Wednesday, April 21, 2004

Busy day! Beautiful sunny day.Testified at my House Appropriations Subcommittee (Chaired by Ralph Regula) in the AM , then rushed to brief Senate and House Staff (at Dirksen 116) from the Homeland Security and Appropriations Subcommittees on progress of Project Bioshield and its possible use to procure drugs for pandemic influenza. Many people present such as Bettylou Taylor of Senate Majority Appropriations, Craig Stevens of House Majority Appropriations and a variety of staffers from Homeland Security Committees, the latter were as usual disdainful of DHS. Bad news relationships between DHS and their respective committees. Also present were Sally Stanfield of DHS (terrific person), Stewart Simonson, Michael (WH Legisl), Tom Reilly of OMB, Ken Bernard of WH Homeland Security Council After meeting, Ken and I rushed to OSTP on 1801 Pennsylvania Ave to meet with the Weapons of Mass Destruction Medical Countermeasures Subcommittee. I am on the Steering Committee of the National Science and Technology Committee (NSTC) Subcommittee on WMD Medical Countermeasures (Chaired by Bill Winkenwerder (DoD) and Phil Russell (HHS). I rarely go to these meetings, but Ken Bernard wanted 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.