– 2006-01-08 23:48:12

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Why Pentagon Didn’t File Hospital Reports
Still, medical experts consulted by the Daily Press said it’s unlikely that the vast majority of the 20,765 hospitalizations resulted from the vaccine. They said that if all hospitalizations had been filed with VAERS, it would have overloaded the system and caused problems for experts trying to analyze the data.

Grabenstein said those were among the reasons that the full number of hospitalizations was not reported. Another reason, he said, was that examinations of the data showed that if there were adverse effects from the vaccine, they were so infrequent, they weren’t detectable by statistical analysis. Doing this type of analysis — instead of simply reporting the incidents to VAERS — provided a more definitive look at the health effects of the vaccine, he said. As a result, “we decided not to file” public reports about all hospitalizations, he said.

Those considerations weren’t relayed to Congress or the public.

During the years covered by the hospitalization report obtained by the Daily Press, dozens of sick veterans who’d received the shot went to Capitol Hill, complaining of various health problems. Some got the shot for the 1991 Persian Gulf War, in which the vaccine had its first widespread use. Others were members of the military forced to take the shots under a mandatory program that began in 1998.

Their complaints had common themes: Fatigue. Chronic pain in joints and other symptoms of arthritis. Tingling in their feet, arms and hands. Mental lapses. Often, more than one of the symptoms were present, making diagnoses difficult.

Sympathetic doctors testified that these complaints were indicative of autoimmune problems, in which the body’s natural protective mechanisms go haywire and start attacking healthy cells and tissue. The doctors said that could result if the vaccine overstimulated the vets’ immune systems. The vaccine primes the system to develop protection against anthrax.

Bewildered and sometimes-angry members of Congress asked how many vets were affected. Pentagon doctors and generals used the cases reported to VAERS – fewer than 100 hospitalizations or other “serious events” from 1998 to 2000 – or said the number was so small, it couldn’t be detected.

Vaccine Reports Are First Line of Defense
The two sets of numbers for how many hospitalizations followed the shot come from a comparison of two sets of data kept by three federal agencies.

The Food and Drug Administration and the Centers for Disease Control and Prevention maintain the only database open to public inspection, VAERS. VAERS is the nation’s first line of defense in identifying possible problems with vaccines after they’ve been licensed, said Susan Ellenberg, who led the FDA’s efforts to monitor vaccine safety from 1993 to 2004.

During congressional testimony before the House Government Reform Committee’s Subcommittee on National Security, Veterans Affairs and International Relations in July 1999, Ellenberg explained how and why the system worked.

VAERS was established to help identify and head off problems once a vaccine is licensed and more people are taking it, she said. The few hundred people typically involved in vaccine or drug testing and licensing trials can’t mimic the diversity of age, race, gender and other biologic variables encountered once the vaccine gets widespread public use, she explained.

Reports to VAERS by civilian doctors and hospitals are mostly voluntary, based on suspicion of a connection between an illness or injury and a vaccination, Ellenberg told Congress.

Doctors and others are encouraged to file a report, known as a VAERS-1, even when they aren’t sure there’s a cause and effect, she said. That’s because VAERS requires as many reports of problems as possible, so experts can identify possible patterns and investigate further, she said.

General’s Testimoney Promised Reports
During the same congressional hearing, Lt. Gen. G. Robert Claypool – then the deputy assistant secretary of defense for health operations policy – assured Congress that military doctors, hospitals and medical officials were filing VAERS-1 forms, too.

And, he said, they were expected to report even more cases than civilians – including all hospitalizations.

“The duty to report adverse medication events has been codified for many years,” Claypool testified. “The joint regulation requires submission of a form VAERS-1 for all adverse events resulting in more than 24 hours of lost duty time or any period of hospitalization. These requirements represent a higher standard than in comparable civilian community health care settings.”

There was no mention that the word “all” didn’t mean all hospitalizations.

Two months later, Lt. Gen. Ronald R. Blanck, then the Army’s surgeon general and the top Pentagon official responsible for the anthrax vaccine program from 1998 to 2000, gave similar assurances to Congress.

He said, “We have a reporting system that when either of those two criteria are met, that is, either a patient is hospitalized following an anthrax immunization or misses duty because of it for greater than 24 hours, we have an active reporting system. That must be reported to us. We, in turn, report it to the Food and Drug Administration, and they have a group that reviews those reactions.”

Clay and other congressional aides say these assurances came in private, too. “We had lengthy conversations that they were supposed to report,” she said.

But the numbers reported were very low. And the Pentagon stuck with them for years to persuade the public that the shot was safe.

In December 2003, Pentagon officials conducted a news conference to rebut a judge’s ruling that the shots had been given illegally and that troops had been used as “guinea pigs.” Grabenstein was asked whether he had “any data on the numbers of people who have had bad adverse reactions to the vaccine and would have required hospitalization.”

He said that only 69 hospitalizations had been reported to VAERS for the anthrax vaccine from 1998 through 2000. A panel of civilian experts had analyzed each, he said, and decided that 11 were results of the shot. The 69 cases were “a complete, exhaustive list of what was reported,” Grabenstein said.

Grabenstein told the Daily Press that his statement wasn’t misleading. He said no one should expect all hospitalizations after vaccination to be reported to VAERS – despite the Pentagon’s written policies – because the number included cases unrelated to the vaccine, sometimes years after vaccination.

He said, “The simple answer is it’s so obvious, it’s never appeared in the memo.”

No Exceptions Noted in Policy Memos
The memo, “Policy for Reporting Adverse Events Associated With the Anthrax Vaccine,” serves as the standing order for all military personnel. It reads: “For the purposes of reporting anthrax vaccine adverse events, a Form VAERS-1 must be completed and submitted using service reporting procedures for those events resulting in a hospital admission or time lost from duty for greater than 24 hours or for those events suspected to have resulted from contamination of a vaccine lot.”

The memo lists additional circumstances requiring a report, but nothing that would permit excluding hospitalizations after vaccination. It refers to the Pentagon’s formal regulations, which don’t include the exclusions that Grabenstein cited.

The data on all hospitalizations after anthrax vaccination comes from the Pentagon’s Defense Medical Surveillance System, or DMSS. This computerized tracking system pulls medical records for every shot, clinic visit, hospitalization or other instance of medical treatment for active-duty military personnel.

Experts in health care and statistics say it’s one of the most important medical databases in the world. That’s because of its precision, its millions of patients, and the diversity of drugs and vaccines used by the armed forces. By design, it’s more complete and accurate than VAERS. Unlike VAERS, its data isn’t open to the public.

Experts: No Excuse for Secret Data
The Institute of Medicine report that Grabenstein cited as supporting the vaccine’s safety and his decision to end the quarterly monitoring program also says the DMSS database should be open to researchers outside the government, with precautions to protect the privacy of individuals’ health records.

This hasn’t been done. Grabenstein said the military had not been able to figure out how to protect individuals’ health records and make it work.

Strom of the institute panel and other experts say it should not be that difficult. “There’s no excuse,” he said. “We use these kinds of data sets in Medicaid and Medicare data all the time. There are technological solutions.”

Cowan, another member of the panel, said the institute’s recommendation was based, in part, on the military saying it couldn’t afford all the analysis that the data was good for: “That way, you get the most of what the American people have invested in.”

Strom said keeping the data from the public only bolstered the perception that the military was hiding the truth about the vaccine.

Walter Schumm is a professor of family studies and an expert on statistical methods at Kansas State University. He said he and other researchers would love to get the DMSS data. He’s a retired Army colonel who’s spent more than a decade using statistical analysis to examine the vaccine’s safety – after friends and others in uniform began complaining about health problems after the shots.

Schumm has used other data made public on the anthrax vaccine to publish several scientific papers that poke holes in the safety assertions made by Pentagon doctors and researchers.

Good science involves people with different approaches to the same problem having a chance to test their theories, Schumm and others say. Their findings might cement the safety assertions, he said, but no one knows for sure until the military loosens its hold on the facts and data.

He said, “If you let independent people have the data, you risk losing control. In combat, letting things get out of control gets people killed, so loss of control is a very sensitive issue. I’m just sure they’re trying to protect their program.”

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