Anthrax Vaccine Network, Inc.
P.O. Box 844 Missoula, MT 59806
PH: 1-888-411-3200 FAX: (406) 542-0832
e-mail: contact@anthraxvaccine.net

Lades and Gentlemen:

We have reviewed your report, The Anthrax Vaccine: Is It Safe? Does It Work? and wish to express our extreme concern about the reports conclusions. The conclusions indicate that your charge to conduct a thorough and objective investigation has been circumvented; and that there are deliberate and serious omissions, given the information you were provided.

The following information was provided to you as a Briefing Book by a member of your committee, George Robertson. The Briefing Book may be found at: http://www.anthraxvaccine.net/BriefDoc/anthraxbriefingbook.doc

Our most serious concerns are:

1. Contrary to IOMs position two years ago, there is now, mysteriously, a large body of research to indicate the vaccine is safe. In an IOM report to the Department of Defense dated March 30, 2000 you stated:

   "There is a paucity of published peer-reviewed literature on the safety of the anthrax vaccine. The committee located only one randomized peer-reviewed study of the type of anthrax vaccine used in the United States (Brachman et al., 1962). However, the formulation of the vaccine used in that study differs from the vaccine currently in use."
   (Ref.: An Assessment of the Safety of the Anthrax Vaccine — March 30, 2000)
   http://www.nap.edu/html/anthrax_vaccine
   
   

   We submit to you that additional data has been supplied by the Department of Defense to conform to its anthrax vaccine immunization program, and that there is still a paucity of objective scientific data.
   
   
2. The vaccine which has been used on the troops is not, in fact, licensed for use against aerosolized anthrax, and is an Investigational New Drug.

   1995 -- SAIC Corporation contracted to develop an Army plan to obtain FDA approval for a license amendment to include aerosolized anthrax exposure saying, This vaccine is not licensed for aerosol exposure expected in a biological warfare environment.
   (Ref.: SAIC Corporation plan, 29 Sep 1995, enclosure to memorandum from Dr. Anna Johnson-Winegar, US Army, to Dr. Robert Myers [MDPH], US Army Medical Research and Material Command, Fort Detrick, Frederick, MD, 5 Oct 1995.)
   
   1996 IND (Investigational New Drug) Application submitted by MBPI, the anthrax vaccine manufacturer, to obtain inhalation anthrax approval.
   This IND application is still pending with the FDA.
   

   This omission of objective and crucial information is fatal to the charge of this committee.
   
   
3. Your report does not acknowledge, identify or indicate any material that is contrary to the committees findings, including Defense Department research. We again refer you to the Briefing Book for a full report. You also solicited, and then ignored, written testimony by Major Russell E. Dingle of the Connecticut Air National Guard, which said in part:

   The U.S. military is virtually the sole proprietor and source of any safety and efficacy data for AVA. As such, the current military opinion of AVA must be addressed in the following context: Either the first forty years of data, observation, and opinion is wrong, or the last two years of data, observation and opinion is wrong...

4. The verbiage in the report doesnt speak to the problems listed on the label, even though the entire new label is included as an appendix. The FDA required a wide range of severe illnesses to be listed on the new label; and the rate of adverse reactions is now 175 times that of the old label. To ignore quantum increases in the adverse reaction rate is unthinkable given the committees charge to evaluate the safety of the vaccine.
   
   
5. There is no acknowledgment in the report of under-reporting in VAERS in general or the military.
   Moreover, there is no recognition that troops live in fear of retaliation for speaking out against the vaccine, and are too often ignored once they become sick. The following testimonies illustrate the point:

   "I remember a Sgt. came to me after I got the boot and said … 'I have the same problems you do but I have 4 more years left before retirement and three kids to take care of ... we cannot come forward and you are a great example why.'" (Gulf War Veteran)

   "I spoke to the press about the vaccine in October without saying anything about the military, our unit, government or anything. Now I am being forced before the med evaluation board this Monday. The letter written by our support group commander and sent forward with my medical records had enough false statements in it to essentially guarantee the end of my career." (Active duty Army troop)

6. The IOM committee fails to mention the manufacturers inability to comply with current Good Manufacturing Practices resulting in the FDA closure of the facility. We refer you to our web site for the full set of FDA reports on this vaccine; and to our Citizen Petition to the FDA documenting BioPorts 1990 change in fermentation and filtering equipment, which resulted in a 100-fold increase in the potency of the vaccine. The omission of these critical facts is fatal to the committees charge to review the safety and effectiveness of the vaccine.
   
   
7. The IOM committee found that, despite limited data on long-term effects, reports of serious illnesses and reports of links to Gulf War Syndrome, no special follow-up efforts should be made.

   No less than five studies of Gulf War Syndrome found a statistically significant association between anthrax vaccine, or multiple vaccines given for the Gulf theater deployment, and the development of Gulf War Syndrome. No studies exists that refute this associationÖ VAERS has to be studied in order to generate hypotheses: that is its purpose. FDA did this and put the information in the current anthrax vaccines package insert. IOM prefers to imply that no chronic symptoms are due to the vaccine, whereas FDA properly notes that some symptoms are reported with sufficient frequencyÖto be included in the vaccines label. Dr. Meryl Nass, in her response to the IOM report.

8. The IOM report points out the double standard that exists between service members and civilians. Given the congressionally mandated and the courts upholding of the overriding requirement to assure the safety of US citizens with respect to prescription drugs, and given the realized risk of exposure to the entire US population, it is implausible that the committee chose to differentiate service members from their families.

   "The anthrax vaccine is effective and safe enough to use to protect U.S. soldiers, says a panel of medical experts. But there are not enough studies to assure its safety for wide use by the public, and a better vaccine is needed, according to a report released Wednesday by the Institute of Medicine."
   Anthrax vaccine found safe for troops -- More study needed before public use
   By Anita Manning, USA TODAY, March 7, 2002

The legal fight over whether this is, or is not, an experimental vaccine, will continue despite the IOM committee's flawed evaluation of the vaccine. Several federal court actions are currently under way. The fundamental issues are these: whether U.S. service members will be granted the right of informed consent; and whether the FDA will be required to enforce the Federal Food, Drug and Cosmetic Act in assuring the public of safe and effective drugs as guaranteed them by federal law, and inherent in the U.S. leadership role in participating in the Nuremberg Convention 57 years ago.

Sincerely,

Kathryn D. Hubbell, President
Anthrax Vaccine Network, Inc.