Is Anyone Watching the Institutional Review Boards?

Before patients join a clinical trial, they must sign an “informed consent” agreement stating they’ve been told all the risks inherent in participating in that particular trial. Each year, hundreds of thousands of people join anyway. In some cases, they do it because they are desperate for the chance to try an experimental therapy on their disease. But mostly they’re motivated by altruism. Once asked, they’re more than happy to lend their bodies to the advancement of medical science.

On the other hand, the drug companies who sponsor a growing percentage of clinical trials may have other motives. As discussed here yesterday, some industry-funded trials are so-called seeding trials, where the company sponsoring the test is primarily interested in getting more doctors to prescribe their drug. Of course, that’s never the stated rationale for the study, since no institutional review board (each institution that takes part in a clinical trial must have an internal IRB that approves the study) is supposed to approve a trial whose only purpose is to sell more drugs.

So how do they slip by? One clue came from FDA deputy commissioner Janet Woodcock’s comments yesterday to the Drug Information Association, which is primarily made up of drug industry professionals. It’s the FDA’s job to monitor IRBs,

According to FDA Webview (subscription required), Woodcock revealed the agency does not have an internal database listing all IRBs. And although it published a proposed rule in 2004 requiring registration of IRBs, the agency is still reviewing public comments. She gave no timeline for its final publication. Moreover, she told the DIA, the agency has issued almost no standards for the field.

While the public thinks most clinical trials are run by university-based scientists subjected to strict oversight by their local IRBs, the field in recent years has been infiltrated by for-profit IRBs loosely affiliated with for-profit contract research organizations, which are playing a greater and greater role in industry-funded research. These organizations often turn to practicing physicians, who can earn extra cash by recruiting their patients for clinical trials.

Woodcock admitted the agency’s regional offices, who are responsible for overseeing this sprawling enterprise, do not have the capacity or the expertise to monitor this activity. It will be interesting to see if the FDA reform legislation that will be introduced in August by Senators Edward Kennedy (D-Mass.) and Michael Enzi (R-Wyo.) will beef up this crucial agency function.