Stars and Stripes: Dr. Meryl Nass: On The
Front Lines Of The Anthrax Vaccine Wars
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Anthrax vaccine critic, Dr. Meryl Nass.
Dr. Meryl Nass: On The Front Lines Of The Anthrax Vaccine Wars
Mar 5, 2001
Dave Eberhart
Stars and Stripes Veterans Affairs Editor
Dr. Meryl Nass, an internist, played a major role in forming a coalition of military personnel, family members and outside experts that has opposed the Pentagon’s anthrax vaccine immunization program. She has consulted for the General Accounting Office, testified before the House Government Reform subcommittee on national security, veterans affairs and international relations and the House Armed Services Committee, and provided testimony to the U.S. Institute of Medicine.
Stripes: What is your professional background?
Nass: I am an internist in private practice. I treat many patients with chronic fatigue syndrome, fibromyalgia and Gulf War illnesses. Since 1989, I have worked to decrease the threat of biological weapons. In 1992 I identified the first known use of anthrax in Zimbabwe, then Rhodesia, during its civil war in 1979. The story can be found in the book “Plague Wars” by Tom Mangold and Jeff Goldberg.
Stripes: What has been your involvement in investigating the Anthrax Vaccine Immunization Program?
Nass: I wrote a short article for ProMED Mail, an Internet mailing list of infectious disease professionals, in December of 1997 describing the lack of information on the safety and efficacy of the anthrax vaccine, and pointing out that it had not yet been ruled out as a contributor to Gulf War Syndrome. I hadn’t realized it at the time, but since the post was on the Internet, it was “searchable.” It came up when people searched using the term “anthrax.”
I started getting calls from servicemembers and their families
inquiring about the vaccine. Then I started getting calls from
people who felt they had become ill from the vaccine.
· Dr. Meryl Nass
The article was cited by The Lancet, an international medical
journal, and was bounced around the Internet. As a result, I started
getting calls from servicemembers and their families inquiring
about the vaccine. Then I started getting calls from people who
felt they had become ill from the vaccine. Then from others researching
it.
Between my efforts, the work of several mothers of vaccine recipients
and refusers, and some very smart reservists, a network formed
to get information out and to interest Congress in the issue.
This movement grew very organically; none of us had any idea how
involved we would become.
Stripes: Can you give a brief history of anthrax as an offensive weapon?
Nass: It may have been used by the Germans against pack animals
in World War I. It was studied by the Japanese starting in the
1930s, and by the United States and Britain in the 1940s, as a
means of germ warfare. Scientific American once showed drawings
of the U.S. cluster bombs designed for anthrax during World War
II. There was a plan to use anthrax against six German cities
if the war in Europe had persisted.
The first large-scale use that we know about was in Rhodesia,
where it appears to have been used to kill cattle owned by black
farmers to prevent them from harboring guerrillas. However, the
poor farmers ate meat from the dead animals, and so nearly 200
human deaths and 10,000 human cases of cutaneous [skin-infected]
anthrax were documented.
Stripes: Was the DoD anthrax vaccine ever licensed by the Food and Drug Administration?
Nass: It was licensed by NIH [ the National Institutes of Health]
before FDA licensed vaccines, during a “window”—Congress
had asked the licensing agency [the division of biologic standards]
to assure efficacy in the 1960s, but the agency was not always
requiring proof of efficacy at the time of licensure.
There is a letter from NIH asking the manufacturer to collect
more data, but then the vaccine was licensed soon after, and it
appears the data were never obtained. Since then, the vaccine
has changed, and various procedures have been instituted, like
the procedure for re-dating expired lots, without required FDA
approval.
Stripes: Over time, did the manufacturing process for the vaccine become degraded and unmonitored?
Nass: Yes. It appears that FDA ignored the anthrax part of the plant for many years, supposedly because their inspectors were not vaccinated and so could not enter the facility. It seems this sloppy manufacturer never bothered to go through any of the normally required processes for adding fermenters, changing procedures, etc.
They never validated their procedures, for example, which is
the first and foremost thing you need to do in vaccine manufacture.
You have to prove that your procedures do what they are intended
to do.
FDA approved use of the vaccine lots based on the manufacturer’s
test data without subjecting the vaccine to outside testing.
Eventually, in February 1998, when the FDA finally did a proper inspection, they quarantined 11 lots formerly approved, and forced the manufacturer to shut down and rebuild their facility.
Stripes: Are there issues with shelf life, varying strengths of different lots, etc.?
Nass: The shelf life (per DoD) appears to be infinite. It is possible also that when vaccine was sent back to the manufacturer at the time of expiration—once it shipped from the manufacturer, it only had a one-year shelf life—that it was remixed with newer vaccine. Thus it is possible that if some early lots were contaminated, the contamination spread to later lots. But this is speculation at this point.
The scientists who used this vaccine in animal experiments
at Fort Detrick had long pointed out the marked variability between
lots. This heterogeneity is common knowledge, but is very unusual
and should not have been permitted by the FDA.
Stripes: Why were critics early on saying that anthrax was inappropriate
for “mass inoculation?”
Nass: Even the CDC [Centers for Disease Control] has said this: See the Dec. 15, 2000, MMWR report on recommendations for the vaccine. Basically, the reaction rate is high, the number of inoculations is higher than for any other licensed vaccine, and the protection is questionable.
Stripes: Why do more women than men have reactions?
Nass: We do not know for sure, but women in general are more susceptible to autoimmune diseases, like lupus and rheumatoid arthritis.
Stripes: Can you cite some cases of reactions you have personal knowledge about?
Nass: Severe rashes, in which all the skin peels off [Stevens Johnson Syndrome]; endocrine organ failure, in which the testes, thyroid and adrenal glands stop functioning; many different kinds of neurological reactions, many autoimmune rheumatological diseases, chronic fatigue and fibromyalgia.
Stripes: Is there really a threat that makes AVIP imperative?
Nass: The GAO in a report published December 2000 claimed that
CIA and State said there was no imminent threat.
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