A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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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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2004-11-18 00:00
Anthony S. Fauci
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.