Tuesday, October 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. 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. Oct. 15 – 18, 2004 – Situation getting very hot and heavy. Kerry campaign trying to make this a political issue saying that the shortage is President Bush’s fault. I have been on every major TV show multiple times talking about the issues and what people need to do. Multiple (daily) White House Conference Calls. Almost constant briefings and press interactions. Will need to go on a New England bus tour this weekend from DC up the corridor to Boston and fly back. Very intense, at least as much as with the anthrax situation, mostly because the election is 2 weeks away. Oct 22-23, 2004 – Continued intensity of activity around the influenza vaccine shortage. Daily White House Conference calls. The DHHS team has broken up into several groups to “tour” the country in a bus for outreach and education to health authorities, the general public and the Press. I was part of a tour that went from D.C. to Philadelphia to Trenton, Newark, NYC, Hartford, Providence, Boston and back (Flew back from Boston). Our team was Claude Allen, myself, Howard Zucker (Deputy Asst Secretary of Health), Bill Hall (DHHS Public Affairs), Sarah Greirich (Claude’s assistant), Kate (?). It went well. This is becoming a serious political issue in that the Kerry Campaign is trying to paint the Bush Administration as responsible for the Chiron mess. President Bush in turn is claiming that liability issues are the cause of Pharma not getting into the vaccine business and that Kerry supports trial lawyers who are the problem (VP candidate Edwards is a liability lawyer).