Study Refutes Claims on NYC foster children's participation in AIDS Drug Trials

The claims made by some denialists over 'experimentation' on New York City foster children (and which convinced some civil rights campaigners and City Council members) have been comprehensively debunked in an independent report conducted by the Vera Institute of Justice. Update: The Vera report can be downloaded from their website. The NYC Administration for Children's Services' press release has been appended to this story. The New York Times reports:

An investigation into the participation of New York City foster children in clinical drug trials for H.I.V. and AIDS over a nearly 20-year period has found no evidence that any children died as a result of the trials or that the foster children were selected because of their race. ... After interviewing dozens of people involved in the trials and reviewing hundreds of thousands of pages of case files, documents and correspondence, the Vera Institute concluded that none of the 532 children in the trials died as a direct result of the medications. (Twenty-five children receiving treatment as part of the trials died during the trial years.) The report also found that foster children were not removed from their families by the city because a parent had refused to consent to a child’s treatment, as some had alleged. In addition, the study said that researchers did not specifically select foster children for enrollment in the trials. And while the foster children were overwhelmingly black and Hispanic, as some critics emphasized, that profile mirrored the demographics of children with H.I.V. infection in the city at the time.

Read the full New York Times article.

Press release of New York City Children's Services

Children’s Services Welcomes Finding of Report on Children in Foster Care Enrolled in Clinical Trials for HIV/AIDS Medication The NYC Administration for Children’s Services today welcomed the release of a report by the Vera Institute of Justice related to the enrollment and participation of New York City children in foster care in clinical research trials for HIV/AIDS in the late 1980s-1990s. The report, commissioned in 2005 by Children’s Services Commissioner John B. Mattingly, provides the public with a full, independent accounting of this important issue following a public inquiry into the matter. Currently, there are no NYC children in foster care enrolled in clinical trials. Children’s Services believes that the findings overall show that child welfare officials in previous administrations acted in the interests of children in the city's care, including these findings: The mortality rate for the 532 foster children in the trials was lower than that of all HIV-infected children in NYC during those same years; evidence that child welfare officials followed then-current written policies to obtain parental consent for nearly 80 percent of children participating in the trials; the representation of African American and Latino children in foster care who participated in the clinical trials was comparable to the representation of African American and Latino children in the total population of NYC children with HIV/AIDS. “We believe Vera’s report emphatically shows that child welfare officials who oversaw the enrollment of these children in trials during the 1980s and 1990s were doing so in an attempt to save lives during a terrible epidemic,” said Commissioner John B. Mattingly. "The city’s efforts to get these children into clinical trials where they could receive the only medication available to them saved many children.” Titled “The Experiences of New York City Foster Children in HIV/AIDS Clinical Trials,” Vera’s report provides a thorough accounting of children’s participation in the trials during earlier city administrations, at a time when NYC was the epicenter of the pediatric AIDS crisis, with one-third of the 9,000 children in the United States with HIV living in the city. The majority of these NYC children were black and Latino; many of them were placed in foster care because their parents were infected, had died or were otherwise unable to care for their children. In the early days of the epidemic, the medications under development to address the disease were tested only on adults, and were not available for HIV-infected children. To ensure that children in the city’s care had access to newly available anti-HIV medications, the officials of the city’s child welfare agency (then a part of the Human Resources Administration, HRA -- becoming a separate agency as ACS in 1996) approved foster children’s participation in clinical trials. Commissioner Mattingly said the report demonstrated the City's commitment to build trust with the public. “We believe that Vera’s exhaustive study will answer many of the critical questions that the NYC community had about the participation of children in the clinical trials.” Children’s Services also has worked for the past few years to strengthen the Agency's clinical trials policy to ensure the safety and protection of children who may need to participate in trials in the future. The report, which is available on the Web site of the Vera Institute of Justice (www.vera.org) details the following key findings:

• 532 children in foster care participated in the trials or studies; 80 died while in foster care; 25 while enrolled in a medication trial. There is absolutely no evidence that clinical trial medications directly caused a child’s death
• The mortality rate (from any cause) of foster children in the trials was lower than that of other HIV-infected children in NYC during those same years.
• The city’s Human Resources Administration followed then-current written policies to obtain consent for children participating in the trials in 78 percent of the cases.
• Latino and African American children were not targeted for participation in clinical trials. Most children in foster care at the time were Latino and African American, and their rate of participation in the trials reflected the distribution of those children in care.
• Children in foster care did not appear to be overrepresented in the clinical trials. The majority of children in clinical trials for HIV/AIDS during this period were not in foster care – only 30 percent of the participants in the trials in NYC were in foster care.
• No children were removed from their families because a parent refused to consent to the child's participation in a trial or study. There was absolutely no evidence that parents, guardians, or foster parents were forced to enroll children in the clinical trials.

The report did find some situations in which there were violations of state and federal regulations and city policy for enrollment, monitoring and file retention. These include:

• The Institutional Review Boards of the hospitals conducting the trials did not consistently apply federal regulations related to the use of an independent advocate for children enrolled in clinical trials.
• Some case records and medical records maintained by contract foster care agencies could not be located despite New York State regulations requiring retention of such records.
• Record keeping by the HRA Pediatric AIDS Unit, responsible for monitoring HIV-infected foster children, was inconsistent.
• Three children out of the 532 who participated in the trials were enrolled in a Phase 1 clinical trial of an HIV vaccine that had not been approved by the then-child welfare commissioner.
• A small percentage of children participated in trials that were not recommended or reviewed by a Medical Advisory Panel.

It is also important to note that while Vera conducted a comprehensive and exhaustive review of available records, including child welfare case management records provided by Children's Services, the researchers were unable to review children’s hospital records because the New York State Department of Health would not allow access to hospital records due to concerns about patient confidentiality. Requests by ACS for access to these records were made repeatedly, in various forms, with several suggestions for strategies to preserve confidentiality. Each time the request was denied. It is possible that such records may contain supplemental information on the above findings, especially where there are gaps around the issues of consent, approval and enrollment. “We now have a largely complete review of the actions of the child welfare side of these trials in New York City. The absence of records detailing involvement of the medical community, which I believe would have confirmed the foster care results, is regrettable,” said Commissioner Mattingly. In addition to commissioning the study by Vera, Children’s Services also asked a group of NYC AIDS activists, advocates, physicians and child welfare experts – many of whom also represent and work closely with communities of color -- to consult with the Agency on the development of a new clinical trials policy and to advise Vera as the research was underway. This group, known as the HIV/AIDS Community Advisory Board, is co-chaired by Debra Fraser-Howze, founding member of the National Black Leadership Commission on AIDS; Ana Oliveira, former Executive Director, Gay Men’s Health Crisis and current Executive Director of the New York Women’s Foundation; and Ernesto Loperena, Executive Director, New York Council on Adoptable Children. Dr. Robert Johnson, interim Dean of the New Jersey Medical School and an expert in pediatric and adolescent AIDS, was solicited by ACS to provide expert advice regarding past and present standards of pediatric HIV diagnosis and management, standards of appropriate medical documentation and record-keeping, and to advise on the new policy. As a result of the inquiry, ACS, in consultation with the HIV/AIDS Community Advisory Board, Dr. Johnson and other medical experts, has revised its policies regarding foster children’s participation in future clinical trials. Although no NYC foster children are currently enrolled in clinical trials, ACS believes that clinical trial participation is appropriate for NYC foster children under certain conditions and given appropriate safeguards. The new ACS clinical trials policy prohibits, for example, participation by children in foster care in any Phase 1 clinical trials in which the safety of drugs is tested. ACS has also instituted systematic methods to oversee contracted foster care agencies’ documentation of healthcare-related services and to ensure proper storage and retrieval of records. In addition, the Agency has substantially overhauled its internal record retention procedures and policies. The BBC report on clinical trials, which aired in 2004 and contributed largely to the public inquiry, was later the subject of an apology letter by the network. Children’s Services can make a copy of that letter available. Vera's report is available at http://www.vera.org/cyj/hivtrials-pubs.html. For information on how to contact members of the HIV/AIDS Community Advisory Board, please contact the ACS Press Office at 212-341-0999. Contact: Sharman Stein or Sheila Stainback at: 212-341-0999