Background: Between 1985 and 2005, at least 532 infants and children in New York City were conscripted as human subjects of clinical trials testing experimental AIDS drugs and vaccines. The New York City Agency for Child Services (ACS), the custodian of foster care children, gave agencies such as Incarnation Children’s Center, permission to conduct experimental AIDS drug and vaccine trials in foster children in its care. ICC received payment for hosting these experimental trials; the medical research centers that conducted the trials received significant grants from both the National Institutes of Health and the manufacturers of the drugs. Among them iss Merck, BristolMyers Squibb, MicroGeneSys, Biocine, Glaxo Wellcome and Pfizer.
In 2004, after ascertaining that there were legitimate issues of concern and the possibility of child abuse–some of which were enumerated in a report by Liam Scheff — The House that AIDS Built, the Alliance for Human Research Protection filed a letter of complaint with the federal Office of Human Research Protection (OHRP).
The AHRP complaint focused on the enrollment of particularly vulnerable foster children in AIDS drug / vaccine experiments and system wide institutional failure to protect the individual child’s best interest in accordance with Federal regulations mandating an independent advocate for each child who is authorized to deny permission for a child’s enrollment in research.
The foster children enrolled in the AIDS trials were denied the dignity of their human right by having been enrolled in medical experiments without the consent of an independent advocate — as mandated by federal regulations.
ACS guidelines stated: “Separate consent need not be obtained for each child.”
This waiver, we believe, is unconscionable; it denied these children their basic human dignity and ascribed to them the status of guinea pigs. The case of the NYC Guinea Pig Kids was included in Harriet Washington’s book, Medical Apartheid (2007.
In November 2004, BBC aired the documentary film– Guinea Pig Kids by prize winning independent documentary film maker, Jamie Doran. After airing the disturbing documentary just once, the BBC came under intense pressure from powerful stakeholders who attempted to politicize the documentary–30 NYC institutions were involved in these AIDS drug experiments in foster children. The BBC abruptly pulled the controversial film from its website, but the 26 minute video is accessible on YouTube . (Transcript is available here and here)
Subsequent independent investigations — by the Associated Press, by the federal Office of Human Research Protections; and by the Vera Institute of Justice — confirmed that ethical standards and federal regulations had been violated. The investigations confirmed that most children did not have an the protection of an independent advocate to give or refuse consent to experimental interventions. Furthermore, the investigations confirmed that the children used in the experiments were predominantly African American (64%) and Latino (30%) raising the specter of racially discriminatory selection. And the Vera Institute, relying mostly on the city agency ACS documents, confirmed that children suffered serious harm — 80 of who died.
The Associated Press reported that the scope of these experiments was much wider; extending beyond New York to “at least seven states.” Among them: Illinois, Louisiana, Maryland, New York, North Carolina, Colorado and Texas. AP reported that more than four dozen different studies were involved. The foster children ranged from infants to late teens, according to interviews and government records.
An investigation by the federal Office of Human Research Protections (OHRP)
In 2006, OHRP confirmed the allegations by the Alliance for Human Research Protection; concluding that Columbia University Presbyterian Medical Center in New York, failed to obtain proper consent from an independent advocate, failed to ensure “equitable” selection and and failed to ensure safeguards for the foster children who “are likely to be vulnerable to coercion or undue influence.”
After a four year investigation by the Vera Institute, which was commissioned in 2005 by the NYC Administration of Child Services at a cost of $3 million, issued its Final Report (2009). The Report will hardly put to rest the controversy surrounding a 20-year period during which predominantly African American and Latino children in foster care were subjected to toxic Phase I and Phase II AIDS drug and vaccine experiments–mostly without parental consent and without the protection of an independent advocate–as mandated by federal regulations in force then and now.
The VERA Institute Report confirmed that the letter of complaint sent by AHRP was the cornerstone for the federal investigation of Columbia University Medical Center’s HIV-AIDS clinical trials.
Executive Summary of the Report findings:
- 532 children in NYC foster care were enrolled in the AIDS clinical trials or observational studies.
- 80 of the 532 children who participated in clinical trials or observational studies died while in foster care;
- 25 of the children died while enrolled in a medication trial.
- 64 children participated in 30 medication trials that were NOT REVIEWED by a special medical advisory panel, as the city’s policy required.
- And 21 children participated in trials that the panel had reviewed, but had NOT RECOMMENDED.
- (In both cases, 13 of the enrollments occurred before the children were placed in foster care.)
The most frustrating aspect of the Vera Institute investigation, acknowledged by its director, Tim Ross, was that the Institute staff never gained access to the children’s primary medical records or the clinical trial records–which the hospitals involved kept sealed under a shield of confidentiality. That shield was endorsed by the state:
The authors of the report “concluded” — on the basis of (admittedly) incomplete, therefore unreliable records that the deaths were “not a direct result of the medications.” However the validity of that conclusion is highly questionable. The Vera Institute did not even have access to minutes from medical center research review boards (IRBs) where the trials were conducted.
Vera Institute investigators were denied access to the crucial primary medical records
The investigation was charged with fact-finding about these highly controversial experiments; including the fact that 94% of the foster children enrolled in the experiments were children of color, most of them were enrolled in violation of federal informed consent requirements for children in foster care. The VERA Institute relied on secondary, child welfare files and Pediatric AIDS Unit (PAU) records both of which are notoriously incomplete.
Even those incomplete welfare files provide a hint of the adverse effects suffered by children who had been subjected to the experimental trials:
The VERA Institute report makes some cogent critical observations about the shortcomings of the OHRP investigation:
AHRP’s concerns were confirmed:
Most of the foster children in the AIDS trials were denied the protection of an independent advocate charged with ensuring that a foster child’s best interest is served by participating in a research project–as mandated by federal regulations. Because the facts do not refute our complaint about the failure to provide NYC foster children the protection of an independent advocate–who may have refused consent for the AIDS drug / vaccine trials in which 80 children are confirmed to have died, the VERA report attempts to whitewash the violations by claiming that:
It boggles the imagination that institutional review boards at premier medical research centers could claim ignorance about a glaring conflict of interest:
The NYC Administration of Child Services guidelines waived a foster child’s right to individual consent
This waiver was in direct violation of federal regulations requiring an advocate for each child. Instead, ACS officials issued altered guidelines: “Separate consent need not be obtained for each child.” This waiver denied foster children their basic human dignity and cast them to the status of guinea pigs.
The ACS Press Release falsely claimed: “evidence that child welfare officials followed then-current written policies to obtain parental consent for nearly 80 percent of children participating in the trials.” In fact, the NYC child welfare agency changed its enrollment policy to speed up the enrollment process.
Read more: AHRP Testimony; The Associated Press investigative reports “Researchers Tested AIDS Drugs on Children” (2004) and Government Tested AIDS Drugs in Foster Kids (2005) by John Solomon, found that less than a third of the children in the AIDS trials had an independent advocate; The New York Times coverage: Belated Charge Ignites Furor Over AIDS Drug Trial (July 17, 2005) by Jamy Scott and Leslie Kaufman; the Institute of Science and Society’s 2005 assessment about the experimental drugs tested on these children.
The New York Times article whited out the fact that 80 children died.
Following the release of the Vera Institute Final Report, the Times report by Lisa Foderaro (Jan. 27, 2009) was a blatant effort to white-wash the evidence of harm found by the investigation. The headline stated: Study Refutes Claims on AIDS Drug Trials and the article misrepresented the findings; misinforming its readers by reporting:
Did The New York Times editors consider the death of 80 Black and Latino children NOT WORTHY of mention in its news report? Those children had been conscripted into toxic AIDS drug and vaccine trials; in violation of ethical standards and federal regulations; denied the protection of an independent advocate who could have prevented the inclusion of a foster child in experimental tests of toxic drugs that were not in the child’s best interest.
Read the stinging critique of this Times story by The Village Voice:
Vera Hassner Sharav
THE VERA INSTITUTE OF JUSTICE
FINAL REPORT
THE EXPERIENCES OF NEW YORK CITY
FOSTER CHILDREN IN HIV/AIDS CLINICAL TRIALS, 2009
Vera Institute reviewers examined the child welfare files of 796 children who might have participated in HIV/AIDS clinical trials.
Read EXECUTIVE SUMMARY
