AHRP Testimony: Protections for Foster Children Enrolled in Clinical Trials Subm

[Guest guest]

Thu, 19 May 2005 17:43:13 +0200

 

" Sepp Hasslberger " <sepp

Fwd: AHRP Testimony: Protections for Foster Children Enrolled

in Clinical Trials Submitted to Cong.Ways & Means Hearing

 

For information -

 

a report of the AHRP's testimony before the House

Ways and Means Committee on the inhuman

experiments foster children were subjected to in

New York's

<http://www.newmediaexplorer.org/sepp/2004/07/15/aids_experiments_on_children_in\

_new_yorks_incarnation_center_a_human_tragedy.htm>

 

 

Incarnation Children's Center and other trial locations

throughout the US.

 

Kind regards

Sepp

 

 

 

 

 

THE ALLIANCE FOR HUMAN RESEARCH PROTECTION

Tel. 212-595-8974

(AHRP) Fax:

212-595-9086

<http://www.ahrp.org/>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-Infcted Infants

 

#345 A Study of Ritonavir (an

Anti-HIV Drug) in HIV-Positive Infants and

Children, last amendment 3/13/2000.

" Replacement infantsŠare either

presumed HIV infected or have already been shown

to be HIV-infectedŠ "

 

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

<http://www.dispatch.com/reports-story.php?story=dispatch/2005/04/24/20050424-A1\

-00.html>http://www.dispatch.com/reports-story.php?story=dispatch/2005/04/24/200\

50424-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 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.

 

 

 

--

 

 

The individual is supreme and finds its way through intuition.

 

Sepp Hasslberger

 

 

My page on physics, new energy, economy: http://www.hasslberger.com/

 

Critical perspective on Health: http://www.newmediaexplorer.org/sepp/

 

Antiprohibition and cannabis: http://www.unsaccodicanapa.com/

 

Communication Agents: http://www.communicationagents.com/

 

Freedom of choice - La Leva di Archimede: http://www.laleva.cc/

La Leva's news: http://www.laleva.org/

 

Robin Good - http://www.masternewmedia.org/

 

Trash Your Television! - http://www.tvturnoff.org/

 

Not satisfied with news from the tube and other controlled media?

Search the net! There are thousands of information sources

out there. Start with

 

http://www.whatreallyhappened.com/

http://www.truthout.org/

http://www.joevialls.co.uk/

http://www.Rense.com/