Gates Package — page 266

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 e-mail. 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 >> -----Original Message----- From: Rick Klausner @gatesfoundation.org] Sent: Friday, October 24, 2003 3:49 PM To: Anthony Fauci (E-mail) Subject: PAVE - please clarify I just came back from speaking at the HVTN and there, as anywhere I go and HIV vaccines are discussed, I am asked about PAVE. Particularly now that PAVE seems to be setting up the same committees the Enterprise agreed to set up and asking some of the same people. I don't know what to tell people, especially since, in marked contrast to the Enterprise, the Gates Foundation has never been talked to about this (none of us). So I talk about how well we are working together, etc etc but everyone I speak to (I never bring it up) seems confused. I am sure that PAVE pre-dated our meetings in the Spring of 2002 about an enterprise approach but we really need to know how to respond about this. You can hear my frustration in this email. Am I mis-reading this? I have not run into anyone who is not "confused".