FAUCI DIARY ARCHIVE — Friday, July 9, 2004 https://faucisdiary.com/diary/2004-07-09 Text below is verbatim from the released PDFs, with the original line breaks. ============================================================================== DIARY ENTRY — Friday, July 9, 2004 Source: Diary Prequel, pp. 101–105 of 2026.07.27_Diary-Prequel-.pdf Words: 2011 ------------------------------------------------------------------------------ 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. 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: Subject: [HEALTHGAP] WashPost: AIDS Activists Misfiring AIDS Activists Misfiring By Sebastian Mallaby Monday, July 19, 2004; Page A17 In the past few years, global AIDS activists have worked miracles. They have shaken rich governments awake, causing international AIDS funding to rise 15-fold. They have beaten back big pharma's jihad against cheap, non-brand medicines, creating an opportunity to treat millions of people in poor countries. But the activists, or at least some of them, are in danger of tipping from heroism into shrill anti-Americanism. The sound bites from last week's AIDS conference in Bangkok were straight out of a Michael Moore movie. Inconveniently for those who enjoy stereotypes, the Bush administration is far and away the leader in the global AIDS fight. This year the United States will spend $2.4 billion on the pandemic, nearly twice as much as all other donor governments combined; attacking the Bush team for indifference to AIDS is like attacking it for inadequate defense spending. But when Randall Tobias, the U.S. global AIDS coordinator, addressed the Bangkok gathering last week, he had to endure 10 minutes of furious heckling before he could get a word in edgewise. What triggers this hostility? The activists' first complaint is that U.S. AIDS spending will finance programs to promote sexual abstinence and fidelity. Never mind that only 7 percent of the money will be spent this way; the abstinence agenda is derided as some kind of kooky anti-scientific plot cooked up by President Bush's evangelical supporters. Yet the plotters actually include very un-evangelical people such as Edward Green, a Harvard medical anthropologist (and liberal Democrat) who's written a book on AIDS prevention. Green has shown how Uganda's success in cutting HIV infection rates from 21 percent to 6 percent depended crucially on teaching abstinence. In the first half of the 1990s, the number of young Ugandans engaging in premarital sex plummeted; by 1995, fully 95 percent of Ugandans reported that they were either abstaining or monogamous. Elsewhere in Africa, experience also supports the Bush administration's desire to make abstinence and fidelity part of its prevention strategy. The evidence from Botswana, South Africa, Kenya and Zimbabwe suggests that there's no clear link between the availability of condoms and reduced HIV rates: All four countries have plenty of condoms yet plenty of infection. Meanwhile in South Africa, the single most promising development is that reported rates of teenage sexual activity have fallen for three years straight, disproving the notion that there's no point in telling youths to change their behavior. In sum, it is not the Bush administration that is ignoring the evidence. It is Bush's critics. The activists' second complaint about the U.S. AIDS program is that it is hostile to generic medicines. Until recently, this was true: Perhaps because of its ties to the big pharmaceutical companies that sell patented drugs, the administration has been scandalously slow to allow cheaper generic copies to be used in its programs. But in May the Bush team finally announced that generics were okay, subject only to a six-week review by the Food and Drug Administration to determine safety and efficacy. The activists do not believe the FDA's change is for real, and their suspicions are reinforced by Cipla, a leading Indian producer of generic AIDS drugs. Cipla's charming joint managing director, Amar Lulla, explains to anyone who calls that he would love to get his drugs approved for distribution in U.S.-financed programs in the poor world but that the Bush administration's fine print is cluttered with obstacles. On close inspection, however, these obstacles aren't serious. For example, Cipla's best known AIDS medicine is called Triomune; it combines three separate antiviral drugs in one pill, simplifying treatment. Lulla says the FDA has not explained whether he needs to demonstrate the safety of combining the drugs this way, in which case Cipla would have to conduct prohibitively expensive clinical trials. But if you go to www.fda.gov/oc/initiatives/hiv/hivguidance.html, you'll find the explanation that Lulla says he's waiting for. Attachment B lists three-drug cocktails that the FDA already accepts as safe, among them one combining stavudine, lamivudine and nevirapine, the three constituents of Cipla's Triomune. Cipla also says it worries that if it files an FDA application, it may be sued by U.S. patent holders. But the FDA's rules allow Cipla to file a statement certifying that its pills are intended for sale outside the United States, a maneuver that would almost certainly eliminate the risk of being sued for U.S. patent infringement. None of this is to deny that the Bush administration panders to the religious right on some issues, or that it's cozy with pharmaceutical lobbyists. After misrepresentations on issues from tax policy to Iraq intelligence, the suspicion with which Team Bush is greeted is partly of its own making. And of course some criticisms of the administration's AIDS program remain fair, notably that it shortchanges multilateral efforts against the killer. And yet the bottom line on the Bush administration's AIDS initiative is that it is huge and serious. The AIDS activists at last week's conference, whose motives are doubtless honorable as well, would do better to redirect their heckling to countries such as Japan and South Korea, which give shockingly little to their cause. When you're fighting an enemy that takes 8,000 lives a day, it pays to pick your targets wisely. mallabys@washpost.com