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From: "veracare" <[log in to unmask]>

Alliance for Human Research Protection A Catalyst for Debate www.ahrp.org

FYI On Friday, October 28, the National Biodefense Science Board (NBSB), a government-appointed panel of "experts" voted its approval (12 to 1) for the government to proceed with an unconscionable medical experiment that would expose healthy US children to the risks of the anthrax vaccine, a vaccine which offers absolutely no direct benefit, but whose risks include serious adverse reactions such as Stevens-Johnson syndrome, neurological disorders, disability and death.

The Alliance for Human Research Protection wrote a letter to the Secretary of Health and Human Services (in June, 2011) outlining our concerns about this radical experiment, which clearly deviates from the precautionary principle in medicine and federal research ethics regulations. See: http://www.ahrp.org/cms/content/view/823/9/  

Under US regulations (45 CFR 46, Subpart D) children may not be exposed to risk if a medical experiment does not offer them a direct benefit. Don't be misled by government propaganda about the risk of an anthrax attack-- a myth perpetuated by the media:    

    Anthrax is NOT CONTAGIOUS -- it cannot be sppread from person to person.    

    Anthrax has neverr posed a threat to the general public; the only people at risk are research laboratory staff who handle anthrax bacteria.    

    The Center for Disease Control, untill recently, recommended vaccination "only for those at high risk, such as workers in research laboratories that handle anthrax bacteria routinely."   

    The FDA label (20008) states: "the vaccine is licensed for use only in adults between the ages of 18 and 65, who are at high risk for exposure to anthrax bacteria."

The NBSB recommendation was made despite its own report acknowledging that: "Currently, U.S. children are not at immediate risk from anthrax and would not benefit directly from pre-event AVA [anthrax vaccine] administration." And "There is no known benefit to vaccinating children in the absence of an imminent threat from exposure to B. anthracis other than potential future benefit."

Their justification is without substance, relying on a hypothetical, highly exaggerated risk from an unlikely event: "Preparation for a national and potentially global threat from the use of B. anthracis spores by terrorists is a major priority for U.S. national security." What evidence exists of any "national and potentially global threat from anthrax"? One is reminded of the purported "weapons of mass destruction" which never materialized, but served as our government's excuse for going to war against Iraq. 

Since 2004, the Dept. of Health and Human Services, which convened the NBSB panel, has overseen Project BioShield to develop and stockpile vaccines and treatments as medical countermeasures to hypothetical bioterrorist attacks. One goal was to develop a replacement for the controversial, 50 year old anthrax vaccine developed by the US Army, which admittedly has severe side effects. The cover story of Sunday's New York Times Magazine, "Ten Years After the Anthrax Attacks, We Are Still Not Ready," by Wil Hylton exposes the lack of leadership, confusion, and even mutual hostility among US government officials charged with developing biodefense countermeasures:

"Last year, two separate review boards evaluated the state of the country's biodefense program, and each report came back scathing." They described "ballooning" government bureaucracy, "lack of coherence," "lack of prioritization," "lack of synchronization" -- and colossal waste.

"Ten years after the anthrax attacks, and with more than $16 billion committed to countermeasure development, there is still broad disagreement among officials over whether the stockpile should include other vaccines.

"[The] challenge is not made easier by the personal hostility that has emerged among many current program heads some of whom have close ties to the commpeting companies they oversee. In the course of several months of reporting, I heard senior officials from each of the major countermeasure agencies question the motives and professional credentials of the others, sometimes in a manner involving spittle. At times it seemed that the most virulent pathogen in biodefense was mutual hostility, and everybody had it." See: http://www.nytimes.com/2011/10/30/magazine/how-ready-are-we-for-bioterrorism.html  

Of particular concern is the motive and professional credentials of the DHHS Assistant Secretary, Nicole Lurie, who proposed the anthrax vaccine trial in children. She did so, despite knowing that the vaccine is mired in controversy, despite knowing the health problems associated with it, despite the government's sweetheart deal with its sole manufacturer, Emergent BioSolutions, all common knowledge within the biodefense community. The panel's 12 to 1 recommendation favoring DHHS's request to proceed with the pediatric anthrax vaccine trial -- with the proviso that another "appropriate" panel be convened to determine the ethical viability [a requirement under 45 CFR 46.407] -- raises serious questions about the integrity of government-convened committees who rubber stamp dubious government initiatives and policies. Knowledgeable critics believe this vote demonstrates the insidious influence federal biodefense funding exerts on academics and physicians who can be counted on to sanction even the most egregious, ill-conceived government initiative and lend credence to hypothetical, unsubstantiated risks. FDA's latest label warnings (2008) states:    

"Since the risk of anthrax infection in the general population is low, routine immunization is not recommended. ... Safety and effectiveness of BioThrax have not been established in pregnant women or nursing mothers, or in pediatric or geriatric populations."

Notwithstanding FDA's licensure for limited usage indications of the vaccine -- and its explicit statement that the vaccine had NOT been tested in geriatric populations -- Daniel Fagbuyi, who chaired the NBSB Anthrax Vaccine Working Group, and is the medical director of disaster preparedness and emergency management at Children's National Medical Center in Washington, D.C., falsely implied that the vaccine had been tested and approved for elderly populations:     

"We can take care of Grandma and Grandpa, Uncle and Auntie. But right now, we have nothing for the children." http://www.washingtonpost.com/national/health-science/federal-advisers-endorse-testing-anthrax-vaccine-in-children/2011/10/27/gIQA95i7PM_print.html    

The single panelist who voted against the recommendation was Patricia Quinlisk, M.D., M.P.H., State Epidemiologist and Medical Director of the Iowa Department of Public Health, who chaired the NBSB panel.  The Alliance for Human Research Protection applauds Dr. Quinlisk's courageous moral stand.

An incisive article discussing the anthrax vaccine and the NBSB's odious recommendation was published by Forbes, titled "The Anthrax Vaccine Boondoggle," by Steve Salzberg , Professor of Medicine and Biostatistics in the Institute of Genetic Medicine at Johns Hopkins University's School of Medicine. See: http://blogs.forbes.com/stevensalzberg/ 

Kudos to The Washington Post for its coverage of two of the three public hearings of the National Biodefense Science Board (NBSB), which informed the public about the Obama Administration's proposal to test the safety and efficacy of the highly controversial anthrax vaccine on healthy US children.

See: Federal Advisers Endorse Testing Anthrax Vaccine in Children, by Rob Stein, published October 28, 2011. http://www.washingtonpost.com/national/health-science/federal-advisers-endorse-testing-anthrax-vaccine-in-children/2011/10/27/gIQA95i7PM_print.html  

See also: Possible Study of Anthrax Vaccine's Effectiveness in Children Stirs Debate , by Rob Stein, published October 24:  http://www.washingtonpost.com/national/health-science/possible-study-of-anthrax-vaccines-effectiveness-in-children-stirs-debate/2011/10/13/gIQAFWLdDM_print.html  

See also: Public Citizen letter to DHHS Secretary Kathleen Sebelius (Nov. 1, 2011) urging her to reject the National Biodefense Science Board's recommendation to conduct pre-event clinical trials of the anthrax vaccine in children: http://www.ahrp.org/cms/%E2%80%A8http://www.citizen.org/documents/letter-opposing-anthrax-vaccine-trials-involving-children-110111.pdf  

See, NBSB panel roster and Ex-Officio government agency officials -- all but one -- who lent their support for HHS proposed unethical experiment on vulnerable, children who are legally precluded from refusing to consent: http://www.ahrp.org/cms/content/view/836/9/ 

See, public reactions at: Read more... http://www.ahrp.org/cms/content/view/835/9/

Contact: Vera Hassner Sharav [log in to unmask] 212-595-8974




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