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:
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, 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/
Contact: Vera Hassner Sharav [log in to unmask] 212-595-8974
http://www.MitchelCohen.com
Ring the bells
that still can ring, Forget your perfect offering.
There is a crack, a crack in everything, That's how the light gets
in.
~ Leonard Cohen