RE: Phase I Drug trials used foster children in violation of 45 CFR 46.409 and 21 CFR 50.56

The Alliance for Human Research Protection (AHRP) has reason to believe that federal regulations for the protection of children as research subjects have been seriously violated in federally funded HIV research.

We have learned that a series of Phase I and Phase II drug experiments were conducted on infants and children who were under the guardianship of the New York City Agency for Children's Services (ACS), and living at Incarnation Children's Center, a foster care facility under contract with ACS.

Excerpt: The British drug authority has banned the use of most SSRI antidepressant drugs for the treatment of depression in children under 18, citing a two-to-threefold increased risk of suicidal behavior and lack of evidence of a benefit for depressed children. Two SSRIs - Paxil and Effexor - are no longer recommended by their manufacturer for use in children. Prozac is no longer recommended by Eli Lilly for children in the U.K.

In contrast to the British medicines authority review of the evidence, the FDA has refused to allow independent scientists to present documented evidence related to these drugs' hazards and their failure to demonstrate a benefit for depressed children.

Comments submitted by The Alliance for Human Research Protection
to The National Academy of Sciences
Committee of the Institute of Medicine on Clinical Research Involving Children

AHRP has been closely monitoring pediatric research trends since passage of the FDA Modernization Act of 1997. We believe that medications used in children should be thoroughly tested for safety, effectiveness and appropriate dose. But unlike adults who can exercise their autonomous right to informed consent, children who are enrolled in clinical trials are non-consensual human subjects. They should not, therefore, be made to assume the burden of testing possibly toxic drugs whose safety is unknown.

On July 3 the federal Office of Human Research Protections (OHRP) issued a stinging indictment of the research review and approval process at some of the nation's most prestigious research institutions--including the National Heart Lung and Blood Institute (NHLBI). http://ohrp.osophs.dhhs.gov/detrm_letrs/YR03/jul03a.pdf

The retirement of Dr. Claude Lenfant, director of NHLBI was announced the same day. See: http://www.ahrp.org/infomail/03/07/03.php]