Vaccine Offer Worries Blumenthal
December 22, 2001
By THOMAS D. WILLIAMS, Courant Staff Writer

Connecticut's attorney general said Friday postal workers and others who have been offered the anthrax vaccine are being drawn into a federal health experiment without the information they need.

Federal officials failed to properly disclose that users of the vaccine will be part of an experiment, and they have failed to make full disclosure about the vaccine's troubled history, Attorney General Richard Blumenthal said.

Blumenthal said he reviewed the disclosure statement to be furnished to prospective users. He said he plans to confer with U.S. Department of Health and Human Services and Centers for Disease Control and Prevention when their officials arrive in Connecticut to offer the vaccine to those exposed to anthrax spores.

Blumental said he may also contact postal union officials to brief them on some of the more important points missing in a five-page consent form volunteers would have to sign before taking what is normally a six-shot series and annual boosters.

He said he is concerned that the vaccine being offered for use as protection against inhalation anthrax has only been licensed for use against anthrax infection through the skin. He is also concerned that Connecticut residents may not be getting enough information about the vaccine's possible side effects.

"We echo Mr. Blumenthal's statements," said John Dirius, president of the Greater Connecticut Local of the American Postal Workers Union, which represents the Wallingford district where the anthrax spores were discovered earlier this year.

"We don't have enough information. We are educating our people now."

The attorney general has spent many months investigating the vaccine. In March 2000, he sent complaints to high-ranking military and health officials calling for a halt to the use of the vaccine for the military. The vaccine has not been proven safe or effective, he said.

The federal consent form, given in advance to anyone who might consider taking the vaccine voluntarily, contains extensive disclosures in its five pages. For instance, it says the vaccine is not normally for use after a victim is exposed to the spores. Normally, says the form, the vaccine is administered to those who have not been exposed to immunize them in the event of exposure.

It says the vaccine is not approved by the FDA for this "investigational" use.

The disclosure form advises users that they will be asked to keep a diary about their health for the first six weeks of the program.

The form also discloses that:

The lot being used, FAV-063, although passing all the manufacturer's tests, has not been approved by the FDA.

The vaccine is not proven to give long-term protection against anthrax.

The vaccine may give the user undesirable side effects, ranging from swelling at the injection site to chronic illnesses such as muscle and joint diseases to miscarriage.

"You read that statement and it makes it clear that we have been forthcoming to the public," said Bill Pierce, a spokesman for the Health and Human Services agency. "We have worked very closely with all the relevant health organizations as well as the unions" whose workers might take the vaccine.

The newest batches of the vaccine are manufactured by BioPort Corp., of Lansing, Mich. They have never been used or approved by the FDA for use.

The vaccine used earlier by the U.S. Department of Defense to immunize more than 511,000 service members in the past three years was approved for use by the FDA. It was made by Michigan Biologic Products Institute.

FDA inspectors have repeatedly failed various aspects of both organizations' manufacturing process. At one point they threatened to close MBPI's operations, but relented.

BioPort failed to get initial FDA approval for its own products in October 2000, but is in the process of being reviewed a second time.

Four years ago, scores of service members declined to take the vaccine despite an order by then-Secretary of Defense William Cohen.

They were expelled from the service or disciplined. Hundreds of pilots and crewmembers in the National Guard and reserves resigned rather than take the vaccine.

Between 5 percent and 35 percent of those using the vaccine have reported adverse effects, the majority of which were not serious