The ICC Investigation – Deaths in Studies with NYC Orphans – AHRP on the VERA Institute Report

ALLIANCE FOR HUMAN RESEARCH PROTECTION
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org and http://ahrp.blogspot.com

The final report of the VERA Institute investigation commissioned in 2005 by the NYC Administration of Child Services will hardly put to rest the controversy surrounding a 20-year period during which 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 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 them 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 authors of the report “concluded” that the deaths were “not a direct result of the medications.”
http://www.vera.org/publication_pdf/clinicaltrials-noappendix.pdf

However the validity of that conclusion is highly questionable inasmuch as the VERA Institute reached that “conclusion” on the basis of (admittedly) incomplete, therefore unreliable records.

MOST IMPORTANT: The VERA Institute acknowledges that its staff never gained access to the children’s primary medical clinical trial records–which the hospitals conducting the trials kept sealed under a shield of confidentiality.

“citing confidentiality laws, the New York State Department of Health (NYSDOH) refused multiple requests from Children’s Services that it use its supervisory authority to allow Vera Institute of Justice staff from Vera or Children’s Services to review clinical trial research or medical records.

This limited Vera’s review in several ways, including the ability to fully document the frequency and severity of toxicity (side effects), the individual outcomes of trial participation for the children in the review, and the existence of valid, signed informed consent documents.” [Executive Summary] http://www.vera.org/publication_pdf/clinicaltrials-noappendix.pdf

Neither did the Vera Institute have access to minutes from medical center research review boards where the trials were conducted.

“Vera could not identify the trials in which an IRB approved a trial under 45 CFR 46.406 or .407. HRA/Children’s Services’ policy required that each institution produce proof of IRB approval, but the policy did not require that the institution identify the category under which the IRB approved the research”

DENIAL OF ACCESS TO THE PRIMARY RECORDS EFFECTIVELY UNDERMINED THE VALIDITY OF THE VERA INSTITUTE INVESTIGATION which was charged with fact-finding about these highly controversial experiments.

The foster children in the experiments–94% children of color–were enrolled, mostly in violation of federal informed consent requirements.

The VERA Institute relied on secondary, child welfare files and Pediatric AIDS Unit (PAU) records both of which are notoriously incomplete.

“Although state regulations mandated that Children’s Services ensure the retention of most of the child welfare files that Vera was asked to review, for 30 percent of the children, some part of the child welfare file was lost, destroyed, or otherwise unavailable.”

“the records of the Pediatric AIDS Unit (PAU) were incomplete, especially after 1995. Problems with the PAU’s record keeping after 1995, including defects in the unit’s electronic database, were noted in the unit’s quarterly reports to supervisors and state officials, including the AIDS Institute.”

Even those incomplete welfare files provide a hint of the adverse effects suffered by children who had been subjected to the experimental trials:

“The child welfare files contained information indicating that some children experienced serious toxicities, or side effects, from trial medications, such as reduced liver function or severe anemia. These toxicities were consistent with toxicities described in published articles about the trials.”

Background:

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, http://www.altheal.org/toxicity/house.htm the Alliance for Human Research Protection filed a 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.

The foster children enrolled in the AIDS trials were denied their human right: they were enrolled in the trial in accordance with New York City ACS guidelines which waive a foster child’s right to individual consent. ACS guidelines stated: “Separate consent need not be obtained for each child.”

This waiver, we believe, denies these children their basic human dignity and ascribes to them the status of guinea pigs. http://www.ahrp.org/ahrpsp

The VERA Institute report confirms that the AHRP letter of complaint was the cornerstone for OHRP’s investigation of Columbia University Medical Center’s HIV-AIDS clinical trials, followed by a nationwide investigation:

“OHRP issued determination letters to 19 institutions across the country for violations related to the enrollment of foster children in the HIV/AIDS clinical trials originally cited in the AHRP letter.366 The 19 institutions included the New York City medical centers Bronx-Lebanon and Bellevue Hospital Centers. 367 The SUNY Health Science Center at Stony Brook had also received a determination letter in February 2006 regarding two of the clinical trials cited.368

Each of these letters refers to an IRB’s apparent failure to categorize the research as 404, 405, 406, or 407 studies and/or to obtain sufficient information regarding the selection of foster children as participants in the trials. At each of the 19 other sites that received the June 2006 determination letters, OHRP approved corrective action plans aimed at preventing future violations.” Links to the 19 letters at: http://www.hhs.gov/ohrp/compliance/letters/2006.html

The VERA Institute report makes some cogent critical observations about the shortcomings of the OHRP investigation:

“The OHRP investigations indicate that IRBs at many institutions across the country did not properly document their activities and did not take the special circumstances of children in foster care into consideration. As is its mandate, OHRP focused its activities on compliance with federal regulations. The investigation at CUMC, however, left many other questions unanswered.

OHRP did not seek to make determinations on how many children in foster care participated in clinical trials or whether the person who signed the consent form had the legal authority to do so, nor did it examine what adverse events or benefits occurred to the children, if any, due to trial participation. The investigation did not examine whether foster children made up a disproportionate number of children in HIV/AIDS clinical trials or specify the policy of New York City’s child welfare agency for enrolling and monitoring foster children in clinical trials.”

Evidence previously uncovered by the Associated Press, confirmed AHRP’s concerns: 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:

“The role and requirements of the independent advocate described in federal research regulations were not well understood by clinical trials researchers and, in some cases, child welfare staff….”

It boggles the imagination that institutional review boards at premier medical research centers could claim ignorance about a glaring conflict of interest:

“In at least six instances where Vera reviewers found that an independent advocate had been appointed, the person appointed had relationships to the institution conducting the trial or a child welfare agency that the federal regulations specifically bar.”

The ACS Press Release 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” when in fact, the child welfare agency changed its enrollment policy to speed up the enrollment process. The New York City ACS guidelines waived a foster child’s right to individual consent in direct violation of federal regulations: “Separate consent need not be obtained for each child.”

This waiver, we believe, denied foster children their basic human dignity and cast them to the status of guinea pigs.

Oddly, The New York Times did not consider 80 children’s deaths worthy of mention in its news report!

See: AHRP complaint: http://www.ahrp.org/ahrpsp

See:The Associated Press report, “Researchers Tested AIDS Drugs on Children” by John Solomon, May 5, 2004, whose investigation found that less than a third of the children in the AIDS trials [“got such monitors even though city policy required them.”]:
http://www.ahrp.org/infomail/05/05/04.php

See: Testimony http://www.ahrp.org/cms/content/view/219/140/

Contact: Vera Hassner Sharav
verac…@ahrp.org

Liam

7 Comments

  1. The role and requirements of the independent advocate described in federal research regulations were not well understood by clinical trials researchers and, in some cases, child welfare staff….”

    “Were not well understood”. What the hell does that mean?

  2. Wow! three million dollars spent 1) for staging a chase, 2) skimming just the surface, and strong conclusions based on “not well understood” regulations. Well, actually, Liam you got a wind of what the outcome of this investigation was going to be 2 years ago, when you were asked to pour your “feelings and opinions” instead of contributing evidence! In conclusion, the govt spent three million dollars to collate everyone’s opinion and feelings… Awesome effort..

  3. A lot can be learned about the outcome of the Vera investigation just based on the “nature of Vera’s questionnaire” i.e. what interviewees were asked, and not asked, and who the interviewees were.. If that sort of information is accessible to the public.

  4. These numbers are shocking. I find it hard to believe that medical records are just disappearing. Does anyone know where the eggs for “Chimeras” come from?

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