August 1

2005: A National Scandal: AIDS Drug Experiments on Children in Foster Care

On March 10, 2004, The ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) filed a complaint with both the Food and Drug Administration and the federal Office of Human Research Protection (OHRP) when we learned that 36 Phase I and Phase II AIDS drug and vaccine experiments had been conducted on infants and children who were under the guardianship of the New York City Administration for Children’s Services (ACS).

We had reason to believe that the experiments were unethical, illegal, and coercive–and that federal regulations have been violated. The children were living at Incarnation Children’s Center, a foster care facility under contract with ACS and the Catholic Archdiocese. Read Testimony Submitted to Congressional Committee, May 18, 2005

The AHRP complaint prompted two separate investigations by the FDA and OHRP. Articles in The New York Post and a documentary by BBC II —Guinea Pig Kids ( broadcast on Tuesday, 30 November, 2004)– raised the alarm among the African-American and Latino community in NYC-some of who have been protesting weekly in front of Incarnation Children’s Center, the site of some of the drug experiments.

We did not know at the time that children in foster care nationwide were subjected to research exploitation at prestigious medical research institutions. An Associated Press investigative report by John Solomon, uncovered a national scandal. The experiments were conducted in “at least seven states — Illinois, Louisiana, Maryland, New York, North Carolina, Colorado and Texas — and involved more than four dozen different studies.

The Associated Press confirms that for more than two decades, government officials colluded with hospitals and researchers to facilitate the enrollment of children who were in the care of the state for experimental drug trials. Nationwide, an estimated 698 to 1,388 foster children were used to test experimental AIDS drugs – at least 465 of those children were in the care of NYC’s ACS – almost all were children of color. Read, Researchers Tested AIDS Drugs on Children, by John Solomon, Associated Press.

The Associated Press confirmed our suspicion that most of the children in the care of ACS did not have a personal advocate – as required under federal regulations. Indeed, of the 465 NYC children in the experiments, only 142 had an advocate. Furthermore, ACS even waived the requirement for individual consent for these children – encouraging them to be herded en masse into drug trials as if they were animals.

“Some foster children died during studies, but state or city agencies said they could find no records that any deaths were directly caused by experimental treatments.”

It is not for those city agencies to decide the cause of death.

These children were exposed to pain, risks, and potentially harmful experimental drugs – the children suffered, some died. In some cases the children were diagnosed with HIV infection – in other cases infants were merely “presumed” to be HIV-infected.

Researchers reported some children had to be taken off the drug because of “serious toxicity.” At least 10 children died from a variety of causes, including four from blood poisoning, and researchers said they were unable to determine a safe, useful dosage. They said the deaths didn’t appear to be “directly attributable” to dapsone but nonetheless were “disturbing.”

“An unexpected finding in our study was that overall mortality while receiving the study drug was significantly higher in the daily dapsone group. This finding remains unexplained,” the researchers concluded.

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