20,000 who got anthrax shot were hospitalized
By Bob Evans
The Daily Press
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 hospi-talized 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.
Lou Gehrig's disease
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 acknowl-edgement 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, D.C., where she was regularly vis-ited 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 medi-cal 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 vis-its 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.
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 problems.
No long-term study
The decision to discontinue the quarterly health monitoring program means that the biggest gap in research about the vaccine re-mains: 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 assem-bled 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. A decision is expected by February.
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 num-ber 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 ef-fects 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.
The Daily Press
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 hospi-talized 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.
Lou Gehrig's disease
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 acknowl-edgement 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, D.C., where she was regularly vis-ited 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 medi-cal 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 vis-its 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.
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 problems.
No long-term study
The decision to discontinue the quarterly health monitoring program means that the biggest gap in research about the vaccine re-mains: 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 assem-bled 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. A decision is expected by February.
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 num-ber 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 ef-fects 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.
