Are Children Adequately Protected
In Biomedical Research Trials?
August 12, 1998
Congress is seriously considering doubling the national
budget for biomedical research trials. Parents should
pay close attention, because the expansion of research
trials, combined with the new FDA Modernization Act
of 1997 and the State Children's Health Insurance Program
(SCHIP), could mean that more children will be enrolled
in government drug studies.
The FDA Modernization Act of 1997 calls for pharmaceutical
companies to increase testing of pharmaceutical drugs
in children. SCHIP, also enacted last year, creates
a new government program under the Department of Health
and Human Services (HHS), giving states some $48 billion
federal dollars to expand their Medicaid programs (including
school-based health centers) or to create new state
health programs. We've already seen significant increases
in psychological testing and Ritalin prescriptions as
a result of Medicaid expansions into school-based health
Who's Protecting the Children?
As the federal government carves out a larger role
in children's health care, will American children be
adequately protected in biomedical research trials?
That depends on whether parents and their children are
fully informed about possible research risks, and whether
biomedical Institutional Review Boards (IRBs) are effective.
If the recent record is any indication, there is much
to worry about.
IRBs are responsible for approving and monitoring
biomedical research studies. Recently, however, Congress
has found that IRBs are failing to protect human subjects
in research trials.
Shades of Tuskegee?
According to U.S. Rep. Edolphus Towns (D-NY), a prestigious
biomedical IRB in New York City allowed medical researchers
at city hospitals to test the drug "fenfluramine" in
children, even though the drug offered no therapeutic
benefit and more than "minimal risk" to the children.
In other words, the children were not being treated
for a medical or psychological condition, but, rather
were being used as research subjects.
This case was brought to the public's attention through
numerous articles published in the New York Post
in April. Reporter Douglas Montero disclosed that researchers
may have put more than 100 city boys, ages 6 to 11,
(mostly black or Latino) at risk by giving each of them
a single dose of up to 10 milligrams of fenfluramine.
(Fenfluramine, half the popular diet drug "phen-fen,"
was pulled off the market in 1997 because it caused
heart damage in some adults.) Montero reports that some
advocacy groups are comparing the child-fenfluramine
experiment to the government funded Tuskegee trials
of the 1940s, where blacks were intentionally denied
treatment for venereal disease.
All medical researchers involved in the current study
emphatically denied hurting the children. Dr. Jack Gorman
of the New York State Psychiatric Institute admitted
the experiment was non-therapeutic, but told Montero,
"All attempts to find solutions to serious mental-health
problems begin with research like this." The National
Institutes of Health Office of Protection from Research
Risk is currently investigating the case.
In response to the enormous public outcry, the House
Government Reform and Oversight Committee held a hearing
on June 11 to examine whether IRBs are adequately protecting
research participants involved in federally funded research.
Official transcripts from those hearings will not be
made public for several weeks as Congress gives witnesses
the opportunity to review their statements (and make
corrections if necessary), before publishing them in
the Congressional Record. However, written testimony
can be found on the Internet at the following address:
Keep in mind that the written testimony excludes the
more controversial statements made during the question
and answer periods. It also excludes information about
documents presented the day of the hearing.
For example, the committee's minority staff made public
a document that shows researchers enticed children into
joining the child-fenfluramine study in New York. Children
were told that if they participated in the experiment,
they would receive a gift and would get to try out some
new video games, while their families would get paid.
At the same time, the children were not fully informed
of potential research risks.
Parents Should Watch
This may represent an aberration in biomedical research
involving children. But children and their parents may
find themselves in similar situations as the federal
government increases funding for biomedical research,
expands Medicaid programs using SCHIP funds, and enforces
the new FDA law encouraging drug testing in children.
Parents interested in maintaining control over their
children's health should pay close attention to these
new federal initiatives.
This article was originally published in the July/August
issue of Health Freedom Watch, the bimonthly
watchdog report published by the Institute for Health