A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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April 14, 2004 - White House meeting (EEOB 476) with Gary Edson, Rick Klausner, Rachel Ingram (Gates) and David Lane (Gates), Martina Strong, Carol Thompson to discuss the role of the Gates Foundation in the HIV Vaccine Enterprise. Rick presented the same case as I did and said that Gates would be willing to invest $100 million this year and that the whole project would probably need $400 million per year for 10 years. He wanted the USG to try to put in more money. Gary was concerned about the fact that we have no new money, although he really likes the Enterprise concept. After Rick left, Gary and I discussed how much if any money would be feasible to invest as new money. As opposed to just challenging the G-8 to join and endorse the process. He wanted to think about it more. One of the issues that he brought up even when Rick was there was the problem of doing something and then getting criticized the way that we have been criticized about PEPFAR.
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April 15-16, 2004 - Series of phone calls and e-mails involving Gary, Kristen and me. Apparently, Kristen really likes the idea about putting some substance (new resources) into the POTUS proposal to the G-8 and Garry asked me to cost out a real center a virtual center and also a vaccine production plant. He sent it to Kristen who asked me for some clarifications and now will run it up to Josh Bolten. This may be a go if we can convince Josh to get some new money. I coasted a real center (with walls) at $55 million for construction and start-up and $47 million for annual operations. I costed a virtual center as $15 million start up and $51 million annual operations. Kristen asked me to brief Alex Azar (General Counsel for HHS) to see if we need any special authority/legislation (similar to BioShield) to make this work more quickly and smoother. She will be out for a week and then we will resume. I handled these calls and e-mails while on a quick trip to Chicago to give a talk at the Clinical Research 2004 meetings. I spoke on Emerging Infections.
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April 19, 2004 - Extensive phone conversation with Josh Bolten (OMB Director), Jim Capretta and Tom Reilly (OMB) regarding the details of my proposal for the "virtual" center for HIV Vaccine as described above. I described in detail the entire proposal to Josh. Josh was very supportive. Issue was where to get the $15 million start-up costs for '05 and the $51 million yearly costs. Josh indicated that he would figure out where to get the money. More than likely that we (NIAID) would have to absorb a portion of it.
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April 20, 2004 - Had nice lunch with Jay Lefkowitz today at The Oval Room on Connecticut Avenue. Beautiful warm Spring day. Jay just wanted to catch up on things with me. We discussed the PEPFAR and the issues associated with it; and the new G-8 proposal that I was working on with Gary Edson. Kristen Silverberg, and now Josh Bolten. Also talked about war in Iraq and the POTUS. Jay also inquired about what I want to do differently if anything. I told him that I wanted to remain in public service and the Secretary of HHS is a job that I would not strive for or promote myself for, but would not refuse if asked. He is thoroughly enjoying his private sector life. After lunch, he invited a friend (Christine Carlisle Jones) to the table for coffee. She is the CEO of a company that is working on freeze preserving eggs from women who might be getting chemo, and he wanted her to meet me. Very attractive and intelligent woman in her 30s. It was great to spend time with Jay. He has become a good friend.
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2004-04-21 00:00
Anthony S. Fauci
April 21, 2004 - Busy day! Beautiful sunny day.Testified at my House Appropriations Subcommittee (Chaired by Ralph Regula) in the AM , then rushed to brief Senate and House Staff (at Dirksen 116) from the Homeland Security and Appropriations Subcommittees on progress of Project Bioshield and its possible use to procure drugs for pandemic influenza. Many people present such as Bettylou Taylor of Senate Majority Appropriations, Craig Stevens of House Majority Appropriations and a variety of staffers from Homeland Security Committees, the latter were as usual disdainful of DHS. Bad news relationships between DHS and their respective committees. Also present were Sally Stanfield of DHS (terrific person), Stewart Simonson, Michael (WH Legisl), Tom Reilly of OMB, Ken Bernard of WH Homeland Security Council After meeting, Ken and I rushed to OSTP on 1801 Pennsylvania Ave to meet with the Weapons of Mass Destruction Medical Countermeasures Subcommittee. I am on the Steering Committee of the National Science and Technology Committee (NSTC) Subcommittee on WMD Medical Countermeasures (Chaired by Bill Winkenwerder (DoD) and Phil Russell (HHS). I rarely go to these meetings, but Ken Bernard wanted me to be there for discussion of 1)Anthrax countermeasure development plan and 2) DoD development of butylcholinesterase (BC). BC is unbelievable. It is a naturally occurring plasma product that neutralizes the effects of VX and Sarin gas. It binds to the phosphogen cholinesterase inhibitors of the gas and protects animals from sarin and VX. It has no toxic side effects. Taly Bar-Shalom from OSTP presented the data. The DoD people wanted NIH to do Phase 1 clinical trials on the plasma derived product and to pay for the development of the recombinant product since they "had no money". The Phase 1 trial would cost from $1 to 10 million depending on the design. The development would cost a few million $. I got up and chastized the army Colonels (Joe Perla et al) and told Bill Winkenwerder that I was astounded that they had a countermeasure for a known threat (Tokyo subway) that is completely effective in animals (rats, hamsters) and totally safe, and yet they say that they do not have any money to develop it. Unbelievable! In some fairness to them, the DoD money for Medical issues is so compartmentalized, that it is difficult for them to move $ from one silo to another. They have no way near the flexibility that NIH has. In addition, Bill Winkenwerder, who is Asst Secretary of DoD for Health, really has no power or jurisdiction and cannot commit resources at a meeting like this. He is a very good guy and promised me that he would find the money. I offered to share with them the effort and cost of a phase 1 trial. In reality, if they drop the ball on the clinical trial and development of recombinant product, I will pick it up. On the way from the Rayburn to Dirksen building, I ran into Hillary Clinton on the street and she gave me a big hug and kiss and we chatted for a few minutes (with her Secret Service people looking puzzled) about AIDS, etc.
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April 23, 2004 - Went to dinner over Dan and Marina Ein's home on Kenmore Drive in NW Washington. Dinner was to bring together people in DC interested in bioterrorism and press folks who cover this. Present among others was Bob Malsam (Head of DC Hospitals) Dan Lucey (Medical Officer of DC DOH), Ceci Connelly (Washington Post), Mike Iskowitz (Newsweek), Jerry Hauer (Biodefense Center at GW) and several others. Among topics that came up was the buzz around town of the recent intelligence that another "big" terror attack will happen soon. The weather was clearing or rain after a major thunderstorm. I had wanted to go to the St. Albans vs Jefferson County (WV) High School baseball game, but it was cancelled because of rain.
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April 28, 2004 - White House (West Wing) - Met in Kristen Silverberg's office to discuss the FDC issue (see above). Much discussion regarding our approach to FDCs in the PEPFAR program. At meeting were the usual group: Kristen, Mark Dybul, Joe O'Neill, Mark McClellan, some FDA economists, Emit (FDA), Carol Thompson. I spoke with Kristen by phone after the meeting about my chose vis-à-vis options.
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April 28-29, 2004 - Gary Edson called me and said that he had a "disturbing" conversation with Patty Stonsifer (Gates) in which she mentioned that the USG should promise NEW resources for the Enterprise proposal to the G-8. Gary asked (and I did) call Rick Klausner to get his take. He is comfortable with our proposal. Gary is concerned that Gates will be lukewarm about our proposal and we will have another example of the POTUS trying to do something good and then getting criticized for not doing enough.
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May 4, 2004 - White House (West Wing) - Me with Gary Edson and Patti Stonecifer regarding the HIV Vaccine Enterprise and the upcoming G-8 meeting in Sea Island, GA. We have come to an agreement that if the POTUS presenting the Enterprise proposal to the G-8, Gates will soundly applaud the effort and work with us to get it going. The USG will not promise an new money over and above the $500+ million that we already spend on HIV vaccine research (this is about 5/6 of the world's total of $640 million). However, we will challenge the other G-8 countries to endorse the Enterprise strategic plan and align current and future resources with the plan.