Are Children Adequately Protected In Biomedical Research Trials?

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 centers.

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....

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.