A military loyalist takes on anthrax vaccine program

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A military loyalist takes on anthrax vaccine program

by Greg Gordon

Minneapolis Star Tribune

Published 08/24/01

WASHINGTON, D.C. -- Minneapolis native 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. "

Symptoms

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 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. "

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. 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 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

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. 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.

--------------------------------------------------------

Sheri Nakken, R.N., MA

Vaccination Information & Choice Network, Nevada City CA & UK

530-740-0561 Voicemail in US

http://www.nccn.net/~wwithin/vaccine.htm

" All that is necessary for the triumph of evil is that good men ( &

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