Diary Prequel Package — page 98

me to be there for discussion of 1)Anthrax countermeasure development plan and 2) DoD development of butylcholinesterase (BC). BC is unbelievable. It is a naturally occurring plasma product that neutralizes the effects of VX and Sarin gas. It binds to the phosphogen cholinesterase inhibitors of the gas and protects animals from sarin and VX. It has no toxic side effects. Taly Bar-Shalom from OSTP presented the data. The DoD people wanted NIH to do Phase 1 clinical trials on the plasma derived product and to pay for the development of the recombinant product since they "had no money". The Phase 1 trial would cost from $1 to 10 million depending on the design. The development would cost a few million $. I got up and chastized the army Colonels (Joe Perla et al) and told Bill Winkenwerder that I was astounded that they had a countermeasure for a known threat (Tokyo subway) that is completely effective in animals (rats, hamsters) and totally safe, and yet they say that they do not have any money to develop it. Unbelievable! In some fairness to them, the DoD money for Medical issues is so compartmentalized, that it is difficult for them to move $ from one silo to another. They have no way near the flexibility that NIH has. In addition, Bill Winkenwerder, who is Asst Secretary of DoD for Health, really has no power or jurisdiction and cannot commit resources at a meeting like this. He is a very good guy and promised me that he would find the money. I offered to share with them the effort and cost of a phase 1 trial. In reality, if they drop the ball on the clinical trial and development of recombinant product, I will pick it up. On the way from the Rayburn to Dirksen building, I ran into Hillary Clinton on the street and she gave me a big hug and kiss and we chatted for a few minutes (with her Secret Service people looking puzzled) about AIDS, etc. April 23, 2004 - Went to dinner over Dan and Marina Ein's home on Kenmore Drive in NW Washington. Dinner was to bring together people in DC interested in bioterrorism and press folks who cover this. Present among others was Bob Malsam (Head of DC Hospitals) Dan Lucey (Medical Officer of DC DOH), Ceci Connelly (Washington Post), Mike Iskowitz (Newsweek), Jerry Hauer (Biodefense Center at GW) and several others. Among topics that came up was the buzz around town of the recent intelligence that another "big" terror attack will happen soon. The weather was clearing or rain after a major thunderstorm. I had wanted to go to the St. Albans vs Jefferson County (WV) High School baseball game, but it was cancelled because of rain. April 28, 2004 - White House (West Wing) - Met in Kristen Silverberg's office to discuss the FDC issue (see above). Much discussion regarding our approach to FDCs in the PEPFAR program. At meeting were the usual group: Kristen, Mark Dybul, Joe O'Neill, Mark McClellan, some FDA economists, Emit (FDA), Carol Thompson. I spoke with Kristen by phone after the meeting about my chose vis-à-vis options. April 28-29, 2004 - Gary Edson called me and said that he had a "disturbing" conversation with Patty Stonsifer (Gates) in which she mentioned that the USG should promise NEW resources for the Enterprise proposal to the G-8. Gary asked (and I did) call Rick Klausner to get his take. He is comfortable with our proposal. Gary is concerned that Gates will be lukewarm about our proposal and we will have another example of the POTUS trying to do something good and then getting criticized for not doing enough.