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.

5 Replies to "Clinical Trials of NYC Foster Children - NYSDOH Coverup Continues"

  • Anonymous
    January 28, 2009 (9:00 pm)

    since the feds fund much of the cost of state based foster care services and that funding is predicated on the states providing certain services and protections for the children in foster care isn’t there some way to leverage a federal level inquiry or response to this issue

  • Andre
    January 29, 2009 (1:06 pm)

    Some critical reviews of the Vera report from Liam Scheff who broke the story, and the AHRP which prodded the investigation forward:

    The summary is that the investigation blocked a lot of information from coming in and that the research methods were hamstrung from the get go.

    Liam Scheff says the interviewer from Vera shut down the interview when he gave them too detailed information. Vera institute replied that they were hamstrung by the federal regulations.

  • Elizabeth Ely
    February 4, 2009 (5:40 pm)

    The only thing VERA worked hard to do was draw conclusions not based on the evidence. The evidence they needed was in the health records of these children, and they didn’t have those. But they went ahead and concluded that 22 of the 25 children who died “during the trial” died of “advanced HIV disease,” not the drugs. These are drugs are designated “black box” by the FDA.

    And this depiction of VERA as “independent” assumes that its monitoring board is unbiased. “Editorial control” over its own report means it’s free to exert its own biases, which may be considerable.

    Also, HIV testing itself is suspect in pregnant women. This is said to be an unproved assertion, but it’s right there in the peer-reviewed literature. It’s not clear that any of these children were sick or at risk before being “treated.” What they were was available, having been removed forcibly from their parents, grandmothers and other caring homes. This is not a rumor; it happened. VERA might have spoken to these people if it had prmitted Liam Scheff to give them their names.

    To anyone familiar with the literal buying and selling of children in the New York City foster care system, this blog is hopelessly naive.

    See and for more information.

  • pharmaceutical Regulatory affairs
    February 25, 2009 (4:21 am)

    A lot of useful is definitely going to prove highly beneficial to the aspirants.

  • Manhattan
    September 4, 2009 (3:32 pm)

    I wonder if any of these kids will develop super powers. You know… since performing medical experiments against foster kids seems like comic book villainy.