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“Protecting the health and informed consent rights of children since 1982.”
The Hartford Courant
June 02, 2001
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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