AHRP Opposes Gov Plan to Test Anthrax Vaccine on Children

The Alliance for Human Research Protection (AHRP)

Opposes a Government Plan to Test Anthrax Vaccine on Children

Since 2011, Kathleen Sebelius, Secretary of the Department of Health and Human Services (HHS), has been seeking to test the vaccine, Biothrax (Anthrax Vaccine Adsorbed) on healthy children[1]—ostensibly to protect American children in the unlikely event of an anthrax attack. 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 that incident were treated with antibiotics which are the treatment of choice—recommended by the Centers for Disease Control (CDC), and approved by the Food and Drug Administration (FDA)—for children (and adults) should they be exposed to anthrax spores. Antibiotics were 100%  effective at preventing disease.[2]The US government also stockpiles monoclonal antibodies and antiserum in case of an anthrax emergency.

Decades of immunogenicity trials in adults have not convinced the FDA of the vaccine’s efficacy following exposure to anthrax. Indeed, the product label explicitly states: “The safety and efficacy of Biothrax in a post-exposure setting have not been established.”[3]

On January 28, 2013, Emergent BioSolutions, manufacturer of BioThrax, acknowledged in a published report the lack of an animal model for demonstrating efficacy:

Animal models of diseases that afflict humans are critical tools for developing medical countermeasures against life-threatening conditions, such as inhalational anthrax, for which clinical evaluation of efficacy is not feasible…. well-established models do not respond to a specific countermeasure (e.g., a vaccine containing a novel adjuvant) in a manner consistent with human response and, therefore, cannot be utilized for the assessment of efficacy of such countermeasures.”[4]  

Why then, expose children who are not at risk of anthrax to a vaccine whose efficacy remains unproven?

Federal regulations[5] [[45 CFR 46.406, 407]  prohibit exposing children to more than a “minor increase over minimal risk” in research unless it:

 “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 “…presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.”

Yet healthy children with absolutely no medical disorder—who are not at risk of anthrax, but who lack legal autonomy to make a voluntary, informed choice—would be exposed to the serious risks of harm, not to speak of significant temporary pain, associated with the anthrax vaccine.

Lacking any evidence, Secretary Sebelius has invoked a simulated an anthrax attack1 (a war game called, “Dark Zephyr”) to justify injecting children with the anthrax vaccine. This proposed experiment, and other “medical countermeasures” research in children that are slated to follow, violate bedrock medical ethics principles[6] and Federal statutory protections.5

The vaccine is not safe: In 2008, CDC reported partial data from its “pivotal safety/ immunogenicity trial” of BioThrax in the Journal of the American Medical Association. The findings of this congressionally-mandated trial revealed that an astounding 12% of participants suffered “serious adverse effects”[7] defined by US regulations as:

“death, life-threatening event, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability or incapacity, congenital anomaly / birth defect…”

Of 186 people who experienced 229 SAEs, seven died. The nature of 213 serious adverse effects has never been publicly disclosed.

In 2008, then-HHS Secretary Michael Leavitt tacitly acknowledged the inherent risks of the vaccine when he invoked the Public Readiness and Emergency Preparedness Act (PREPA) to declare an “anthrax emergency,”[8]granting unprecedented immunity from legal liability through 2015 to the manufacturer of BioThrax (Emergent BioSolutions) and everyone involved in any aspect of an anthrax vaccination program.

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 answers to safety questions, either.  Thus the HHS proposed trial will have no scientific value, rendering it unapprovable under federal law.5

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, a cynical ploy to avert attention from the experiment’s true purpose, which is to expand the BioThrax license to include children, and thereby justify huge 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…. [T]hat profit margins of [this] magnitude… were not only agreed to but were not a point of controversy… raises broader questions about the integrity of the procurement system…”[9]

 Questions requiring responses from HHS:

  • Will their parents be informed that the manufacturer (and everyone involved in justifying, planning, and executing the program) is shielded from all liability by the PREPA law?
  • Will parents be informed that 12% of participants in a previous trial suffered serious adverse events, including brain damage and death?
  • Whose children will be conscripted as human subjects, and who will bear responsibility for a child’s injury?

Approval of the HHS proposed anthrax vaccine experiment would be a throwback to the ignoble history of US-government sponsored experiments that brought shame to our nation, including the Tuskegee and Guatemala syphilis experiments and numerous tests that have exposed disadvantaged children[10] to diseases, radiation, dangerous drugs, lead poisoning.[11] 

For the complete AHRP report on this subject,  see: http://www.ahrp.org/cms/content/view/907/9/

 

Meryl Nass, MD                                                                     Vera Sharav

Board member, AHRP                                                           President, AHRP

 

 

 References



[1] Presidential Commission for the Study of Bioethical Issues. (2012, May 17). President’s Bioethics Commission Welcomes Secretary Kathleen Sebelius. 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

[4] Savransky V, Sanford D, et al. Pathology and Pathophysiology of Inhalational Anthrax in a Guinea Pig Model, Infection and Immunity, Jan. 28, 2013. http://iai.asm.org/content/early/2013/01/24/IAI.01289-12.full.pdf+html

 [5] US Code of Federal Regulations. Protection of Human Subjects http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subpartd

[7]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

[8] 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

[9]  Lilly, S. (2010). Getting Rich on Uncle Sucker. Center for American Progress. Available from: http://www.americanprogress.org/issues/open-government/report/2010/10/20/8544/getting-rich-on-uncle-sucker/

[10] Grodin M and Glantz L. Children As Research Subjects: Science, Ethics, and Law,1994;  Sharav VH. Children in Clinical Research: A Conflict of Moral Values, American Journal of Bioethics, 2003. http://www.ncbi.nlm.nih.gov/pubmed/14560714 .

[11] Higgins /Grimes v. Kennedy Krieger Institute, Court of Appeals of Maryland, 2000, 2001.
http://www.courts.state.md.us/opinions/coa/2001/128a00.pdf