Diary Prequel Package — page 173

of vaccine candidates for an HIV vaccine. On Nov. 16, 2007 I received a letter from a group of basic scientist/animal model HIV researchers asking to meet with me following the failed STEP trial in which vaccinated people with pre-existing Ad5 titers actually seemed to have an increased risk of HIV acquisition compared to placebo. They felt that we were wasting money on vaccine trials which they claimed had no basis to predict success based on animal model data. They were particularly concerned about going ahead with Gary Nobel's VRC trial -PAVE 100 that tested 3 DNA primes followed by an Ad5 boost. However, others point out that the animal model has not been validated in the human and so unfortunately, we are really flying blind. In any event, in a manner similar to how I handled the AIDS activists >20 years ago in that same room (31/7A-24), I listened and suggested that we have HIV Vaccine Summit to discuss the direction of AIDS research. Hence the meeting today. Just a few days ago, a group called AIDS healthcare Foundation stated that we should stop ALL HIV vaccine research and put the money towards proven prevention activities. We had the Summit today and it was enormously successful. I played an active leadership role in the process as opposed to just listening. The meeting was chaired by Warner Greene and Adel Mahmoud and there were 3 panels: 1) basic discovery chaired by Jim Hoxie and Dennis Burton; 2) animal models chaired by David Watkins and Malcolm Martin; and 3) Clinical Research chaired by Scott Hammer and Julie Overbaugh. Great press coverage. I concluded at end of meeting that we would indeed turn the knob more towards basic discovery research and promised an immediate $10 Million for a broad RFA to come from moneys saved from truncating some of the clinical trial activity such as a tighter PAVE 100. Recall that our budget has been flat for the past 5 years and so there is no extra money coming in. Below is an article from the NY Times by Larry Altman from Mar. 26 that summarized the Mar. 25 meeting: Rethinking Is Urged on a Vaccine for AIDS By LAWRENCE K. ALTMAN WASHINGTON -- Researchers must go back to the drawing board before they can develop an effective vaccine against H.I.V., AIDS experts said at a scientific meeting on Tuesday. And Dr. Anthony S. Fauci, the top federal official responsible for AIDS research, agreed that more fundamental knowledge is needed about H.I.V. and the way the body and experimental vaccines respond to it before the goal of a licensed H.I.V. vaccine can be reached. Dr. Fauci, the director of the National Institute of Allergy and Infectious Diseases, pledged to re-evaluate the use of all $1.5 billion his agency spends on AIDS research to come up with the necessary money. "Everything is on the table," Dr. Fauci said at the one-day meeting, a Town Hall-type discussion for vaccine researchers on how best to spend federal H.I.V. vaccine money in light of a budget that has been flat for several years.