A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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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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2004-07-23 00:00
Anthony S. Fauci
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.