The Alliance for Human Research Protection (AHRP) is urging citizens to write to your elected officials and to your media contacts to express your concerns about an inhumane experiment on children.

Help ensure that children’s human and legal rights are protected from unwarranted, high risk, painful medical experiments.

The Obama Administration led by Kathleen Sebelius, Secretary of Health and Human Services (DHHS), is engaging in fear mongering, promoting the specious claim that children are less safe than adults in the unlikely event of a bioterrorist anthrax attack. Lacking any credible evidence of an anthrax risk, Secretary Sebelius—a political appointee—is invoking fictional scenarios of a simulated anthrax attack to override hard-won Federal statutes that were enacted over the last 35 years to protect children from medical experiments that put them at risk with no benefit. 

 "Secretary Sebelius asked the Commission for ethical advice on the development of medical countermeasures for children.  Broadly speaking, medical countermeasures are pharmaceutical and non-pharmaceutical products used to prevent the health effects of a chemical, biological, radiological, or nuclear event; large-scale natural disaster; or naturally occurring, emerging infectious disease....The question that sparked this broad charge from Secretary Sebelius to the Commission is how to treat children who have been exposed to anthrax; it was a question that arose during a Homeland Security exercise" http://bioethics.gov/cms/pressrelease1

Simulated exercises (or "War Games") are NOT evidence-based! 
The safety hazards of BioThrax are substantiated by documented evidence.

FACT: There is no credible evidence of an impending anthrax threat: no government official has cited any evidence of a threat.

FACT: Antibiotics—not the anthrax vaccine—are the proven protection against anthrax. Antibiotics proved to be 100% effective for people exposed to anthrax-laced letters in 2001—which was not a bioterrorist act. The FBI concluded that the sender was a US military scientist—who is dead.

FACT: If ever children were exposed to anthrax spores, they would be given antibiotics, such as Ciprofloxacin or Doxycycline, which have been FDA-approved for pediatric use against anthrax—and recommended by CDC.

FACT: FDA has not licensed BioThrax for use following exposure to anthrax spores.
The BioThrax label warns: “The safety and efficacy of BioThrax in a post-exposure setting have not been established.”

“I think it’s pretty clear that antibiotics are very, very effective against the disease...  Would the vaccine provide anything beyond that?  I’m not sure….”

Help stop a Corporate-Government fear mongering scheme aimed at expanding civilian use of a dangerous vaccine—BioThrax—with no proven benefit.

Read our letter to Dr. Amy Gutmann, Chair of the Presidential Commission on the Study of Ethics fully documenting our argument: children_anthraxvaccine_moral_cliff

How safe is the current anthrax vaccine?   

The Government Accountability Office (GAO) reported to Congress in 2007 that: “Officials at the Military Vaccine Healthcare Centers Network and CDC estimate that between 1% and 2% of vaccinated individuals “may experience severe adverse events, which could result in disability or death.”

Safety data from a “pivotal safety / immunogenicity trial” conducted by CDC at taxpayer expense has been withheld from the public. Partial findings reported in 2008 in JAMA:  186 people suffered 229 “serious adverse events”[SAEs] during the trial with 7 deaths. That means that 12% of the subjects in CDC’s “pivotal trial” suffered SAEs.
 

“The following AEs were classified as serious (SAE), consistent with US regulations: death, life-threatening event, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability or incapacity, congenital anomaly or birth defect, and a medical event that required medical or surgical intervention to prevent one of the other outcomes.”

The entire history of the anthrax vaccine enterprise is about bad science, false claims about efficacy, undisclosed scope of severe adverse events, deceptive promotion by government healthcare agencies.

FACT: In 2008, HHS Secretary Michael Leavitt invoked the Public Readiness & Emergency Preparedness Act (PREPA) to declare an "anthrax emergency" despite written assurance by Homeland Security Secretary Michael Chertoff, that no anthrax emergency existed.  Leavitt’s declaration, in effect until 2015, granted unprecedented, broad immunity from all legal liability to the vaccine manufacturer (Emergent BioSolutions), government program planners, healthcare and other providers—everyone involved in every aspect of an anthrax vaccination program. 

Indeed, this unilateral suspension of legal responsibility for vaccine injury is a tacit acknowledgment of the inherent risks.  Why else would Secretary Leavitt have immunized the manufacturer, and all public and private officials involved from legal liability?

Since 9/11 biodefense contractors—especially, Emergent BioSolutions (a.k.a. BioPort), mfg. of BioThrax--have been cashing in on billions of dollars in non-competitive government contracts.

FACT: Decades of immunogenicity trials in adults have not produced acceptable data to convince the FDA of the vaccine’s efficacy following exposure to anthrax. This is due to the absence of a valid animal bridging model of survival data from vaccinated experimental animals to survival in humans.

The inescapable conclusion is that the proposed trial—or any that DHHS may propose--cannot answer meaningful efficacy or dosing questions, nor can it answer safety questions—which would require using thousands of children.

The hazards for children in countermeasure research are real—the anthrax emergency is not.

From its inception, the proposed anthrax vaccine experiment violates bedrock medical ethics principles, the Hippocratic Oath—“First, do no harm,” the Nuremberg Code, and the Federal statutory protections.

This government-initiated experiment fails to meet the statutory standard in Federal regulations prohibiting exposing children to greater than a “minor increase over minimal risk” in research:

“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” [45 CFR Sec. 46.406] 

 “…the research presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.” [Sec. 46.407]

Healthy children with no “disorder or condition” who will be vaccinated will suffer significant temporary pain and will be put at risk of serious harm in such an experiment. The risk of anthrax is speculative, not “a serious problem affecting children’s health or welfare.”

The pediatric trial will have no clinical or scientific value, much less be “of vital importance.”

Judged by the ethical standards of science, medicine, and law, the DHHS proposed vaccine trial is unapprovable and should not be performed. Why then, are children being targeted by DHHS Secretary Sebelius for a BioThrax vaccine Test?

Major General John Parker, MD, retired, co-chair of the Anthrax Vaccine Working group, of the National Biodefense Safety Board (NBSB) stated at a public meeting of the Presidential Commission on the Study of Bioethical Issues (2012) that he and the NBSB “strongly support having safety trials for a children’s vaccine…” [Safety studies would require tens of thousands of child subjects.] When asked by an ethicist, what a pediatric study would accomplish since children would still be given antibiotics should they ever be exposed to anthrax? 

Dr. Parker acknowledged that NBSB’s rationale for supporting a scientifically bankrupt and ethically and legally unapprovable anthrax vaccine trial in children was to provide credibility to the government’s promotional vaccine campaign. In other words, the trial’s purpose is for public relations: “to be able to say that we know the vaccine is safe” or “to be able to say we tested the vaccine in pediatric populations.”  

“We debated that question. And—it boiled down to a very human type thing that, if we’re talking to a parent about giving a child a vaccine, it would be a much better situation to be able to say that we know the vaccine is safe.”

“[We need to] sustain the credibility of the United States Government through the Department of Health and Human Services.  This credibility is sustained by the United States Government being able to say we tested the vaccine in pediatric populations.”

This level of cynicism, the misrepresentation of a promotional trial as science, and especially the lack of respect for children’s rights and human dignity is truly shocking.

Whose children will be the sacrificial lambs in a corporate-government collusion scheme to expand the BioThrax stockpile and expand civilian vaccinations?

• Will prospective parents be informed that the manufacturer is shielded from liability by law?
• Will prospective parents be informed that in CDC’s “pivotal BioThrax trial” 12% of adults suffered serious adverse events which are defined by FDA as death, a life-threatening event, or one causing hospitalization, disability, birth defect, or other serious medical event?
• What if a child is disabled or dies?  Since everyone involved in the planning, execution, and providing the apologia has been indemnified, who bears responsibility for the plight of the children?  
• None of the children in egregious past government experiments were recruited from middle or upper class households. None came from the educated academic class—those who sponsored, designed, conducted, and benefited from the experiments.

DHHS Secretary Sebelius’ letter to you as Commission chairperson, requesting this study, is disingenuous and intentionally misleading when she states: 

“The safety of our children is paramount, and it is vital that we thoroughly address any and all ethical considerations relative to having adequate and available safety and immunogenicity data on our medical countermeasures to protect them before, during and after an event.”

She insinuates that the proposed trial will provide “adequate and available safety and immunogenicity data” and that will “protect” children. Curiously, she refers to “our children”-- does that indicate her intent to volunteer her own child or grandchild?   Most troubling, however, is her use of the phrase ‘before, during and after an event.’

This is a clue to the real purpose of the proposed BioThrax experiment: it foreshadows an intention to vaccinate, possibly even to mandate pre-event anthrax vaccination in children.

Approval of DHHS’ proposed experiment would be a throwback to the ignoble history of US government- sponsored, non-therapeutic medical experiments that have brought shame to our nation, including Tuskegee and Guatemala syphilis experiments and many tests on disadvantaged children, that exposed them to diseases, radiation or dangerous drugs. 

Resist ever-widening use of a dangerous vaccine that yields no medical benefit, no proven protection against anthrax, and stop the waste of billions of taxpayer dollars.

“…the $217 million in revenue from those [2009] sales would indicate a markup in the neighborhood of 300 percent... a markup of even half the size suggested by this annual report seemed mind boggling... The fact that profit margins of the magnitude negotiated by Emergent were not only agreed to but were not a point of major controversy within the agencies[DHHS] that agreed to them raises broader questions about the integrity of the procurement system...”

Read our letter to Dr. Amy Gutmann, Chair of the Presidential Commission on the Study of Bioethics Issues, fully documenting (in 40 pages) the scientific, ethical and legal facts buttressing our argument against this outrageous exploitaion of children as human guinea pigs: children_anthraxvaccine_moral_cliff

Meryl Nass, MD                                                                                                             Vera Sharav
AHRP Board of Directors                                                                                                  President, AHRP
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