A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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March 17, 2010 - For the past 2 Mondays have had the usual Situation Room White House meetings with Heidi Avery . Same theme - she is pushing HHS and I am very much on her side. Looks like a plan is taking shape. I am impressed with the relative incompetence of the HHS group. They seem clueless and short on leadership. Tom Frieden of CDC shines in my mind as an independent thinker with good ideas and a person who marches to the beat of his own drum. Gave talk to the NIAID Fellows on a "Career at NIH Monday, 15 March. They loved it. Radio and TV Correspondents Association Dinner - Black tie at Convention Center. Terrific night. Went alone but met with wide range of the usual cast of characters: Chris Wallace (Fox News - they invited me); multiple Senators, etc.
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March 19 - 22, 2010 - Contamination of Rotarix (Rotavirus vaccine from GSK) with porcine circovirus (PCV-1). Spent many hours on conference calls over the weekend with FDA, CDC and HHS to determine roll-out. Difficult issue here is the message. There is no indication that there is a safety concern here since PCV-1 does not cause disease in pigs or in man; yet this virus should not be in the vaccine. It was at high concentrations even in the seed stock. The message is that the FDA recommends putting a hold on administration of the vaccine (without pulling it from the market) until the situation can be examined more closely. The potential downside is that this vaccine is used mainly in the developing world and if the vaccinations stop, kids will die of rotavirus disease. Merck makes Rotatec, which is used mainly in the USA and so the FDA recommends that where possible, clinicians switch from Rotarix to Rotatec. We fully understand that this might not be possible in the developing world and so we understand if they continue to use Rotarix.
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March 24, 2010 - Continue intense WH meetings with Heidi Avery in Sit Room tonight. I finally put together my version of how the USG should take responsibility for the advanced development, preferably in a physical facility that we buy or rent. The facility at Texas A & M is a good model. Heidi really likes the idea. Laura Petrou called me and said that she heard that I was more forward looking about all of this than the FDA (Peggy), CDC (Tom) and HHS (Nicki) and wanted to hear from me about my ideas. She was actually receptive. The issue here is really that HHS does not want the WH (Heidi) to get in front of the Secretary. Yet the HHS process is slow, too cautious and bureaucratic. Heidi still calls me off line for my ideas.
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March 27, 2010 - Phone call on Saturday with Heidi. She wants to get more money for NIAID to help in the process of bringing investigators from concept to very early development in order to increase the pipeline of products in addition to all of the things that we have been talking about regarding "advanced" development.
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2010-03-29 00:00
Anthony S. Fauci
Mar. 29, 2010 - Continue with the Monday evening weekly meetings with Heidi Avery at the WH Sit. Room. Usual suspects. Still Heidi pushing and everyone but me pushing back. Peggy Hamburg seems her usual spacey self often not even having read the documents that Heidi distributes for comment. Jesse Goodman (wonderful guy) continues to be reserved and cautious in typical FDA fashion, but cannot articulate well. Nicki Lurie is a good person, but over her head. In fairness to her, she is caught between a rock and a hard place in trying not to let this get ahead of the Secretary who in my mind is distracted or does not really care about this. Nicki keeps pushing back on Heidi's "transforming initiative". Zeke Emanuel comes to most of the meetings and is with Heidi and me in wanting to push this. In typical Zeke fashion, he is brilliant, but shoots often from the hip. Mike Kurilla is doing a great job with me and probably understands the proposed process better than anyone in the room. Andy Weber of DoD (assistant Secretary) is a good guy, but he is just trying to keep the DoD in the "game"
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Mar. 31, 2010 - Meet with Alan Bernstein (Executive Director of the "Global HIV Vaccine Enterprise" (see above comments about my negative reaction to this unnecessary group). Alan is a good guy, but is heading a superfluous organization. In any event, his multiple layers of "working Groups" has come up with a Strategic plan for the "Enterprise". Peggy Johnston is all over this and so she shields me from the week-byweek dealings of this organization (I am one of the Founding Council Funders). Meeting in my office with Alan since wants me very much to approve of the plan since NIAID is the major world funder of HIV vaccine research. Meeting In NYC next week of the Enterprise Council and so he is here to pay respects and make sure that I am on board. The Plan is OK, but NIAID will do what we think is best for vaccine development. Later in the day, the HHS Flu team (me, Nicki Lurie, Jesse Goodman, Peggy Hamburg, Tom Frieden, Laura Petrou, Jenny Backus, etc) meets with Sebelius in her private conference room. We present the supposedly penultimate draft of the MCM Review that she ordered and that we have been working on for weeks trying to reconcile it with Heidi's initiative. Nicki gives a terrible presentation; Sebelius is confused as to the "scope" of the review that she ordered - was it a review only of medical countermeasure (MCM) development or a review of end-to-end process of responsdng to health crises, including flu. I tried to clarify for Nicki, and Sebelius agreed with me. We need to keep it focused. Back to the drawing board on a few issues. One issue is how much money should we ask for in the 2010 flu supplement and the 2011 budget to fulfill some of the gaps identified in the review and in what is proposed by Heidi.
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April 5, 2010 - After Action Review of the H1N1 response in Nicki and Jesse's home in Bethesda (near the Palisades section). Beautiful home with magnificent view of the Potomac and the opposite Virginia shore. Beautiful sunny day. Present - Nicki, Jesse, Robin, Steve Redd, Anne Schuchat, Laura Petrou, Makala Ross (OS). Good discussions.
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April 6-7, 2010 - Went to NYC night before and had great dinner and time with Jenny and Meg. I stayed at "W" hotel at Union Square. Went for run on April 5 evening past Larry Kramer's Apartment; called, but found out later that he was asleep on his couch and did not hear the phone. In front of Larry's Apt. (2 Fifth Avenue - right across the street from Washington Square Park), ran into Bob Bazell (NBC News), who live in the same apartment. Next AM (April 7) went to Enterprise headquarters and met with the leadership to discuss the "Plan". Beautiful day. I stayed for AM. Present were Alan, Tachi Yamada, Peter Piot (new Chair of Council), Manuel Romaris (EU), Catherine (Kate) Hankins (UNAIDS-WHO). Seth Berkley (IAVI), Jose Esparza (BMGF), Peggy Johnston, Yves Levy (INSERM), Rafi Ahmed (Emory and chair of the Scientific Committee). Good discussions. I kept them on track about what NIAID would or would not agree to).
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April 14, 2010 - Dedicated the Special Unit at the Clinical Center for vaccine studies. Honored Stewart Simonson for the role he played in pushing through the red tape to get this done. Had nice ceremony with Cliff, John Gallin, Gen Jim Gilman (USAMRIID), Stewart, etc. Group went to Black's restaurant on Woodmont Avenue - Bethesda) for drinks on the outdoor terrace (pretty cold). We continue to have endless meetings with ASPR on the Medical Countermeasure (MCM) review led by Nicki Lurie with Laura Petrou and Jenny Backus involved. I now attend by conference call since it is a waste of time to go down town for these drawn out discussions. Theme is post-mortem on the pandemic flu response and how do we incorporate what Heidi Avery wants into the Secretary's (HHS) MCM review. The incompetence and amateurishness of HHS crew in general is noteworthy. I love Jesse Goodman, but he just does not get it that the FDA is a major part of the problem; and he is one of the very best FDA people.