Fwd: [SSRI-Research] Children in Clinical Research: A Conflict of Moral Values

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[sSRI-Research] Children in Clinical Research: A Conflict of Moral

Values

 

Children in Clinical Research: A Conflict of Moral Values

Vera Hassner Sharav, MLS

President, The Alliance for Human Research Protection

http://www.bioethics.net/journal/infocus.php?vol==3 & issue==1 & articleID=R

 

Abstract

 

This paper examines the culture, the dynamics and the financial

underpinnings that determine how medical research is being conducted on

children in the United States. Children have increasingly become the subject

of experiments that offer them no potential direct benefit but expose them

to risks of harm and pain. A wide range of such experiments will be

examined, including a lethal heartburn drug test, the experimental insertion

of a pacemaker, an invasive insulin infusion experiment, and a fenfluramine

³violence prediction² experiment. Emphasis, however, is given to

psychoactive drug tests because of the inherent ethical and diagnostic

problems involved in the absence of any objective, verifiable diagnostic

tool. Effort is made to provide readers comprehensive reference sources to

evidence-based reports about the serious risks these drugs pose for adults

and children so that the reader may judge whether the benefits (if any)

outweigh the risks for children. The first ethical issue raised by these

experiments is: did the severity of illness in these children justify their

exposure to short and long-term risks? The ethics of the experiments will be

evaluated by referring to existing codes of medical research ethics‹the

Nuremberg Code, the Declaration of Helsinki, and the federal Code of

Regulations. The thirteen cases presented will demonstrate that children are

being used in ever more speculative experiments, often in the absence of a

therapeutic intent, but a significant chance for causing harm and / or

discomfort. Some of the experiments were designed to explore the mechanisms

of pathology and pharmacological interventions, or the response of

neurological brain receptors to chemical provocation (³challenge²). Others

were designed to test the safety or efficacy of new drugs, even to test

these drugs on healthy children who were hypothesized to be ³at risk.²

Children and adolescents have been subjected to ³forced dose titration²

experiments that induced a spectrum of severe adverse effects, including

insomnia, extreme restlessness, agitation, (akathisia) and self-injurious

behavior. FDA reports show that suicide is a significant issue in

psychotropic drug trials‹in pediatric trials the problem is even greater.

The paper aims to demonstrate how the enactment of the Better

Pharmaceuticals for Children Act (incorporated into the Food and Drug

Administration Modernization Act, FDAMA), set in motion a radical shift in

public policy by providing huge financial incentives to pharmaceutical

companies to test new or patented drugs in children. Federal policy shifted

from one aimed at protecting children by setting limits on permissible

research risks, to a policy aimed at broadening the inclusion of children as

test subjects. It will be shown how the FDA and the Department of Health and

Human Services lifted regulatory restrictions to permit research involving

greater than minimal risk to be conducted on healthy children, claiming that

all children are potentially " at risk " of a future condition. Children were

in this way deprived of regulatory protections. An argument will be made

that the approval of nontherapeutic, harmful experiments‹such as exposure of

toddlers to lead poison‹under the current gate keeping system raises serious

doubts about the sustainability of institutional review boards (IRBs) as

protectors of human research subjects. Children, who are precluded from

exercising the adult human¹s right to informed consent, are being exploited

as commodities for commercial ends. It is the position of the author that

nothing less than the enactment of a federal law mandating a radical

overhaul of the current research review system, with independent checks and

balances, will provide children the legal protections they need. Ten

specific recommendations are offered to protect children from harmful

experiments.