Vaccine Refusal Pardon Sought

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Vaccine Refusal Pardon SoughtShays Asks Amnesty For Those Punished

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-->By THOMAS D. WILLIAMS

Courant Staff Writer

 

January 16 2005

 

U.S. Rep. Christopher Shays is proposing amnesty for hundreds of military

service members punished or chased from the military for refusing the

controversial anthrax vaccine that a federal court judge has since deemed

improperly licensed.

 

" We need to make sure those who opted out of the [vaccine] program are not

punished, " said Shays, R-4th District. " An unproven vaccine administered against

an uncertain threat is simply not good policy and no punitive measures should be

taken against those who chose their health over fulfilling an ill-informed

requirement. "

 

Since the vaccinations began six years ago, nearly 500 active-duty service

members have refused the vaccine and more than 100 have been court-martialed,

according to data filed in federal court. About 500 to 1,000 pilots and flight

crew members have retired or transferred from the Air National Guard or reserves

rather than take the vaccine, government statistics as of early 2004 show.

 

In 2002, the U.S. Government Accountability Office reported that the vaccine's

systemic adverse reaction rate was 100 times higher than the 0.2 percent rate

reported on the product's label. Adverse vaccine reactions include immune

disorders, muscle and joint pains, headaches, rashes, fatigue, nausea, diarrhea,

chills and fever. At least a half-dozen deaths and a number of birth defects

have been attributed to use of the vaccine.

 

After U.S. Secretary of Defense William Cohen mandated the vaccinations in 1998,

eight veteran Connecticut Air National Guard combat pilots - almost a quarter of

the 103rd Fighter Wing - resigned in protest. On average, a pilot with nine

years of experience costs the government $6 million to train, government

research shows.

 

Since that time, two of those pilots, Majs. Thomas Rempfer and Russell Dingle,

now in the Air Force Reserve, have become two of the leading challengers of the

legality of the vaccine. They have used their research to petition federal

agencies and meet with officials of the Department of Defense and federal drug

and health agencies to try to block forced use of the drug.

 

For more than three years, Shays and state Attorney General Richard Blumenthal

have called for Pentagon officials to cease use of the vaccine until more

studies on its safety and effectiveness are undertaken. They have urged pardons

for all punished for refusing the drug.

 

" As a taxpayer, " Blumenthal said, " I am very concerned that the Defense

Department has spent literally tens of millions of dollars to train pilots and

other highly trained personnel who may be [and are] barred from serving [their

country] by [vaccine] policies that have been wrongly applied and incorrectly

justified. "

 

Shays is planning to introduce legislation soon to correct the record of any

member or former member of the Armed Forces subjected to any job sanctions

because of his or her refusal to submit to anthrax vaccinations.

 

In part due to Dingle's and Rempfer's research, U.S. District Judge Emmet G.

Sullivan in Washington, D.C. ruled Oct. 27 that the anthrax vaccine is either " a

drug unapproved for its intended use, or an investigational new drug. " Pentagon

officials need to obtain the informed consent of each service member inoculated

or a presidential waiver to allow its continued use, the judge concluded.

 

He remanded for reconsideration the Food and Drug Administration's finding that

the anthrax vaccine is effective against aerosolized or inhaled anthrax. The

vaccine originally was developed to fight anthrax infection absorbed through

human skin contacts with infected animals. It was not licensed for inhalation of

the laboratory-made spores used as biological warfare.

 

Although the Department of Defense filed a notice of appeal of Sullivan's ruling

Dec. 24, the FDA responded by opening a 90-day period of public commentary on

the drug. That allows the vaccine's opponents, including Dingle and Rempfer and

service members who sued the government to obtain Sullivan's ruling, to submit

evidence that it is unsafe and ineffective.

 

But Rempfer said Sullivan's ruling requires the FDA to do more than solicit

public comment. He says if the Pentagon wants to continue mandatory use of the

vaccine, the FDA is required by regulation to conduct new health vaccine studies

and permit an expert scientific panel to review all aspects of the drug.

 

" We're just trying to make the FDA follow their own rules and regulations, "

Rempfer said.

 

Blumenthal agreed the vaccine needs the review of an expert panel excluding

those connected to the FDA or BioPort Corp., the manufacturer.

 

However, FDA spokeswoman Lenore Gelb said the vaccine is still legally licensed.

Right now, she said, the FDA is simply complying with Sullivan's order to open

the 90-day public comment period on the drug.

 

DOD spokesman Jim Turner said, " The [Pentagon] continues to believe that the

repeated FDA determinations that anthrax vaccine is safe and effective for the

prevention of anthrax disease, regardless of the route of exposure, were made in

accordance with applicable procedural requirements and are correct. "

 

If service members feel they were wrongly punished for refusing the vaccine, he

said, they can request relief from the Boards for Correction of Military

Records. " He added, however, that " pending outcome of the appeal, conclusions

about the legal status of the vaccination program prior to the district court

decision are premature. "

 

Copyright 2005, Hartford Courant

 

 

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