A military loyalist takes on anthrax vaccine program
Minneapolis Star Tribune
Published 08/24/01
WASHINGTON, D.C.—Minneapolis native John Michels Jr.
graduated from the Air Force Academy, flew reconnaissance missions for 5=BD
years and serves as a reserve officer.
He wasn’t keen about using his private law practice to
challenge the Pentagon’s plan to protect 2.4 million American troops from
anthrax, but he is doing just that.
Last spring, Michels, son of a former Minnesota Vikings
offensive coach, sued the government in federal court on behalf of an Air Force
pilot and a physician—the first two active-duty officers to be disciplined for refusing
to take the anthrax vaccine for fear it would harm their health.
The suit contends that the vaccine is an “unapproved drug”
and that the Defense Department and Food and Drug Administration have illegally
authorized its use to guard against a biological weapons attack. The Pentagon
and FDA reject the arguments.
Michels, who performs his reserve duty for the Air Force’s
judge advocate general’s office, said this week that associates have told him
privately, “You’re infuriating generals,” a complaint he understands.
“I went to the company school, served on active duty with
the company in a lot of different positions,” Michels said from his suburban
Virginia law office. “Probably, the perception is that I am not supporting the
company anymore.
“I look at it a little differently. ... When we start
court-martialing people for arguably engaging in an activity that they see as
their right, then I have a problem with that.”
The controversy stems from the complaints of scores of
military personnel that the anthrax shots made them chronically ill with
fatigue, auto-immune diseases, severe joint pain and other ailments. Some
critics of the vaccine, which was among injections administered to U.S. troops
who fought in Iraq in 1991, believe it contributed to the mysterious Gulf War
syndrome that has afflicted thousands of soldiers.
Although a vaccine shortage has slowed the program to a
near standstill, Pentagon spokesman Jim Turner said, “It’s still our position
that the anthrax vaccine is, and always has been, a safe and effective means to
protect our men and women from the lethal consequences of weaponized anthrax.”
Turner cited data showing that more than 2 million doses
of the vaccine were administered to 519,847 military personnel through July 18,
with 1,592 reporting adverse health effects and 54 -- about one in 10,000 --
requiring hospitalization.
In Minnesota, 603 of the 12,000 members of the Air and
Army National Guard were ordered to take the shots before deployments in Korea
and the Persian Gulf, said Maj. Gary Olson, a Guard spokesman. He said that
none refused and that two reactions, both minor, were recorded. Air Force
Reserve spokesman Al Eakle said that 17 of 1,200 members of the
Minneapolis-based 934th Airlift started the shots but that only two
completed the series before the program was curtailed. None reported health
problems, he said.
Still, the vaccination effort announced in December 1997
by former Defense Secretary William Cohen remains steeped in controversy.
Hundreds of active-duty troops, reservists and National Guardsmen have refused
the shots, some resigning to avoid a confrontation. The vaccine’s sole manufacturer,
Michigan-based BioPort Inc., repeatedly failed plant inspections needed to gain
an FDA license. And a congressional committee has called for suspension of the
program.
In a 12-page letter to the FDA in March, Connecticut
Attorney General Richard Blumenthal summed up the central theme of Michels’
suit. He asked acting FDA Deputy Commissioner Bernard Schwetz to declare the
vaccine, which has never been tested on humans against inhalational anthrax, an
“investigational new drug.” With such a designation, the Pentagon would be required
to obtain each soldier’s informed consent before administering the shots. The
current policy, Blumenthal argued, “forces able, loyal, highly trained military
personnel to put at risk either their health or their careers.”
The Pentagon has dealt firmly with those refusing to take
the shots, disciplining, jailing or forcing resignations from 441 service men
and women. Former Air Force Maj. Sonnie Bates, a Dover Air Force Base transport
pilot who was the first active-duty officer to disobey such an order, was discharged
last year after 13=BD years in the service. Capt. John Buck, an emergency room
physician at Keesler Air Force Base in Mississippi, was court-martialed in May
and sentenced to $21,000 in fines and confinement to the base.
Michels said that when a friend asked him to help
represent Bates last year, he had no interest. But he went to work pro bono
when he looked at the vaccine’s licensing history.
His suit contends that the only FDA license, granted to
the Michigan Department of Health in 1970, limits marketing of the vaccine to
protecting people who risk anthrax exposure through the skin, such as lab
researchers, veterinarians and others in contact with animal hides.
In 1996, the suit says, the state health department asked
the FDA to place the vaccine in “investigational new drug” status for use
against inhalational anthrax—the invisible, airborne spores likely to be used
by terrorists. The FDA’s failure to object effectively approved the application,
Michels said.
He contends that, if the drug is indeed “investigational,”
the Pentagon has a problem: In 1998, responding to concerns about Gulf War
syndrome, Congress barred the use of investigational new drugs on military
personnel without their informed consent. The next year, President Bill Clinton
issued an executive order laying out similar restrictions.
FDA spokeswoman Lenore Gelb rejects these arguments,
saying the anti-anthrax potion is “an approved vaccine, period.”
BioPort, which bought the vaccine manufacturing operation
in 1998, hopes to win FDA release of new vaccine lots by next spring.