In late 2008, nearly five years after Liam Scheff broke the story of children being used in drug trials in New York City’s ICC Orphanage, the city of New York released its three-million dollar cover-up “investigation” of the events. The official version: 80 children who’d been in trials died (25 during, 55 after), but the drugs ‘could not be to blame.’ How did they know? They didn’t – they didn’t look at drugs, medical records, or interview families or children. They just repeated the official version. The reporter in this news broadcast is Rebecca Myles of WBAI in New York City. The images in this video are of HIV tests, the orphanage, AIDS drug studies and effects (Nevirapine), and the NIH clinical trials.
All of this is censored from the Wikipedia
WBAI Interview: Scheff, Vera Institute, Rebecca Myles for WBAI: Tim Ross 29 percent have died
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.”
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.” Continue reading The ICC Investigation – Deaths in Studies with NYC Orphans – AHRP on the VERA Institute Report