal directly with me.
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Dec. 11, 2002 - A truly terrific day! Cheney came to VRC and I presented an updated version of Project Bioshield in the context of going from concept to product in the VRC. Present at meeting were: Cheney, Scooter Libby, Carol Kuntz, Noreen Hynes, Seth Carus, Elias Zerhouni, Tommy Thompson, Stewart Simonson, Phil Russell, Gary Nabel and his staff. Cheney and Libby were "wowed" by my presentation and by the VRC Cheney instructed his staff to do whatever is necessary to facilitate what I am doing including giving me special authorities. Immediately after the VP visit, I rushed down to the WH to present "Project BioShield" to Josh Bolten in the context of the VP wants me to sell the concept to Josh. Present at the meeting were Josh, Kristen Silverberg, Richard Falkenrath, Tommy Thompson, Scooter Libby, Stewart Simonson, et al. Josh questioned the need for the vaccine purchase fund component of Project BioShield (good questions). I defended it even though this really is not my bag (Bill Raub was the original designer of it). At the end of the meeting, Josh seemed supportive of the entire project. Clearly the VP is driving this process. Another amazing event. The vaccine policy roll-out is under very close hold at the WH. Today I received one of my many calls from George Stephanopoulos of ABC. George pointed out that the President gave an interview with Barbara Walters to view on Dec. 13 in which he said that he would allow vaccination of the entire population on a voluntary basis. George thought that this constitutes the long-awaited announcement of the policy. I told George that the Pres. was probably just speaking in broad generalities since I know that there will be a formal announcement with me involved at the WH. George seemed convinced; however, the ABC people pursued this and confronted the WH who inexplicably confirmed the story and said that the roll-out would be Friday (Dec. 13). I heard about this when I was in Josh Bolten's office presenting Project BioShield. My phone rang and CBS said that ABC had broken the story on the policy on the basis of the Barbara Walter interview. They wanted me on their show to discuss. I said that I knew nothing about this and therefore could not appear. I hung up and mentioned this to Kristen Silverberg. She knew nothing and immediately called Dan Bartlett (WH Press Office). I did not hear what they said; however, apparently what happened is that the press confronted the WH with the Walters interview and the WH caved in and admitted to the policy. The crazy thing is that it has now hit the press, but the WH will not let us talk about it since the President has not officially announced it. We still do not really know what the policy will be nor when it will be announced. More later! Dec.12, 2002 - Much activity back and forth with the White House and the DHHS regarding putting the finishing touches on the President's Statement and the policy in general. In particular, Kristen Silverberg and checked frequently with me. In midafternoon she called me down to the White House with Stewart Simonson to go over word-for-word the President's statement. We were the only DHHS people asked to do this. Big surprise in the statement was the fact that we will make vaccine available to the public before 2004 by allowing people who insist on vaccination to enter into an ongoing clinical trial (Cangene, Acambis, etc.) or by creating a special IND protocol (using Aventis-Pasteur). Exciting few hours at the White House with Karl Rove, Andy Card, Josh Bolten, Mike Gerson (President's speechwriter), Kristen, Susan Neeley (Public Affairs for Homeland Security), Dan Bartlett (Deputy to Ari Fleischer)Stewart and I having lively back and forth conversation. I insisted that they emphatically emphasize that we do not recommend vaccine to the general public; however, we will make it available to those who feel they still want it even though it is not recommended. I consider this a great victory since I am concerned about tens of millions of people getting vaccinating, which will surely lead to some serious adverse events. After the WH, Stewart and I went to the Department and worked on Qs and As for hours until around midnight. Also, we briefed the Governors of the States and the State Health Officials by teleconference. Dec.13, 2002 - Day of the announcement by the President. The DHHS team including me went to the WH at 1:00 PM in preparation for the 2:15 PM announcement. We met in the Roosevelt room and discussed the policy with Ari Fleischer, Dan Bartlett, and others. Bill Winkenwerder represented the DoD. Big surprise was that we learned the President would get the vaccine himself since he felt that as Commander-in-Chief of the Armed Forces, he could not order the troops to do something that he himself would not do. He will say that Laura and his children will not be vaccinated since they are part of the general public. President makes announcement. On stage with him was me, Tommy Thompson, Gov. Ridge, Julie Gerberding, Bill Winkenwerder, someone from State Dept. Afterwards, the President left and we all gave brief remarks and answered questions. The rollout went extremely well. I was on CNN and Julie and I were on the Jim Lehrer NewsHours together. I had been scheduled by Ari Fleischer to go on all of the Sunday talk shows with Tommy Thompson on Dec. 15; however, we were bumped by the breaking news of Trent Lott facing forced resignation because of his "segregationist" comments at the birthday party of Strom Thurmond. Nonetheless, I got my picture in both the NY Times and The Washington post standing next to the President and TGT. Also, over next few days I appeared on CNBC, WTOP radio and NPR - "Talk of the Nation"
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Dec. 18, 2002 - Another exciting day at the White House. Clearly, Scooter Libby and the VP are in favor of pushing for the Vaccine Trust Fund. OMB and the WH economic advisors have a problem with the concept of a trust fund. As usual, Carol Kuntz has been very supportive. Was called down to a meeting at the WH with OMB people (Jim Capretta), the VP staff (Carol K., Seth Carus, Noreen Hynes), DHS people (Richard Falkenrath, et al), Kristen Silverberg, Ken Bernard, Stew Simonson, Phil Russell, Bill Raub. We had to discuss the vaccine research plan. Again, must concern as to why we need a trust fund instead of an appropriation. I explained that one (the fund) is mandatory and the other (appropriation) is discretionary. Jim Capretta came up with the idea of a "Permanent and Definite Appropriation" that would be mandatory and multiyear. In the middle of the meeting, Scooter Libby called me on my cell phone and said that he was going into a meeting with the VP and the President at 1:00 PM (it was now 11:30 AM) and he needed for me to write a 1⁄2 pager on the concept of a mandatory fund for vaccine (he said trust fund, but we subsequently hashed out a Perm. And Def. Appr. He also wanted a microbe by microbe breakdown with time-lines and costs - all by 12:55 PM. In addition, he wanted me to meet with the CEOs of "Big Pharma" to determine if they would support this. I rushed to the DHHS with Stew, Kerry Weems, Phil Russell and Bill Raub and put together a great package to e-mail and FAX to the VP's office (Carol K.) arriving a few minutes before 1:00 PM. They loved it. We will wait to see what happens.
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Dec. 19-22, 2002 - Still much activity with the VP continuing to push to help us get a Permanent and Definite Appropriation for purchase of countermeasures, particularly, but not exclusively for vaccines. There is much concern about botulism and acquiring botulism anti-toxin. Many phone calls and meeting with Stewart Simonson with whom I now speak with and/or meet at least several times per day. Carol Kuntz and Noreen Hynes are trying to help us. They asked us to put together a programatic assessment of our procurement needs for countermeasures without consideration of budget constraints. We had previously put together a $4.2 billion package concentrated mostly on MVA and rPA (anthrax) with only about $450 million over 10 years for other countermeasures. We presented this several days ago to OMB people in the presence of Kristen Silverberg (see above). OMB was miffed that they had not seen these numbers before, when in fact the numbers were contained in our budget submission for '04, but were not specifically designated as purchase. Clearly OMB is resisting the VP's attempts to get this fund through. The new "no budget constraint" package that we put together was approximately $15.0 billion over 3 years (FY04 - 06) with considerable amount now to other countermeasures such as botulism, plague, Ebola, tularemia, Rift Valley Fever, EEE/VEE/WEE, Staph. Enterotoxin, antibiotic resistance, pandemic flu, WNV, etc. Even though this was put together by Phil Russell with help from DMID, the VP wants me to defend it to OMB since they are cashing in on my reputation and scientific credibility. The VP has set up a meeting for Dec. 23 at the WH with himself and Scooter Libby teleconferenced from Jackson Hole and me, Mitch Daniels, Nancy Dorm (OMB Deputy Director), Tommy Thompson, the VP's staff, etc. (see below).
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Dec. 23, 2002 - Critical meeting at the White House (see above). Attending were VP Cheney and Scooter Libby by teleconference from Jackson Hole; Stewart Simonson, Phil Russell, Kerry Weems (Budget, DHHS), Carol Kuntz, Noreen Hynes, Seth Carus, Nancy Dorm (Deputy Director OMB), Tom Reilly and Jim Capretta (OMB). Issue was that Scooter and the VP had asked Carol Kuntz a couple of days ago to put together a threat related proposal for a wide range of microbes with no concern for budget to be used for procurement of products. It should be program and need driven. Carol tasked me to do this with Phil Russell. I worked until late through the night of Dec. 22 fine-tuning this and learning it cold. The proposal went beyond MVA, rPA, and included botulism, plague, tularemia, Ebola and other hemorrhagic fevers, pandemic flu, West Nile. Etc. The proposal came to $15 billion from FY'04 - '06. The OMB had agreed several days ago to creating a "Permanent and Indefinite (first it was definite) appropriations authority to purchase vaccines for BioT for a total of $4.2 billion. In typical OMB fashion, they were against any new spending. The intense interest of the VP was the reason why we were being listened to. Importantly, Carol Kuntz called OMB people to the meeting (Mitch Daniels was supposed to be there, but he was out of town) but did not warn them that they would be faced with a $15 billion exercise in front of the VP. I convinced Carol to let them know at least a few minutes before the meeting started. They were mortified and enraged that they were not warned in advance. As Nancy Dorm said, every time she sees me, it costs her billions of dollars. The VP called upon me to present the proposal. Nancy did not get it. She was tied down in process. She insisted that the original agreement was for vaccines only and not what she called "countermeasures" such as botulism antitoxin and Cidofovir, which were on the list. She did not understand that "Countermeasures" is the big umbrella under which are vaccines, antitoxins, etc. Also, she argued that we she not include in the purchasing authority anything that was not licensed. I proposed that we should include anything that was "licensable", i.e. on the way to license by the FDA, but perhaps months away because of the FDA process. The VP very clearly was on my side and did not hide it. He even said to Nancy " Do you expect me to go to the President and the American people and say that we cannot provide countermeasures against threats that we either know or strongly suspect that Iraq has because we do not want to broaden authorities and because the "process" will not allow it?" She then said that she would work with us to get something out. The VP was spectacular! It was a classic example of OMB not being able to get beyond process and missing the entire point of the concept. Amazingly, Nancy said that "look what happened with the smallpox vaccine. We bought it and now we are not even going to use it widely". She considers the smallpox vaccine situation, which was one of the great successes of the year to be a failure since many Americans would opt not to take it. She does not understand that the fact that we have it is critical. Amazing! The meeting ended with the VP clearly in my corner. My relationship with him, Scooter and the whole staff, particularly Carol is getting very strong.
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Dec. 24, 2002 - Nice surprise today. At 1:00 PM, I received a call in my office. I answered the phone since everyone else had left for the 1⁄2 day Christmas eve. On the other end someone sang the full verse of "Happy Birthday". It was Secretary Thompson calling from Wisconsin on a cell phone from a shopping center.
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Dec. 26, 2002 --
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Dec. 30, 2002 -- Another meeting at the White House with OMB people. They are still trying to resist the Pemanent and Indefinite Appropriations, particularly for pandemic flu. Attending meeting were me, Stewart Simonson, Seth Carus, Carol Kuntz, Barry Glendennin, Tom Reilly, Bill Raub, Phil Russell. We went back and forth and it was clear that Secretary Thompson and VP Cheney want this, but OMB does not. Again, the VP and DHHS are relying on my reputation to drive this through.
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Jan. 3, 2003 - Another meeting at the White House with Carol Kuntz, Seth Carus, Noreen Hynes, and Stewart Simonson on the pending Project Bioshield Legislation. VP Cheney is still trying to get this into the State of the Union address. I am still counseling Carol regarding her CML. Jan. 4 -- Jan 9, 2003 -- Continual back and forth about the language for my new authorities and for the permanent and indefinite appropriations authority for procurement of countermeasures. Much opposition from OMB. Scenario is Stewart Simonson, Carol Kuntz, Scooter Libby and the VP against OMB. Trying to keep NIH Director Elias Zerhouni in the loop. He is somewhat (not a lot) concerned that I am in the driver's seat here, but in all, he has been quite good about it. VP's people keep asking me to provide materials for them to strengthen our arguments. This has become almost a full-time job. Also, I have had a URI with sinusitis for at least 6 weeks and this has made 19 hour days difficult. We (NIAID) had to move our Winter Program Retreat from Shepherdstown, W.Va. to Bethesda since Stewart and others felt that I like would be needed on the phone or to go to WH during the 2 days of the retreat (Jan. 9-10).
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Jan. 10, 2003 -- Meeting at the White House with Kristen Silverberg, Carol Kuntz, Noreen Hynes, Seth Carus, Richard Falkenrath, Ken Bernard, Stewart Simonson, WH speechwriters Amy Jensen and Gordon Johndroe. Purpose of meeting was to prepare for the possibility that the President will announce Project Bioshield at the State-of-theUnion Address in a couple of weeks. I had to present to the group the background and. rational for the special authorities for the NLAID director as well as the Permanent and indefinite appropriations authorities to purchase countermeasures. In addition, we explained the special use licensure of countermeasures by the FDA. For the latter part of the meeting, Mark McClellan (FDA Commissioner) joined us by phone. We will have follow-up meeting next week.
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Jan. 11, 2003 -- Had an all day meeting of virtually all the players in biodefense organized by Richard Danzig (former Secretary of the Navy) at Strategic Analysis, Inc. in Arlington, VA. We did case studies of possible catastrophic bioterror events and discussed the need to establish a BAT team or biological anti-terrorist team to be available to the President for advice and service in the event of a catastrophic attack. Present was among many others: Julie Gerberding, David Franz, Lisa Gordon-Hagerty, Josh Lederberg, Richard Danzig, Bill Patrick. Entire attendee list is in my files. Jan. 13 or 14, 2003 - Meeting in the West Wing (Ward Room) of the White House with Kristen Silverberg, Ken Bernard, Carol Kuntz, Amy Jensen, Sally Canfield (DHS), Jim Capretta, Tom Reilly, Richard Falkenrath, Stewart Simonson and others from WH communications to continue to fashion the precise language of the Project Bioshield (authorities, Procurement, FDA regs) in preparation for getting this into the President's State of the Union (SOTU) address . We wrangled a bit about the precise language. We will meet again in 2 days to finalize it.
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Jan. 17, 2003 - Another meeting at the White House in Andy Card's office (he was not there). Met with all of the above (Jan. 13/14) plus Patrick Aylward and minus Amy Jensen, Jim Capretta, and Richard Falkenrath to continue discussion. We went over comments regarding draft legislation and discussed the role-out for the SOTU address. Also, the WH has decided that soon after the address (around Feb. 3) the President will role out Project Bioshield more formally at an event likely at DHHS or at NIH. I will be there and then will be called upon to do a lot of briefings of the Press and Congress.
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Jan. 22, 2003 - Just heard from Ken Bernard at the WH that the President has decided to include Project Bioshield in the SOTU address. Also, he plans to visit the NIH on Feb. 3 to roll out the plan.
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Jan. 23, 2003 - Another important meeting in the White House with the same people as on Jan. 17 plus Amy Jensen, Ginger Loper. Putting the final touches on the 3 Bills (a) Permanent and indefinite authority, b) Special FDA authorization of products in emergency, and c) my special authorities. Also, discussed plans for President's visit to NIH. After the meeting, went to see Josh Bolten to get a feel for what the President would like to do during his visit. Josh invited Kristen Silverberg and I into his office to meet and talk with Mr. Sandy...... (Ambassador to China) and Bo Derek. We discussed AIDS in China and then Josh and I went out of the room and talked about what the Pres. Might want to do. Apparently he likes to observe technical things, but does not like to "sit down and be a prop". Went back to EEOB to a going away party for Seth Carus and Noreen Hynes. It appears that Elias Zerhouni is getting uneasy and insecure about my dealings in Biot, particularly with the WH connection. When I dutifully told him today that the Pres was coming to NIH, he said that he really needed to become more visible in the arena of Biodefense.
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Jan. 24, 2003 - More activity back and forth with Gary Edson, Jay Lefkowitz and me on the AIDS issue. It is still alive. They now want me to bring back Peter Mugyenyi from Uganda to meet with Mitch Daniels (and me). he dY
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Jan. 26, 2003 - Peter M. arrives from Uganda and Mark Dybul and I prep him for the White House visit. We have late lunch-early dinner at Mark;s house to brief Peter. SuperBowl Sunday.
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Jan 27, 2003 - We (Peter and I) meet with Mitch Daniels. Mitch seems genuinely moved by Peter's description of AIDS in Africa and is very deferential to Peter and me. Gary and Jay ask that I plan to spend the entire day at the White House on Tuesday, the day of the State of the Union Address. Something is up, not sure. They even suggest that Peter might join a group of VIPs in a satellite site (i.e. White House or EEOB) to watch the SOTU address.
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Jan. 28, 2003 - One of the most amazing and important days of my life! Spent the entire day (11 hours) at the White House. I arrive at the White House and Gary Edson and Jay Lefkowitz inform me that the President has decided to adopt our AIDS Implementation plan - the full version!!! $15 billion over 5 years starting with $2 billion in FY2004. $10 billion will be entirely new money including $1 billion to the Global Fund for HIV/AIDS Tuberculosis and Malaria. Peter Mugyenyi will sit next to Laura Bush in her box at the Capitol for the speech. I spend the whole day at the WH proofing the SOTU, fact checking, preparing and proofing Qs and As with Jay and Gary. The WH personnel are all congratulating me for pulling this off. Josh Bolten told me that I am his hero; Karl Rove and Andy Card are generously congratulatory towards me. Gary, Jay, Kristen, Josh, et al ask me to stay at the WH to have pizza with them and watch the SOTU address. I had to leave at 7:00 PM to prepare for my Senate Hearing on Smallpox the next day. The SOTU was fabulous. He rolled out BOTH Project BioShield and the AIDS initiative - 2 things conceived of and planned by me (with obvious help from many, particularly with BioShield). This has truly been an historic day!
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Jan. 29, 2003 - Testified to the Senate Appropriations Subcommittee Hearing chaired by Arlen Specter. Also present were Sens. Harkin and Murray Hearing on Smallpox vaccination plan. Julie Gerberding and I testified. Concern on the part of local health officials and hospital people that the USG plan does not provide for compensation to people injured by receiving the vaccine. Hearing went quite well. Spent the rest of the day at the WH doing post SOTU briefings and handling press calls. I used Jay Lefkowitz's office. We sent off Peter back to Uganda. At the end of the day, I briefed Ari Fleischer for 1 hour on Project Bioshield.
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Jan. 30, 2003 - Testified at the Senate HELP (Health Education Labor and Pensions) Subcommittee Hearing with Julie Gerberding again on the subject of smallpox vaccine plan. Issue of compensation came up again. At the Hearing was Sens. Judd Gregg, Bill Frist, Alan Reed, Barbara Mikulski, Hiliary Clinton. Hearing went well. Spent rest of day at the Department are downtown doing Congressional Briefing to HELP committee on Project BioShield and to Secr. Thompson on Smallpox. Did the CNN Wolf Blitzer show with Secr. Thompson, Julie G., Mark McClellan (FDA) and Jerry Hauer on the subject of the HHS Biodefense Command Center.
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Jan. 31, 2003 - Spent most of day at DHHS and the WH. President gave absolutely wonderful speech at the WH to the PACHA (Presidential Advisory Committee of HIV/AIDS) and the African Ambassadors. He truly reflected his commitment and passion concerning our moral obligation to do something about HIV/AIDS internationally. He mentioned me specifically. Interesting that the activists who were completely trumped by the POTUS announcement, now can only complain that only $1 billion of the $10 million new money is going to the Global Fund.
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Feb. 1-2, 2003 - Much preparation for the President's visit to NIH and for the briefing of the President on Feb. 3 on BioShield. Many calls from WH I am asked by WH people to fact check things that he will say. Also, they want me to be responsible for arranging the details of his visit to the Vaccine Research Center. His advance people keep calling me and Kristen and others keep asking if everything is going OK.
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Feb. 3, 2003 - Another magical day! In the AM, I brief the POTUS on Project BioShield. Place = Roosevelt Room of the WW. Present are POTUS, VP Cheney, Tom Ridge, Tommy Thompson, Scooter Libby, Condi Rice, Karl Rove, Josh Bolten, Kristen Silverberg, Adm Abbott, Ari Fleischer, Dan Bartlett, Ken Bernard, Elias Zerhouni, Carol Kuntz, etc. I played major role in walking him through the Project. We rush back to NIH to greet him (Flying in on Marine One) at the VRC. We give him a tour and he is smash hit with the staff. We go over in motorcade to Natcher Building where he gives major address. He specifically mentions me as an old friend and someone who he thanks on the part of the country because I have been for many years THE general in war on AIDS. His speech drew applause every time he would mention me, Zerhouni, or AIDS in Africa Plan, but no applause when he spoke of the likely need to go to war with Iraq. He leaves and I spend rest of day and also Feb. 4 doing press calls to describe in detail Project BioShield.
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Feb. 4, 2003 - The world knows that the President's Plan came from me and I am briefing many people. The WH refers all questions about Project BioShield and The President's AIDS Plan to me Got a call from Richard Feachem, President of the Global Fund for AIDS, Tuberculosis, and Malaria, congratulating me on the Plan, but expressing concern that since the USA only put $1 billion new money in the Fund over 5 years that now the other countries would be reluctant to contribute more to the fund than the USA. I told him emphatically, but in a nice way, that I disagreed. The original purpose of the Global Fund was not to replace bilateral agreements, but to complement them. Feachem is essentially saying that the other $9 billion in new money does not really count in a matching game since we did not put this in the Global Fund. Unbelievable. I have now told people. This is not about the Fund or about your particular choice of how you give money. It is about saying the lives of people in Africa and the Caribbean. Another looming problem is the Mexico City Agreement which states that Foreign NGO who counsels on abortions or who supports the performance (with funds) of abortions is not eligible for USG funding. This might make the implementation of the Plan through NGOs difficult. Also, I need to check with the US Trade Representative about the generics and breaking patents.
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Feb. 6, 2003 - Snow storm in DC. Went out to dinner with Stew Simonson and driving back home from Etrusco's restaurant on DuPont Circle I hit a patch of ice on Cathedral Ave., spun around twice and broad sided a telephone pole. No other cars or people involved. I was unhurt and drove my wrecked car home. Luckily it still ran since only the side doors (passenger side) were destroyed.
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Feb. 6 - 12, 2003 - Much briefing of White House and Congressional staff on Project BioShield and the President's AIDS plan. Much, much activity. The WH wants me in on all briefings.
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Feb. 13, 2003 - Delivered Plenary lecture at the 10th Conference on Retroviruses and OIs in Boston. Spoke on Role of viremia in host abnormalities. Very well received; it was hard core basic science, which was in sharp contrast to the publicity that I have been getting for the policy issues. Returned in early afternoon to go to WH to brief Congressional leaders on Project BioShield. Received secret briefing from CIA Torrey Froscher (Deputy Director, WINPAC, CIA). Present were Admr Stephen Abbott, Tom Ridge, Tommy Thompson, Jim Capretta, Kristen Silverberg, Chris Cox and Ginger Poers (Special Assistants to the president for Leg Affairs), Sens Gregg, Congressmen Burr, Turner Cox, Tauzin, Sen Collins; Sally Stansfield, Stewart Simonson, Carol Kuntz. The President walked in during the meeting and greeted the Congressmen and gave me a special warm greeting saying that the "A" team was there. He now has his special name for me. It is not Tony or Dr. Fauci it is "Fauci".
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Feb. 13, 2003 - Received wonderful FAX from Bono congratulating me on the AIDS initiative. Referred to us as "partners in crime". Did more briefings on the hill as well as briefing of activists Paul Davis, Asia Russell, Rachel Cohen (MSF) on the Pres. initiative. Still much concern out there that we did not put all of the money in the Global Fund. Yet, the Global Fund has not really done anything yet. Also, issues such as generic drug purchase and the Mexico City Agreement (MCA) have come up. Importantly, Jay Lefkowitz is supporting my view that even if organizations would not qualify to receive USG funds because they are not in accordance with the MCA, i.e. they do counseling that encourages abortion or they actually do abortions, they can in fact receive funds as long as they use them for treatment and not abortion performance or counseling. Major victory for me if Jay supports me since otherwise many groups would be disqualified to participate in the AIDS implementation plan. Also, according to the TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement, the WTO countries would not permit breaking of patents or use of generic. However, in paragraph 6 of the Doha Ministerial Declaration on the TRIPS, members could use "compulsory licensing themselves or have a third party compulsory license for them to make drugs in the case of an epidemic emergency such as AIDS, malaria, TB, cholera, Ebola, etc. so long as certain conditions are met such as this must be in poor countries and drugs cannot be sold back to rich countries. Thus, the TRIPS agreement will not interfere with our giving money to poor countries to buy generic or compulsory licensed drugs. Please refer to TRIPS and Doha documents. Feb. 14 - Mar. 2 - I have been leading (with Stew Simonson and occasionally Mark McClellan (FDA) many, many briefings of senators, Congressmen and staffers on Project BioShield. The WH has proposed our legislation. Zerhouni is acting extremely insecure and (I believe) inappropriate regarding the mentioning of NIAID in the authorizing legislation for BioShield. He and Stew and having a terrible fight since Stew insists that NIAID remain in the language. I am trying not to get caught in the middle. A few days ago, I presented the Jimmy and Rossalyn Carter Award of the NFID to former Congressman John Porter.
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Mar. 3, 2003 - Had dinner with Senator Bill Frist in his Majority Leader's Office in the Capitol. He regularly (on Mondays) brings together people with whom he likes to discuss various topics. This time it was bioterrorism. Besides me was Herb Pardes, Mark Halperin (NBC News), Stuart Taylor (Editor, National Journal), Georges Benjamin (Director, American Public Health Assoc), Bill Madia (Oak Ridge), Rev. Anthony Davis (Director, DC Black Church Initiative), Michael Byrne (Dept. of Homeland Security, Coordinator for DC, MD, and VA) and Ginny Wolfe (Counselor to Sen. Frist).
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Mar. 3 - 10, 2003 - Many briefings on Project BioShield. Most recent on Mar. 10 at the White House with the usual cast of people, i.e. Kristen Silverberg, Ken Bernard, Carol Kuntz, Stew Simonson, Tom Reilly (OMB), some people from DHS and OMB.
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Mar. 12, 2003 - Conference call with me connected to about 50 industry people organized by John Kelly of PhRMA to explain BioShield to them. Always a concern about anti-trust laws and so the General Counsel for PhRMA (Ken Ewing) made sure that no questions were asked by industry that would violate this. 2003 March 12 Teleconference on Pr Stewart Simonson told me yesterday that he resigned because of serious clash with Jerry Hauer. I offered him a job at NIAID that he was very moved by. Got a call today that Secretary Thompson insisted that he does not resign. Stew gave in to TGT.
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Mar. 13 - 16, 2003 - We are getting closer to war with Iraq. The French, Germans, and Russians are threatening to block any attempt on the part of the USA to have the UN pass a resolution that if Iraq does not immediately comply with Resolution 1441 and disarm, the UN will use force to disarm them. USA, Britain and Spain may go it alone. I am extremely concerned about the appearance in Asia (Hong Kong, Quangdong Province in China, Vietnam, Thailand, Singapore of a mysterious acute respiratory syndrome. Thus far 400 people, 150 in last week, 9 deaths. We have no idea what it is, but the attack rate nosocomially is very high. More than 30 health workers in Hanoi got infected from a single patient. Many people on respirators. The new disease is called Severe Acute Respiratory Syndrome (SARS). On evening of March 16, had a great dinner at Galileo's in DC. Host was Bono who is in town to receive an award on St. Patrick's day (March 17). Small dinner at which Bono paid very kind tribute to me for putting together the President's Emergency 1g of Iraq begins. Plan for AIDS Relief. At dinner were Chris Grady, Bono, Sens. Leahy, Dodd, Santorum, Steve Case and wife Jean, Comedian Chris Tucker, Josh Bolten and girlfriend (?name), Jamie Drummond, Bobbie Schriver, Cardinal ? from DC, Father Perry and others.
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Mar. 17, 2003 - Gala St. Patrick's Day dinner and Award Ceremony from The Ireland American League at the National Building Museum. Humanitarian Award to Bono. Chris and I sit at Bono's Table as his guest. Bono recognizes me in his acceptance speech. Pres. Bush gives Saddam Hussein 48 hours to leave Iraq or we will attack.
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Mar. 18, 2003 - Senate passes Project BioShield Bill. I hold meeting on Medical/Chemical Biodefense Research at the Bethesda Hyatt as a sequel to February 26 meeting on Radiological Biodefense. I am trying to frame the landscape of this to pursue an appropriate research agenda.
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Mar. 19, 2003 - Bombing of Iraq begins.
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Mar. 19-28, 2003 - Major focus on war. Push towards Bagdad; massive precision bombing; Iraqi irregulars have executed GIs on El Azeera TV to the horror and anger of USA; SARS is getting out of control. 1500 cases and 53 deaths worldwide. At first, investigators isolated a paramyxovirus (metapneumovirus) at first seen on EM. However, this may have been a mistake since several groups led by CDC are now finding an unusual form of coronavirus (common cold). Briefed the VP on SARS and recent cardiac complication of smallpox vaccine via teleconference. March 27 - Testified with Secretary Thompson on Project BioShield at the House Energy and Commerce Committee. Several members (mostly Democrat) are balking at the mandated appropriations authority. They are reluctant to give up the power of the purse.
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March 28, 2003 - I gave a talk on Bioterrorism at the American Dental Association meeting in DC on March 28. The last person to come to the microphone to ask a question after my talk said that he had waited many years to publicly address me. He related that in 1979, his 7 year old daughter was gravely ill on a respirator with a diffuse autoimmune-like disease that her doctors could not figure out. She was moribund and they were about to give up on her. A doctor said that there was only one doctor in the country that he thought could come up with something and so they called me. Apparently, I spent over an hour on the phone walking through with them a plan for the patient that included plasmapheresis together with cytoxan and prednisone. Within days, his daughter began improving, got off the respirator, spent over a year in rehab, graduated high school, went to Barnard College, graduated first in her class, became a Ph.D. pathologist, got married and had a child. She is entirely well now. He said that he just wanted to thank me publicly for "saving his daughter's life". The audience gave me and him a standing ovation. It was one of the most moving things that I had experienced. the March 29 - April 1, 2003 - It is hitting the fan. SARS is getting out of control. More than 1800 cases and 62 deaths worldwide. 3.6% mortality. Clusters of cases appearing mostly in Hong Kong and China. Now there are 17 countries. USA has 72 cases in 27 states - no deaths yet. It appears that it is spread by respiratory droplets, but also recent evidence that by fine aerosal and objects - not unlike other coronaviruses. I will brief the POTUS this week on SARS. The war in Iraq is raging with troops engaging the Republican guard close to Bagdad. More myocarditis complications with smallpox vaccine. What a week so far!!!
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April 4, 2003 - Big day! US army captures Iraq International Airport. I testify before the House Government Reform Committee on the subject of Project BioShield. Mark McClellan testifies with me. The House (Shays, Waxman, Chairman Case generally support the concept of BioShield, but have some concerns such as with the "permanent" and indefinite Appropriations Authority. After the Hearing I, together with Julie Gerberding and Tom Ridge, brief President Bush, Laura Bush, VP Cheney, and the senior White House Staff on SARS and Smallpox vaccine program. We bring executive order to the POTUS on quarantine for SARS and he signs it. At meeting are Josh Bolten, Karl Rove, Ari Fleischer, Richard Falkenrath, Adm Steve Abbott,, etc. POTUS and VP as usual very warm and complimentary to me and to Julie. After the meeting, I spoke with Josh Bolten and volunteered to go to Iraq for the President if the Iraqis use biological, chemical or radiological weapons on our troops. I offered this to allow a public appreciation of the link (my being a civilian health authority) between Iraq and the danger of bioterrorism against the USA civilian population.
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April 5-9, 2003 - Incredibly busy. I have testified at >6 Congressional Hearings over the past few days on SARS, Appropriations, AIDS, Biodefense, etc. SARS is spreading. Have been on many network TV shows discussing SARS - CNN (several different shows), Good Morning America, News Hour, CNBC, etc. Iraq is falling; Bagdad occupied by US troops.
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April 10, 2003 - Wonderful day. Went with Chris ( my father, Denise and Jack Scorce were also there) to Ellis Island to receive the Ellis Island Family Heritage Award. Other awardees included Yogi Berra, Bob Hope, Cicely Tyson, Abie Abraham (hero of the Bataan Death March). It was a wonderful ceremony with a fantastic video of my history including the ship's manifest with my grandfather Antonio Fauci's name.
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April 11 - 18, 2003 - Iraq war over as troops occupy essentially all of Iraq. Saddam missing as is most of Iraqi leadership. Much attention now focusing on SARS. Cases now at 3400 with 175 deaths. Much media interest. For example, on April 17 alone I appeared on Channel 5 News, Diane Rehm Show, Charley Rose, CNN's Aaron Brown, and CNN International in addition to several print media.
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April 19, 2003 - Just an unrelated historical note to put all of this in perspective. My daughters are doing marvelously well in school and sports. All 3 are virtual straight As (an occasional A-). Megan and Ali excel in gym and Jenny is doing extremely well in multiple varsity sports. She clearly is the best varsity diver at NCS. She is on the first ill . Heis team varsity for cross-country and just this year (junior year) has taken up crew. She loves it and is a starter on the varsity 4 person lightweight boat. Thus far, they are 3 for 3 in meets; I saw a meet at the Georgetown Harbor today.
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April 20-28, 2003 - War is essentially over. Still no weapons of mass desctruction. Still doing an incredible amount of press. Did This Week with George Stephanopoulos on Sunday, 27th April.
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April 29, 2003 - Amazing day!!! Spoke at a Republican leadership lunch at the Senate together with VP Cheney. We were there to promote S-15 (the legislation for BioShield). I was extremely warmly received by the Senators with many complements from Sens. Frist, Hatch, Stevens. I presented my thing and then the VP got up and praised me for my leadership on Project BioShield and made a few comments on the threats. We (Ginger Loper and I) next took the WH limo to the WH for the President's ceremony on the Emergency Plan for AIDS Relief, aimed at drumming up support for the legislation for the plan's funding. The ceremony was supposed to be in the Rose Garden, but was moved to the East Room because of weather. The President was wonderful to me, specifically winking and saying "Hello Tony" as he was scanning the crowd. He then made the comment in his speech to the group that he wanted to specifically thank me for all of my work on behalf of mankind. After the ceremony, he specifically came down to greet people and put his arm around my shoulder and thanked me again for all that I have done. It was a terrific day. April 30-May 1, 2003 - Much effort on my part in working the Congress (briefing Senators and Congressmen and staff) in support of Project BioShield. Clearly the reluctance on the part of the Congress has to do with not wanting to give up the control of the "purse" to a mandatory and indefinite appropriations authority.
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May 2, 2003 - Did "Field Hearing" in Harrisburg, PA for Sen. Specter on SARS. He is running for re-election and clearly wanted to impress his constituents. It worked.
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May 3, 2003 - Great evening. I received the "Golden Plate Award" of the Academy of Achievement. It was a Gala affair at the Mellon Auditorium in Washington, D.C. I was on a panel chaired by Mike Wallace of "60 Minutes" during the day and had a black tie dinner in the evening. Other awardees were Jose Carreras (did not show), Hillary Clinton, Sen. Tom Daschle, Bob Dylan, author and Washington Post columnist Thomas Friedman, Rudy Giuliani, Donald Graham (CEO of Washington Post), Baroness Susan Greenfield, Dr. Robert Sanger, Leonard Lauder (CEO of Estee Lauder), Trent Lott, John McCain, Simon Peres, Franklin Raines, Justice Antonin Scalia, Robert Strauss, Archbishop Desmond Tutu, Alvaro Uribe Velez, President of Columbia. The banquet was attended by all of the Glitterati including President Clinton who was the hit of the night, dancing away like crazy . It was a wonderful time with incredible entertainment including Patti Austen, Ray Charles, Aretha Franklin, and Chuck Berry who drove the house down. article on me in The Financial Times with full ally syndicated Parade Magazine of The x the May 3 to 13, 2003 - Spending almost full time working with White House on trying to shape the BioShield Legislation with the Senate and House. I have daily been briefing senators (such as Sen. Byrd) and staff of the House as well as members such as Henry Waxman, Chris Cox, Fred Upton, etc. on why they should support the President's (Sen. Judd Gregg's) Bill. Congress is reluctant to make the purchase authority "Mandatory, permanent, and indefinite" It seems now that we are winning the battle for mandatory, but it is going to be tough to get permanent and indefinite. We will have to settle for a cap according to the budget resolution and a sunset at 10 years. People at the White House that I am working closely with are Ginger Loper, Candi Wolff, Carol Kuntz, Ken Bernard, Chris Cox, Mike Allen et al. Also, during this time I gave the Commencement Address at Emory in front of 14,000 people and received an honorary degree.
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May 14 - 20, 2003 - Continued doing Congressional briefings and Hearings on BioShield and SARS. The epidemic is appearing to come under control. Spent sometime today (May 20) helping the White House write the POTUS speech on the AIDS initiative. Wonderful thing happened yesterday. The WH is planning a signing ceremony for the AIDS Bill ($15 billion authorization). It was originally schedule for May 28. I wrote an e-mail to Gary Edson and Jay Lefkowitz saying that I had to give the Commencement Address at SUNY Downstate on May 28 and if it occurred then, would they send my regrets to the POTUS. Jay responded by e-mail that since I was the honored guest, they will change the ceremony to May 27. Amazing!
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May 20 - 27, 2003 - Busy time for Bioshield and giving Commencement Addresses (Emory, Albany Medical, Univ. of MD and SUNY Downstate) and receiving honorary degrees (Emory, Albany, Univ. MD, Yale). Major article (feature piece) on me in the weekend edition of The Financial Times; mostly very flattering with the usual few jealous comments from "unamed sources".
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May 28, 2003 - Historic day. President Bush signs the Authorizing legislation for the President's Emergency Plan for AIDS Relief in the Dean Acheson Auditorium of the State Department. Again, he specifically thanked me in his speech for my work on AIDS and for being there. I was given a "seat of honor" in the first row. In his speech the President used word-for-word the sentence that I composed for him describing the initiative as the "largest single up-front commitment in history to an international public health initiative involving a single disease"
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May 31, 2003 - Extraordinary feature article on me in The Financial Times with full page picture and complimentary story.
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June 8, 2003 - Feature story on me in the nationally syndicated Parade Magazine of The Washington Post.
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June 8-18, 2003 - Continued activity and briefings, conference calls concerning the Bioshield Legislation. White House still relying me on pushing the prospect of emerging and reon Iraq with several th Alan Murray and Gloria Borger to mandatory versus discretionary funding for Bioshield. Also a number of network and CNN TV appearances on emerging disease including SARS and monkey pox.
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June 18, 2003 - Went to West Wing of WH to brief General John Gordon the new Director of the WH Office of Homeland Security and Special Assistant to the President for Terrorism. I briefed him on what the NIH Biodefense Research Agenda was. Good guy. We had a nice discussion. Also, delivered a standing room only Grand Rounds at the Lipsett Auditorium on SARS.
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June 19, 2003 - Appeared on a panel at the Council of Foreign Relations with Ted Koppel (Chair), Patti Stonesifer (Gates) and Senator Durbin to discuss "Are we prepared to deal with global pandemics?".
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June 20, 2003 - Appeared on CNN's Lou Dobbs show to discuss emerging and reemerging diseases.
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July 2, 2003 - Attended White House ceremony for the announcement of Randall Tobias as the Coordinator of the President's Emergency Program for AIDS Relief. Randy is former CEO of Lilly. Pres. (as usual) mentioned me and said that it was an honor to have me there. I strongly recommended to TGT that Mark Dybul be appointed in the State Department to the new program to help Joe O'Neill who was clearly emerging as the second in command.
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July 2 - 7, 2003 - Much attention paid to post-war guerilla action in Iraq with several USA service people getting killed in terrorist/guerilla action.
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July 8, 2003 - Attended meeting in Situation Room of the White House chaired by Richard Falkenrath. Attending were Deputies of all of the relevant agencies, Carol Kuntz, Ken Bernard, Jorge Tavel, Bob Kadlac etc. Purpose was to agree upon a long range Plan for SARS called CONPLAN. Also, discussed revamping the organizational structure among the various Agencies for a coherent Biodefense Agenda. Appeared on CNBC's Capitol Report with Alan Murray and Gloria Borger to discuss the President Bushes Emergency Plan for AIDS Relief. I had the opportunity to praise the POTUS for his leadership in this Plan.
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July 9, 2003 - Visited new AIDS Coordinator for the Plan (Randall Tobias) at the State Dept. and briefed him on how the President's Plan came about and how I suggest he implement it. I strongly suggested that he get Mark Dybul to work for him since Mark was so important in putting the details of the plan together.
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July 12-18, 2003 - Trip to Paris for the 2nd Annual International AIDS Society (IAS) meeting. I gave the "Extraordinary Plenary" lecture on Monday, July 14 on the topic of "HIV and AIDS: 20 Years of Science". I was immediately followed by Nelson Mandela who gave a lecture on the societal aspects of 20 years of AIDS. My talk was extremely well received; many said that it was the best talk that they had ever heard me give. There were >5000 people in the main auditorium at the Palais de Congres in Paris. Of particular note was the fact that prior to leaving for Paris, Dr. Brian Brink who is the Senior Vice President for Health of Anglo American Corporation, a gold mining firm in South Africa had contacted me. Brian is an advisor to Mr. Mandela on HIV/AIDS and was asked to write Mandela's speech for the meeting. Brian called me and asked for suggestions about what Mandela should say. I mentioned to Brian that Mandela had been seriously criticizing Pres. Bush for the Iraq war and that it would be very important for Mandela to publicly congratulate and praise Bush for the $15 billion Emergency Plan for AIDS Relief. I said that Mandela would lose credibility if he did not do this. I even made up a paragraph for him to put into the speech. Brian agreed, but said there was no guarantee that Mandela would actually include it in the speech. To my great pleasure, Mandela included the paragraph practically word-for-word. I let Jay Lefkowitz know about this by e-mailing him from Paris. Jay was very pleased and said that he would mention this to the President.
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July 19-30, 2003 - Have had a number of briefings with TGT as well as the VP's staff (Carol Kuntz et al) on various subjects such as smallpox, anthrax, SARS, etc. Constituencies still upset that NIAID will have to do advanced development and some procurement of rPA anthrax vaccine to the tune of about $250 million even though the Congress removed the $250 million from our budget that OMB put in to do this. Josh Bolten (now OMB Director, replacing Mitch Daniels) has allowed us to spend this over 2 years instead of 1 year. Nonetheless it will be a burden. There are philosophical questions here regarding how much advanced development should be done by NIAID versus the drug companies. We are trying to allow BioShield to pay for some of the advanced development instead of limiting it just to the actual procurement of countermeasures.
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August 1, 2003 - Briefing at the White House. Two parts to the briefing. Jorge Tavel and Heather Wingard of CIA briefed on threat assessments and I briefed on Countermeasure Development. Present at briefing were: Carol Kuntz, Stewart Simonson, Andrew Hallman (CIA), Heather Wingard (CIA), Dr. McCreary (DHS), Bill Parrish (DHS), Parney Albright (DHS), Sally Stanfield (DHS), Ken Bernard (OHS), Jorge Tavel (OVP), Richard Falkenrath (for while, OHS), Julie Gerberding (CDC) Carol was very pleased with my presentation as I touched on all of the points that we had previously discussed with the Vice President such as genetically modified organisms, botulism, etc.
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August 1 - 21, 2003 - Summertime lull. Usual issues. Zerhouni pushing his "Roadmap" agenda . Few people can figure out what it really is and how it will be implemented. IOM report on the "Structure of NIH" came out. As usual, they commented on things that they were not asked to comment on. They pushed having greater resources in the Office of the NIH Director and having more "high risk" research to be managed out of the OD as well as trans-NIH research planned out of the OD. Seems like Zerhouni wrote the report. Also, and amazingly, they recommend 5 year term limits for IC Directors with the possibility of only 1 five year renewal.
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August 21, 2003 --I
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August 28, 2003 -- Showed General John Gordon (Director of White House Office of Homeland Security) around NIAID , i.e. Vaccine Research Center where Gary Nabel and I gave him a tour and also Building 40 with Brian Murphy. Gordon loved it and was quite impressed. With us were Stewart Simonson and Ken Bernard.
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August 29, 2003 -- Briefing of General Gordon in Situation Room of White House on update of biodefense efforts. DoD also briefed as did Parney Albright of DHS. I have a new friend in General Gordon. August 30 -- Sept.7, 2003 -- Usual stuff going on. Will return to WH to brief Gen. Gordon again since he asked about my concems where I had mentioned the gaps in Chem. and Rad. Biodefense during my last visit to the WH. Also, have been discussing with Bob Kadlec the possibility of going to Iraq with him to visit the medical people and establish contacts. Moral at NIH very low due to the lack of clarity of Elias Zerhouni as to exactly what he is
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Sept. 11, 2003 -- Briefed General John Gordon in the West Wing of the WH on our plans for Chem/Rad/Nucl countermeasure research. Also, the question of the "breakthrough" by Craig Venter in synthesized the Phi X bacteriophage in 10 days. DoE is selling this as a major breakthrough and the WH has reacted by wanting to restrict the research dissemination. I argued that this is important, but it is not a conceptual breakthrough, only a derivative improvement in technology that is already widely disseminated in Biotech companies and private scientists. I argued for transparency as well as cultivating a culture of responsibility among scientists by a RAC-type approach to this research. Present at the briefing was Gen. Gordon, Stewart Simonson, Ken Bernard, Fran Townsend (Deputy to Gen. Gordon and former CIA Associate Director). They loved the briefing. They want me to brief the deputy secretaries tomorrow and Andy Card next week.
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Sept. 12, 2003 -- Gave another briefing in the Situation Room of the White House to General John Gordon. Present were Ken Bemard, Carol Kuntz, Robert Card (Deputy Secretary of DoE), Ari Patrinos, Phil Russell, Larry Kerr, Harriet Meiers -- Deputy to Andy Card. Topic was the Craig Venter situation. I presented the facts and pushed for an NIH RAC-like approach and argued again for transparency and cultivating a culture of responsibility. Adjourned with Carol Kuntz to her office and discussed the anthrax threat and the capabilities of Al Quaeda in this regard. Will brief the VP within a couple of weeks on a progress report of biodefense at NIH.
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Sept. 17, 2003 -- Another briefing in the White House Situation Room for Gen Gordon regarding Venter issue. DoE did the briefing (Ari Patrinos) and I presented the proposal rwer back finally. of having the NIH Recombinant DNA Advisory Committee (RAC) serve as a mechanism to provide a "culture of responsibility" among scientists similar to what was done in the mid-1970s. At the briefing was the usual people - Gen Gordon, Ken Bernard, Richard Falkenrath, Carol Kuntz, several DoE people, WH communications people, etc. Decision was to put together a briefing for the Secretaries.
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Sept. 18 -19, 2003 - Went to NYC to give Plenary Lecture at the AIDS Vaccine 2003 meeting. While I was there, Hurricane Isabel hit Washington, D.C. and there was widespread devastation with major power outages (3 million people in DC, VA, and MD without power). Power not expected to be restored for at least 1 week.
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Sept. 24, 2003 - Power back finally.
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Sept. 25, 2003 - White House meeting with Jay Lefkowitz, Gary Edson, Mark Dybul, Joe O'Neill, Carol Thompson to discuss the controversy regarding $2 Billion versus $3 billion in FY '04 for the President's $15 billion, 5 year plan. Bono and other activists want a full $3 billion in '04. However, if we did that, then we would put less in '05, '06, etc. I recommended to Jay et al to stick with the Plan and leave flexibility to match other funds by 1/3. See below my e-mail to Jay from 9/25/03: Jay/Gary: Just a recap of my suggestion from this afternoon for your consideration. Mark was on the same page on this also. I believe that we must remind people and strongly underscore that the President's Plan is a $15 billion program over 5 years involving 14 countries. Within the context of such a plan (we must emphasize this point), the best way to spend the money and thus to save the most lives is by phasing in with $2 billion in the first year and more than $3 billion per year in subsequent years. We all realize that more money can be spent globally on AIDS and thus more lives can be saved. This is a no-brainer. We never said that the President's Plan of itself would cover all of global AIDS. We should not get into an "absorptive capacity" argument since no matter how clear we are, people will confuse absorptive capacity in the President's Plan of 14 countries and absorptive capacity for the rest of the developing world. I suggest that we take a 2 pronged approach. 1) We stick with the President's Plan as it has been outlined, and; 2) We publicly recognize that more money can indeed be spent on AIDS globally. We are hoping that other countries will follow the President's lead and put more money into programs either bilaterally or through the Global Fund. In fact, we are willing to go the extra mile and to contribute 1/3 of the global effort if other countries rise to the occasion. In '03, the world total was $3.6 billion with $1.4 billion by us (39%). Since we are giving $2 billion in '04, the rest of the world should give $4 billion. If the rest of the world gives more than $4 billion, we will match them by 1/3. Thus, if they want us to give $3 billion in '04, the rest of the world must total $6 billion. If this happens (which it will not), then we will put the additional money into a mix of Global Fund and other countries (beyond the original 14) bilaterally. In this way we show leadership and flexibility. If no one else gives an additional penny, we still are committed to the President's Plan as we have outlined. If other countries meet the above mentioned benchmarks, then we are flexible enough to match them by 1/3. Finally, if the Congress appropriates a couple of hundred million over the $2 billion and the President signs such a Bill, we would give that additional money to the Global Fund and/or additional countries and back up our contention that our funding plan for the 14 countries is indeed sound. I would be happy to discuss this further with you. Thanks, Tony
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Sept. 26, 2003 - White House meeting on Bioshield with the usual suspects - Stewart Simonson, Jorge Tavel, Ken Bernard, Bill Winkenwerder, Larry Kerr, etc. We are getting ready for finalizing the legislation. After the meeting in the EEOB, I went over to the West Wing to see Richard Falkenrath. NIAID will be awarding 2 NBLs (BSL-4 labs) and 9 RBLs (BSL-3 labs) on Sept. 30. I have been getting incredible lobbying pressure from people like Sen. Hillary Clinton and others for their state or district sites. Chicago is in the running for an NBL and the President is going to Chicago on Sept. 30. The WH wants me to delay the announcement until 2:00 PM after the President leaves Chicago since Chicago got an RBL, but not an NBL and the WH wanted to avoid any embarrassment for the President to be there when bad news arrived.
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Oct. 7, 2003 - Briefing in the Situation Room of the White House for Andy Card on the Craig Venter issue of synthesizing microbes. Also at the meeting were: Tommy Thompson, Spencer Abraham (Secr. Of DoE), Dan Bartlett; General Gordon; Ken Bernard, Harriet Miers (Card's Deputy), Bob Card from DoE, Ray Auerbach (DoE), Bruce Alberts (NAS), Gerry Fink giving summary of Fink Report on "Biotechnology Research in an Age of Terrorism", which is an NAS/NRC report; Stewart Simonson; Carol Kuntz; Larry Kerr; I have essentially been adopted by the WH to be the one who explains the science of Venter's work. This, I was the major briefer. Also, I have been spearheading the NIH effort to create a subcommittee of the RAC to provide the "culture of responsibility" for the scientific community on these issue similar to the 1970s with the RAC following the Asilomar Meeting in 1974.
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Oct. 13, 2003 - Went to White House ceremony (President's speech) and reception to commemorate Columbus Day. The President specifically greeted me in his remarks saying how proud he was of how I was the General in the Global War on AIDS. After the ceremony, I ran into Josh Bolten in the hallway of the EEOB. He asked about my opinion of the controversy of $2 billion versus $3 billion in FY '04 for the President's Emergency Plan for AIDS Relief. Bono has been giving the WH a hard time saying that the President was reneging on his promise when in fact he promised $15 billion over 5 years staring with $2 billion in '04 (see above). He specifically asked my opinion of how Randy Tobias was doing as the new AIDS head of the program. He indicated that he did not think that there was anything wrong, but that he was getting the vague feeling that things were not moving along as aggressively as he thought that they would be. He asked me to quietly check it out.
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Oct. 16, 2003 - Had breakfast (at his invitation) with Jay Lefkowitz at the White House Mess to say goodbye. He is leaving as Director of Domestic Policy Council to return to his law firm in its NYC branch. He will likely return after 2 years for the President's 2nd term (if this occurs). We had a great conversation in which he mentioned how honored he was to work with me on the President's Emergency Plan for AIDS Relief, the MTCT plan and to a lesser extent on the stem cell issue. I sincerely told him that he was second to none in people that I have worked with at the WH over the past 19 years. He asked my help in making sure that the AIDS Plan does not get derailed by the mischief of USAID in trying to lobby the legislation such that power is taken away from Randy Tobias and he would not be given an independent account.
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Oct. 17, 2003 - Went to going away reception in Indian Treaty Room of EEOB at White House in honor of Jay Lefkowitz. Great time just talking to the White House crew and others that I have gotten to know over the past 2+ years: Jay, Margaret Spelling, Kristen Silverberg (just back from Iraq and will replace Jay), Karl Rove, Scooter Libby, Josh Bolten, Ginger Loper (WH Leg. Affairs), Terrell Halaska, Allen Gilbert, Mark McClellan (FDA), Scott Whitaker, Ladd Wiley, Alex Lazar, etc.
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Oct. 24, 2003 - Met with Sen. Barbara Mikulski to try to convince her not to support Rep. Chris Van Hollen's attempt to block the construction of the biodefense building (Bldg. 33) on the NIH campus and move it to Ft. Detrick. He keeps calling it a bioterror building. She was sympathetic, but indicated that we must engage the community more. Fact is....we have been doing this, but a very recalcitrant few do not want to building on campus no matter what. This is the same group that did not want to fence put up around NIH. This is a political issue since Van Hollen made 2 campaign promises: 1) no fence; and 2) no biodefense building. He already lost the first and does not want to lose the second. We will try to work with him. Also present at the meeting were several of Mikulski's staff, Elias Zerhouni, John La Montagne, and Marc Smolonsky. Also, I hosted Julie Gerberding to deliver the NIAID Joseph Kinyoun Lecture and then took her to dinner with John La Montagne, Ed Tramont, Pamela McInnes.
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Oct. 25, 2003 - Had biodefense strategizing meeting at Wye River Conference Center run by Richard Danzig. Discussed issues related to dealing with mass casualties. The usual suspects were there - DA Henderson, Julie Gerberding, David Franz, Michael Osterholm, Bill Patrick, C.J. Peters, George Tavel, people from DoD, FBI, CIA, etc.
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Oct. 27, 2003 - Had a Policy Coordinating Committee for an "end-to-end" analysis of biodefense responsiveness at the White House EEOB. Meeting run by Ken Bernard and Bob Kadlec. Attended by all the usual suspects from each agency - CIA, FBI, DHS, HHS, OMB, OVP, etc. After the meeting I met with Bob Kadlec about the possibility of going to Iraq to interact with the medical and research community. Apparently, the copies of HPIM-15 that I had sent to Iraq through Kristen Silverberg were a smash hit and the Iraqis want very much for me to go to Iraq. However, over the past few weeks there has been a great escalation of insurgency and terrorism with many suicide bombings and rocket and rocket propelled grenade attacks on both military and civilian targets. It appears that the terrorists are targeting the Iraqis who are cooperating with the USA in trying to rebuild the country. Kadlec does not trust the security associated with the ministries of health to provide for my safety. He actually feels that if word gets out that I am coming that I would be targeted by snipers. He feels that if I go, he will arrange for CIA operatives to get me into the country and move around "under the radar" and that CIA operatives would provide my security. We decided to wait a few weeks before resuming plans about going to Iraq and consider going in January/February. Bob will have to go there at this time anyway to continue search for weapons of mass destruction.
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Oct. 29, 2003 - Met with Ray Gilmartin (CEO of Merck) and Adel Mahmoud (Merck) to discuss ways that Merck can collaborate with NIAID in AIDS and in biodefense. Great meeting. Also, discussed how Merck can interact with BioShield process. Anacostia Post lat
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Nov. 3, 2003 - Carol Kuntz informed me that the Vice President wants me to brief him on what we are doing with Rad/Nucl research and countermeasures. This is tough since this is not really my issue; however, the VP wants it and so we will put something together for him
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Nov. 5, 2003 - Meet in my conference room with Israeli Ambassador to the USA - Daniel Ayalon to discuss potential for collaborations with Israel. We got along very well; he is quite engaging. We discussed scientific collaboration as well as our difficult situation in Iraq with the insurgency and terrorism.
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Nov. 6, 2003 - Meeting at the EEOB (White House) to discuss how I will brief the VP on
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Nov. 7, 2003 - Still sorting out the likely anthrax contaminant at the Anacostia Post office. Met in my office today with the South African activist who last year refused to be treated with ART for his HIV because the S. African government was not providing treatment for the rest of the country. He is a very gentle person and a true hero. He just wanted to come and meet with me.
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Nov. 13, 2003 - Met with the PCC (Policy Coordinating Committee) regarding the response to the Fink report. The PCC adopted for the most part the responses of the DHHS to the Fink report. We (Stewart Simonson, Stuart Nightingale, Amy Patterson, Lana Skirboll, John La Montagne) have been working on DHHS's response for several weeks now. Also, I was on conference call this afternoon with Secret Service, DHS, DHHS, FBI regarding a letter that contained ricin that was sent to Greenville, SC; however, now a letter addressed to the White House also containing ricin has been discovered. The discussions among the Secret Service, FBI, Department of Transportation, etc. is chaos. It is somewhat embarrassing. The discussion centered around the investigation and not the public health issues until DHHS (Bob Blitzer) brought up the fact that we really need to find out who might have been exposed. This phone call was like the Keystone Cops!
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Nov. 14, 2003 - Continual conference calls regarding the ricin incident. It turns out that someone crushed some castor beans and stuck crude material into an envelope to blackmail the Dept. of Transportation. Letter was also sent to WH. Bottom line - no health threat.
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Nov. 20, 2003. VP wants me to take care of the Nucl/Rad countermeasure situation since he does not have confidence in the scattered others. Issue is that this is not my primary area of expertise. He wants me to do it anyway. Nice compliment, but this will be a lot of work. Also, Anthrax situation evolving at Anacostia Naval Post Office. Possibly contaminant.
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Nov. 20, 2003 - Went to West Wing of WH to brief VP Cheney on Nuclear and Radiological Threat Countermeasures. As I was crossing Pennsylvania Avenue to enter West Wing at 9:30 AM, there was an alarm that a small aircraft had encroached upon WH airspace. WH was evaculated and many machine gun armed Federal police appeared. After a while they let us in, but the VP had already been scooped off to safety and so the meeting was cancelled and rescheduled for a few days from now. President Bush was in UK at the time.
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Nov. 25, 2003 - Briefed the Vice President today with Scooter Libby, Stewart Simonson, Carol Kuntz and Jorge Tavel in attendence. I spoke about Nuclear/Radiological countermeasures and our need for a strategic plan and the need for someone (us - DHHS/NIH) to take the lead in this since the effort is fragmented and DoD has been neglecting this area since the end of the Cold War. I also gave him a progress report on our microbial biodefense program. He loved both presentations and related to Carol, (who told me) that the briefing was "very impressive, very impressive, in fact great!" I am still having trouble with Zerhouni who is infuriated that the VP's people are "excluding him" from these briefings. In fact, they merely maintain that the VP does not like crowds and he does not like the chain of command to be present on briefings to him. Zerhouni cannot accept that. I am trying to explain this to Zerhouni, but he is just plain angry.
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Nov. 28, 2003 - Significant Influenza A activity already with a variant strain (Fujian) that is not contained in current vaccine. This is quite early for heavy burden of influenza cases. 4 deaths of children in Colorado. Concern mounting that we will have a very bad year. I have been on CNN (X2) CNBC and Good Morning America over the past 2 days to talk about this.
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Dec. 1 - 7, 2003 - Trip to Africa as part of Secr. TGT's delegation. Cameroon (fuel stop + ambassador handshake), Zambia, Rwanda, Kenya and Uganda. Most incredible visit. Included Julie Gerberding (CDC), Elias Zerhouni, Randy Tobias (Ambassador for President's Emergency Program for AIDS Relief (PEPAR), Richard Feachim (Director of Global Fund for AIDS, Malaria, and TBC), Peter Piot (UNAIDS), Amb. Richard Holbrooke (UN Ambassador for Clinton, now representing business coalitions), Bill Winkenwerder (DoD), Senator Don Nichols (R-OK), Congressman Dave Weldon (RFL), Linda Conlin (Assist. Secr. For Trade Development, Dept. of Commerce, Ann Peterson (USAID), plus many other VIPs plus a large number of CEO-types in industry such as Hank McKinnel (CEO-Pfizer), CEO Peter Dolan of BMS, Chris Viehbacher (Pres., GSK), John Martin (CEO, Gilead), Per Wold-Olsen (Pres. Merck Europe/Middle East/Africa), etc. In addition, many people from faith-based organizations such as Father O'Brien (Pres. Les Aspin Center at Marquette) and Shepherd Smith (Institute for Youth Development). Christy Feig from CNN was on board as was Sabin Russell from San Francsico Examiner and Marilyn Marchione from Milwaukee Sentinel. Purpose of the visit was fact finding and to get industry involved in economic impact of AIDS in Africa. So many incredible aspects to trip with the underlying theme that the Africans (particularly in Uganda) are showing that they are ready for implementing the PEPAR and the Global Fund (see below the experience in Tororo, Uganda). Also, many new friends from the delegation. Zambia (Dec. 1-2) - Greeted by US Ambassador Martin Brennan and Zambian Minister of Finance and Economic Development Emmanuel Kasonde and Zambian Minister of Health Brian Chituwo. Stayed at the Zambezi Sun Hotel at the evening had a local dinner (open pit outdoor barbecue) at a Boma. Also, walked down to Victoria Falls which was absolutely breathtaking. Looked across the Zambezi River to Zimbabwe. Participated in a World AIDS Day parade through the city center of Livingston. Many locals came out to greet us. Visited a faith-based organization St. Francis Community Home-Based Care Center as well as LISCA Linda Center giving care to children - called LISCA. Rwanda (Dec 2-3) On afternoon of Dec. 2, flew to Kigali, Rwanda and immediately went to the Genocide Memorial. Clearly this was one of the 2 most important parts of the trip. I spoke with many Rwandans who suffered from the genocide and the enormity of it really is not appreciated by the world in general. In 1994, over a 4 week period in April, the majority Hutus slaughtered 800,000 to 1 million Tutsis while the world watched and did nothing. In fact, the French actually came in to protect the Hutus against Paul Kigame's (Tutsi) rebel army that came in from Uganda to stop the massacre. I ultimately had an audience with now-President Paul Kagame in the Presidential Palace. We also spoke with many Rwandans whose families escaped. (Please refer to history books about the massacre). Of not, as in my visit to South Africa in 2002 vis-à-vis Apartheid, the Rwandan Society in dramatically impacted by the genocide. Most ministers are people who fought together with Kagame to stop the genocide. Those who were there said that atrocities were unimaginable. Machete-killing of tens of thousands of people, women, children per day until bodies cluttered the streets and the rivers. Of note, 13% of the population of 8.2 million are infected with HIV and so AIDS potentially will kill more people than the genocide massacre. During visit, met with US Ambassador Margaret McMillion. Visited Kabgayi Hospital 1 hour outside of Kigali. TGT gave a gift of a cow named "Elroy" (after his hometown in Wisconsin). On the previous night (Dec. 2) we had an extraordinary discussion among the delegation. We had just received a high red alert that there would be a terrorist attack against US interests, particularly hotels and possibly ground to air missiles at aircraft in Kenya the next day. There was a frank discussion at dinner at the Milles-Collines Hotel among delegates led by Jay Hodes (chief of DHHS Security) and TGT. Decision was that anyone among government people could opt out and go straight to Uganda skipping Kenya; however, all non-government people were bumped off and sent directly to Uganda except for a very few like Sabin Russell and some others. I definitely wanted and did stay with the group as did Julie Gerberding and Elias Zerhouni. The Milles Collines Hotel was where the Hutu Command post was during the genocide. The next day we went to Kabgayi (see above), then flew to Entebbe Airport Uganda, left off about 70 people and the remaining 25 - 30 went back to Kenya. We were flying on a German Charter (same one as last year with German pilot Chris who formerly was a Luftwaffe Major). On the approach to Nairobi airport, Chris slowed down for about 15 minutes to "cool" the engine ( to decrease chance of hear-seeking missiles) and then dove sharply to the landing field. All went well. Kenya (Dec 3-4). In Kenya, we went to a rather boring Global Coalition Event and then had a reception at the residence of US Ambassador William Bellamy. Security was depressing. From the airport, we were escorted downtown by a truck-load of Kenyan Army soldiers all with AK47s. The entire perimeter of the hotel was blocked off to traffic and the hotel road had a truck full of soldiers. On my floor (room right next to TGT) there were 3 armed police throughout the night. Next day we went by plane to Kisumu, Kenya to tour the HHS Kisian facilities run by CDC and Kenya Medical Research Institute. We had a nice lunch at the Kisumu Yacht Club on the shores of Lake Victoria. Uganda (Dec 4-5). Flew to Entebbe on Dec. 4, then drove to Kampala to join rest of delegation. During takeoff from Nairobi Airport, pilot Chris made a very sharp and steep turn to the right an up to avoid any possible surface-to-air missiles. Had casual dinner and exchanged stories in Sheraton Hotel. Dec. 5 was clearly the highlight of the trip. Drove to Tororo (4 hour drive) to visit the TASO Program of Home Based AIDS Care (HBAC). We broke up into more than 20 groups of 3 to 5 people and were led into the bush by a lead community person ona motorcycle. We followed in a van. Our lead cyclist was a beautiful 25 year old Ugandan named Irene Athiene. She took us to 2 homes (mud and/or brick complexes) where TASO clients were in their first few months of ARVs that are delivered to them by Trene. In my van was Sabin Russell, Tom Ansfield (Univ. of Wisconsin Medical Center), 2 others and Alex Coutinho, CEO of TASO. Coutinho is amazing!! A true hero. He knew the details of every patient and their families and was truly a man of the land of Uganda. He was totally comfortable in the bush and the clients loved him She lived with her mother-in law and about 7 children. Note -- she was one of 3 wives of the husband who died last year of AIDS. One of his other wives died of AIDS and the other left for Kampala (HIV-status unknown). Of the 7 children only 3 ver and the others were from the husbands other wives. She had just lost her 1 year old baby to AIDS and 2 of the other children of other wives were infected with HIV. She was taking care of all of them with the help of her teen-age daughter. Her 17 yo son helped out by working. She owns 6 acres, 3 pigs and some chickens. Ugandan women cannot own turkeys. Her husband stone grave was clearly visible on the property. Her major concern was to stay alive long enough for her 17 yo son to become 18 so that he could inherit the land. It is tradition in Uganda, that when a man dies of HIV, when his wife then dies of HIV or anything else, the property goes to the brothers-in-law unless there is an adult male in the house. P| in-laws have been abusing her since her husband died and she did not trust them. The Ugandan government under Pres. Museveni is trying to change some of this. She was a wonderful and courageous woman who understood very well what HIV was, what her CD4+ T cell count was (10 cells) and how she would need to train her children to avoid infection. The myth that one cannot deliver treatment, prevention and care in rural Africa is just nonsense, particularly here in Uganda._The second home was that of a40 yo woman with a similar story to that of =_ She live in an extended family compound of 6 huts. She too had children (3), but none were infected. The "co-wife" moved to Kampala after the husband's death. Also living there is her brother-in-law who is infected, her mother-in-law and several children. lis very serious, but incredibly dignified. She is highly intelligent and knows all about her disease (CD4 count, etc. 179). TASO is working miracles here. Also, on ana were 2 graves -- her the > of Tikrit, Iraq!! husband and other brother-in-law. She is not abused by her in-laws and states proudly that they love her very much. It was clear from their reaction that she was correct. After Tororo, we went to the Grandmother's (JAJA/Mildmay) house in Jinja, Uganda. This was a beautiful facility that was more a referral facility that a primary care place. Next day (Dec 6) went to Mulago Hospital grounds and visited the TASO Mulago Center for a ribbon cutting of a new building largely built by Pfizer through a donation from Hank McKinnel. It is a beautiful facility. After this we went to Entebbe and visited the Uganda Viral Research Institute on Lake Victoria. I gave a small speech. The Rakai group supported by NIAID gave a booth presentation led by Noah Siwanuka (Spelling?). After this we had dinner at the Lake Victoria Hotel in Entebbe and took off for Frankfurt right after midnight on Dec. 7 with a fuel stop in Larnaca, Cyprus. General Comments: See above in Introduction. Also, in Uganda, CDC program director Jonathan (Jono) Mierman was wonderful...very enthusiastic and goodaggressive person. Also, interacted with Minister of Health Jim Muhwezi. He has an interesting history. He is trained as a lawyer, was a political activist against Idi Amin and Mobutu. Was jailed, shot himself (3 escaped and 1 was killed) out of jail, escaped to a hotel that was surrounded by hundreds of troops that were looking for him. He dressed like a woman and slipped away right in front of the soldiers. He escaped to the North where he joined Museveni. He became a Brigadier General in the Ugandan resistance army and after Museveni won, he was made chief of intelligence. After 10 years there, he was made Minister Of Health. Similar to the Kagane story in Rwanda, practically all of the ministers started off as fighters in the resistance army with the person who ultimately became President, in this case Museveni. None of these places are really a democracy since opposition parties are generally restricted. It just happens that Museveni is an enlightened President. Became friends with Tommie Thompson, TGT's daughter who is very nice. Also, developed beginnings of bonding relationships with many people including Sen. Nichols, Cong. Weldon, Randy Tobias, Richard Holbrooke and many of the staff at HHS that I already knew well, as well as Elias Zerhouni. As experienced as I am, I was greatly moved by the trip. I learned much and was deeply moved by the experience in Tororo. I felt so good and yet humbled about my role in developing the $15 billion PEPAR program. It may turn out to be my greatest accomplishment.
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Dec 7, 2003 - Major scandal at NIH with article in L.A. Times that shows that high NIH officials including Steve Katz, John Gallin and others have made hundreds of thousands of dollars consulting for pharmaceutical and biotech companies.
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Dec. 8-10, 2003 - Much media attention regarding the Fujian strain of influenza and the early indications of a bad season with deaths of children in Colorado and elsewhere. Vaccine has run out and people are panicking. 83 million doses distributed. I have already been and will be on CNN multiple times, MSNBC, CNBC, CBS, etc.
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Dec. 13, 2003 - Saddam Hussein captured by US Army outside of Tikrit, Iraq!! Leave for Iraq!
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Dec. 16, 2003 - Went to dinner reception at the home of Assistant Secretary of Defense for Health Affairs William Winkenwerder in honor of Dr. Khudair Abbas, Health Minister of Iraq. Present among others were Kristen Silverberg (who spent time in Iraq - see above regarding the books of HPIM-15 that I sent to Iraq), Ken Bernard, Surgeon General Richard Carmona, Congressman Fred Upton, etc. Iraqs really want me to go to Iraq for moral support of the Iraqi medical establishment and health system. They were all very appreciative of the books that I sent. It is still very dangerous in Iraq, but I am pursuing going with Secretary Thompson in Jan/Feb if possible.
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Jan. 21, 2004 - Over the past month a number of issues have arisen. There have been 34 cases of SARS in China. The Fujian strain of Influenza A escalated and now is declining. It may be that it was just a moderate year that peaked early and had people worrying about it being a catastrophic year. It may turn out that it was not that bad. Big worry is the appearance of H5N1 with 4-5 cases of jumping from chicken to man in Viet Nam and massive chicken illnesses and deaths in Viet Nam, S. Korea and Japan. We are all busy in planning for a potential pandemic flu. No transmissions from person to person. Also, we had been working on the document in response to the IOM report on "dual use" microbes. We (HSC, DHS, etc) established a Memorandum of agreement and a Charter for the National Science Advisory Board for Biosecurity to advise the Secretary, HHS, the Director, NIH, and the Secretaries of all of the Agencies involved in the conduct and support of potential dual use research in the life sciences. I presented the MOA and the charter to the Deputies in the situation room in the White House. It was well received and will ultimately be signed by the Secretaries. On the way out of the WH, I saw Margaret Spellings who said that the President was talking about me today in that he wanted to be briefed by a group including me and Julie Gerberding on prevention of HIV/AIDS by abstinence, be faithful and condoms (ABC). Jan. 21 - Feb. 25, 2004 - Very busy with many issues. Two Congressional Hearings: 1) House Gov. Ops - Pandemic Flu; 2) Full Approp (Senate) on BSE. Also, much stress with situation of outside activities. I was "interviewed" by Alan Slobodin as was Andy von Eschenbach, Francis Collins, Don Lindberg and ethics offices about "lecture awards". Does not appear to be a problem for me, but they will likely force much greater restrictions on outside activities. White House (Gary Edson) has asked me to put together a proposal for eradication of a few "neglected diseases" in developing countries similar to what I did for the PEPFAR. I was very persistent and finally got into TGT's party to go to Iraq. I feel almost an obligation to do this for my country even though I must admit it is a bit scary. It sounds corny, but it is the "Band of Brothers" feeling that I seem not to be able to get away from. I am a visible public servant and this is what I do. This is probably the most dangerous situation I will have ever been in. Will report details when I return.
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Feb. 26, 2004 - Leave for Iraq! Feb. 26 - Mar. 1, 2004 Feb. 26 - Left for Amman, Jordan - Iraq on a Gulf Stream air force aircraft from Andrews Air Force Base. Trip purpose - "show the USA flag" in the context of health issues and determine whether the USG/DHHS/NIH can do more in the Middle East. On the trip was Secretary Thompson (TGT), Andy von Eschenbach, Bill Steiger, Press- Sanjay Gupta, Christy Feig and Joe Farre (CNN) and Mark Sherman (AP); Security - Jay Hodes. In Amman/Iraq we met Charles Curie (Head, SAMSA), Howard Zucker, Dr. David Smith (Humanitarian and Refugee Services), Andy Knapp and Mike Lonetto (Security advance), Adm Van der Wagner (USPHS). We landed in Marka Airfield in Amman and almost immediately changed planes to an Air Force C-130 to Baghdad. This would turn out to be one of the most memorable days of my life. In the approach to Saddam Airport we did a sharp "corkscrew" landing in which it felt like the plane flipped over. The airforce guys explained that this is the way that they avoid shoulder to air missiles as well as sporadic fire from AK 47s. In addition, the airport gets randomly mortared every day. These are just pockets of insurgents that rarely hit targets, the real targets are the convoys of troops accompanying cars (like ours) and isolated troops on patrol, as well as more recently, Iraqi police and officials who are trying to rebuild the country. We went from the airport to the "Green Zone" (relatively safe with high security, despite the fact that rocket and mortar attacks occur on almost a daily basis; these usually do not hit specific targets, but do cause casualties) in Baghdad with several car-loads of Special Forces and DoD Criminal Investigation Division (CID) security people and 4 Humvees full of Military police manning M-4s and fixed machine guns. The ride to Baghdad was thrilling and frightening. The alignment of the motorcade was that every time we passed a person(s) walking along the highway or a parked car or truck, the special forces car would insert themselves between the suspects and TGT's car (I was riding with TGT). When we passed an overpass or a car on our right, the Military police would aim their machine guns up at the overpass and swing around the turret of the machine gun as we passed the overhead. The reason is that frequently insurgents drop grenades from overpasses and run. We passed cars driving with people or when cars pulled up alongside, the military police and special forces would wave them over and point their guns directly at the driver. Reason - frequently, isolated cars drive by and shoot at the convoy. First stop - meeting with Ambassador Paul (Jerry Bremer) in his office in the imperial Palace formerly main palace of Saddam and now headquarters of the Coalition Provisional Authority (CPA). Tom Foley (Bremer's Deputy) was not present, but we met him later on in the trip). Had great discussion of the difficulties in transition to the governing council. He made an interesting statement that democracy is a concept that is foreign to the Iraqis. They are taking a lot of time with their constitution and agreeing on their form of government since they seek "consensus". Democracy means that the majority rules, and as we see in the USA, the minority has much power and the balance can and does changes. The Iraqis are not used to the majority winning a vote since historically, minorities get persecuted. They need to understand that minorities are minorities for a particular idea/law/regulation and that Sunnis, Shia's and Kurds can be minority, majority or both. Sunnis and Shia's can live together since there are many, many mixed marriages. Highly intellectual discussion. Bremer is an impressive man. Also, met Jim Haveman who is the USA Health person (also impressive). Jim was with us for most of the remainder of the trip in Iraq and Jordan. He thanked me for the books that I sent to Iraq from McGraw-Hill. Had lunch at the home of MOH Khudair Abbas. Present at the lunch was Dr. Ebrahim Al-Jafari, head of the Shiite Party and member of the Iraqi Governing Council (IGC)and Dr. Rajaa Khuzai a women OB/GYN physician and also member of the IGC. Had a very stimulating conversation regarding Iraqi politics, the history of Iraq medicine and how Iraq was the "jewel" of medical care and training in the 50s, 60s and early 70s. When Saddam came into power, he diverted money to weapons and neglected health. The system deteriorated and now it is terrible. They want to restore it. I also heard first hand of the cruelty and true insanity of Saddam and his sons Uday and Qusai and how they tortured and killed at will. Many of the people at lunch lived in exile or remained in Iraq, but had relatives who had been jailed, tortured or killed. The defining experience of the day was the visit to IBN Sina Hospital which is the combat (trauma) support hospital. I had to constantly hold back tears. Everyone carried a weapon in the hospital, even the doctors and nurses performing procedures in the OR or trauma rooms. I say young kids (18-25 yo soldiers) with bullet wounds in the face. Common wound is a cheek-through-cheek bullet that either kills the victim or goes right through without hitting vital structures. I am told that it is a common wound by snipers since the troops wear body armor up to their neck and a helmet down to their eyes. It is one of the few exposed parts. One such soldier was wheeled in as we were touring the hospital. He had just been shot. I say shattered legs, abdominal wounds and Iraqi citizens shot in cross-fire and Iraqi insurgents getting x-rayed with a special forces person pointing an M-4 at him in case he tried to escape. I saw an Iraqi collaborator who was helping the Special Forces in the North and another Iraqi came up to him when no one was around and shot him in the back of the head. The bullet miraculously went through one posterior jaw and exited the face. When taken to the hospital, he told the SF who the attacker was that left him for dead and the SF had just left the hospital to "take care of him". Many army physicians and nurses recognized me either from TV or more often from Harrison's. I ran into a young neurosurgeon - Major Koop who knew me from HPIM. Upon return to the airport via "ambush alley", the 2 main Humvees of the 4 that escorted us back had young women at the machine guns. I inquired about this to our SF driver and he said that as of this week, women soldiers have more confirmed kills than men soldiers. Upon take off, we had the same corkscrew maneuver, but this time 2 airmen were at each window with radio contact with the cockpit in case they saw puffs of smoke or flashes indicating a shoulder to air missile or Ak-47 , at which point they would alert the pilot to divert. Landed in Amman; we did not sleep at the Rasheed Hotel in Baghdad since it was recently attacked with rockets while Paul Wolfowitz was staying there. Had a marvelous dinner at the home of the Jordanian MOH - Dr, Said. S. Darwazah. Also present was our team (minus the press), plus the US Ambassador to Jordan (Edward W. "Skip" Gnehm), Dr. Samir Khleif, (NCI), Director of the King Hussein Cancer Center in Amman and Said's brother Mazen and his father Samih. We talked for hours about the complex issues of Israel and Palestinians and Iraq and USA. It is clear that they want to live in peace with Israel, but they all feel that the USA in unfairly siding with Israel on not disallowing settlements. Clearly, one of the most stimulating evenings I have spent. The Jordanians are truly wonderful people and very friendly and affectionate to Americans. The food was incredibly good.
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Feb. 28, 2004 - Visited the King Hussein Cancer Center in Amman. Dr. Samir Khleif showed us around the modern facilities that have NIH-style telemedicine in real time. Toured the pediatric cancer wards with patients who had ALL, squamous cell carcinoma of ear and other tumors. There is a Jordanian Program called Project Iraq in which selected patients are chosen from sick Iraqis and are transferred to the Cancer Center for treatment. We say several Iraqi mothers with their sick children. Had a nice warm conversation with Princess Ghaida Salaam who is married to Prince Talal ibn Muhamed (Nephew of the late King Hussein) and Princess Dina who is also married to the nephew of the late king. Both women were beautiful, articulate and spoke perfect English. Princess Ghaida is the Chair of the Board of the Center and she recognized me from TV and said that she always wanted to meet me. I showed her my Harrison's textbook in the KHCC library. She spent years in DC and graduated from Georgetown in the 1980s. After the tour we had lunch and discussed the various programs. Afternoon was free and we visited archeological ruins in Amman. That evening, we had dinner at the home of Princess Ghaida. This was a most unusual evening; I was incredibly impressed by the Princess's husband Royal Prince Talal bin Muhamed. He and Princess Ghaida both graduted from Georgetown in the 1980s. He gave me a wonderful history of the Muhamed family that descended from King Faisal I, hundreds of years ago. The family split and one line took over Jordan and the other first went to Syria and then Iraq. He knew Sadam and his sons since he was a little boy and he feels that they were horrible sociopaths. He used to play with them as a child during visits to Iraq and vice versa for Jordan. Sadam gave him several guns as gifts. In Arab countries, a gift of a gun is a show of respect and affection. Talal was the favorite of his uncle King Hussein and told many stories of his loving relationship with the King. He proudly showed me his incredible gun collection (rifles, shotguns, and pistols). He was in the Jordanian paratroopers, is a polo player and rides motorcycles. I feel that this person could really be my friend if circumstances allowed. Very intellectal and stimulating discussion at dinner regarding the war in Iraq and the Israel-Palastine situation. He fees that the USA should have military rule in Iraq for 5 years before even considering handing over the government to the Iraqis. He said that the Iraqis would understand and respect this since what they want most is security. He feels that a situation similar to MacArthur and Japan would be desirable. We discussed how this would not be feasible politically in the USA, i.e. having a long-term occupation of Iraq. He is afraid of the instability that would follow in Iraq and the region if we handed the control of the government over to a governing council (which he feels is made up of some good people, but some people with no credibility such as Chalaby). In addition, he feels that the US military is so respected for their force and discipline, that this is the reason why the Iraqis fled. He stated that the Iraqis are a "fierce" and proud people and if the UN or the Poles and Spanish took over the security, the Iraqis would chew them up and anarchy would prevail. He states that no Arab country wants the USA to leave any time soon. a)
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Feb. 29, 2004 - Last day in Iraq...mostly in the red zone. Some very exciting and somewhat scary moments with the convoy getting caught in traffic in another "ambush alley" (narrow streets and high buildings where insurgents frequently shoot down on US troops from roof-tops or windows). During several of these "stalls" in traffic, the special forces, military police escorts and the CID (criminal investigation division) of the army jumped out of the cars and ran alongside with their M-4s pointed a the roofs and windows. They also ran up to cars that were blocking traffic and pointed drawn pistols and cocked M4s right into the cars to get people to move. Visited the MOH in the AM, the Women's clinic, had lunch with Iraqi health people. This was all in the "red zone" and the SF had sniper observers on the roofs of the buildings surrounding the facility that we were visiting. We then left for the airport had a wonderful dinner at Baghdad airport (Bob Hope Dining Hall) with the troops of the 1st Armored Division, Military Police Brigade, the First Cavalry, and the 101st Airborne. Our troops are incredible, including the women. They are extremely well disciplined, polite, good looking and nice. General Scaparroti (Chief of Combat maneuvers) brought TGT and me into the "classified" command room of the base and showed us how they track hostilities on a real time giant computerized map screen. Met an incredible woman Major Rogers who was a beautiful, articulate and smart, 35-ish deputy chief of intelligence for the command. Also met Col. Flake who was the combat coordinator - one tough looking soldier. Also met Major (Doctor) John McGrath from the Medical Corps. He knew me right away since his wife is a physician (Allergist/Immunologist) and always talks about me. He asked for and got a picture of us together. Finally, we flew on Blackhawk helicoptors to Balad AFB to catch a C-17 to Rhein-Main AFB in Germany. The trip on the Blackhawk was tense and exciting. I sat 2 feet from the machine gunner who was focusing on the ground looking for flashes from small arms fire that happens all the time and usually misses the helicoper. As soon as they see a flash they immediately strafe the area with the M-50 machine gun. We flew all in the dark to avoid detection. We landed at Balad, stayed for awhile and mixed it up with the troops and then flew to Rhein-Main AFB near Frankfurt. From there we picked up the Gulfstream and flew back to Andrews AFB. We landed at 6:00 AM, March 1, 2004.
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March 2-19, 2004 - Following the Iraq trip a number of relatively important issues have arisen. There is sweeping interest in the conflict of interest arena with EZ forming a Blue Ribbon Panel on Conflict of Interest chaired by Norman Augustine and Bruce Alberts. Also, the NIH Ethics Advisory Committee (NEAC) is now reviewing all out side activity requests (as well as any already approved ongoing outside activities) for high ranking NIH officials such as IC Directors, Deputies, Scientific Directors, Clinical Directors, etc. The NEAC is co-chaired by Raynard Kington and Michael Gottesman. Happily they have approved my ongoing activities, including Harrison's. I met with the Blue Ribbon Panel and urged them to distinguish between outside activities that could be conflictual such as consulting for drug companies and those that are purely academic such as writing, editing, lecturing (not on your immediate work) and awards. They seem to "get it". I hope that their recommendations reflect this. Several investigations will come including GAO, IG, and a least 2 Congressional Committees. Also, the Congress is developing a subliminal hostility towards NIH because of the prior doubling of the budget and because our advocates are still screaming for a 10% increase in FY2005 instead of the 2.5% increase of the PB. Sen. Dominici called the NIHers "pigs" who are never satisfied. Moral in quite low. Good stuff going on with Gary Edson and the "neglected diseases" project. He really likes the proposal that I put together for Lymphatic Filariasis (LF) and leprosy and malaria. We are going through the exercise now of several meetings back and forth in deciding what to have the POTUS propose to the G-8 meeting in June in Sea Island. They want to have the POTUS show global leadership and urge the other G-8 countries to put up money and get involved; however, since we are already doing so much, he wants us to put up very little new money. We will probably have to re-direct money - no good deed goes unpunished. Gary also wants me to explore the possibility of making the HIV Vaccine Enterprise a possible proposal. He had spoken to Patty Stonesifer and she mentioned that Rick Klausner and I were working on this together. John Kerry won Democratic nomination prior to convention and he and Bush are going at it already. The big issue is the terrorism that is going on in Iraq with foreign Muslim extremists with ties to Al Quaeda almost daily blowing up mostly Iraqis and some US soldiers. Massive terrorist attack in Madrid a few days ago with bombs in trains; hundreds killed. Muslim extremists claim responsibility and say that they did it because Spain has helped the USA in Iraq. Incident occurred right before the Spanish elections and resulted in overthrow of the Party that supported Bush.
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March 24, 2004 - Had interesting and full day. Went to the National Defense University at Fort McNair, Washington, D.C. to participate in the DHS exercise of a hypothetical aerosolized anthrax attack on Chicago. It was for the benefit of press leaders. Secretary Ridge, Susan Neely (Assist. Sec. for Public Affairs, DHS), Ed Thompson (CDC) were the main players. It was exciting and the press totally enjoyed it and got engaged in active Qs and As. Virtually all of the senior producers and correspondents of networks, CNN, Fox, etc were present as were top print media. Frank Sesno (CNN) moderated it and Aaron Brown (CNN) was present. Tom Ridge relied virtually totally on me to answer medical questions. Also, had meeting at PEPFAR Headquarters (2100 Pennsylvania Avenue, N.W.) with Gary Edson, Randy Tobias, Robin Cleveland (OMB), Mark Dybul, Joe O'Neill and Ambassador Lange to discuss how we can work an AIDS issue into the upcoming G-8 meeting in June at Sea Island, GA. Gary and I proposed the possibility of highlighting the HIV Vaccine Enterprise that Rick Klausner and I have been working on for the past year. It would cost the USG virtually no new money since the "Enterprise" is a virtual organization that is proposing a strategic plan as described in our Science article. The POTUS can urge the G-8 countries to make a political commitment to make the Enterprise work.
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April 2, 2004 - White House (Situation Room) - Had meeting today as a culmination of a series of PCC meetings related to preparedness against pandemic influenza. We have been working with DHS, the VP's office and DHHS to develop a white paper of needs and plans. Today we brought it to the PCC + deputies (Claude Allen of DHHS). Meeting was chaired by Richard Falkenrath. Present were several WH and departmental people including Kristen Silverberg, Ken Bernard, Carol Kuntz, Bill Winkenwerder, Stewart Simonson, Allen Gilbert. We came to a good understanding of what we are ultimately going to put before the full deputies and ultimately the Principals.
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April 5, 2004 - White House (West Wing) - Met with Gary Edson. Attending were Carol Thompson, David Nelson and Gary's assistant Martina Strong. Discussed the G-8 issue regarding Gary's concern that the other countries will bring up the issue of generics and PEPFAR, i.e. the false impression that we (USG) are against generics , particularly the generic fixed dose combination of D4T, 3TC and nevirapine. Gary does not want the POTUS to be embarrassed if others blind side him with this. The PEPFAR people (Tobias et al) should have straightened this out at a recent (March 29-30) meeting in Botswana. There was a debate about WHO "pre-qualification" of these drugs and our concern about the criteria and data upon which these drugs were pre-qualified. Also, we discussed the issue of the POTUS proposing an endorsement of the HIV Vaccine Enterprise as our AIDS proposal for the G-8 meeting in June at Sea Island, GA. We will work with Gates (Patty Stonesifer) to endorse this, but the Gates Foundation is going to want us to promise even more money for an AIDS vaccine. Note that we are already spending>$500 million, vastly more than all other groups put together. Gary will rewrite the POTUS's G-8 proposal regarding the Enterprise and run it by me, Kristen Silverberg, Secretary Thompson, Amb. Tobias before we launch it to the G-8.
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April 6, 2004 - White House (EEOB) - Met with Kristen Silverberg, Robin Cleveland, Randy Tobias, Mark Dybul, Alan Gilbert, Press person from WH (?name, a woman), Joe O'Neill, and others to discuss issue of the bad press we are getting regarding the misperception that the USG and PEPFAR will not buy generics, particularly the fixed dose combination (FDC) of D4T, 3TC and nevirapine that CIPLA and Ranbaxy are selling. Decision was made to have Randy Tobias write and Op-Ed for The NY Times or the Washington Post (I will review it for him) and then have me and Randy as necessary do the TV circuit to get the truth out , i.e. that we will buy any drugs , even generics, so long as they are of high quality (safe and effective) and the lowest possible price.
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April 6-12, 2004 - Not much opportunity to implement issue above on April 6 because the entire Press is consumed with the deteriorating conditions in Iraq. Major insurgencies by both Sunnis (Fallujah) and Shiites (Baghdad) against American troops. Several US troops are getting killed each day and insurgents have resorted to kidnapping civilians from other countries who are working in Iraq, i.e. Japanese, Australians, UK, Chinese, etc. Bad situation that is getting worse.
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April 13, 2004 - White House (West Wing) - 2 meetings. First regarding the issue of the HIV Vaccine Enterprise and whether we should make this an initiative for the POTUS to present at the upcoming G-8 Summit in Sea Island, GA. Present was Kristen Silverberg, Martina Strong (Gary Edson's assistant), Joe O'Neill, Carol Thompson. I presented the idea to Kristen and explained what Gary and I had been working on for the past several weeks. I explained how we wanted the POTUS to challenge the G-8 to endorse and support the enterprise. The USG is already investing for FY-04 about $488 million while the entire world's contribution (including the USG) is about $600 to $640 million (these non-USG numbers are estimates. Hence, most of the action is us. She liked the idea and wanted to pursue it. She said that it would be a home run if we could spice it up with some new money. She mentioned about $100 million. I brought up that the usual scenario would be that NIH would have to absorb this "new" money since there really is no new money. Kristen feels that if anyone can squeeze new money out of Josh Bolten, it is me. She is going to bring the issue up to Josh. The second meeting was with Kristen, Joe O'Neill, Carole Thompson, Mark Dybul, Randy Tobias, Jenday Fraser (new US Ambassador to South Africa). Meeting took place in Margaret Spellings office since it is one of the larger offices. Margaret was not there. Discussion was regarding the options of how to address the FDC/generics situation in the context of the PEPFAR. We discussed a number of options. Our goal is to get the lowest possible price for drugs that are clearly safe and effective. Big issue with FDA since they clearly will not approve a drug based only on "pre-qualification" by WHO. There is much misunderstanding (see above) about the USG supposedly blocking generics since we are in the pocket of PHARMA. This is nonsense since we are concerned that we will be buying drugs that are not even generics; they are "knock-offs" from branded drugs. I like the option of pressuring our drug companies to put 3 drugs in a blister-pack (would take 1 month for the FDA to approve) to avoid the issue of potentially low quality Faces. Other good option is to work with the FDA to speed approval (probably take 1 year since you would have to do some pharmacokinetics and bioavailability studies first) of FDCs contained the branded drugs. Simultaneous option would be to ask the South African Medicine Control Council (their FDA) to regulate the knock-off FDCs and to only buy it if they approve them. This would be Africans making decisions for Africans. The only problem is that if they reject the drugs, it might look like a typical erratic South African move, i.e. Mbeki and Shabalala Misemang are notoriously weird. Alternatively, if they accept the drugs with scrutinizing them and they are no good, we would be buying bad drugs.
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April 14, 2004 - White House meeting (EEOB 476) with Gary Edson, Rick Klausner, Rachel Ingram (Gates) and David Lane (Gates), Martina Strong, Carol Thompson to discuss the role of the Gates Foundation in the HIV Vaccine Enterprise. Rick presented the same case as I did and said that Gates would be willing to invest $100 million this year and that the whole project would probably need $400 million per year for 10 years. He wanted the USG to try to put in more money. Gary was concerned about the fact that we have no new money, although he really likes the Enterprise concept. After Rick left, Gary and I discussed how much if any money would be feasible to invest as new money. As opposed to just challenging the G-8 to join and endorse the process. He wanted to think about it more. One of the issues that he brought up even when Rick was there was the problem of doing something and then getting criticized the way that we have been criticized about PEPFAR.
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April 15-16, 2004 - Series of phone calls and e-mails involving Gary, Kristen and me. Apparently, Kristen really likes the idea about putting some substance (new resources) into the POTUS proposal to the G-8 and Garry asked me to cost out a real center a virtual center and also a vaccine production plant. He sent it to Kristen who asked me for some clarifications and now will run it up to Josh Bolten. This may be a go if we can convince Josh to get some new money. I coasted a real center (with walls) at $55 million for construction and start-up and $47 million for annual operations. I costed a virtual center as $15 million start up and $51 million annual operations. Kristen asked me to brief Alex Azar (General Counsel for HHS) to see if we need any special authority/legislation (similar to BioShield) to make this work more quickly and smoother. She will be out for a week and then we will resume. I handled these calls and e-mails while on a quick trip to Chicago to give a talk at the Clinical Research 2004 meetings. I spoke on Emerging Infections.
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April 19, 2004 - Extensive phone conversation with Josh Bolten (OMB Director), Jim Capretta and Tom Reilly (OMB) regarding the details of my proposal for the "virtual" center for HIV Vaccine as described above. I described in detail the entire proposal to Josh. Josh was very supportive. Issue was where to get the $15 million start-up costs for '05 and the $51 million yearly costs. Josh indicated that he would figure out where to get the money. More than likely that we (NIAID) would have to absorb a portion of it.
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April 20, 2004 - Had nice lunch with Jay Lefkowitz today at The Oval Room on Connecticut Avenue. Beautiful warm Spring day. Jay just wanted to catch up on things with me. We discussed the PEPFAR and the issues associated with it; and the new G-8 proposal that I was working on with Gary Edson. Kristen Silverberg, and now Josh Bolten. Also talked about war in Iraq and the POTUS. Jay also inquired about what I want to do differently if anything. I told him that I wanted to remain in public service and the Secretary of HHS is a job that I would not strive for or promote myself for, but would not refuse if asked. He is thoroughly enjoying his private sector life. After lunch, he invited a friend (Christine Carlisle Jones) to the table for coffee. She is the CEO of a company that is working on freeze preserving eggs from women who might be getting chemo, and he wanted her to meet me. Very attractive and intelligent woman in her 30s. It was great to spend time with Jay. He has become a good friend.
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April 21, 2004 - Busy day! Beautiful sunny day.Testified at my House Appropriations Subcommittee (Chaired by Ralph Regula) in the AM , then rushed to brief Senate and House Staff (at Dirksen 116) from the Homeland Security and Appropriations Subcommittees on progress of Project Bioshield and its possible use to procure drugs for pandemic influenza. Many people present such as Bettylou Taylor of Senate Majority Appropriations, Craig Stevens of House Majority Appropriations and a variety of staffers from Homeland Security Committees, the latter were as usual disdainful of DHS. Bad news relationships between DHS and their respective committees. Also present were Sally Stanfield of DHS (terrific person), Stewart Simonson, Michael (WH Legisl), Tom Reilly of OMB, Ken Bernard of WH Homeland Security Council After meeting, Ken and I rushed to OSTP on 1801 Pennsylvania Ave to meet with the Weapons of Mass Destruction Medical Countermeasures Subcommittee. I am on the Steering Committee of the National Science and Technology Committee (NSTC) Subcommittee on WMD Medical Countermeasures (Chaired by Bill Winkenwerder (DoD) and Phil Russell (HHS). I rarely go to these meetings, but Ken Bernard wanted me to be there for discussion of 1)Anthrax countermeasure development plan and 2) DoD development of butylcholinesterase (BC). BC is unbelievable. It is a naturally occurring plasma product that neutralizes the effects of VX and Sarin gas. It binds to the phosphogen cholinesterase inhibitors of the gas and protects animals from sarin and VX. It has no toxic side effects. Taly Bar-Shalom from OSTP presented the data. The DoD people wanted NIH to do Phase 1 clinical trials on the plasma derived product and to pay for the development of the recombinant product since they "had no money". The Phase 1 trial would cost from $1 to 10 million depending on the design. The development would cost a few million $. I got up and chastized the army Colonels (Joe Perla et al) and told Bill Winkenwerder that I was astounded that they had a countermeasure for a known threat (Tokyo subway) that is completely effective in animals (rats, hamsters) and totally safe, and yet they say that they do not have any money to develop it. Unbelievable! In some fairness to them, the DoD money for Medical issues is so compartmentalized, that it is difficult for them to move $ from one silo to another. They have no way near the flexibility that NIH has. In addition, Bill Winkenwerder, who is Asst Secretary of DoD for Health, really has no power or jurisdiction and cannot commit resources at a meeting like this. He is a very good guy and promised me that he would find the money. I offered to share with them the effort and cost of a phase 1 trial. In reality, if they drop the ball on the clinical trial and development of recombinant product, I will pick it up. On the way from the Rayburn to Dirksen building, I ran into Hillary Clinton on the street and she gave me a big hug and kiss and we chatted for a few minutes (with her Secret Service people looking puzzled) about AIDS, etc.
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April 23, 2004 - Went to dinner over Dan and Marina Ein's home on Kenmore Drive in NW Washington. Dinner was to bring together people in DC interested in bioterrorism and press folks who cover this. Present among others was Bob Malsam (Head of DC Hospitals) Dan Lucey (Medical Officer of DC DOH), Ceci Connelly (Washington Post), Mike Iskowitz (Newsweek), Jerry Hauer (Biodefense Center at GW) and several others. Among topics that came up was the buzz around town of the recent intelligence that another "big" terror attack will happen soon. The weather was clearing or rain after a major thunderstorm. I had wanted to go to the St. Albans vs Jefferson County (WV) High School baseball game, but it was cancelled because of rain.
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April 28, 2004 - White House (West Wing) - Met in Kristen Silverberg's office to discuss the FDC issue (see above). Much discussion regarding our approach to FDCs in the PEPFAR program. At meeting were the usual group: Kristen, Mark Dybul, Joe O'Neill, Mark McClellan, some FDA economists, Emit (FDA), Carol Thompson. I spoke with Kristen by phone after the meeting about my chose vis-à-vis options.
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April 28-29, 2004 - Gary Edson called me and said that he had a "disturbing" conversation with Patty Stonsifer (Gates) in which she mentioned that the USG should promise NEW resources for the Enterprise proposal to the G-8. Gary asked (and I did) call Rick Klausner to get his take. He is comfortable with our proposal. Gary is concerned that Gates will be lukewarm about our proposal and we will have another example of the POTUS trying to do something good and then getting criticized for not doing enough.
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May 4, 2004 - White House (West Wing) - Me with Gary Edson and Patti Stonecifer regarding the HIV Vaccine Enterprise and the upcoming G-8 meeting in Sea Island, GA. We have come to an agreement that if the POTUS presenting the Enterprise proposal to the G-8, Gates will soundly applaud the effort and work with us to get it going. The USG will not promise an new money over and above the $500+ million that we already spend on HIV vaccine research (this is about 5/6 of the world's total of $640 million). However, we will challenge the other G-8 countries to endorse the Enterprise strategic plan and align current and future resources with the plan.
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May 12, 2004 - Big White House day! The President visited the NIH for a "No Child Left Behind - Read First" ceremony. It was held at NIH since the NICHD had some activities in this area. Ceremony held in Natcher Auditorium. I sat in second row and the POTUS recognized me from the stage and greeted me individually noting that I was in the audience. After his talk, he came down to "work the rails" and chatted with me for about a minute on International AIDS. He mentioned that he had just met with the Health Minister of Angola. He was as usual very complementary to me. In the afternoon had a meeting in the WH with Kristen Silverberg, Allan Gilbert, Randy Tobias, Joe O'Neill, Mark McClellan, Lester Crawford and many others about fixed dose combination ARVs (FDCs) and the PEPFAR. We have developed a plan and a roll-out strategy. After the meeting, went to Indian Treaty Room and had a going away reception for Richard Falkenrath of the Homeland Security Council (HSC). Had nice chats with John Gordon (chief of HSC), Tom Ridge, Josh Bolten, Carol Kuntz, Clay Johnson and many others.
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May 19, 2004 - Good day! Project BioShield legislation passed the Semate by a 99-0 vote. The White House asked me to attend a press conference with Sens. Frist, Gregg, and Kennedy as well as Secretary Thompson at the Capitol. We briefed the press and I answered several questions. TGT called me the "father" of the BioShield Bill.
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May 27, 2004 - Went to a nice retirement celebration at the White House (Indian Treaty Room of EEOB) for Gen. John Gordon (Director of the Homeland Security Council). I have developed a very nice relationship with John over the past year or so and he was very glad to see me there. Attending were Andy Card, Condoleezza Rice, Karl Rove, Harriet Meiers, among others. Getting ready to go on June 8-10 to Savannah, GA for the G-8 conference at Sea Island. The White House (Gary Edson et al) wants me there to answer press questions regarding the HIV Vaccine Enterprise Proposal that the President will make to the G-8. Gary asked me to get Peter Piot (Director of UNAIDS) to write an editorial praising the proposal at about the time that it is announced. I am working on this.
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June 2, 2004 - Testified before the House Commerce Committee on Science chaired by Mr. Bilirakis for the NIH Priority Setting in anticipation of reauthorization of NIH. Testified with Elias Z., Andy VonEschenbach and Nora Volkow. Tough questions, but the Hearing went well. Immediately went to brief an IOM Panel on Biodefense. They were very flattering of me and the work that we have done.
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June 3, 2004 - Busy day. Went to Ali's Lower School Graduation and rushed to testify at House Select Committee on Homeland Security chaired by Chris Cox with Jim Turner as ranking minority. Chris Hayes and Joe Barton were there. Many tough questions since the Presidential race is heating up and the Dems want to give the impression that the Administration is not doing enough on Biodefense even though we have accomplished a lot. I did very well. Immediately after the Hearing I rushed to DHHS and briefed Sec. Thompson on the G-8 meeting and the HIV Vaccine Enterprise. Then I rushed to the White House for a meeting called in the West Wing by Kristen Silverberg on the POTUS proposal (maybe) to facilitate vaccine development by addressing liability, intellectual property, tax benefits, and monopoly issues. After WH rushed to go to Jenny's Sports Banquet. She received MVP for the Diving Team.
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June 8-10, 2004 - Went to Savannah, GA (Sea Island) for the G8 Summit hosted by the USA. I was part of a White House Team that served as Presidential Surrogates to brief the Press before, during and after the President's proposals of initiatives to the G8 leaders gathered in Sea Island (UK - Tony Blair, France - Jacques Chirac, Germany - Gerhard Schroder, Italy - Berlusconi, Japan, Canada - , Russia - Putin, and USA). The other surrogates on the Team were: Elliott Abrams (Special Assist. To the president and Senior Director for Near-East and North African Affairs at NSC); Andrew Card (WH Chief of Staff); John R. Bolton (Under Secretary of State, Arms Control and International Security); James L. Connaughton (Chairman, Council on Environmental Quality); Glyn T. Davies (G8 Political Director); Kristen Forbes (Member, Council of Economic Advisors); Jendayi E. Fraser (Special Assistant to the president and Senior Director for African Affairs at NSC); Robert Joseph (Special Assistant to the president and Senior Director for Proliferation Strategy, Counterproliferation and Homeland Defense); Alan P. Larson (Under Secretary of State, Economic, Business, and Agricultural Affairs); Constance Berry Newman (Assistant Administrator for Africa of USAID); Randall Quarles (Assistant Secretary of Treasury for International Affairs); Condoleezza Rice (National Security Advisor to the President); Frances Fragos Townsend (Assistant to the President and Homeland Security Advisor); Dan Bartlett (White House Communications Director); Scott McClellan (Assistant to the president and White House Press Secretary); Gordon Johndroe (Laura Bush's Press Secretary); and Jim Wilkinson (Deputy National Security Advisor for Communications at NSC). My job was to brief the press at formal and informal briefings on the Health Issues which were mainly the Global HIV Vaccine Enterprise (see above), the Polio Eradication Initiative, and to a much lesser extent, the Famine Initiative. I also briefed on the progress of PEPFAR the Global Fund for AIDS, Malaria and TB and the issues on Fixed Dose Combination (FDC) and co-packaged antiHIV drugs. The weather was beautiful and we stayed at the Westin Resort Hotel on Hutchinson Island in Savannah. All I did was work and did not get off the compound. The security to get on and off the compound was as tight as I have seen anywhere except for Iraq. The Press center was adjacent to the Hotel. I spent most of the time in the White House press unit with White House staff led by Pamela Stevens, Paul Morrell, Jim Wilkinson, Barry Bennett (Deputy of Communications, G8 Summit Planning Organization, Colby Cooper, Dana Perino, M.C. Koch, Jana..?, Corey..? and others. It was exciting to be there and I ran into virtually all of my reporter friends on the White House Press Corps including among others, David Gregory, Terry Moran, Norah O'Donnell, Ann Compton, Bill Plant, John Roberts. I had a great interview with an AP reporter Scott Lindlaw, whom I had not met before. The initiatives were very well received. However, as I have seen before, unpredictable events shape everything. Former President Ronald Reagan and died a few days before and the press was totally saturated with Reagan history and funeral news to the point that the G8 issues were literally pushed from the front page. I appeared on TV only one time on CNN and that was for an interview with Anderson Cooper on my impressions of Reagan's legacy on AIDS, particularly during the early years when he did not even mention AIDS publicly. I stated on camera that the criticism of this silence on the part of the activists was certainly justified; however, the activists are being too harsh (Larry Kramer wrote a piece calling him worse than Hitler) since many things occurred behind the scenes that were good. For Example he allowed me to go out and be proactive and speak on behalf of the gay constituents. Also, Surgeon General Koop was allowed to mail his report to every household in the USA. I also got some press with interview in foreign TV such as VOA, Al Jazeera, Canada National TV, BBC, etc. Also, a few mentions of my briefings in WSJ, and many papers that picked up the major AP story by Scott Lindlaw. Otherwise, there was much less press for the G8 in general and for me than would have occurred had not Reagan died.
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June 18, 2004 - Attended a farewell party at the White House for Gary Edson. He is leaving NSC to work in the campaign. His main job will be to prepare the POTUS for the debates with Kerry. I was the only non-WH person at the reception that was hosted by Condi Rice and Steve Hadley of NSC. In her praising of Gary for his work, she mentioned 2 accomplishments among many: 1) the millennium account, and 2) the PEPFAR. When she spoke of the PEPFAR, she caught my eye and said, "Oh Tony Fauci is here; they were the team that did this. Tony was the brains and Gary was the brawn".
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July 9, 2004 - 2 meetings in West Wing. First was a top secret briefing of Fran Townsend, the new Director of the Homeland Sceurity Council. She replaced Gen. John Gordon who retired in June (see above). Present at the briefing were Ken Bernard, Bob Kadlec, Larry Kerr, Kate Spitler (CIA) and some others. Purpose was to brief Fran on the experiments that were being proposed regarding genetically engineered monkeypox virus to duplicate what was shown in the mousepox model where inserting the IL-4 gene into mousepox made it lethal and elusive for both vaccine and therapy. Debate was whether to do experiments and whether to classify them. Purpose of doing experiments was to determine whether the mousepox work also applied to the monkeypox. In addition, if it did, then we needed to develop countermeasurs such as anti-IL-4 drugs. Fran was extremely complimentary to me saying that above all people, she wanted to know what my opinion was and she wanted me to explain the details and implications of the experiments. Next meeting was in the office of Faryar Shirzad (replaced Gary Edson on NSC; see above). Present was Martina Strong. Purpose was to plan the Fall meeting of the G-8 Vaccine Enterprise as promised by the POTUS. We discussed what the format of the meeting should be and what level of representation from G-8 countries should be there. I suggested at least a top scientist from each country and then for formality, we should have the Ministers of Health there after the strategic plan had been finalized.
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July 11 - 16, 2004 - Went to the XV th International AIDS Conference in Bangkok. The depth of misunderstanding about the PEPFAR and the reason why the PEPFAR wants expedited approval by FDA of the "copy" generics that are being used before USA money is used to buy them is huge. The activists were out in full force disrupting Randy Tobias's speech with signs of "He's Lying". Ultimately they let him speak, unlike the situation in Barcelona in 2002. There was an extraordinary amount of USA bashing by activists, the liberal press and even by international figures such as Kofi Annan who stated that the USA was not showing leadership because we were not giving more to the Global Fund. He seems to have selective amnesia regarding the PEPFAR's $15 billion program. Chirac made a similar statement. Issues that were particularly misunderstood were: 1) why the USA was not giving billions to the Global Fund; 2) why we wanted to have an expedited approval of copy generics before the PEPFAR paid for these drugs; 3) Why the DHHS only allowed 50 people from HHS to attend the meeting. Most people claimed that it was because the activists booed TGT at Barcelona and because we were upset that we were not controlling the agenda. Before the meeting a group of far-right Congressmen wrote to the organizers of the meeting saying that they condemned the meeting since more faith-based organizations were not given prominent roles in the meeting and because not enough emphasis was placed on abstinence. This made the USA look real bad. Stupidly, the DHHS restricted the numbers of meeting participants generally without doing it by category and as it turned out, some scientists who were already on the program had to cancel out. Thus, the topic was this stupidity rather than all of the good things that were happening. The activists were more misinformed than I have ever seen. They had no idea what they were talking about. All they wanted to do was condemn the Bush Administration. Bush asked the FDA (through Tobias, me, Kristen Silverberg and others) to provide expedited review of these FDC products so that we could have some guarantee of the safety and quality of the product before USA taxpayer money paid for it.(see above). This was the correct thing to do. Can one imagine if we tried to give drug to Africans by a process that was "not good enough for Americans"" We would all get killed by Congressional Committees and activists, some of which are the very ones who are crying for generic drugs right now. By the way, the approved drugs are now available for hundreds, not thousands of dollars in Africa. The claim of the generics companies that the drugs are available for $140 does not take into account that it cost much more for shipping, storage, etc. and so the real price is not that far away from the brand price. Furthermore, no one is going without drug since it is not the generics versus nothing. The PEPFAR is buying the brand name drugs and distributing them. The response was that the administration is in bed with PHARMA since we do not want to allow generics for fear of PHARMA losing money. The generics are "pre-qualified" by the WHO. However, the WHO is not a regulatory agency. The FDA and Tobias and I pleaded that the generics companies submit the applications and give the FDA a chance to show that they could give an expedited review. We were asking for clinical data that Medicines Sans Frontiers already has and has published, plus biochemical equivalency and pharmacokinetic data and plant inspection, all of which are real easy to get. However, no generic company has thus submitted applications. They say that they do not have to since WHO has prequalified them. The real reason is that they are afraid that the FDA will actually find that the product may not be good. I think the product likely is fine, but the mistrust on the part of the rest of the world for FDA and the USA is palpable. This likely relates to the situation in Iraq. The other source of contention is the situation of Global Fund versus PEPFAR. I took great issue with the incredibly inappropriate public statement by Kofi Annan about the lack of USA Leadership in Global AIDS (Kofi, did you forget your leadership on the Rwanda genocide??). I tactfully blasted him and this concept on BBC radio and TV and CNN. I was quite discouraged by this Conference. The science was irrelevant although my Special Lecture on HIV Pathogenesis went very well and was extremely well-received. A major issue is that the USA is doing some stupid things like allowing the restriction of numbers of scientists at the meeting and by having the far-right people act like they are representing the USA. However, this time, the activists and the international community are even worse. They are totally misinformed about what is really going on, but they are louder than ever. This in turn feeds the far-right and it becomes a vicious cycle. The following is a Washington Post article that summarizes the situation very well:
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July 19, 2004 - Appeared on the Jim Lehr Newshour defending the USA position on PEPFAR. Steve Lewis from the UN was my "opponent" and we duked it out over the bilateral approach of PEPFAR versus the multilateral approach of the Global Fund. I said both are good and working. He feels that the USA should put all of its money into the Global Fund. He also did not understand the need to have some sort of approval for generic copy drugs (see above). Everyone told me that I appeared cool and collected while Steve was shrill.
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July 21, 2004 - Two visits to WH today. The POTUS invited me to be at the signing ceremony for the BioShield Legislation in the Rose garden. I was asked to go up on the stage for the photo with the POTUS and the VP as well as Tom Ridge, Congressmen Chris Cox and Waxman, House Speaker Dennis Hastert, Senators Ted Kennedy, Bill Frist among others. Michael Allen of WH Legislative Affairs was my advocate to get me on the platform. The White House protocol women (?name) wanted Julie Gerberding on the platform (even though she had nothing at all to do with BioShield) since there were no women there and she bumped me. Michael insisted and they compromised by putting us both up there. The POTUS, VP and Senators were very nice with me. I now know all of these people very well. In the afternoon, I briefed Carol Kuntz. Ernie Takafuji accompanied me. Carol is great, but she is going through one of her periodic periods of sadness and anxiety about her CML even though she is in a crisp remission on Gleevec. I intermittently give her private psychotherapy and I did so that night.
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July 22, 2004 - Testified with Secretary Thompson and Julie Gerberding to the Senate Committee on Health, Education, Labor and Pensions (HELP) on Public Health preparedness, surge capacity and medical countermeasures. Present were Chairman Judd Gregg, Ted Kennedy and Lamar Alexander. It was a very friendly hearing and very complimentary to me and the others.
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July 23, 2004 - West Wing - Had individual photo op with VP Cheney together with the entire "team" that worked on BioShield. Many people there: Stewart Simonson, carol Kuntz, Scooter Libby, Sally Canfield (DHS) (she just announced that she is leaving Tom Ridge and going to work for Speaker Hastert), Mark McClellan, Ken Bernard, Michael Allen, Brenda Becker, Sharon...(Sen. Gregg's staff), Noreen Hynes, Seth... (Noreen's husband), Vince Ventimiglia (Sen Gregg's Committee Staff). I will provide full list later. Very happy occasion. Again, VP was very gracious towards me.
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August 11, 2004 - Met at EEOB Room 283 with Carol Kuntz and Bruce Miller and Dorothy.... to discuss tentative plans to determine whether IL-4 gene inserted into monkeypox would have the same effect as IL-4 inserted into mousepox virus, i.e. it would suppress the immune response enough to allow lethal disease in the animal. This relates to concerns that terrorists will genetically engineer variola with IL-4 and so override vaccination and cidofovir. Carol wanted to know which of several options for experiments I would favor. A White Paper was drawn up by the Office of Homeland Secrurity (Ken Bernard) with the various options. Of note, I had previously briefed Frances Townsend in the White House Situation Room a couple of weeks ago (not recorded above) on the same topic. I favor Option #3 which is to conduct the research on IL-4-altered monkeypox in monkeys and do it as classified research. However, we should announce that we will be conducting such experiments so that people do not get suspicious that we are totally hiding things. We would keep the design, details and results classified since if we found out that it did work in monkeys , but did not yet have a countermeasure for it, then we would expose our vulnerabilities.
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Sept. 1, 2004 - Had a interesting day. Flew by helicopter from the Pentagon to Fort Detrick to visit USAMRIID with Deputy Secretary of DoD Paul Wolfowitz, Bill Winkenwerder, and a number of other DoD and DHS senior staff to hear presentations by Gen Lester Martinez-Lopez and others regarding why the DoD should support the planned new Biodefense Research Campus at Ft. Detrick. The Army wanted me there since they know that I am an articulate advocate of their cause. The meeting went very well and I finally got a chance to meet and intensively discuss with Wolfowitz.
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September 13, 2004 - For the past few weeks, I have been involved in a number of briefings of Carol Kuntz and Stewart Simonson regarding Biodefense and the concern about the emergence of an H5N1 bird flu that has been smoldering in Asia (Thailand, Viet Nam, China, Taiwan, etc) with jumping of cases from chickens to humans. President Clinton had quadruple bypass surgery at Columbia-Presbyterian Hospital related to unstable angina this past week. I contacted Senator Clinton's office to get his private e-mail address to send him my personal best wishes. Today, I had an official briefing at the White House for Carol Kuntz and Bruce Miller (her deputy) on research plans and strategy for countermeasures for "Genetically Engineered Microbes". The presentation was very well received. Carol gave me a "redlined" copy of the Bioshield Legislation that was signed by President Bush and VP Cheney as a special gift from them to me due to my work on the development and passage of BioShield.
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Oct. 4, 2004 - Meeting in the Situation Room of the White House to brief Ken Rapuano (Deputy to Fran Townsend) on the IL-4 - monkeypox experiment that is being proposed as a classified experiment to be performed by DHS. I presented the rationale behind the experiment. Also present were Carol Kuntz, Ken Bernard, Stewart Simonson, Maureen McCarthy, Gerry Parker, et al. Although NIAID will not perform these experiments, Fran Townsend wanted to make sure that I did the briefing since she trusts me. The plan is for me to make the same presentation to Colin Powell and Donald Rumsfeld soon after the election.
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Oct. 5, 2004 - Historic day today with the UK regulatory agency suspending the license of Chiron to ship out their influenza vaccine to the USA because of issues related to the inspection of the plant in Liverpool. This is a huge issue for the USA since Chiron was scheduled to supply about 46-48 million doses or about 50% of our yearly requirement of 100 million doses. Only Aventis Pasteur (50 millioin doses) and Medimmune (2 million doses of Flumist) are available. We heard about this abruptly this AM as we (Julie gerberding and I) were getting ready to testify at House Hearing on Thimerasol in Influenza vaccines.
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Oct. 6, 2004 - Trip to Duke to honor retirment of Ralph Snyderman as Chancellor. White House conference call at the airport in Raleigh-Durham on way back regarding the influenza vaccine issue.
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Oct. 7, 2004 - Trip to Duke to honor the retirement of Ralph Snyderman. Gave talk on Emerging Infectious Diseases. White House conference call on Influenza issue (see above). Incredible amount of media appearances: radio, TV, print. As much as I have ever done.
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Oct. 8, 2004 - Big time Congressional Hearing on influenza vaccine problem before the House Government Reform Committee. I testified with Julie Gerberding and Lester Crawford of FDA. More media, White House Conference calls, and Jim Lehr NewsHour to finish the day.
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Oct. 9, 2004 - Front page story in the Washington Post saying that the UK regulatory authorities told our FDA about the problem at the end of August with the implication that the FDA failed to act in preparing for the shortage. Acting FDA Commissioner Lester Crawford explained on our regularly scheduled White House Conference Call that this is misinformation. As we (me, Julie and Les) have stated all along, Chiron kept reassuring us that there was a problem with about 4 million does due to contamination with Serratia marcescens. Never did anyone say to FDA or CDC (nor did Rino Rapualli say to me) that there was a serious enough problem to suspend licensure. John Kerry came out with ugly statement saying that the Administration is covering up.
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Oct. 10, 2004 - Things still hot and heavy with the Chiron/influenza situation. Had another White House conference call with Margaret Spellings, Alan Gilbert, Phil Hall, Harriet Miers (Deputy Chief-of-Staff), Jon Burks, Ken Bernard, Trent Duffy, Scott Whitaker, Julie gerberding, Les Crawford and Bruce Gellin. Also more media appearances for me.
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Oct. 12, 2004 - Important White House meeting at 1:00 PM in Roosevelt Room on the Flu situation. Chaired by Margaret Spellings and Harriet Miers. Also present were Fran Townsend (HSC), Joel Kaplan (OMB), Jack Marburger (OSTP), Alan Gilbert, Hobbs, Leitch, Montgomery, Jackson, Amit Sachdev (FDA), Stewart Simonson, Julie Gerberding, Suzy DeFrancis (WH Communications), McGrath. We discussed strategies to handle problems. I gave a background of flu vaccines in general together with the nature of the current problem. Julie gave the plan for trying to get equitable distribution of the remaining doses from Aventis Pasteur that have not already been distributed. The issue of the conflict in statements from our FDA and the British regulatory authorities (MHRA). They said they told the FDA about the seriousness of the problem weeks ago and our FDA says no. Our FDA is correct since I was hearing the same thing. We believe the UK people have over-reacted and now it has caused a mess here in the USA and they are embarrassed to retract. Important point that I brought up and again called Margaret Spellings about the evening of today was that John Kerry would likely try to embarrass the President in the debate on Oct. 13 by saying that the FDA knew and covered up and that he believes the Brits. I suggested to Margaret that the FDA come out with a forceful statement BEFORE the debate declaring that the UK did not tell them about the problem so that the President is not left hanging out there. Margaret agrees and they will do this on the morning of Oct. 13.
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Oct. 13-14, 2004 - Multiple HHS and White House conference calls regarding the influenza vaccine crisis. Report from FDA's Jesse Goodman who just returned from UK is that the Liverpool plant really did have some serious GMP problems and potential bioburden problems. Our FDA agrees with the findings of UK regulators, but not necessarily with their action. However, it is too close a call for us to say that we would have released the lots. Therefore, we will publicly say that the lots from Chiron are unusable. We further discussed other issues about how we can get more vaccine from AVP or from Canada or from anyone else. If we go with Canadian vaccine, this would have to be done by an IND since it is not licensed by FDA. Most we can get is 2-3 million doses. Even this is a logistic nightmare to do under an IND. Present on Conference call with WH are Spellings, Silverberg, Miers, Dan Bartlett, Trent Duffy (Deputy Press Assistant), Alan Gilbert, and HHS team of Julie, Stewart, Les Crawford, Scott Whitaker, and me.
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Oct. 15 - 18, 2004 - Situation getting very hot and heavy. Kerry campaign trying to make this a political issue saying that the shortage is President Bush's fault. I have been on every major TV show multiple times talking about the issues and what people need to do. Multiple (daily) White House Conference Calls. Almost constant briefings and press interactions. Will need to go on a New England bus tour this weekend from DC up the corridor to Boston and fly back. Very intense, at least as much as with the anthrax situation, mostly because the election is 2 weeks away. or
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Oct 22-23, 2004 - Continued intensity of activity around the influenza vaccine shortage. Daily White House Conference calls. The DHHS team has broken up into several groups to "tour" the country in a bus for outreach and education to health authorities, the general public and the Press. I was part of a tour that went from D.C. to Philadelphia to Trenton, Newark, NYC, Hartford, Providence, Boston and back (Flew back from Boston). Our team was Claude Allen, myself, Howard Zucker (Deputy Asst Secretary of Health), Bill Hall (DHHS Public Affairs), Sarah Greirich (Claude's assistant), Kate (?). It went well. This is becoming a serious political issue in that the Kerry Campaign is trying to paint the Bush Administration as responsible for the Chiron mess. President Bush in turn is claiming that liability issues are the cause of Pharma not getting into the vaccine business and that Kerry supports trial lawyers who are the problem (VP candidate Edwards is a liability lawyer).
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Oct. 25, 2004 - Went to LA to be Keynote Speaker at a USC conferenec on Multi-Sector involvement in research (Government, Industry, Academia). Afterwards I gave a press conference with the Editorial Board of the LA Times. The topic of influenza vaccine dominated the conversation. Oct. 26- Nov. 8, 2004 - Daily White House conference calls on influenza situation. Trying to get additional doses from Aventis, Medimmune and foreign sources. Bush re-elected. Very good for me since the team stays in place. Horrible tragedy - John La Montagne, my beloved friend, colleague and Deputy Director of NIAID dies suddenly on Nov. 2 after disembarking from flight from DC to Mexico City (his birthplace) on passport line in Mexico City. He had a pulmonary embolus, very likely from the flight with venous thrombosis.
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Nov. 12, 2004 - Meeting in Roosevelt Room of WH to discuss the plans for influenza preparedness and for pandemic flu plans. Major points are what we have been discussing for the past few weeks about providing incentives for PHARMA to get involved and stay in flu vaccine field. We (DHHS team) are proposing back end guaranteed purchases for overflow doses; liability protection, tax breaks, research to develop cell culture based and recombinant DNA approaches to replace egg-based approaches; advanced purchase and stockpiling of vaccine for children. TGT presented and I filled in. Present were: Karl Rove, Josh Bolton, Margaret Spellings, Kristen Silverberg, Alex Azar, Scott Whitaker, Grant Dixton, David Leitch, Harriet Miers, Alan Gilbert, Carol Kuntz and others.
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Nov. 17, 2004 - House Hearing of Government Reform Committee on the flu crisis today. I testified together with Julie Gerberding and Lester Crawford (Acting FDA Commisioner). Mostly they slammed FDA for not acting more aggressively to monitor the Chiron plant and pick up contamination. Bush shuffling around his Cabinet following election victory. People that I know are moving out of positions where it was good to have a contact for me and into positions where it is also good to have a contact. Condi Rice to State, Margaret Spellings to Education. Much rumor about TGT and whether he will go to DHS or whether it will be Fran Townsend if Tom Ridge leaves. 'Investigations.
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Nov. 18, 2004 - Hearing today before House Commerce and Energy Investigations. Together with Julie and Les Crawford.
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Nov. 19, 2004 - I arranged a meeting among Medimmune (Flumist), the FDA, and Stewart Simonson to try to pursue ways to get broader approval and utilization of Flumist for next year to make up for the anticipated shortages since Chiron will almost certainly not be able to re-fill the gap by next year. Present at the meeting were Medimmune CEO David Mott, President Jim Young, VP of Reg Affairs Peter Patriarca, CMO Edward Connor, Sr. Director Scientific Affairs Kathleen Coelingh. From FDA were Les Crawford (Acting Comm) and Jesse Goodman (head of CBER). Also, Stewart Simonson, Bruce Gellin, Pamela McInnes, Ralph Tate. I am trying to be the facilitator to have FDA look at Medimmune data on 50 to 64 year old people sooner rather than later so that Medimmune can produce an extra 10 million doses for next year. They need approval for this age group or else then cannot take the risk of making 10 million more doses and not be able to sell them.
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Nov. 30, 2004 - Memorial service hosted by me at Natcher Building at NIH for John La Montagne. I delivered Eulogy (see speeches file). I am only starting to come to grips with the intense feeling of grief and sorrow at having lost John. I really liked him very much. He was such a fine human being. Present at the Memorial Service were Secretary Thompson, Margaret Spellings, Carol Kuntz, Stewart Simonson, Julie Gerberding, D.A. Henderson and hundreds of other friends of John. I have appointed Cliff Lane as the Acting Deputy Director of NIAID.
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Dec. 3, 2004 - Secretary Thompson resigns and asks me to come down to the Department as he makes his announcement. He brought me into his office alone and with both of us in tears he expressed his gratitude and admiration for my service to him, the DHHS and the country. I expressed my mutual feelings for him. Below is his resignation statement: Dear Friends, This morning, I submitted to President Bush my resignation as Secretary of Health and Human Services. It was a difficult decision and one I did not make easily. But after nearly 40 years of public service, it is time for me and my family to move onto the next chapter in our life. It has been my honor and privilege to serve President Bush and the nation with each of you in this dynamic Department. As I have often said, our 67,000-member family is home to the finest employees in the federal government. When you work at HHS, the greatest doctors, scientists and public servants in the world are your coworkers. I am truly grateful for the opportunity to work with all of you in this noble calling. I am extremely proud of the work we did together at America's Department of Compassion. President Bush set forth an ambitious agenda for our Department. And I love a big challenge. Since the day I walked through the doors of this building, we have worked tirelessly to better the health and well-being of the American people and our neighbors throughout the world. Thanks to your work, * We delivered on our promise to modernize Medicare with prescription drug coverage - the most historic improvement to Medicare since it was created in 1965. Now seniors and the disabled will get substantial help paying for the modern medicines and preventive services that extend and enhance their lives. * We're spending more in medical research than any time in our history. And the President opened the door to federal funding of groundbreaking stem cell research. * We're investing in our long-neglected public health system, making our nation better prepared to fight disease or biological attacks. We're improving the safety of the food we eat and import. * We're developing the new medicines and vaccines to protect our citizens from disease or bioterrorism. * Our children are healthier than ever, with health coverage and immunization rates at record highs and childhood drug usage going down. * We turned America's attention to disease prevention, motivating Americans to eat better and exercise more in order to improve their health and quality of life. * And we're waging a bold new global fight against HIV/AIDS, committing an unprecedented $15 billion toward eradicating this scourge. This will be a jewel in the President's legacy - and our years at HHS. Together, we also faced challenges that were unpredictable and unimaginable. * HHS was among the first on the ground to care for New York City residents and assist in the aftermath of 9/11. * From the day I arrived, we spoke of the need to better prepare for bioterrorism, and together we helped this nation weather the first biological attack on its people with the anthrax letters. * We expanded our cache of smallpox vaccine, so we can now protect every man, woman in child if this vicious disease were to return. * We protected America from SARS and we helped the world understand this mysterious disease so we could contain its spread. * We're leading the world to prepare for a world flu pandemic and Avian flu. * And, together with our public health partners, we have helped this nation manage an unexpected influenza vaccine shortage. That is quite a record in four short years. You all should be proud. And, best of all, we are working together more closely than ever before to better serve American families. We truly are One Department - with the best and brightest working together across agencies to solve our nation's toughest problems. And we truly are the Department of Compassion. I will miss you all more than you can ever know. I will forever cherish the friendships I made here the last four years. And I will always be in awe of the talent, dedication and drive of the people of the Department of Health and Human Services. Keep leading this nation forward. Keep putting the well-being of our people first. And keep changing the status quo in search of a better way. You will always be in my prayers and in my heart. With gratitude and friendship, Tommy G. Thompson
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Dec. 20, 2004 - Terrible time over the past couple of weeks with a 4 part story by an AP reporter on the Jonathan Fishbein issue and the HIVNET 012 story. Fishbein is a Title 42 on a 2 year probation period in DAIDS. His performance was terrible and Ed Tramont and Jon Kagan decided to remove him. He got a high-priced whistleblower lawyer and claimed whistleblower status despite the fact that he "blew the whistle" AFTER he was informed that he would be removed. He leaked internal documents regarding the technical difficulties with HIVNET 012 (use of nevirapine for prevention of mother-tochild transmission (MTCT) of HIV. In that landmark trial it was shown that the drug in a single dose was safe and effective for prevention of MTCT. The use in these circumstances has likely saved tens of thousands of children's lives in developing countries, particularly sub-Saharan Africa. The paper appeared in Lancet in 1999 and several papers have corroborated the safety and efficacy of Nev. For MTCT prevention. Since the results of the trial (HIVNET 012) were so striking, the maker of Nev (BI) decided to use the data from the trial to expand the licensed indication of Nev to MTCT in the USA. Upon inspection of the site and the data collection procedure, the FDA and an auditor ruled that there were "technical" problems that would not allow licensure. Ed Tramont decided to have a more comprehensive look at the "technical" difficulties and ultimately found that the procedure was sloppy (not surprising for an inexperienced African site); however, the data were sound, i.e. Nev is still safe and effective. A low level person in DAIDS wrote a safety report that exaggerated (in Ed Tramont's mind) the negatives and indicted the entire trial. Ed used the report from the more comprehensive audit and changed the lower level report to indicate that there were technical difficulties, but this does not change the results of the trial. Fishbein in his attempt to not get fired for incompetence (totally unrelated and anteceding the issue of HIVNET 012) went to the Congress (Sen. Grassley - who never met a whistleblower that he did not love) and finally the AP. The AP story was incredibly misleading in that it published Fishbein's "whistleblower" claims of widespread misconduct in DAIDS, our (mine and others) failure to notify the president about the problems with HIVNET 012 before he launched the $500 million MTCT program, and a variety of other charges. This raised a lot a stink with and ABC Nightly News show. Surprisingly, the regular media did not take it up much, but it was all over the internet circuit. I worked hard to keep it off CNN, NBC, Washington Post, NY Times by pre-emptively discussing the truth with the reporters. We are "hand-cuffed" in what we can say since the Fishbein issue is a personnel matter and the Privacy Act is involved, Also, the Whistleblower statute (even though Fishbein is technically not a whistleblower since he blew after he was fired). Interesting how the laws protect the scoundrels. Our major concern is that this publicity will cause the uninformed to stop using Nev for MTCT. Of note, Rev. Jesse Jackson published his typical demagogue-like letter condemning President Bush, accusing Ed Tramont of "crimes against humanity", etc. Will give more follow-up soon.
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Dec. 20, 2004 to Jan. 14, 2005 - We have been occupied almost full time with doing damage control against the Dec. 13, 14, 15, 2004 AP articles by John Solomon. We have put on the NIAID Website a Q and A series that cogently addresses all of the allegations. This has apparently angered the reporter who is going after Cliff Lane and I now. Someone from the inside (Solomon said OGE, but I do not know whether I can believe him) "blew the whistle" on Cliff and I with the preposterous allegations that we are receiving hundreds of thousands of dollars from the IL-2 patent and that we are investing millions of dollars of NIAID money to support IL-2 research. Also, the whistle-blower told Solomon that I made Cliff Clinical Director as a quid pro quo for his putting me on the patent. Also, he queried whether my wife Christine gave the ethics approval of the ESPRIT IL-2 trial. This is nasty business. Cliff was made Deputy Clinical Director in 1986 and full Clinical Director in 1991. The patent was done in 1997. Chris has always recused herself from any actions on NIAID business. The Bayh-Dole Act requires that government employees file patents through the US Government on all inventions made during official government business. I originally did not want to be on the patent because I am NIAID Director. I was told by OGC and OTT that it was required since I was a clear inventor and to leave me off of the patent would make the entire patent subject to invalidity. I then queried of OGC as to whether royalties constituted a "financial interest" and thus subject to conflict of interest laws under 18 USC, Section 208a. I qually puts out ht found out that years ago the OGE ruled and the DoJ confirmed that royalties collected by government employees on patents owned by the government on which the employee is an inventor cannot be considered as a financial interest and so cannot be a conflict. The royalties are considered government compensation similar to performance awards and salaries. I was still uncomfortable about taking royalties because of my high visibility and so I told Mark Rohrbough (OTT for NIAID at the time) to have the government NOT send me the checks. He related that they were legally required to give me the check in order to fulfill the requirements of the Federal technology Transfer Act (FTTA). Thus, I have given every penny of my royalties to charity - The Foundation for NIH, Inc. Total royalties since 1997 = $45,072.82. Finally, I put the royalties on my financial disclosure statement (SF278), but OGE told me to take it off since it was equivalent to government salary that does not go on SF278. Nonetheless, Solomon wrote an article on the IL-2 story on Jan. 9 with the theme that Cliff and I should have let patients know about the "conflict" (even though there was no conflict). I believed that I saved the day by speaking with the reporter and explaining all of the above. It would have been better if my name was not associated with any COI story, but at least he mentioned about giving the money to charity as well as the fact that I tried to put the amount on my financial statement. The reporter has FOIA'ed our SF278s and so who knows what other smearing he might try to do with misinformation. Jan 15 - Feb. 3, 2005 - Story came out in AP about the IL-2 patent. The reporter (John Solomon) did indeed mention that I was required to file a patent and that I tried not to accept the checks and ultimately gave the money to charity. Also, he mentioned that I was told to take off the entry of the money on my SF278. In the end, it was not nice to have a story about me with a implication that I did something wrong, when in fact, I went out of my way to avoid conflict. The AP story led to CBS Evening News doing a story on the same thing on Feb.1. However, their angle was that I was the hero/Saint in trying to avoid conflict, and the NIH would not let me do the right thing. I came out looking good and the NIH looking foolish. In the end, it would have been better if the piece did not air. Fishbein issue: This abscess continues to fester. Fishbein continually puts out missives on his brother's Website (honestdoc.org) about "widespread misconduct and scientific fraud at NIH" and plays the role of defender of the public health. The Privacy Act (he is involved in a personnel matter) forbids us to respond. We are faced with the impossible situation of not being able to respond to this psychopathologic accusations. He can go public, but we cannot respond publicly. This is untenable. Influenza: Avian flu (H5N1) is still percolating in Asia (mostly Viet Nam and Thailand). Most recent cluster of cases in Viet Nam. We are continually having conference calls with the usual suspects on preparedness - Carol Kuntz, Julie Gerberding, me, Stewart Simonson, Lester Crawford, etc. Had a meeting in the West Wing of the WH on Feb. 2 with Claude Allan who has replaced Margaret Spellings as Assistant to the President for Domestic Policy. Present were Julie Gerberding, Stewart S., Allan Gilbert, Bruce Gelling, Amit (FDA), etc. We updated Claude who will brief President Bush. Feb. 3 - Mar. 8, 2005 - Another stress and crisis issue. A microbiologist named Ebright from Rutgers circulated an open letter(to Elias Zerhoun) among all the microbiologists stating that his analysis of study section data of non-biodefense grants over the past few years shows a decrease at the same time as the biodefense funding shows an increase. The letter was published in Science, first as an e-publication and then almost 2 weeks later (March 11) as a printed letter in Science. Problem is that the data that he pulled was via CRISP that is not designed to do comparative analysis of funding trends. The letter was signed by >700 microbiologists. The hidden agenda of Ebright and a very small group of signees (like Stanley Falkow) was that they feel that we should not be spending any money on biodefense research. They came to the conclusion in the letter that biodefense research was "hurting" non-biodfense infectious diseases research by diverting money away. They released the letter to the press without ever calling us or even sending the letter to us. This created a media storm and put us on the defensive to respond to what turns out to be entirely misrepresentative data. They took information from 4 out of 30 study sections that really misrepresent the big picture. The study sections involved mostly reflect activity in NIGMS that may be funding fewer "model organism" grants for reasons that have nothing to do with biodefense funding. I was furious! Clearly some few individuals were pushing their anti-biodefense agenda and the rest of the microbiology community was following like sheep. When several were asked about this after the media storm, they were embarrassed (such as Barry Bloom) and said that they really did not think that this was what they were signing on to. Many newspaper articles appeared and I led the rebuttal in the newspapers, NPR, and several speeches. EZ and I will write a letter in response to Science. Clearly when you examine the data correctly, non-biodefense has done as well or better at NIAID as the rest of NIH, i.e. when you compare the percent increases from year to year from 2001 to 2006. Also, much of biodefense money is also spilling over to non-biodefense or "dual-use" projects such as innate immunity, influenza, SARS, diarhheal diseases, etc. Clearly, the Ebright letter is misleading. Problem is that since all money is now tight, people are acting as expected, i.e. they want to blame someone or something for their personal and specific issues. Now they are blaming biodefense resources with a sub-text of anti-Bush Adminstration and anti-Iraq war. It is really ridiculous how they distort and I am in the middle of the fray. However, this is one that I will not back down on. On March 7, I met in my office with Michael Gerson, former top speech-writer for President Bush and now senior advisor and Assistant to the POTUS. Mike wanted to discuss ideas for addressing neglected or other diseases as an initiative for the POTUS to put before the G-8 summit. This is very similar to last year's activities (see above). I will work with him on a malaria intiative (see last year) and a TB in HIV disease initiative. Apparently Gary Edson and Josh Bolton sent him my way. I will be submitting the malaria and TB proposals for the POTUS consideration. March 8 - March 27, 2005 - Continued concern about the H5N1 bird flu in Viet Nam, Thailand, and Cambodia. Most severe now in Viet Nam. Working closely with Stewart Simonson, Julie Gerberding and the DHHS on Pandemic Influenza Preparedness. Mar. 27 - April 1 - Phenomenal vacation with Chris and the girls for Spring Break in Costa Rica. First vacation that I have had unassociated with a lecture or other business in 20 years since our honeymoon. Went for 2 1⁄2 days at Papaguyo Beach and 2 days in rain forest and Arenal Volcano. Did zip wire rides over the canopies. One of the most exciting things that I have done.
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April 4, 2005 - Amazing day at White House today. Briefed the President on AIDS (domestic and International). Reason for briefing was preparation by the WH for the reauthorization of the Ryan White AIDS Care Act originally passed in 1990. The POTUS wanted to make sure that we were not short-changing domestic AIDS in light of all of the money (PEPFAR) that we have recently been putting into international. Briefing from 9:20 AM to 10:05 AM. The POTUS walked into room and immediately greeted me and although the briefing was supposed to be predominantly on Ryan White, he asked me many questions for about 20 minutes. It was a 2-way conversation between him and me. At the meeting also were VP Cheney, Scooter Libby, Andy Card, Karl Rove, Dan Bartlett, Scott McClellan, Josh Bolten, Kristen Silverberg, Secretary Leavitt, Claude Allen, Joe O'Neill, Philo Hall, Tevi Troy. Wonderful interaction between me and POTUS...great day Also, today I went to and presented a major lecture at the IOM Pandemic Influenza meeting in honor of John La Montagne. After that I got briefed by the IOM committee reviewing the HIVNET012 trial (see Fishbein above). They totally agreed with us and said the trial was effective, ethical, and safe. Went back to WH to brief Claude Allen on Influenza together with Stewart Simonson, Julie Gerberding, Philo Hall, Dean Casey, Tevi troy, Kristen Silverberg. This was in preparation of Secretary Leavitt and I briefing the POTUS on Wednesday , April 6. However, the POTUS meeting will be postponed until next week since the POTUS will go to Rome for the Funeral of Pope John Paul II.
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April 4 - 27, 2005 - More of the same with Fishbein situation. IOM panel report came out very clearly supporting all that NIAID and we had been saying about HIVNET-012. In typical fashion, John Solomon of AP and Sen Grassley (who parrots everything that AP says) are claiming that the IOM panel report is invalid since some members of the panel receive NIH grants and so are conflicted. The Fishbein/Grassley/AP axis is clearly one of the most unethical and disgraceful situations that I have ever experienced. They all have no integrity and absolutely no regard for the truth. We are now working on a possible settlement with Fishbein to make this craziness go away. He may well ask for totally undeliverable conditions. The DHHS is still reluctant to allow us to fire Fishbein because they are afraid of Grassley.
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April 27, 2005 - Briefed the President about the potential for an H5N1 pandemic influenza. At briefing were the POTUS, the VP, Karl Rove, Josh Bolten, Kristen Silverberg, Dan Bartlett, Scott McClellan, Fran Townsend, Michel Gerson, Claude Allen, Julie Gerberding, Sec. Leavitt, Scooter Libby, Philo Hall, Rajeev, etc. The POTUS was very pleased with the briefing and asked the right questions. He was favorably disposed to our suggestion of considering having the USA public have kits of antimicrobials (Tamiflu, CIPRO, etc) in their homes in case of an emergency in order to get around the problem of distribution of drug to tens of millions of people in an emergency. We are going to pursue this approach with Symposia to get the flavor of what the community thinks of it and then we will pursue it.
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May 12, 2005 - Met today in Building 31, 7A-24 with the Ugandan Vice president Professor Gilbert Bukenya, who is former Dean at Makerere University in Kampala. We had met previously when he was still in academics and now he is VP. We discussed collaborations between Uganda and NIAID. Over the past couple of weeks we are still engaged in trying to settle the Fishbein issue. He continues to attack. Cliff Lane is leading the arbitration effort for a settlement. It is clear that he, his brother Rand, his mother and their lawyer Steve Kohn are bad people, well beyond the lawyer issue; they really suck without care for lives of people whom their lying endangers. Also, morale at NIH is the lowest that I have ever seen it. House Chairman Joe Barton is trying to "reauthorize the NIH" by consolidating ICs and putting much more money into the NIH Director's office. We cannot tell if Barton is doing this on his own or if Zerhouni is behind it. I tend to think that it is a bit of both, but that Barton is the main driver. Also, the conflict-of-interest issues have not been settled.
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May 23 - 27, 2005 - Things again heating up with avian flu in Vietnam with press reports that the virus in evolving with possible resistance to Tamiflu and greater number of clusters in Vietnam. Lesser virulence could mean that virus is adapting to humans better. It is likely that all of this just reflects better surveillance and reporting as opposed to a significant degree of evolution of the virus. Nonetheless, the press has jumped on this and I have been on CNN a few times, Jim Lehrer Newshour, Lou Dobbs (CNN) and CSPAN for a Congressional Hearing on Flu (Energy and Commerce with Chairman Deal). Also, several briefings at DHHS and the White House with the usual suspects. May 30 - June 3, 2005 - Bird flu activities continue with briefing at DHHS a couple of times. White House briefing on June 2 on purchases of Tamiflu versus vaccine in VP's ceremonial office in White House. Present were: Carol Kuntz, Binita Ashar (Carol's assistant, Tom Reilly (OMB), Norris Cochran, Jeremy Katz, Rajeev Venkkaya, Lance Leggitt, Stew Simonson, Bill Raub, Kerry Weems, Bruce Gellin, Laura Lawlor (by phone), Jesse Goodman, CDC by phone - Julie Gerberding, Charles Schable, Steve Bice, David Baden. We are trying to reconcile the budget projects for FY 05 and 06 and 07 with the purchase needs for stockpiles of H5N1 vaccine and tamiflu. My role was important since we are doing the clinical trials with the H5N1 to determine the correct dose. This will then determine whether we will buy and how much depending on the required dose. We already have 2 million doses of vaccine in bulk and we plan to buy 20 million more vaccine doses. Also we are thinking of 20 million more treatment doses of tamiflu. Also, White House briefing with Carol Kuntz on June 3 on biologics biodefense.
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May 24, 2005 - Have had continual trickling in of cases of human infections with H5N1 with most recent count of 218 cases and 124 deaths. Fifty countries now have birds infected and 10 have birds and humans infected. Of note that about 1-2 weeks ago it became apparent that there was a family cluster of 7 cases in Sumatra, Indonesia. Recent evidence strongly indicates that this was human-to-human spread similar to the small cluster in Thailand in 2004 where 11 year old girl infected her mother and aunt who nursed her in the hospital before she died. Similar situation in Sumatra where father nursed 10 year son and others in family slept in small room while one or 2 people were coughing all night. Bottom line was a media blitz. I was asked by HHS and White House to go to "Pebble Beach" on the White House grounds and do wall-to-wall interviews to allay fears. Fact is that the cluster looks like it is dead-ending. I did interviews with NBC Evening News, CBS Evening News ABC World News tonight, Nightline, CNN Wolf Blitzer Situation Room, WTOP radio, MSNBC TV, etc. Big time exposure. HHS was very pleased with how I handled this volatile situation.
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June 3 - 14, 2005 - I have not been recording events since I have been very busy, but over the past 10 days or so there has been considerable activity around the area of pandemic flu, biodefense, etc. I have briefed DHHS people as well as WH people. In addition, on June 13 we had a Hearing of the House Government Reform Committee for Biodefense chaired by Rep. Christopher Shays. I testified along with Stewart Simonson, Dale Klein (DoD), Joe Vitko (DHS), and Ron Saldareni (formerly of American Cyanamide and nowon an IOM Committee of Biodefense). The Hearing was mostly blasting DoD for disorganization and "wasting money". Also, I went on my yearly trip to review the Gaslini Institute for Lorenzo Moretta from June 8 - 10. We are in the final stages of finally officially firing Jonathan Fishbein. The issue is that Sen Grassley and his Committee will likely come after us for this since they always take the side of whistleblowers, even though Fishbein is not really a whistleblower as he blew the whistle after he was told that he would be fired for performance. June 14 - July 2, 2005 - Many activities around briefings of White House, DHHS and Congressional Hearing continue. Had 2 more Hearings within said period: 1) Senate Foreign Relations on HIV Vaccines with actress Ashley Judd; 2) Hearing of House Government Reform Committee on Influenza Pandemic Threat. I testified with Jim LeDuc (CDC) and Bruce Gellin (HHS). Have been on CNN and all over C-SPAN. We finally fired Jonathan Fishbein (on July 1) amid angry threats from Sen. Grassley's staff. I must include in my book how totally vicious and completely unethical that crew is. They are a disgrace to government. They totally distort the Fishbein story and attack the NIH and everyone else, all in the name of protecting "whistleblowers" even though he is not a whisteblower.
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July 14, 2005 - Lots of stuff going on. Had more Congressional Hearings. Today had Hearing on success or failure of Project BioShield. Testified before House Government Reform Committee chaired by Tom Davis (R-VA) and Henry Waxman as Minority. Also, Chris Shays there and Congressman Issa, Davis, Issa, Cummings. I testified with Stewart Simonson, and Joe Vitko (DHS). Interesting issues around current BioShield (BS) legislation. The original Bill for BS was strong and contained indefinite authority to purchase for stockpile as well as other strong incentives for industry. Remember when I went around to the House and Senate at the behest of the VP to push BS, several Senators and Members, particularly Sen. Byrd tried to neuter the Bill since they did not want to give big Pharma too much. Now we have a Hearing where the Congress is chiding us since we have not gotten enough products through BioShield. The reason is that the big companies do not see any major advantage since they have no liability protection, no tax incentives and no patent advantages, and not a big pot of money. This is an amazing irony. Went to White House for a regularly scheduled (have not been reporting on these) PCC on Pandemic Flu Preparedness. Co-Chaired by Rajeev Venkayya (HSC) and Lance Leggitt (DPC). Reps were there from every cabinet department, CIA, etc. I presented that we actually had a vaccine sine the results of the dosing shows a clear dose-response curve for the prime-boost. We tested 7.5, 15, 45, and 90 ugm and clearly 90 gave a good protective response after 1 dose and an amazing response after 2 doses. Now we have to figure out the right dose sparing (adjuvant) strategy and/or the right combination of prime/boost. On the way out of the WH, ran into Bob Woodward. Of note, I had just read his new book "Secret Man" about Deep Throat Mark Felt. I congratulated Bob on the book and discussed it a bit. Reauthorization language for the NIH has been circulating for comment. It is incredible. It give all of the power to the NIH Director by eliminating individual appropriations and by creating an IC within the NIH to "carry out" research. Importantly and I must put this in the book. Chairman Barton has threatened to a group of constituency groups who had come to him objecting about the bill that if any NIH IC Director publicly opposes the Bill, he will open an investigation of that IC until the person begs for the legislation. This is after they had "asked for comments". This is a clear case of blackmail and in my mind is unethical, and possibly illegal. I was told this over the phone by his Committee Staffer Cheryl Jaeger.
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July 14-22, 2005 - Looks like the Reauthorization Bill is getting some opposition from constituents; however, Barton is trying to ramrod it through. Zerhouni testified at House Hearing. It is still unclear how specifically he orchestrated this. My sense is that Zerhouni inadvertently created this monster in that he declared the NIH "broken" when he came in as Director. All he wanted was a little more power and some money to "be somebody". However, Barton seized on this to "be somebody" by radically changing the NIH. Zerhouni may now be left with unintended consequences of his early attempts at getting a bit more power.
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July 25 - 29, 2005 - One of the most extraordinary weeks that I have experiences (see below)
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July 25, 2005 - Briefed Secretary Leavitt on briefing that I will give tomorrow to VP Cheney on Biodefense countermeasure development. Leavitt will accompany me to the White House. Real good team at the DHHS with Leavitt and Chief-of-Staff Rich McKeown. They are very good people. NPR played the piece on "This I Believe" that I had pre-taped for them. I have received many verbal and e-mail comments from far and wide about how moved people were by the piece.
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July 26, 2005 - Briefed VP Cheney on Biodefense Countermeasure update for 1 hour. I was the primary and only briefer. Present were Sec. Leavitt, Scooter Libby, Carol Kuntz, Bruce Miller (Carol's Deputy), Stewart Simonson. We discussed progress since my last briefing of the VP as well as some of the problems that we are facing with BioShield 1. The Bill does not go as far as we had originally planned and the big companies are still not incentivized enough. We are left dealing with smaller companies like VaxGen, Acambis, and others when we really want to engage the Merck's and Glaxo-Smith Kline's. The VP loved the briefing and resonated very well with me and the group. While waiting in the upper West Wing Lobby to go into see the VP, I ran into Sens. Ted Kennedy and John McCain. Kennedy and I have evolved into a very warm and comfortable relationship over the years. This is only the 3rd time that I had met McCain, but I never really had a chance to talk to him before. Had nice conversation about the books that they are writing. Ted is writing a book about his dog.
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July 27, 2005 - Busy, Busy day. Briefed VP Cheney again for 1 hour, this time with Sec Leavitt on Pandemic Influenza. Also, present were Carol Kuntz, Julie Gerberding, Scooter Libby, Bruce Miller, Rajeev Venkayya, and some others. This is a prep for Sec. Leavitt's upcoming briefing of the POTUS on July 29. I will accompany him there also. Carol was not too pleased with the briefing. She confided in me that HHS does not seem to be as prepared and definitive as she wants (excluding me, she said). We (HHS team) worked on the briefing afterwards to make it better. Also, appeared on Diane Rehm Show (Susan Page substituting for Diane) to discuss Pandemic Flu.
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July 28, 2005 - Even busier day today. Spent 3 hours in White House Situation Room with Julie Gerberding, Carol Kuntz, Kristen Silverberg, Bruce Gellin, Michael Jackson (Deputy at DHS), Alex Azar, Tom Reilly (OMB), Joel Kaplan (OMB), Tevi Troy (NSC), Ken....., and others to sharpen and focus the presentation of Sec. Leavitt for the POTUS for the following day. Then Julie and I testified before the House Committee on Homeland Security, Subcommittee on Prevention of Nuclear and Biological Attack. Chaired by John Linder, minority - Jim Langevin. Also present were Chris Shays, Jane Harmon, Ed Markey, Normal Dicks, Eleanor Holmes Norton, Donna Christensen, Bennie Thompson, Ron Simmons, Bobby Jindal, Michael McCall, Jim Gibbons. Good Hearing for me, but only fair for John Vitko (DHS). Also testifying were Julie Gerberding and Gen. Eric Schoomaker. One of several Hearings on BioD. Norton gave Julie some flack (she always gets on Julie). After the Hearing we (Julie and I) went back to HHS and spent the next 2 hours again briefing Sec. Leavitt for the POTUS briefing. At the briefing were Leavitt, Rick McKeown, Alex Azar, Natalie Kochnour, Bill Raub, Bruce Gellin, Stewart Simonson. We are getting close to having it right.
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July 29, 2005 - Another amazing day. Spent a couple of hours together with Julie Gerberding and Bruce Gellin at DHHS again pre-briefing Sec. Leavitt for the visit with the POTUS. Then went to White House and briefed the POTUS for 1 hour on Pandemic Flu in the Roosevelt Room. The POTUS was very engaged and went back and forth in an animated and interested way with Julie and me and the Secretary. He vowed to do whatever is necessary to stop the onset of a Pandemic Influenza. He turned to Josh Bolten (OMB Director) and indicated that no expense should be spared. He essentially gave us a mandate to take care of this problem in no uncertain terms. Present at the briefing were: VP Cheney, Karl Rove, John Bolten, Andy Card, Harriet Meiers, Fran Townsend, Kristen Silverberg, Dan Bartlett, Scott McClellan, Mike Chertoff, Tevi Troy, Julie Gerberding, Sec Leavitt, and others. In the late afternoon, I showed around the NIH Michael Gerson who was with Miss America Nicole Johnson Baker and her husband Scott Baker. He was visiting the NIH to look around and get a feel for the place. We presented an HIV-infected IL-2 patient (Terry Brown) and discussed our IL-2 work. Then we went across the street and discussed malaria with Tom Wellums. Mike Gerson is very interested in domestic AIDS. He will get back to me to work on this since he wants to put an initiative of this sort into the 2006 State of the Union Address. Very successful meeting.
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August 7, 2005 - Major Sunday news day with front page article in NY Times predominantly quoting me) regarding the successful preliminary data from the NIAIDfunded H5N1 vaccine trial that showed safety and an immune response that would be predictive of protection. This is obviously very good news in our comprehensive plan for pandemic influenza preparedness. This article in the Times kicked off a very positive media frenzy with front page articles in virtually every newspaper (it was on the Times web page the night before and so other papers picked it up) including Washington Post, Baltimore Sun, Wall Street Journal (Web), AP, Reuters, etc, etc. I appeared on ABC Nightly News on Sunday night, NPR's All Things Considered" on Sunday, CNN American Morning on Monday AM. Very positive "ink" weekend".
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August 17, 2005 - Briefed Secretary of State Condoleezza Rice at the State Dept. on the threat of Pandemic influenza. Also present were Sec/ Mike Leavitt, Rich McKeown, Bill Steiger, Julie Gerberding, Bruce Gellin, Bill Raub, Dan Singer, and a few Assist. Secs in DoS. We gave Dr. Rice a primer on Pandemic flu and also discussed the international implications, particularly related to the recent findings that migratory birds have brought H5N1 to chicken flocks in Siberia, Russia, Mongolia, and Kazakhstan and flyways will likely bring it to India and Europe. She was very gracious and was glad to see me again since I had briefed her a few times on HIV/AIDS and biodefense when she was at NSC
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August 19-28, 2005 - Very productive meeting of editorial board of Harrison's Principles of internal Medicine (HPIM) - 17 and McGraw-Hill publishers at Spring Creek Ranch in Jackson Hole, WY to plan the 17th Edition that will be published in 2008. We returned there after our 1991 planning meeting for a prior edition. I am the editor-inchief for the 17th and I picked Jackson Hole. Great choice. Beautiful weather and above all, Bob and Colleen Grady have a beautiful home there and our girls stayed with them while Chris and I stayed at the Spring Creek Ranch. Did fishing (caught several cutthroat trout), hiking and just relaxing, although I worked every day (1 1⁄2 day off) on the book. Very frightening experience when Bob, Colleen, Chris and the girls took a (supposedly 6 hour) 12 mile hike on the Teton Crest trail. A bit reckless on Colleen's part in that we started late (1:45 PM) and would have cut it close to get to destination by nightfall. Trail we difficult, but incredibly beautiful. Unfortunately, we got lost (wrong turn) and lost >2 hours. We hiked the last hour+ in the dark. Alison was totally frightened. We saw up close several bull moose, mountain lion tracks and wolf tracks. Danger was being stranded in the woods overnight with temperatures going down to <40 F every night. We finally made it to the fire road and out by 9:25 PM.
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August 29, 2005 - Hurricane Katrina totally wrecked New Orleans, parts of Mississippi, Alabama and Florida. Levies caved in New Orleans and Lake Pontchartrain poured into New Orleans together with the river. May be biggest natural disaster in USA history. Thousands dead and stranded. Hundreds of thousands of refugees living under terrible conditions unable to be rescued. Cliff Lane and I are planning a consulting arrangement with IDSA and RCEs for infectious diseases. More to come. Bird flu activities continue with migratory birds now infected in Russia, Siberia, Kazakhstan. Europe worried.
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September 1, 2005 Senator Arlen Specter Senator Patrick Leahy Committee on the Judiciary United States Senate Dear Senators: I am writing to request that you question Supreme Court nominee John G. Roberts about his role in a particularly shameful chapter in the history of the AIDS epidemic in the United States: the hysteria that led many communities to bar children with AIDS from attending school. In 1985, unfounded fears over AIDS transmission were sweeping across the country. The Centers for Disease Control and Prevention (CDC) responded on August 30, 1985, by issuing a landmark scientific statement. The agency reviewed all available evidence and concluded that there was no evidence of spread through casual contact. CDC recommended that most children with AIDS "should be allowed to attend school and after-school] day-care and to be placed in a foster home in an unrestricted setting." Two weeks later, President Reagan had an opportunity to reassure the nation. Draft briefing materials for a major press conference advised the President to say that "as far as our best scientists have been able to determine, AIDS virus is not transmitted through casual or routine contact." Yet in his role as Associate Counsel to President Reagan, Mr. Roberts recommended striking this statement from the President's briefing. Claiming that AIDS transmission through casual contact was a "disputed scientific issue," Mr. Roberts wrote that "we should assume that AIDS can be transmitted through casual or routine contact." Five days later, when asked whether it was safe for children with AIDS to go to school, President Reagan did not cite the nation's leading public health officials. He instead stated, "I can understand both sides of it." The President's failure to speak clearly about scientific understanding of AIDS transmission is now widely understood to have stoked the hysteria about AIDS and the social stigma suffered by children with AIDS. I urge you to question Judge Roberts about his actions in this case. How he answers will shed needed light not only on the past, but also on Judge Roberts's future approach to using scientific evidence in the formulation of law and policy. LANTOS, CALIFORNIA ONE HUNDRED NINTH CONGRESS PLOWENES, NEWYORK EDOLPHUS TOWNS, NEW YORK rary McrUGH, NEWYORK Cc 3 f (5 I it dv St t S PAUL E. KANJORSKi, PENNSYLVANIA ONC MCR ROADS ongress ol tye Canite ate CAROLYN B; MALONEY, NEW YORK GIL. GUTKNECHT, MINNESOTA C.A, DUTCH RUPPERSBERGER, HUSETTS Senator Arlen Specter Senator Patrick Leahy
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September 1, 2005 Background In the summer and fall of 1985, the nation was swept up in a tide of hysteria about th presence of children with AIDS in public schools. Parents and school authorities worried th AIDS might be transmitted through casual contact among children and widespread panic ha begun to set in. That summer, an Indiana school had barred 13-year-old Ryan White, a hemophiliac with AIDS, from returning to school.' Protesters organized mass boycotts of N York schools that had decided to allow children with AIDS to attend." It was a time of grea and confusion. At the same time, however, scientific evidence had emerged to demonstrate that the of transmission from casual contact was certainly remote and very likely nonexistent. Basec this evidence, public health experts drew up comprehensive guidelines on the issue of AIDS children in schools. The goal of the effort was to counter the prevailing hysteria with the fa actual risk. On August 30, 1985, the Centers for Disease Control and Prevention (CDC) issued t first public health recommendations for children with AIDS.' The recommendations began reviewing available evidence to date. According to CDC, not a single case of AIDS in the United States was known to have been transmitted in "school, day care, or foster-care settin; through other casual person-to-person contact." The agency also pointed out that not a sing! one of the family members of over 12,000 AIDS patients had been reported to have AIDS. / agency concluded that "casual person-to-person contact as would occur among schoolchildr appears to pose no risk." CDC recommended that most children with AIDS "should be allo to attend school and after-school day-care and to be placed in a foster home in an unrestricte setting." In drafting and publicizing the guidelines, leading public health experts attempted to parents' fears by raising public awareness of overwhelming scientific evidence that AIDS cx not be transmitted through casual contact. Director of the National Institute for Allergy and Infectious Disease Dr. Anthony Fauci stated, ""There's no evidence the virus is spread by ca: contact, by saliva, by coughing, by any of the normal contact children might have in the ' 4IDS Victim Kept From School in Indiana, New York Times (Aug. 1, 1985). ? The New Untouchables; Anxiety over AIDS is Verging on Hysteria in Some Parts 0 Country, Time (Sept. 23, 1985). 3 Centers for Disease Control and Prevention. Current Trends Education and Foster Senator Arlen Specter Senator Patrick Leahy
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September 1, 2005 classroom setting." CDC director Dr. James Mason described the risk of getting AIDS fror another child in schools as akin to the risk of "being struck by lightning when you walk out: front door in the morning" and "much less than the chance of the boiler that heats the build blowing up."* He stated that AIDS was causing an "epidemic of fear" that was "entirely unnecessary." Inside the White House In the midst of a battle to counter ignorance and panic with science and reason, Presi Reagan held a press conference on September 17, 1985. It was a critical moment. Even tho more than four years had passed since the first cases had been reported, it would be the first that the President had discussed AIDS in public. In preparing for this appearance, the White House staff debated what the President should say about the transmission of AIDS. Draft briefing materials provided to the White House counsel's office advised that tl President clearly explain the views of leading scientific experts. He was to say, "as far as ov best scientists have been able to determine, AIDS virus is not transmitted through casual or routine contact."" Yet in a memo dated September 13, 1985, John G. Roberts, who was then Associate Counsel to the President, advised a completely different approach. In an internal memo, Mr Roberts recommended deleting any reference to the best scientific evidence. He gave severz reasons. First, Mr. Roberts argued that the President should not provide information to the pul on a technical point. He wrote that the President "thas no way of knowing the underlying val of the scientific 'conclusion,' which has been attacked by numerous commentators.'"* No citations were provided. Second, he expressed concern that relating the views of the country's top scientists c embarrass the president if the state of scientific evidence changed. * 4s schools opened across the nation this month, the spectre of young AIDS' victims attending classes with healthy children has created an epidemic of fear..., United Press International (Sept. 15, 1985). > U.S. Counters Public Fears of AIDS, New York Times (Sept. 15, 1985). ° Id. 7 John G. Roberts, Deborah K. Owen, Memorandum for Fred F. Fielding, Domestic ee, ements eet.Bn et ae gee et ee Senator Arlen Specter Senator Patrick Leahy
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September 1, 2005 Third, he endorsed the scientific idea that "we should assume AIDS can be transmitte through casual or routine contact, as is true with many viruses." He stated that the assumptic that AIDS can be transmitted through casual contact could be overcome only when "it is demonstrated that it cannot be." At the same press conference, the President provided technical information to the put on the impact of tax reform and trade policy. But Mr. Roberts apparently did not object to tl use of these data on the ground that the President was not an expert. Mr. Roberts provided no scientific support for his assumption that AIDS can be transmitted through casual contact. Moreover, his standard for dislodging that assumption w require scientists to conclude otherwise with absolute certainty, a standard that is not applied elsewhere in medicine or public health. Sadly, President Reagan followed Mr. Roberts's advice. At the news conference on
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September 1, 2005 asked to explain why he blocked President Reagan from referring to the views of our nation leading scientific experts, why he substituted his own uninformed scientific judgment for th and whether he regrets contributing to a climate of unsubstantiated fear. Judge Roberts also should be asked to explain his actions in the context of how he v the appropriate role of scientific evidence in the formation of law and policy. One importar question is whether he would now defer to the medical judgment of public health officials, ; failed to do in 1985. This issue came before the Supreme Court in Schoo! Board of Nassau County v. Arline, 480 US. 273 (1987), which involved a school teacher with tuberculosis w had been fired from her job. In that case, the Court held: In the context of the employment of a person handicapped with a contagious disease agree with the amicus American Medical Association that this inquiry should includ "findings of facts, based on reasonable medical judgments given the state of medical knowledge about the nature of the risk (how the disease is transmitted) ... and the probabilities the disease will be transmitted ...." In making these findings, courts normally should defer to the reasonable medical judgment of public health officials. Similarly, the case of Bragdon v, Abbott, 524 U.S. 624 (1998), involved a patient wi HIV whose dentist had refused to treat her. In that case, the court stated: In assessing the reasonableness of [the dentist's] actions, the views of public health authorities, such as the U.S. Public Health Service, CDC, and the National Institutes Health, are of special weight and authority.'* Another important question relates to the role of scientific certainty in regulatory anc judicial decision-making. In 1985, Mr. Roberts appeared unwilling to take any position on| transmission in the absence of complete scientific certainty. He applied a standard that requ scientists to prove a negative, a requirement that can be impossible to satisfy. But the Supreme Court must make decisions in the absence of total scientific certain For example, in the recent case of Roper v. Simmons, (125 S.Ct. 1183), the Court held the d penalty to be unconstitutional when applied to those who commit crimes under the age of 18 reaching this conclusion, the Court relied on an array of studies and expert opinions that "tend[ed] to confirm" the limited maturity and sense of responsibility of juveniles under 18. 2 4rline, 480 U.S. 273, 288 (1987). Emphasis added. '° Abbott, 524 U.S. 624, 650 (1998). The Court continued: "The views of these organizations are not conclusive, however. A health care professional who disagrees with tl prevailing medical consensus may refute it by citing a credible scientific basis for deviating the accepted norm." /d. The Court then found that there should be a remand to allow this k 2. PR Sig ae x < bee. Senator Arlen Specter Senator Patrick Leahy
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September 1, 2005 also relied on the apparent lack of deterrent effect of the death penalty on juveniles, despite absence of absolute proof for that conclusion. While noting that "it is unclear whether the d penalty has a significant or even measurable deterrent effect on juveniles," the Court held th ""the likelihood that the teenage offender has made the kind of cost-benefit analysis that atte any weight to the possibility of execution is so remote as to be virtually nonexistent.'"!* In our increasingly complex world, law and science frequently intersect. Understanc Judge Roberts's views on these important issues will shed considerable light on his approac! the responsibilities of a Supreme Court justice. It would be a significant departure from the Court's current jurisprudence were he to seek to impose a standard of proof that requires absolute scientific certainty, as he appeared to do in the fall of 1985. Conclusion On April 8, 1990, Ryan White died. In an editorial eulogizing Ryan, President Reag stated: "We owe it to Ryan to make sure that the fear and ignorance that chased him from hi home and his school will be eliminated."'® The President implicitly acknowledged that he h been wrong not to support the findings of his own experts sooner, and that his refusal to trus evidence had only contributed to the isolation and shame that surrounded AIDS. It is important for the Senate and the American public to hear whether Judge Roberts learned the right lessons as well. Sincerely, Cling A, Wyprrrnn-- Henry A. Waxman Ranking Minority Member S$ se Ge eee Pe le.Ow. PRO... CU ERS Se Ae Far. Sept .7, 2005 - Still major disaster in New Orleans, Mississsippi, Alabama. Likely major repercussions about lack of ppreparedness on the part of State, local, and Federal government in not heading warnings for years that the levees could not withstand a category 4 or greater hurricane. In fact, the levees caved in and N.O. was flooded 80%.
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Sept. 2, 2005 - Interesting situation. Congressman Henry Waxman might use an old document to help block the Bush nomination of John Roberts to the Supreme Court. See letter in attachment: TOM DAVIS, VIRGINIA, CHRISTOPHER SHAYS, CONNECTICUT DAN BURTON, INDIANA MICHAEL A. TURNER, OHIO DARRELL ISSA. CALIFORNIA 2157 RAYBURN HOUSE OFFICE BUILDING MARYLAND HENRY A. WAXMAN, CALIFORNIA, RANKING MINORITY MEMBER TOM DENNIS J. KUCINICH, DANNY K. DAVIS, ILLINOIS MARK E. SOUDER, INDIANA a OD RUSSELL PLATTS. PENNSYLVANIA House of Representatives Ws LACY CLAY, MISSOUR CHRIS CANNON, UTAH neh Nephi ayy Saba ceiceiieR Mave COMMITTEE ON GOVERNMENT REFORM ase een eae CANDICE MILLER, MICHIGAN LINDA T. SANCHEZ, CALIFORNIA VIRGINIA BROWN-WAITE, FLORIOA BRIAN HiGGING, NEW YORK JON C, PORTER, NEVADA ; , ELEANOR HOLMES NORTON, KENNY MARCHANT, TEXAS WaSHINGTON, DC 20515-6143 ' LYNN A. WESTMORELAND, GEORGIA , DISTRICT OF COLUMBIA PATRICK T. MCHENAIY, NORTH CAROLINA Mavsorrry (202) 225-5074 CHARLES W. DENT, PENNSYLVANIA FAcSamLe (202) 225-3976 RD NONE VIRGINIA FOXX, NORTH CAROLINA Minority (202) 225-5051 Se : TTY (202) 225-6852 http://reform.house.gov
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Sept. 9, 2005 - Briefed Pres. Bush today in the Roosevelt Room on update in Pandemic Influenza Preparedness. This was in follow-up of our previous meeting on July 29. I was with Sec. Leavitt, Julie Gerberding, Bruce Gellin. On the White House side was the POTUS, VP Cheney, Scooter Libby, Josh Bolten, Scott McClellan, Andy Card, Attorney General Alfred Gonzales, Harriet Meiers, Robert Zoellig from DoS, and others. The POTUS was very engaging. Half- jokingly he said that "Tony will have to fix this problem for us with his research..." Another good and productive briefing of the POTUS. Mention was made about not repeating the errors of Hurricane Katrina response.
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Sept. 14, 2005 - Briefed Carol Kuntz today on the DHHS $7 to 9 billion supplemental budget request for FY2006 for Pandemic Influenza Preparedness. She wanted my opionion so that she could transmit this to the Vice President who wants to know what I think of the feasibility of the request
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Sept. 15, 2005 - Accompanied Sec. Leavitt and Bruce Gellin and Julie Gerberding to brief 3 cabinet secretaries today on Pandemic Flu. Briefed Sec. of VA Jim Nicholson, EPA Administrator Steve Johnson and Treasury Secretary Snow. Got an e-mail from Fran Townsend of HSC who mentioned that the President has mentioned that he always feels more comfortable when he knows that I am working on important health problems (see visit to the POTUS on Sept. 9).
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Sept. 19, 2005 - Again, accompanied Sec. Leavitt, bruce Gellin, Julie Gerberding and Bill Raub to brief Sec of Agriculture Johanns and Admininstrator of USAID Andrew Natsios on plans for Pandemic Influenza Preparedness.
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Sept. 23, 2005 - Had very interesting and enjoyable evening at a reception at the home of Mark and Nicole Wallace in honor of Kristin Silverberg in celebration of her confirmation (a couple of months ago) as Assistant Secretary for International organizations in DoS as well as her birthday. Present among many others were a number of White House personnel such as Michael Gerson, Josh Bolten, Michael Allen, Randy Tobias (DoS), etc. Interesting part of the evening were the in depth and intense discussions that I had with Josh Bolten and Mike Gerson about the difficulties in funding the POTUS's planned programs over the next few years given the fact that Hurricane Katrina will cost over $100 Billion and Hurricane Rita is still percolating in the Gulf of Mexico. Important dilemmas - Do you let the deficit explode? Do you cut domestic programs (difficult to do since the amount would be trivial compared to what is needed)? Do you defund the war in Iraq (impossible)? Do you abandon all or (as I suggested) part of the Tax Cut program? Very enjoyable and interesting evening. The Wallace's live on 4434 - Hawthorne Street, which is 2 blocks from my house. Christine Grady accompanied me.
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Sept. 28, 2005 - Sec. Leavitt, Julie Gerberding, Bruce Gellin, General Gordon (CIA) and I briefed a groups of Senators on H5N1 influenza pandemic potential in a "top secret" briefing at the Capitol. Among the Senators were: Ted Kennedy, Barrack Obama, Tom Harkin, Durbin, Reid, Patrick Leahy, Max Baucus as well as others. Typical Washington phenomenon ensued - two days later they proposed an amendment to a Defense Bill for $4 billion dollars for H5N1 preparedness emphasizing buying Tamiflu instead of the balanced Vaccine/Therapy approach that we had suggested. In addition, they knew (we told them) that we were preparing a big ($7-9 Billion) supplemental request for the HHS FY2006 budget for vaccines/drugs. It was clear that they wanted to trump the Administration since the bill was proposed by Democrats as well as Frist, who is clearly positioning himself to run for President in 2008. I love it!!
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Sept. 30, 2005 - Appeared again (many times now) on the Lou Dobbs CNN Show to discuss bird flu. He obviously respects me very much. Of note, lately the DHHS people in OC (Bill Hall, Suzy DeFrancis Christina Pearson, and mostly Patti Conrad- I am not sure who is the culprit) have been hijacking the media requests for me when we ask for permission (routine) to accept. Usually these are "rubber stamp"; however they are trying to insert the secretary on shows that specifically ask for me. I feel that this is fine since the Secretary should trump everyone. However, they are lying about it since they are telling us that when they offer up the Secretary, the shows are glad to have the Secretary instead of me. However, I heard directly from Wolf Blitzer of CNN that he had specifically asked for me. The DHHS people called him up and said that I could not do it since I had a prior commitment and they suggest that the Secretary take my place. We had made it perfectly clear to the DHHS people that I was totally free and able to do it. They are really acting poorly. Why do not they just say that they want to insert the Secretary and not lie about it and give the networks the choice of me versus the Secretary. I guess I have no recourse. At the end of the day it will backfire on them.
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Oct. 6, 2005 - A fever pitch is on about the Pandemic Influenza preparedness related to the heightened awareness of the potential, the fact that new cases were seen over the past few weeks in Indonesia, the POTUS giving a speech before the UN General Assembly about the need for international preparedness, the meeting of Sec. Leavitt and I and others with CEO's off pharmaceutical companies, and a series of briefings that Leavitt, Bruce Gellin and I have been giving to members of Congress and Senators. Many media appearances by me despite the above steering to Leavitt. Leavitt himself has been terrific. We are quite a team with the media and the briefings. Today, Leavitt and I briefed the POTUS in the Oval Office at 1:00 PM. Hot sticky day for October. The POTUS had the usual extremely attentive and warm receptions for me. He joked that he had mentioned my name at a press conference that he held yesterday and he does that whenever he wants to appear smart. He just mentions my name and people assume that he knows what he is talking about. We had a few laughs about other things also. At the briefing were the usual cast of characters including: the VP, Andy Card, Josh Bolten Scooter Libby, Dan Bartlett, Scott McClellan, Fran Townsend, Tevi Troy, Rajeev Venkayya, Candi Wolff, etc. We briefed him in preparation for the meeting that is will have tomorrow in the Roosevelt room with the CEOs of Pharma to encourage them to help us prepare for pandemic flu.
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Oct. 7, 2005 - More media appearances, NBC, CNN, German TV, BBC, etc. Leavitt and I helped POTUS in the Roosevelt room talk with the CEOs regarding how we can engage them in building a vaccine production capacity. The POTUS heard from them what I had told him the previous day, i.e. that we much revitalize the production capacity not just for H5N1, but we must create a sustainable market and capacity for seasonal flu that will then provide a major head start in the event of a pandemic flu. CEOs present were: David Mott of MedImmune, David Williams of Sanofi-Pasteur, JP Garnier of GSK, Dick Clarke of Merck and Howard Pien of Chiron. Again, the POTUS was very interactive with me when he came in and left. He concentrated heavily on the CEOs during the meeting. Afterwards, Scott McClellan had Leavitt and I give a press conference in front of the White House. Multiple cameras, etc. I will leave for SE Asia tomorrow with Leavitt to visit Thailand, Cambodia, Laos, Viet Nam, and Indonesia.
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October 8 - 18, 2005 - Trip to SE Asia as part of delegation of Secretary of HHS Michael Leavitt. Countries visited - Thailand, Cambodia, Laos, Viet Nam, and Indonesia. Purpose of the trip was fact-finding in association with the threat of an H5N1 pandemic influenza. Delegation included Michael Leavitt, Paula Dobriansky (Under Secertary of State for Global Affairs), Jong-Wook Lee (Director-General, WHO), Kent R. Hill (Acting Assistant Adm. For Global Affairs, USAID), James Butler (Deputy Under Secretary of Agriculture for Farm and Foreign Agriculture Service), Suzy DeFrancis (Assistant Sec. for Public Affairs, DHHS), Julie Gerberding, Margaret Chan (Assistant Director general and Rep of WHO for Pandemic Influenza), H.E. Changchui (Assistant Dir.-Gen., Food and Agriculture Organization - FAO-), Alejandro Thiermann Pres. World Organization for Animal Health - OIE ), Kenneth Bernard (Advisor to WHO Dir. Gen.), William Steiger, Kerry Weems (Deputy Chief-of-Staff, DHHS), Vaughan Turekan (Special Assistant to Paula Dobriansky), Allyson Bell (Director, Scheduling and Advance, DHHS), Jay Hodes and Michael Lonetto (Security). Please see files for details of whom I met and when. I will list some of my impressions below. Major impression of the trip was the consistencies as well as the variabilities of the 5 countries visited. Thailand was certainly the most advanced. They were taking very seriously cleaning up and keeping clean the commercial poultry industry. They export chicken (mostly parts pre-cooked) all over the world. The problem is with the small farmers who have variable number of chickens in their back yards. The most disturbing yet very interesting was Cambodia due to a society that was still trying to recover from the Khmer Rouge genocide. It is a beautiful people; very Left IAD sensual looking. Men almost effeminate. The sexuality of both men and woman stood out. (This was also seen to some extent in Thailand.) The Institut Pasteur in Phnom Penh is the best science they have there. I was very impressed with Laos. I expected a stark, Communist-style society. It was very warm and friendly. People seemed to look upon us as if we were normally there. They did not stare, nor did they smille too much. They were "very normal" looking. Bill Steiger and I had a terrific time running around the track in the National Stadium. The Laotian National Track team was practicing there at dusk and we ran until it got dark. Viet Nam was amazing. Hanoi was a vibrant, bustling exciting-appearing city. The most amazing experience was trying to walk across the street with the motor scooters and cars going very fast and literally messing into each other from multiple different directions. It was incredible that they did not hit each other continually. The word from the CDC folks who were with us was that you needed to just cross the street and not look or speed up or slow down. Just cross at the same pace and the scooters and cars will avoid you. It was scary. Haiphong was a different story. It was more stark and gray. The Vietnamese women are incredibly beautiful. We stayed at the Hanoi Hilton - beautiful hotel, run by Vietnamese, but very western. It seems incredible now given the energy, beauty and talent of these people that we could ever had been at war with them for so many years. Interestingly, they seemed to love Americans. It appeared to be very genuine. Indonesia was similar to what I imagine Hong Kong to be. Many skyscapers in an Asian country. The polluted stench in the air was similar to (but not quite as bad as) Delhi.
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Oct. 8, 2005 (Saturday)- Left IAD
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Oct. 9, 2005 - Arrive Bangkok via Tokyo on commercial flight. Met by Ambassador Ralph (Skip) Boyce and Health Attaché Jordan Tappero. Skip was terrific and we hit it off very well during the trip. He knows Jim Huskey from prior DoS activities. He was in Beijing with Jim during the Tianman Square incident. Stayed at Conrad Hotel. Settled in at hotel. Extremely hot and muggy. This was just at end of rainy season and we expected rain, but got very little throughout the trip. However, I can remember the heat. Visited with deputy Prime Minister in the ornate, but beautiful Government House. Of note, the Deputy PM mentioned how happy he was that Thailand offered assistance to USA during the Katrina Hurricane disaster. Also met with Health Minister Suchai Charoenratanakul and Prat Boonyawongvirat Acting permanent Secretary. Our CDC is not entirely satisfied with the performance of the health ministry. The Thais seemed to be fixated on whether and how much Tamiflu the USA will give them for their stockpile. We celebrated the 25th Anniversary of the Thai MOPH - US HHS/CDC (TUC) Collaboration. Had multiple meetings and luncheons with United Nations reps and NGOs. Here and elsewhere, we had numerous Press Conferences. Suzy DeFrancis (Assistant Secretary for Public Affairs) clearly did not want Julie or I in the spotlight (see above comments). She literally kept the press away from us so that they would concentrate on the Secretary. The Secretary was cool about everything; Suzy was the problem. Had a great reception at Skip Boyce's house. Typical Ambassador's house and party.
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Oct. 11, 2005 - Next day we toured a typical commercial poultry farm - Charoen Pokphand Foods PCL.. Much press. We all suited up with protective gear (booties, caps, gowns, etc.). The commercial farms are very careful about bird flu and are meticulous in preventing infections. There was no history of infection in these flocks - all infections in backyard and small farm flocks. We visited a small poultry farm and saw the differences between commercial and small farms. Had lunch at airport restaurant and took off for Phnom Penh, Cambodia Arrived at Cambodia and checked into Raffles Hotel in Phnom Penh. Got a "Country Briefing" from U.S. Ambassador Joseph Adamo Mussomeli. He is a very good guy - relaxed and friendly, but very competent. That afternoon and evening we met with the Cambodian Minister of Health - Nuth Sokhom and signed a memorandum of understanding. Had a reception at the Raffles Hotel and then to bed.
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Oct. 12, 2005 - Series of meetings with officials. Met first with Minister of Agriculture, Forestry and Fisheries. It was clear that Cambodia was far less well-prepared than Thailand for a bird and/or human pandemic. Met with Deputy Prime Minister and Amb Mussomeli had a firm exchange with the Deputy Prime minister in which Joe objected to the fact that the Cambodians had arrested a Cambodian Journalist for writing a story negative to the regime. Next visited the Institut Pasteur in Phnom Penh. The Institut Pasteur has 29 foreign satellite institutes throughout the world. Cambodian institute began in 1935, but was wiped out by the civil war and then by Khmer Rouge. It was re-established in 1995. Sirenda Vong is a young scientists at the Institut Pasteur who made a very nice presentation about their work. He is a rising star in my mind.. Lasted only part of a day. Met with King Norodom Sihamoni and toured the Imperial Palace. The King is an exballet dancer. He is single. Visited the Genocide Museum. The story is horrible. 1.2 million people (10% of the population) were murdered, usually following torture over a 5 year period. After the Khmer Rouge took over, they evacuated Phnom Penh and literally murdered anyone who was middle class and/or educated. They murdered people merely if they wore eyeglasses. They had this genocide maniac mentality (similar to the Nazis) of documenting everything that they did. The walls of the museum showed thousands of photos of people who were put into the prison (now museum) which was originally a high school. They would photograph them, document their arrest, torture them and then kill them. Either they died of the torture, starvation, etc. or they sent them to the killing fields to be hacked or bludgeoned to death. They kept meticulous medical records of the dying and deaths of the prisoners. We then visited with a group of NGOs who explained to us the problem of trafficking in Cambodia. It is a complex problem since the people who are trafficked are usually sold by their family because of poverty. That afternoon, we flew to Vientiane, Laos and check into Lao Plaza Hotel. Bill Steiger and I had a terrific evening run (right as the sun set) in the National Stadium where the Lao National Track Team was practicing. donesia. Stay at Had a reception-dinner that night at the home of Amb. Patricia Haslach.
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Oct. 13, 2005 - Spent day in Vientiane meeting with a variety of Ministers. Met with Minister of Public Health Dr. Ponemek Daraloy. He is a good person, well-regarded in health circles in SE Asia. He is an old Pathet Lao. Visited Mahoset Hospital and then visited the Prime Minister and the Minister of Foreign Affairs.. Signed MOU. Met with Dr. Siene Saphangthong and then in mid-afternoon flew from Wattaya International airport to Hanoi, Viet Nam.. Arrived at Hanoi Noi Bai Airport. Motorcade from airport to downtown Hanoi was fascinating as we passed a bustling suburb with extremely interesting "vertical" architecture of homes and offices. Checked into the Hanoi Hilton Opera Hotel.
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Oct. 14, 2005 - Met with Minister of Health Tran Thi Tring Chien. Then went to National Institute of Hygiene and Epidemiology and met with its Director Dr. Nguyen Tran Hien. He is a terrific person and I sent him a signed copy of Harrison's after I returned home. Also met with the Minister of Agriculture and Rural Development Cao Duc Phat. Also, met with Prime Minister Phan Van Khai in a very elaborate Government Palace at 1 Bach Thao Street, Ba Dinh District with an enormous bust of Ho Chi Minh. The Prime Minister was extremely impressive. He spoke on all of the issues without notes. He was well-versed and clearly knowledgeable about specific issues. Had dinner hosted by the MOH.
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Oct. 15, 2005 - Great experience. Visited the "wet markets" in Hanoi and got an great feel for the bustling nature of this vibrant city. Drove 2 hours 15 minutes to Haiphong and visited Provincial Health Department. We had lunch at Van Tue Restaurant for Government Officials and then went to Viet Tiep Hospital to visit their Clinics. It was in this region that the cluster of cases occurred. MOL visited with the family who got sick and who were featured on CNN a few weeks ago. Big difference between Haiphong and Hanoi in that Haiphong is clearly more dreary and less vibrant.
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Oct. 16, 2005 - Flew to Tan Son Nhat International Airport in Jakarta, Indonesia. Stay at Four Seasons Hotel Jakarta.
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Oct. 17, 2005 - Visited NAMRU-2. Was apparently a problem in that the Indonesian government was threatening to cut off dealings with NAMRU-2 because they thought that NAMRU-2 was being critical of them. We finally sorted it out and at the end of the day got the president of Indonesia to endorse NAMRU-2. We met with Coordinating Minister of people's Welfare and Coordinating Minister of the Economy. There are issues in Indonesia of difficulty in transparency related to the diffuseness of the country. 17,000 islands with a population of 220 million (4th largest country by population). Met with President Yudhoyono. He was very impressive and knowledgeable. Flew from Jakarta to Tokyo on PM of Oct. 17 and arrived in Tokyo on Oct. 18 ) Dulles Airport.
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Oct. 18, 2005 - Flew Tokyo to Dulles Airport.
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Oct. 19, 2005 - "Intrigue" at the White House Upon return from SE Asia, we have just heard that the overall responsibility for Pandemic Influenza will be handed over to the Homeland Security Council (HSC) run by Fran Townsend. Also, DHS will be playing a more significant role. We believe that this relates to several factors: 1) the preparedness planning involves multiple agencies and so there is a need for a coordinating entity. 2) The WH is concerned about the fact that it has taken so long to get a plan out and now we realize that we need an Federal Plan (all agencies) as well as a National Plan (State, Local, Federal). 3) Anxiety about the failures of FEMA around Hurricane Katrina and the need to have centralized control over a potential disaster (in this case pandemic flu). 4) WH staff wanting to assert themselves Also, it is becoming more and more obvious how the Public Affairs people at HHS are trying to block Julie Gerberding and me from being out front with the Press. They keep intercepting requests by the Press for me and Julie to put the Secretary out there. This was seen in SE Asia and again is seen here. However, there is so much press going on that I am getting plenty. They are, however, sucking off the good offers that I get (network TV). In this regard, I am still doing a lot of CNN
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Oct. 19, 2005 - Incredible evening. U2 gave a concert at the MCI Center in D.C. Bono arranged for premier tickets for Chris and me. We met with Bono in the hospitality suite before the concert and exchanged warm hugs and discussions. Amazingly, in the middle of the concert in front of >25,000 people, Bono dedicated a song ("Miracle Drug") to me. He praised me and said that I was doing wonderful things for HIV/AIDS globally and then dedicated the song to me. After the concert, he invited Chris and me to a private reception at his hotel - The Ritz-Carlton in Georgetown - for drinks and discussion. Everyone was bussing that he dedicated a song to me. I thanked him and we discussed the need to keep up the PEPFAR program and make sure that we do not stop drugs in people because the program phases out. There is no sign that the Administration will phase the program out after the 5 years are up.
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Oct. 20, 2005 - Am wearing thn with exhaustion. No sooner did I return from SE Asia that I had to go to Chicago to receive the 2005 Scientist of the Year Award from R & D Magazine. Took place at a black tie affair at the Navy Pier in Chicago.
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Oct. 21, 2005 - Much press regarding trip and updating on pandemic flu. The whole world is getting exorcised. Chickens now infected in Russia, KazakstanChina, Romania, Turkey. Clearly, migratory birds are bringing the disease West. Was on CNN, C-SPAN, NPR, Bloomberg News, etc.
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Oct. 24 - 28, 2005 - Hectic week with bird flu and grand jury indictment of I. Lewis "Scooter Libby" for perjury, obstruction of justice and making false statements in the er, and veil the investigation of the leak that Valerie Plame was a CIA agent. She is the husband of Jim Wilson who has been criticizing the war in Iraq. Oct. 24 - briefing by me , Julie, Bruce Gellin and Secretary Leavitt (MOL from here-on) of several cabinet members in the Cabinet Liaison Office in EEOB. Subject - pandemic flu. Oct. 25, 26 - Boston to deliver Baruj Benacerraf Lecture at Harvard and Dana Farber Cancer Center. Nice dinner at Harvey Cantor's house to celebrate Baruj's 85th birthday. Say Jenny in Cambridge after the dinner on Oct. 25. Wonderful time with my amazing daughter! Oct. 27 - continue briefing of Hill members. Briefed Tom DeLay, Steny Hoyer, and others. Incredible attention to pandemic flu in this country. Oct. 28 - Briefed Speaker of the House Dennis Hastert. The POTUS will unveil the Pandemic Plan at NIH on Nov. 1. I have been doing considerable press.
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Nov. 1, 2005 - POTUS came to NIH to unveil the National Flu Pandemic Plan. Beustiful Fall day with crystal clear skies and temperature around 65-70. I along with Sec Leavitt, Elias Zerhouni, Julie Gerberding, and others greeted him as he arrived. During his speech he specifally thanked me for my work. Attending the speech in Natcher Auditorium were several Cabinet Secretaries including Coni Rice, Minetta, Mike Chertoff, Johanns among others. With the POTUS was Karl Rove, Fran Townsend among others. POTUS gave a good speech. Afterwards, I did a media blitch and appeared on CNN Wolf Blitzer, CNN Lou Dobbs, CBS Evening News, Charlie Rose and did many print and radio interviews. Ted Kennedy is concerned about the liability issue. He agrees that we should give liability protection to the pharmaceutical companies to keep them in the business of influenza vaccine manufacturing. However, he feels that we must also provide compensation for those that might be injured by the vaccine. He appealed to me to discuss this with the administration. He followed this up 2 days later by having his staffer (David Bowen) call me and get more advice from me about how they could tackle this problem.
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Nov. 2 - 3, 2005 - Testified with MOL, Julie G., Bruce Gellin, and Bill Raub at both the Senate and House Appropriations Subcommittees for HELP. We discussed the President's Plan as well as the more detailed HHS Pandemic Plan. We were generally well received, but there was the usual partisan skepticism on the part of the Democratic regarding the fact that the Plan asks the States to put up about 75% of the cost for a portion of the Tamiflu that would go to them. The point was made that the States do not have enough resources to do this. MOL makes the point that this is a co-pay situation similar to what is done for prescription drugs in Medicare and Medicaid. Much press. Big stuff going on with the indictment of Scooter Libby. The Democrats are trying to drag in the VP and the entire WH, claiming that there was a wide conspiracy to cover-up the fact that the WH distorted intelligence to get us into a war with Iraq and that Joe Wilson was smeared by outing his CIA wife in order to get back at him for disagreeing with the evidence used for going to war with Iraq.
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Nov. 3, 2005 - Top secret meeting at EEOB regarding conduct of certain experiments in the area of developing countermeasures. Cannot elaborate because of top secret nature of discussions. More press regarding Pandemic flu plan.
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Nov. 4, 2005 - Tesitified before the House Government reform Committee with Tom Davis Chairing. Same cast = MOL, me, Julie, Raub, Gellin. This was a tougher Hearing in that this Committee is generally tough. Both the Republicans and Democrats gave some heat to us. As usual, the tough ones (Chris Shays, Dan Barton, Henry Waxman) were quite deferential to me and so I did fine. Dennis Kucinich made a spectacle of himself by pushing MOL on the issue of taking over Roche's patent for Tamiflu. Kucinich wanted a government takeover and MOL argued that this would be a disincentive for companies to ever make scarce products (MOL is absolutely correct).
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Nov. 5, 2005 - Met Senator Bill Frist at the St. Alban's - St.Stephen's/St Agnes football game (2:30 PM) at St. Albans field. Beautiful Fall afternoon. Temperature = 70 and totally sunny. St. Albans won 42-20. Frist's son Brian plays for St. Albans (junior year - special teams and safety). Frist discussed a whole range of issues, particularly pandemic flu. He wanted my opinion on the budget bill for flu ($7.1 Billion). Also, ran into Tim Russert at the game. He told me that he wanted me for "Meet the Press" to talk about bird flu within the next couple of weeks.
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Nov. 9, 2005 - Spirited Hearing before the Senate Foreign Relations Committee on Pandemic Flu. I testified along with Julie G., Andrew Natsios (USAID), and Paula Dobriansky (DoS). Committee chaired by Paul Lugar. Present at Hearing were Sens. Dodd, Biden, Obama, Sarbannes (all Dems.) They kept pushing Julie and me about "who is in charge?" We explained that it is primarily a health issue and in this regard, Sec. Leavitt is in charge. In the sense that the issue may involve multiple Agencies, this is coordinated through the Homeland Security Council and Fran Townsend is in charge. They did not like the latter and were pushing for a "Flu Czar". We said that this was a bad idea. There was a lot of animated back and forth. After the Hearing, I met with Olafur Ragnar Grimsson, President of Iceland. He was referred to me by Congressman Ed Markey (D-MA). He is sponsoring an Icelandic Drug Co ("Actavis") that makes generics for HIV drugs and he wants to get Iceland involved in helping out with global AIDS by making 3-in-1 drugs available free to some countries and sold at minimal prices to others. He wanted my advice. I strongly suggested that he contact PEPFAR in the form of Mark Dybul. I also suggested that he contact "Doctors without Borders" and Bono's people (Jamie Drummond). I will help them out to connect. They had already approached Bill Clinton and the Clinton Foundation, but felt that they did not really have a substantive network.
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Nov. 10, 2005 - Frenetic activity continues. Briefed together with Bill Raub and Julie G. (by phone) and Jerry Parker (Stewart Simonson's Deputy at OEPHP) Secretary of Commerce Gutierrez (he is last of the Cabinet Secretaries to be briefed). Bruce Gellin is in Geneva with Stewart for Global Planning meeting for Pandemic Flu. They stopped in Paris to visit Institut Pasteur. This was in the middle of the riots around Paris by Muslim French Nationals who are enraged at poor living conditions and alleged prejudice in French Society against them. We also briefed the House Armed Services Committee and I gave a personal 1on-1 briefing to my old friend Sen. Barbara Mikulski. She was gracious and very glad to see me. This evening Sec. Leavitt and I and Michael Osterholm (connected from Minnesota) did the Nightline Show with Ted Koppel from D.C.
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Nov. 20, 2005 - Press still hot and heavy. I appeared on "Meet the Press" with MOL, Julie Gerberding, and Mike Ryan (WHO) about bird flu. Many e-mails saying that I gave a great interview.
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Nov. 23, 2005 - Press activity still very heavy. I appeared today on the Diane Rehm Show and CNN's "The Situation Room". Michael Osterholm sent me an e-mail saying that he was concerned that I was saying on the air that the probability of an H5N1 pandemic this winter is low. He says that "health reporters" are e-mailing saying that I am giving confusing messages. I am absolutely certain that the "health reporter" in question is Laurie Garrett who is inherently hysterical. I am disappointed in Michael since it is very clear that I am saying that the probability of a pandemic (in the broad sense - any new virus) occurring is very high based on historical precedence. However, the probability of there being an H5N1 pandemic of the scale of the 1918 Influenza over the next month or two is low. NONETHELESS, we must assume the worse case scenario and prepare as if it will happen in its worse form and it will happen soon. I have been very consistent about this. I am actually asking the actuarial and probability people like Don Burke to figure out if we can add some science to this concept.
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Nov. 25, 2005 - HHS Flu Summit for States will take place on Dec. 5. Julie Gerberding and I are at collegial "odds" with the DHHS people (Laura Lawlor and John Ogwanobi) in that we feel that the Department and the CDC specifically should be the first ones discussing the Plan. The Agenda as of today has MOL (as appropriate) speaking and then we bring on Rajeev from HSC, Jeff Runge from DHS, a person from DoA. Julie does not come on until after lunch. Even I (speaking on the science of flu as I usually do) come on before Julie. There is already concern in Congress and in the Press as to "who is in charge". I feel that the CDC should be right up front on this. HHS and MOL are is charge, but the major health instrument for preparedness and response is the CDC.
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Nov. 26-30, 2005 - Media continues for me with Lou Dobbs, CNN Wolf Blitzer (The Situation Room), WTOP radio, CBS News, etc. regarding bird flu. The preparation of DHHS for the States Flu Summit on Dec. 5 is a major mess. Laura Lawlor somehow has taken over the preparation and it seems that no one knows what we are supposed to do. MOL has taken a major interest in a 75 city tour of himself, Julie, me and perhaps others to tell the States of their "responsibility" to be prepared locally for a pandemic flu. Every time this subject comes up, the States push back by saying that they have no money and the Federal Government is giving them an unfunded mandate. What I see is a clear example of a Secretary who is a good person who has gotten too personally involved in an issue and who is doing some of the planning off the top of his head and as a result there really is no one truly in charge of making sure something is done correctly. Everyone on his staff (John Ogwanobi, Suzy DeFrancis, Kerry Weems, etc.) is afraid to say that the 50 states tour is likely to be a disaster. They are like a Greek Chorus telling him in this case that it is a good idea. They do not know what the goal is or even why they are doing it. I strongly suspect that Suzy DeFrancis deep-down thinks that this is a campaign swing and , frankly, MOL does also to some degree. I have told Stewart Simonson and Bruce Gellin that I feel it would be a disaster. I do not want to be a part of it and have asked Stewart to tell Rich McKeown this. Rich is the most sensible one there and so hopefully I can get out of most or all of the tour. They want me for my credibility, but this is local and state public health stuff, which is not my area. Also, I am hearing that the White House knows how disorganized they are and are getting anxious The attacks in the press on Stewart Simonson seem to be winding down, but Sarah Luecke of the WSJ will be coming out with a big article. I have spoken to her and hopefully she will give a balanced story.
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Dec. 1, 2005 - World AIDS day. I was invited by the White House to be a Principal at the POTUS Speech (EEOB 450). As with last year, the POTUS specifically recognized me as being in the audience for all of the work that I have done in AIDS. Peter Mugyenyi from Uganda was there as was an AIDS mother from South Africa and her 2 children who had benefited from the PEPFAR program.. Had coffee with Julie Gerberding after the ceremony at Starbuck's on Pennsylvania Avenue and she feels exactly the way I do about the States Summit and the "tour" (see above).
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Dec. 2, 2005 - Had pre-Table Top preparation at HHS with MOL, Julie Gerberding, Stewart Simonson, Bill Raub, Bruce Gellin, Jesse Goodman, Rich McKeon and the entire DHHS staff. I have concern over these exercise since they are unrealistic and always make everyone look bad. I tried to interject some common sense into the discussions, but there were too many people who were acting like they knew what they were talking about. I generally do not like those "group" briefings of the Secretary since everyone trials to look smart and few people have a clue of what is going on. That evening, went to an incredible affair at the Kennedy Center with Christine. It was the Grand Opening of the Family Theater sponsored by the Catherine B. Reynolds Foundation Series for Artistic Excellence. After the show which included extraordinary superstars, we had dinner on the stage of the Eisenhower Theater!!. It was incredibly elegant and all the Washington Glitterati were there. At my table with Chris was David Rubenstein of the Carlyle Group, Super-Attorney Bob Barnett, UNICEF President Ann Veneman, Former Sen. John Breaux (D-La), Rita Braver (producer for CBS). At the dinner were every media and politico you could imagine. The dinner was amazing and we all had a great time.
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Dec. 5, 2005 - Big meeting ("Summit") at the Grand Hyatt in DC to roll out the plan to visit all 50 states to talk up pandemic flu preparedness. Present were health officers of the big cities and all the states. Presentations by MOL, Julie Gerberding, me and the usual cast of characters. I am very anxious since MOL wants to take me with him on the tour to visit 75 locations in all 50 states to talk up preparedness. I just do not have time for this. Stewart Simonson and even Rich McKeown are aware of this and are trying to get me out of it. However, MOL is so enamored of me that he wants me with him.
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Dec. 6, 2005 - Strange article (Profile of me) on the front page of the Wall Street Journal by Bernie Wysocki. It made it look like I have 100s of millions of dollars of biodefense money that I dole out at my whim to contractors. The article was very likely (almost certainly) instigated by the lobbyists from BioPort (AVA anthrax vaccine) and from Hollis Eden (countermeasures for rad/nuc) who want contract money and did not get it. The article was extremely confusing since it mixed up what we do (research) and what HHS does (procure via BioShield). Also, it made it look like there was no peer review and that I just hand out money to the "Fauci Club".
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Dec. 16, 2005 Paradoxically, mostly favorable responses to the WSJ article. Most people interpreted it as indicating that I was a powerful player. Publicity dying down about bird flu around holidays. MOL went on the first of the State trips to Minnesota. With the help of Rich McKeown, I got out of the trip. Julie Gerberding went and feels as I do that these series of trips will be a waste of time for us. Article came out in WSJ by Sarah Lueck on Stewart Simonson with major quote by me defending him. It was a fair article and will likely reverse the trend of bad press that he has been getting as being the "Michael Brown of Public Health preparedness". Went to the VP's mansion for a Christmas Party on Dec. 15 and then went to Lessons and Carols at the National Cathedral right afterwards. Took Stewart Simonson and his parents (who are in town for the holidays).
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Dec. 16-31, 2005 - Reasonably calm. Still doing press regularly related to pandemic flu. On Dec. 27, 28, 29 did Today Show, Good Morning America, and CNN "The Situation Room", respectively. Bush popularity polls going up slightly after a terrible year related to Iraq, prison abuses, Valerie Plume leak (Scooter Libby, Karl Rove), Katrina, etc. POTUS speaking more to the press and admitting more that certain things have not gone well. Am still trying to be low profile in requirement to travel with MOL on his 50 State tour.
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Dec. 27-28, 2005 - Drove up to NYC with Chris and the girls to do Christmas sightseeing and to visit my father who does not travel down to DC/VA for the holidays the way he used to do years ago. Had a great time. Went to Bryant Park around 42nd Street and 5 Avenue (near NY Public Library and saw the Kenneth Cole tented exhibit in cb the Park. It was a series of photos and plastic molds of foot imprints of people who had devoted themselves to fighting the AIDS epidemic. My footprint was up there along with Angelina Joli, Brad Pitt, Whoopie Goldberg, Larry Kramer, Bono and a large number of other notables.
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Dec. 31, 2005 - Carol Kuntz took Chris, me and the girls on a private tour of the West Wing. It was terrific. I got an interesting new perspective of the place since I have been there so many times over the past several years that I take it for granted and never really "look around". It was great to have a personal tour and take my time looking at rooms and furniture, some of which I have sat in when briefing the POTUS and others.
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Jan. 4, 2006 - Met with David Rubenstein, Founder and CEO of The Carlyle Group. He made me an amazing offer to join the firm as head of a Medical Venture Capital component of the Group. Compensation projected to be in the millions per year with a base salary of $1 million! Obvious question is whether I want to get out of the classical scientific/public servant arena.
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Jan. 26-29, 2006 - Attended the World Economic Forum in Davos, Switzerland to participate in 2 events: 1) a dinner panel discussion on Pandemic Influenza and 2) a plenary panel moderated by Ira Flatow (NPR - "Science Friday") on Pandemic Influenza. Other panel members included David Nabarro of WHO, David Stout of Glaxo-Smith Klein, the Minister of Health of Spain. The meeting was unexpectedly enjoyable in that I went to "close-up" panel discussions, breakfasts etc with people like President Muschaaraf of Pakistan, President Karzai of Afghanistan, Bill Gates, Bono, Queen Rana of Jordan, Bill Clinton, a number of journalists, etc. I was particularly impressed by leaders such as Karzai and Muschaaraf. The activity and press interest in Pandemic Flu has calmed down somewhat with other issues in the news (Supreme Court Justice Sam Alito confirmation, Iraq, the Hamas election victory in Palestine, etc.) Yet I still did a few CNN broadcasts from Davos.
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Feb 3, 2006 - Attended Distinguished Lecture Series at Hilton Hotel with Chris. Lecture by Bono to a crowd of several thousand in the Hilton Ballroom. Bono spoke about his vision, etc. He stopped during the talk to recognize me in the audience as a "hero" of his who has done an enormous amount for global HIV/AIDS, particularly in being the main player working with President Bush in developing PEPFAR. Then several times throughout the speech when he mentioned global health or AID he would look in my direction and mention my name saying something like "I am sure that Tony would agree that...." Bono has been incredibly generous to me in his public recognition of me. He also mentioned that the USA and the world should support his "One Campaign". Of note, Jenny (Fauci) is a leader among the Harvard students in the One Campaign efforts. Feb. 3 - March 6, 2006 - Continued intensive interest in the potential for an H5N1 pandemic influenza with several media appearances. Also, I testified on March 2, 2006 before the House Appropriations Subcommittee for Foreign Operations together with Julie Gerberding, Kent Hill (USAID) and Ambassador Nancy Powell (DoS). Did Diane Rehm show in addition to other media. Spent an 90 minute lunch briefing the Washington, D.C. Bureau of ABC News (particularly George Stephanopoulos's people) on bird flu.
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Feb. 13, 2006 - Had dinner with Rahm Emanuel (Democratic Caucus Head and brother of Zeke Emanuel), Christine Grady, Zeke Emmanuel, Mary Richardson and a Washington Post reporter (?name) at Central Restaurant at 1001 Pennsylvania Ave, NW. We were in the middle of an ice storm that did not deter us. Had very interesting and enjoyable conversations with Rahm about the Democratic Congress and the potential Democratic candidates for President in 2008. Rahm used to work for Bill Clinton when he was POTUS and was part of Clinton's original campaign team. Rahm feels that Hillary has the inside track because of the Clinton machine, her experience, and lots of money. However, he feels that Barack Obama will give her a tough race.
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Mar. 7, 2006 - Gave laudatio remarks at a reception in the Dirksen (430) Building at 6:00 PM (beautiful crisp Winter day) in honor of Peter Piot who was celebrating 12 years at UNAIDS. I reflected about his early days at Projet SIDA in Kinshasa, Zaire with Tom Quinn and Jonathan Mann. Also, honored at the reception was Michael Iskowitz, formerly Sen. Kennedy's Staffer, former White House AIDS Deputy Coordinator and recently at AIDS Action. He is entering a private consulting arena. Met and spoke with Sen. Hillary Clinton who recognized me specifically in her remarks.
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Mar. 8, 2006 - Took quick trip to NYC to brief the NY Bureau of ABC News with David Westin (President) hosting me. Afterwards, rushed back to DC to do a teleconference with the officials from all of the DC area (MD and VA) school officials from private high schools.
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Mar. 12, 2006 - Had tea at the Four Seasons with members of the Mothers to Mothers to be (M2M2B) an African Program founded by Dr. Mitchell Besser (Rich Besser's brother) and involving HIV-infected South African women who have delivered babies (some infected, others not) and who now work with other mothers to be who are HIV-infected to educate them, empower them and help them live a positive life. They are visiting the USA at the request of First Lady Laura Bush stemming from her trip last year to Africa where she met these women. The Mothers Program is partially funded by PEPFAR. I will Chair a panel discussion at Georgetown tomorrow where the women will discuss their work.
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March 13, 2006 - Presentations at the White House (East Room) with Laura Bush and Randy Tobias followed by brunch in the State Dining Room. Mrs. Bush thanked me for serving as the Panel Chair. Had good conversations with Kristen Silverberg, Randy Tobias, Michael Gerson, Carol Thompson and other White House folks. After the presentations at the White House we went to Georgetown (Healy Building - Gaston Hall) for the panel discussion. It was a beautiful sunny an unseasonably hot (84F) day for March 13. Other members of the Program were Gene Falk and Robin Smalley.
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Mar. 21, 2006 - First day of Spring 2006. Had phone conversation with Carol Kuntz today and she was concerned that there have been "policy time" briefings with the POTUS regarding pandemic flu involving Sec. Leavitt where she thought that I should definitely have been included. The POTUS asked some questions that Rajeev Vankaaya and Leavitt could not answer that Carol knew for sure that I would have been able to answer. Carol asked whether I was having a problem with HHS. I told her not at all, but I did mention to her my suspicion that HHS is trying to shed all of the light on Leavitt (probably because of his political aspirations) and having him share the spotlight with me or Julie Gerberding is something that makes HHS nervous. We continually see this when press ask for me and HHS diverts them to Leavitt when we ask them for clearance for me. Welcome to Washington!! nse and SN1
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April 3, 2006 - Over the past 2 weeks, there has been continued medium-high interest in the ever expanding bird flu situation with a constant low-level stream of new human cases and more countries getting either migratory birds or chicken flocks infected. Current number are 188 infected and 103 dead. Recently, there has been migratory birds (mostly swans) infected with H5N1 detected in Western Europe. France as only country with some domesticated chickens and turkeys infected. They quickly handled it by culling. Other countries such as Italy had migratory bird(s) infected, but no chickens and still chicken sales in supermarkets and restaurants has plummeted by as much as 50 to 60%. My prediction is that infected migratory birds may (not definitely) make it to USA and that there will be very little contamination of chickens because of the agriculture controls. Yet, it will affect (by misperception) the chicken industry. There has been some backlash among people in press about the over-hyping of the threat. I am in good shape here since I have always maintained that the threat, although non-quantifiable, is likely low. This is in contrast to others such as Rob Webster, who says that there is a 50% chance that we will have a bird flu pandemic among humans with H5N1!!! I have no idea how he came up with that number. Also, my friend Michael Osterholm is also singing doom and gloom.
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April 6, 2006 - Had dinner with Tara O'Toole of the Univ of Pittsburg Biodefense Program. She had just testified at the BioShield Hearing on the Hill and wanted to get my perspective on how things were going with the Biodefense effort and if there was anything that she could do for me. I explained to her that the reason the current BioShield effort was not successful was that the Congress did not approve the Bill that I and VP Cheney and Scooter Libby had originally proposed. The Congress limited the money to $5.6 Billion instead of an unlimited authorization to draw from the Treasury and the Appropriations Committees still controlled how much could be spent each year. Also, we could not do advanced development for products. This put off the big companies (not enough money) and the little companies (advanced development) and so the process has not been entirely successful. We are attracting marginal companies like VaxGen that cannot get to the goal post.
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April 8, 2006 - Attended the Annual Gala of the National Hospice Foundation at the Hilton Hotel on Connecticut Avenue, N.W. where I presented the Global Vision Award to Ambassador Richard Holbrooke. At my table were Holbrooke, Margaret Warner from the NewsHour, her husband John Reilly, Ann Morgan Vickery and Bob Kyle of Hogan and Harston. Usual gala-like atmosphere. Has a chance to catch up with Richard Holbrooke, who is currently the President and CEO of the Global Business Coalition on HIV/AIDS. We reminisced about our trip to Africa with Tommy Thompson in 2003.
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May 2, 2006 - Dedicated Building 33 as the C.W. Bill Young Center for Biodefense and Emerging Infectious Diseases. Terrific ceremonies with speakers being: me, EZ, Secretary Leavitt, Ralph Regula, Bill Young. Tour of building, many festivities, beautiful sunny day.
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May 25, 2006 - I have not been recording this type of thing of late even though I have gone to several of these, but I went tonight to the 18th Annual National Education & Leadership (NELA) Awards Gala at the Omni-Shoreham given by the Sons of Italy. I was the guest of Chuck Conconi (Washingtonian Magazine, formerly columnist for Washington Post) and his wife Janelle. At the Table were Ed Henry (CNN White House Correspondent), Lloyd Hand, Mike Petruzzelo (Managing Director of Qorvis Communications) and Mr. Thompson (?first name) African American billionare and his date Cheryl Lee (CEO of BET). Pres. Clinton and Hillery Clinton were guest speakers. Ran into the usual DC crowd - Sen Chris Dodd, Congresswoman Rosa DeLauro, Franco Nuschese (Owner of Café Milano - who was also an awardee), etc.
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June 11 - 17, 2006 - Went to Tuscana with Chris and the girls for a few days and then went on to Genoa for the annual review of the Gaslini Institute. Wonderful time had by all. Stayed in an amazing converted farm house (to a villa) owned by a friend of Jim Huskey's from the Embassy in Florence. The weather was amazing - warm and totally sunny during the day and cold at night requiring a fire in the fire-place and blankets in bed. Sunsets over the Tuscan hills with a glass of chianti was incredible.
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June 20, 2006 - Did a one hour face to face briefing of VP Cheny in his West Wing office on pandemic flu. Also present was Carl Kuntz, David Addington (new chief of staff replacing Scooter Libby and Scott Diechman (new health person for the VP). As usual, it was a lively briefing. It is clear and Carol told me that the VP has said this that the VP very much looks forward to being briefed by me. The day was a typical hot sunny 90 degree day in DC.
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July 26, 2006 - Has been a busy few weeks with relatively mundane institute issues. Weather has been very hot - ~95+ degrees. Two days ago David Stout and Jean-Paul Garnier from Glaxo-Smith Kline called and briefed me on the great success of their H5N1 clinical trial using their proprietory adjuvant ASO3. They got terrific results with 3.8 micrograms X2 with adjuvant giving predictably protective responses in >80% of people compared to the Sanofi study (see above) that gave predictably protective responses at 90 micrograms X2 without adjuvant in only about 50% of people. I spent the greater part of July 26 with the press (mostly print - NY Times, Washington Post, USA Today, AP, Phil Inquirer, Bloomberg, Baltimore Sun, etc) as well as CNN (Christy Feig). This is an important advance in trying to prepare for a pandemic flu since it seemingly overcomes the obstacle of a prohibitive requirement of high dose.
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July 27, 2006 - Went to NYC to participate in the Pandemic Flu Summit at City Hall. Part of Secretary Leavitt's program of visiting every state and some additional cities within states to talk about pandemic influenza preparedness. Mayor Michael Bloomberg hosted us. Secretary Leavitt spoke about the history of the 1918 pandemic in Utah and said that he came from a small town. When it came to my turn to talk about the science of pandemic flu, I told the Mayor and the audience that I came from a small town called "Bensonhurst" and I brought the house down. I mentioned that my father was born a few blocks away on Elizabeth Street and Grand Street in Little Italy. The day was sweltering hot and sunny. I got an exciting ride back to LaGuardia by an attractive young security woman named April who works in the regional office of the Inspector General of HHS. She got me through traffic with sirens and blinking lights to catch my 3:30 PM Delta Shuttle in order to get to DC in time to pay respects at the retirement party of Carol Kuntz at the White House. In her office in private, I gave her a gift of a statuette of Dr. Joseph Kinyoun with the inscription: "To Carol R. Kuntz With appreciation from your friends at NIAID" She burst into tears.
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August 15-16, 2006 - Things have been fairly uneventful since last entry (July 27). I was one of the featured panelists at the 16th International AIDS Conference in Toronto on August 16. The session was "25 Years of AIDS - Reflecting Back and Looking Forward". Each of us gave a 7 minute presentation followed by a panel discussion. I spoke on the "Scientific Response". Also presenting was Peter Piot of UNAIDS, H. Broadbent (AIDS patient), Gregg Gonsalves, and E. Madraa (African Community person). Session Moderated by Richard Horton, Editor of Lancet, and chaired by Mark Wainberg and Helene Gayle (organizers of the conference). There were 30,000 people at the conference and about 6000-7000 people in the audience for our session. Of note, a group of USA activist wanted to protest the fact that the USG was spending $90 million dollars on prevention this year and they thought that all that the USG was doing was purchasing the Orasure quicktest for HIV. In fact, they were incorrect and a good part of the $ was going for actual prevention education. The group was very nice and almost apologized for disrupting my session. They stormed on stage with the usual chanting and signs that said "George, listen to Tony" and "This is only a test!" (referring to the Orasure test). They disrupted me for the agreed-upon 2 minutes and then let me give my talk. I started the talk by saying "Thank you for the kind introduction" and the audience laughed. The talk was very well received. The major theme of the meeting was "Time to Deliver", but the real theme was prevention. The meeting was opened by Bill Clinton and Bill and Melinda Gates. I did a lot of press during the meeting and after I returned (Diane Rehm Show).
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August 28-29, 2006 - Went to Amsterdam for the AIDS Vaccine 2006 Annual Meeting. Invited by Joep Lange. On the evening of Aug. 28 I was part of a "Town Hall" - type meeting in Amsterdam where we discussed "Viral Threats" The panel consisted of Ab Osterhaus of the University of Rotterdam, Marie-Paul Kieny from WHO, Jaap Goudsmit from Crucell. It was moderated by a Dutch TV anchor. I gave the Opening Ceremony Keynote lecture on the evening of Aug. 28 and provided a "provocative" talk on "An AIDS Vaccine: Will It Ever Fit the Classical Paradigm?" It was extremely well-received by an audience of about 1000. Others that took part in the Opening Ceremony were Job Cohen (Mayor of Amsterdam), Hans Hoogervorst (Dutch Minister of Health), Princess Mabel van Oranje-Nassau (Director, EU Affairs, Open Society Institute), Jean-Francois Rischard, Former VP of the World Bank, and David Salisbury (Director of Immunization, UK Department of Health). We had a beautiful boat ride down the Amstel River to the Maritime Museum followed by dinner with all of the speakers and Joep Lange at the Amstel Hotel. Charming evening, but the weather was raining and cool.
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Sept. 3, 2006 - Had a most interesting dinner over Ellen and Gerry Sigal's house in DC. Guest were Sherry Lansing (Hollywood producer - "Fatal Attraction", Black Rain" and former actress) and her husband, Billy Friedken (Multiple Academy Award winning Producer, Director and Writer - "Exorcist", "The French Connection", etc. ) He is now producing (successfully) operas all over the world. Also there were Joe Wilson, the ambassador involved in the big Washington issue of the Administration "misleading" the American public about WMDs in Iraq and his wife Valerie Plame , the CIA secret agent that was "outted" by Robert Novack's column and for which Scooter Libby has been indicted for perjury. It was a most interesting discussion. Valerie and Joe seemed like very nice people despite being trashed by the Administration. Valerie insisted that she was still under cover despite the fact that it is reported that she had a desk job when she was outted. Joe, as he has said on TV multiple times, feels that the WH officials are all a "bunch of liars". Also present were Washington power-lawyer (Watergate, Whitewater, 9/11 Commission) Richard Ben-Veniste and his wife Donna.
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Sept. 12, 2006 - Went to farewell reception at the Atrium of the Equinox Restaurant in DC for Michael Gerson (former speechwriter and current Assistant to the President). Reception given by DATA (Bono's group) Saw old friends their such as Erin Chapman Thornton and Jamie Drummond from DATA. Mike is going to do a regular column for the Washington Post and Newsweek. Later in the evening went to an "Alliance for Aging Research" dinner and awards night at the Four Seasons Hotel in Georgetown at the invitation of Allan Fox of FoxKiser Law Firm (old friend - formerly of Jacob Javits and Ted Kennedy staff). Dinner honored Sens. Orin Hatch and Evan Bayh. During Hatch's remarks, he specifically mentioned that he and I were dear friends and that I am one of the great heroes in medicine and public health.
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Sept. 13, 2006 - I played a major role in the 90th Birthday Party for Dr. C. Everett (Chick) Koop at the Cosmos Club. I delivered remarks. The 2 MCs were Hilary Clinton and Orin Hatch. My friendship with Sen. Clinton grows as she continues to be very kind and warm towards me. I roasted Chick a bit, and the audience loved it (see my written remarks). tion of the next
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Sept 25-27, 2006 - Trip to San Francisco for International Assoc. of Physicians for AIDS Care (IAPAC) and ICAAC meetings and to speak at The Commonwealth Club. I gave talks on HIV/AIDS - the next 10 years (ICAAC); the decade of HAART (IAPAC) and emerging diseases (Commonwealth Club). The talks and the trip was a roaring success. Great weather, spent Sunday with Bob and Colleen Grady and Matthew and my family (minus Jenny in Brazil). Great hotel in SF - the "W" across the corner from the Mosconi Center
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Oct. 10, 2006 - Attended the swearing in ceremony for Mark Dybul as the U.S. AIDS Coordinator with the Rank of Ambassador at the State Department (Benjamin Franklin Room). Presiding was Secretary Condi Rice with Laura Bush present. I was given a "seat of honor" in the first row - sat next to Michael Gerson (former speech-writer for Pres. Bush). During her remarks, Condi specifically mentioned me - telling the story of how this all started (PEPFAR) years ago when the POTUS had his staff including Condi in the Oval Office and the POTUS was told by Tony Fauci, who is here with us today, that a lot of progress has been made in the treatment of HIV disease so that we could have a global impact. The day was a beautiful Fall day - bright sun and 75 F.
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Oct. 19, 2006 - A lot of political maneuvering regarding the election of the next Director-General of WHO Kristen Silverberg (now at State as Assistant Secretary) asked me about it at a dinner at Mark Dybul's house the day before his swearing in (see above). The 2 candidates that I prefer are either Margaret Chan (Hong Kong) or Julio Frenk (Minister of Health of Mexico). Shigeru Omi from Japan, Bernard Kouchner from France (MSF), and Pascoal Mocumbi (Mozambique) are also among the contenders. Christopher Murray from Harvard called me today to push for Julio Frenk since he feels that he is the one who understands best the connection between science and public health. He knows that the White House has been and will contact me for my opinion and so that is why he called.
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Oct. 20, 2006 - Served on a Panel at the Annual meeting of the White House Fellows Foundation and Association held at the Chamber of Commerce. Subject was "Community Engagement and Preparedness" relating to terrorist and natural disaster threats. On panel with me was Lee Hamliton, former co-chair of the 9/11 Commission and Patricia McGinnis, President and CEO of the Council for Excellence in Government. Had nice conversation with Lee Hamilton who is the Director of the Woodrow Wilson Center in DC (he has been a friend for a few years). Lee has been asked by President Bush to join with James Baker to come up with some alternative approaches to settling the quagmire in Iraq, i.e. a mid-course correction.
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Oct. 21, 2006 - Went to NIAF annual dinner at the Hilton Hotel with Chris. Usual celebrity show. Many friendly interactions with media (David Gregory of NBC; Sam Donaldson of ABC; etc). Hilarious impersonation of George W. Bush by comedian. I received this award in 1994. Major awardee tonight was Supreme Court Justice Samuel Alito.
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Oct. 22, 2006 - Went to the Grand Opening of the House of Sweden (Swedish Embassy plus offices and art shows) on Georgetown Waterfront (right next to Sequoia restaurant). King Carl Gustav and Queen Sofia were greeting everyone. Amazingly beautiful structure with views of the canal and the Potomac. Crisp Fall night with bright stars. Of note, Queen Sofia asked specifically to speak with me after the greeting line finished since she had been told of my work with HIV/AIDS. She is committed to helping Russia with its problem of HIV since she feels that the Russians would be more amenable to getting help from the Swedes than from the USA. She wanted to talk about how we (she and I ) could work together on this. Had good discussion with Kristen Silverberg about the problems the Administration is having.
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Nov. 28, 2006 - Attended and spoke at the Aspen Symposium in DuPont Circle (DC). It was an unusual gathering of Iranian scientists meeting with various US officials, particularly in the Dept. of State and HHS. I was a main speaker and exchanged information with Iranians on HIV/AIDS, TB, and other diseases in Iran. It was surprisingly frank and open given the tense relations between USA and Iran surrounding the Iranian nuclear program. If fact, the Iranians who came to the USA were a bit nervous about the political fall-out for them. I dealt with Kamiar Alaei and his brother Arash Alaei on ID issues in Iran. Also present was Dr. Abolhassan Nadim, the Chair of the Iranian Epidemiological Association.
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Dec. 2, 2006 - Annual Christmas Party at Sam and Jan-Smith Donaldson's House in McLean. Have been going to these parties for at least the past 10 - 15 years. The usual interesting and warm crowd was there. This party is probably the most friendly of all of the D.C. "glitterati" parties, mostly because of the warmth and friendliness of Sam and Jan as well as the fact that the same people come every year +/- whoever is hot at that time in the news. Over the years, we have run into virtually everyone who is "known" in DC. Some highlights from this year. Nice conversation with Colin Powell about AIDS in African-Americans. The recent UNAIDS numbers are out showing that of the new infections in the USA, among men, 50% are in Blacks and among women 65% are in Blacks. On Nov. 30, I was supposed to be on the CNN Paula Zahn Show speaking about this, but at the last minute, their producer (Marie....) cancelled because she said that they have a guest who is really the "face of AIDS, since she got infected from her boyfriend by heterosexual sex". Turns out the guest is Regan Hoffman, the editor of POZ Magazine. Regan is a beautiful, blond, blue-eyed WASP from Connecticut who clearly accidentally got infected from her white boyfriend who was almost certainly bisexual. For every one of these, there are 10,000 poor black girls in an inner city area who got infected from their drug-user boyfriends. So there they were: beautiful, blond, blue-eyed and wealthy Paula Zahn speaking on TV with beautiful, blond, blue-eyed (likely also wealthy) Regan Hoffman smiling and saying how grateful she is that she has all the opportunities for treatment. Her only "concern" is that the mother of her new boyfriend was concerned that she was infected; but now all is well because the boy's mother is an "educated person". I had watched this on TV and almost vomited. This was as far from the reality of what the "face of AIDS" is than I could ever imagine. On Nov. 29 at a big HIV Prevention Meeting at the Mandarin Hotel in DC chaired by John Bartlett of Hopkins and Ken Mayer of brown, one of the themes and the points that I made in the press conference is that AIDS in the USA was assuming the face of a young black woman. My good friend Phill Wilson (CEO of the Black AIDS Institute in LA) gave an eloquent talk on this subject and he should have been with me on CNN instead of my getting bumped by Regan. I was pissed because that one 5-10 minute segment on Paula Zahn likely undid by 100-fold the points that I and Phill were trying to make at the conference. I had mentioned this to my CNN Producer friend Christy Feig and she was also appalled and has since brought it up to the CNN Board. In any event, at Sam's Party, I was still pissed and discussed this with Powell who has been spending time on the lecture circuit talking about prostate cancer, particularly in black men. His comment was "What do you expect?.... It is CNN." He promised that he would bring up the issue of AIDS in Black America in his lectures. I have known Colin for years from the time that he was Secretary of State and I had briefed him on AIDS and went to the UN with him during an UNGASS years ago. Also, had discussions with my old friend Lee Hamilton who is co-chairing the Iraq Study Group that will be giving their report to the Congress and the President in a few days. It will be extremely critical of the execution of the Iraq War and rebuilding. Also discussions with - Antonin Scalia, George Will (ABC), Nina Tottenberg (NPR), Bob Shieffer (CBS), Bill Plante (White House correspondent) and many others.
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Dec. 4, 2006 - Things mostly quiet on the NIH front. Big problems in Iraq that are dominating the news with insurgency and civil war. Bush is having a very hard time. Democrats have taken control of House and Senate, mostly by voter protest of the war in Iraq. Had World AIDS Day with usual press interest. Secretary Leavitt wanted me to go to China with him from Dec. 6 to 13; I first said yes, but then backed out since I really do not want to travel during this busy period and the purpose of the trip was secondary to my interest and involvement, i.e. economic and trade considerations with only a side order of health. Jenny Fauci doing great in Brazil. She loves it and will return on Dec. 23. I am getting more and more involved in Global Health issues such as malaria, health care work force support in developing nations through the DDCF, XDR tuberculosis, etc. Have given many talks over the past few weeks on these issues.
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Dec. 13, 2006 - I hosted a press conference to announce the breakthrough study that was prematurely stopped by the DSMB. Study was the use of medically supervised adult male circumcision in Kenya (Kisumu) and Uganda (Rekai) to determine effect on HIV transmission. Results were striking. Study was safe and led to a 48% (Uganda) to 53% (Kenya) decrease in transmission. Big printed press coverage including front page of NY Times.
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Dec. 14, 2006 - Big White House Malaria Summit sponsored by Malaria No More and Introduced by Laura Bush with the POTUS giving Keynote Lecture. Held as 1⁄2 day meeting at the National Geographic Society Headquarters on 17th Street in DC. I had helped Gary Edson who was consulting for Malaria No More in the scientific background for the meeting which was mostly talks by African Health Ministers, Melinda Gates, Faith-Based people (Rick Warren, etc.), Paul Wolfowitz, Margaret Chan (WHO DG). I had nice chats with each of these. Purpose was to increase awareness of malaria and he how with little money we can dramatically reduce malaria, particularly in Africa. Spoke of results in Africa of the President's Malaria Initiative (PMI) that over the past 2 years with $1.2 Billion for bed nets, indoor spraying with insecticides, and ACT (Artemisinincombination therapy) malaria has been markedly decreased in certain countries. MC was Isaiah Washington of "Grey's Anatomy" TV show. I met and interacted with the usual cast. Also included Sens. Pat Leahy, Bill Frist, etc. VP Cheney's Annual Christmas Party. Chris did not come since she was setting up for the reception following the Annual Lessons and Carols at the Cathedral (I went later). Usual festivities with many people there. Spent much time talking to Carol Kuntz. Also, Scooter Libby was there awaiting start of his trial for providing false information to the Special Investigator (Fitzgerald) about the Joe Wilson/Valerie Plame issue. Spoke more with Isaiah Washington.
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Jan. 29, 2007 - Iraq war going very badly with civil war among Shia and Sunnis and insurgency running wild. Bush popularity in USA way down. The war is dominating the political scene in USA and particularly DC including discussions by Presidential candidates. Went to an interesting dinner tonight at the Metropolitan Club hosted by Dr. Ward (Trip) Casscells in honor of the Surgeon General of the Armed Forces of Iraq - Samir Abdullah Hassan, M.D. I sat next to him at dinner. Good guy and smart and tough. He explained the disaster that USA inadvertently promulgated by dissolving the Iraqi military. The Provisional government (Paul Bremer) dissolved the Iraqi medical corps and so now they do not have any army hospitals or army doctors to take care of the wounded and sick Iraqi soldiers. Also told me that the entire bureaucracy in Iraq (sewer, transportation, utilities) was run by the military and so when Bremer dissolved the military he completely destroyed the infrastructure of the country. Samir feels that this was an amazing blunder. Also, by dissolving the police, we now have anarchy in Iraq with criminal elements running wild.
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Feb. 14, 2007 - Briefed Bruce Miller (VP Cheney's Chief of staff for biodefense) at the White House on AIDS, Pandemic Flu, Malaria, and biodefense in preparation for my future briefing of the VP that Bruce will set up.
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March 5, 2007 - Went to great memorial for Art Buchwald at the Eisenhower Theater of the Kennedy Center at the invitation of Art's son Joel and his wife Tamara. Many VIPs there including Ethel Kennedy, Ben Bradlee, Tom Brokow, Dave Barry, and most important people in the media in DC and nationally. It was a warm and hilarious event filled with stories about Art and film clips of him
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March 6, 2007 - Busy day. Unfortunately, Scooter Libby was convicted today on 4 of 5 counts of lying to FBI and grand jury in association with the Joe Wilson/Valerie Plame CIA leak. Had House Appropriations Subcommittee Hearing today and it went well. Also, had a farewell dinner at Oceanaire in honor of Alex Azar who is stepping down as deputy Secretary at HHS. The old HHS crowd was there including former Secretary Tommy Thompson. Had a great conversation with him. He has put his name in as a candidate for Republican nominee for President. He is optimistic about winning the Iowa Caucus. He discussed with me the best plan that I have heard yet about how to handle the dreadful Iraq situation. Also, at the dinner were Janet Rehnquist, Stew Simonson, Scott Whitaker, Bruce Gellin, Lester Crawford (recently convicted for lying on his financial disclosure when he was FDA Acting Commissioner), Paula Staudard, and others. Very cold day in DC with temps in the teens.
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March 13, 2007 - Briefed Vice President Cheney today in his WH office on second floor. Beautiful "pre-Spring" day with temps around 50 and sunny skies. He wanted briefing on Pandemic flu and biodefense. I included a discussion about HIV/AIDS particularly the great success of PEPFAR since I wanted him to know that this Administration has done more than anyone in the world for Global AIDS. The briefing was as usual for the VP and me, i.e. very friendly and expressing multiple times how pleased he was to get briefed by me since he enjoys it so much. Also in the room were David Addington (Chief-of-Staff), Bruce Miller (Chief for Biodefense), Steve...? And Scott Deitchman.
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March 16, 2007 - Have been preparing for a briefing of the POTUS on pandemic flu preparedness. Interesting evolution of process. The HSC staff (Joel Bagnell and Rajeev Venkaaya) want us (HHS) to present a major discussion of "gaps" in stockpiling and others want us to just update the POTUS. Friendly tension going on. Today, we (me, Bill Raub, Bruce Gellin and Eric Hargan - Deputy Secretary) briefed the Deputies in EEOB 208 in preparation to brief the Principals and then the POTUS. Among them were junior staffers from WH as well as Rajeev, Joel Bagnell, Bruce Miller, Scott Deitchman, Jeff Runge. Continued disagreement about what the Secretary (MOL) will ultimately present to the POTUS.
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March 19, 2007 - MOL, Bill Raub and I briefed the principals today in final preparation for the POTUS briefing. Present were Fran Townsend, Michael Chertoff, Joel Kaplan (now Deputy Chief-of-Staff to Josh Bolten), Joel Bagnell, Bruce Miller, other cabinet people. Briefing went better than on March 16. We are about ready to brief the POTUS.
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March 20, 2007 - Dinner at the Mellon Auditorium on Constitution Avenue, N.W. (13th Street) for Research! America. Usual DC Glitterati. At my table was Susan Dentzer (Newshour), Sam and Jan Donaldson, Tenley Albright, Paul Rogers. Awardees were Don Seldin, Joe Goldstein, Mike Brown, Mike Wallace, Sen. Orin Hatch among others. George Stephanopoulos was MC and I spent time catching up with him (knew him from Clinton White House days). Was a coldish night outside. Chris and Meg and Ali went off to California (Big Sur/Monterey) for Spring break. Wish I could have gone, but POTUS briefing tomorrow.
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March 21, 2007 - Briefing of POTUS today at 2:30 - 3:30 PM in Roosevelt Room on Pandemic Flu preparedness. Secretary Leavitt, Bill Raub and I briefed him. I did most of the formal briefing on state of the threat, vaccines, antivirals and diagnostics. Bill spoke on community mitigation strategy and the stockpile. MOL spoke on overall responsibility of the USG versus states. Present were the POTUS, VP, Karl Rove, Josh Bolten, Joel Kaplan, Dan Bartlett, Fran Townsend, Candi Wolff, Mike Chertoff, Paula Dobriansky (Undersecretary of State), several people from Joint Chiefs of Staff, Rajeev Venkayya, Joel Bagnell. Briefing went very well. POTUS was as usual very friendly and deferential to me. Was at times serious and at times jocular with his characteristic joking around. When he came into the room, he looked at me and said "Fauci, glad to see you Tony. I see we have the first team here today". It was the first day of Spring and it was unseasonably cold out and cloudy.
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March 29, 2007 - Very interesting day. First, Megan received notification that she is accepted at Columbia, Barnard, and Yale with waiting list at Harvard and Dartmouth. Her top choices are Columbia and Dartmouth and so she will wait to hear more from Dartmouth before making choice. Went to a reception given by National Italian American Foundation (NIAF) given at a private home in Georgetown (3032 - N Street, N.W.) in honor of Mayor Adrian Fenty. Got to meet him again and chat. Did not previously know this, but his mother is an Italian American. Ran into my old idol from Brooklyn - Ken Aspromonte (brother of Bobby Aspromonte also my idol from the old days), baseball great from Lafayette High School and Brooklyn sandlot baseball who then played in Major Leagues. He was born and raised in Bensonhurst like me and we shared some warm discussions. Beautiful Spring evening. After the reception went to Café Milano and had dinner with the NIAF Board of Trustees. Towards the end of the dinner, got up to go to men's room and ran into Franco Nuschese, owner of Café Milano (who has always been very warm towards me). He insisted on taking me into a private party in the restaurant that he was throwing for prominent blacks in DC and the nation. I immediately ran into Secretary of State Condi Rice and Colin Powell who were very warm and engaging with me. This was particularly true of Colin Powell who threw his arms around me and gave me a bear hug with a kiss on the cheek. Over the past couple of years, I have gotten to be friendlier and friendlier with Colin, having seen him at various functions such as Sam Donaldson's Christmas Party, etc. All in all, a good evening.
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April 17, 2007 - Scooter Libby contacted me and asked that I write a letter to Judge Reggie Walton via Scooter's lawyer William Jeffress to serve as a character reference for Scooter. Scooter has been found guilty of perjury and obstruction of justice in connection with the Valerie Plame/Joe Wilson CIA leak (see above). He is appealing the 1 by case but may be sentenced to jail before his appeal is heard. The purpose of the letter is to try and keep Scooter out of jail during the appeal. I wrote him a very supportive letter.
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April 18, 2007 - Testified before the House Committee on Homeland Security together with Gerry Parker, Jesse Goodman (FDA) and Jeff Runge (DHS) on the successes and failures of Bioshield. Committee chaired by Jim Langevin. Hearing called because several of the companies that were trying for Bioshield procurement contracts had failed, i.e. Vaxgen for rPA and Hollois Eden for Neumune (to protect and regenerate BM after radiation). Richard Hollis testified against the USG and Dr. Davis from HGS (that makes AbThrax - monoclonal antibody against anthrax toxin) testified favorably towards the USG. Hollis looked like a whiner and the Hearing went fine. It is clear that Bennie Thompson, the overall Chair is in the pocket of the lobbyists as his questions reflected a "presumption" of failure on the part of DHHS and BioShield.
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April 20, 2007 - Briefed Joel Bagnell and Rajeev Venkayya at the WH on the rolling out of justification for classified research. Some friendly tension between Joel and me in that they wanted us (CDC, FDA, HHS, NIH to sign off on the roll-out document and there was a phrase in there that did not clarify that we do not do classified research. It asked us to justify with all of our research why it should be unclassified making the default position that everything should be classified. I had them change it to read that we should explain why it is not classified as opposed to justifying it as being unclassified. We came to an agreement.
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April 24, 2007 - Had lunch with Scooter Libby today at the Daily Grill in the Bethesda Hyatt. Hot muggy and sunny day. Has been cold up until now. Scooter looked very worn and down. I gave him a big hug and he looked like he was going to have tears. I asked about the trial and he said that they really expected a not guilty verdict and that is why they did not pull out all of the stops and ask the VP to testify. Also, it was clear that Reggie Walton was "preening" for this since he had the courtroom wired for the press and bloggers which they never do. He proclaimed complete innocence and is hoping that Bush will pardon him. He is sad that he has not been pardoned already and feels that perhaps if it looks like he will go to jail the POTUS will then pardon him. He feels that there are politicos in the WH who do not want the POTUS to pardon him since it will make the Administration look even worse that the 30% approval ratings. I told Scooter that I could not imagine that the POTUS will allow him to go to jail, particularly with the VP pulling so hard for Scooter. I spent the rest of the time briefing Scooter about biodefense updates. Also, had meeting at the White House called by Rajeev Venkayya and Mike Magan on XDR-TB including reps from CDC (Julie G. and Ken Castro), HHS (Craig Vanderwagen, Gerry Parker) DoD, DHS, State, USAID, Mark Dybul. Bottom line was to coordinate the multi-Agency efforts. Good meeting. We (NIAID) has already put together a strategic plan as has CDC and so HHS looked good. Mark Dybul mentioned that the Policy Time with the POTUS on PEPFAR funding did not go well today.
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April 25, 2007 - Had a lunch/reception at the White House followed by a presentation by Laura Bush and President Bush in the Rose Garden to celebrate the first ever Malaria Awareness Day in the USA. Day was sunny, hot and muggy. I was given a reserved seat in the second row. Had major and important conversations during the reception with Randy Tobias, Mike Gerson and Josh Bolten. Apparently, at a meeting with the POTUS yesterday on PEPFAR funding, there was some opposition to maintaining the funding level. Likely the major mover of this restricted funding was Karl Rove. Condi Rice is out of the country, but will be supportive of expanded funding. Josh Bolten is supportive also. Josh asked me what I thought and I came on strong. Josh pointed out that this was supposed to be a $15 billion program with $3 billion per year for 5 years. Josh said that at the time that I developed the program, I said that we could not absorb the entire $3 billion in the first years and so we would do more in the later years. Now the program is at $5 billion per year, which means that just to sustain it without increases would cost $5 billion per year for 5 years or $25 billion. Many conservatives would oppose this as a bottomless pit. I also argued that we should get rid of the mandated 33% for abstinence of the 20% prevention money. I am attaching an e-mail that I sent to Josh after getting back to my office in which I clarify my position: Josh: It was good to see you at the Malaria event today and I appreciate your listening to Randy, Mike and me. I know that you are very much supportive of the full funding and even increase of the initiative and I know that this view is not shared by all. However, just to reiterate what I said to you and what you already know, this is one of the most important things that this administration has done and is doing. The people of Africa look upon us with great admiration and gratitude because of PEPFAR. We just cannot let it slip. True, we cannot commit to treating every infected person in the target countries, particularly since there are 4.3 million new infections worldwide each year, mostly in developing countries. However, we are making significant progress in prevention. I know that you are aware of how impressive the circumcision data are. In addition, although we are still years away from a vaccine, the most recent candidate has entered a phase 2 trial internationally (including Africa). Even if it does not totally prevent HIVinfection, there is a reasonable chance that it will slow the progression of disease if people do get infected, and this will result in lower levels of virus in their bodies, which in turn makes transmission to others less likely. I tell you this because I believe that we are on the cusp of a slowing down of transmission, which would dampen the possibility of a "bottomless pit" of infection in target countries for which we would feel obligated to treat. Finally, with regard to prevention, I am sorry that I was at first not clear about my position on abstinence being mandated as one third of the 20% prevention piece of the pie. We get enormous bad press (that often overshadows the enormous good that we are doing) because we mandate a specific number for abstinence. The faith-based organizations are going to push abstinence with the prevention money that we give them anyway. Therefore, abstinence will indeed be pursued through PEPFAR. By mandating it, those who do not think that this is the way to go will only drop out of the funding stream and declare the program dysfunctional when it really is a breath-taking success. On balance, it is my opinion that if we remove mandated categories of prevention, abstinence programs will still go on in Africa and PEPFAR will be praised by everyone, deservedly so. I am sorry if I came on somewhat strong at the White House with you, but I feel deeply that PEPFAR is such an historically great program (that would not exist if it were not for you) and I want it to function optimally. As always, if you need me to pitch in on this and articulate my views to anyone, please call upon me. I would jump at the chance. Thank you and best personal regards, Tony During the Rose garden ceremony, the POTUS actually got up and played the drums with a troop of Senegalese/American dancers who provided entertainment on the stage in the Rose Garden. As he left the stage and went back to the Oval Office, we caught each other's eyes and he said "Hi Denny", walked a few steps, turned around, came back and said "What am I talking about, Hi Tony"; he laughed and went on.
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April 27, 2007 - Went to the National Cathedral this AM to see Megan receive the honor as one of 12 NCS girls to be inducted into the "Cum Laude Society" . It was a beautiful ceremony at the Cathedral. Found out during the evening as I was on the way to a Nats Baseball game (call from Greg Folkers) with Bob Seder, Stewart Simonson, and Gary Nabel that Randy Tobias just abruptly resigned effective immediately. There is a woman who runs an "escort service and sexual fantasy service" who is being charged with running a prostitution ring. She is a bit bizarre and is using as a defense that if her girls did prostitution, then they did it on their own. For some unexplainable reason, she released the cell phone numbers of the clients of her girls and Randy's number was on the list. ABC News confronted Randy and he stated that he merely used the girls to get massages and had no sex, but he resigned anyway. My impression is that unlike Attorney General Alberto Gonzales who will not resign and keeps embarrassing the POTUS with his incompetence in handling the firing of the Federal Attorneys, Randy does not want to cause more bad press for the POTUS. Irony is that Randy runs the AID Programs which require recipients of Federal Funds to condemn prostitution. This is probably the reason that he resigned, i.e. the appearance of hypocracy. April 28-May 6, 2007 - Just a very busy time for me preparing for the Board of Scientific Counsellors Review of my Lab (LIR) to take place on June 4. Weather turned absolutely beautiful - typical DC Spring with sunny skies and balmy temperatures. Have been following over the past several weeks the St. Alban's baseball team. They are having their best year in decades. Danny Hultzen (pitcher/first base) is clearly the best pitcher in the league and one of the best hitters.
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May 7, 2007 - Went to the British Embassy for a Garden Party in honor of the visit to the USA of Queen Elizabeth and Prince Philip. Everyone who is anyone in DC was there. Spent time speaking with Sen. Joe Lieberman, House Speaker Nancy Pelosi, Majority Leader of House Steny Hoyer, Columnist David Brooks, CNN's Judy Woodruff, Fox News Chief Editor Britt Hume, Former Mayor of Baltimore Schmoke, Harvey Fineberg of IOM, etc. Spoke with Prince Philip who showed an astounding lack of understanding of what is biomedical research. He asked me what I did and I explained. He said "Of medical stuff; that is statistics, i.e. numbers". I explained that we actually do research to answer questions. He insisted that it was all about statistics of diseases. I said that the statistics inform us of the extent of the problems, but then we do basic and clinical research to diagnosed, prevent and treat diseases. He then said, "Oh yes, like I said, it is all about numbers". I hope that he was just jet-lagged.
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May 10-14, 2007 - Had one of the most intensely busy weeks in recent memory with preparations (rehearsals) for my upcoming Board of Scientific Counselors review of LIR, NIH Budget Retreat, NIH Roadmap Retreat, Commencement Address at Penn State, Major talk in Miami to AAI, NIAID National Advisory Council Meeting, and Senate srsity College of Extremely busy: Appropriations Hearing Testimony - all in 5 working days. It was exhilarating in a strange sort of way. Almost like being on call as an intern and having 5 admissions in a row. After a while, it does not make any difference how many they send you. Weather has been spectacularly beautiful - typical Washington Spring weather. Sunny, dry, warm in day, cool at night.
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May 19, 2007 - Gave Commencement Address at Penn State University College of Science
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May 24, 2007 - Went to Sons of Italy Annual NELA (National Education Leadership Awards) dinner at the Washington Grand Hyatt Hotel on 10th and H Streets. I took Megan with me and she really enjoyed it. Sitting at our table was Nancy Pelosi and Rosa DeLauro. Megan got to meet and speak with them as well as Hilary Clinton, Geraldine Ferraro, Italian Ambassador Castellenata among others. Megan was amazed as Sen. Clinton was on her way out after having presented Geraldine Ferraro with an Award and we thought that we would not have the opportunity to introduce her to Megan. Hilary walked past me, caught my eye and gave a big smile, and threw her arms around me in greeting. Megan could not believe it. I introduced Megan and Clinton asked about her school and her plans for next year. May 24 - June 17, 2007 - Extremely busy: Sometime since last entry (May 24) I was informed by Jack Marberger (Science Advisor to the POTUS) that I would be receiving the National Medal of Science in a White House ceremony in July. I am humbled. Also, Scooter Libby convicted by seemingly vengeful and self-absorbed Judge Reggie Walton and sentenced to 30 months - amazingly excessive! Also, Walton published all of the letters written on Scooter's behalf including mine. Other letter writers were Paul Wolfowitz, Donald Rumsfeld, General Pace, Henry Kissinger, etc. Science magazine (Jon Cohen) wrote a small piece about my writing a letter. He originally thought that I would be in trouble since I did it on Government Stationary. Sorry John - I got clearance by OGC - Ethics Division since the CFR says that I can do this. Typical Jon, good person that he is, he is still trying to get me on something - the instincts of a reporter!
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June 3, 2007 - Gave Commencement address to Megan's NCS graduating class. It was a thrill giving it from the main pulpit at the National Cathedral. It was extremely well received; got many, many personal comments and e-mails. Please see text of speech in my files. Megan won many awards - Science Award, Community Service Award, Major Award voted by students as best all-around student, Major Award voted by faculty as best all-around student (first time at NCS that same student got both)
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June 4, 2007 - Underwent Board of Scientific Counselors 4 year review of my laboratory - Laboratory of Immunoregulation. I received the highest possible score (Outstanding). I had been preparing for this review for almost 1 year since I wanted to nail it given that I am Director of NIAID and my review would be carefully scrutinized.
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June 6, 2007 - Major, major world publicity regarding patient who had Extensively Drug resistant tuberculosis (XDR-TB) and traveled by plane to a number of countries in Europe despite somewhat bungled instructions by Georgia (he is from Atlanta) Health Officials and the CDC to not travel. The CDC looking real clumsy on this and the media continue to go after Julie Gerberding (Director, CDC) about this and other issues. I believe that she is being treated unfairly by the press and the Congress. In any event, I appeared with Julie and a customs official (Speaker crossed the border from Canada to New York after secretly flying from Prague to Montreal) at a Senate Appropriations Committee Hearing (Tom Harkin, Chair) on the subject. I was there to discuss the science of TB. Julie got slammed by the Committee and Speaker was on the next panel and said that the CDC was lying. What a mess. I was on major media appearances for the next week - Nightline, NBC News, 20/20 (about Heimlich and malaria treatment for HIV), NPR Morning Edition, WTOP Radio, CNN American Morning, etc)
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June 18, 2007 - Informed by Don Koshland of the Lasker Foundation that I will be awarded the Lasker Award for Public Service in September ($150,000.00) - amazing. Thus, in 2007 I have won the Kober Medal for Physician Scientist, the National Medal of Science for Basic and Clinical Research and now the Lasker Award for Public Service. I have a lot to be thankful for! Ironically, had dinner over Ellen and Gerry Sigal's house last night with Joe Wilson, Bill Wilson and Melody (Confidante of the Kennedy's), Richard and Donna Ben-Veniste, Judge Judy who is trying the crazy $54 million "lost pants in the Dry Cleaners case and her husband Greg. I mentioned to Ellen that if Joe was pissed at me because I wrote a letter for Scooter, then I would not come to the dinner. Joe was very gracious and insisted that I be there. We had a good discussion and he said that he understood why I wrote the letter. He, however, is filing a civil suit against VP Cheney, Karl Rove, and Scooter and so it is not over yet. Amazing how different are the perspectives of what happened between Scooter and Joe/Valerie. I am in the unusual situation of being friends with both parties.
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June 18, 2007 - Accompanied First Lady Laura Bush at Howard University Hospital for a roundtable discussion of the implementation by Howard of the new CDC recommendations for the "Routinization" of HIV testing. Celia Maxwell (former NIAID fellow) led the discussion for Howard. Very cordial interactions with the First Lady and her staff, particularly Katy Montgomery. She was engaged and interactive. Very hot day in DC - sunny, slightly hazy and 94 degrees F. I explained to her the benefits that are coming out of this testing program as well as the PEPFAR program internationally.
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June 18, 2007).
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June 21, 2007 - Met with Nancy Pelosi in her "Speakers Office" at the Capitol to discuss the funding of the University of California at SF Center for AIDS Research (CFAR). They did not get the funding amount that they had hoped for and we finally worked it out to everyone's satisfaction by getting some extra money from OAR and the NHLBI to give them the additional $771,000.00 that they requested. Nancy was satisfied. I went with Elias Zerhouni and Marc Smolonsky from OLA at NIH. Her main staffer was Scott Brule. Nancy was as usual very warm and cordial to me. We discussed a plan that she had to get extra money to the NIH through a budget supplemental. She felt that if we wrap in the cancer package, all of the Congress would be in favor even though it was understood that it would go way beyond cancer. Elias and I and Marc will world on a strategic plan for the initiative and get back to her. Visited by USA Ambassador to Indonesia (just appointed) Cameron Hume. I know Cameron from time he was Ambassador to South Africa and we (Cliff Lane) established the Phidisa Project with the South African Military to treat HIV infection in the military. Cameron left South Africa and became (briefly) Ambassador to Sudan (during the Darfur crisis). He is on his way to take over in Jakarta and wanted me to brief him on Pandemic Influenza threat and what the USA is doing in this area. Indonesia is a hot spot for recent cases of chicken to human H5N1 Chris and I had dinner tonight at the home of Australian Ambassador to the USA Dennis Richardson and his wife Betty to celebrate the visit of immunologist Ian Frazer (wife Caroline) who is the 2006 Australian of the Year. His research led to the development of the HPV vaccine with Merck (Gardasil). Good food and conversation at the beautiful Ambassador's residence at 3120 Cleveland Avenue, N.W. Balmy Spring night in DC. June 21 - July 4, 2007 - POTUS commuted 30 month jail sentence for Scooter Libby, but did not pardon him. The conservatives are enraged that the POTUS did not go far enough to pardon Scooter and the liberals are saying that the commutation was a "disgrace". Went to the Gala Dinner of "The Golden Plate" with Chris. Usual celebrity gala. Met Hillary Swank for the first time. Others at the dinner were Alberto Gonzales, Margaret Spellings, David Rubenstein (Carlyle Group), and many many others. Sitting at Table with Chris and me were: Gen. Ralston (former Chairman of Joint Chiefs) Mac Macarty (former Chief-of-Staff to Pres. Clinton, Ann Venneman (UNICEF Director and former Sec. Dept. of Agriculture. Entertainment by Brooks and Dunn - country singers who were fantastic (winner of many country music awards) Went to a Cocktail Buffet at Jamie Gorelick's house on June 30 and met with the usual cast of DC notables: Richard Ben-Veniste, Bill Jeffress (Scooter's lawyer), David Ignatius of the Washington Post, Seth Waxman (lawyer), Judy Woodruff (PBS), Al Hunt (Bloomberg News), Mark Shields (Newshour), etc. Living discussions about Washington Politics, including the fact that I wrote a letter for Scooter.
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July 5 - 7, 2007 - Went to the Aspen Ideas Festival in Aspen, CO. Presented a session on "Emerging and Re-Emerging Infectious Diseases: The Perpetual Challenge to Global Health". Beautiful mountain weather - warm, no humidity, clear skies. Met and interacted with many, many notable people: Colin Powell, Bob Hormats (Vice-Chairman of Goldman Sachs), Rahm Emanuel, Tim Wirth, Margaret Spellings, Dan Glickman (former Sec. Agriculture and current CEO of Motion Picture Association of America), Walter Isaacson (CEO of Aspen Institute), Jim Woolsey (Former Director CIA), Jim Lehrer and his wife Kate (Lehrer NewsHour), and many, many more. Very enjoyable experience. Perhaps started a friendship with Corby Kummer, whom I had not met or heard of before. He is senior editor at The Atlantic magazine. He is one of the most { was respected food journalists and he "narrated" the meal that was served to us at a very elegant dinner on July 6 at Plato's restaurant hosted by Booz, Allan, Hamilton. They brought in a chef from Denver and provided a meal made only from local ingredients (lamb, vegetables, corn soup, etc.). We had long discussions and we flew back together from Aspen to Denver. He offered Chris and me use of his Boston Apartment when we come to Boston to visit Jenny.
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July 10-14, 2007 - Went to Genoa for my yearly review of the Gaslini Institute. It was the usual pleasant interactions with Lorenzo Moretta, Alain Fischer, and Sergio Romagnani (Committee members) as well as the people of Gaslini such as Gianni Melioli, Giovanni Rossi, Alessandro Moretta. Since I was not allowed to take the honorarium this year of any more, this might be my last time doing this.
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July 21 - 25, 2007 - Went to Sydney Australia with Chris, Megan and Alison to present the opening session plenary lecture on the topic of "HIV/AIDS in 2007: Much Accomplished, Much To Do". We had to turn around quickly and come home and thus cancel our plans for a mini-vacation in Australia together. Reason was that I had to return to DC to receive the National Medal of Science (see below). The trip was nonetheless very enjoyable notwithstanding the length of travel time. My talk went over very well, got much press and turned out to be the defining theme of the meeting that caught on with the press and the other speakers.
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July 27, 2007 - Received the National Medal of Science from the POTUS at a 1:50 PM White House ceremony in the East Room. Hot, sunny Washington day. I was one of 8 people who received the award for 2005 (yes 2005 - they are 2 years behind in awarding them). The POTUS was very nice with me. The Army Major who announced the names completely blew the pronunciation of my name despite having a phonetic crib in front of him. The POTUS laughed and when I went up to the podium to get the medal and shake his hand, he put his arm around me and whispered in my ear "Maybe this guy does not know what you name is, but I certainly do". There was a nice reception after. Condi Rice gave me a hug and kiss and joked about the mispronunciation of my name. We saw the POTUS leave from the WH lawn on Marine One Helicopter to spend the weekend at Camp David. In the evening we had an elegant dinner with many guests from government at the Ritz Carlton on 22nd and M Streets, N.W. Guests at my table were Elias Zerhouni and John Gallin together with Denise and Jack Scorce. Nice time. I felt rather humbled by the amazing accomplishments of the other awardees (mostly physicists and engineers). July 27 - August 30, 2007 - A number of relatively minor issues over the past 4 weeks. Had laparoscopic surgery for right indirect inguinal hernia on August 2 at Sibley Hospital by Dr. Martin Paul. Minor complications of 2 1⁄2 weeks of severe pain over the mesh that had developed a "seroma". It is fine now. Went to Seattle, WA to deliver opening session plenary lecture at the HIV/AIDS Vaccine 2007 meeting run by Larry Corey. Talk well received. Have been having very "scratchy" voice that has significantly interfered with my lecture since my Plenary in Sydney (when I first noticed it) in July. I had laryngoscopy by Dr. Michael Siegel. It should some very minor "singer's nodules" similar to what Pres. Clinton had but much less severe (Dr. Siegel took care of Clinton), as well as some inflammation indicating esophageal-laryngeal reflux. Will start on antacids. Word is now out that I will receive the Mary Woodard Lasker Award for Public Service on Sept. 28, 2007 in NYC (see below). August 30 - Sept. 13, 2007 - Went to NYC on Sept. 8 to visit my father for his 97th birthday. Recently had baloon valvuloplasty of aortic valve for progressively refractory CHF. Remarkable improvement following procedure. NYC was beautiful and warm. Chris, Jenny and Ali were with me and we had fun as always in NYC. Megan is in Chicago with City Year (Americorps) and is lonely and sad since this is first time away from home.
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Sept. 14, 2007 - Big day. Went to White House for Karl Rove's farewell party. Moving speeches by Josh Bolten (who showed PowerPoint slides on Karl's years with the POTUS here and in Texas), the POTUS who choked up a few times when talking about Karl, and Karl himself who gave a very moving thank you to his friends at the WH. He recounted how after Bush won the election Karl did not want to come to DC with the POTUS because he felt that although he was a good political strategist and tactician, he did not like internecine warfare and he saw that during the administration of the POTUS's father George H.W. Bush shook his head in agreement with this. Karl went on to say that it would not be this way during his administration since it will be like a family and he would not allow backbiting. My thought was that although this is an admirable thing, it might have had the unintended consequence of having a closed system that did not accept outside ideas very well. In any event it was a warm affair. I had the opportunity to chat with Josh Bolten, Karl Rove, Fran Townsend, Mike Chertoff, Charles Krauthammer, and many other notables. After the ceremony we waved the POTUS off from the balcony in Marine One on the way to Camp David for the weekend. I had a scheduled briefing of First Lady Laura Bush's staff with Anita McBride (Chief-of-Staff), Carrie Underwood (Deputy Director of Policy and Projects), and several others. The briefing went very well. I talked about global health issues and what the FLOTUS could do for the last year domestically and internationally to promote the health agenda. I will be suggesting places that she could visit. To do an event similar to what we did together at Howard University (see above -
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Sept. 15-16, 2007 - Press announcement for the Lasker Award. Almost immediately, scores of congratulatory e-mails started arising. My picture was in the Washington Post with an article; article in NY Times and picture and article on Monday (Sept.17) in USA Today.
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Sept. 19, 2007 - Over the past few days, literally hundreds of e-mails and letters coming in regarding Lasker Award from friends, colleagues, people I knew years ago such as nurses from H-4 ward at NY Hospital, White house people, congressmen, etc. Today had meeting at White House (EEOB-428) run by NSC (Mike Falan) and HSC (Rajeev Venkayya) to discuss updating and broadening the vision of the NSC/HSC TB White Paper that we (NIAID) had contributed to a couple of months ago when we introduced our Research Agenda for MDR/XDR-TB. Beautiful Fall day (crisp and sunny). Meeting from 9:00 to 11:00 AM followed by briefing from Tachi Yamada (Gates Foundation) who came from Seattle to present to us (USG) out of courtesy the new $282 million Gates TB initiative. In preparation for this I alerted Rajeev that we really needed to coordinate the many USG activities on TB and present it in a vision format so that the POTUS could claim the legacy of having addressed AIDS (PEPFAR), malaria (President's Malaria Initiative - PMI) and now TB. It would be the 3rd leg in the stool of his Global Diplomacy program. Rajeev agreed - unfortunately, he will be leaving government on Sept. 26. It was great working with him over the past few years. His background is that he trained as an MD at Michigan and was actually Chief Medical Resident when Tachi was Chairman of Medicine at Michigan. In any event, we will update and sharpen our USG White Paper.
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Sept. 20, 2007 - Another great crisp Fall day. Heard real bad news regarding the Merck AIDS vaccine trial 502 in which adenovector HIV was immunogen. Study done mostly on gay men and phase 2b was looked at by DSMB on usual periodic look. Trial closed for "futility" in that the data showed that more people got infected in vaccinate group versus unvaccinated group (19 vs 11 - not significant, but highly suggestive). Also, viral set point exactly same in infected people who were vaccinated versus those that were not. Trail stopped - press releases imminent. It is going to be a hot time. People will focus on whether we should proceed with the Phase IIb of PAVE 100 (Gary Nabel's VRC trial). The latter also was a adeno vector, but is different in 3 ways: 1) it has a DNA prime; 2) it has envelope; 3) it is done also in heterosexuals. More to come. Went to Gate-sponsored dinner at Le Paradou Restaurant at 678 Indiana Avenue, NW in honor of retiring President of Botswana Festus Mogae. I had met the President in 2002 when I went to Africa with Tommy Thompson in 2002 to develop PEPFAR. At the dinner were: Todd Summer and Cheryl Scott (Gates), Jeff Struchio (Merck), Bobby Pittman (NSC Director of African Affairs), Congresswoman Nita Lowey, Tommy Thompson, Max Essex (Harvard School of Public Health), Ambassador John Lange (former Amb to Botswana), Jendayi Frazer, Assistant Secretary of State for African Affairs. Nice evening. I commiserated with TGT about his failed attempt at Republican nomination for President. Nice conversations with Nita Lowey about Iraq (Democrat viewpoint), and warm conversation with Mogae regarding my work on AIDS.
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Sept. 25, 2007 - Was panelist at Science Magazine's annual retreat of their staff at their headquarters in Washington, DC. Chaired by Editor Don Kennedy. Lively discussion about the future of science and biomedical research. DSMB discontinues trial of Merck HIV vaccine based on Adenovirus vector. Possible that vaccine actually made things worse. Big setback for HIV vaccinology.
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Sept. 26, 2007 - Farewell reception at White House for Rajeev Venkayya (Deputy Director - Homeland security Council). I have worked closely with Rajeev for 5 years on Biodefense. He rose from WH intern to deputy Director in 5 years. He is someone to watch; good guy; physician trained at U of Michigan and UCSF. Usual cast of WH people, i.e. Fran Townsend, etc.
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Sept. 27 - 28, 2007 - Glorious 2 days in NYC for the Lasker Awards. Dinner on night of Sept. 27 at La Grenouille (Mary Lasker's favorite restaurant). Lasker Lunch at Pierre Hotel on Sept. 28. Ralph Steinman received Basic Science Lasker; Alan Carpentier and Albert Starr (Starr-Edwards heart valve) received the Clinical Lasker; and I received the Public Service Lasker. On Friday, Sept. 28, the Washington Post did a very large piece on me called "The Honored Doctor" talking about the Lasker, the National Medal of Science, the Kober Medal and other honors. I have received literally several hundred letters and e-mails and greeting in person related to the Lasker and the Post article. With me in NYC were Chris, Ali and Jenny. Megan had to stay on Chicago with "City Year".
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Oct. 4 - 5, 2007 - Went to Aspen for the World Biomedical Forum. Gave 4 to 5 talks on AIDS, Pandemic Flu, Emerging infections, etc. Again, usual cast of notables there. Very nice time. Weather in Aspen and DC has been spectacular for past couple of weeks. Sunny, Warm and no rain.
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Oct. 11, 2007 - Featured speaker at a Global Health Symposium at the Italian Embassy on Whitehaven Street in DC. Spoke on "HIV/AIDS in 2007: Much Accomplished, Much To Do". Much congratulatory activity by the Italians related to the Lasker and the Post article.
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Oct. 12, 2007 - Dinner at the Café Milano in association with the national Italian American Foundation (NIAF) dinner the following night (Oct. 13). Franco Luschese found me a prime seat. The whole restaurant was for the NIAF dinner. I sat next to Jerry Vale. So many people who I knew from other such meetings were there: Yogi Berra, Tony LoBianco, Dion (and the Belmonts), Nancy Pelosi, etc. etc. Great meal; nice time.
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Oct. 13, 2007 - Took Ali to the Annual NIAF Gala at the Hilton. She loved it since she wanted to meet Nancy Pelosi and Ellen Pompeio (star of TV's Grey's Anatomy). She got to meet and take picture of both. Usual glitterati were there: Antonin Scalia and Sam Alito; Nancy Pelosi; Yogi Berra; Dion; Jerry Vale; George Tenet (I wanted to connect with him, but we did not cross each other); Connie Stevens; Pater Pace; etc. etc.
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Oct. 16-17, 2007 - Went to Seattle to participate (Panel) in the Bill and Melinda Gates Malaria Forum at the Sheraton Hotel at Union and 6th Streets in Downtown Seattle. Mild and on and off rain. Good meeting. Just starting to see the galvanizing of interest and enthusiasm and finally even considering the possibility of eliminating and eradicating malaria. Melinda and Bill gave an inspiring speech at 9:00 AM on Oct. 17. All the malaria people were very pleased that I was there to show the "flag". I have become increasingly interested and supportive of malaria including my long-term support of Stephen Hoffman (Sanaria) and his irradiated sporozoite vaccine. Had a unique evening at dinner at the home of Bill and Melinda Gates on Oct. 16, 2007. It was obviously a spectacular home, but I did not get the tour since while Melinda was giving the other guests a tour, Bill wanted a private conversation with me. He was fascinated by how I have been running NIAID; said that he had heard so much about me and happy finally to meet me in person. He wanted to know how I navigated the politics of DC, how I prioritized, how much flexibility I had in the budget, etc. etc. It was a very nice conversation aimed at his wanted to get to know me and my responsibilities better. Present at the dinner were: me, Bill and Melinda Gates, Tachi Yamada, Regina Rabinowitz, Margaret Chan (WHO), Michel Kazatchkine (Global Fund), Brian Chituwo (MOH of Zambia), Tedros Adhanom Ghebreyesus (MOH of Ethiopia), Michael Leavitt (Sec. HHS), David Mwakyusa (MOH of Tanzania), Ann Veneman (UNICEF), also MOH of Mozambique Paolo Ivo Garrido and former MOH of Nigeria (Forgot her name).
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Oct. 18, 2007 - Lectured in Building 31, Room C10 to the Mortimer Zuckerman Fellows . This is a group funded through Harvard that takes medical, Law, and Business students from throughout the country and funds them for 1 - 2 year fellowship to study at either the Kennedy School of Government, the Harvard School of Public Health or the Harvard Business School to learn other disciplines, i.e. medical students will go to the School of Government, and Law students will go to School of Public Health. They wanted to hear about me and how I got to where I am and my view of public service. I lectured for 45 minutes and took over 1 hour of questions. They were extremely enthusiastic about me and what I said.
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Oct. 19, 2007 - Went to Boston to give Sheldon M. Wolff memorial lecture on "HIV/AIDS in 2007: Much Accomplished, Much To Do". Largest crowd in the history of Tufts Grand Rounds (so I am told). Saw Lila Wolff. Got to Boston early (cloudy day, but warm for October) and had breakfast with Jenny at Peet's Coffee House in Harvard Square. Had first talk with Jenny about her personal "situation". Went very well. That evening went to home of Ron and Beth Dozoretz for a reception for the Fellows. The fellows were so happy that I was there. The Dozoretz's live at 3005 - 45th Street, N.W. (2 blocks from my house). At the party were many DC elites such as David Gergen (co-sponsor of event), Sandy Berger, Ron Carey (Newsweek), etc.
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Oct. 26, 2007 - Gave talk at the opening of Sanaria's new facility. Sanaria is Biotech company making an irradiated sporozoite malaria vaccine. Stephen Hoffman is the CEO and I have been very supportive of him over the past 20 years. He recognizes this every time he speaks in public. Also at the Grand Opening were Congressman Chris Van Hollen, Sen. Cardin (D- MD), Montgomery County Executive Ike Legget and others.
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Oct. 27, 2007 - Great day. Went to ISL/IAC cross country championship meet held at Episcopal High in VA. NCS and St. Albans won everything - JV and Varsity and under 15. In the NCS JV race the first 11 runners over the finish line were from NCS. Ali came out 6th in the race!
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Oct. 29, 2007 - Went to dinner at Positano restaurant in Bethesda with Bob Gallo (part of our years long tradition of dinner in Bethesda to "catch up" on what is going on. Discussed the interesting topic of matching Bob, Luc Montagnier and me for nomination for the Nobel prize for AIDS now that I have won the Lasker Award. It could be helpful to Bob if I am on the "ticket" since there is no controversy connected with me and this could make it a more desirable slate since the 2 of them alone always evokes memories of controversy. Oct. 29 - Nov. 1, 2007 - Full week of meetings with Ministers of Health from G-8 and their senior staff on topic of Global Health with an emphasis on Biodefense. Ministers that were present include: The Honorable Mike Leavitt, U.S. Secretary of Health and Human Services The Honorable Michael Chertoff, U.S. Secretary of Homeland Security The Right Honorable Tony Clement, MP, Minister of Health, Canada The Honorable Markos Kyprianou, Esq. Commissioner for Health, European Commission The Honorable Ulla Schmidt, Federal Minister of Health, Federal Republic of Germany The Honorable José Angel Córdova-Villalobos, M.D., Secretary of Health, Mexico The Right Honorable Dawn Primarolo, MP, Minister of State for Public Health, United Kingdom Dr. Donato Greco, Head, Department of Prevention and Communication, Ministry of Health, Italy The Honorable Kenta Matsunami, Parliamentary Secretary for Health Labor and Welfare, Japan Dr. Anarfi Asamoah-Baah, Deputy Director-General, World Health Organization. I gave talk at VRC to the senior staff. Had elegant receptions and dinners at the Corcoran Gallery (Oct. 31) and Library of Congress (Nov. 1).
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Nov. 2, 2007 - Went to Boston to give Keynote at meeting of Harvard Business School Alumni Association - held at Harvard Medical School. Spoke on Emerging Infections. Had dinner with Jenny at Taranta's restaurant in the North End on Friday night, Nov. 2. Had nice discussions about career options as she is now approaching graduation from Harvard. She wants to take at least a year working at something that she loves (not sure yet what that is - could be a year in Cuba or a domestic political campaign) and then go on to graduate school. Nov. 7. 2007 - Ellen Sigal invited me and I attended the "Friends of Cancer" Awards night at the Hotel George on Capital Hill (E Street). "Leadership" Awardees were Ted Kennedy, Sen,. Mike Enzi, and Bob Young (former NCA/Fox Chase). Ted Kennedy explicitly said that he would like me there and wanted to greet me. He mentioned me warmly in his acceptance speech. Afterwards had dinner with a select few from the reception - Ellen Sigal, Marlene Malek, Sherry Lansing, John Porter, Amy McGuire Porter, Elias Zerhouni, Melody Miller (former staffer for Ted Kennedy). Lively discussions (particular with Sherry Lansing who is a terrific person - she had been at my Lasker Award ceremony). Nov. 7 - 8 , 2007 - Very discouraging news from the Merck HIV vaccine trial (502/503 - STEP and Phambili Trials) using adenovirus 5 (Ad5) vector and gag, pol, nef inserts. Took place in North and South America, Caribbean, Australia (STEP) and just beginning in Southern Africa (PHAMBILI). First DSMB look stopped the trial on futility for 2 major endpoints (Acquisition and Viral Set Point). Real problem is that it looks like people with the higher underlying Ad5 titers had greater risk of acquisition in the vaccinated versus the placebo group. Unclear why this is so but may be that giving Ad5 to people with underlying Ad5 immunity triggers robust activation providing vulnerable targets for infection upon exposure to the virus. This has important implications for future trials with Ad vectors such as upcoming PAVE 100 trial - ethical issues. Stay tuned. On evening of Nov. 8 gave Keynote After Dinner talk to the Association of Independent Schools of Great Washington (AISGW). Kathy and Dan Jamieson were there as were heads of schools and senior officials for the DC/VA/MD independent schools. Talk went very well - "Our Responsibilities as World Citizens: Looking Through the Lens of Global Health". I spoke at The Potomac School in Virgina. Hugh crowd.
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Nov. 8, 2007 - Testified before the House Commerce and Energy Committee (Joe Barton, Chair). MOL, Julie, me, Bill Raub. Topic = pandemic flu. Somewhat different twist. Much discussion about funding. Some Republicans such as Barton feel that we should not have an emergency supplement, but that we should have offsets. This is contrary to what House Appropriations Chairman Jerry Lewis said at the Appropriations Hearing (see above). He feels that it should be new money.
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Nov. 14, 2007 - Attended 60th Anniversary Gala for Meet the Press (invited by Tim Russert. Held at 555 Pennsylvania Avenue, N.W. in the new Newseum Building. Another affair of all the glitterati of the Washington, D.C. press and politicians - John McLaughlin, David Gregory, Norah O'Donnell, Fred Fielding, Ben Bradlee, Mike Gerson, Sen. Kennedy, Kerry, Former Sen. McGovern, Tom Ricks (Washington Post), Al Hunt, Dana Perino, Dana Priest, etc. etc. Elegant affair, good food, plenty of cheer.
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Nov. 30, 2007 - Chris an I attended a Holiday Dinner Party at the White House hosted by the President and First Lady. I had been at several Holiday receptions at the White House around Christmas Time, but this was the first time that I attended a Holiday Dinner. There were about 75 - 100 people in attendance. Wonderful affair! The POTUS and First Lady circulated freely with guests as we had cocktails in the foyer adjourning the East Room. Spent several minutes talking with the POTUS and First Lady separately. He and she had just finished an AIDS event in Mount Airy to commemorate World AIDS Day (Dec. 1 - tomorrow). The POTUS had a large 50 foot red AIDS Ribbon hung from the front portico of the White House and he was excited about pointing it out to me. The POTUS in his usual generous way with me kept introducing me to people at the reception as one of the world's greatest scientist who will get us an AIDS vaccine. Again, as usual, he was very warm and friendly with me. Dinner was elegant - pumpkin soup, lamb, fine wines and champagne. The evening was crystal clear and cold (around 40 F). After dinner we had Christmas carols by the Army Choir and a trumpet and piano medley of Holiday Songs by 2 young black men from New Orleans (?names). Nov. 30 - Dec. 9, 2007 - Pre-Iowa caucus heating up with Obama closing the gap with Hillary Clinton who is front-runner. Romney and Giuliani neck in neck on the Republican side. Despite the fact that election is 1 year away, election politics is dominating the news. The "surge" in troops in Iraq appears to be working in cutting down the violence, but this is still a tenuous situation. Latest NIE states that Iran (contrary to what was previously thought) has halted their nuclear weapons programs. Life in DC as active and political as ever.
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Dec. 9, 2007 - Invited by Catherine and Wayne Reynolds to attend a small private dinner with Chris at Café Milano's restaurant for Holiday Cheer. Amazing night. About 15 people in the private Placido Domingo Room of Café Milano. Attending among others was VP and Mrs. Cheney, Bill Marriott, Sen. Thad Cochrane and his girlfriend, Elias and Nadia Zerhouni, Chris Wallace (Fox News), Alma Wildenhorn, John and Debbie Dingell, Mike and Meryl Chertoff, among others. Spent nice time speaking with the VP about Stephen Hayes's book "Cheney" that I just finished 2 days ago. We had fun since we discussed the parts of his earlier years from the book such as his sports in high school. Also discussed with Lynne Cheney the part about her giving him an ultimatum of shaping up in school or she would leave him as his girlfriend. He had flunked out of Yale twice.
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Dec. 11, 2007 - Another exciting Washington social night. First visited home of Ellen and Gerry Sigal at 2909 - 44th Street, N.W. just 2 blocks from our house. Occasion was book signing party for Valeria Plame Wilson to celebrate publishing of her new book "Fair Game" about her outting as a covert CIA agent. Chris and I have gotten to know her and her husband Joe Wilson over the past year, mostly through the Sigal's. Interesting irony (see previous notes) that I am friends with Joe and Valerie at the same time as I am friends with Scooter Libby. Had to leave party early to go to Italian Ambassador Giovanni Castellenata's residence. On way out as I apologized to Joe for leaving early, he joked "As long as you are not going to a party at the VP's house". In fact, that is exactly what I am doing on Thursday (see below). Function at Italian Ambassador's house was fun. Party to honor the visit of Italian President Enrico Napolitano. Usual DC glitterati were there - Mike and Meryl Chertoff, Colin Powell, Lee Hamilton, Frank Balducci (author), D.C. Mayor Adrian Fenty and wife Michelle, former head of Italian CIA Carrado Cantatore (had nice conversation with him about Italian covert ops in Iraq - i.e. Italian Special Forces are still operating there even as Italian troops pull out), Sen. Pat Leahy, etc. I sat next to my good friend Cecilia Piccione (Chief-of-Staff to the Ambassador).
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Dec. 13, 2007 - Two issues today: Went down to White House with Mark Dybul to visit Dan Price (new SHERPA for the upcoming G-8 meeting in July, 2008). Dan, at the suggestion of Gary Edson, was looking for some bold initiatives for finish off the legacy of the POTUS over the next 11-12 months. Gary mentioned to Dan how I had developed the PEPFAR program. We discussed various options. I brought up several such as elimination of TB and malaria, and aggressively addressing neglected tropical diseases (NTDs). Mark had the great idea of using the PEPFAR infrastructure that has been built up over the past 4 years to deliver the meds for NTDs. The bulk of the costs for attacking NTDs is the delivery systems since the drugs are free (ivermectim) or very cheap. In addition, Mark suggested major tax breaks for private sector corporations that donate their expertise such as computer programming, etc. Mark and I were charged with putting together a proposal. This matches nicely with what HHS, NSC, and HSC are asking me to do with putting a bold program together for TB together with CDC, FDA, USAID, and DHS. After talking to Dan, we walked over to Josh Bolten's office and described briefly the plan to him. He likes it a lot and urged us to go forward. Seems strikingly similar situation to what we did with PEPFAR 5 years ago. This evening I went to the Christmas Party at the Vice President's mansion. Chris is in Boston having given a lecture and ran into a big snow storm. She is stranded in Boston and will have to take a train home that will get her in during the middle of the night. I took Ali to the VP party and she had an exciting time meeting the VP and such notables as David Addington (Chief-of-Staff to the VP), Joel Bagnol (HSC), Bruce Miller (VP's Staff, Carol Kuntz, etc.
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Dec. 14 - 19, 2007 - Series of the usual (now becoming enjoyable since I remember names after seeing them so often) holiday parties, mostly centered around NCS/STA. Weather unusually mild. Looking forward to Jenny and Megan coming home
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Dec. 20, 2007 - Meeting (pre-PCC) at EEOB run by Mike Magan of NSC and Bob Kadlec of HSC to flesh out possibility of putting together a major POTUS initiative on "Control or Elimination of Tuberculosis" to announce at the State of the Union Address in Jan. 2008. After having various agencies present a totality of a program that would cost billions, it was decided that since there really will not be any new money, or if there was, it would be very little, we should focus on the well-circumscribed topic of TB Vaccine research. I was tasked to do this and to write language for the State of the Union Address. In my proposal, I presented the case that this would cost relatively little. NIH spends $150 million in 2007 on TB research ($120 M is NIAID). Of this $20 million is on TB Vaccine Research - this is about 25% of world's TB vaccine research spending with Gates spending about 45% (they spend most of their TB money on vaccine). The Global Plan to Stop TB - 2006-2015 calls for $184 million in 2009 (the FY that we are talking about). If we tripled our spending by adding $40 million to the $20 million, this would give $60 million. Right before the meeting Rajeev Venkayya (who left HSC and will be joining Gates) called and e-mailed me saying that he has arranged a call between Secr. Leavitt and Tachi Yamada from Gates to agree that Bill Gates, Jr. will commit to a significant increase in Gates funding for TB if the USG puts up more money. I have submitted a proposal for a $40 million increase for FY 2009 and I have included language for the Address. Let us hope that this flies. Then I will have had impact on PEPFAR, the President's Malaria Initiative (PMI) and now the TB initiative.
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Dec. 22, 2007 - Has breakfast at Panera in Chevy Chase with Terry Lierman who is now Chief-of -Staff to House leader Steny Hoyer (an old friend). We discussed the usual politics and I mentioned that the only job that I would take in a new administration is Secretary of HHS. Terry said that everyone knows in the democratic party that I am most qualified, but that I have "a Bush problem" in that I am too closely associated over the years with the Bush's. Such is Life; I am not at all upset about this since who knows what will happen and besides, I do not covet the job.
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Dec. 23-27, 2007 - Discovered that Megan has an 8 mm left ovarian cyst - likely a dermoid that needs to come out for fear of torsion/twisting since it is so big. She is seen by Mark Reiter's group and Mark is arranging to have it removed on Dec. 31 laparoscopically by a woman in his practice. He will assist. He is giving her the VIP treatment, but I know too little about the laparoscopic skill of the people in his practice. I do not want to upset the apple-cart, but ordinarily I would get David Jacobs involved; yet I do not want to interfere with the natural flow. David would probably insist that someone else outside that practice do the procedure. Mark wants to be in charge since he delivered Megan and feels a strong responsibility to her. I am conflicted and will hope for the best.
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Dec. 28, 2007 - Lucky for us that Dr. Sedghi (Megan's primary GYN doctor asked for a repeat sonogram. Turns out the "cyst" was a loop of bowel. She has a normal pelvis on repeat sono. Welcome to medical practice in the USA! The radiologist actually called it a dermoid cyst based on "calcification", which now turns out not to be present.
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Dec. 28, 2007 - Jan. 4, 2008 - The White House is getting excited about the possibility of pushing my TB vaccine research intitative for the G-8 and for the SOTU Address. Met on Jan. 3 with Mike Magan and Patrick Marcham of NSC about pushing forward my TB intiative. Also, Mike wants me to put together a similar initiative for a malaria vaccine. I will present this to Dan Price (with Gary Edson present) on Monday at the White House. Possibility exists for a two-fer, i.e. TB + Malaria vaccine initiatives. A lot of activity (e-mails, phone calls, meetings) going on similar to the time right before we went ahead with PEPFAR in Jan. 2003. There is the usual concern on the part of NIH, HHS, and OMB as to where the new money will come from. I have been very open in keeping Elias Zerhouni and HHS informed of my White House meetings. Jan. 5 - Jan. 18, 2008 - Democrat and Republican primaries getting very hot. No clear leader with the GOP. Fred Thompson dropped out; Rudy Giuliani counting on Florida as he has done poorly so far in Iowa, NH, Nevada, Michigan and SC. Romney dropping and McLain bouncing back with wins in NH and SC. Dems race ugly with Bill and Hillary attacking Obama. This is causing racial tensions and blacks are getting pissed at Bill and Hillary. Bill is acting inappropriately in attacking Barack in an angry fashion. He is also clearly lying about what Barack has said and done. My initiatives are still percolating at the WH. Now they have asked me to put together a malaria vaccine and malaria drug discovery proposal. Will discuss these on Jan. 28 at the WH. Weather has been bitter cold in DC - very sunny, but freezing.
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Jan. 19, 2008 - Dinner at Capitol Hilton Hotel to celebrate Sam Alito getting the Lido Award. Dinner sponsored by NIAF. John Salamone (Executive Director of NIAF) asked Chris and me to sit at Alito's table along with Gen. Peter Pace and his wife Lynne. Had nice evening speaking with Martha-Ann Alito (Sam's wife). She is starting an "Italian Dinner Club" and invited me to join. I am considering it.
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Jan 25, 2008 - Gave lecture Global health at USA Families Conference at the Mayflower Hotel. The speaker before me was my friend former Senator Tom Daschle. Tom gave a great talk on health care in the USA based on a book that he has just written. Of note, he is the health advisor for Barack Obama. This is good since Tom likes me a lot and this could be my entry into getting to know Obama a bit better since I know Hillary much better than I do Obama. This evening went with Chris to an elegant "private" dinner (black tie) at the Academy of Achievement Town House at 1222 16th Street, N.W. given by Catherine and Wayne Reynolds. They have been very generous to me in inviting me to these great affairs. In typical Catherine Reynolds style, the details of the evening were amazing. Great food and elegant wines (Montrachet and Margaux) and champagne (Dom Perignon). Guests were terrific. Sens. Daschle, Cochrane, Byron Dornan; Bob Barnett,; Congressman Dingle; Mack McCarty; John Negroponte; Mike Chertoff Steve and Alice Rosenberg, maries. Bruce Miller. etc. Highlight of the evening was the command private performance by Bernadette Peters, who was amazing - talented and beautiful at 60 years old (next month)! I was struck by how short she is in real life. Google lists her as 5'3", but she was about 1.5 inches shorter then I and she had spiked (3 inch) heels on - great looking woman and incredibly nice as we spoke with her after the performance.
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Jan. 26, 2008 - Activity mostly centered around the Democrat and Republic primaries. McCain surging from way behind, Giuliani is out. Obama closing in on Hillary.
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Jan. 28, 2008 - Went to White House to nail down with Dan Price, Gary Edson, Patrick Marcham, Mark Dybul, Paul Brown, Bobby Pittman and others the various aspects of the initiatives that the POTUS might want to announce at G-8, or the Upcoming (Feb) Africa trip, or the DC Global Health Summit. My TB vaccine initiative ($40 million) is in. Malaria vaccine and drug discovery is likely out. Neglected Tropical Diseases is in. That night, in the SOTU Address, the POTUS asked for $30 billion for PEPFAR and praised the POTUS Malaria Initiative (PMI).
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Feb. 1, 2008 - Did dry run of my upcoming presentation to VP Cheney on Bruce Miller. He really liked it. Will soon set up for the VP.
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Feb. 3, 2008 - NY Giants beat NE Patriots in an upset in the Super bowl played in Phoenix. NY's defensive line kept Tom Brady off balance all night and Eli Manning played incredibly well.
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Feb. 4, 2008 - CROI meeting in Boston. Went to show the flag, meet with African investigators from Uganda (Rakai) and see vaccine presentations. Ron Desrosiers gave his talk about the imbalance between discovery and development in vaccine agenda and said there is no evidence that any existing vaccine candidate will work. I do not necessarily disagree; however, he was terribly gratuitous in saying that "The NIH has lost its way on vaccine research". It is easy to criticize and place blame...much easier than having creative ideas to solve the problem. He is not a bad guy, but he was an asshole today.
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Feb. 6, 2008 - Had lunch at café Milano with Franco Nuschese (Owner of Café Milano) to discuss an issue with the United Arab Emirates (UAE). He would like to bring the health minister to the USA and have me show him around the NIH. Also, he wants me to go to UAE and help them with advice about research programs, i.e. establish an NIH-like system in UAE. Franco knows the Middle east well since he has many contacts there and want to help the country develop their biomedical research enterprise. He will arrange appropriate meetings.
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Feb 8-9, 2008 - Flew to San Francisco and took "red-eye" back to give the Merle Sande memorial Lecture at the Gladstone Institute at SF General Hospital (Mission Bay Campus). Warner Greene (Director, Gladstone) and Tom Quinn arranged the visit. I gave a lecture of "HIV/AIDS in 2008" and paid tribute to merle. Told some stories about our friendship and experiences on the NY Hospital House Staff together where he was my resident when I was an intern. Very moving evening with many of merle's old friends from NY Hospital, SF, Utah and Uganda.
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Feb. 14, 2008 -- Had meeting with Carl Dieffenbach, Peggy Johnston, Larry Corey, Scott Hammer (Chair, PAVE 100 clinical trial), JJ. McGowan, Hugh Auchincloss, Cliff Lane, Carole Hudgings, Patty Conrad, Ralph Tate, Gary Nabel to discuss the great dilemma about proceeding or not with PAVE 100 in light of the failure of the recent Merck STEP trial of a somewhat similar T cell based vaccine for HIV (see reports of STEP study failure). STEP trial was performed within the HVTN (by Larry Corey's operation). It used an adenovirus (Ad) 5 vector prime and 2 boosts with gag, pol, nef. DSMB stopped study because of "futility" in that the vaccine did not protect against acquisition of infection (not expected to since it is a T cell vaccine) and also did not alter set point of virus. Importantly, for reasons that no one can figure out, vaccinees (not placebos) who had high pre-existing titer of antibody against Ad5, did worse than unvaccinated in acquisition of infection. The PAVE 100 trial (VRC-Gary Nabel) is also using a T cell vaccine approach with 3 DNA-gag, pol, nef, env prime/boost followed by an Ad5-gal pol env 4" shot. Question is whether we should go ahead with the PAVE 100. Basic researchers in AIDS (Ron Desrosiers, Doug Richman, Dennis Burton, etc.) want to stop all vaccine clinical trials until we figure out the "basic science". We should actually probably tilt the balance more towards discovery rather than development of vaccine candidates since we still have no idea what a protective immune response is or even how or if we can elicit it. However, the "basic" people have their own whining agenda since they feel that any money towards a trial is money away from their grants. Also, they are very jealous of Bart Haynes who got a lot of money for CHAVI (which is actually more basic than applied). I am holding a "Summit" on March 25, 2008 to examine this balance between basic and applied in HIV vaccine research.
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Feb. 16, 2008 -- Another trip to the White House (EEOB) to visit with Bob Kadlec concerning the Global Health Initiatives that we are working on. Everyone is actively engaged in "sprinting to the finish line" of the administration with various transforming initiatives (see above). Bob (who is with HSC) is emphasizing more the Global Security issue, which includes things that I am involved in such as pandemic flu, biodefense, etc. We are working on initiatives to present to the POTUS.
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Feb. 19, 2008 -- Briefed VP Cheney in his West Wing office at 10:00 AM (crisp, sunny day). This was one of several briefings that he has requested of me over the past 7 years. T updated him on pandemic flu threat, seasonal flu, AIDS, emerging IDs, malaria, TB, biodefense. Bruce Miller (VP's chief of Homeland Security) told me before the lecture that yesterday when he was flying back from the long weekend with the VP on Marine 2, the VP spontaneously said "Isn't Tony Fauci going to be briefing me tomorrow. I am really looking forward to his briefing; I always learn a lot from them". Bruce said that this was the first time that the VP has made such a comment about an upcoming briefing the day before the briefing in the 7 years that Bruce has been with the VP. The briefing went very well and the VP was very engaged, particularly about flu and about the dire situation in Washington, D.C. re: HIV/AIDS. He was shocked at the numbers - DC is 9X the national average for prevalence; 5% of the entire DC population is infected.
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Feb. 20-21, 2008 - Went to University of Chicago to deliver interdisciplinary lecture on HIV/AIDS. Had dinner with Megan at Volare restaurant. Went over very well and then flew early on AM of 21 Feb to DC to go directly to the White House for meeting with Dan Price, Gary Edson, Mark Dybul, Patrick Marcham, Paul Brown, Tim Ziemer to discuss malaria, TB, health care workers and other initiative. I am pushing for the tripling of resources ($20 M to $60 M) for TB vaccine research. We had a big week with the POTUS visit to Africa and receiving great praise and affection for the PEPFAR and PMI programs. POTUS announced a $350 M, 5 year program on Neglected Tropical Diseases (NTDs) to include attempt to eradicate in 300 million people in certain African , Asian and Latin American countries - Lymphatic filariasis, Onchocerciasis, Schistosomiasis, trachoma and ground worms (whipworm, hookworm, and roundworm). This is the same program that Gary Edson and I proposed 3 years ago and so our prior work has belatedly come to fruition. Great news!
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Feb. 26, 2008 - My picture and a story concerning me (in part) appeared in the Science Section of the New York Times today. It was related to the interview that I gave in Toronto last summer to 2 small children with the theme of explaining HIV/AIDS to little children. The filmakers were the children's parents.
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Mar. 3, 2008 - Participated in a State Department function for Jenna Bush on the occasion of celebrating her new book "Ana's Story: A Journey of Hope". Took place in the main auditorium of the State department. I was the main speaker and spoke on "The Global Effects of HIV/AIDS and the origins of PEPFAR". Other speakers were Kristen Silverberg, Assistant Secretary of State for International Organization Affairs, and Karl Zinmeister, Director of the White House Domestic Policy Council. Got a chance to chat a fair amount with Jenna Bush as we waited together for the affair to begin. She is a very nice person who said that she was "in awe" of me because of all of the amazing things that I have accomplished over the years. She worked for UNICEF for a year in Jamaica and also spent time in Panama doing AIDS work. Very nice person; has a smile exactly like her father. I gave a history of the origins of PEPFAR and a short summary of HIV/AIDS. I showed the MMWRs from June 4 and July 5, 1981. When Jenna got up to speak, she remarked to the audience how impressed she was with me and my work over so many years and when I showed the 1981 slide, she was floored by the fact that I was involved in AIDS then and that was the year that she was born.
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Mar. 5, 2008 - Meeting in White House (EEOB 445) led by Bob Kadlec of HSC.. Was "Top Secret" meeting on anthrax threat with emphasis on drug resistant and even vaccine resistant anthrax. Based on supposed intelligence that Al Qaeda has been "talking about" anthrax and based on supposed documents captured from Al Qaeda. We were briefed by 2 CIA young women who provided the same vague, soft and even embarrassingly bad intelligence that I have been briefed on several times before by CIA. One gets a very bad impression of the quality of our intelligence based on meetings such as this. Also present were Julie Gerberding, Art Friedlander, Ben Petro, Gerry Parker and a whole bunch of CIA, Counter-terrorist people, Defense intelligence people, etc. Subject was how do we protect against drug resistant anthrax and vaccine resistant anthrax.
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Mar. 8, 2008 - Busy and nice social evening. Dropped in briefly to the NCS Annual Spring Festival "Casino Night" at the Athletic Center. Said hello to the usual suspects and then went to the Newseum at 555 Pennsylvania Avenue to celebrate the 65th Birthday of Gerry Sigal. Beautiful setting with bay window view of the Capitol Dome. Great food, drink and dancing. Joe Wilson and Valerie Plame at our table. Elias and Nadia Zerhouni were dancing away with us on the dance floor. DC was beautiful with crisp cold weather (upper 20s) and clear sky.
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Mar. 10, 2008 - Another in a long string of Global Health initiative meetings at the White House (EEOB 374) led by Dan Price (see above) with Gary Edson, Mark Dybul, Patrick Marcham, Mike Magan, Paul Brown, Dana DeRuiter. Mainly discussed Dan plans for the upcoming G-8 meeting in Japan (he is USG Sherpa). Issues are NTDs, heath workforce, HIV, Malaria, and TB. I was there representing the malaria and TB initiatives (see above). Apparently Josh Bolten is enthusiastic about both, but HHS is not supporting it since their priority in a bad budget year is pandemic flu and biodefense. Nonetheless, I am still going to these meetings and pushing the TB and Malaria agenda . I can do this since Dan Price (with Josh Bolten's approval) is including me in the process even though the HHS is against it.
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Mar. 19, 2008 - A most amazing and unique evening. Michael Gerson (former Bush speech-writer and advisor) and current Washington Post columnist (see other discussions above) invited Chris and me to his house for a private dinner with President and Laura Bush. Other guests were Fred and Barbara Barnes (Fred is Executive Editor of The Weekly Standard , Bill and Hara Haley (Bill is pastor of a DC Church and is interested in AIDS in Africa), and Mike and his wife Dawn. Dinner was at Mike's home at 2412 Crest Street, Alexandria. It was somewhat surreal, but incredibly enjoyable. The occasion was just that Mike is good friends with the POTUS and when he had breakfast with the POTUS a few weeks ago he asked the POTUS if he would like to have dinner over his house some time with a few friends. The POTUS gladly accepted and said that he almost never goes out to private dinners at people's homes because no one ever asks him, likely because they would reasonably assume that he would not accept. Evening started at 7:00 PM. We had to get their earlier (^:45 PM) since the secret service closed the roads (395) to make way for the motorcade. We had about 45 minutes of cocktail hour (POTUS had non-alcoholic beer). Very friendly chatting about a variety of subjects. My long-time impressions of the POTUS held true that he is a very warm, funny and considerate, self-effacing person. Laura was great also. Laura and the POTUS specifically thanked me for saying such nice things about him and Laura at Jenna Bush's event at the State Department (see Mar. 3 above). POTUS said that Jenna saw him and Laura that night and told them how kind I was to them in explaining the POTUS role in PEPFAR. He sounded very sincere in thanking me for "making my daughter proud of me". Dinner was terrific with nice wines, tomato soup, steak/potatoes, salad with bacon, and fruit dessert. At dinner we discussed frankly a wide variety of topics including: War in Iraq; his recent trip to Africa; his dealing with various Heads of State; the upcoming Summer Olympics in Beijing and why he really must attend despite the current misbehavior of China in brutally suppressing the Tibetan call for freedom. He told a great story of when former Prince and now King of Saudi Arabia visited him at his ranch in Crawford and negotiations about the Israel/Palestine problem came up. They reached an impasse since the POTUS thought that the Prince was being frankly anti-Semitic and the discussions stalled. The POTUS would not yield on one point and the Prince announced that he was leaving. POTUS sent in Colin Powell to convince him not to but Colin cane back and told POTUS "Boss, I am getting nowhere with him; you have to step in". The POTUS visited the Prince, perceived the "chilly" atmosphere in the room and said before we discuss anything, let me tell you what my religion has done for me. The prince agreed and then the POTUS asked the Prince to talk about what the Prince's religion means to him. This warmed up the chill and POTUS took him out on his pickup truck to tour the ranch alone. As they were talking about the problem, a turkey hen jumped up in front of the truck and just stayed in the road. The POTUS said that he had never seen a turkey on the road before. POTUS explained what a turkey was and how Ben Franklin almost got the turkey to be the National bird, but the bald eagle won out. The Prince said that in his country god often speaks to people through birds and this is clearly a sign from god. After that, the negotiations flourished and POTUS and the king have been the best of friends. The conversation also included discussions about us and our families. The POTUS and Laura were very interested in Jenny's thesis on women in the criminal justice system. I explained what she was doing and how she decided on this topic. He seemed very connected and empathetic to the problems of young girls getting caught up in the system. He also expressed concern that black leaders are not speaking up more about black men abandoning their children after they have them leading to the incredible statistics of outof-wedlock pregnancies among blacks. POTUS also thinks that the Dems will go into the convention with Obama ahead and that it will be a behind closed doors brokered convention. He said, "if it is a behind closed doors convention, there is no chance that Obama will out-maneuver the Clinton machine. She will be the nominee, split the party and McCain will win. After dinner we all went over an Photo album of the POTUS and First Lady's recent visit to Africa. The President left at about 9:25 PM in a 6 to 8 car motorcade. All in all it was an incredibly memorable evening. Earlier in the day I briefed Ms. Sandra Roelofs, the First Lady of Georgia. She is Dutch and a nursing student. She was interested is speaking to me because she had heard about my AIDS work. We spoke of TB, AIDS and other IDs. She had earlier in the day had lunch with Laura and Jenna Bush. Actually, Laura mentioned this to me at Gerson's house.
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Mar. 25, 2008 - I organized and ran what might be an historic meeting today on the future of HIV Vaccine Research. Ever since the disappointing results from the STEP trial (Merck ad5 prime-boost - see above), there has been increasing pressure within ourselves and in the scientific and certain activist communities to re-evaluate whether we should turn the knob of support more towards basic discovery as opposed to clinical trials of vaccine candidates for an HIV vaccine. On Nov. 16, 2007 I received a letter from a group of basic scientist/animal model HIV researchers asking to meet with me following the failed STEP trial in which vaccinated people with pre-existing Ad5 titers actually seemed to have an increased risk of HIV acquisition compared to placebo. They felt that we were wasting money on vaccine trials which they claimed had no basis to predict success based on animal model data. They were particularly concerned about going ahead with Gary Nobel's VRC trial -PAVE 100 that tested 3 DNA primes followed by an Ad5 boost. However, others point out that the animal model has not been validated in the human and so unfortunately, we are really flying blind. In any event, in a manner similar to how I handled the AIDS activists >20 years ago in that same room (31/7A-24), I listened and suggested that we have HIV Vaccine Summit to discuss the direction of AIDS research. Hence the meeting today. Just a few days ago, a group called AIDS healthcare Foundation stated that we should stop ALL HIV vaccine research and put the money towards proven prevention activities. We had the Summit today and it was enormously successful. I played an active leadership role in the process as opposed to just listening. The meeting was chaired by Warner Greene and Adel Mahmoud and there were 3 panels: 1) basic discovery chaired by Jim Hoxie and Dennis Burton; 2) animal models chaired by David Watkins and Malcolm Martin; and 3) Clinical Research chaired by Scott Hammer and Julie Overbaugh. Great press coverage. I concluded at end of meeting that we would indeed turn the knob more towards basic discovery research and promised an immediate $10 Million for a broad RFA to come from moneys saved from truncating some of the clinical trial activity such as a tighter PAVE 100. Recall that our budget has been flat for the past 5 years and so there is no extra money coming in. Below is an article from the NY Times by Larry Altman from Mar. 26 that summarized the Mar. 25 meeting:
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Mar. 26, 2008 - Rave reviews coming in regarding "my leadership" during the Summit. Went down to White House (NEOB 5235) to brief OSTP WH Science Advisor Jack Marburger and his staff together with staff from FLOTUS on the HIV vaccine situation, particularly given all of the publicity. I had appeared on NBC News, VOA, Bloomberg TV as well as articles in Washington Post, NY Times (see above) and WSJ. Now we need to follow-up with RFA's etc. April 1 and 2, 2008 - Visited Princeton University to Deliver the Inaugural Adel Mahmoud Lectureship and to participate in a Panel discussion with Bill Frist, Andrew McGuire, and Beatrice Hahn at a Symposium on "No Country Left Behind: Transforming Global Health given by the Woodrow Wilson School of Public and International Affairs. Bill Frist spent some time telling the audience that if it were not for me PEPFAR would not have happened. Had dinner at a Princeton mansion, went to Adel Mahmoud's and Sally Hodder's home (where I stayed overnight - beautiful modern Salvatore Dali-like home) for after dinner cocktails with some of the Princeton Faculty. Was very impressed with the commitment to teaching students that I saw among the faculty as well as the competency and popularity of Shirley Tilghman (President). Next day taught a class in the Dept. of Molecular Biology run by Leon Rosenberg and Adel Mahmoud. Spoke about the evolution of my career. Students were great. On evening of April 2, had long interview with Meredith Wadman of Nature who is doing a story on PEPFAR and wanted a bit of the history. April 3 - June 10, 2008 - Very busy and eventful times. Had virtually no time to enter events into diary. We try to summarize. The Democratic primary loomed hot and heavy with Hillary refusing to concede despite the fact that numerically it was impossible for her to pull ahead of Barack Obama. Finally after the Oregon (Obama) and South Dakota (Clinton) primary, she begrudgingly conceded on June 6. April 21 - Participated with Sec. Leavitt in a "Georgetown Conversations" function at the home of April and John Delaney in Potomac, MD. This series is sponsored by Meryl Chertoff (Mike Chertoff's wife) and Larry Gostin. Bring together a bunch of prominent people in an elegant home and make brief statement, followed by Qs and As and then dinner. Very enjoyable. April 26 - Went to Chicago for the AAP Annual Meeting to induct Bob Seder into the AAP (I sponsored him). Saw Megan and had a nice brunch and then went to L.A. for the Milken Institute's Annual Global Conference where I participated in 2 stimulating Panel Discussions on Global Health. Greg Simon (Al Gore's former Chief-of-Staff) got me involved. Met a lot of political financial backers at the meeting. Had dinner at the L.A. mansion (Sunset Boulevard) of Lynda and Stewart Resnick and gave dinner remarks. May 2 - Went to Sommerville, NJ to a Merck retreat to help them decide what they are going to do with their HIV vaccine program following the disappointing results of the STEP study. Many players in the field were there: David Baltimore, Dennis Burton, David Ho, Ron Desrosiers, Jerry Sadoff, a bunch of Merck people. Decision is that although they want to stay intellectually involved and make reagents available to others, they are really going to suspend further studies. May 13 -- Very sad day! May 19 -- Went to Paris to the Institut Pasteur to give a lecture at the Symposium commemorating "25 Years of HIV", i.e. the discovery by Montagnier. Gave initial lecture on our recent paper in Nature Immunology on the new receptor for HIV -- a4B7. Had good time in Paris seeing old friends. Had dinner in the Eiffel Tower with the whole group -- sat next to Alice Daubry -- Director of the Institut Pasteur. May 30 -- AIDS Vaccine Research Subcommittee (AVRS) meeting in Bethesda to discuss decision of whether to proceed with the PAVE 100 study of the VRC. The AVRS voted 23 to 3 to go ahead. Decision will come soon. June 1 -- Gave Commencement Address at UMASS and also saw Jenny in Boston with her friend Endria Dickinson. Had good time.
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June 4, 2008 -- Jenny's graduation from Harvard. J.K. Rowlings gave a great commencement address. Wonderful time despite very cold (for June -- 52 degrees) and raining for 2 days. Jenny graduated magna cum laude. Had nice dinner at Artu in the North End. June 10 -- Big honor. Was invited by President of the U.N. General Assembly Dr. Srgjan Kerim to deliver a Keynote Address at the 2008 U.N. General Assembly High-Level Meeting on HIV AIDS. Addresses were by Secretary-General Ban Ki-Moon, Pres. Kerim, Peter Piot, PWA Ms. Ratri Suksma from Malaysia. This was followed by several Heads of State (El Salvador, Togo, Mozambique, Burkina Faso, and Central African Republic). Jenny was in NYC interviewing for jobs and she was there for the presentations. She was excited by it. Have a great photo of me at the podium of the UN General Assembly giving my speech.
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June 11, 2008 -- It was publicly announced by the White House today that I will receive from the POTUS at the WH the Presidential Medal of Freedom on June 19. Other honorees will include: Dr. Benjamin Carson, Congressman Tom Lantos (posthumously and accepted by his widow), Gen. Peter Pace, Donna Shalala, and Laurence Silberman.
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June 17, 2008 - I will be attending his memorial service at the Kennedy Center tomorrow. Bono called me today to congratulate me on receiving the Presidential Medal of Freedom. I caught him up on my family and mentioned that Megan was starting at Columbia in September. His daughter Jordan (JoJo) is also starting Columbia. He asked me to send him Megan's contact information since he is worried that his daughter will be lonely since she is coming directly from Ireland. Perhaps they will become friends.
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June 18, 2008 - Attended the memorial service for Tim Russert at the Kennedy Center. Extraordinary Washington affair with the total "A list" present. Hosted by Tom Brokaw. See book published in 2013 called "This Town" by Marc Liebovich for full details of the ceremony.
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June 19, 2008 - Extraordinary day at the White House for the Presidential Medal of Freedom Ceremonies. Crisp, clear blue sky, sunny and comfortable day. A lot of joy in the presentations (see my written file records of what was said about me by the POTUS). Very good media coverage. The presentations for everyone were very warm. Lots of wonderful pictures. Many guests (some of whom came for me) such as Justice Scalia, Sam Donaldson, Cuba Gooding, Judge Merrick Arlen, Gen. Richard Meyers,, etc. I had very warm interaction with the POTUS. When we approached him with my group of 10 (Chris, Jenny, Ali, Denise and Jack, Cliff Lane, Hugh Auchincloss, J.J. McGowan, Greg Folkers and Patty Conrad) to take a group Picture, the POTUS hugged me and put his lips to my ears and said, "I love you Tony, Thanks for all you do for our country and the world". The ceremony took place in the east Room and the reception took place in the Banquet room of the East Wing. After the ceremony we watched from the balcony as the POTUS took off in Marine One for a tour of the flood damage in Iowa. After the reception, Chris took off with Ali to fly to Chicago to bring home Megan from her year there. Jenny is home after graduation trying to decide what she will do next year.
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June 21 - 29, 2008 - Extraordinary trip to Greece with Chris, Jenny, Megan and Alison. I went first to Thessaloniki to deliver Keynote Address at the Immunocompromised Host Society Chaired by Steve Holland. Spoke on HIV/AIDS (of course). Then met family in Athens where I received an honorary doctorate at the University of Athens sponsored by Haralampous (Harry) Moutsopoulos, my old friend from NIH days 30 years ago. Absolutely fabulous time, elegant hotel (Grand Bretagne), wonderful food, elegant ceremony (very formal with old robes), sight-seeing at Acropolis, Agora, Old Olympic Stadium. Then spent 3 days on the island of Santorini (Ali picked the place) in a beautiful, but understated beachfront Hotel with Harry and his wife Foteini. Santorini is a volcanic island of indescribable beauty. Perfect weather - no clouds at all for 1 week in Greece. Great hospitality, especially from Harris Roussos, an old and dear friend of Harry's who runs the biggest hospital in Athens and who owns an elegant home in Santorini. They threw a "Greek-Style" party for us one night. Spent evenings eating <s working with elegant meals at mountain cliff restaurant or on the beach. Visited Oia, Fira - stayed at Kamara Beach. One of the best vacations (albeit brief) that I have ever experienced.
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July 3, 2008 - Gave lecture at the Ideas Festival at Aspen, CO on HIV/AIDS in 2025: Will we have a vaccine and a cure by then?". Usual ambiance of Aspen with nice dinner on the night of July 2 catered by the famous Alice Waters of Chez Panisse in Berkley, CA and narrated by Corby Kummer, renowned food critic of The Atlantic (also the person who lent us his apartment in Boston for Jenny's graduation (see above). Met usual celebrities at dinner. Spoke with Chris Jennings (Clinton's Health person who is now with the Obama Campaign since Obama won the primary. He wants to get me involved as a person to advice the campaign informally about what they are on track with certain issues.
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July 6, 2008 - Wonderful day. Chris Hultzen arranged to have Danny and Joe Hultzen and their friend Austin do "batting practice" with me at STA field. Danny pitched to me and it was terrific. I hit several line drives to outfield, but the distance was poor, nothing like the fence shots that Danny and the others were hitting. It is clear that my power is no where near Danny's and the others. I pitched to Danny and he hit some over the right field fence.
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July 17, 2008 - Made what some are saying is a "landmark decision not to proceed with the PAVE 100 HIV vaccine trial of the NIAID VRC product. This followed weeks and months of committee meetings and recommendation such as the AIDS Vaccine Research Subcommittee (AVRS) who voted to proceed and the Strategic Working Group (SWG) who voted not to proceed. The issue was that the Merck STEP trial failed and actually had some safety issues. The PAVE trial is somewhat different (3 DNA primes and an Ad5 boost containing env) from the STEP trial (3 Ad5s without env), yet the preliminary immunological data from PAVE 100 was in my mind (some such as Gary Nabel disagreed) not much better than those of STEP. I received many e-mails from people arguing for and against. The decision was mine alone and I decided to reject the proposed PAVE trial of 2400 people since it was powered to do immunological correlates on a subgroup who might seem to benefit even if the endpoint of the entire group was not "effective", i.e. decrease in viral set point after infection. I argue that if the trial failed, I am not interested in the immunological correlates in a subgroup since this has no statistical value. There was much activity in the Press about my decision and the feedback was overwhelming that I had made the right choice. I encouraged Larry Corey of HVTN and Scott Hammer the PI of PAVE to come back to me with a "leaner, meaner" protocol that is less expensive, fewer people, less samples to ask if the product works. If it does, then we will go back and do immune correlates.
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July 30, 2008 - Christine, Meg and Ali left for Rwanda to spend 2 weeks working with Paul Farmer in his Clinic. More later.
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July 30, 2008 - Invited to the White House (East Room) to witness and celebrate the signing by the POTUS of the reauthorization of PEPFAR at $48 Billion. The law is officially H.R. 5501 - The Tom Lantos and Henry J. Hyde United States Global leadership Against HIV/AIDS, Tuberculosis and Malaria reauthorization Act of 2008. The usual cast of HIV-related characters was there. It felt good to see the attention, success and promise of a project that I developed. Now we need to make sure that this reauthorization ultimately turns into an appropriation. July 31 - Sept. 15, 2008 - Busy summer with little time with family. Chris and girls went to beach while I stayed for duties at work. Chris, Megan and Ali went to Rwanda to work with Paul Farmer for 2 1⁄2 weeks. I did not go since I had to give Keynote Lecture at the IAS Meeting in Mexico City (August 3-8). I focused on a discussion of whether we will ever have a "cure" or a vaccine for HIV. It stirred much discussion and was well received. We moved Megan into her dorm at Columbia last week in August. It was great fun. I have a very good feeling about Columbia and hope Megan has a good experience. Jenny has taken a job teaching in a Charter School in the Brownsville Section of Brooklyn (adjacent to Bedford-Stuyvesant). She is living in Prospect Heights-Crown Heights. After my childhood growing up in Brooklyn, I never would have imagined that my 22 year old daughter would be living in the toughest section of Brooklyn. She loves teaching the children. Amazing political season in Washington, D.C. Sarah Palin has been chosen as John McCain's running mate and this has shifted the momentum (amazingly so) to the Republicans since she has energized the far-right conservative base. I may be prejudging, but she seems to be totally unqualified to be Vice-President (or President) of the USA. On Sept. 14, went to a great BBQ party at Sam Donaldson's home in McLean, VA. All the usual suspects were there with whom I have become friends with over the years and we talked election year politics: Colin and Alma Powell, Lee Hamilton, Bob Barnett, Fred and Marlene Maleck, John and Debbie Dingel, Bill and Janet Cohen, Wayne and Catherine Reynolds, Steve and Alice Rosenberg, Ben and Candy Carson, Birch and Kitty Bayh, and many others. On the evening of Sept. 15 Chris and I attended one of the spectacularly elegant reception/dinner parties hosted by Wayne and Catherine Reynolds at the Eisenhower Theater of the Kennedy center to celebrate the re-opening (after upgrading) of the Theater. Again, all the usual suspects of Washington glitterati were there - most people from Sam Donaldson's party the night before as well as many other media, government and military people: Gens. Jim Walston, Wesley Clark, James Jones, Colin Powell; the Eisenhower grandchildren (Anne and Susan); journalists (Chris Wallace, Wolf Blitzer) and on and on. Really a very relaxed evening with spectacular entertainment. The reception was in the foyer outside the Theater and the dinner was right on the Theater Stage with performances by dance troupes, Jane Alexander, the entire original cast of "Mame" right within a foot or two of the dinner tables. Wayne and Catherine do it again! in
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Sept. 16, 2008 - Testified before Rep. Henry Waxman's House Committee on Oversight and Government Reform in Rayburn House Building Room 2154. Topic = HIV prevention in light of the new numbers from CDC showing that the incidence in USA of HIV is worse than was previously calculated - 56, 300 versus 40,000. Other main witness was Julie Gerberding with Kevin Fenton of CDC and Tom Insel of NIH as backups. Hearing went very well - generally friendly. Maxine Waters gave Julie Gerberding a hard time about not acting with leadership in a "crisis". I stated that needle-exchange works and that abstinence only does not work. This may upset some ideologues in HHS or the WH. Mild Fall day - slightly cloudy.
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Sept. 23-30, 2008 - Major crisis on Wall Street and in the banking industry with big banks and financial institutions failing - Lehman Brothers (Bankrupt), Fannie Mae and Freddie Mack taken over by the government, AIG bailed out by the government; many buyouts and mergers, stock market plunged by 777 points in 1 day - largest drop ever. Congress trying to agree on a $700 Billion bailout package for financial institutions to restore the credit flow in the USA. Big problems!!
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Oct. 1, 2008 - On Sept. 23, 2008 Elias Zerhouni announced that he would step down as NIH Director at the end of October, right before the election to avoid any confusion about political issues and to call attention to the vacancy for the incoming transition. I was asked to be Acting Director and refused; Steve Katz was considered but was rejected by the WH because of the LA Times story on him and conflict of interest a few years ago. Betsy Nabel either withdrew her name or was not asked because of an issue of a COI of one of her recently hired Senior Advisors. Raynard Kington (current deputy NIH Director) should have been asked directly but was not. Not clear why the DHHS and/or the WH are uncomfortable with him. One version is that he is not well known in the Congress and among constituencies; anther more cynical version is that the WH has a problem with a gay man (he is married and has an adopted child). The WH and/or DHHS tried to then get me to agree to be publicly appointed as a "Senior Advisor" to the Acting Director to quell the concerns of the outside people and indicate that a strong, visible, experienced person such as me was "watching the store" even though Kington would be appointed as the official Acting Director. I told Elias and Jamie Burke (White House Liason Office) that this was impossible and no way would I do this. I told them explicitly that I did not want to do it in the first place; second - it was an insult to Kington and would undermine his authority; third - people would come directly to me and circumvent Kington's authority; fourth - it looks stupid. She actually agreed and so the decision was to appoint Kington cleanly and have me be available "behind the scenes with no announcements" to advise him if he needed advice.
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Oct. 2, 2008 - Gave Inaugural Ben Kean Lecture on Global Health at New York Presbyterian Hospital - Weill Cornell Medical Center. Great déjà vu feeling about my years there. Much adulation among house staff at lecture and morning report.
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Oct. 3 - 4, 2008 - Went to Parent's Weekend at Columbia for Megan. Jenny (living in Brooklyn) joined Chris and me for a couple of dinners with Meg. Went to ColumbiaReleased by Chairman Rand Paul Princeton football game. Great weekend. Jenny, Meg and I watched the Sarah Palin - Joe Biden debate. What an idiot Palin is!! Stock Market is tumbling badly. It is scary as it looks like it is crashing as a result of the bank credit crunch that is causing anxiety of Wall Street. When this settles, I will rethink the advisability of my even being invested in Wall Street as opposed to safe Money Market investment or T bills.
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Oct. 6, 2008 - Big news today. Nobel Prize in Medicine or Physiology given to Francoise Barre-Sinoussi and Luc Montagnier for HIV and to Harald Zur Hausen for HPV discovery.. This is a big slight to Gallo, likely because of the controversy from the 1980s. The Committee could have given the 3 (limit) to HIV and save HPV for another year; yet they combined them and thus Gallo was out since it is clear from the 1983 Science paper that Montagnier and Barre-Sinoussi discovered the virus first, although Gallo proved cause effect one year later and discovered TCGF (IL-2) that allowed everyone to grow T cells in culture and hence grow the virus. Gave the after dinner address at the Woodrow Wilson Internal Center for Scholars Dinner for their Board of Trustees, Councilors, and Scholars at the Ronald Reagan Building in DC. Cool, crisp night. I was invited by Lee Hamilton. Many notable people there including Sam and Jan Donaldson, Marvin Kalb, Robin Cook, etc. I spoke on HIV/AIDS: An Historical Perspective. Talk extremely well received.
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Oct. 11 - 16, 2008 - Traveled to Cape Town, South Africa to deliver a keynote address at the 2008 AIDS Vaccine Meeting on "An HIV Vaccine: Science and Policy". The talk was very well received. I spoke of the particular challenges of HIV vaccinology compared with "classical" vaccinology. Weather was beautiful and the city was in my mind a cross between San Francisco and Rio de Janeiro. We took a drive on Monday AM, Oct. 13 around the countryside to vineyards and around the historical parts of the city. Most disturbing to me was the conditions that I saw at the "townships" a few miles outside of the city. Particularly disturbing was Khayelitsha township that seemed to go on for miles with huts that were made of corrugated tin roofs and plywood and other soft material. The huts were smack next to each other with very little room between them to even walk outside. Apparently they have electricity in some huts and common water sources and latrines, but I cannot imagine anyone living there. The black South Africans say that it is not as bad as it looks and they are gradually trying to phase them out and replace them with regular housing. I cannot judge since this is the first time that I have seen them, but I would flatten the whole thing now and build high-rises. Problem is that hundreds of thousands of people live there and you cannot just displace them now without a facility to put them in. I have some concern at this point that the Vaccine Enterprise in the person of Allan Bernstein is looking for ways to change the direction of HIV vaccine research even though he has been in the field only for months. He is a very good guy, but I repeat my usual statement of "everybody wants to be somebody" and "beware of people who do not have real day jobs". They tend to try and change things that they do not yet even understand. Oct. 17 -- 25, 2008 -- The polls are starting to swing heavily towards Barack Obama. He may indeed be our next President.
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Oct. 20, 2008 -- Attended funeral of Paul Rogers ("Mr. Health") at the National Cathedral. Sad day. He was a great advocate for biomedical research. I got to know him well over the past 24 years together with his wife Becky. We went to many functions together over the years.
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Oct. 22, 2008 -- Participated in the dedication of the new NBAAC facility of DHS at Fort Detrick. Since NIAID is a partner in that "Biodefense Campus", it was important that I be there for the ceremony. Met with Gen George Weightman (he of the Walter Reed Arny Hospital scandal -- bad conditions for wounded veterans of Iraq war -- Was not his fault, but he got caught holding the bag) who is the US Army Commander. Cliff Lane gave me tour of our facility in Ft. Detrick -- designed to do sophisticated imaging studies on non-human primates.
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Oct. 26, 2008 -- Received Maxwell Finland Award from the IDSA and gave the ICAAC Award Lecture at the Annual ICAAC\IDSA meeting at the DC Convention Center on "Global Health and infectious Diseases: A Look to the Future". It was amazing. There were 11,000 people in the audience! Clearly the largest crowd that I have ever spoken to live even counting all of the Keynotes lectures that I have given at many International AIDS Meetings. Lecture very well received. Next day (Oct. 27) went with Chris to the IDSA and ICAAC president's reception at the American Portrait Gallery on 8" Street and F Street, N.W. beautiful crisp (55 F) clear Fall days for both occasions.
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Oct. 30, 2008 -- Farewell ceremony for Elias Zerhouni as NIH Director. I gave a strong laudatory for him (see my printed speeches). Much speculation that I will be next NIH Director. Interesting -- 6.5 years have gone by since I was faced with this same choice and the best decision that I made was to say no to George Bush. So many good things have happened to me professionally since then. I doubt that I want to do it.
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Nov. 4, 2008 -- Barack Obama will be our new POTUS!! Everyone excited about this. We spent elective night at a party next door with Rob Stein and Ellen Perry and some friends (Dan and Gigi Green -- former ABC Producer of Nightline and others). Stock Market crashing -- no one seems to know when bottom will come
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Nov. 8, 2008 -- I presented an award post-humously to Paul Rogers at an Arthritis Foundation black tie gala. Steve Lawton (his longtime
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Nov. 10, 2008 -- Stock market still crashing -- no end in sight. Big Federal bailouts of banks and credit companies to the tune of $1 trillion and more; yet slide continues.
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Nov. 14, 2008 -- I receive the "FREDDIE Award" for Public Service (known as the Oscars for medical media) from MediMedia at a Philadelphia Gala at the Crystal Tea Room in the old Wannamaker Building. Chris, Megan, Ali, Stewart Simonson, Cliff Lane, Patty Conrad, and her friend Betsy Wilder were there. Big surprise was that Bono made a video that was shown in which he lauded me as a true global hero and one of the most important people in the world over the past many decades. Very flattering and in keeping with how kind Bono has been to me over the years.
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Nov. 18, 2008 -- Received the VIDA Award for Leadership from the National Hispanic Health Alliance at the Willard Hotel in DC.
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Nov. 19, 2008 -- Tom Daschle named as DHHS Secretary. I will soon be approached for NIH Director job. Am struggling with this, but my commitment to HIV/AIDS and Global Health, particularly with the new exciting issues of "treatment as prevention" and the challenges of an AIDS vaccine , not to mention malaria and TB keep me engrossed in what I am doing.
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Nov. 20, 2008 -- NIAID sponsors the Annual Kinyoun Lecture. This year's speaker was Ralph Steinman who won the Basic Medical Research Lasker Award in 2007 at the time that I won the Lasker Public Service Award.
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Nov. 20, 2008 -- See below -- soon to appear in US News and World Report America's Best Leaders: Anthony Fauci, National Institute of Allergy and Infectious Diseases
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Nov. 21, 2008 - Went to dinner party at Ellen and Gerry Sigal's home. Present were Chris Grady, Ellen, Gerry, Richard and Donna Benveniste, Bill and Melody Wilson, Larry and Carla Silverstein, Neera Tanden and husband Dan. Neera is on the Obama transition team and I am sure that Ellen in her quest to get me to become NIH Director set this up for us to meet. I am very reluctant to take the job and soon I will likely have to tell the Obama people "no" if they ask. Prior to the Sigal dinner party I gave remarks at the opening reception for the TAG Workshop on Eliminating Viral Persistence and Eradicating HIV infection. This is becoming a very hot issue that I have been pushing in the sense of a "functional" cure.
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Nov. 22, 2008 - Was invited by former President George H.W. Bush to attend the christening of the new aircraft carrier USS George H.W. Bush at Norfolk , VA on Jan. 10, 2009. Nov.24, 2008 - Breakfast and panel discussion at the National Press Club in association with my (and others) receiving the recognition of America's Best Leaders 2008 (24 Leaders Who are Making a Difference) by U.S. News & World Report and the Center for Public Leadership of the John F. Kennedy School of Government at Harvard University. David Gergon MC'd the affair and C-SPAN-2 covered it. We also all appeared in the
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Nov. 25, 2008 - Received a call from Aaron Pickrell who is running the Obama transition team for HHS and sub-agencies. He said that my name is actively being discussed for NIH director and he wanted to know if I was interested. I was frank and honest with him saying that I wanted to remain as NIAID Director, but I want to be part of the Obama team and perhaps we could work out something informal (without title) or more formal (?Special Assistant or Special Advisor to the POTUS) for issues on Global AIDS, Emerging infections, and Biodefense. He said that he would run this up the ladder and see how people react. My real desire is to stay where I am but to be called upon as I have been for 20+ years on issues mentioned above. I do not want to give up my solid base of scientific credibility. I hear that Francis Collins is aggressively campaigning for the job of NIH Director - not surprising.
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Nov. 29, 2008 - Had brunch with small group of people at Richard and Donna BenVeniste's house. He is a great guy with whom Chris and I have developed a nice friendship. He asked about the NIH Director job and suggested without my implying that I should tell the Obama people that I want to do both NIAID Director and NIH Director. This is what I agreed upon with Tommy Thompson 6 years ago, but the WH (Clay Johnson) blocked it and said that I could take one or the other. I picked NIAID Director. I actually do not think that doing both jobs would work, mainly because people would jump on the "appearance" of conflict every time that I made a decision that they did not like or if their grant did not get funded, and on and on. Also at the brunch was Carl Feldbaum, the IG of the DoD during the Carter Administration and his son Harley who is at Hopkins School of Public Health and is very interested in "Health Diplomacy". He has been an admirer of mine for years as a student. I hope to help him and perhaps advise him on career choices.
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Nov. 30, 2008 - Sunday AM (pouring rain). I had backed out of the Redskins- NY Giants game with Gene Elrod because my daughters were home for Thanksgiving weekend. Got a call from Jay Lefkowitz who is writing a brief history of PEPFAR for a trade journal (forgot which one). He wanted to do a historical fact check with me about the timing of meetings that we had with Josh Bolton, Gary Edson, Kristen Silverberg in the WH. His version of events was strikingly close to my historical memory. During the conversation he asked about the NIH Director job and we reminisced about the Bush years. Interesting fact that he dropped. He related that he was having a conversation with Bush during the time of the NIH Director decision and Bush said, "why not just appoint Tony Fauci". Jay agreed. Jay now casually mentioned that Karl Rove was against my candidacy. He did not say why. I could be that he was against the "dual" appointment or perhaps he was influenced by Sen. Brownback's concern about my stance on fetal tissue and stem cell research. I guess that I will never know.
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Dec. 1-8, 2008 issue of U.S. News & World Report. Other winners who were present were: David Baltimore, Regina Benjamin, Benjamin Carson, Manuel Diaz (Mayor of Miami), Marian Wright Edelman, Fiona Anne Harrison, Freeman A. Hrabowski (Pres. U of MD, Baltimore County, Dave Levin (Founder of KIPP Foundation, Linda Rottenberg (CEO, Endeavor), Mike Feinberg (C0-founder of KIPP), Maria Zuber (MIT). Awardees who were not there: Lance Armstrong, Jeffrey Bezos (CEO, Amazon.com), Terence Blanchard and Herbie Hancock (Thelonius Monk Institute of Jazz), Robert Gates (Secretary of DoD), Amory Lovins, Anne Mulcahy (CEO Xerox), Indra Nooyi (CEO, PepsiCo.) Junior Officers DoD, Jeffrey Sachs, Steven Spielberg, Michael Tilson Thomas Music Director, SF Symphony. David Gergon asked each of us what we would recommend to President-Elect Obama as an area that he should pay attention to. I stressed the need for support of biomedical research and also the importance and moral obligation that we have towards promoting Global Health and its potential for "Health Diplomacy".
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Dec. 6, 2008 - Annual Christmas Party at Sam and Jan Donaldson's home. As usual, great time with the standard cast of characters some of whom are: Colin Powell, Wolf Blitzer (CNN), Bob Barnett, George Will, Ellen and Gerry Sigal (told me that Francis Collins is "aggressively" campaigning for the job of NIH Director. I told her that I preferred to stay at NIAID.), Bob Mueller (FBI), Gen. James Jones (new National Security Advisor for Obama; we spoke about the importance of biodefense and gave him my card). Great time was had! After the Donaldson party went to the National Zoo (Amazonia) for the 50th Birthday party for Greg Folkers thrown by his significant other Sheila Stinson.
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Dec. 7, 2008 - (Sunday) - got e-mail asking me to call Mike Froman from the Obama Transition Team, wanting to know if I was interested in the NIH Director's job. He said that Obama had mentioned my name to him and asked that he contact me. I told him what I told Aaron Pickrell on Nov. 25 (above) that I felt that I could serve Obama, his administration, and the American people better in my current job and expressed a willingness to work closely with them the way I have with the Bush and Clinton Administrations. He understood and asked if I would be willing to help vet names for them as they narrow the search. I told him that I would be happy to do that.
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Dec. 9, 2008 - Chris and I went to the VP Mansion for the Annual Christmas Party. Bitter-sweet since this is the last one that I will have gone to the mansion for the Bush Administration and maybe (who knows?) the last visit that I might make to the VP mansion. Chris and I reminisced that the first time we came here was when George H.W. Bush was VP in the early 1980s and how we returned several times for receptions and brunches as the VP and I became friends. Tonight there was the usual cast of people who I had the opportunity to talk to and thank for the years of working together and helping each other out. First and foremost was VP Cheney who expressed his appreciation for "all that I have done for our country" over the years that we had worked together and beyond. Also, reminisced with Bruce Miller (VP's Chief for biodefense), David Addington (VP Counsel), Mike Chertoff, Mike Leavitt, Bob Kadlec.
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Dec. 10, 2008 - On an unseasonably warm night for December, went to the Mandarin Hotel in Washington, D.C. (12th and Maryland Avenue, SW) to receive the "25 Greatest Public Servants" Award from the Council for Excellence in Government. It was somewhat of a big deal. Other awardees who were present were Everett Alvarez (Viet Nam pilot POW), Lee Hamilton, Sen. Richard Lugar, Tom Ridge, Donna Shalala, Shirley Jackson (President Rensselaer Polytechnic Institute). Other awardees who were not there were: James Baker, Mayor Mike Bloomberg of NYC, Mayor Richard Daley of Chicago, Former VP Al Gore, Tom Kean, Ted Kennedy, Congressman John Lewis, Wilma Mankiller, Norman Pinetta, George Mitchell, Sandra Day O'Connor, Peter Peterson (Chairman, Council on Foreign Relations, Colin Powell, Alice Rivlin, Robert Rubin, George Schultz, Paul Volker, John C. Whitehead Former deputy Secr. Of State. Interesting evening with a lot of friendly discussions about the Obama transition. Clay Johnson of OMB was there and said a few words about the Bush Administration and told the large dinner crowd that we are leaving the government and the country better than we found it - the entire audience was struck silent. You could feel the discomfort in the room. I sort-of like Clay (even though he screwed me years ago re: the NIH Directorship), but he clearly proved how out-of-touch he and the Administration people are.