Conditional Approval for Anthrax Vaccine Trial in Children

March 20, 2013

20 Mar (AHRP) -The Presidential Commission for the Study of Bioethical Issues released its “[ ] Pediatric Research on Medical Countermeasures” Report and recommendations, on Tuesday, March 19, 2013.  The Report and the Commission Chair, Dr. Amy Gutmann, who presided over a press teleconference took great pains to convey the impression that above all, “the safety of children” and highest ethical standards must be upheld.

The Commission’s recommendations are being promoted as if they provide more stringent protections for children than the existing Federal statutory protections which prohibit exposing children to more than “a minor increase over minimal risk” when the research offers no prospect of direct benefit for the child subjects.  [45 CFR 46.406 and 407]  They do not.

What do you suppose led the Press to be so confused about whether the Commission opened the door to testing anthrax on children, or whether the Commission concluded that children should NOT be exposed to the vaccine?

The Presidential Commission for the Study of Bioethical Issues

Reuters – Test of Anthrax Vaccine in Children Gets Tentative OK
National Review -“Anthrax Vaccine Testing Okayed for Children”
The Scientist -Anthrax Va OK for Kids
MedPage -Panel OKs Baby Steps for Ped Anthrax Vax Tests
BBC– US Panel Backs Trial for Anthrax Vaccine on Children

Associated Press – “Panel: Thumbs Down on Anthrax Vaccine Test in Kids”
NPR – “Bioethics Panel Warns Against Anthrax Vaccine Testing On Kids,”
Medscape – Vaccine Testing in Children: Strict New Guidelines
Washington Post – “The Obama administration’s bioethics commission on Tuesday laid out guidelines for testing anthrax vaccine in children that   make such studies extremely difficult and probably impossible.”

The Commission’s deliberations and its report and recommendations suffer from deliberate ignorance (ie., denial) about the body of evidence documenting the hazards posed by the vaccine and the lack of evidence for its effectiveness against the disease. I say deliberate because scientific reports and government documents have been submitted to the Commission by AHRP Board member, Meryl Nass, MD, beginning in February 2012 .

On Feb. 18, 2013, AHRP submitted a comprehensive substantive report addressed to Amy Gutmann, Chair of the Commission, documenting the scientific evidence about the safety and efficacy of the vaccine from adult trials and military experience. We also laid out the ethical and legal standards that must guide pediatric research—and cited judicial rulings that explicitly restricted the use of children in non-therapeutic research that puts them at greater than “minimal risk.”

For complete article go to AHRP.

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