AHRP Leads Opposition to Proposed Anthrax Vaccine Trial in Children

Friday, 08 July 2011

The Alliance for Human Research Protection speaks out against a US government-proposed anthrax vaccine experiment on children. Such an experiment would sacrifice children’s welfare, much as canaries sent into the coal mines were sacrificed.

The National Biodefense Science Board,convened a two day meeting of the Anthrax Vaccine Working Group at the request of the Department of Health and Human Services. The July 7 meeting was open to the public, followed by a closed meeting on July 8.

Below are the written two-minute allotted public comments submitted by AHRP board members, Meryl Nass, MD and Vera Hassner Sharav. VHS attended the July 7 meeting and will have a follow-up post.

Below these comments is an excerpt from the FDA-approved Anthrax Vaccine Adsorbed (Biothrax) label warning.

July 7, 2011

Dear NBSB members:

Performing experiments in non-consenting children, especially when they do not have a condition the experiment is designed to address, is carefully regulated. Thus, according to Protection of Human Subjects in the Code of Federal Regulations (Part 46.407) a federal advisory committee must review the proposed research, and opportunity for public comment is required.

My fear is that the work you and I are expending on this question may be merely to meet the letter of the law, and not the spirit.

The intent of this federal law is to protect vulnerable child subjects from abuse by a research enterprise. The bottom line on anthrax vaccine is that we do not have any idea how well it will work in humans. Vaccinated monkeys and rabbits appear to do well after challenge… except that many vaccinated monkeys in Art Friedlander and Bruce Ivins’ tests 20 years ago did develop cases of anthrax, though they eventually survived. Other species of animals do less well with the vaccine when challenged.

The vaccine is unsafe, due to a small percentage of severe illnesses that do not resolve. These often resemble Gulf War Syndrome, characterized by fatigue, chronic pain and other symptoms. Don’t believe me: ask Renata Engler, whose Vaccine Healthcare Centers staff have documented chronic illnesses in several thousand young anthrax vaccinees. Ask why CDC officials told the GAO that 1-2% of vaccinees may develop illnesses resulting in disability or death. Ask why CDC has failed to publish the final results of its clinical trial of 1564 subjects, though data collection ended in 2007.

Yes, the Defense Department has managed to produce plentiful literature supporting the excellent safety and efficacy profile of this vaccine. DOD’s job is to fulfill its missions, not to win prizes for scientific accuracy or honesty.

The claims in the Q and A provided for parents of potential subjects are misleading or worse, and once children become ill those claims may come back to bite this committee and any others who signed off on the trial.

Sincerely,

Meryl Nass, M.D.

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