Waxman hearing probes IRB shopping, GAO sting

Share this article:
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. 
Share this article:
close

Next Article in Features

Email Newsletters

More in Features

Leadership Exchange: How Do We Get Beyond the Pill?

Leadership Exchange: How Do We Get Beyond the ...

As its focus moves from manufacturing to service, pharma needs to partner with healthcare neophytes as well as established players. James Chase asks six experts to assess the risks and ...

FDA and off-label uses: a balancing act

FDA and off-label uses: a balancing act

FDA's current re-examination of its off-label promotion policies in light of the First Amendment is a delicate balancing act between its rock-solid traditional enforcement posture and a diverse new electronic ...

Read the complete August 2014 Digital Edition

Read the complete August 2014 Digital Edition

Click the above link to access the complete Digital Edition of the August 2014 issue of MM&M, with all text, charts and pictures.