An institutional review board (IRB) in the US has complained about being targeted in a ‘sting’ operation to inform a Congressional hearing on IRBs scheduled for later this week.

Coast Independent Review Board of Colorado Springs had already publicised its discovery during “a routine audit” that a clinical trial protocol submitted by Device Med Systems of Clifton, Virginia for a medical device called Adhesiabloc was fraudulent in violation of US state and federal law.

Specifically, credentials for the principal investigator were found to be forged; neither the principal investigator nor the medical director involved was licensed in the Commonwealth of Virginia; the Department of Health Professions for Virginia, which allegedly issued the forged license, had no record of having ever granted the licence, nor of the licence number listed on the forged credentials; and the Department had never issued a licence in the format presented by the study sponsor.

A visit by Coast IRB to the presumed site of testing revealed that it was in fact a strip mall in Clifton, Virginia. Moreover, a 510(k) FDA number (this refers to the pre-market notification system for devices in the US) given for the purported medical device did not exist in the records of the US Food and Drug Administration, the review board added.

Coast IRB announced its discovery in a press release, saying it had notified the Criminal Fraud unit of the US Department of Justice, the Federal Bureau of Investigation, the FDA and the Commonwealth of Virginia Department of Health Professions of the fraud. It also supplied information to the Subcommittee on Oversight and Investigations of the House Energy and Commerce Committee, which has arranged a hearing on ‘Institutional review Boards that Oversee Experimental Human Testing for Profit’ for 26 March 2009.

At the time, Coast’s chief executive officer, Daniel Dueber, commented: “We are informing the media in the hopes of alerting those who might otherwise become study subjects that this appears to be a fraudulent trial. We are also doing so because we want other institutional review boards to learn of our experience and avoid review of this trial pending the result of federal and state investigations”.

Just two days later, though, Coast IRB put out another press release explaining that it had since learned the fraudulent trial was part of a Congressional ‘sting’ operation.

“Apparently at the behest of the US House Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, agents submitted false credentials and clinical trial data to Coast IRB and possibly other IRBs to induce them to perform reviews,” Coast stated. “Evidence of the progress of the trials could then form the basis for arguments critical of the FDA and in favor of greater regulatory oversight.”

Could be illegal

Unless the sting was undertaken pursuant to a court order or under the auspices of the Department of Justice, it could be illegal, “violating wire fraud, mail fraud, and state laws against fraud and false credentialling”, the IRB warned.

As Coast pointed out, Dueber had been asked by subcommittee staff to “submit to an informal interview” before giving testimony at the hearing on 19 March. “Following notice from Coast IRB that the fraud had been detected, committee staff informed Coast that the hearing would be postponed until March 26, 2009 and that the chairman of Coast IRB and possibly another Coast official would now have to appear for a ‘transcribed interview’ with committee staff,” it said.

“We are doing our level best to ensure protection for subjects of clinical trials under our review, an objective we share with the Food and Drug Administration,” Dueber commented. However, coverage of the issue in The New York Times – which said the undercover operation was handled by the Government Accountability Office – questioned why Coast had only started looking into the Adhesiabloc study five months after it gave Device Med-Systems the all-clear for its clinical trial.

According to the Times, the trigger for closer scrutiny was a letter from the Subcommittee inviting Dueber to testify about the offending study – although the latter reportedly told the newspaper it had never occurred to him that anyone would develop a fictitious clinical trial.