Until 1998, there existed no published papers that explored whether receiving anthrax vaccine was related to Gulf War illnesses. Instead, several expert committees (lacking experience with anthrax) were asked to comment on whether anthrax vaccine was likely to be a cause of Gulf War Illnesses. The committees were given DOD briefings, did not review the literature (there were no published studies of safety or efficacy for the licensed anthrax vaccine), concluded that a relationship was unlikely, and then recommended against further research (1).

Studying American veterans was particularly difficult because many were not told whether they were given anthrax vaccine, and the vaccinations were specifically not entered into service members' shot records. Other centralized vaccine records have been lost. Despite concerns about the investigational status of anthrax vaccine when used for biological warfare, no informed consent was obtained from service members at the time of the Gulf War, and no waiver of informed consent was sought from the FDA.

The Canadian Department of National Defense (DND) hired a consulting company (Goss Gilroy Inc.) to study the health of Canadian Gulf Veterans and look at various exposures. Their report was published on the DND website. They found a significant relationship between receiving non-routine (biological warfare) immunizations and developing chronic fatigue, a very common symptom of GWS (2).

In 1999 a British study examined a large number of Gulf War exposures in large cohorts of British Gulf War and non-deployed Gulf-era veterans, and Bosnia veterans. They found that for both the Gulf War and the Bosnia veterans, receiving anthrax vaccine was related to developing an illness consistent with Gulf War Syndrome (GWS). They wrote, "Vaccination against biological warfare and multiple routine vaccinations were associated with the CDC multi-symptom syndrome in the Gulf War cohort (3)."

This group published a follow-up paper in the British Medical Journal that claimed that only Gulf War veterans who received vaccines after deployment, not before, showed this relationship. However, they later retracted this conclusion, and acknowledged that the timing of vaccination did not affect the relationship between vaccination and GWS.

A study of Kansas Gulf War veterans was published in 2000 (4). This study also found that deployment vaccines were related to GWS: 34% of Gulf War veterans met the definition for GWS, while only 4% of non-deployed, non-vaccinated Gulf-era veterans met the definition. However, 12% of Kansas Gulf-era veterans who were vaccinated in preparation for deployment, but then were not sent to the Gulf, also met the GWS definition. The paper concluded, "Vaccines used during the war may be a contributing factor."

A second study of British Gulf War veterans was published in 4/2001. This study looked at the relationship between various Gulf War exposures and subsequent health. It did not look at specific deployment vaccines, but instead evaluated the number of vaccinations received in relation to GWS. It said, "Consistent, specific, and credible relations, warranting further investigation, were found between health indices and two exposures, the reported number of inoculations and days handling pesticides (5)."

The Veterans Administration collected data on thousands of Gulf War veterans who presented for evaluation of Gulf War Syndrome. Although unpublished, the data were presented at a conference on GWS in January 2001 (6). The VA asked veterans if they thought they had received anthrax vaccine at the time of the Gulf War, among many other potential exposures, and inquired about symptoms of illness. Those who believed they had received anthrax vaccine were twice as likely to report a multitude of symptoms as those who believed they were not vaccinated.

These are all the Gulf War data that are available in the open literature. Every study that examined the question of whether vaccines in general, or specific non-routine vaccines, or anthrax vaccine alone may have contributed to GWS, has found a positive relationship.

The French Ministry of Defense (MOD) recently convened an advisory committee to study GWS chaired by Professor Roger Salamon. This committee reviewed the existing world literature on GWS, and suggested that "multiple vaccinations given during the war, particularly those for anthrax, botulinum and plague, seem associated with an excess of (GWS) signs and symptoms (7)."

There are no published long-term adverse event data from the anthrax vaccine immunization program, which began vaccinating service members in March, 1998. However, the unpublished study done by Captain Jean Tanner at Dover Air Force Base suggests that recent anthrax vaccine recipients face similar medical problems as the Gulf War veterans (8).

Meryl Nass, MD
207 865-7000
mnass@anthraxvaccine.org

________________________

1. Expert committees listed in my Testimony to the House National Security Subcommittee, April 29, 1999.  http://www.house.gov/reform/na/hearings/testimony/nass2.htm

2. http:// www.dnd.ca/menu/press/Reports/Health/health_study_eng_1.htm

3. Unwin C et al. Health of UK servicemen who served in the Persian Gulf War. The Lancet 1999; 353:169-178.

4. 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.

5. 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.

6. 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

7. www.gulflink.org/france/RAPPORTa.doc

8. www.anthraxvaccine.org/Report.pdf
    www.anthraxvaccine.org/data.pdfwww.anthraxvaccine.org/remarkst.pdf