Anthrax Vaccine Complaints on the Rise

The Hartford Courant
June 2, 2001

Anthrax Vaccine Complaints On Rise
by Thomas D. Williams

The federal system tracking complaints from people who receive vaccinations showed a sharp increase in reports of adverse reactions to anthrax inoculations in the second and third years they were required of military service members.

The anthrax vaccinations, ordered by the Department of Defense for all 2.4 million military personnel as protection against possible use of a biological warfare agent, began in early 1998. Since then, the Vaccine Adverse Event Reporting System has collected complaints of more than 200 reactions defined as fatal, life-threatening, or resulting in hospitalization or permanent disability out of more than 1,500 complaints. The federal agencies monitoring the complaints, however, acknowledge that the medical results of 45 percent of 1,300 complaints initially classified nonserious are either unknown or unresolved, indicating that the number of serious reactions could be higher than 200.

So far, about 500,000 service members have received 2 million inoculations in the series of six shots plus boosters. Reactions range from swollen arms, rashes and fever to more serious symptoms, such as a progressive muscle-weakening condition leading to paralysis and long-term neurological disorders.

Complaints to the reporting system – which even federal officials acknowledge typically represent as few as 10 percent of all adverse reactions to vaccines – can be filed by vaccine users, doctors and medical personnel. They are sent to the system's headquarters in Rockville, Md., recorded into a computerized system and monitored by federal health agencies, such as the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention.

In at least two cases, the number or seriousness of complaints about a vaccine has led to federal investigations. For example, in 1999, federal health officials investigated the new rotavirus oral vaccine to help control serious stomach disorders in babies after complaints of bowel obstruction tripled from three instances to nine. The probe eventually found a connection between the complaints and vaccine reactions that led the manufacturer to take the drug off the market.

The complaints made about anthrax vaccinations are being reviewed and studied by an Anthrax Vaccine Expert Committee, known as AVEC. It is made up of outside academic doctors and officials from the Department of Defense, the Health Resources and Services Administration (the government's public health agency), the FDA and the CDC. "To date, no evidence of a pattern in the occurrence of serious adverse events has been found by the {expert committee's} review of all of the anthrax vaccine-associated VAERS reports,'' said Barbara Reynolds, a spokeswoman for the CDC.

In March, the CDC did announce it would undertake a seven-month study to look at issues involving the anthrax vaccine. Critics of the anthrax vaccination program say the federal agencies should have investigated the drug immediately after last year's rise in adverse reaction complaints, to determine whether it was safe enough for continued use. "In the last few years, about eight drugs have been withdrawn or taken from the market due to safety problems,'' said Dr. Meryl Nass, who has studied the vaccine for 12 years and testified about it during court and congressional inquiries. "Yet the U.S. Food and Drug Administration has staunchly refused to pay attention to a growing number of medical studies showing the relationship between the anthrax vaccine and adverse reactions of those using it.''

Because of the adverse reactions and a lack of confidence in the vaccine, scores of service people have declined to take the vaccine and have been disciplined or expelled from the active armed services. Many others in the military reserves or National Guard have resigned rather than be inoculated.

Politicians, including Rep. Christopher Shays, R-4th District, who headed a congressional committee that investigated the vaccine, have called for a halt to the vaccination program.

An analysis of complaints to VAERS shows that within the first 15 months of the program, there were 42 complaints, mostly classified as nonserious, resulting from the more than 634,000 immunizations given to about 223,000 service members.

Between March 1999 and October 2000, the number of overall complaints rose to 1,561. The Pentagon credited the rise in adverse reaction complaints to the increase in the number of shots. But in late 1999, the Defense Department brochure advising service members of drug issues changed the adverse reaction rate from 0.2 percent, which appears on the label of the drug, to between 5 percent and 35 percent.

The James Madison Project, a Washington-based nonprofit group established in 1998 to promote government accountability and the reduction of secrecy, wrote to the FDA to demand a change in the vaccine package insert warnings reflecting those percentages. That request, made in early 2000, has still not been resolved.
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