[Congressional Record Volume 144, Number 85 (Thursday, June 25, 1998)]
[Extensions of Remarks]
[Pages E1220-E1221]
From the Congressional Record Online through the Government Publishing 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.

                          ____________________