The New York City Administration for Children’s Services (ACS) today said it has contracted with the Vera Institute of Justice to conduct an independent review of ACS policy and practice regarding the enrollment of HIV-positive children in foster care in clinical drug trials during the late 1980s and 1990s. Children’s Services also announced the formation of a panel of national health care experts to examine clinical trial issues and review Vera’s findings.
The last child to enter an HIV-related clinical trial while in foster care did so in 2001. There are no ongoing HIV-related clinical trials involving children in foster care in New York City .
The Vera Institute of Justice, a New York-based not-for-profit research institution which works with government to study a variety of social issues, will research ACS policies and procedures to ensure that HIV-positive children and children with AIDS who were in the care of ACS were appropriately enrolled in the correct clinical drug trials. The analysis organized by Vera will also examine whether:
- all necessary consents by parents and other guardians were obtained by ACS ;
- the children met the medical criteria to be enrolled in the trials;
- ACS properly monitored children after they were enrolled;
- enrollment in the trials was appropriate based on sound medical knowledge at the time.
The purpose of the drug trials was to develop effective treatments for pediatric AIDS, at a time when there were no known, FDA-approved medications available to treat children with the disease, and many children were dying. ACS Commissioner John B. Mattingly said the agency has asked Vera to conduct the study in order to address ongoing questions from the public and the press about the history of the clinical trials.
“We are taking this step because, while we believe that the policies in place at the time reflected good practice, we acknowledge the need for transparency in all of our dealings with the public,” said Commissioner Mattingly. “In order for us to be effective in our mission to protect New York City’s children, we must have a sense of mutual trust with those families we seek to serve.”
After an exhaustive search for all available records as part of an ongoing review called for by the commissioner, ACS staff determined at the beginning of April that approximately 465 children likely participated in the trials between 1988 and 2001, with a large majority participating before 1996. The majority of children in New York City who were HIV positive were diagnosed during the mid-1980s through the mid 1990s, and the highest number of deaths occurred from 1990 to 1995. The children in foster care who participated in the trials were in the care of approximately two dozen independent agencies under contract to ACS.
Vera will organize a review of case records and medical records for all of the children identified as clinical trial participants, and will prepare a public report regarding its findings. Vera will also seek to locate as many of the children as possible to ascertain their current medical condition. Concurrently, Children’s Services will conduct additional case record reviews to ensure that every child in foster care who participated in clinical trials has been identified.
Vera’s work will be reviewed by an independent committee of medical experts in pediatric AIDS, medical ethics and the design and makeup of clinical trials. These experts – whose work will be funded by private foundations – will provide oversight for Children’s Services current policies and comment on the Vera review. The committee’s findings will include recommendations for future ACS policy regarding clinical drug trial participation, as well as an analysis of the procedures and protocols that were used in the past. The Vera Institute is in the process of creating its own, separate advisory committee of medical professionals, bio-ethicists, community representatives and other experts to assist Vera staffers in their work.
Pediatric HIV/AIDS was a national medical crisis which affected some 13,927 children under age 13 in the U.S. through 2003, according to estimates by the Centers for Disease Control. The percentage of affected children in New York City was the highest by far of any jurisdiction in the country, with 3,634 children under age 13 who were HIV-positive or diagnosed with AIDS from 1979 through 2003, according to the New York City Department of Health and Mental Hygiene.
According to the National Institutes of Health, between 12,000 and 13,000 children under age 13 participated in NIH-sponsored pediatric AIDS clinical trials nationally between 1986 and the present. These participants included children who were HIV positive and had not yet developed AIDS, as well as children who had progressed to the more severe disease (AIDS).