A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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Oct. 4, 2004 - Meeting in the Situation Room of the White House to brief Ken Rapuano (Deputy to Fran Townsend) on the IL-4 - monkeypox experiment that is being proposed as a classified experiment to be performed by DHS. I presented the rationale behind the experiment. Also present were Carol Kuntz, Ken Bernard, Stewart Simonson, Maureen McCarthy, Gerry Parker, et al. Although NIAID will not perform these experiments, Fran Townsend wanted to make sure that I did the briefing since she trusts me. The plan is for me to make the same presentation to Colin Powell and Donald Rumsfeld soon after the election.
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Oct. 5, 2004 - Historic day today with the UK regulatory agency suspending the license of Chiron to ship out their influenza vaccine to the USA because of issues related to the inspection of the plant in Liverpool. This is a huge issue for the USA since Chiron was scheduled to supply about 46-48 million doses or about 50% of our yearly requirement of 100 million doses. Only Aventis Pasteur (50 millioin doses) and Medimmune (2 million doses of Flumist) are available. We heard about this abruptly this AM as we (Julie gerberding and I) were getting ready to testify at House Hearing on Thimerasol in Influenza vaccines.
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Oct. 6, 2004 - Trip to Duke to honor retirment of Ralph Snyderman as Chancellor. White House conference call at the airport in Raleigh-Durham on way back regarding the influenza vaccine issue.
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Oct. 7, 2004 - Trip to Duke to honor the retirement of Ralph Snyderman. Gave talk on Emerging Infectious Diseases. White House conference call on Influenza issue (see above). Incredible amount of media appearances: radio, TV, print. As much as I have ever done.
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2004-10-08 00:00
Anthony S. Fauci
Oct. 8, 2004 - Big time Congressional Hearing on influenza vaccine problem before the House Government Reform Committee. I testified with Julie Gerberding and Lester Crawford of FDA. More media, White House Conference calls, and Jim Lehr NewsHour to finish the day.
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Oct. 9, 2004 - Front page story in the Washington Post saying that the UK regulatory authorities told our FDA about the problem at the end of August with the implication that the FDA failed to act in preparing for the shortage. Acting FDA Commissioner Lester Crawford explained on our regularly scheduled White House Conference Call that this is misinformation. As we (me, Julie and Les) have stated all along, Chiron kept reassuring us that there was a problem with about 4 million does due to contamination with Serratia marcescens. Never did anyone say to FDA or CDC (nor did Rino Rapualli say to me) that there was a serious enough problem to suspend licensure. John Kerry came out with ugly statement saying that the Administration is covering up.
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Oct. 10, 2004 - Things still hot and heavy with the Chiron/influenza situation. Had another White House conference call with Margaret Spellings, Alan Gilbert, Phil Hall, Harriet Miers (Deputy Chief-of-Staff), Jon Burks, Ken Bernard, Trent Duffy, Scott Whitaker, Julie gerberding, Les Crawford and Bruce Gellin. Also more media appearances for me.
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Oct. 12, 2004 - Important White House meeting at 1:00 PM in Roosevelt Room on the Flu situation. Chaired by Margaret Spellings and Harriet Miers. Also present were Fran Townsend (HSC), Joel Kaplan (OMB), Jack Marburger (OSTP), Alan Gilbert, Hobbs, Leitch, Montgomery, Jackson, Amit Sachdev (FDA), Stewart Simonson, Julie Gerberding, Suzy DeFrancis (WH Communications), McGrath. We discussed strategies to handle problems. I gave a background of flu vaccines in general together with the nature of the current problem. Julie gave the plan for trying to get equitable distribution of the remaining doses from Aventis Pasteur that have not already been distributed. The issue of the conflict in statements from our FDA and the British regulatory authorities (MHRA). They said they told the FDA about the seriousness of the problem weeks ago and our FDA says no. Our FDA is correct since I was hearing the same thing. We believe the UK people have over-reacted and now it has caused a mess here in the USA and they are embarrassed to retract. Important point that I brought up and again called Margaret Spellings about the evening of today was that John Kerry would likely try to embarrass the President in the debate on Oct. 13 by saying that the FDA knew and covered up and that he believes the Brits. I suggested to Margaret that the FDA come out with a forceful statement BEFORE the debate declaring that the UK did not tell them about the problem so that the President is not left hanging out there. Margaret agrees and they will do this on the morning of Oct. 13.
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Oct. 13-14, 2004 - Multiple HHS and White House conference calls regarding the influenza vaccine crisis. Report from FDA's Jesse Goodman who just returned from UK is that the Liverpool plant really did have some serious GMP problems and potential bioburden problems. Our FDA agrees with the findings of UK regulators, but not necessarily with their action. However, it is too close a call for us to say that we would have released the lots. Therefore, we will publicly say that the lots from Chiron are unusable. We further discussed other issues about how we can get more vaccine from AVP or from Canada or from anyone else. If we go with Canadian vaccine, this would have to be done by an IND since it is not licensed by FDA. Most we can get is 2-3 million doses. Even this is a logistic nightmare to do under an IND. Present on Conference call with WH are Spellings, Silverberg, Miers, Dan Bartlett, Trent Duffy (Deputy Press Assistant), Alan Gilbert, and HHS team of Julie, Stewart, Les Crawford, Scott Whitaker, and me.