Saturday, January 29, 2011

More Bad News for Duke University Medical (from the FDA)

The Science Insider (Breaking News From the World of Science Policy) is a terrific website and I thank them for sharing this article from The Cancer Letter

FDA Audits Halted Duke University Clinical Trials Data Related to Genetic Cancer Predictors –
A “Padded” Resume of Experience That Did Not Exist
January 28, 2011
The studies were carried out and then halted upon finding out that one of the biostatisticians lied about his background.  Much of the published information on the trials has now been retracted and now the FDA is looking into the situation to get additional information.  Credentials and backgrounds on qualifications are certainly creeping into the news quite frequently today.  Not too long ago a pilot even had the AMA fooled on his false credentials of being a doctor.  How do these folks do this I wonder with all of us being so connected today?  It seems like such discrepancies should be showing up sooner, that is if anyone decided to check them out. 
The fallout continues from a decision to halt controversial cancer trials at Duke University last year: In an article today, The Cancer Letter is reporting that the U.S. Food and Drug Administration (FDA) is auditing data related to the trials. The Duke genomics center run by a prominent cancer researcher, Joseph Nevins, has been disbanded, although a Duke spokesperson says that decision was already in the works and is unrelated to the FDA audit.
It's a long and winding story that dates back several years to initial queries from two biostatisticians at MD Anderson Cancer Center. They expressed concerns about the science behind genetic cancer predictors developed by two Duke researchers, oncologist Anil Potti and Nevins. After the biostatisticians contacted the Duke scientists and the journals that published their work, Duke launched trials based on the technology, using it to assign patients to different treatments. In the summer of 2010, The Cancer Letter reported that Potti had padded his resumé and claimed he was a Rhodes scholar when he wasn't. He resigned, and the trials were halted. Several papers describing the technology have recently been retracted.

I am not a big fan of federal government agencies.  But I am grateful to the FDA in this instance for protecting patients.

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