Pentagon ties to FDA attacked

By Reni Winter

The Sun Herald (Biloxi, MS)

 

May 16, 2001

 

KEESLER AFB -- A 1999 e-mail exchange between defense officials in Washington highlights oversights in military anthrax vaccine use and raises questions about the relationship between the Department of Defense and the Food and Drug Administration, a lawyer for Air Force physician John Buck said Tuesday.

 

Lead defense attorney Frank Spinner offered that e-mail, and about 30 other defense documents, to support the testimony of Dr. Meryl Nass during the second day of pretrial presentations in the court-martial of Capt. Buck, an emergency room physician at Keesler Medical Center.

 

Buck is charged with refusing a lawful order to receive a series of vaccinations against anthrax, a deadly bacteria that Defense Department officials believe could be used in germ warfare. Spinner said Buck will plead innocent to the charge if the case continues to trial.

 

Spinner spent the day Tuesday trying to convince Lt. Col. Mark Allred, the judge who is hearing Buck's case, that the mandatory anthrax vaccination program breaks numerous laws regarding the use of experimental drugs and proper drug licensing and testing.

 

If Allred rules the order was not lawful, the case will be over, with Buck the victor, although defense attorneys expect the government to appeal if that is the outcome.

 

While questioning Nass, Skinner presented the e-mail as evidence against the Defense Department and FDA and their relationship to BioPort, the only company licensed to produce anthrax vaccine in the United States.

 

"I believe we are digging ourselves a hole that will be too difficult to crawl out of," Brig. Gen. Eddie Cain wrote to Col. John Wade regarding the anthrax vaccine. "If we provide any more oversight, BioPort could technically be called a (government-owned contractor-operated manufacturer). And if you think Congressman Shays was critical of the current relationship between FDA & DoD, wait until he finds out that DoD is calling all the shots on-sight."

 

Rep. Christopher Shays, R-Conn., chairman of a congressional subcommittee on national security, veterans affairs and international relations, said Tuesday the anthrax vaccination program is heading toward almost certain collapse. He accuses the Defense Department and FDA of "coddling the vaccine maker, BioPort. We've known for some time DOD was propping up a company and a vaccine that would otherwise never survive normal scrutiny by the FDA or the commercial marketplace."

 

Allred denied a request by his defense lawyer to call expert witness Kwai Chan. Allred did, however, listen all day to testimony by Nass, a Freeport, Maine, internist and self-taught anthrax expert. She said standard FDA procedures were not followed in licensing of the anthrax vaccine used by the military and that scientific data-collection procedures were not followed in tests the government asserts were done on the vaccine.

 

The Defense Department's Anthrax Vaccine Immunization Program Agency, however, claims that 13 human studies have adequately assessed the safety of the anthrax vaccination.

 

Today, the defense team will continue to question Nass and discuss more of the 50 documents introduced Monday. The prosecution is also likely to question Nass today.

 

Reni Winter can be reached at 896-0538 or at rbwinter@sunherald.com