Amid anthrax worries, many veterans
decry military's vaccination program
By Carlos
Bongioanni, Stars and Stripes
SAN DIEGO — Civilians who want the anthrax vaccine but can’t get
access may be surprised that a growing coalition of concerned citizens —
mostly military — is decrying its use.
Many objecting to the vaccine are military veterans who say they have
been severely injured by it. Others were court-martialed for refusing the
inoculation. Some say the inoculation is riskier than treating anthrax
infection with antibiotics.
Meanwhile, "We’ve gotten a tremendous amount of calls"
asking about the vaccine, said Bernie Adams, an official with BioPort
Corp., a company that manufactures the vaccine.
One group filed a citizens’ petition Monday asking the U.S. Food and
Drug Administration to declare the vaccine "unsafe, ineffective or
misbranded."
Air Force Reserve Maj. Tom Rempfer, who co-authored the petition, said
the military’s mandatory anthrax inoculation policy "is leaving an
indelible stain on the integrity of the U.S. military."
The program raises fundamental questions about the "ethics and
illegalities of the orders," said Rempfer, a pilot who said he was
forced to resign from the Connecticut Air National Guard after he
questioned the shot program three years ago.
Rempfer’s 31-page document, filed under section 12 of the U.S. code,
alleges that the FDA improperly approved the vaccine. It also notes that
the FDA has repeatedly found the Michigan-based BioPort, guilty of
operating under unsanitary conditions, having contaminated products and
using unapproved procedures.
Army Lt. Col. John Grabenstein called efforts to discredit the vaccine
an "active disinformation campaign" and "a tempest in a
teapot."
There is no problem with the vaccine’s safety or efficacy, said Grabenstein,
the deputy directory of clinical operations for the military’s Anthrax
Vaccine Immunization Program.
"There is nothing remarkable about this vaccine, except all the
hoopla. There are lots of anecdotes, lots of folks saying they’ve gotten
sick after vaccination," he said. "But the rules of scientific
evidence show that the vaccine causes no problems, except the usual local
soreness and occasional rashes."
It doesn’t cause cancer or multiple sclerosis or fibromyalgia or
chronic fatigue syndrome or any of the other myriad of illnesses they’re
claiming," Grabenstein said.
No unbiased panel has concluded that the vaccine is unsafe, he said.
At least six independent panels have investigated the vaccine and
determined it to be safe and effective, he added.
The Defense Department has a Web site at www.anthrax.org.mil
that addresses many concerns about the anthrax issue. The site stresses
that the anthrax vaccine is safe.
Still, in 1998, the FDA revoked BioPort’s license to make the vaccine,
because it had repeatedly failed to comply with established production
standards. The plant has failed subsequent inspections, and has remained
closed for production.
Grabenstein said the discrepancies were minor – just a lack of
detailed record keeping. At issue, he said, were "little
things" like workers not documenting if or when lab equipment had
been tested to see if it had been cleaned properly after use.
The FDA also quarantined most of the anthrax stock that BioPort had
produced for the Defense Department, because it failed quality control
standards.
The FDA found contamination in the production area, Grabenstein said.
The vaccines failed purity tests, he said, because the ingredients that
make up the vaccine hadn’t been mixed precisely to specifications.
"They were just barely off in some cases," he said. Instead
of 12 parts, they may have found only 11 parts of a particular ingredient
in the mix, he explained.
"If you’re making a cake, it doesn’t make much of a difference.
It still comes out pretty much the same. But with pharmaceuticals, those
kinds of things are not tolerated at all," Grabenstein said.
"The FDA expects extraordinary strict accuracy. In this case,
they were just barely off on the amount of salt water or preservative
they added. The vaccines are still good, they just didn’t meet that
strict FDA standard."
Grabenstein said he has had four anthrax shots and would have
continued the routine if not for the inoculation slowdown. And he would
not hesitate to take a shot of the quarantined doses, because they are
that safe, he said.
Those comments sound familiar to retired Army Maj. Glenn MacDonald, a
Vietnam War veteran who is editor in chief of MilitaryCorruption.com.
The Web-based news organization specializes in writing stories about
injustice in the military.
"The military lied to us about Agent Orange in Vietnam,"
said MacDonald, who recalled the military telling troops the anti-foliage
agent was perfectly safe.
He said the military is lying about the anthrax vaccine.
The military has had to severely curtail its mandatory anthrax
inoculation program as supplies have dwindled since BioPort’s operations
were shut down.
Dr. Meryl Nass, an internist in Freeport, Maine, who has studied
anthrax and published numerous papers on the subject, said roughly 6
million doses of the vaccine are in quarantine, leaving less than 25,000
for military use.
With the near-hysteria in the States over the anthrax-exposure cases,
Nass said she fears the FDA will cave into military pressure and release
the vaccine for "experimental" or "investigational"
use.
DoD spokesman Jim Turner said the agency is not discussing any issues
about anthrax stockpiles and their possible use.
"Current events have led us to a state of war," he said, in
explaining why he would not discuss the stockpile.
If the DOD is allowed to use the vaccine as an investigational drug,
Nass said she cautions troops to note the lot number of their vaccine.
Her Web site at www.anthraxvaccine.org
links to her research, including lists of lots that are under quarantine.
The stock of quarantined anthrax at BioPort could be used in
emergencies as an investigational drug, said an FDA official, who asked
not to be identified.
"The military has that option, in times of crisis," he said.
Nass said servicemembers have the right to refuse shots from these
lots, because federal laws forbid the use of investigational drugs
without informed consent.
RELATED STORY:
CDC
seeking emergency access to military's vaccine supply
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