Nature Biotech reports CGS skepticism about IRBs-for-hire

Posted by Marcy Darnovsky February 5, 2008
Biopolitical Times
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Here's a belated pointer to an article published last September in Nature Biotech. "Death in gene therapy trial raises questions about private IRBs" opens with concerns raised by Biopolitical Times' own Osagie Obasogie, in an op-ed about Jolee Mohr's summer 2007 death in a gene transfer trial for rheumatoid arthritis sponsored by the biotech company Targeted Genetics:
[T]he institutional review board [IRB] charged with ensuring that the trials were conducted ethically is a for-profit enterprise also on Targeted Genetics' payroll. When a review board is being paid by the company that it is supposed to oversee, incentives often lean the wrong way: toward helping industry profit and away from patient safety. Such practices are common in today's clinical trials, and they put people's lives in danger. With so much money in play and so little enforceable oversight, corners may be cut more often than we'd like to think.
The FDA allowed the trial to resume in late November, saying that the gene transfer product was not responsible for Mohr's death. But a few days later, the NIH committee responsible for overseeing gene transfer tests reached a different conclusion, refusing to rule out the experiment as a factor.

We'll probably never know for sure. But as Osagie pointed out in his op-ed, "[T]his isn't simply about regulatory failure. It's also about how profit motives embedded in the clinical trial process can undermine patient safety."