Biothrax for Kids is Back! Now for an Ethics Review! / DHHS

The DHHS' momentum to test anthrax vaccine in kids did not abate after the NBSB advisory committee suggested the pediatric trial should go forward, following review by an ethics panel.  That way the NBSB members would not be the last ones holding the bag.

On January 10, DHHS Secretary Sibelius (ex-Governor, insurance commissioner and lobbyist) -- who has looked increasingly pinched since coming to head DHHS and carry Obama's dirty water -- asked the Presidential Commission for the Study of Bioethical Issues to fast-track a review of testing countermeasures in children.  They begin their study on Feb 2-3, with a final report due late in 2012.

With Ass't Secretary Nicole Lurie busy defending herself and her department against a Congressional investigation of their smallpox drug contract, Sibelius has put herself in the anthrax vaccine line of fire.

Medical Countermeasures for Children:

On Jan. 10, Secretary of Health and Human Services Kathleen Sebelius asked the Commission for ethical advice on the development of medical countermeasures for children. The Commission is well aware that this issue garnered significant public interest last fall when another Federal advisory committee recommended pediatric testing of the anthrax vaccine.  The Commission is honored that the Secretary has asked for its advice on this important ethical issue.  The Commission is reviewing the request carefully and expects to begin work shortly on a timeline to deliver a report in late 2012.

Under the Code of Federal Regulations (46.407) the proposed study can't be done, since anthrax is not a serious problem affecting the health and welfare of children... and in any event, the vaccine is NOT a treatment for an acute exposure (antibiotics are) -- since it takes at least 35 days to develop high antibody levels:

SUBTITLE A: DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A: GENERAL ADMINISTRATION

PART 46: PROTECTION OF HUMAN SUBJECTS

Subpart D: Additional Protections for Children Involved as Subjects in Research

46.407 - Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

HHS will conduct or fund research that the IRB does not believe meets the requirements of 46.404, 46.405, or 46.406 only if:

(a) The IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and

(b) The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, has determined either:

(1) That the research in fact satisfies the conditions of 46.404, 46.405, or 46.406, as applicable, or

(2) The following:

(i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;

(ii) The research will be conducted in accordance with sound ethical principles;

(iii) Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in 46.408.