NGO Probe to Look at Foster Kids in AIDS Drug Trials – NYC

Sat, 23 Apr

After a year of stonewalling, the New York City Administration for Children’s Services has announced that it would seek “an independent review” of the AIDS drug trials that were conducted on children in the agency’s foster care program.

ACS acknowledges that “around 465 HIV-positive children were enrolled in drug tests between 1988 and 2001.”

The children were used to test highly experimental drugs in Phase I and Phase II trials in which babies and children in foster care were used to test the safety of various AIDS drugs and vaccines that were tested in multiple combinations.

A complaint file by The Alliance for Human Research Protection with the FDA and the federal Office of Human Research Protections in March 2004 has resulted in two continuing investigations. See: https://ahrp.org/ahrpspeaks/HIVkids0304.php

The focus of the AHRP complaint was that the use of foster care children in experimental drug trials are prohibited under federal regulations. The ACS and the NYS Department of Health overreached their authority when they targeted foster care children for the trials.

No information has been given about the children’s condition before and after the experiments, nor has either ACS or the National Institutes of Health AIDS division provided information about the adverse effects the children may have suffered from the highly toxic drug cocktails that they had been given. Allegations have been made that the children who refused or could not swallow the drugs had a tube surgically inserted in their stomach to ensure compliance.

Contact: Vera Hassner Sharav
212-595-8974

April 23, 2005
Probe Looks at Foster Kids in Drug Trials
By THE ASSOCIATED PRESS

NEW YORK (AP) — A city agency that put more than 400 HIV-positive foster children into clinical trials for AIDS drugs has asked for an independent review of the program after children’s rights advocates said it amounted to exploitation.

John Mattingly, commissioner of the Administration for Children’s Services, said the inquiry would investigate whether the agency had the necessary permission from parents or guardians to include the children in the research from the late 1980s to 2001.

The agency stressed that it does not believe there were ethical lapses, but it wants to make sure the program’s policies were proper and had been strictly followed.

“If people in our community begin to feel we have done the things these fringe groups are saying, the community won’t be able to trust us to investigate abuse and neglect,” Mattingly said Friday.

The tests were approved by the National Institutes of Health and were conducted at some of the best-known hospitals in the city.

However, advocates like the Alliance for Human Research Protection have accused the agency of exploiting the children and subjecting them to medical harm.

Vera Hassner Sharav, president of AHRP, questioned whether any review called for by the agency itself could be credible. She called for a federal investigation.

“These children are devalued,” she said, “and the city and state devalued them further.”

The Vera Institute of Justice, a nonprofit organization in New York, will conduct the inquiry. The group did not immediately respond to a call seeking comment Friday.

The ACS said around 465 HIV-positive children were enrolled in drug tests between 1988 and 2001, the majority before 1996. The tests were conducted to help determine what kind of drugs would combat HIV and AIDS in children.

The review also will examine whether the children fit the medical criteria to be included in the tests and if the enrollments were appropriate given the medical knowledge of the time, according to the ACS.

Mattingly said he did not believe that any children had died from their participation in the research.

He said investigators will try to find as many of the participating children as possible to assess their current medical condition, and the agency will also be reviewing records to see if there were more children who participated.

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On the Net:

NYC Administration for Children’s Services: http://www.nyc.gov/acs

Alliance for Human Research Protection: https://ahrp.org

Vera Institute of Justice: http://www.vera.org/

THE NEW YORK TIMES
April 23, 2005
Private Firm to Investigate AIDS Charges Against City
By LESLIE KAUFMAN

The city’s Administration for Children’s Services has hired an outside research firm to investigate allegations that the city inappropriately put foster children into medical trials for AIDS drugs in the 1980’s and 1990’s and that foster parents who objected to the trials lost custody of the children.

The agency also said it would form a panel of national health care experts to review the findings of the investigation, to be conducted by the Vera Institute of Justice, a New York-based nonprofit research group. The agency’s commissioner, John B. Mattingly, said he thought that children’s services had acted appropriately but that he has asked for the outside investigation to allay concerns raised by some reporters and by a minority advocacy group. Most of the children in the trials were African-American or Hispanic.

“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,” Mr. Mattingly said. “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.”

Accusations that the city had allowed babies in foster care who were not perilously ill to be used in medical testing of AIDS drugs were first reported in The New York Post in 2004.

At the time, officials from the agency and from the hospitals where the trials had taken place said they had been legitimately conducted on only foster children dying of AIDS who had no other medical options at the time.

But when Mr. Mattingly took over as commissioner last August, he decided to do an internal review of agency records to be sure that no inappropriate trials had been conducted.

Yesterday, he said that exhaustive reviews of available records had produced no evidence that the agency acted wrongly. The review by the agency staff, he said, determined that about 465 children had taken part in the trials between 1988 and 2001, with most participating before current treatments for AIDS became commonly available.

He said that according to the records only two children were removed from foster parents who refused to undergo the trials and that both of those children had serious medical conditions that required treatment.

But Vera Hassner Sharav, the president of the Alliance for Human Research Protection, a Manhattan-based medical watchdog group that has pressed for a more thorough investigation, said that the agency could not be relied upon to conduct a fair investigation. She said that documents filed with the federal government showed that many of the foster children were only presumed to have AIDS. “It’s a hell of a thing to give a child toxic drugs when they are only presumed to have AIDS,” Ms. Sharav said.

Copyright 2005 The New York Times Company

THE NEW YORK POST
PANEL TO PROBE FOSTER KIDS’ HIV-DRUG TRIALS
By DAVID SEIFMAN

The city has asked an independent group to determine whether proper procedures were followed when 465 HIV-positive children in foster care were put in clinical drug trials from 1988 to 2001, officials said yesterday.

The Administration for Children’s Services has contracted with the Vera Institute of Justice, a not-for-profit research organization, to examine whether the required parent or guardian consents were obtained, whether the medical criteria were met and whether ACS correctly monitored the situation.

Vera has also been asked to locate as many of the children as possible to ascertain their current medical conditions.

The study’s results are expected in three months. A panel of nationally recognized experts will then review the findings.

“There’s no litigation. There are no hearings. We’re doing this to set the record straight,” ACS spokeswoman Sharman Stein said.

Advocates have questioned why these kids – most of them black or Hispanic – were the ones subjected to the medical tests. Stein has pointed out that treatment back then was not as developed as it is today and that virtually every HIV-afflicted child in the United States was in some clinical trial.

Of the 13,927 kids under 13 diagnosed as HIV-positive between 1979 and 2003, 3,634 lived in the city, the Health Department said.

Nationally, 12,000 to 13,000 kids under 13 participated in pediatric-AIDS clinical trials sponsored by the National Institutes of Health between 1986 and the present.

No trials are under way here involving foster kids.

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