Talking points: anthrax vaccine preliminary injunction
Meryl Nass, MD
Safety: Critique of National Academy of Sciences Report
1. The National Academy of Science (NAS) produced four reports that dealt
with anthrax vaccine. All of those reports, except the last one, admitted
there was insufficient evidence to show long-term vaccine safety. The
final report, by the Committee to Assess the Safety and Efficacy of Anthrax
Vaccine, acknowledged that "statistically significant elevations in rates
for outpatient visits were also found for certain malignant neoplasms,
portal vein thrombosis, and acute pulmonary heart disease, among others"
(page 118 of The Anthrax vaccine: Is It Safe? Does It Work? National
Academy Press, Washington D.C. March 2002). Furthermore, there were higher
rates of hospitalizations for diabetes, asthma, Crohn's Disease, thyroid
cancer, in situ cervical and breast cancer, other intestinal disorders and
multiple sclerosis (ibid, pp 120-121).
This National Academy of Science Committee (paid for by the Defense
Department) never said anthrax vaccine had proven long-term safety.
Instead, the panel agreed with the three earlier NAS panels that "the
available data are limited." But they then chose to interpret the lack of
data as showing "no convincing evidence at this time that personnel who
have received AVA have elevated risks of later-onset health events."
How could they say this, when seven studies of Gulf War veterans had linked
vaccinations to chronic illnesses in veterans? The Committee conveniently
dismissed all seven studies by saying that since veterans' vaccination
records were missing, the studies' results were unreliable. (However, in
the two British and one Canadian study linking vaccinations to GWS,
vaccination records were NOT missing. Furthermore, who lost the US
records? The Defense Department, of course, which knew it would be much
harder to link vaccinations to later diseases without the records.)
How Many People Are Affected?
2. At least 150,000 US Gulf War veterans, and soldiers inoculated in
preparation for deployment to the Gulf War, received anthrax vaccine in
1990 and early 1991. Many who were vaccinated but never deployed have
developed "Gulf War Syndrome" (GWS) - illnesses identical to those of many
anthrax vaccine recipients today. They had no other exposure in the Gulf
to account for their illnesses.
3. One million soldiers and military contractors have received anthrax
vaccine since March 1998. They have filed over 3,000 adverse event reports
to the FDA reporting problems they experienced following vaccination.
4. According to the FDA, an additional 475,000 US soldiers received
anthrax vaccine between 1991 and 1998.
5. This totals 1.6 million Americans who have been vaccinated against
anthrax since 1990, more than one in every 200 Americans. How many have
developed chronic illnesses and disabilities as a result?
6. The epidemiological studies looking into long-term effects of
anthrax vaccination come from research on Gulf War veterans. A Canadian
study linked chronic fatigue to anthrax and plague vaccinations. A British
study linked anthrax vaccine to Gulf War Syndrome in vaccinated veterans of
both the Gulf War and the Bosnia conflict. Studies of US GW veterans from
Ohio and Boston have linked anthrax vaccine to GWS. Studies from Kansas
and the UK that looked at vaccinations in general, without separating
individual vaccines, found that receiving vaccinations for the Gulf
deployment related to developing GWS.
7. The Kansas study (by Lea Steele) found that being vaccinated in
preparation for a Gulf deployment, but never going to the Gulf, increased
the chance of developing GWS in veterans by 8%.
8. A study done at Dover AFB by an air force pilot indicated that
about 30% of those vaccinated for anthrax developed at least one chronic
medical problem soon afterward.
9. Assuming 5% of 1,600,000 people have developed illnesses resembling
GWS or other serious medical conditions from anthrax vaccine, then a total
of 80,000 people have developed this serious illness as a result of their
military vaccinations in the last thirteen years. (We still lack enough
reliable information to know for sure how many have become ill, but this is
a reasonable estimate for now.)
10. The GAO found that 60% of those who developed illnesses that occurred
shortly after vaccination did not seek treatment within the military, and
tried to keep their illnesses hidden to avoid adverse effects on their
careers. This is probably why military statistics do not reflect an
increased number of serious illnesses, overall, in those vaccinated.
11. Of the 40% that did seek treatment within the military, well over 90%
have been told the vaccine had nothing to do with their illnesses.
Is the vaccine licensed for inhalation? Is it effective for inhalation?
12. The currently used anthrax vaccine was licensed in 1970 using safety
and efficacy data from an earlier, different anthrax vaccine. Then and in
1985, the FDA noted that the data only showed protection for skin
(cutaneous) anthrax, not inhaled anthrax. Because DOD also knew the
vaccine was not licensed properly for inhalation, it held a series of
meetings in the mid 1990s to discuss what it would take to get the vaccine
a license that included inhalation. The Investigational New Drug
application, prepared by DOD and filed in 1996, acknowledged that a major
purpose of the application was to license the vaccine for inhalation.
Because DOD has never been able to generate convincing data to show the
vaccine is effective in people for inhalation anthrax, it has been unable
to get the license changed. It does not matter how many monkeys lived or
died in anthrax experiments, because DOD cannot show that the monkey
experiments are predictive of human survival. Furthermore, two other
vaccines developed for biological warfare turned out to be ineffective for
inhalation. We simply do not know if the vaccine protects against
weaponized anthrax.
13. The National Academy of Sciences panel went out on a limb and claimed
the vaccine protected against all known or plausible engineered strains of
anthrax. This is utter rubbish. In animal models, this vaccine has not
protected against all strains of anthrax. Furthermore, how can they say it
will protect against bioengineered anthrax, when they do not know which
genes were changed by genetic engineering? In fact, the defense department
sponsored a secret project to bioengineer an anthrax strain that would be
vaccine resistant. This claim is a good example of how the authors of the
report actually ignored the existing science on anthrax.
14. Claims that Al Qaeda sought anthrax, and other "threats" that have
just appeared in the media, designed to support continued mandatory
vaccinations, miss the point. Why were civilians given antibiotics, which
were 100% effective? Why do plans for civilian readiness in future
continue to emphasize antibiotics above vaccine? No vaccine is available
to civilians, despite the DOD saying they have a more than adequate supply,
and Bioport wanting to sell vaccine. Why? If civilians got this
"licensed" product and got sick, they could sue Bioport for damages, and go
after the FDA for inadequate testing and warnings on the label. DOD, FDA
and Bioport only want to vaccinate a captive population that has little or
no legal recourse when injured (due to the Feres Doctrine, which prohibits
servicemembers from suing the government for any injury sustained "incident
to military service"😉.