E-mails Suggest Pentagon Pressured FDA On Anthrax Vaccine

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E-mails among high-ranking Pentagon supervisors amid a 1999 congressional
inquiry of the anthrax vaccination program indicate the Department of Defense
was exerting improper pressure on the manufacturer and the federal agency
regulating the vaccine, says U.S. Rep. Christopher Shays, R-Conn.

Shays is chairman of a congressional subcommittee that concluded the
vaccinations should stop because the drug has not been proven legal, safe or

In one e-mail, a Pentagon official discusses how other agency supervisors
were urging the U.S. Food and Drug Administration and the manufacturer of the
vaccine to release lots that had been held up for scrutiny by the FDA. The
lots of vaccine were needed to inoculate military members under the mandatory
anthrax vaccination program begun in early 1998.

The Feb. 22, 1999, e-mail to U.S. Army Brig. Gen. Eddie Cain, an anthrax
program supervisor who has since retired, was sent by Dr. Michael Gilbreath,
a civilian Pentagon biological defense employee.

Gilbreath said it was unprofessional for DOD officials to put pressure on the
manufacturer, BioPort Corp. of Lansing, Mich., to release vaccine lots for
use, when the lots were being held by the FDA to check either on
effectiveness, safety or both.

"I have received information this morning from BioPort that individuals
within the DOD contacted them and threatened that DOD would circumvent
BioPort and contact the FDA regarding availability of anthrax vaccine lots
currently under review at the FDA,'' Gilbreath wrote. "Any such actions by
DOD would be inappropriate.''

The e-mail documents surfaced during preliminary arguments at the
court-martial of Air Force Capt. John Buck at Keesler Air Force Base in
Biloxi, Miss.

Buck, a doctor in the Air Force, refused an order to take the vaccine, saying
it has not been proven to be safe, effective or properly licensed. Buck
argued the military court should use the e-mails, the conclusions of a
government watchdog agency and the congressional inquiry led by Shays to
prevent his court martial.

The judge in Buck‚€™s court-martial, Lt. Col. Mark Allred, ruled Thursday Buck
cannot introduce such evidence at the trial. Allred said the vaccine is
properly licensed and administered for a warranted military purpose. Buck
said today he is asking the Air Force if he can resign without a court

Shays disagrees with the judge. He said the e-mails confirm "what we have
long suspected. DOD was laying a heavy hand on FDA and [the congressional
watchdog, the U.S. General Accounting Office] to stifle disagreement and
dissent. Without DOD as a patron and protector, BioPort's anthrax vaccine
facility would have, and should have, been closed by the FDA long ago.''

"The FDA, otherwise known as an aggressive regulator of biologics producers
in the private sector, appears to have been cowed into a submissive posture
by the Pentagon,'' Shays said.

FDA spokeswoman Lenore Gelb said the agency would not comment.

In one of the e-mails, sent by Cain on May 3, 1999, to Army Col. John V.
Wade, he predicted that Shays might be upset with the Pentagon's influence
over the FDA. Shays had already repeatedly criticized the FDA for failing to
provide adequate vaccine safety oversight of both the manufacturer and the

"If you think Congressman Shays was critical of the current relationship
between FDA & DOD, wait until he finds out that DOD is calling the shots
on-sight,'' he wrote.

Cain did not explain what "on-sight'' meant, but the site of most of the
anthrax vaccine controversies has been BioPort's plant in Michigan. Shays
said that is what he believes Cain was discussing.

"The implications of DOD actually operating the plant are significant in that
it could bring DOD directly under FDA's regulatory purview as a de facto
licensee and vaccine manufacturer,'' Shays said.

James Turner, a defense department spokesman said it was not clear what Cain
meant by suggesting the defense department was controlling vaccine oversight
at the manufacturing plant, rather than the FDA. The department did not have
representatives on site until later, he explained.

The Pentagon currently reviews all BioPort submissions to the FDA for
technical accuracy, Turner said. The vaccine, he said is safe, effective,
legal and necessary to protect all service members.

The e-mails also reveal that the Pentagon was having trouble countering the
U.S. General Accounting Office's assertion that the vaccine is improperly
licensed, and that it has not been proven safe and effective. Cain indicated
in one e-mail that then Secretary of Defense William Cohen would be writing
to the GAO, whose findings have consistently gone against the Pentagon, to
protest "the expertise put on this (vaccine) project'' by the watchdog

"If we cannot answer these [hearing] questions, we (DOD and the
Administration) are in big time trouble,'' Cain said in the May 3 e-mail.
"‚€¶We are digging ourselves a hole that will be too difficult to crawl out

Lisa Reiss, president of the consumer group, the Connecticut Vaccine
Information Alliance, said the Pentagon's actions do not surprise her at all.

She said the defense department is merely being aggressive with the FDA, a
role normally played by drug manufacturers hungry to sell a product.

But by pushing the FDA and the manufacturer to use a questionable drug, she
said, Pentagon officials violate service members' basic human rights to make
an informed decision about whether it is safe for them to take the drug.

Shays again called for a halt to the vaccination program.

"It's long past time to give up this futile effort to drag a 1950s medical
technology into the 21st century,'' Shays said. "No one else's health should
be put at risk, and no more military careers should be destroyed on the altar
of this unquestionably failed vaccine program.''