GAO Sting Raises Questions About Medical Trial OversightMar 27, 2009 | Parker Waichman LLP
A sting operation that allowed investigators to gain approval to test a fake medical device is raising serious questions about the oversight of medical trials. According to the Associated Press, as part of the sting, the Government Accountability Office (GAO) was also able to register a fictitious institutional review board with the Health and Human Services Department (HHS).
The GAO investigation focused on institutional review boards, which are charged with ensuring the safety of humans in trials involving medical products. According to Dow Jones Newswire, the GAO investigation ran from January 2008 to earlier this month, and was done at the request of the investigative subcommittee of the House Energy and Commerce Committee.
According to the Associated Press, the GAO said that historically, such boards were run by academic institutions. But increasingly, medical device and drug makers are relying on boards not affiliated with such institutions.
The GAO investigation was detailed at a hearing yesterday before the House Energy and Commerce Committee's oversight and investigations panel. According to The New York Times, the hearing followed incidents in recent years in which patients have died during clinical trials or companies have submitted fraudulent data to the Food and Drug Administration (FDA) to get new medical products approved.
According to the GAO, one private review panel, Coast IRB, LLC., of Colorado Springs, unanimously approved a fake medical protocol for testing which called for a full liter of a fictitious product to be poured into a woman's stomach after surgery. Coast IRB's minutes of the approval meeting showed that board members thought the protocol was "probably very safe," the Associated Press said.
According to GAO, the Coast IRB approval came after two other private boards rejected the protocol. One called it "junk", while a member of another board said it was the "riskiest thing I've ever seen on this board," the Associated Press reported.
According to the Times, Coast IRB can usually be counted on to approve medical products. Over a five-year period, Coast reviewed 356 study proposals and rejected only one, according to data presented at the hearing. Meanwhile, since 2004 the company’s revenue has more than doubled, to $9.3 million in 2008, the Times said.
Rep. Bart Stupak (D-Mich), chair of panel, raised concerns that clinical researchers may be tempted to engage in "IRB shopping," and choose review boards based on how quickly and inexpensively they approve studies.
While the CEO of Coast IRB admitted the board got "hoodwinked", he also tried to pin blame on GAO investigators, according to the Associated Press. Daniel Dueber claimed that the GAO violated federal and state criminal laws by falsely representing itself to be a medical device company and forging a medical license.
Dueber asserted that the Coast IRB board was fooled because it had "never had the experience of having a fraudulent group lying to us about their existences and about their licenses." Dueber actually had the gall to call on the FDA and the U.S. Department of Justice to investigate the fake GAO company, Dow Jones Newswire said.
According to the New York Times, Coast IRB has a troubled history. Last year, it received a warning letter from the FDA after officials discovered it had used an unqualified person to approve an advertisement to recruit trial subjects for a different, real study. According to the FDA letter, that approval had come after qualified reviewers working for Coast had found the advertisement unacceptable.
As part of the investigation, the GAO was also able to register a fake review board with HHS using an online registration form, the Associated Press said. This despite the fact that the president of that bogus board was a dog named Trooper.
All review boards must register with HHS before they can oversee a clinical trial, Dow Jones said. The director of HHS's Office for Human Research Protections told the House panel that it doesn't consider whether these review boards are adequate to oversee clinical trials, even though it is required to by law.