[Congressional Record Volume 144, Number 85 (Thursday, June 25, 1998)]
[Extensions of Remarks]
[Pages E1220-E1221]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]
PROTECT CHILDREN AND MENTALLY DISABLED PERSONS INVOLVED IN MEDICAL
TRIALS
______
HON. EDOLPHUS TOWNS
of new york
in the house of representatives
Wednesday, June 24, 1998
Mr. TOWNS. Mr. Speaker, today I rise to introduce a bill which will
increase oversight protection for children and mentally disabled
individuals who participate in clinical research trials. I am proud
that this bill has received bi-partisan support. Mr. Shays of
Connecticut, Mr. Barrett of Wisconsin, Mr. Burton of Indiana, and Mr.
Waxman of California are original cosponsors of this measure.
Institutional Review Boards serve as the principal line of defense
for the protection of human subjects who participate in clinical
research. These boards review and approve a research plan before the
research is carried out and ensure that any risks are warranted in
relation to the anticipated benefits. The Department of Health and
Human Services (HHS) is the primary Federal department sponsoring
biomedical and behavioral research. Its regulatory apparatus for
overseeing such research consists of two principal tiers of review: one
at the research institution level and the other at the Federal level.
Both tiers are responsible for ensuring that individual researchers and
their research institutions comply with Federal laws and regulations
for protecting human subjects.
However, the GAO and the Inspector General of the Department of
Health and Human Services have found that these Boards are falling down
on the job. In numerous reports over the last 5 years, each of these
oversight agencies have found that IRB's are conducting reviews too
quickly and with members who lack expertise in the subject areas, that
they conduct minimal review of approved research, tend to allow for
unauthorized expansion of research plans or ``creep'' and that their
membership and institutional affiliations may present real and apparent
conflicts of interests. Both the GAO and the Inspector General warned
that these serious deficiencies may jeopardize the protection apparatus
necessary for people who participate in medical research. In a recent
hearing of the Subcommittee on Human Resources, of which I am the
ranking member, we uncovered a case which may be the realization of the
fears expressed by the GAO and the IG.
In New York City, a prestigious IRB permitted a research project
which used the drug Fenfluramine. Researchers devised a trial which was
reputedly designed to determine whether a relationship existed between
aggressive behavior and the brain chemical serotonin. Fenfluramine is a
class IV amphetamine which occupies the same status as drugs such as
darvon and xanax. It is half of the diet drug ``phen-fen''. Prior to
being withdrawn from the market in 1997 by the FDA, its only approved
use was weight control. Because the drug for safety or efficacy on
children under 12 years of age. Therefore, no one knows whether this
drug may adversely affect children under 12. The research plan called
for the participation of male children between the ages of 6-11 years
old whose siblings had been adjudicated as delinquents. None of the
children sought for the study had any history
[[Page E1221]]
of violent or aggressive behavior. There is no evidence that any of the
older siblings had any history of violent or aggressive behavior. The
research plan specified that all children recruited should be African-
American or Hispanic. Caucasian children were specifically excluded.
Prior to the lab portion of the tests, the children were placed on a
low protein diet for 72 hours which affects the levels of serotonin in
the brain. The children were denied food for 12 hours prior to the
test. After receiving Fenfluramine, a catheter was placed in the arms
of the participants to enable the researchers to withdraw blood easily.
Blood was withdrawn about once an hour during the five-hour tests. The
blood readings were used to measure levels of serotonin activity in the
children. Because this experiment involved an approved drug which was
being given to measure physical and biological responses, FDA approval
was not needed. After the experiment, the children and their parents
were paid and sent home. Subsequently, several parents have complained
that their children have suffered illnesses which they did not have
prior to this ``challenge''.
In numerous memos ranging over a 2-year period, the IRB asked the
researchers to explain the scientific premise of their experiment in
greater detail and to explain the necessity of exposing children to a
procedure which the IRB deemed to constitute ``more than minimal
risk''. After 2 years of correspondence, these issues were never fully
addressed. Additionally, Federal regulations require that studies
involving human subjects recruit participants in an ``equitable''
fashion. Here, the research plan breached that requirement because it
specifically excluded White children without any medical reasons for
the exclusion. The IRB approved this study despite these problems.
Although the Food and Drug Administration and the Office of
Protection from Research Risks are charged with the responsibility of
investigating complaints involving human subject research, such
investigations are rare. Both agencies rarely conduct more than 100
investigations at any given time. Corrective actions or sanctions are
imposed on a fraction of those researchers investigated. The Office of
Protection from Research Risks is currently investigating this New York
study. However, they estimate that it may take up to a year to conclude
this investigation. Clearly, we need to assure that Federal officials
are empowered to take a proactive role in research abuses. However that
will be difficult because currently, IRBs are not required to register
or engage in any certification process. We do not know how many IRBs
operate in this Nation. Therefore, we cannot know the extent of their
use of children and other vulnerable populations.
The bill that I introduce today requires that any IRB that uses
children or mentally disabled individuals in research must report to
the Secretary of Health and Human Services concerning the participants,
the nature, objectives and reasons for the research and the source of
funding. The Secretary will be required to make this information
available to the public. I believe that this bill will impose sunshine
on this secretive process and will afford greater oversight by the
government and by concerned members of the public. I ask all of my
colleagues who are concerned about children and the mentally disabled
to join me in supporting this bill.
____________________