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.

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]

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:

“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].

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.

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]

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.

Why 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.

A 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]

Questions 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 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?

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] 

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

Meryl Nass, MD                                                            Vera Sharav

Board of Directors, AHRP                                            President, AHRP

mnass@roadrunner.com                                               veracare@ahrp.org

References

1. Presidential Commission for the Study of Bioethical Issues. Welcomes Secretary Kathleen Sebelius. (2012, May 17). Available from: http://bioethics.gov/cms/pressrelease1
2. 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
3. Prescribing Information. BioThrax Vaccine Adsorbed. Available from: http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/UCM074923.pdf 
4. 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
5. 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
6. 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
7. 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/
8. 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
9. 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