Source:
http://www.washingtonpost.com/wp-dyn/articles/A3983-2001Dec19.html

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

Jason 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 Steven Johnson'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 Anthony 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. John 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 Kathryn 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."