US Congressional Sting Operation Exposes Gaps in Health System

Thousands of medical research groups that monitor clinical trials on behalf of the drug industry may face tougher regulations in the wake of a congressional sting operation that found gaps in the nation's oversight of experiments on humans.

The sting, detailed at a House Energy and Commerce Committee hearing Thursday, involved the creation of a fictitious company and a fake medical device, a surgical adhesive gel. The sham firm then applied to three for-profit oversight groups -- called institutional review boards, or IRBs -- for approval to begin a clinical trial using their adhesive on human subjects.

Drug and device makers along with hospitals and university research facilities must retain an independent IRB to oversee the methodology and safety issues for human studies. Corporations cannot get Food and Drug Administration approval for their products without an IRB certifying their clinical trials. About 6,350 IRBs are registered with the Department of Health and Human Services.

Lawmakers have raised concerns over whether IRBs routinely approve medical studies for paying clients. The committee leaders are considering whether to introduce a bill to strengthen IRB regulations.

Two IRBs contacted by the GAO's sting operators -- Argus IRB of Arizona and Fox IRB of Illinois -- rejected the Adhesiabloc proposal because of unanswered safety questions.

"We realized it was a terrible risk for the patient … It is the worst thing I have ever seen," an Argus IRB reviewer said, according to a slide shown at the hearing.

Coast IRB LLC of Colorado Springs, Colo., did approve a study for the fictitious adhesive gel, "Adhesiabloc." Five months after approving the study for abdominal surgery patients, Coast learned that neither Adhesiabloc nor its maker, Device Med-Systems of Virginia, existed.

Coast CEO Dan Dueber said in an interview that the congressional case was illegal entrapment. At the hearing, Mr. Dueber testified, "The GAO perpetrated an extensive fraud against my company. You pulled the wool over our eyes -- congratulations." Because the product was fake, it was never used.

As part of the sting, the committee also created a sham IRB to see whether the Department of Health and Human Services, which registers IRBs, would certify their fictitious group.

The committee, working with the Government Accountability Office, Congress's investigatory arm, named the CEO of the fake IRB Truper Dawg, after a staffer's three-legged dog, now deceased. Other fake names included "April Phuls" and "Timothy Wittless," which lawmakers said should have signaled irregularities to HHS. The department registered the IRB.

At Thursday's hearing, the toughest complaints were reserved for HHS. Rep. Joe Barton of Texas, the committee's ranking Republican, asked one HHS official: "Do you have any sense of outrage?" Referring to Coast, he continued, "What steps are being taken right now to decertify these charlatans?"

The director of HHS's office that registers review boards, Jerry Menikoff, said at the hearing that his bureau had only recently received the committee information about Coast, and would look into the matter.