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Lingering Worries Over Vaccine

Some Servicemen, Scientists Question Safety, Effectiveness of Anti-Anthrax

Shots

By Shankar Vedantam

Washington Post Staff Writer

Thursday, December 20, 2001; Page A19

Nietupski was ordered to take three shots of anthrax vaccine in

February and March 2000, right before he was deployed to South Korea as a

U.S. Army reserve officer.

Within weeks, Nietupski developed a host of medical problems that an Army

medical evaluation concluded were related to the vaccine: Blood clots

appeared in the aspiring fighter pilot's legs and a bloody mucus dripped into

his mouth; he was diagnosed with chronic fatigue syndrome and an allergic

reaction called 's syndrome.

" I was very healthy and never went to doctors before I took the vaccine, "

said Nietupski, 29, in an interview yesterday, describing how his life

changed after the shots. " Now if you look at me the last 18 months, I have a

medical record six to eight inches thick. "

As thousands of postal workers and Senate staffers who were exposed to

anthrax bacteria during this fall's attacks debate whether to take the

anthrax vaccine, they face a brutally difficult decision: Should they listen

to those like Nietupski and avoid the vaccine, or should they listen to the

exhaustive scientific evaluations that have found the vaccine to be generally

safe?

Compounding the difficulty of the decision is the spotty record of the

vaccine's manufacturer, which has been repeatedly cited by the Food and Drug

Administration for inferior manufacturing processes, and a general lack of

understanding about whether the vaccine will work -- or is even necessary.

Federal health officials did not specifically recommend the vaccine when they

announced Tuesday they would make it available for those considered at high

risk because they may have been heavily exposed. And doctors responsible for

care on Capitol Hill and those responsible for the care of thousands of

Washington's postal workers have offered differing conclusions about what

patients should do.

" The actual data show that in animals there is in fact no difference between

vaccine and antibiotics versus antibiotics alone, " said Fauci, the

nation's top infectious diseases expert. " The only consideration is purely

theoretical. "

Workers exposed to anthrax spores, said Fauci, might still be harboring

spores in their lungs despite two months of antibiotics. Giving them vaccine

while continuing the antibiotics might help.

While the anthrax risk and vaccine benefits are both unknown, the vaccine

carries some known risks. Individuals who were extremely worried about the

risk for anthrax could decide to accept that risk and take the vaccine, Fauci

said. Those less worried could decide to continue only with antibiotics, or

take no new medicines.

The anthrax vaccine contains no live bacteria, said Fauci, who directs the

National Institute of Allergy and Infectious Diseases. It comprises proteins

secreted by the bacteria. The vaccine is designed to get the immune system to

recognize the proteins -- and therefore the bacteria -- and destroy both.

Since March 1998, the Department of Defense, the largest user of the vaccine,

has administered 2.1 million doses of the vaccine to 524,000 people to

protect them against a possible biological weapons attack. Most have received

six doses -- three in the first month, and then booster doses at six-month

intervals. Most recipients have been active-duty soldiers, but reservists and

some civilians have been vaccinated as well.

" We have conducted 18 human safety studies -- short and long term --

retrospective and prospective, " said Lt. Col. Grabenstein, deputy

director for clinical operations of the DOD's Anthrax Vaccine Immunization

Program. " In aggregate, what they show is anthrax vaccine has a side effect

profile similar as that of other vaccines. "

Severe allergic reactions are seen in 1 per 100,000 people, he said. Military

researchers said up to 16 percent of people may experience rashes, 14 percent

to 25 percent may experience headaches, 12 percent to 15 percent joint aches

and up to a third muscle aches. Patients also report painful stinging and

burning reactions at the injection site.

Referring to accusations that there are many more serious adverse events,

Grabenstein said, " lots of people are confusing, 'it happened after

vaccination' with 'it happened because of vaccination.' " The vaccine's

safety had been evaluated by a number of independent civilian scientists,

including those at the National Academy of Sciences, he said.

The FDA said the vaccine being offered is substantially the same vaccine that

has been tested for decades. Although the manufacturer, BioPort Corp. of

Lansing, Mich., is still completing safety inspections, the FDA believes the

vaccine being offered to the public is safe.

" There's nothing we feel that would concern us about the safety " of the

vaccine being offered, said Zoon, the FDA's chief vaccine regulator,

in an interview yesterday.

Those assertions are sharply at odds with those made by people who say they

have been affected by the vaccine. In congressional testimony and on Internet

bulletin boards, former and current servicemen report wide-ranging problems

that the government has been unwilling to acknowledge.

Jon Irelan, 42, a retired Army major and ranger, said he fell ill after

receiving the fourth shot of anthrax vaccine while in Saudi Arabia.

Both Irelan and Nietupski said they fear the vaccine they received was

contaminated because of problems at BioPort. Nietupski said he cannot sue,

because the DOD had indemnified the company -- protection that applies under

the civilian vaccination plan as well, under terms arranged by the Health and

Human Services Department.

" Why are you indemnifying BioPort if they are making a safe product? "

Nietupski said. " I had to take this shot or I would have been

court-martialed. Now . . . I can't sue the Army and can't sue BioPort, even

though the vaccine caused these chronic multi-system disorders. "

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U.S. Anthrax Vaccine Plan Sows Confusion and Anger

By Ceci Connolly and Avram Goldstein

Washington Post Staff Writers

Thursday, December 20, 2001; Page A01

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 A. 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 ,

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 , a professor of public health and health policy at

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. 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, 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. H. (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 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 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 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 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 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 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. "