April 15, 2009
Waxman hearing probes IRB shopping, GAO sting
Drug companies that shop among competing institutional review boards, especially those that operate for profit, to get the most favorable clinical study results, and a Government Accountability Office “sting” operation against one of them came under scrutiny at a March hearing of the House Energy and Commerce Committee's Oversight and Investigations Subcommittee, headed by Rep. Henry Waxman (D-CA).
The GAO reported on an investigation conducted on Coast IRB after subcommittee members learned about IRB troubles during Ketek hearings in 2007, where it became known that an IRB allowed the study of Sanofi-Aventis' antibiotic to continue without examining reports about fraud it had received.
The GAO said it created a fictitious company and and then shopped for an IRB that would approve a clinical trial with the product. Investigators then prepared an erroneous and sloppy protocol for three IRBs they had identified as not having stringent documentation requirements.