This week, we reported that the Food and Drug Administration left medicines on the market for years after discovering they were approved based on fraudulent studies by Cetero Research, which did testing for drug companies worldwide.
Turns out that wasn't an anomaly: The agency's slow, secretive response in the Cetero case mirrors how it handled an earlier instance of scientific misconduct at another contract research organization, MDS Pharma Services.
The FDA found that data produced from 2000 through 2004 at two MDS facilities in Quebec, Canada, were questionable.
As it would do with Cetero, the FDA announced it was requiring drug manufacturers to redo many of the MDS studies conducted during the five-year problem period. And, just as in the Cetero case, the agency declined to make public a list of the 217 generic drugs, both on the shelves and awaiting approval, that it said could be affected by MDS' potentially faulty research. Full story...
Related posts:
Turns out that wasn't an anomaly: The agency's slow, secretive response in the Cetero case mirrors how it handled an earlier instance of scientific misconduct at another contract research organization, MDS Pharma Services.
The FDA found that data produced from 2000 through 2004 at two MDS facilities in Quebec, Canada, were questionable.
As it would do with Cetero, the FDA announced it was requiring drug manufacturers to redo many of the MDS studies conducted during the five-year problem period. And, just as in the Cetero case, the agency declined to make public a list of the 217 generic drugs, both on the shelves and awaiting approval, that it said could be affected by MDS' potentially faulty research. Full story...
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- Big Pharma routinely suppresses data from clinical trials...
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