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http://www.ctnow.com/news/health/hc-anthrax0116.artjan16,1,5490246.story?col
l=hc-headlines-health
Hartford Courant (subscription), CT

Vaccine Refusal Pardon Sought
Shays Asks Amnesty For Those Punished

January 16, 2005
By THOMAS D. WILLIAMS, Courant Staff Writer

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."




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