Gates Package — page 269

From: "Rick Klausner" @gatesfoundation.org> To: "Fauci, Anthony (NIH/NIAID)" <AFAUCI@niaid.nih.gov> Subject: RE: PAVE - please clarify Date: Sat, 25 Oct 2003 10:36:45 -0400 Importance: Normal Tony, I keep looking at my email to you to see whether it sounded angry, which I was not, or just confused and truly looking for clarification. Maybe this is what happens through the terseness of a quick email. I am confused about PAVE and fully recognize that much of this confusion is because of information/perceptions that come via the filter of others. This was particularly intense at the HVTN meeting and especially with Europeans and Africans who seem (they are explicit) to be worried, threatened, wary of "an American Takeover" (I am not sure what is beneath it except that the distrust of the USG is so enormous around the world). When I say that PAVE is for USG coordination, that you and we are working closely together and well, and that the enterprise is truly about a global compact - not a US hegemony for HIV vaccines, they counter that that is not what they are being told when they (Non US people) are asked to be part of new planning committees. I do not push to understand because I do not want to communicate that we have no communication with NIAID about PAVE. My line - you need to know- to everyone is that we are in agreement and I also say that PAVE is a really important step that is perfectly compatible with the Enterprise. My frustration is that I do not know what is going on and when I turn to Helene (who I hope is in contact with Ed and Peggy as I am always reinforcing to her how important that is) she also doesn't know and also feels confused. I think that it would be helpful to ask Jose to visit NIAID (he starts with us Nov 1) and work to raise the level of communication. I am also sure that we can straighten this out and we can be as helpful to all of this as possible. Rick -----Original Message----- From: Fauci, Anthony (NIH/NIAID) [mailto:AFAUCI@niaid.nih.gov] Sent: Friday, October 24, 2003 5:20 PM To: Rick Klausner Subject: RE: PAVE - please clarify Rick: Two things: 1) I really do not have any idea what you are talking about, and 2) I am very, very sorry that you are upset and obviously angry. I cannot figure out what the issue is. I have been saying and doing nothing more or less than what we have discussed many times. The PAVE is a partnership of government agencies facilitated by NIAID. We have been planning this for a long time and it relates only to clinical trials, particularly phase 3 trials. It was further instigated by DHHS wanting to have consistency in what we do among agencies (NIH and CDC). Since the NIAID has developed a strong relationship with the DoD, they have been brought into this partnership now consisting of 3 agencies (NIAID/NIH, CDC, and DoD). The purpose was to create consistency and harmonization in clinical trials (protocols, laboratory measures, etc.) run by the government so that the agencies can synergize. Since we (mainly the NIAID) also collaborate with many other entities, we would offer our partnered network to any group that wishes to collaborate provided that they agree to share the common goal of transparency, consistency, and harmonization. This would have happened whether or not there was an Enterprise. The "Enterprise" is much bigger in scope than the PAVE, but the PAVE can certainly be an important part of the Enterprise. You and I have discussed this several times. When I speak about vaccines I almost always (with minor variations) talk about: 1) what the Federal government, particularly NIAID is doing; 2) the need for a new look and an accelerated effort, i.e. the Enterprise; and 3) the role that the PAVE may play in the Enterprise. I am attaching one of my typical talks that goes through this sequence of thoughts. I do not think that I can be any more clear. I always end with a slide showing the PAVE being a part of the Global Vaccine Enterprise. If people are confused, they either are not listening or they do not want to hear. Please take a look at these slides and see if they do not indicate what I have said to you several times and above in this email. Again, I am very sorry that this has upset you. I hope that we can straighten this out. I would be happy to speak with you at your convenience. I will be at a meeting in Wye River on Saturday AM and early afternoon, but I will be either in the office or home for the rest of the weekend. Best regards, Tony << File: AIDS Vaccine Enterprise-PAVE.ppt >>