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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 US
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.
Stars
and Stripes March 2001
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