A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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Dec. 4 - 10, 2002 - Incredible amount of action going on. Many calls and interactions with VP Cheney's staff (Carol Kuntz, Noreen Hynes, Seth Carus) regarding Project BioShield. The VP wants to come to NIH and have me show him around the Vaccine Research Center (VRC) in the context of the "Advanced Project Development" of Project Bioshield. Project Bioshield has caught on with the VP and his staff. Scooter Libby is becoming a strong ally and fan of mine. At the same time there is a lot of buzz as to when the President is going to announce his vaccine policy. Many leaks, interestingly most from the WH itself. We are busily preparing our Qs and As for the announcement. Elias Zerhouni feeling a bit out of the loop. I am trying to keep him informed, but the WH and DHHS wants to deal directly with me.
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Dec. 11, 2002 - A truly terrific day! Cheney came to VRC and I presented an updated version of Project Bioshield in the context of going from concept to product in the VRC. Present at meeting were: Cheney, Scooter Libby, Carol Kuntz, Noreen Hynes, Seth Carus, Elias Zerhouni, Tommy Thompson, Stewart Simonson, Phil Russell, Gary Nabel and his staff. Cheney and Libby were "wowed" by my presentation and by the VRC Cheney instructed his staff to do whatever is necessary to facilitate what I am doing including giving me special authorities. Immediately after the VP visit, I rushed down to the WH to present "Project BioShield" to Josh Bolten in the context of the VP wants me to sell the concept to Josh. Present at the meeting were Josh, Kristen Silverberg, Richard Falkenrath, Tommy Thompson, Scooter Libby, Stewart Simonson, et al. Josh questioned the need for the vaccine purchase fund component of Project BioShield (good questions). I defended it even though this really is not my bag (Bill Raub was the original designer of it). At the end of the meeting, Josh seemed supportive of the entire project. Clearly the VP is driving this process. Another amazing event. The vaccine policy roll-out is under very close hold at the WH. Today I received one of my many calls from George Stephanopoulos of ABC. George pointed out that the President gave an interview with Barbara Walters to view on Dec. 13 in which he said that he would allow vaccination of the entire population on a voluntary basis. George thought that this constitutes the long-awaited announcement of the policy. I told George that the Pres. was probably just speaking in broad generalities since I know that there will be a formal announcement with me involved at the WH. George seemed convinced; however, the ABC people pursued this and confronted the WH who inexplicably confirmed the story and said that the roll-out would be Friday (Dec. 13). I heard about this when I was in Josh Bolten's office presenting Project BioShield. My phone rang and CBS said that ABC had broken the story on the policy on the basis of the Barbara Walter interview. They wanted me on their show to discuss. I said that I knew nothing about this and therefore could not appear. I hung up and mentioned this to Kristen Silverberg. She knew nothing and immediately called Dan Bartlett (WH Press Office). I did not hear what they said; however, apparently what happened is that the press confronted the WH with the Walters interview and the WH caved in and admitted to the policy. The crazy thing is that it has now hit the press, but the WH will not let us talk about it since the President has not officially announced it. We still do not really know what the policy will be nor when it will be announced. More later! Dec.12, 2002 - Much activity back and forth with the White House and the DHHS regarding putting the finishing touches on the President's Statement and the policy in general. In particular, Kristen Silverberg and checked frequently with me. In midafternoon she called me down to the White House with Stewart Simonson to go over word-for-word the President's statement. We were the only DHHS people asked to do this. Big surprise in the statement was the fact that we will make vaccine available to the public before 2004 by allowing people who insist on vaccination to enter into an ongoing clinical trial (Cangene, Acambis, etc.) or by creating a special IND protocol (using Aventis-Pasteur). Exciting few hours at the White House with Karl Rove, Andy Card, Josh Bolten, Mike Gerson (President's speechwriter), Kristen, Susan Neeley (Public Affairs for Homeland Security), Dan Bartlett (Deputy to Ari Fleischer)Stewart and I having lively back and forth conversation. I insisted that they emphatically emphasize that we do not recommend vaccine to the general public; however, we will make it available to those who feel they still want it even though it is not recommended. I consider this a great victory since I am concerned about tens of millions of people getting vaccinating, which will surely lead to some serious adverse events. After the WH, Stewart and I went to the Department and worked on Qs and As for hours until around midnight. Also, we briefed the Governors of the States and the State Health Officials by teleconference. Dec.13, 2002 - Day of the announcement by the President. The DHHS team including me went to the WH at 1:00 PM in preparation for the 2:15 PM announcement. We met in the Roosevelt room and discussed the policy with Ari Fleischer, Dan Bartlett, and others. Bill Winkenwerder represented the DoD. Big surprise was that we learned the President would get the vaccine himself since he felt that as Commander-in-Chief of the Armed Forces, he could not order the troops to do something that he himself would not do. He will say that Laura and his children will not be vaccinated since they are part of the general public. President makes announcement. On stage with him was me, Tommy Thompson, Gov. Ridge, Julie Gerberding, Bill Winkenwerder, someone from State Dept. Afterwards, the President left and we all gave brief remarks and answered questions. The rollout went extremely well. I was on CNN and Julie and I were on the Jim Lehrer NewsHours together. I had been scheduled by Ari Fleischer to go on all of the Sunday talk shows with Tommy Thompson on Dec. 15; however, we were bumped by the breaking news of Trent Lott facing forced resignation because of his "segregationist" comments at the birthday party of Strom Thurmond. Nonetheless, I got my picture in both the NY Times and The Washington post standing next to the President and TGT. Also, over next few days I appeared on CNBC, WTOP radio and NPR - "Talk of the Nation"
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Dec. 18, 2002 - Another exciting day at the White House. Clearly, Scooter Libby and the VP are in favor of pushing for the Vaccine Trust Fund. OMB and the WH economic advisors have a problem with the concept of a trust fund. As usual, Carol Kuntz has been very supportive. Was called down to a meeting at the WH with OMB people (Jim Capretta), the VP staff (Carol K., Seth Carus, Noreen Hynes), DHS people (Richard Falkenrath, et al), Kristen Silverberg, Ken Bernard, Stew Simonson, Phil Russell, Bill Raub. We had to discuss the vaccine research plan. Again, must concern as to why we need a trust fund instead of an appropriation. I explained that one (the fund) is mandatory and the other (appropriation) is discretionary. Jim Capretta came up with the idea of a "Permanent and Definite Appropriation" that would be mandatory and multiyear. In the middle of the meeting, Scooter Libby called me on my cell phone and said that he was going into a meeting with the VP and the President at 1:00 PM (it was now 11:30 AM) and he needed for me to write a 1⁄2 pager on the concept of a mandatory fund for vaccine (he said trust fund, but we subsequently hashed out a Perm. And Def. Appr. He also wanted a microbe by microbe breakdown with time-lines and costs - all by 12:55 PM. In addition, he wanted me to meet with the CEOs of "Big Pharma" to determine if they would support this. I rushed to the DHHS with Stew, Kerry Weems, Phil Russell and Bill Raub and put together a great package to e-mail and FAX to the VP's office (Carol K.) arriving a few minutes before 1:00 PM. They loved it. We will wait to see what happens.
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Dec. 19-22, 2002 - Still much activity with the VP continuing to push to help us get a Permanent and Definite Appropriation for purchase of countermeasures, particularly, but not exclusively for vaccines. There is much concern about botulism and acquiring botulism anti-toxin. Many phone calls and meeting with Stewart Simonson with whom I now speak with and/or meet at least several times per day. Carol Kuntz and Noreen Hynes are trying to help us. They asked us to put together a programatic assessment of our procurement needs for countermeasures without consideration of budget constraints. We had previously put together a $4.2 billion package concentrated mostly on MVA and rPA (anthrax) with only about $450 million over 10 years for other countermeasures. We presented this several days ago to OMB people in the presence of Kristen Silverberg (see above). OMB was miffed that they had not seen these numbers before, when in fact the numbers were contained in our budget submission for '04, but were not specifically designated as purchase. Clearly OMB is resisting the VP's attempts to get this fund through. The new "no budget constraint" package that we put together was approximately $15.0 billion over 3 years (FY04 - 06) with considerable amount now to other countermeasures such as botulism, plague, Ebola, tularemia, Rift Valley Fever, EEE/VEE/WEE, Staph. Enterotoxin, antibiotic resistance, pandemic flu, WNV, etc. Even though this was put together by Phil Russell with help from DMID, the VP wants me to defend it to OMB since they are cashing in on my reputation and scientific credibility. The VP has set up a meeting for Dec. 23 at the WH with himself and Scooter Libby teleconferenced from Jackson Hole and me, Mitch Daniels, Nancy Dorm (OMB Deputy Director), Tommy Thompson, the VP's staff, etc. (see below).
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2002-12-23 00:00
Anthony S. Fauci
Dec. 23, 2002 - Critical meeting at the White House (see above). Attending were VP Cheney and Scooter Libby by teleconference from Jackson Hole; Stewart Simonson, Phil Russell, Kerry Weems (Budget, DHHS), Carol Kuntz, Noreen Hynes, Seth Carus, Nancy Dorm (Deputy Director OMB), Tom Reilly and Jim Capretta (OMB). Issue was that Scooter and the VP had asked Carol Kuntz a couple of days ago to put together a threat related proposal for a wide range of microbes with no concern for budget to be used for procurement of products. It should be program and need driven. Carol tasked me to do this with Phil Russell. I worked until late through the night of Dec. 22 fine-tuning this and learning it cold. The proposal went beyond MVA, rPA, and included botulism, plague, tularemia, Ebola and other hemorrhagic fevers, pandemic flu, West Nile. Etc. The proposal came to $15 billion from FY'04 - '06. The OMB had agreed several days ago to creating a "Permanent and Indefinite (first it was definite) appropriations authority to purchase vaccines for BioT for a total of $4.2 billion. In typical OMB fashion, they were against any new spending. The intense interest of the VP was the reason why we were being listened to. Importantly, Carol Kuntz called OMB people to the meeting (Mitch Daniels was supposed to be there, but he was out of town) but did not warn them that they would be faced with a $15 billion exercise in front of the VP. I convinced Carol to let them know at least a few minutes before the meeting started. They were mortified and enraged that they were not warned in advance. As Nancy Dorm said, every time she sees me, it costs her billions of dollars. The VP called upon me to present the proposal. Nancy did not get it. She was tied down in process. She insisted that the original agreement was for vaccines only and not what she called "countermeasures" such as botulism antitoxin and Cidofovir, which were on the list. She did not understand that "Countermeasures" is the big umbrella under which are vaccines, antitoxins, etc. Also, she argued that we she not include in the purchasing authority anything that was not licensed. I proposed that we should include anything that was "licensable", i.e. on the way to license by the FDA, but perhaps months away because of the FDA process. The VP very clearly was on my side and did not hide it. He even said to Nancy " Do you expect me to go to the President and the American people and say that we cannot provide countermeasures against threats that we either know or strongly suspect that Iraq has because we do not want to broaden authorities and because the "process" will not allow it?" She then said that she would work with us to get something out. The VP was spectacular! It was a classic example of OMB not being able to get beyond process and missing the entire point of the concept. Amazingly, Nancy said that "look what happened with the smallpox vaccine. We bought it and now we are not even going to use it widely". She considers the smallpox vaccine situation, which was one of the great successes of the year to be a failure since many Americans would opt not to take it. She does not understand that the fact that we have it is critical. Amazing! The meeting ended with the VP clearly in my corner. My relationship with him, Scooter and the whole staff, particularly Carol is getting very strong.
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Dec. 24, 2002 - Nice surprise today. At 1:00 PM, I received a call in my office. I answered the phone since everyone else had left for the 1⁄2 day Christmas eve. On the other end someone sang the full verse of "Happy Birthday". It was Secretary Thompson calling from Wisconsin on a cell phone from a shopping center.
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Dec. 26, 2002 --
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Dec. 30, 2002 -- Another meeting at the White House with OMB people. They are still trying to resist the Pemanent and Indefinite Appropriations, particularly for pandemic flu. Attending meeting were me, Stewart Simonson, Seth Carus, Carol Kuntz, Barry Glendennin, Tom Reilly, Bill Raub, Phil Russell. We went back and forth and it was clear that Secretary Thompson and VP Cheney want this, but OMB does not. Again, the VP and DHHS are relying on my reputation to drive this through.
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Jan. 3, 2003 - Another meeting at the White House with Carol Kuntz, Seth Carus, Noreen Hynes, and Stewart Simonson on the pending Project Bioshield Legislation. VP Cheney is still trying to get this into the State of the Union address. I am still counseling Carol regarding her CML. Jan. 4 -- Jan 9, 2003 -- Continual back and forth about the language for my new authorities and for the permanent and indefinite appropriations authority for procurement of countermeasures. Much opposition from OMB. Scenario is Stewart Simonson, Carol Kuntz, Scooter Libby and the VP against OMB. Trying to keep NIH Director Elias Zerhouni in the loop. He is somewhat (not a lot) concerned that I am in the driver's seat here, but in all, he has been quite good about it. VP's people keep asking me to provide materials for them to strengthen our arguments. This has become almost a full-time job. Also, I have had a URI with sinusitis for at least 6 weeks and this has made 19 hour days difficult. We (NIAID) had to move our Winter Program Retreat from Shepherdstown, W.Va. to Bethesda since Stewart and others felt that I like would be needed on the phone or to go to WH during the 2 days of the retreat (Jan. 9-10).