Here’s a story that’s gotten quite a bit of press overseas but not much in the United States even though it happened in New York. In the late 1990s, the National Institute of Allergy and Infectious Diseases and a number of other agencies and companies apparently sponsored several clinical studies of AIDS drugs on children who were in foster care in New York.
The children were under the care of Incarnation Children’s Center which the city of New York contracts with to take care of foster children who are HIV-positive.
Clinical research with children is always controversial, but here rather than the parents granting consent for the experiments, public agencies made that decision. This is especially problematic since some of the clinical studies involved Phase I (basic safety research) studies on infants. For example, here’s how the Alliance for Human Research Protection summarizes one such study,
Phase I Study: A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed-HIV-Infected Infants. ACTG # 292.
Infants 2 to 6 months of age were the subjects of this Phase I vaccine trial “to assess whether this vaccine is more immunogenic than placebo following the third vaccination.” Additionally these infants received PNU-IMUNE 23 vaccine at 24 months of age
The experiment was sponsored by Lederle-Praxis Biologicals
According to the Alliance for Human Research Protection, there were a number of adverse event reports, but the National Institute of Allergy and Infectious Diseases has rejected a Freedom of Information request to release the reports. The adverse events could be very minor things or they could be very severe — and if the state is going to decide to give consent for infants, it should certainly be required to make the adverse event reports and other information the AHRP has requested to examine how well state and federal authorities actually protected the rights and interests of these children.
I’m surprised this isn’t a major story — I guess questionable experiments on children just can’t compete with Janet’s breasts or Ted Kennedy’s outbursts.
Phase I Drug Trials Used Foster Care children in Violation of 45 CFR 46.409 and 21 CFR 50.56. Alliance for Human Research Protection, March 10, 2004.
There are no revisions for this post.