Third Tri-Service Task Force
Third Tri-Service Task Force
Fighting for Veterans with Vaccine Syndrome – The Anthrax Vaccine Immunization Program (AVIP), is the name of the policy set forth by the U.S. federal government to immunize its military and certain civilian personnel with the BioThrax anthrax vaccine. It began in earnest in 1997 by the Clinton administration.
Thank you for inviting me to testify before this Health Subcommittee. My name is Meryl Nass, and I practice internal medicine in Bar Harbor, Maine. I have conducted a specialty clinic to treat patients with fibromyalgia, chronic fatigue syndrome and Gulf War illnesses for eight years. I also have a longstanding interest in the scientific evaluation and prevention of bioterrorism, particularly anthrax. Since 1998, I have spoken and written about the many soldiers and veterans who became ill after receiving anthrax vaccinations, usually with illnesses indistinguishable from Gulf War Syndrome. I hope to clarify outstanding questions about the vaccine in this talk.
Is there a Gulf War Syndrome?
How can I possibly ask that question, 16 years after the Gulf War ended? I brought it up because many people still deny the reality of this frequently serious illness. Last week, a new patient of mine, who presented with a severe, classic case of Gulf War Syndrome (per the CDC’s case definition, ) and was unable to work, informed me that his VA doctor did not believe in Gulf War Syndrome. He had never been given a diagnosis, and both he and his wife wondered if his problems were ‘all in his head.’
Six months ago, the Washington Post ran a front page article on Gulf War Syndrome titled, “Funding Continues for Illness Scientists Dismiss” written by David Brown, a physician journalist. Brown misrepresented the findings of the Institute of Medicine, claiming it “reached the same conclusion that half a dozen other expert groups had: Gulf War syndrome does not exist.”  Brown set up a straw man he then knocked down: that there is no cluster of symptoms unique to Gulf War veterans. He is correct: the symptoms of Gulf War Syndrome are not unique. Instead, they overlap closely with those of chronic fatigue syndrome, fibromyalgia, multiple chemical sensitivity, and irritable bowel syndrome.
But why should anyone expect Gulf War Syndrome to be a novel illness? The body has only limited ways of responding to environmental insults. Different noxious exposures can cause identical lung or kidney diseases, or cancers. Although Gulf War Syndrome may not be absolutely unique in its clinical features, the development of this syndrome in 25% of US veterans of one war is unprecedented.
According to the 2004 Report of the DVA’s Research Advisory Committee on Gulf War Veterans’ Illnesses, there are an estimated 200,000 Gulf War 1 veterans with chronic, ‘Gulf War’ illnesses related to their deployment. According to the Washington Post’s David Brown, 199,000 Gulf War veterans receive compensation for such illnesses.
Why Is This Illness so Often Dismissed?
DoD and DVA together have spent $260 million on Gulf War illness research. But the research findings are often contradictory; a large number of studies focused on psychological factors instead of physical illness; and there have been very few breakthroughs. According to John Feussner, M.D. (in the aforementioned Washington Post article) who was DVA’s chief research officer from 1996 to 2002, “After hundreds of millions of dollars and a decade or better of research, we really haven’t made any significant findings.”
However, the research methods used in these studies have been repeatedly criticized by GAO. For example, models investigating sarin exposure and subsequent illness were inadequate to identify areas of sarin exposure . Insufficient coordination and analysis of the huge Gulf War research portfolio has persisted. Media reports have focused more on the lack of a unique syndrome and the negative studies than on the clinically relevant, validated research results.
Gulf War Syndrome does not have an ICD-10 code. It is not described in medical textbooks yet, and it is not taught in medical schools. The massive, confusing body of published research is extremely difficult for the non-specialist, let alone a journalist, to understand. Veterans have so many symptoms they often appear to have psychiatric, rather than physical, illness to uninformed medical practitioners. Therapies recommended by the DVA emphasize the use of psychiatric medications as primary treatment modalities. All these factors have conspired to create a smoke screen that both the ill veteran, the competent medical practitioner and policymakers have trouble penetrating.
A closely related smokescreen has been created around the safety of anthrax vaccine and its role in Gulf War illnesses.
Despite the finding by a Senate committee in 1994 that anthrax vaccine was being considered as a possible cause of Gulf War illnesses, and the statement by the Persian Gulf Veterans Coordinating Board that “all potential causes [of Gulf War illnesses] that have been identified are being investigated,” when I first reviewed the portfolio of federal research on GWS in 1999, I was surprised to find that of 166 studies listed, none looked specifically at anthrax vaccine. Since 1999, a dozen Congressional hearings and seven expert committees have investigated anthrax vaccine safety and made research recommendations. Yet, since then the DVA and DoD have failed to correct the omission of anthrax vaccine-specific Gulf War illness research.
I reviewed the (latest available)2005 Annual Report to Congress on Gulf War Veterans’ Illnesses, which lists a total of 300 separate studies at a cost of $260.6 million dollars. Not one title mentions anthrax vaccine.
Contrary to the DVA and DoD research funding priorities, anthrax vaccine has not been dismissed as a possible cause of Gulf War illnesses by the experts. Since 2000, three expert panels have reviewed Gulf War illnesses and commented on the possible role of anthrax vaccine. Here are some of their findings and recommendations:
1. Institute of Medicine Committee on Health Effects Associated with Exposures During the Gulf War:
2. 2004 Independent Public Inquiry on Gulf War Veterans’ Illnesses (UK) report:
3. VA Research Advisory Committee on Gulf War Veterans’ Illnesses:
The research to determine the extent of anthrax vaccine’s contribution to Gulf War illnesses has simply not been done.
Could the smokescreen be deliberate? The Office of the Secretary of Defense contracted with the RAND Corporation to produce eight volumes on various Gulf War illness exposures. Since 2000, only one has remained unavailable: the study of vaccines and Gulf War illnesses. Dr. Beatrice Golomb completed this report in 1999, but it was not published. At DoD direction she revised the report in 2004-5, and for a time the RAND website promised publication in 2005, but it still remains unpublished. Neither DoD nor RAND has explained why.
Even the journal Science commented on the perceived lack of objective science in Gulf War illness research:
“Questions about the Pentagon’s ability to objectively study Gulf War illness have dogged the department for years and spawned numerous conspiracy theories. Removing those doubts has proven difficult. Just 6 weeks ago, an independent panel reported that the Pentagon had worked “diligently … to leave no stone unturned.” But that conclusion was spoiled by nasty disputes among panel members and staff, some of whom charge that its review was flawed and anything but independent.” 
What do we know about anthrax vaccine and adverse health effects?
There are two diametrically opposed bodies of work on this subject. Studies performed by the Defense Department since 1998 have uniformly found the anthrax vaccine to be safe, as did one Institute of Medicine (IOM) Committee funded by the Defense Department. However, that committee chose to ignore all anthrax vaccine-related studies of Gulf War illnesses, and also failed to use the traditional weight-of-evidence approach. The DoD studies are filled with methodological errors, as outlined by FDA in the vaccine label. Yet it was these studies that formed the primary basis for the 2002 IOM report used by DoD to validate the vaccine’s safety.
Because the US Army developed the anthrax vaccine, owns the patent, owns the production equipment, owns most of the vaccine stockpile, has indemnified the vaccine manufacturer against all claims regarding lack of safety or efficacy, and chose to vaccinate its troops with an insufficiently tested and improperly licensed vaccine on a mandatory basis, it is potentially at risk for large financial losses if the vaccine is found to be dangerous, its production negligent, or if the vaccine stockpile cannot be used. (One case of a disabled civilian Merchant Mariner, vaccinated with anthrax and smallpox vaccines, was settled for 2 million dollars.)
The non-DoD studies suggest the anthrax vaccine was a contributor to Gulf War illnesses, and a cause of multiple chronic medical problems. These studies include one by Unwin et al., which found British anthrax vaccinations to have increased the risk of chronic Gulf War illnesses by 50% in Gulf War veterans, and by 230% in a small cohort of vaccinated Bosnia veterans. The Canadian Department of National Defense hired a contractor to investigate Gulf War exposures and subsequent illnesses. Anthrax vaccine recipients had a 92% greater chance of developing chronic fatigue than unvaccinated veterans. A DoD-HHS Anthrax Vaccine Expert Committee found that combinations of symptoms suggestive of Gulf War illnesses reported to the FDA-CDC’s Vaccine Adverse Event Reporting System (VAERS) occurred 2-3 times as often as would have been expected by chance alone. Females have had higher rates of Gulf War illnesses than male veterans; females also have two times the rate of immediate systemic adverse reactions to anthrax vaccine as males, and file reports to VAERS at 3 times the rate of males. Schumm and Wolfe both determined that anthrax vaccine was a risk factor for Gulf War illness in separate cohorts of veterans.
As of June 26, 2007, the Vaccine Adverse Event Reporting System had received a total of 5359 adverse event reports for anthrax vaccine. These included 670 reports that FDA had designated serious, and 44 reports of deaths.
Raw data from the military’s Defense Medical Surveillance System in 2001 revealed statistically significant increased rates of hospitalizations after vaccination, compared to pre-vaccination, for heart attacks, psychosis, depression, breast cancer, thyroid cancer, gallbladder and bile duct cancers, uterine cancer, diabetes, blood clots, asthma, multiple sclerosis and abnormal PAP smears in 300,000 soldiers. Yet no focused studies of these relationships have been conducted or made public since.
An unpublished Navy study of active duty women inadvertently vaccinated during the first trimester, revealed a 39% greater rate of birth defects in vaccinated mothers, compared to mothers who received anthrax vaccine at any other time. An Army study found no increased rate of birth defects in vaccinated mothers, but did not examine first trimester vaccinations, and was admittedly not adequately powered to examine the issue.
Easily verifiable, but non-public, DoD and CDC data suggest that anthrax vaccine is associated with birth defects and long-term adverse effects. Just last month the GAO, citing CDC and Vaccine Healthcare Center officials as sources, reporting that 1-2% of anthrax-vaccinated individuals “may experience severe adverse events, which could result in disability or death.”  Since the CDC has been conducting a trial of anthrax vaccine in 1564 subjects since 2002, and the Vaccine Healthcare Centers have performed full evaluations on over 2,400 putative vaccine injuries, most following anthrax vaccinations, officials of these agencies should be knowledgeable about the effects of the vaccine. However, no published studies exist to confirm that 1-2% of vaccine recipients have serious or life-threatening adverse events, and the true number may be more or less than this. The number of deaths that were definitely caused by the vaccine is also unknown.
The evidence is convincing that anthrax vaccine is a contributor, but not the only contributor, to Gulf War illnesses.
How many individuals may be affected?
It is uncertain how many deployed Gulf War and non-deployed Gulf “era” veterans received this vaccine. The Pentagon estimated that 150,000 deployed 1991 Gulf War veterans received anthrax vaccine. The VA Research Advisory Committee on Gulf War Veterans’ Illnesses staff, using the 40% anthrax vaccination rate in self-reports, estimated that 285,000 veterans received anthrax vaccine in the Gulf War period. Reports exist of experimental anthrax vaccines that were used in addition to the licensed vaccine. There are very few available records of who received any anthrax vaccines in theater during Operations Desert Shield and Desert Storm. (Yet the Pentagon did a study in over 400 Fort Bragg soldiers two years after the war, in which booster doses of anthrax and botulinum toxoid vaccine were administered. The Pentagon was somehow able to identify the number of anthrax and botulinum toxoid vaccines administered during the subjects’ Gulf War deployment, and the dates, for all soldiers in the study.)
Subsequent to the Gulf War, FDA estimated that 475,000 soldiers received anthrax vaccine between 1991 and 1998, yet very few veterans have anthrax vaccine listed in their medical records from this period. Since 1998, 1.6 million soldiers have received anthrax vaccinations, averaging 4 doses each. An unknown number of military contractors and merchant mariners have also received anthrax vaccinations.
Thus over two million American soldiers have been vaccinated since the 1991 Gulf War, half of whom have been vaccinated since the start of Operation Iraqi Freedom. Consequently, DVA may continue to see large numbers of veterans who have become ill as a result.
How can DVA improve its research and its care of ill Gulf War veterans?
Ideally, DVA will follow the model that DoD and CDC, under Congressional directives, pioneered. DoD and CDC jointly created a Vaccine Healthcare Centers Network of four clinics, which perform very detailed and complete evaluations of patients. This provides a solid basis for treating complex patients by establishing firm diagnoses, and furthermore allows for a strong bond to develop between the patient and the provider. This bond is particularly important for the patients, whose condition is likely to be poorly understood by other providers, and who may have lost trust in the military and DVA systems.
DoD also created a Deployment Health Center at Walter Reed, where a similar detailed diagnostic process can take place, and patients undergo inpatient training about their condition and how best to manage it. This type of center might also be beneficial for Gulf War illness and vaccine-injured patients.
If DoD was required to contribute to the long-term care of some ill soldiers, it might place a higher priority on the safety of the countermeasures and other exposures to which its troops are subjected. Congress should consider instituting a mechanism that would extract a financial penalty from the Pentagon when its decisions lead to high rates of (preventable) chronic medical illnesses in its soldiers.
 VA RAC 2004 Report: www1.va.gov/rac-gwvi/docs/ReportandRecommendations_2004.pdf “A substantial proportion of veterans of the 1990-1991 Gulf War continue to experience chronic and often debilitating conditions characterized by persistent headaches, cognitive problems, somatic pain, fatigue, gastrointestinal difficulties, respiratory conditions and skin abnormalities…Research studies conducted since the war have consistently indicated that psychiatric illness, combat experience, or other deployment-related stressors do not explain Gulf War veterans’ illnesses in the large majority of ill veterans…”Progress in understanding Gulf War veterans’ illnesses has been hindered by lack of coordination and availability of data maintained by DOD and the Department of Veterans’ Affairs.”
 GAO-04-821T. June 1, 2004 : “The modeling assumptions…were inaccurate because they were uncertain, incomplete and nonvalidated.” “DOD and VA’s conclusions about no association between exposure to CW agents and rates of hospitalization and mortality…cannot be adequately supported because of study weaknesses.”
 GAO-04-767. June 1, 2004: “”Interagency coordination of Gulf War illnesses research has waned. In addition, VA has not reassessed the extent to which the collective findings of completed Gulf War illnesses research projects have addressed key research questions…This lack of comprehensive analysis leaves VA at greater risk of failing to answer unresolved questions about causes, course of development, and treatments for Gulf War illnesses.”
 Senate Committee on Veterans’ Affairs. Is military research hazardous to veterans’ health? Lessons spanning half a century. December 8, 1994. S. Prt. 103-97. https://www.gulfweb.org/bigdoc/rockrep.cfm
 Research Working Group of the Persian Gulf Veterans Coordinating Board. The Annual Report to Congress: Federally Sponsored Research on Gulf War Veterans’ Illnesses for 1998, Appendices. Department of Veterans Affairs. June 1999. pp 7-13.
 Institute of Medicine Committee on Health Effects Associated with Exposures During the Gulf War. Gulf War and Health. Volume 1: Depleted Uranium, Pyridostigmine Bromide, Sarin, Vaccines. National Academy Press, Washington, DC. 2000.
 VA Research Advisory Committee on Gulf War Veterans’ Illnesses. Scientific Progress in Understanding Gulf War Veterans’ Illnesses: Report and Recommendations. September 2004. www1.va.gov/rac-gwvi/docs/ReportandRecommendations_2004.pdf
 from Chapter 4: “The committee did not include various studies that sought to identify risk factors for the health problems reported by some Gulf War veterans.” Committee to Assess the Safety and Efficacy of the Anthrax Vaccine. Medical Follow-Up Agency, Institute of Medicine. Anthrax Vaccine: Is it Safe? Does it Work? National Academy Press 2002; Washington, DC.
 Ibid. Committee to Assess the Safety and Efficacy of the Anthrax Vaccine. Medical Follow Agency, Institute of Medicine. Anthrax Vaccine: Is it Safe? Does it Work? National Academy Press 2002; Washington, DC. From Chapter 1: “Several previous IOM committees evaluating possible causal associations between vaccines or other exposures and specific health outcomes have chosen to describe their findings with a weight-of-evidence approach (IOM, 1991, 1994, 2000b)…The current committee chose not to use that approach because it was not asked to evaluate exposure to AVA as a cause of specific health outcomes. Rather, the committee was asked to provide an overall evaluation of the anthrax vaccine’s safety.”
FDA criticized these studies’ methodologies in the vaccine label, stating:
“In addition to the VAERS data, adverse events following anthrax vaccination have been assessed in survey studies conducted by the Department of Defense in the context of their anthrax vaccination program. These survey studies are subject to several methodological limitations, e.g., sample size, the limited ability to detect adverse events, observational bias, loss to follow-up, exemption of vaccine recipients with previous adverse events and the absence of unvaccinated control groups.”
 The vaccine license was pulled by Federal Judge Emmett Sullivan of the 1st District Court in December 2003 and October 2004 for failures in the licensing process. FDA subsequently issued a Final Rule and a comment period, reestablishing the license, but new litigation was filed in December 2006 challenging the license on the basis of inadequate safety and efficacy data.
 Francis v. Maersk Line Limited and United States of America. Case No. C03-2898C. U.S. Dist Ct. for the Western District of Washington, ruling by Judge John C. Coughenour, Dec 9, 2005 to deny Def. motion to deny admissibility of Plaintiff expert witness
 Goss-Gilroy. Study of Canadian Gulf War Veterans: NR-98.050. Study contracted by the Canadian Department of National Defense, released June 29, 1998 and published on its website, accessed between 1999 and 2001 but no longer at the previous URL: https://www.dnd.ca/menu/press/Reports/Health/health_study_eng_1.htm.
 Sever JL, Brenner AI, Gale AD et al. Safety of anthrax vaccine: an expanded review and evaluation of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS). Pharmacoepidemiology and Drug Safety 2004; 13: 825-840.
 Schumm WR, Jurich AP, Bollman SR et al. The long term safety of anthrax vaccine, pyridostigmine bromide tablets, and other risk factors among Reserve Component Veterans of the First Persian Gulf War. Medical Veritas 2005;2:348-362.
 Copies of the serious VAERS reports and all VAERS reports were obtained by FOIA and uploaded to my website: https://www.anthraxvaccine.org/serious_VAERS_reports.pdf and https://anthraxvaccine.org/all_VAERS_reports.pdf
 Presented to the Committee to Assess the Safety and Efficacy of the Anthrax Vaccine. Medical Follow-up Agency, Institute of Medicine. Washington, DC. 2001. Can be accessed in the IOM reading room. 4 tables are published in Appendix G of the IOM report (cited in footnote 17) provide some of this data. I have uploaded some of the raw data tables for public access at the following locations: https://merylnass.googlepages.com/AMSAtitlepage.pdf
 LaClair B. Overview of exposures and health conditions reported by countries who served in the 1990-1991 Gulf War allied coalition. Presentation to the Department of Veterans’ Affairs Research Advisory Committee on Gulf War Veterans’ Illnesses. December 12-13, 2005. Washington, DC.
The safety and efficacy of anthrax vaccine have not been
established, and the preponderance of the world’s literature
shows the vaccine is unsafe, and a contributor to Gulf War
Syndrome as acknowledged in the vaccine’s package insert
Ever wonder what else was in the box along with the vaccine? The Department of Defense withheld the BioThrax Package Insert from troops. Below is the package insert available for download and viewing.
Gulf War Illness (GWI) is a multisystem disorder of unknown etiology that has afflicted many veterans of the 1990-91 Gulf War who have sustained progressively worsening health since the war1. Recent studies have demonstrated the presence of active inflammation in GWI2,3 and, in addition, a positive association of the levels of C-reactive protein (CRP), an inflammatory marker, with GWI symptom severity3. Moreover, we have shown that GWI serum contains substances that are harmful to neural cultures4`, a detrimental effect that can be prevented by serum of healthy GW veterans4 and partially so by pooled human immunoglobulin G (IgG)5. Although possible exposure to environmental toxins in war theater has been traditionally blamed for GWI6, the evidence above3-5 and the fact that the disease also afflicted nondeployed veterans7, point to other causes, including the vaccines administered to GW veterans4,5,7, such as the vaccine against anthrax. Here we present, for the first time, evidence indicating the presence of the harmful anthrax protective antigen PA63 in the serum of 15 veterans suffering from GWI, as follows. First, we confirmed that the addition of GWI serum to the culture had a detrimental effect, including decreased cell spreading and increased cell apoptosis, as reported previously4. And second, we found that the concomitant addition of specific polyclonal or monoclonal antibodies against PA63 had a remarkable protective effect on N2A cultures, significantly ameliorating cell spreading and reducing cell apoptosis. These results document that the adverse effects of GWI serum on neural cultures are due, in part, to persistent pathogens derived from the anthrax vaccine. We hypothesize that these anthrax pathogens persisted in the blood of the GWI veterans tested because of inability of those veterans to make antibodies against them, probably due to lack of Human Leukocyte Antigen (HLA) protection8. Finally, our findings point to a possible successful intervention in GWI consisting in neutralizing (by administering specific antibodies) and/or removing (by plasmapheresis) those harmful anthrax antigens.
Since the end of the 1991 Gulf War, there have been reports of unexplained, multisymptom illnesses afflicting veterans who consistently report more symptoms than do nondeployed veterans. One of the many
possible exposures suspected of causing chronic multisymptom illnesses Gulf War veterans is squalene,
thought to be present in anthrax vaccine. We examined the relationship between squalene antibodies
and chronic symptoms reported by Navy construction workers (Seabees), n = 579. 30.2% were deployers, 7.4% were defined as ill, and 43.5% were positive for squalene antibodies. We found no association
between squalene antibody status and chronic multisymptom illness (p = 0.465). The etiology of Gulf War
syndrome remains unknown, but should not include squalene antibody status.
Published by Elsevier Ltd
Although the Naval Health Research Center claims they found no correlation between Gulf War Syndrome and Squalene antibodies; Operation Truth will not simply accept this as an answer. As a team, we believe that there is a connection between vaccine(s) and the veteran. We believe that this yet unknown connection is why certain veterans are affected by such a deteriorating illness and others are not. We will continue our research in this field and try to find a connection.
The anthrax vaccine was never proved to be safe and effective. It is one cause of Gulf War illnesses, and recent vaccinees report symptoms resembling Gulf War illnesses.
The vaccine’s production has been substandard. Without adequate evaluation, the Food and Drug Administration recently approved (retrospectively) significant changes made to the vaccine’s composition since 1990. The vaccine’s mandatory use for inhalation anthrax is “off-label.”
A skewed review of the vaccine literature by the Centers for Disease Control and Prevention (CDC) led to remunerative collaborative research with the army, involving civilian volunteers. Despite acknowledging possible fetal harm, the CDC offered the vaccine to children and pregnant women.
New trends could weaken prelicensure efficacy and safety review of medical products intended for biodefense and avoid manufacturer liability for their use.