Wednesday, 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.