Dr. Meryl Nass: On
The Front Lines Of The Anthrax Vaccine Wars
Dave Eberhart
Stars and Stripes
March 5, 2001
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."
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: How about anthrax vaccine in general, their successes
and failures?
Nass: There is essentially no good data. The one study of this
vaccine, done in the late 1960s, only performed active
surveillance for 48 hours, and one nurse was discouraged from
reporting reactions at the site that administered the most
vaccine. We do know, according to William Patrick, former head of
the offensive biowarfare program at Fort Detrick, Md., that one
vaccinated worker took his mask off in an anthrax "hot room"
at Fort Detrick, got a whiff of anthrax and died.
Personally, I think the vaccine is better than nothing for random
strains of anthrax that used to be found in woolen [goat hair]
mills. [These mills have all closed in the United States] But I
doubt it will be of much use when specially selected or
genetically engineered strains of anthrax are used as biological
weapons. Such highly virulent strains are very likely to override
vaccine-induced immunity.
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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Source: http://www.stripes.com/servlet/News/ViewArticle?articleId=100036840&frontpageId=100036836