The Alliance for Human Research Protection (AHRP) Opposes Administration’s Plan to Test Anthrax Vaccine on Healthy Children
Katherine
Sebelius, Secretary of the US Department of Health and Human Services (HHS),
has proposed testing anthrax vaccine in children—ostensibly to protect American
children in the unlikely event of an anthrax attack.[1] But no credible
evidence of an impending anthrax threat has ever been cited. The only US
anthrax threat, in 2001, was traced by the FBI to a US military scientist who
committed suicide in 2008.
Persons
exposed to anthrax-laced letters in 2001 were treated with antibiotics, which
were 100% effective at preventing disease. [2] The US government also
stockpiles monoclonal antibodies and antiserum in case of an anthrax emergency.
exposed to anthrax-laced letters in 2001 were treated with antibiotics, which
were 100% effective at preventing disease. [2] The US government also
stockpiles monoclonal antibodies and antiserum in case of an anthrax emergency.
Why
then, expose children who are not at risk of anthrax to the vaccine? HHS
Secretary Sebelius has invoked a simulated anthrax attack (a “war game” named Dark
Zephyr)
to justify injecting children with the anthrax vaccine.[1] However, decades of
immunogenicity trials in adults have failed to demonstrate the vaccine’s
efficacy following exposure to anthrax due to the lack of a reliable animal
model, and inability to bridge animal results to humans. Indeed, the
FDA-approved product label explicitly states: “The safety and efficacy of
Biothrax in a post-exposure setting have not been established.”[3]
then, expose children who are not at risk of anthrax to the vaccine? HHS
Secretary Sebelius has invoked a simulated anthrax attack (a “war game” named Dark
Zephyr)
to justify injecting children with the anthrax vaccine.[1] However, decades of
immunogenicity trials in adults have failed to demonstrate the vaccine’s
efficacy following exposure to anthrax due to the lack of a reliable animal
model, and inability to bridge animal results to humans. Indeed, the
FDA-approved product label explicitly states: “The safety and efficacy of
Biothrax in a post-exposure setting have not been established.”[3]
The
proposed experiment and other “medical countermeasures” research in children
slated to follow would put healthy children with no medical disorder at risk of
serious harm, in violation of bedrock
medical ethics principles. [4] Secretary Sebelius attempts to override hard-won
Federal statutes enacted over the last 35 years to protect healthy children
from medical experiments that put them at greater than a “minor increase
over minimal risk”
with no potential direct benefit unless:
proposed experiment and other “medical countermeasures” research in children
slated to follow would put healthy children with no medical disorder at risk of
serious harm, in violation of bedrock
medical ethics principles. [4] Secretary Sebelius attempts to override hard-won
Federal statutes enacted over the last 35 years to protect healthy children
from medical experiments that put them at greater than a “minor increase
over minimal risk”
with no potential direct benefit unless:
“The
intervention or procedure is likely to yield generalizable knowledge about the
subjects’ disorder or condition which is of vital importance for the
understanding or amelioration of the subjects’ disorder or condition,” and “… the
research presents an opportunity to understand, prevent, or alleviate a serious
problem affecting the health or welfare of children. [45 Code of Federal
Regulations,
Sec. 46.406, 46.407].
intervention or procedure is likely to yield generalizable knowledge about the
subjects’ disorder or condition which is of vital importance for the
understanding or amelioration of the subjects’ disorder or condition,” and “… the
research presents an opportunity to understand, prevent, or alleviate a serious
problem affecting the health or welfare of children. [45 Code of Federal
Regulations,
Sec. 46.406, 46.407].
In
2008, CDC reported partial data from its “pivotal safety/immunogenicity trial”
of Anthrax Vaccine Adsorbed (BioThrax) in the Journal of the American
Medical Association.
The findings of this congressionally-mandated trial reveal that 12% of
participants suffered “serious adverse events” defined by US
regulations as: “death, life-threatening event, initial inpatient
hospitalization or prolongation of hospitalization, significant or persistent
disability or incapacity, congenital anomaly…” [5] Of the 186 people
who experienced 229 serious adverse events, seven died. The nature of 213 serious adverse
events has never been publicly disclosed.
2008, CDC reported partial data from its “pivotal safety/immunogenicity trial”
of Anthrax Vaccine Adsorbed (BioThrax) in the Journal of the American
Medical Association.
The findings of this congressionally-mandated trial reveal that 12% of
participants suffered “serious adverse events” defined by US
regulations as: “death, life-threatening event, initial inpatient
hospitalization or prolongation of hospitalization, significant or persistent
disability or incapacity, congenital anomaly…” [5] Of the 186 people
who experienced 229 serious adverse events, seven died. The nature of 213 serious adverse
events has never been publicly disclosed.
Also
in 2008, then-HHS Secretary Michael Leavitt tacitly acknowledged the inherent
risks of the vaccine by invoking the Public Readiness and Emergency
Preparedness Act (PREPA) to declare an “anthrax emergency” and grant
unprecedented immunity from legal liability through 2015 to the manufacturer,
Emergent BioSolutions, and everyone involved in any aspect of an anthrax
vaccination program.[6]
in 2008, then-HHS Secretary Michael Leavitt tacitly acknowledged the inherent
risks of the vaccine by invoking the Public Readiness and Emergency
Preparedness Act (PREPA) to declare an “anthrax emergency” and grant
unprecedented immunity from legal liability through 2015 to the manufacturer,
Emergent BioSolutions, and everyone involved in any aspect of an anthrax
vaccination program.[6]
Given
available, effective remedies—i.e., antibiotics—in the unlikely event of an
anthrax emergency, a pediatric trial of a vaccine of unknown efficacy will have no clinical value, much less be “of
vital importance.” It
is therefore ethically unjustifiable. Given the inability to bridge animal
efficacy data to humans, the proposed trial will be unable to determine
efficacy and dosing in children.
The limited number of children to be studied cannot provide adequate
safety information, either. Thus
the proposed trial will have no scientific value, rendering it unapprovable
under federal law.
available, effective remedies—i.e., antibiotics—in the unlikely event of an
anthrax emergency, a pediatric trial of a vaccine of unknown efficacy will have no clinical value, much less be “of
vital importance.” It
is therefore ethically unjustifiable. Given the inability to bridge animal
efficacy data to humans, the proposed trial will be unable to determine
efficacy and dosing in children.
The limited number of children to be studied cannot provide adequate
safety information, either. Thus
the proposed trial will have no scientific value, rendering it unapprovable
under federal law.
Why
would government officials seek to conduct an experiment on children that would
violate scientific, ethical, and
legal standards? Hint: follow the money.
would government officials seek to conduct an experiment on children that would
violate scientific, ethical, and
legal standards? Hint: follow the money.
HHS
officials invoke the specter of bioterrorism, citing no evidence of a threat. In fact, the experiment’s true purpose is to expand the BioThrax license to include
children, and justify additional vaccine purchases for the civilian stockpile.
officials invoke the specter of bioterrorism, citing no evidence of a threat. In fact, the experiment’s true purpose is to expand the BioThrax license to include
children, and justify additional vaccine purchases for the civilian stockpile.
A
2010 report by the Center for American Progress suggests that Emergent is
cashing in on billions of dollars in non-competitive government contracts:
2010 report by the Center for American Progress suggests that Emergent is
cashing in on billions of dollars in non-competitive government contracts:
“…
the $217 million in revenue from those [2009] sales would indicate a markup in
the neighborhood of 300 percent.… The fact that profit margins of the
magnitude negotiated by Emergent were not only agreed to but were not a point
of controversy within the agencies [HHS and DOD] that agreed to them raises
broader questions about the integrity of the procurement system…” [7]
the $217 million in revenue from those [2009] sales would indicate a markup in
the neighborhood of 300 percent.… The fact that profit margins of the
magnitude negotiated by Emergent were not only agreed to but were not a point
of controversy within the agencies [HHS and DOD] that agreed to them raises
broader questions about the integrity of the procurement system…” [7]
Questions
requiring responses from HHS:
requiring responses from HHS:
·
Will
parents be informed that 12% of participants in a previous trial experienced
severe adverse events, including brain damage and death?
Will
parents be informed that 12% of participants in a previous trial experienced
severe adverse events, including brain damage and death?
·
Will
parents be informed that the manufacturer (and everyone involved in justifying,
planning, and executing the program) is shielded from all liability by the
PREP Act?
Will
parents be informed that the manufacturer (and everyone involved in justifying,
planning, and executing the program) is shielded from all liability by the
PREP Act?
·
Whose children will be sought
as subjects and who will bear responsibility for a child’s injury?
Whose children will be sought
as subjects and who will bear responsibility for a child’s injury?
Approval
of this HHS-proposed experiment would be a throwback to the ignoble history of
US-government sponsored medical experiments that brought shame to our nation,
including the Tuskegee and Guatemala syphilis experiments, and numerous tests
that exposed disadvantaged children to diseases, radiation, dangerous drugs,
[8] and lead poisoning. [9]
of this HHS-proposed experiment would be a throwback to the ignoble history of
US-government sponsored medical experiments that brought shame to our nation,
including the Tuskegee and Guatemala syphilis experiments, and numerous tests
that exposed disadvantaged children to diseases, radiation, dangerous drugs,
[8] and lead poisoning. [9]
For
the complete AHRP report on this subject, see: http://www.ahrp.org/cms/images/stories/articles/children_anthraxvaccine_moral_cliff_final_2-28.pdf
the complete AHRP report on this subject, see: http://www.ahrp.org/cms/images/stories/articles/children_anthraxvaccine_moral_cliff_final_2-28.pdf
Meryl
Nass, MD Vera
Sharav
Nass, MD Vera
Sharav
Board
of Directors, AHRP President,
AHRP
of Directors, AHRP President,
AHRP
mnass@roadrunner.com
veracare@ahrp.org
veracare@ahrp.org
References
- Presidential
Commission for the Study of Bioethical Issues. Welcomes Secretary Kathleen
Sebelius. (2012, May 17). Available from:
http://bioethics.gov/cms/pressrelease1 - Centers for Disease
Control. (2002). Use of Anthrax Vaccine in Response to Terrorism:
Supplemental Recommendations of the Advisory Committee on Immunization. Mortality
and Morbidity Weekly Report, 51(45), 1024-1026. Available from:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5145a4.htm - Prescribing
Information. BioThrax Vaccine Adsorbed. Available from:
http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/UCM074923.pdf - The Nuremberg Code.
Available from: http://www.ushmm.org/research/doctors/Nuremberg_Code.htm; The National
Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research. Available from: http://videocast.nih.gov/pdf/ohrp_research_involving_children.pdf - Marano, N. et al.
(2008). Effects of a reduced dose schedule and intramuscular
administration of Anthrax Vaccine Adsorbed on Immunogenicity and safty at
7 months. JAMA, 300(13), 1532-1543. Available from:
http://jama.jamanetwork.com/article.aspx?articleid=182656 - Department of
Health and Human Services. (2008, October 6). Declaration under the Public
Readiness and Emergency Preparation Act. Federal Register, vol 73, issue
194. Available from:
http://www.gpo.gov/fdsys/pkg/FR-2008-10-06/html/E8-23547.htm - Lilly,
S. (2010). Getting Rich on Uncle Sucker. Center for American Progress.
Available from: www.americanprogress.org/issues/open-government/report/2010/10/20/8544/getting-rich-on-uncle-sucker/ - Grodin, M.A,
& Glantz, L.H. (1994). Children As Research Subjects: Science,
Ethics, and Law. NY: Oxford University Press; Sharav, V.H. Children in
Clinical Research: A Conflict of Moral Values. American Journal of
Bioethics, 2003: ww.ncbi.nlm.nih.gov/pubmed/14560714 - Higgins
/Grimes v. Kennedy Krieger Institute, Court of Appeals of Maryland, 2000,
2001. Available from: http://www.courts.state.md.us/opinions/coa/2001/128a00.pdf