Dear Committee Members,

Thank you for the opportunity to come before the Committee and present materials to you today.

I wanted to provide you with some history of previous Gulf War investigations. To this end, I have included pages 1-6, 58, and 61-62 of the Second Report of the Committee on Government Reform and Oversight: Gulf War Veterans’ Illnesses: VA, DOD Continue to Resist Strong Evidence Linking Toxic Causes to Chronic Health Effects, dated November 7, 1997.

I believe the original rationale for formation of this IOM Committee is found on page 4, recommendation 2. Page 58 gives an example of how research and investigation of chemical agent exposures by the VA was delayed for years based on inaccurate data provided by the DOD. Pages 61-62 touch on the issue of missing records. Although Army Surgeon General Ronald Blanck told the Government Reform National Security Subcommittee that there was no directive to not record immunizations in the medical record at the time of the Gulf War, I am happy that the Office of the Special Assistant for Gulf War Illness (OSAGWI) confirmed several months ago that this policy was in place (to not record immunizations) and that it changed after the war ended.

Included as well is Appendix A: Account of Events Related to Health Concerns of Gulf War Veterans, prepared for The Health Impact of Chemical Exposures During the Gulf War, a research planning conference held February 28-March 2, 1999. This provides a useful historical framework for what has gone on before your Committee was formed.

The next document in your packet is the 1998 VA Annual Report to Congress of Federally Sponsored Research on Gulf War Veterans’ Illnesses for 1997. Of the 130 studies of 16 different possible exposures, not one reviews anthrax vaccine.

Several expert committees have previously deliberated on the possible role of anthrax vaccine in Gulf War Illness. I enclose the remarks of

a) The NIH Technology Assessment Conference Summary: The Persian Gulf Experience and Health

b) The Defense Science Board Task Force on Persian Gulf War Health Effects, June 1994, and

c) The Presidential Advisory Committee on Gulf War Veterans’ Illnesses (PAC), Final Report, December 1997

Each committee essentially said that given the 20 year history of use of the vaccine without reports of longterm adverse effects, that the vaccine would not be expected to cause GWI. Only the PAC provided references. The references specific to anthrax vaccine are included in your packet. All are to DOD briefers; Dr. Phillip Russell was at Johns Hopkins when he briefed the PAC, but was formerly Commander of US Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick. In his role as Commander, he wrote an article on military vaccines (Takafuji ET and Russell PK. Military Immunizations. Inf Dis Clin North America 1990;4:1, 143-58) in which he said that unlicensed anthrax vaccine had been used on servicemembers. Since licensed vaccine was also available, this suggests that at least two anthrax vaccines have been used (several were developed at Fort Detrick) and possibly an unlicensed vaccine is or has been responsible for illness.

Recent revelations of the Government Accounting Office (GAO) demonstrate that there is no record of safety. Veterinarians and animal husbandry workers have never received the vaccine routinely. It is not even known how many people received the vaccine before the Gulf War, but 200 to 2,000 people, who were never followed up, was the estimate given by Dr. Kwai-Cheung Chan, Director, Special Studies and Evaluation, National Security and International Affairs Division, GAO, to Congressman Shays’ Subcommittee on April 29, 1999 in his verbal testimony.

(accessible through Lexis-Nexis)

A former IOM Committee head, Dr. John Bailar, apologized for his committee’s findings after the fact, when information regarding chemical weapons exposures became public. I belabor this point because, although your charge is to review "published literature," it would be a shame to miss critical information available to you that has not been published in the scientific literature, and thereby reach conclusions that are meaningless.

As I made clear to the Committee previously, there are NO published studies of safety or efficacy for the current anthrax vaccine. There are several unpublished studies, which I was not permitted to give the Committee in September. However, an article appeared in JAMA last week referring to these studies but omitting crucial information and slanting other data. (Anthrax Vaccine: Evidence for Safety and Efficacy Against Inhalational Anthrax, Friedlander AM, Pittman PR, Parker GW. JAMA 282;22:2104-6).

I made the suggestion to Dr. Sox in September that, although the committee cannot review unpublished studies, all these studies and additional data have been reviewed by the GAO (Drs. Chan, Rodriguez and Sharma), who have provided reports to Congress on their contents. Why not have the GAO brief your Committee?

Dr. Sox thought it was a good idea. Subsequently, however, your staff has informed me that the GAO has not been asked to brief the Committee, and briefings on the DOD unpublished studies will be given by DOD briefers.

In my opinion, it is imperative that you learn about the existing data from sources outside the DOD, as well as from DOD sources. DOD reports to Congress have been grossly inaccurate with respect to anthrax vaccine, and the same may occur before your Committee. Texts of testimony before Congressional committees investigating the anthrax vaccine make this abundantly clear, and there have been 10 such hearings since March 1999. I include here Congressman Shays’ statement at the July 21, 1999 hearing, and that of Captains Michelle Piel and Jon Richter, two pilots from Dover Air Force Base who believe that the anthrax vaccine has caused them to become ill. Also enclosed is a letter from Dr. Craig Michael Uhl in last week’s Air Force Times, who questions the safety of the vaccine and left military service because of it.

Enclosed in your packet are two very interesting articles from the veterinary literature which describe the types of adverse reactions and vaccine contamination which have occurred in the past, and the difficulties in assigning an adverse event to a vaccine, given the size of the cohorts in usual vaccine trials:

1. Roth JA. Mechanistic Bases for Adverse Vaccine Reactions and Vaccine Failures. Adv Vet Med 1999;41:681-700

2. Glickman LT. Weighing the Risks and Benefits of Vaccination. Adv Vet Med 1999;41:701-713

4. FDA’S VACCINE SURVEILLANCE: THE VACCINE ADVERSE EVENT REPORTING SYSTEM (VAERS)

The only way FDA reviews adverse reactions to vaccines is through the VAERS system. Although reports may be provided by health care professionals, affected persons or their families, most people and many health care providers are unaware of the system, which has been in place for nine years. Reports are taken by an FDA contractor, which codes the information using a special thesaurus termed COSTART.

If the adverse effects people report are not included in COSTART, they will not be properly coded and counted. Furthermore, VAERS depends upon the likelihood that adverse events are suspected as being associated with vaccination, and that they will be reported. In the case of adverse events which occur following anthrax vaccination, military health providers have been told that only classic allergic reactions may be due to the vaccine, and that other reactions that have been reported by servicemembers, such as rashes and joint pains, must be due to something else. In addition, military health providers have been specifically told not to report to VAERS any reaction, unless it leads to at least 24 hours of lost duty time, hospitalization, or if contamination of the entire vaccine lot is suspected. This has, in my opinion, made the VAERS system incapable of serving its assigned role: to identify possible vaccine-related illness in excess of the expected numbers.

A one page sheet I wrote on this issue is included in your packet, as well as a page from the Anthrax Vaccine Implementation Plan document, which documents when providers are to report, and when not to report, to VAERS.

I enclose a press release from the FDA dated 3/11/97: FDA Warns Michigan Biologic Products Institute (MBPI) of Intention to Revoke Licenses. MBPI had not complied with FDA-mandated improvements to their plant for several years, which led to this threatened action. Since MBPI was the only manufacturer of the US anthrax vaccine for humans, they were allowed to remain open and to rehabilitate their physical plant. However, the vaccine servicemembers have received from at least 1991 to the present was manufactured during the time MBPI was in violation of numerous federal regulations regarding "good manufacturing practices." The inspection report of the facility conducted in February 1998 is on my website: www.anthraxvaccine.org.

Enclosed also is a page showing that when 31 existing vaccine lots were subjected to supplemental testing by the manufacturer in 1998, only 6 passed. Most of the 31 lots had expired and been redated for an additional 3 year period, either one or two times. No supplemental testing was conducted before the vaccine was used in the Gulf War, and previously expired lots were used then as well.

a) One issue that has been raised in trying to determine the role of anthrax vaccine in GWI is the lack of records documenting immunization. However, there are various ways to get around this hurdle. For one, most vets believe they know whether they received "Vac A" or one of the other names that anthrax vaccine went by at the time of the Gulf War.

b) One of the unpublished anthrax vaccine studies was conducted on over 400 servicemembers at Fort Bragg in 1993-5. It was designed to see whether a booster dose of anthrax vaccine given a few years after the initial injection(s) during the Gulf War, would yield antibody titres resembling a primary vaccination or a booster vaccination. To be enrolled in the study, records of the GW anthrax vaccination status had to be available; all those enrolled had one, two or three previous doses of anthrax vaccine. They also received booster doses of botulinum toxoid vaccine in this study.

Here we have a cohort of over 400 people whose dates and numbers of anthrax vaccinations are known. They should be studied for possible long-term illnesses, with the awareness that they were subject to various other exposures which could also contribute to illness.

c) PA is the primary antigenic component of anthrax vaccine. Anti-PA titres are routinely done at Fort Detrick. Such titres could be done on veterans affected with GWI to determine their vaccination history. However, they may well have unmeasurable titres at this point in time. Could PCR primers be constructed to measure small amount of anti-PA antibody, to definitively identify who received anthrax vaccine?

d) Nondeployed but vaccinated Gulf Era vets should be studied. There are a surprisingly large number of them who report symptoms consistent with GWI. To date, no studies have been done of this group.

e) Many spouses and other family members of Gulf War veterans report similar illnesses as their spouses. The most likely cause is a transmissible microorganism. A less likely possibility is contamination by materials brought home in the veteran’s belongings, such as depleted uranium.

The most likely source of an agent transmitted to thousands of family members is vaccine contamination. To my knowledge, no studies for contamination have been conducted of the vaccines used in the Gulf War. A study of veterans for the presence of mycoplasma is beginning. I suggest that residual vaccine bottles be studied as well, for all potential transmissible contaminants.

I also believe it is essential to study spouses afflicted with severe "GWI-like" illnesses, and to my knowledge, no such studies have been done. Their veteran spouses should have titres or PCR testing to document the vaccines they received at the time of the Gulf War.

I have asked several persons afflicted with Gulf War-like illnesses to speak to the Committee today, and I appreciate your willingness to accept these testimonies.

Dr. Rokke asked me to provide the Committee with some information, which has been added to your packet.

Again, I greatly appreciate the Committee’s interest in the possible role of anthrax vaccine in GWI. Please contact me if I may be of any assistance. My phone number is 207 865-7000.

Sincerely yours,

Meryl Nass, MD