Diary Prequel Package — page 41

Dec. 14, 2001 - Spoke with Rick Klausner about his perception about NIH Director. Rick feels that the WH is not leveling with Thompson since he has heard that they think that doing both jobs (NIH and NIAID) is a "non-starter" and they are against it. There is a disconnect here since Thompson feels that they (WH) will accept this, and he merely needs to get the Brownback issue out of the way. Something is strange here since Thompson is talking about getting the President to announce me before Christmas and Rick says the "rest of the WH" is against this. Stay tuned. Dec.15, 2001 - Sat. meeting at NAS regarding recommendations of giving anthrax vaccine to people who were exposed to anthrax and who are just finishing their 60 course of antibiotics. I, Jeff Koplan, D.A. Henderson, and Kathy Zoon (FDA) playing major role of setting policy and advising the Secretary. Dec. 16-19, 2001 - Much controversy and last minute scrambling in getting the consent form and the protocol out for the discretionary use of anthrax vaccine in exposed people who had been receiving antibiotics, but who are coming off their 60 day course. The CDC is really relinquishing their responsibility of doing a good job with the informed consent. They handed us a piece of junk as a draft. Stewart Simonson (Counsel to Secr. Thompson) has asked me to help get it right. I had been working all day and into the night on Dec.16-19 revising the consent forms and helping people get straight why DHHS is offering the vaccine to people. The Press are very suspicious and as usual critical of the Administration. I have exhaustively reviewed the data (with Cliff Lane as a great help) and come to the conclusion that vaccine + antibiotics is no better than antibiotics alone for post-exposure. Yet, Dr. John Eisold (the Navy physician who takes care of Capitol Hill people) is insisting that the Senate staffers also get the vaccine. We are in a dilemma. It is true that there is a "theoretical" reason to make the vaccine available in that animal studies show persistence of spores weeks after antibiotics and there is a fear that after antibiotics are discontinued the disease will occur. I would not take antibiotics. However, Eisold and the Senate Staffers are demanding that they get the anthrax vaccine. In fact, I received a phone call from Ms. Laura Petrou from Senator Daschle's staff on Dec. 19, 2001 enraged that we were taking so long in getting the vaccine to the staffers. Apparently, D.A. Henderson and Tommy Thompson had told Daschle that the vaccine would be available 2 days ago. They were insistent. The blacks in the postal service are quite skeptical. I have insisted that if I am going to help we must not "recommend" the vaccine since the data in animals show that it is not better than antibiotics alone. The difficult situation is that politically we essentially have to give it to the Senate staffers since they are demanding it. If we give it to them and do not offer it to the postal workers, we will be accused of racism and not treating the postal workers equally. Remember that they were outraged that the Senate staffers got antibiotics right away and the postal workers only got antibiotics after 2 people at Brentwood died. Therefore, we are offering, but not recommending the vaccine for any of the 9000 people who were put on 60 antibiotic course. We are not explicitly telling the public that this is really the rationale for what is going on. There is some confusion as to why we are not recommending it and if we are not recommending it, why are we even offering it. I have