U.S. ANTHRAX VACCINE PLAN SOWS CONFUSION AND ANGER



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Last Updated

14 Dec 2002

Source: Washington Post, December 20, 2001.

U.S. Anthrax Vaccine Plan Sows Confusion and Anger

By Ceci Connolly and Avram Goldstein, Washington Post Staff Writers

Postal workers expressed frustration and confusion yesterday over the federal government's plan to offer them anthrax vaccine on an experimental basis, complaining they do not have the medical information to make such a difficult decision.

Even as the Bush administration scrambled to meet the legal requirements of such an unprecedented proposal, lawmakers and local officials reacted bitterly to the lack of guidance they were receiving eight weeks after the Centers for Disease Control and Prevention began formulating the plan.

"First it was Cipro; then it was the other pill. Now it's this," said Willard Tucker, an employee at the Brentwood postal facility. "Why do we have to be guinea pigs for them? They don't even know what's going on."

Adding to the confusion, Mayor Anthony A. Williams said last night that District officials were advising against vaccination and recommending that workers contact the CDC.

Postal workers in New Jersey, still waiting to be contacted by federal officials, said they are relying on news reports for guidance.

"We don't know how to protect ourselves," said Dianne Fazekas, who worked beside two co-workers at a Hamilton, N.J., postal facility who contracted inhalational anthrax. "We read in the paper that the spores can reactivate themselves after we stop the medicine. We also read that the vaccine has problems and we'd have to sign a release if we take it. Nobody knows what to think."

On Capitol Hill yesterday, inoculation of congressional workers was postponed a day because federal officials had not completed the necessary consent forms laying out the risks associated with taking a vaccine that has not been approved as a post-exposure treatment.

At the same time, inspectors from the Food and Drug Administration gave a partial endorsement to the vaccine maker, BioPort Corp., after conducting an evaluation at the plant in Lansing, Mich., as part of the company's efforts to win final approval for the vaccine.

The FDA made seven "observations," issues that BioPort must address, said Kathyrn Zoon, the agency's top vaccine evaluator. Many of those issues were addressed while inspectors were at the facility, she said, such as the company's procedures and rules.

But it was the fresh wave of uncertainty that dominated discussions in post offices, a conversation that was often tinged with an element of race and resentment over how postal workers were treated during the anthrax attacks.

"We've been pushed to the side and that frustrates me," said George Bryant, who said he has felt from the start that postal workers have been treated differently from congressional aides. "I think they know more than they're telling us. I'm really scared. I just want to know what's going on."

Bailus Walker, a professor of public health and health policy at Howard University, said the government's handling of the anthrax attacks has only reinforced long-held suspicions.

"There is a long-standing, deeply ingrained concern in the black community about being used as guinea pigs," he said. "As much as we try, we have not been able to remove from the minds of the black community the Tuskegee episode. . . . We confront it almost monthly as we try to get blacks to participate in clinical trials. This just feeds it." Tuskegee refers to a notorious federal study in which treatment was withheld for 40 years from hundreds of poor black sharecroppers with syphilis.

On Tuesday, Health and Human Services Secretary Tommy G. Thompson announced that the anthrax vaccine would be made available to about 3,000 people on the East Coast who may have been exposed to spores. The decision was prompted by concerns that the spores may survive longer in the lungs than had been thought and could still make people sick once their 60-day courses of antibiotics end.

In the announcement, Thompson did not make a recommendation on who should receive the vaccine but said individuals could opt instead to take antibiotics for an additional 40 days or simply monitor their health and watch for symptoms of anthrax disease.

"It appears that once again federal officials do not have a comprehensive plan of action," said Rep. Christopher H. Smith (R-N.J.), recalling the confusion that arose when 1,000 postal workers were told one Friday afternoon in October to get antibiotics to protect against anthrax. "In the first go-round we tried to exercise some patience as the experts found their way. This time there is no excuse."

Last night CDC Director Jeffrey P. Koplan offered some insight on who should consider receiving the three-shot vaccine regimen. They include individuals who were in proximity to tainted mail, such as the 70 people in and near Senate Majority Leader Thomas A. Daschle's Hart Building offices, anyone who had contact with one of the five people who died of inhalational anthrax and anyone who was in an area that was "heavily contaminated" with anthrax bacteria, such as the Brentwood and Hamilton postal facilities, he said.

"Those are the individuals at higher risk who may want to consider these more aggressive options," he said in an interview.

Yet one day after Thompson announced his decision, it was clear many critical aspects of the plan remained unresolved or strayed from standard regulatory practice.

Although anthrax vaccine has been licensed in the past for inoculating high-risk groups such as soldiers, it has never been used as a treatment for people who may have been exposed to the bacteria. Because of that, the CDC must submit a detailed request outlining why and how it will conduct the treatment. This is known as an investigational new drug (IND) program.

"INDs are used when you are experimenting on people," said Mary Pendergast, former deputy commissioner of the FDA. Two key documents, she said, are the scientific protocol and the consent form that all participants must sign. Both must be approved by independent panels whose responsibilities include ensuring the safety of patients.

"You must give the person who is giving consent all the relevant information so they can make a wise decision whether to take the experimental drug," she said.

Koplan said the agency's institutional review board was still revising the consent form and the scientific protocol last night.

Prominent physicians, meanwhile, disagreed publicly over what patients should do.

Capitol physician John Eisold, in an e-mail to congressional workers, said that while federal officials remained neutral, he was recommending the vaccine for about 70 people exposed to an anthrax-laden letter sent to Daschle (D-S.D.).

"If the federal government leaned toward Eisold and said we really should be giving it and recommending it, the other people would say, 'Why are you doing that? Why are you exposing us to risk?' " said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases. "If you lean the other way, the Eisold people would say, 'Wait a minute -- we want it.' "

But the lack of specific recommendations left many people bewildered.

Lana Lawrence, a freelance photographer who was in the hall outside Daschle's office, was told for the first time yesterday by a military doctor that she was at high risk.

"He said, 'I have no doubt you inhaled spores,' " she said. Still, he had no advice on taking the vaccine. "I've been through enough with this already," she said, noting she is leaning toward vaccination. "I don't want to go through the holiday season with even a remote chance of coming down with anthrax."

Staff writers Andrew Demillo and Dale Russakoff contributed to this report.