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Anthrax Vaccine Safety Data - Will CDC Panel Advise Mandatory Shots for First Responders?
By Alliance for Human Research Protection www.ahrp.org
October 20, 2008

"It would be virtually unprecedented in modern times to mandate any vaccination on civilian populations without the clear existence of a current outbreak of disease."

Yet, the government seems Hell bent on doing just that.

Below is a letter addressed to the Center for Disease Control Advisory Committee on Immunization Practices, by AHRP board member, Meryl Nass, MD, who offers to provide them with a confidential draft of the paper, which reviews a large variety of published and unpublished materials. Dr. Nass alerts the ACIP members to the existence of the most comprehensive database on the anthrax vaccine--including data on 1.9 million vaccinated people-- which is maintained by the Defense Medical Surveillance System.

Below that is an article Global Security Newswire--setting the vaccine's serious safety issues aside--there are other hurdles involved in inoculating first-responders:

"Among the challenges facing any mass inoculation effort for first responders would be finding a method of tracking a complicated anthrax shot regimen for millions of personnel who might come and go from their jobs, according to the June meeting minutes. The schedule for the existing vaccine calls for six priming shots over an 18-month period, followed by annual boosters. Recent medical research suggests that fewer shots might be needed to establish immunity, but the official regimen has not yet changed"

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org

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From Meryl Nass MD:

Dear ACIP Member,

I am writing to bring to your attention information on anthrax vaccine you have probably not seen.

As you may know, I have written about anthrax vaccine, and discussed it in several Congressional hearings and before two IOM committees. I wrote a review article on anthrax vaccine safety at the request of the journal "Drug Safety," but due to insufficient data it was not published, and I am waiting to add to it with data from the CDC clinical trial that took place from 2002 through 2006 or 2007. I will be happy to provide ACIP members a confidential draft of the paper, which reviews a large variety of published and unpublished materials.

The most important database on anthrax vaccine safety will be found in the Defense Medical Surveillance System, which includes millions of person-years of data on inpatient and outpatient medical encounters for 1.9 million anthrax vaccinees, pre and post-vaccination, and all other military members since 1998. (Comparing the vaccinated cohort pre and post-vaccination was what the 2000-2002 IOM committee reviewing anthrax vaccine felt was the most reliable way to use the database, since deploying, vaccinated service-members as a group are healthier than their non-deploying peers.)

Initial review of this database by IOM revealed that hospitalizations for certain disorders, including breast and thyroid cancer, Crohn's disease, pulmonary thromboembolism, and at least five psychiatric disorders occurred at rates 2-5 times higher (with statistical significance) in the post-vaccination, compared to pre-vaccination period. I suspect that knowledge of these data led CDC's Data Safety Monitoring Board to select two cases of breast cancer that were diagnosed during the CDC clinical trial as "possibly related" to anthrax vaccination. The IOM library has these data from 1998-2001, and I am sure ACIP can obtain a copy, as I have. The remaining data may be requested from the Defense Department.

The military's four Vaccine Healthcare Centers (VHCs) have performed complete evaluations on over 2,000 persons who claimed illnesses following anthrax vaccinations. A surprisingly large number of these individuals presented with very similar syndromes (especially CFS and FMS-like illnesses), and the reports acknowledge this. Colonel Renata Engler, MD, the Army's top immunologist, directs the VHCs at Walter Reed, and has also posited a new case definition of a "Myalgia Myositis" condition associated with anthrax vaccine. Her conference presentation on this condition is on the internet, and I will be happy to provide the URL if you are interested. I strongly urge ACIP to ask Dr. Engler or one of the other VHC physicians to discuss anthrax vaccine safety with ACIP prior to your vote on its use in first responders.

The last important dataset is the CDC clinical trial. It seems unconscionable to vote on expanding anthrax vaccinations to up to 3 million additional recipients without careful study of the unblinded CDC data, as well as the databases I have discussed above. For one in eight participants to have experienced a serious adverse event -- during a 43 month clinical trial in which 83% of participants received anthrax vaccine - seems extremely high, especially when only 180 participants were 50 years or older at the trial's onset.

The Brachman study used a very different vaccine (in fact it used more than one vaccine and more than one dosing schedule, but that is another story) and vaccinees were only followed for adverse events for 48 hours. The Brachman results have little bearing on the current anthrax vaccine, for which there exists no human efficacy data, as you know.

The chairman of the CDC trial's Data Safety Monitoring Board, Dr. Plotkin, was a principal investigator of the Brachman trial. Given the controversy surrounding both vaccines, some might consider that a significant conflict of interest. I would therefore urge you to review the unblinded CDC adverse event data for yourselves, as only by comparing the adverse events between the placebo vaccinees and anthrax vaccinees will you be able to infer which events are likely vaccine-related.

Please let me know if I may provide additional information to you. I would appreciate an acknowledgement that this email has reached its intended recipients.

I'd like to thank you very much for considering these thoughts.

Best wishes,

Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609
mnass@gwi.net
W 207 288-5082 ext 1220
C 207 522-5229
Pager 207 818-0708
H 207 244-9165

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See: Panel May Advise Anthrax Shots for First Responders
By Elaine M. Grossman
Oct. 16, 2008
Global Security Newswire