THE ALLIANCE FOR HUMAN RESEARCH PROTECTION
142 West End Avenue Suite 28P
New York, NY 10023
www.ahrp.org Tel. 212-595-8974
May 28, 2013
President Barack Obama
The White House
1600 Pennsylvania Avenue, NW
Washington, DC 20
Dear President Obama,
We, the Alliance for Human Research Protection, are gratified by your determination to redirect the focus of our national policy, recognizing that “No nation could preserve its freedom in the midst of continual warfare…This war, like all wars, must end. That’s what history advises. It’s what our democracy demands…”
“There have been no large-scale attacks on the United States, and our homeland is more secure…In sum, we are safer.”
Mr. President, we ask that you instruct your Secretary of Health and Human Services to abandon the unprecedented ill-advised plan to test the anthrax vaccine and other dangerous so-called “medical countermeasures” in otherwise healthy children.
Inasmuch as there is no evidence that American children are at risk of a bioterrorist attack, such medical experiments are explicitly prohibited by Federal statutes. Accordingly, children may not be exposed to more than a “minor increase over minimal risk” in research 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” [45 CFR46.406
“…the research presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.”
[45 CFR 46.407
The planned anthrax vaccine experiment was initiated on the basis of a simulated exercise—called “Dark Zephyr”— not on the basis of real evidence of risk.
After decades of testing, the effectiveness of the anthrax vaccine (BioThrax) following an attack has never been proven, and its safety problems are of considerable concern. Indeed, the FDA-approved label states: “The safety and efficacy of BioThrax in a post-exposure setting have not been established.”
Children exposed to this controversial vaccine will be put at significant risk of harm—not to mention severe pain—with no benefit for them. Furthermore, given the vaccine’s failure, after decades of testing in adults, to demonstrate its effectiveness, a pediatric trial is unlikely to succeed. Therefore, the 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 proposed vaccine trial is ethically and legally unapprovable and should not be performed.
Given the clear and present danger of harm to the children who will test the vaccine, and the lack of evidence to justify such testing, it is unwise for your administration to take responsibility for exposing children to unjustifiable risks of harm—risks that you would not want your own daughters to be subjected to—on the spurious basis of a speculative war game.
Alliance for Human Research Protection (AHRP)
Advancing Honest and Ethical Medical Research
Please read how “Bioethics” is being used by government officials to subvert statutory protections for children: a_radical_ethical_deviation_bioethics_anthrax_part_i