The company's current manufacturing techniques provide greater potency
compared with earlier versions of the drug, said the Government Accountability
Office, Congress' investigative arm. The manufacturer, BioPort Inc., says
there's no difference in the drug made since 2002 that might cause health
TOP GENERAL NOT TOLD MONITORING TO END
The decision to discontinue the quarterly health monitoring program means that the biggest gap in research about the vaccine remains: There are no systematic long-term studies of the health of those who've taken the drug. Most studies that the Pentagon cites as support for the vaccine's safety involve monitoring that lasted days to a few months.
None lasted as long as five years, the minimum length of time recommended by a nationally recognized panel of scientists assembled by the Institute of Medicine in 2002. The institute is a nonprofit organization that provides expert advice to Congress and other government agencies.
After the quarterly reviews of the vaccine's effects stopped, more than a million troops were forced to take the vaccine - until a federal judge ruled last year that the drug had never been adequately licensed for protection against anthrax use in warfare.
He ordered the military to make vaccination voluntary. The Pentagon is appealing that ruling. Lawyers argued the case Thursday, and a decision is expected by February.
VACCINE MONITORING STILL IMPORTANT
Grabenstein said he decided to halt the quarterly studies after consulting the chairman of the Institute of Medicine panel and its staff, and with doctors affiliated with the military. He acknowledged that he didn't consult the general who ultimately was responsible for the anthrax program.
The chairman of the institute panel, Brian Strom, said he didn't recall what was discussed at the time about the quarterly reports. But he said, "I think they should continue to be using it," in case there's a problem.
Another panel member, Linda Cowan, said she's sure the committee expected quarterly reviews to continue and pointed to a number of the panel's recommendations and findings that she said clearly contradicted Grabenstein's interpretation of its report.
Strom and Cowan emphasized that they thought the vaccine was still safe.
Beth Clay isn't so sure. She directed the staff of Congress' House Government Reform Committee investigation into the anthrax vaccine from 1998 to 2001. She continued working on the subject as a congressional staff member through 2003, after her Republican boss was no longer chairman of the committee.
Clay said the military's decision not to report all the hospitalizations gave the public and Congress a rosier picture of the vaccine than it deserved.
"We were never given this data," she said. "Had we seen this, the committee would have had significant questions" and would have demanded more information about the program.
After reviewing the report obtained by the Daily Press, Clay said it raised several questions about the vaccine's safety. She said Congress was never told about the detailed level of data in the report but was assured regular monitoring of the vaccine and its health effects would continue.
Terminating the quarterly reviews would seem to break those promises, she said. "It's just appalling that they didn't keep up with this," she said.
LINK BETWEEN VACCINE, HOSPITALIZATIONS?
Steve Robinson is executive director of the National Gulf War Resource Center, a lobbying and advocacy group for veterans. He said he was stunned when he learned that the reviews had stopped: "They track the flu vaccine and not the anthrax vaccine, which is totally crazy to me."
He said discovery of the hospitalization data showed that the Pentagon couldn't be trusted to monitor the vaccine's safety.
"You can't let Enron investigate Enron, and you can't let DOD (the Department of Defense) investigate DOD," he said. "We work with the people who have been hurt by this vaccine every day."
No one knows how many, or how few, of the 20,765 hospitalizations are
directly attributable to the vaccine. Ruling out certain illnesses, such as
broken bones or injuries from falls or other accidents, might appear a safe bet.
But military doctors have documented cases where broken bones and other injuries
from falling were the result of vaccine-induced loss of consciousness affecting
the nervous system - sometimes beginning months after vaccination.
The difficulty of figuring out what's related and what isn't is why safety officials encourage people to file reports even if they're not sure.
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.
GENERALS' TESTIMONY 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.