Clinical Trials -- Who's Protecting Patients?

Nearly two years ago, three reporters for Bloomberg News exposed the lax government oversight of drug and device industry clinical trials, which enroll hundreds of thousands of patients every year to test new products. Their story concluded:

Every year, scores of people in the U.S. are injured and killed in clinical trials, while receiving little or no medical care. Unable to oversee human safety in most clinical trials in the U.S. by itself, the FDA has left much of the job to for-profit review boards.

Sadly, this crucial element of the story -- the privatization of the Institutional Review Board process that is the first line of defense for patients participating in clinical trials -- got left out of yesterday's front-page New York Times coverage of the Health and Human Service Department inspector general's report. Indeed, a close reading of the IG report shows that the investigators steered clear of discussing the conflict of interest inherent in turning over ethics and safety monitoring to private firms.

The report focused instead on the fact that the federal backstop for clinical trial safety and ethics is largely nonexistent. The FDA checked just one percent of clinical trial sites between 2001 and 2005 and almost never reviewed the performance of IRBs, which are primarily responsible for protecting the human subjects participating in the trials. Indeed, nearly three-quarters of few inspections it did conduct had nothing to do with protecting patients, but instead involved checking the validity of trial data. And in the few cases involving violations of patient rights that resulted in warning letters, the agency almost never conducted follow-up investigations to ensure compliance.

Remarkably, the FDA doesn't even know how many firms are in the IRB business, or whom they are. Among its recommendations, the report asked the FDA to register these firms. Deputy commissioner Janet Woodcock responded that the FDA and Office of Human Research Protection inside HHS had proposed an IRB registry in 2004, and were “working diligently” to complete it.

Meanwhile, an increasing number of industry clinical trials are moving offshore to India, China, and eastern Europe, where regulatory oversight is, if anything, even less stringent.