Wednesday, September 24, 2014

On the last Secretary’s call, Burwell tasked me to get the HHS team together and fashion out a consensus about the way forward following ending of phase 1 vaccine trial at NIH. I had long conversation with Tom Frieden this AM and he is starting to come around. Seems he will be OK with an RCT simultaneously done with a Stepped-Wedge Trial. I arranged a conference call at 5:30 PM with me, Tom, Nicki Lurie, Peggy Hamburg, Lu Borio, and Anne Schuchat. We came to agreement that we will do the two trials (RCT + Stepped Wedge) simultaneously. CDC (Anne and Tom) feel that the RCT may be so difficult to implement that the Stepped-Wedge approach might give us some information, while the RCT could fail. Cliff and I feel just the opposite. However, in order to get things moving, we came to a compromise. I will report this to the HHS Secretary’s call tomorrow. Continue to have press interest: Bloomberg News TV; WTOP Radio; pre-show interview with CBS 60 Minutes for future show.