Magazine
Coasting Without Oversight
A scandal at an IRB highlights an industry problem
By Ed Silverman
What comes to mind when we think about a scandal involving prescription drug safety? For most, Vioxx is probably the example that comes to mind. Perhaps others would cite the hoopla surrounding antidepressants and disclosure of clinical trial data or the off-label marketing of antipsychotics. In general, though, the controversies have focused spotlights on behavior by the drug marketers.
But a recent episode illustrates that safety scandals can just as easily exist further up the food chain — specifically, institutional review boards, or IRBs. These are the oversight groups comprised of doctors, scientists and others who perform a behind-the-scenes, but crucial function — they are chartered to oversee the methodology and safety issues for human clinical trials that are run by drug and device makers, as well as hospitals and universities.
Simply put, “the IRB is designed for patient protection,” said Dr. Stephen Goldman, a former medical director of the FDA’s MedWatch post-marketing surveillance program. Dr. Goldman, now an independent consultant focusing on pharmacovigilance, risk communication and clinical safety, added, “[The IRB is] supposed to ensure that a trial involving actual patients conforms with good clinical practice. It’s the overseer that grants approval for a trial to proceed.”
Without certification from an IRB, in fact, a drug or device will not receive product approval from the FDA. Not surprisingly, there are a good many IRBs out there — about 6,350 IRBs are registered with the U.S. Department of Health and Human Services. The tally includes numerous for-profit enterprises, since there is clearly an opportunity to make big money from companies that are trying to speed products to market.
But there are some important questions that appear to have gone unasked – are for-profit IRBs confusing their obligation to paying clients with a needed commitment to patient safety? With this potential conflict of interest in mind, who exactly is in the best position to oversee the for-profit overseers? And is oversight currently conducted properly, if at all?
As it turns out — and this should not surprise you — oversight can go lacking. And the nasty case of Coast IRB underscored this deficiency in stark and disturbing terms. A sting operation conducted last year by the House Energy and Commerce Committee and the General Accountability Office found that the Colorado Spring, CO, firm had approved a study for a fictitious product called Adhesiabloc, which was supposed to be an adhesive gel.
The committee and the GAO also created a fake clinical trial and solicited Coast to ensure the study was safe for human research. But it wasn’t until five months later — when the committee invited Coast’s chief executive to testify about IRB oversight — that the IRB learned that the gel and its alleged manufacturer, an operation based in Virginia called Device Med-Systems, never existed.
By then, Coast had given its blessing for the trial to proceed. Two other commercial IRBs, however, rejected the submission, calling it a “piece of junk” and “too risky.” But Coast was apparently all too eager to issue an endorsement. According to the GAO report, Coast “approved our bogus research protocol for human subjects testing after only minor edits to our submission materials, even though we were a bogus company with falsified credentials and an unproven medical device.” However, the GAO did note that none of the three IRBs approached in the sting bothered to check the counterfeit medical license or the résumé of the alleged Device Med-Systems chief executive that were also submitted.
While there were no human subjects involved, the revelation caused a brief sensation on Capitol Hill. In testimony before the committee last March, Coast IRB’s chief executive, Dan Dueber, struck an outraged posture, decrying the sting and claiming that congressional investigators “perpetrated an extensive fraud against my company.” Despite his complaints of entrapment, however, Mr. Dueber quickly vowed to overhaul operations. Yet the damage was done. Within one month, Coast IRB agreed to halt reviews of any studies regulated by the FDA, which amounted to approximately 300 trials involving some 3,000 investigators.
By the end of April, in fact, Coast was toast. The IRB began the process of closing its doors in the wake of the intense scrutiny and its credibility gap. Meanwhile, numerous device- and drugmakers and biotechs began the uncomfortable task of rifling through their records to determine whether Coast was at any point involved in approving and overseeing parts of countless clinical trials. There were no reports of any company halting a trial due to Coast’s activities, but you can be sure a public relations disaster would have ensued if any had.
Since this came to light, there has been precious little public discussion by executives from the biopharmaceutical industry about this sorry fiasco. But it’s probably a safe bet that the Coast sting operation has raised anxiety levels. A drugmaker may be correct to assert that safety concerns involving a reckless IRB are not its responsibility and, moreover, that it can be difficult for a company to know whether any particular IRB is overseen properly. But that misses the point.
Such explanations cannot paper over repeated episodes of questionable behavior, which suggest that an entire industry process lacks appropriate checks and balances — and undermines patient safety as a result. The sting clearly illuminated the potential conflicts that exist when an IRB places client interests first. As the GAO noted, “Since the transaction involved privately funded human subjects research and did not involve any FDA-regulated drugs or devices, GAO’s bogus IRB could have authorized this testing to begin without needing to register with any federal agency.”
The Coast IRB scandal, unfortunately, lays bare a need for additional oversight and enforcement, which drug and device makers should support. It would be in their interest to do so, because it may help regain public confidence in the practices that, taken together, comprise the research, development and marketing of their products.
“This episode shows, basically, that some IRBs are just approving anything,” said one congressional source familiar with the Coast sting, but who asked not to be identified. “The real issue is that nobody knows exactly how big a problem any of this really is, which is the upsetting part. The HHS or Congress should be looking very closely at this. Right now, only the [National Institutes of Health’s] Office of Human Subject Research looks at an IRB — if it gets federal money. But the others are completely unregulated. There’s simply insufficient oversight. And who wants that?”
