AHRP Testimony: Protections for Foster Children Enrolled in Clinical
Trials Submitted to Cong.Ways & Means Hearing
Wed, 18 May 2005
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Tel. 212-595-8974 Fax:
212-595-9086
http://www.ahrp.org
142 West End Ave. Suite 28P
New York, NY 10023
Testimony by The Alliance for Human Research Protection
Committee on Ways and Means Hearing on Protections for Foster Children
Enrolled in Clinical Trials
May 18, 2005
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 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. 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 46.406 or 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 IRB) 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
ACS 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 were 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 infantsare 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 kids, Sunday, April 24, 2005]
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 ever been studied by any responsible government or
other agency, 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 participating 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 on Accreditation
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.
Vera Hassner Sharav, President, AHRP
John H. Noble, Jr, PhD, Treasurer
David Cohen, PhD, Secretary
~~~~~~~~~~~
FYI
The invited panel of witnesses to the hearing are:
Panel: Alan Fleischman, M.D., Senior Advisor, The New York Academy
of Medicine, New York, New York Roberta Harris, Deputy Secretary, Wisconsin
Department of Health and Family Services, Madison, Wisconsin Marjorie
Speers, Ph.D., Executive Director, Association for the Accreditation of
Human Research Protection Programs, Inc. Moira Szilagyi, M.D., Ph.D.,
Fellow of the American Academy of Pediatrics, on behalf of the American
Academy of Pediatrics
Not a single invited witness remotely represents the interest of the
children who were targeted and used as human guinea pigs to test experimental
AIDS drugs and vaccines!
Not a single invited witness represents the concern of the African-American
and Latino community whose children were targeted.
Not a single invited witness represents any of the child welfare agencies
or rsearch institutions that are under federal investigation for their
role in the enrollment of these children.
