By Thomas D. Williams
The Hartford Courant
May 18, 2001
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-4th District.
Shays is chairman of a
congressional subcommittee that concluded the vaccinations should
be stopped because the vaccine has not been proven legal, safe or
effective.
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
vaccine was 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 defense officials to put pressure on the
manufacturer, BioPort Corp. of Lansing, Mich., when the lots of
vaccine were being checked by the FDA for effectiveness, safety
or both.
"I have received information
this morning from BioPort that individuals within the [Department
of Defense] contacted them and threatened that [the Pentagon]
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 [the
Pentagon] 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. After
the ruling, Buck said he will ask the Air Force to allow him to
resign.
Shays disagrees with the judge.
He said the e-mails confirm "what we have long suspected. [The
Pentagon] was laying a heavy hand on FDA and [the congressional
watchdog, the U.S. 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."
"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 May
3, 1999, from Cain, the retired anthrax program supervisor, to
Army Col. John V. Wade, Cain 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
Pentagon.
"If you think Congressman
Shays was critical of the current relationship between FDA &
[the Department of Defense], wait until he finds out that [the
Department of Defense] 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 [the
Pentagon] actually operating the plant are significant in that it
could bring [the Department of Defense] 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 said.
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 agency.
"If we cannot answer these [hearing]
questions, (the Department of Defense 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 of."
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."