Ethics Newsline®

WASHINGTON
One of the more ethically controversial research practices in science — clinical trials in which millions of human are given experimental drugs or newly developed medical devices — receives little oversight, according to a new watchdog report.

The U.S. Health and Human Services Department’s inspector general says that over a six-year period the Food and Drug Administration (FDA), the agency in charge of supervising clinical trials, inspected just one out of every 100 trial sites, according to a report from USA Today.

The problem, according to the report, is that the FDA does not even have a comprehensive list of clinical trials taking place, meaning that the government is unable to identify all of the sites or institutional review boards that oversee the ethical, legal, and scientific requirements for the studies, reports the Associated Press.

Also, the report claims that the FDA has only 200 inspectors responsible for more than 350,000 test sites, according to Reuters. When negative findings were reported by inspectors, the report maintains, they were downgraded more than half of the time after being reviewed by top officials in Washington.

FDA officials say that Congress has failed to provide adequate funding for the agency to do its job.

In an MSNBC commentary, Dr. Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, argues that the lack of hard data on human experimentation is “beyond belief,” considering that “the government agencies responsible for monitoring research with animals collect exactly that data every year. How can it be that we know how many pigs, frogs, rats, and monkeys are used in research and who uses them without knowing what is going on with respect to human beings?”

Caplan maintains that some fundamental ethical issues go unexamined because of the agency’s troubles: “Are too many poor people disproportionately recruited for research? Who knows? Are the elderly in nursing homes underrepresented in clinical trials? Who can tell? Should more children be involved in studies of new drugs? Cannot say. Is it more likely that people get injured in for-profit test centers than in academic research settings? No data is available to answer that question.”