Did Pentagon Put ‘Improper Pressure’ on FDA?
Emails sent in 1999 between "high-ranking" Department of Defense officials indicate that the Pentagon was "exerting improper pressure" on the manufacturer of the anthrax vaccine and the FDA, according to Rep. Christopher Shays (R-Conn.), who chairs a congressional subcommittee that "concluded the vaccinations...ha[ve] not been proven legal, safe or effective" and should be stopped. The Hartford Courant reports that the emails came to light during the court-martial of Air Force Capt. John Buck, a physician who refused to take the vaccine. One email, dated Feb. 22, 1999, and sent by civilian Pentagon biological defense employee Dr. Michael Gilbreath to U.S. Army Brig. Gen. Eddie Cain, a now-retired anthrax program supervisor, discusses how Defense Department officials were pressuring the FDA and BioPort Corp., the sole vaccine manufacturer, to release vaccine lots that had "been held up for scrutiny by the FDA" over concerns of safety and effectiveness. FDA officials have repeatedly cited BioPort for violations of "manufacturing procedures" at the company's Lansing, Mich., plant. Another email, dated May 3, 1999, and sent by Cain to Army Col. John Wade, predicts that Shays -- who had, at the time, already "repeatedly criticized" the FDA for inadequate safety oversight of BioPort -- would be upset to find out that the Pentagon was "calling the shots on-sight." Though Cain did not explain what "on-sight" meant, Shays said the email implies the Pentagon was "actually operating" the BioPort facility.
In response, Pentagon spokesperson James Turner said the department did not "have representatives on site until later," the Courant reports, noting that the Defense Department "currently reviews all BioPort submissions to the FDA for technical accuracy." Shays, who heads the House Government Reform Committee's national security subcommittee, said the emails confirm "what we have long suspected. (The Pentagon) was laying a heavy hand on FDA and (the congressional watchdog, the General Accounting Office) to stifle disagreement and dissent. Without (the Pentagon) as a patron and protector, BioPort's anthrax vaccine facility would have, and should have, been closed by the FDA long ago" (Williams, Hartford Courant, 5/18).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.