FDA Bars Doctors from Drug Trials…

It took a very long time for anything to legally happen, some up to a decade.  I guess Merck was not alone with ghostwriters, as other incidents are now beginning to surface.  Under an amount of pressure recently, the FDA is establishing timelines for disqualifications, and now with additional funds, there’s some great software that can help track these issues before they go years being unnoticed or not addressed.  BD 

June 6 (Bloomberg) -- U.S. regulators have barred seven doctors from conducting clinical trials of drugs and medical devices so far this year, as many as in the three previous years combined, after lawmakers complained about delays in discipline. The Food and Drug Administration disqualifies researchers that the agency finds were involved in misconduct, including falsifying results, during studies. Among those banned this year, according to the FDA's Web site, was Maria Anne Kirkman Campbell, who pleaded guilty to fraud in 2003 in connection with a study on a Sanofi-Aventis SA antiobiotic.

Campbell, who worked as a family physician, said in a phone interview today from Gadsden, Alabama, that she regretted what she had done, and didn't know that the FDA had banned her from clinical trials. She was accused of fabricating data for the drug Ketek, and pleaded guilty to one count of mail fraud. ``I pretty much succumbed to the pressure that Aventis was putting on me,'' she said. ``My life is ruined. I have no career or anything.''

Bloomberg.com: News

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