Bates suing Defense, FDA regarding anthrax vaccineFrom: "\"Doc\" Melson" <firstname.lastname@example.org>
9 2001 12:00AM By Kate House, Staff writer
Former United States Air Force major Sonnie Bates said he still
keeps his uniform in his closet at his Ellendale home next to the uniform he
currently wears as a corporate airplane pilot.
Sometimes when he looks at it, he says to himself that someday,
he'll wear his military uniform again. Bates, who used to be stationed at
Dover Air Force Base, was honorably discharged from the military last year
after refusing an order to take an anti-anthrax vaccine.
Now, he and a Mississippi Air Force doctor are suing the United
States Department of Defense, United States Secretary of Defense Donald H.
Rumsfeld, Tommy Thompson, United States secretary of Health and Human
Services, the Food and Drug Administration and the lone maker of the vaccine,
BioPort, Inc., regarding the legality of administering the drug.
The suit contends that the vaccine is investigational because of
the purpose for which it is being used. Bates and Capt. John Buck of Ocean
Spring, Miss. got together on the case after Bates's attorneys assured him
they would stay with the case.
"They saw the opportunity to accelerate that when John Buck's
case came up," Bates said.
Buck, an emergency physician at Keesler Air Force Base in Biloxi,
Miss., is currently facing court martial for refusing the order to take the
six-shot series. His trial is scheduled to come up on May 14.
Both Bates and Buck both refused the order to take the shot after
they saw others become ill after taking the vaccine. The drug's safety and
efficacy were questioned by the FDA in the mid-90s after an investigation of
some of the manufacturing processes and quality control practices.
In the past, the military has contended that the drug is safe and
necessary to protect troops against the threat of anthrax as a biological
weapon when troops are deployed for more than 30 days to the Persian Gulf
area. James Turner, a spokesman for the DOD, said the department does not
discuss pending litigation. However, he did say that it is the DOD's policy
to follow FDA rules and that the FDA has determined that it is a licensed and
effective vaccine to fight against anthrax.
"We do believe it is safe and effective," Turner said. "It is not
investigational new drug."
But the thrust of the lawsuit, at this point, is not to prove
whether or not the vaccine is safe, but the legality of administering the
drug. Bates said that, according to his research, the FDA licensed it for use
in 1970, specifically for mill workers, cattle ranchers and vets, or anyone
who might come into contact with certain animals and could get anthrax on
However, the FDA gave the stipulation that the drug must be
re-approved if it is ever used for any other purpose. Bates said the military
approached the Michigan-based drug company around the time of the Gulf War
about mass producing the vaccine to protect against airborne anthrax as a
At that time, he said, the drug's status not only became
investigational because of changes in the way it was being manufactured, but
it was not approved for protection against inhaled anthrax.
Since the military mandated vaccination program started in 1998,
over 500,000 soldiers have been administered the drug.
Turner cited a 1999 letter written to members of United States
Congress by the Food and Drug Administration that read, "The labeling for the
Anthrax Vaccine Adsorbed does not mention route of exposure (e.g.,
cutaneous), per se. Use of the vaccine for protection against both cutaneous
and inhalation anthrax exposure is not inconsistent with the labeling for
Anthrax Vaccine Absorbed."
If Bates and Buck win their case, it could provide argument for
Bates and others who have left the military over the vaccine to be readmitted
if they wish.
"They should have the option," Bates said. "I think most people
would give it a strong thought, like, I don't want back in that system that
treated me like that. But if you have people like myself who knew from a very
early age ... I knew I was going to be an Air Force pilot and I never wavered
on that one bit."
He said if a person devotes 14 years to a career and then
suddenly has to leave it on bad terms, they want the option to return.
"I keep my uniform up in my closet next to my corporate pilot
clothes and I look at it nearly every day thinking, one of these days, my
goal is to be able to wear that, because I should be able to," Bates said. "I
didn't do anything wrong. I didn't break the law."
Mark Zaid, Bates and Buck's attorney, said the ultimate objective
is to end the Anthrax Vaccine Inoculation Program.
"Hopefully, we won't have to prove anything to accomplish that.
The record pretty much speaks for itself," Zaid said.
Buck said vaccine adverse reaction reports, upon which he said
the military heavily relies, are "grossly underestimated," and that only 1%
are reported to the FDA. Of those who receive the vaccine and have adverse
reactions, many do not complain. He said administering the drug without
service members' informed consent is a violation of their rights.
Bates said he does not think an apology or an admission of guilt
from the Department of Defense is feasible, but he said he would like a
formal statement from the FDA that the drug is experimental or
"Overall, I hope that the American public in general will learn
more about the responsibilities of the FDA and the products that we use and
how we have a responsibility as a society to monitor that process," he said
this day to the ending of the world,
we in it shall be remember'd;
few, we happy few, we band of brothers;
he to-day that sheds his blood with me
be my brother; be he ne'er so vile,
day shall gentle his condition:
gentlemen in England now a-bed
think themselves accursed they were not here,
hold their manhoods cheap whiles any speaks
fought with us upon Saint Crispin's day".
Henry V by William Shakespeare