Meryl Nass,
MD
To the Editor:
In March 2002, an Institute of
Medicine (IOM) committee reported that not only was anthrax vaccine safe, it was
entirely effective against all anthrax strains and routes of infection. However, no human data exist to support
these claims, and the published literature disputes them (1).
In 2000, a different Institute of Medicine Committee
investigating the cause of Gulf War Syndrome wrote, “The committee concludes
that there is inadequate/insufficient evidence to determine whether an
association does or does not exist between anthrax vaccination and long-term
health effects” (2).
Since 1998, five studies have been published that linked
anthrax vaccination to the development of Gulf War Syndrome (GWS) (3,4); anthrax
and /or plague vaccination with GWS (5); or specific vaccines received for Gulf
deployment with GWS (6,7). The
Veterans Administration has presented, but not yet published, data from a sixth
study that shows anthrax vaccinees from the Gulf War have many more medical
problems than non-vaccinees (8). A
seventh study showed that recent anthrax vaccine recipients in the UK suffered a
high rate of systemic reactions that prevented 28% from driving or lifting for
48 hours. Seventy-one percent of
the (voluntary) vaccine recipients dropped out after one or more vaccinations,
and did not complete the four dose series (9).
Is there another body of literature that shows the vaccine to
be safe long-term, which swayed the IOM?
No, there is not. There exists no published research
disputing the vaccine's relationship to subsequent illness in Gulf War
veterans. Two CDC studies have been
said to show the vaccine is safe (10, 11), but in fact, each study acknowledged
it had no statistically valid data on the subject of anthrax vaccine and GWS
(12).
The IOM decided to ignore all the above research, and instead
based its conclusions on unpublished research done by the Defense Department,
which paid for the IOM study.
Although some of this research, using the Defense Medical Surveillance
System database (spanning several million person-years) suggested that four
autoimmune diseases and two cancers were statistically related to anthrax
vaccination, the IOM chose to ignore this evidence as well. These conditions are multiple sclerosis,
diabetes, asthma, Crohn's Disease,
thyroid cancer and breast cancer (13, 14).
The anthrax vaccine is manufactured at a facility the FDA
shut down in 1998 for failing to correct major manufacturing problems, such as
assuring vaccine sterility and inability to produce homogeneous vaccine
lots. The manufacturer had also
failed to report to FDA multiple instances of vaccine lots that failed
testing. Some of those lots had
been distributed for use, and one, Lot 16, was used to vaccinate Canada's
Defense Minister and troops.
The Army has indemnified the manufacturer against all claims,
both for illnesses that might develop following vaccination, and for those that
might occur due to vaccine failure after an anthrax exposure. The vaccine's manufacturer maintains no
private liability insurance for anthrax vaccine-related claims. Any such claims must be paid for by the
Department of Defense.
Currently a number of lawsuits are in the courts related to
problems with the anthrax vaccine; several involve deaths following anthrax
vaccinations. With virtually
thousands of people claiming post-vaccination illnesses, the defense department
could face a major financial loss from vaccine-related side effects, as well as
the loss of its flagship vaccine program for biological defense.
Many Gulf War veterans believe that the military decision to
classify their vaccinations at the time of the Gulf War was done pre-emptively,
with the knowledge that adverse effects were likely to develop. The lack of documentation of their
vaccinations has been a major stumbling block to obtaining compensation for
post-war illnesses, said to affect between 100,000 and 200,000 veterans.
On Friday May 17, Defense Department spokesman Jim Turner
revealed that the military is resuming anthrax vaccinations for “at risk”
troops, but that troops receiving the vaccine will not be disclosed “for
security reasons. The thinking is
that would-be attackers would not know which troops are protected.” Given that 500,000 doses were recently
released, and manufacture of vaccine is proceeding rapidly, why not vaccinate
all troops deployed to the Middle East, and advertise the fact, if the vaccine
is really as good as claimed?
The military has apparently decided that the Gulf War
strategy of classifying vaccinations, and omitting them from troops'
immunization records has stood it in good financial stead. Thus we are now to see the resumption of
an egregious practice that magnifies the difficulties of diagnosis and treatment
of subsequent medical illnesses.
The practice will no doubt be effective in immunizing the Defense
Department against subsequent claims.
Meryl Nass, MD
1. Brachman PS,
Friedlander AM: Anthrax. In Plotkin SA, Mortimer EA (eds): Vaccines, ed
2. Philadelphia, WB Saunders, 1994, p 729
2. Institute of Medicine. Gulf War and Health. Volume I.
National Academy Press 200. Washington DC. Page 313.
3. Unwin C et al. Health of UK servicemen who served in the
Persian Gulf War. The Lancet 1999; 353:169-178.
4. Schumm WR et al. Self-reported Changes in Subjective
Health and Anthrax Vaccination as Reported by Over 900 Persian Gulf War Era
Veterans. Psychological Reports 2002; 90: 639-53.
5. http:// www.dnd.ca/menu/press/Reports/Health/health_study_eng_1.htm
6. Steele L. Prevalence and patterns of Gulf War Illness in
Kansas
veterans: Association of symptoms with characteristics of
person, place,
and time of military service. Am J Epidemiol 2000;
152:991-1001. C
7. Cherry N et al. Health and exposures of United Kingdom
Gulf War
veterans. Part II: The relation of health to exposure. Occup
Environ Med 2001; 58: 299-306.
8. Mahan CM, Kang HK, Ishii EK et al. Anthrax vaccination
and
self-reported symptoms, functional status and medical
conditions in the
national health survey of Gulf War era veterans and their
families.
Environmental Epidemiology Service, Veterans Health
Administration,
Washington, DC. Presented January 25, 2001 @ Research Working
Group:
Military and Veterans Health Coordinating Board Conference on
Illnesses
among Gulf War Veterans: A Decade of Scientific
Research.
9. Hayes SC and
World MJ. Adverse Reactions to Anthrax Immunization in a Military Field
Hospital. J R Army Med Corps 2000; 146:191-5.
10. Fukuda K et al. Chronic Multisymptom Illness Affecting
Air Force Veterans of the Gulf War. JAMA 1998; 280: 981-8.
Iowas Persian Gulf Study Group. Self-reported Illness and
Health Among Gulf War Veterans. JAMA 1997;277:238-45.
12. Nass M. The Anthrax Vaccine Program: An Analysis of the
CDC's Recommendations for Vaccine Use. Am J Public Health 2002; 92:
715-21.
13. Institute of Medicine. The Anthrax Vaccine: Is It
Safe? Does It Work? National
Academy Press 2002. Washington DC. Appendix G.
14. http://www.redflagsweekly.com/nass/2002_march11.html
15. Jelinek Pauline. Anthrax Vaccination Policy Reviewed.
Associated Press, May 17, 2002.