The Anthrax Vaccine: New Questions, Weak Data

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The anthrax vaccine: New questions, weak data

BY BOB EVANS

Daily Press (Newport News, Va.)

Posted on Fri, Dec. 09, 2005

NEWPORT NEWS, Va. - The Pentagon never told Congress about more than 20,000 hospitalizations involving troops who'd taken the anthrax vaccine, despite repeated promises that such cases would be publicly disclosed.

Instead, a parade of generals and Defense Department officials told Congress and the public that fewer than 100 people were hospitalized or became seriously ill after receiving the shot from 1998 through 2000.

They also showed Congress written policies that required public reports to be filed for hospitalizations, serious illnesses and cases where someone missed 24 hours or more of duty.

But only a sliver of those cases were reported, while the rest were withheld from Congress and the public, records obtained by the Daily Press show.

Critics of the vaccine, veterans' advocates and congressional staffers say the Pentagon's deliberate low-balling of hospitalizations helped persuade Congress and the public that the vaccine was safe.

Keeping the actual number of illnesses secret contributed to a shorter list of government-recognized side effects for the drug, giving patients and physicians a false idea of what might constitute a vaccine-related illness or problem. Doctors are expected to know the full list of side effects and alert federal drug safety officials whenever they see a repeat of those symptoms.

Repeated evidence of the same adverse side effect after a vaccination is one of the most telling signs of a systematic problem with a drug or vaccine, as opposed to a coincidental relationship, vaccine safety experts say.

During the Daily Press' investigation of the vaccine and its effects, the newspaper found three cases of amyotrophic lateral sclerosis - ALS, or Lou Gehrig's disease - that the military hadn't reported. The disease destroys muscles and nerves, is always fatal and rarely hits people younger than 45.

One of the three cases involves Navy Capt. Denis Army of Virginia Beach, Va. Army died in 2000, after developing symptoms less than a week after his first anthrax vaccination - and a few days before his 45th birthday. His widow filed the first public acknowledgement of his death and its temporal connection to the vaccine this year. That occurred after she talked to a Daily Press reporter and learned that she could file a report with the federal Vaccine Adverse Event Reporting System, or VAERS.

Navy Petty Officer 2nd Class Kristin Shemeley died of ALS in 2001, at 29. Her symptoms began about two months after her third shot, a sworn legal document detailing her illness says.

Before Shemeley died, she spent 14 months in Walter Reed Army Medical Center in Washington, where she was regularly visited by high-ranking military officers, said her mother, Ginger Shemeley of Quakertown, Pa. She says her daughter repeatedly told those generals and admirals that she was suffering because of the vaccine and even pleaded with one of them to stop giving it to troops. Several of those generals and admirals had promised Congress that such cases would be publicly reported to VAERS.

The military never filed a VAERS report on Kristin Shemeley. Ginger Shemeley filed one after her daughter died.

Col. John Grabenstein, director of the military's vaccine agency, said no one from the military intentionally misled Congress or the public. He said the 20,765 hospitalizations merely followed vaccinations in time, without documented proof of a cause-and-effect relationship.

He said a statistical analysis showed that those who'd been vaccinated weren't more likely to be hospitalized or likely to seek medical treatment than those in the military who hadn't been vaccinated from 1998 through 2000.

Some medical experts say this approach doesn't adequately address the problems of many people who report illnesses after anthrax vaccination. That's because the approach is limited to comparing rates of illness involving one symptom or disease - instead of the complex combination of symptoms and illnesses that many veterans report after getting their shots.

The data that the Daily Press used to document the underreporting of hospitalizations came from a report that Grabenstein supplied in response to the newspaper's request. It had never been made public.

It covers 1998 through 2000, when the Pentagon did detailed evaluations every three months to compare hospitalizations, clinic visits and medical treatment data for those who'd been vaccinated, compared with troops who hadn't. This quarterly analysis stopped and hasn't been done since, Grabenstein said.

The practice of not reporting all hospitalizations continues.

Quarterly analysis of the vaccine's effects ended just as the nation's only manufacturing site for the drug regained its license. That was in 2002, after federal inspections found many safety and other problems that prompted a shutdown and renovation that began in early 1998.

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http://www.kansascity.com/mld/kansas...n/13368280.htm

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