This is pretty amusing. A few days ago, I got a press release from an Institutional Review Board (IRB) contractor called Coast IRB. IRBs are the organizations that monitor human clinical research to make sure everything is done in accordance with modern ethical standards, so ideally these folks would take their jobs pretty seriously. Apparently Coast IRB does:
On Friday, March 6, 2009, Coast IRB, an Independent review board, discovered that a protocol submitted to it for review of a medical device called Adhesiabloc by a Device Med Systems of Clifton, Virginia, was in fact fraudulent in violation of federal and state law. Upon receipt of proof of the fraud, Coast IRB and its CEO, Daniel Dueber, ordered the immediate termination of the clinical trial, referred evidence to federal and state authorities for investigation and prosecution, and instituted measures to prevent a recurrence.
So far, so good. They found out that someone was trying to set up a shabby clinical trial, and they called shenanigans. Today, though, Coast IRB felt the need to issue a new press release:
In a press release issued on March 10, 2009, Coast IRB informed the public that it had discovered what appeared to be a fraudulent clinical trial submitted to that Independent review board for evaluation. Coast IRB has since learned that the fraudulent trial was apparently commenced as part of a congressional “sting” operation. Apparently at the behest of the U.S. 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. 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.
So they stung the sting operation, and by sending out a press release about it, blew the cover off the whole thing. Was that wrong? Well, the folks at Coast aren’t taking any chances – they’re going on the offensive:
Unless pursuant to a court order or under the auspices of the Department of Justice, the sting could be illegal, violating wire fraud, mail fraud, and state laws against fraud and false credentialing.
First you bust an apparent fake clinical trial, then you out a Congressional sting operation, and now you’re arguing that Congress actually broke the law by initiating the sting. Is this really the right tone to take? At least the parties will have an opportunity to discuss the matter further:
Coast IRB CEO Daniel Dueber had been asked by subcommittee staff to submit to an informal interview prior to giving testimony before the committee on March 19. 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.
Um, did we do something wrong? Did you? Let’s not take any chances – try reminding everyone that we’re on the same side:
“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,” said Daniel Dueber, CEO of Coast IRB.
Honestly, I wish the folks at Coast IRB the best of luck. They’ll probably need it.