Diary Prequel Package — page 102

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