Anthrax Anthrax vaccine for children
Infamous Endorsement of Anthrax Vaccine for Children
Alliance for Human Research Protection
A Catalyst for Debate
www.ahrp.org
2011 Nov
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 spread from person to person.
• Anthrax has never 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, until recently, recommended vaccination
"only for those at high risk, such as workers in research laboratories that
handle anthrax bacteria routinely."
• The FDA label (2008) 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 competing
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’ 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
veracare@ahrp.org
212-595-8974