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.
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