CLINICAL TRIALS: Lawmakers Want Patient Protections
Responding to a government report released yesterday that pointed to "cracks" in the system that protects patients in clinical trials, members of Congress called for major changes in the way the government oversees studies involving human subjects. The report was officially released to a congressional subcommittee, and is "the first in what is expected to be a series of highly critical looks at protections for people in medical trials." Since the report began circulating late last week, it has raised concerns that the patient protection system is in "jeopardy," possibly endangering the patients who participate. Rep. Edolphus Towns (D-NY) said yesterday that the system "needs to be torn down and rebuilt," echoing the concerns of many other lawmakers.
Looking For Solutions
USA Today reports that "Congress must decide whether to leave the changes to the system in the hands of the oversight agencies and research industry, or to enact laws" (Davis, 6/12). Witnesses who testified on Capitol Hill yesterday said "repeatedly ... that the review and oversight system for clinical testing did not have the resources needed to strengthen protections." For instance, one of two federal research risk protection panels has only one full-time investigator to review potential risks in human trials, the New York Time reports (Eichenwald, 6/12).
Gary Ellis, who heads the Office of Protection from Research Risks at the National Institutes of Health, suggested that Congress should "focus on privately funded human studies, including those at fertility clinics and weight-loss clinics, many of which are completely free from the system of oversight for federally funded work." The government report offers another solution: Requiring institutional review boards to "track more carefully the progress of the studies they have approved, to make sure researchers are doing what they said they would" (Weiss, Washington Post, 6/12). Click here to download a pdf version of the federal report, which was prepared by the Health and Human Services Inspector General.