Diary Prequel Package — page 231

lon Auditorium on March 16, 2010 - Research Amer!ca Awards Gala at the Andrew Mellon Auditorium on Constitution Avenue. Usual cast of characters. 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. 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. 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. 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.