Hartford Courant: Sen Dodd queries to the FBI and the FDA on anthrax vaccine

[Guest guest]

This just keeps getting better and better!!!!!! Way to go Tom and

Russ!!!!!!!!!!!!!!!!!!!!!!!!!!!

Snip: " Two Connecticut U.S. Air Force Reserve officers are among those

challenging the military's use of the vaccine and have persuaded U.S. Sen.

Dodd, D-Connecticut, to investigate the accuracy of Pentagon

officials' contention that the vaccine is safe.

Lt. Col. E. Dingle and Maj. L. " Buzz " Rempfer contend that three

of the officials minimized the number of service members fleeing the military to

avoid vaccination. Two others, they say, misrepresented, the vaccine's license,

which they say has not been properly approved. The officials targeted in the

lawsuit, all now retired, include three generals from U.S. Air Force, U.S. Army

and U.S. Marine Corps, an assistant secretary of defense, and a top anthrax

researcher at U.S. Army Medical Research Institute for Infectious Diseases.

Dodd had written the Department of Defense Inspector General ph E. Schmitz

in April asking him to give the complaints " the consideration they deserve. "

Dodd later learned that Schmitz in November 2002 turned the complaints over to

the public corruption section of the FBI and criminal investigators for the FDA.

So Dodd recently redirected his queries to the FBI and the FDA. The inspector

general concluded one officer's testimony had lacked " the necessary element of

`straight-forwardness,' " and was " inconsistent with the [military] guidelines

for honesty. "

http://www.ctnow.com/news/custom/newsat3/hc-anthraxvacc1223.artdec23,1,7081583.s\

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Judge Assails Vaccine Plan

Strikes Down Military's Mandatory Anthrax Shots

December 23, 2003

By PAULINE JELINEK, Associated Press And THOMAS D. WILLIAMS Courant Staff Writer

WASHINGTON -- The Pentagon must stop requiring military personnel to take the

anthrax vaccination against their will, unless President Bush signs a special

order, a judge ruled Monday.

Millions of shots have been given and hundreds of service members have been

punished for refusing them since the mandatory vaccinations started in 1998.

The central question in the case is whether the drug is experimental or

unapproved for use against inhalation anthrax, said Judge Emmet G. Sullivan of

the U.S. District Court in Washington.

The federal government approved the vaccine three decades ago. But plaintiffs in

the class action suit - unidentified active duty, National Guard and civilian

defense employees - say the license does not include approval for use against

inhalation anthrax.

Two Connecticut U.S. Air Force Reserve officers are among those challenging the

military's use of the vaccine and have persuaded U.S. Sen. Dodd,

D-Connecticut, to investigate the accuracy of Pentagon officials' contention

that the vaccine is safe.

Lt. Col. E. Dingle and Maj. L. " Buzz " Rempfer contend that three

of the officials minimized the number of service members fleeing the military to

avoid vaccination. Two others, they say, misrepresented, the vaccine's license,

which they say has not been properly approved. The officials targeted in the

lawsuit, all now retired, include three generals from U.S. Air Force, U.S. Army

and U.S. Marine Corps, an assistant secretary of defense, and a top anthrax

researcher at U.S. Army Medical Research Institute for Infectious Diseases.

The Pentagon maintains that the vaccine is not experimental and that it is

licensed for protection against anthrax whether it is inhaled or absorbed

through the skin.

Sullivan noted that the label on the vaccine does not specify which method of

anthrax exposure it protects against. He cited a 1998 law prohibiting the use of

certain experimental drugs unless people being given the drug consent or the

president waives the consent requirement.

Connecticut's attorney general, Blumenthal, who had expressed concerns

about the military's anthrax vaccine program to the secretary of defense in

2001, on Monday welcomed the federal court's action.

" This decision vindicates our call to protect the rights of servicemen and women

who may be compelled to accept a vaccine of questionable safety and efficacy, "

Blumenthal said in a statement.

Congress had passed the 1998 law amid fears that the use of such drugs may have

led to unexplained illnesses - known as Gulf War Syndrome - among veterans of

the 1991 Persian Gulf War.

" The women and men of our armed forces put their lives on the line every day to

preserve and safeguard the freedoms that all Americans cherish and enjoy, " said

Sullivan.

" Absent an informed consent or presidential waiver, the United States cannot

demand that members of the armed forces also serve as guinea pigs for

experimental drugs, " Sullivan said.

The Pentagon had no immediate comment.

Sullivan rejected the government's concern that military discipline would be

harmed if courts intervene between soldiers and their military superiors.

Believing Iraq and other nations had produced anthrax weapons, then Secretary of

Defense Cohen in 1997 ordered the armed forces immunized.

Shots started in 1998 for soldiers in areas believed to present the highest risk

of infection - the Persian Gulf, then Korea.

Although the government does not recommend vaccinating the general public, it

says the vaccine overall is very safe, with rare severe side effects .

But hundreds of military personnel have refused the shots, worried they could be

connected to complaints of chronic fatigue, memory loss and other problems.

A spokesman for Dodd said recently that neither the FBI nor the U.S. Food and

Drug Administration's criminal investigation division has answered his questions

about the vaccine, but have promised to do so.

Dodd had written the Department of Defense Inspector General ph E. Schmitz

in April asking him to give the complaints " the consideration they deserve. "

Dodd later learned that Schmitz in November 2002 turned the complaints over to

the public corruption section of the FBI and criminal investigators for the FDA.

So Dodd recently redirected his queries to the FBI and the FDA. The inspector

general concluded one officer's testimony had lacked " the necessary element of

`straight-forwardness,' " and was " inconsistent with the [military] guidelines

for honesty. "

In November, U.S. Sen. Jeff Bingham, D-N.M., introduced a Senate resolution

suggesting that the vaccine be voluntary for service members and that the

military clear the records of those who have refused to take the vaccine. That

same month the Defense Department conceded that it was likely that Spc.

Lacy, a 22-year-old Army Reservist, died from reactions to the anthrax and small

pox vaccines.

Rempfer and Dingle allege that the five military officials needed to cover up

the use of an unneeded, unsafe and ineffective drug because they were forcing

service members to take it, and punishing them when they refused. Despite their

complaints, Dingle and Rempfer have never been interviewed or informed of any

conclusions to the inquiries.

Dingle and Rempfer began supplying transcripts of the high-ranking officials'

testimony to the Pentagon inspector general in January of 2000. In the

complaint, which was rejected within a month, they claimed that three of the

officials grossly minimized numbers of service members leaving the military to

avoid taking anthrax shots. They said another official, then a surgeon general,

" misrepresented " the purpose of a vaccine license.

The Pentagon backed an application seeking the FDA's approval of a vaccine to

protect humans against airborne anthrax spores. While the approval was not

granted for that use, the military began administering the vaccine, which

Dingle, Rempfer and others say is illegal.

The drug was licensed in 1970 to protect humans against skin exposure to animals

infected with anthrax. Rempfer and Dingle allege the vaccine's manufacturing

process was changed without FDA approval and that the change increased the

reported adverse reaction rate.

The vaccine is properly licensed, the application was unnecessary and the

vaccine has proved safe and effective, say FDA and Pentagon spokespersons.

Since the vaccinations began, 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.

Approximately 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 show.