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The IOM decided to ignore all the above research, and instead based its conclusions on unpublished research done by the Defense Department, which paid for the IOM study.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.
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.
15. Jelinek Pauline. Anthrax Vaccination Policy Reviewed. Associated Press, May 17, 2002.