Clinical Trials of NYC Foster Children – NYSDOH Coverup Continues
As I editorialized here in 2005, between 1986 and 2001 hundreds of NYC foster children were involuntarily enrolled in medical experiments. Soon after the story broke in the NYT, NYC commissioned a study by the widely respected Vera Institute for Justice. Almost four years later, that long awaited (forgotten?) study was finally released today.
After interviewing people familiar with the drug trials, reviewing policy documents, and examining the child welfare files of 796 children, Vera staff identified 532 children who were enrolled in 88 clinical trials and observational research studies.
The Vera Report identifies the procedures established to enroll and monitor these children, determines whether the procedures were followed, and discusses children’s outcomes. It also includes the recommendations of Vera and its Clinical Trials Advisory Board to help child welfare staff, elected representatives, and community advocates address the concerns raised by some of the findings.
In my opinion, Vera worked hard to keep the process fair and independent. Unlike Harvard Law School’s Berkman Center, Vera demanded and got complete access to files and records and the full cooperation of staff; full editorial control over the final report; and oversight by Vera’s own advisory board.
The most disturbing aspect of the report is the complete lack of cooperation by the NYS Department of Health which engaged in an ongoing cover-up by refusing to release medical records:
Vera reviewers found a significant amount of medical information in the child welfare files. However, citing confidentiality laws, the New York State Department of Health (NYSDOH) refused multiple requests from Children’s Services that it use its supervisory authority to allow staff from Vera or Children’s Services to review clinical trial research or medical records. This limited Vera’s review in several ways, including the ability to fully document the frequency and severity of toxicity (side effects), the individual outcomes of trial participation for the children in the review, and the existence of valid, signed informed consent documents.
The Vera review found evidence that supported some concerns about the participation of foster children and their families in clinical trials. This evidence includes violations of state regulations, Children’s Services’ own policies for clinical trial review and enrollment, and federal regulations for protecting human subjects.
The NYSDOH has information which it is withholding which might shed additional light on Vera’s findings. Perhaps NYSDOH, like Harvard’s Berkman Center, is in the pocket of, in this case, the drug industry which sponsored the medical experiments or maybe not. I don’t know enough about how NYSDOH and big pharma operates to address this issue. What I do know is that Governor Patterson, Attorney General Cuomo and the NYS Legislature should all conduct their own review of NYSDOH to make sure that NYC’s most vulnerable children were not sold by the government to the drug industry in its relentless pursuit of profits.