An exchange of letters on my May 2002 article in the American Journal of Public Health between the Army’s Assistant Surgeon General and myself:
American Journal of Public Health November 2002, pp 1707-9
SCIENTIFIC EVIDENCE SUPPORTS ANTHRAX VACCINATION
A commentary by Meryl Nass that describes anthrax vaccination as unsafe and ineffective1 repeats assertions made by the author in previous settings,23 assertions that have been considered and dismissed by multiple government experts and civilian scientific committees.4 Critically, it neglects a recent review by the Institute of Medicine (IOM) of the scientific evidence for the safety and effectiveness of this vaccine.4
Thoughtful readers will appreciate the scrutiny applied by the IOM in its review. Not surprisingly. the institute gives more weight to cohort studies than to case reports. Regarding the vaccines effectiveness, the IOM review states,
“… the available evidence from studies with humans and animals, coupled with reasonable assumptions of ana1ogy shows that AVA (anthrax vaccine adsorbed) as licensed is an effective vaccine for the protection of humans against anthrax, including inhalational anthrax, caused by all known or plausible engineered strains of .B. anthracis.
As to the safety of the anthrax vaccine, the review has this to say:
“The committee found no evidence that people face an increased risk of experiencing life-threatening or permanently disabling adverse events immediately after receiving AVA, when compared with the general population. Nor did it find any convincing evidence that people face elevated risk of developing adverse health effects over the longer term, although data are limited in this regard (as they are for all vaccines).”
The Lancet quotes IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine chairman Brian Strom as saying, “If we had a bias to begin with, it probably was against the military. I felt we just had to turn over the right stone and we’d find a smoking gun out there. But we didn’t find it, and we looked hard.”
The commentary omits several useful facts. Every lot of anthrax vaccine used in the United States met US Food and Drug Administration (FDA) lot-release specifications, both before and after the FDA’s January 2002 approval of the manufacturer’s renovations.4 The FDA quality-control requirements specified in 1999, before the anthrax vaccine shortage developed, were the same requirements met in 2002. In addition, a May 2001 trial of an Air Force physician who disobeyed his commanding officer by refusing vaccination began with 1.5 days of testimony by Nass, testimony that the judge eventually ruled as having no material value to the jury.
Anthrax vaccine is a safe and effective vaccine, in the considered opinions of America’s most accomplished scientists. The scientific evidence to support this finding appears in the IOM report for all to read.
George W Weightman, MD
About the Author
The author is assistant surgeon general of the United
States Army Falls Church, Va.
Requests for reprints should be sent to George W Weightman, MD, 5109 Leesburg Pike, Falls Church, VA 22041 (e-maiL George. Weightman@otsg.amedd,army. mu).
References
1. Nasa M. The anthrax vaccine program: an analysis
of the CDC recommendations for vaccine use. AmJ
Public Health. 2002:92:715—721.
2. Sidel VW, Nass M, Ensign ‘F. The anthrax dilemma. Med Global Survival. 1998;5:97—104.
3. Nasa M. The Department of Defense’s anthrax vaccine experiment. Maine Thogressive. 1998; December. Available at: http://www.maineprogressive.org/ 121998/anthrax.htm. Accessed Sep 13, 2002.
4. Joellenbeck LM, Zwanziger LL, Durch IS, Strom
BL, ads. The Anthrax Vaccine: is It Safe? Does it Work?
Washington, DC: National Academy Press; 2002.
5. Sever IL, Brenner Al, Gale AD Lyle TM, Moulton
LH, West DJ. Safety of anthrax vaccine: A review by the
Anthrax Vaccine Expert Committee (AVEC) of adverse
events reported to the Vaccine Adverse Event Reporting
System (VAERS). Pharmacoepidemiology Drug Safety.
2002; 11:189—202.
6. Larkin M. Anthrax vaccine is safe and effective—but
needs improvement, says 1051. Lancet. 2002;359:951.
NASS RESPONDS
In September 2000 an earlier Institute of Medicine (IOM) committee discussed the paucity of published data on the anthrax vaccine and drew no conclusions about its long-term safety.i But the IOM committee referenced by Weightman, funded by the Defense Department, gave enthusiastic support to the anthrax vaccine,2 solely on the basis of controversial, mostly unpublished military research.
This second IOM report completely ignored the significant body of evidence relating anthrax vaccine to chronic diseases.3 Three additional 2002 papers have linked anthrax vaccine to optic neuritis,4 joint problems,5 and Gulf War syndrome.6 Research suggesting increased birth defects postvaccination was ignored as well.7
Far from turning over every stone, the IOM committee performed a review remarkable only for its bias.8 For example, the IOM compared “immediate onset” reaction rates from a patient-initiated survey at Dover Air Force Base9 with the results of an Army study, and found them comparable in number and type, validating the Dover study. The IOM report, however, omitted the chronic illness rate following vaccination in the Dover study: over 29%.
Similarly, the report’s Appendix G lists diagnoses for which the incidence increased significantly following vaccination. Identical illnesses were reported to the US Food and Drug Administration’s Vaccine Adverse Event Reporting System, and many were noted in the vaccine’s package insert.10 But the IOM responded paradoxically. After noting that elevated rates of multiple sclerosis, diabetes, Crohn’s disease, myocardial infarction, thyroid cancer, and other diagnoses might be “signals of a possible causal relationship” and “deserve continued surveillance,” the report specifically recommended against special surveillance for long-term effects of anthrax vaccine.
My pretrial testimony at the court-martial of CPT John Buck, MD, was supported by 65 exhibits, primarily government documents, that proved the vaccine had never demonstrated human safety or effectiveness, nor was licensed for its current use. The military judge refused to let the jury hear this evidence.
In contrast, a spring 2000 hearing before Canada’s highest military judge led to the ruling that mandating this vaccination constituted a violation of the Canadian Charter of Bights and Freedoms.11 Consequently, Canada no longer requires anthrax vaccinations for its troops, whereas the US military has resumed vaccinations, enforced with courts-martial at which the evidence will never be heard.
Furthermore, despite the Defense Department’s continued denials, in May the Department of Veterans’ Affairs made adverse reactions from anthrax vaccine a compensable cause of disability.
To correct Weightman’s final misstatement: anthrax vaccine lots have been distributed in the absence of Food and Drug Administration approval. One vaccinated Canada’s defense minister.12
Meryl Nass, MD
About the Author
Meryl Nass is with Parkview Hospital and Midcoast Hospital, Brunswick, Me, and Maine Medical Center, Portland, Me.
Requests for reprints should be sent to Meryl Nass, MD, 124 Wardtown Rd, Freeport, ME 04032
(e-mail:mnass@gwi.net)
References
1. Fulco CE, Liverman CT, Sox HC, eds. Gulf War
and Health: Volume 1. Depleted Uranium, Pyridostigmine
Bromide, Satin, and Vaccines. Washington, DC: National
Academy Press; 2000.
2. Joellenbeck L, Zwanziger LL, Dutch IS, Strom
BL, eds. The Anthrax Vaccine: Is It Safe? Does It Work?
Washington, DC: National Academy Press; 2002.
3. Nass M. Anthrax vaccine not safe and effective. Emerg Med News. 2002:24:44.
4. Kerrison JB, Lounsbury D, Thirkill CE, Lane RG, Schatz MP, Engler RM. Optic neuritis after anthrax vaccination. Ophthalmology 2002;109:99—104.
5. Geier DA, Geier MR. Anthrax vaccination and
joint related adverse reactions in light of biological
warfare scenarios. Clin Exp Rheumatol. 2002;20:
217—220.
6. Schumm WE, Reppert EJ, Jurich Al’, et al. Self-reported changes in subjective health and oaths-ax vaccination as reported by over 900 Persian Gulf War era veterans. Psychol Rep. 2002;90:639—653.
7. Ryan M. Assessment of birth defects among infants of women who received anthrax vaccine: Information for the Institute of Medicine, Washington DC.
2002.
8. Nasa, M. On eroding the values of science: the Institute of Medicine’s report on the anthrax vaccine.
Available at: http://www.redflagsweekly.com/naas/ 2002 mas-chll.html. Accessed September 9, 2002.
9. Tanner J. Survey results of the 9th Airlift
Squadron. Presented at: Third Anthrax Vaccine Safety
and Efficacy Committee Meeting; April 17—18, 2001:
Washington, DC.
10. Anthrax vaccine adsorbed (Biothrax) [package insert]. Lansing, Mich: Bioport Corporation; 2002. Available at: http://www.fda.gov/cber/label/ biopavaOl3lO22LB.pdf. Accessed September 9, 2002.
11, Standing court martial for the trial of Ex-Sergeant Michael Richard Kipling. Canadian Forces. 17th Wing, Winnipeg, Manitoba. Canada, between 15 February and 5 May 2000 [transcript]. Available at http://www.
majorbates.com/law/canadatranscripthim Accessed October 15, 2002.
12. Rees A. Their Dangerous Dose. Vancouver ProvInce. June 25, 2000.
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