Blumenthal Urges Halt To Anthrax Vaccine Rule

By Thomas D. Williams

Hartford Courant

March 23, 2001

Connecticut Attorney General Richard Blumenthal, saying that 2.4 million service people are being used as "guinea pigs,'' asked federal officials Thursday to halt the military's mandatory anthrax vaccination program.

Blumenthal said service people are being coerced to "put at risk either their health or their careers" under the program, which is intended to protect against biological warfare.

In letters to U.S. Secretary of Defense Donald Rumsfeld and acting Food and Drug Deputy Commissioner Bernard Schwetz, Blumenthal said federal officials have been ignoring the conflicts service members face in either taking the vaccine or refusing to do so.

"The U.S. government so far has refused to recognize or appreciate the danger and the personal dilemma it is imposing on its military personnel, despite their repeated concerns [about] an unlicensed drug never proved safe or effective for humans,'' Blumenthal said.

"Unfortunately, and directly contrary to law, the [vaccine program] is being administered to military personnel under threat of imprisonment, loss of pay and discharge,'' he said. "In effect, the military is forcing its personnel to serve as human guinea pigs for an unlicensed drug that has not proven to be safe or effective."

For more than a year, the attorney general has expressed his concerns about the vaccine to federal and state military, health and consumer officials, who have thus far taken no action on his arguments.

On Thursday, a proposed bill to prevent the Pentagon's forced use of "experimental" drugs such as the anthrax vaccine on Connecticut National Guard troops was approved by the General Assembly's public safety committee. That committee sent it on to the public health committee for further consideration.

Connecticut and Massachusetts are believed to be the only two states nationwide considering such legislation.

U.S. Food and Drug Administration and Department of Defense officials insist the vaccine is properly licensed, and is safe and effective.

Both Lenore Gelb, a spokeswoman for the FDA, and James Turner, a spokesman for the Pentagon, said Thursday their agencies had not received Blumenthal's letters, so federal officials could not comment.

Blumenthal expressed concern in December that if Connecticut National Guard troops and Reserve members suffer adverse reactions to the vaccination, it could put the state at risk of having to pick up medical costs. Blumenthal said the program is depleting the strength of the armed forces, including those serving Connecticut, because many, especially in the reserve and guard, resign rather than take the vaccine.

Since the mandatory vaccinations began in early 1998, hundreds of service members have been punished or have resigned rather than take the drug. Scores of other service members have complained of serious reactions to the vaccine.

Blumenthal cited the conclusions of an extensive investigation by the U.S. House Subcommittee on Government Reform, spearheaded by U.S. Rep. Christopher Shays, R-4th District. The committee recommended stopping the inoculations until the manufacturer develops a safe, effective and an appropriate drug.

The attorney general said the only license for the anthrax vaccine was granted in 1970 to a former manufacturer of the drug "exclusively for agricultural and veterinary settings,'' not for mass inoculations of troops. The drug was tested and approved to protect veterinarians and wool and farm workers from exposure to the animal bacteria through cuts in the skin, not for spores inhaled into the lungs as would occur in biological warfare attacks, Blumenthal said.

The Pentagon, supported by high-ranking FDA officials, argues the original license is broad enough to cover inhalation issues. Still, in 1996, the former manufacturer, the Michigan Department of Health, and the Pentagon sought a license approving the drug for those inhaling anthrax spores. The application has never been granted and remains pending. Two Connecticut Air Force Reserve majors, Russell Dingle and Thomas Rempfer, have complained to U.S. Sen. Christopher J. Dodd, D-Conn., that the Pentagon sought to cover up their complaints about the license application.

Blumenthal said extensive investigative work by Rempfer and Dingle, who were forced to resign as Air National Guard pilots in 1998 when they challenged the inoculations, prompted his complaints to Rumsfeld and Schwetz.