Warning! Traumatic Topic:. EXPOSED! What CPS Thinks is in the Best interest of the Child?
Posted by innerpeace5 on Tuesday, January 26, 2010 6:22:22 AM
CPS (DHHS) HAS TO BE STOPPED FAST
Statement of Vera Hassner Sharav and John H. Noble Jr., Ph.D.,
Alliance for Human Research Protection, New York, New York
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 experiments had been conducted on infants and children who were under the guardianship of the New York City Administration for Children’s Services (ACS). The children were living at Incarnation Children’s Center, a foster care facility under contract with ACS and the Catholic Archdiocese. We had reason to believe that the experiments were unethical, illegal, and coercive–and that federal regulations have been violated. ******We did not know at the time that children in foster care nationwide were subjected to research exploitation at prestigious medical research institutions.*******
Historically such children have been abused and exploited in medical experiments—for that reason, federal regulations were enacted to restrict the use of foster care children in research. The Associated Press confirms that for more than two decades, government officials colluded with hospitals and researchers to facilitate the enrollment ofchildren 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. How ironic it is that children, who were placed by the courts into the protective custody of foster care agencies pursuant to the provisions of the Adoption and Safe Homes Act of 1997, should end up further victimized by their caretakers.
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.The Code of Federal Regulations (45 CFR 46.409 and 21 CFR 50.56) prohibits subjecting children who are wards of the state to experiments involving ***greater than minimal risk***:
(A) Children who are wards of the State or any other agency, institution, or entity can be included in research approved under 6.406or 46.407 only if such research is:1) related to their status as wards; or
2) conducted in schools, camps, hospitals, institutions, or similar setting in which the majority of children involved as subjects are not wards.
(b) If the research is approved under paragraph (a) of this section,the IRB shall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis.
The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child’s participation in the research and who is not associated in any way (*** except ***in the role as advocate or ***member of the IR ***with the research, ****the investigator(s)****, or ****the guardian organization.*** The Phase I and Phase II experimental drug and vaccine trials in question were unrelated to their status as wards–the NYC- ACS enrollment guidelines applied to foster care children only. The ACS guidelines falsely stated that the trials posed “minimal risk,” and the guidelines clearly focused on facilitating rapid enrollment of as many foster children as possible—rather than ensuring that the trials were in the ****children’s best interest****: [Attached]
“ACS will review clinical trial protocols for HIV-infected children as soon as such protocols become available, before a specific hospital decides to participate in the study. The National Institutes of Health (NIH) and pediatric AIDS specialists throughout New York State will make S aware of protocols as soon as they are in final form, before hospitals are ready to enroll children. This procedure will expedite ACS’ decision-making even before physicians are ready to start treating children in the protocols.”
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. Phase I and Phase II drug experiments involve the highest level of risk, uncertainty, and discomfort—the safety and toxicity of drugs as well as maximum dose tolerance are tested in these trials. Experiments at that testing stage are unlikely to have any direct benefit for the children in whom the drugs are tested. In some trials children were diagnosed with HIV infection—in some cases infants merely presumed to be HIV-infected:
#292: A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seve n Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
#345 A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive Infants and Children, last amendment 3/13/2000.“Replacement infants…are either presumed HIV infected or have already been shown to be HIV-infected…”Infants and children were exposed to experimental HIV vaccines—which have never been successful:
#218 A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1gp160 and gp120 in Children >=1 Month Old with Asymptomatic HIV Infection.Although more than 4 AIDS drugs had never been tested in children, foster care children were exposed to an 8 drug cocktail “some at higher than usual doses” (which was reduced to 7 drugs because of “significant toxicity” 11/9/ 2001).
#1007 ******Multi-Drug****** Antiretroviral Therapy for Heavily Pretreated Pediatric AIDS Patients: A Phase I Proof of Concept Trial Among the drugs tested in foster care children, is Nevirapine, a drug whose safety has been the center of controversy. [AP] Because Nevirapine confers resistance following even a single (low) dose, its manufacturer cautions that its use should be restricted to “previously untreated women with HIV infection who present at labor” for the prevention of mother-to-child transmission of HIV. Yet, 4 to 17 year old children in foster care were exposed to Nevirapine. A Phase I trial of a Glaxo Wellcome drug, Valacyclovir hydrochloride was terminated in 1997—
Why? Typically, trials terminated at such an early stage show unacceptable levels of toxicity.The Associated Press reported: “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. ACS Commissioner, John B. Mattingly, testified before a City Council General Welfare Committee, that he knows of just 19 children—out of 465—who remain within the NYC foster care system.
In addition, a series of recent investigative media reports from Texas,Florida, Ohio, New York, California, Illinois, raise concerns that over 50% of all children in foster care are currently being prescribed untested, experimental combinations of powerful, mind altering, psychotropic drugs—including antipsychotics (e.g., Risperdal, Zyprexa),anticonvulsants (e.g., Depakote, Neurontin), antidepressants (Zoloft, Paxil, Prozac, Celexa and others), tranquilizers (Klonopin, Xanax),stimulants (Ritalin, Adderall), as well as heavily sedating drugs such as the anti-hypertensive medication clonidine. These prescribing patterns are essentially uncontrolled experimental drug trials. [See: The Columbus Dispatch series by Encarnacion Pyle. Forced medication, straitjackets, Sunday, April ,2005 ://www.dispatch.com/reports-story.php?story=dispatch/2005/04/24/20050424-A1-00.html
Clinical trials approved by the FDA study only a *single* drug given in tightly controlled dosages. Combinations of two and three or more different psychotropic drugs have simply never been studied in a rigorous and responsible manner.
Furthermore, the foster parents and social workers who are mostly entrusted with supervising these children have less than rudimentary knowledge about these drugs’ adverse effects, and even less skills in monitoring these children to avoid dangerous drug reactions. This is of course less than the protection afforded subjects in ordinary clinical trials.
It is worth repeating:
none of these idiosyncratic drug combinations — called polypharmacy–have never been studied by any responsible government or otheragency, and the children receiving them may be considered guinea pigs in a gigantic uncontrolled medical experiment.
How can the Congress fail to take strong corrective action?
The public has a right to know:
How many children in foster care have been enrolled in clinical trials?
What happened to foster children who were used as human guinea pigs?
What adverse effects did the children suffer during and after participation?
How many children died during the experiments?
A question has been raised about the size of the cemetery plot in which children in ACS custody are buried: Were any children buried in mass graves?
What were the specific sources of funding for these Phase I and Phase II clinical trials?
Did the foster care agencies or foster families receive payment, fees, or other rewards for enrollment of the children in these trials?
How much money was paid to the researchers and articipating hospitals?
What happened in 2001 that the AIDS drug trials in foster children were stopped?
What other drug trials are being conducted on foster children?
The other questions we pose below suggest that there may have been a breakdown in the implementation of the Adoption and Safe Families Act and/or related federal law governing the protection of children in foster care. Our questions, by extension, suggest that the Council onAccreditation of Family and Children Services (COA), and one of its two founding organizations, the Child Welfare League of America (CWLA), may not be meeting their obligations. Child protection falls within the purview of the juvenile and family court system, which remands abused and neglected children into the care of public and private, non-profit foster care agencies.
In our view, the courts have ultimate jurisdiction and responsibility for what happens to these vulnerable children. The Congress may want to consider a dual approach in dealing with the issues at hand. Child welfare laws operate by regulating the care-givers. Child abuse reporting laws, for example, require health, school, and social service personnel to report suspected child abuse. If such laws were to define “suspected child abuse” to include enrollment of foster children in Type I and Type II clinical trials, in violation of the protections afforded by 45 CFR 46.409 and 21 CFR 50.56), there would be many more eyes watching to protect children from overreaching biomedical researchers who, history has shown, have abused their authority to exploit children in foster care.
Were there violations of the provisions of the Adoption and Safe Families Act and/or related child welfare legislation by officials of the foster care agencies that permitted enrollment of foster children in Phase I and Phase II clinical trials?
Should not the supervising foster parents and/or social workers have reported suspected child abuse in these high risk, Phase I and Phase II clinical trials of experimental drugs and vaccines?
What training, if any, is provided to supervising foster parents and/or social workers about the conditions that must be satisfied by reference to 45 CFR 46.409 and 21 CFR 50.56 in order to justify enrollment of foster children in ANY biomedical research involving greater than minimal risk?
Is there a need for new federal legislation that would amend the Adoption and Safe Families Act and/or 45 CFR 46.409 and 21 CFR 50.56 to expressly define children in foster care a “protected class,” whose enrollment in ANY biomedical research would trigger appointment of an independent research ombudsman under the supervision of the juvenile or family court that remanded the foster child into state custody?
Finally, if, as we argue, the courts have ultimate jurisdiction and responsibility for what happens to children whom the courts remand to the protective custody of state and private, non-profit foster care agencies,then the Congress might wish to consider amending the existing requirement for the appointment of a child advocate by the IRB pursuant to 45 CFR 46.4.09 and 21 CFR 50.56 to require instead that the child advocate be appointed by and be held accountable to the court of original jurisdiction for foster children who may be subjected to biomedical research involving greater than minimal risk. The courts, we believe, are the last recourse that foster children have to protect them from the predatory practices of those who would exploit and take advantage of their vulnerability.
We should remind ourselves that the measure of a society is how it treats its most vulnerable citizens.