Public Citizen’s Health Group Changes Leadership, But Wolfe Remains On Prowl
Wolfe steps down to become senior advisor but remains a vocal critic of the pharmaceutical industry and FDA, as his appearance at the Avandia advisory committee meeting demonstrated.
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Avandia Committee Gives Split Vote To Drug, But FDA Clear Winner
A re-adjudication of cardiovascular events in the RECORD trial reassured members of a June 5-6 advisory committee that the study findings are reliable, but did not erase uncertainties about CV risk associated with rosiglitazone.
FDA Intellectual Bias Policy Takes Wolfe Off Contraceptives Safety Review
FDA offered Public Citizen’s Sidney Wolfe a seat at the table for discussion, but no vote. Members need to report relevant information about their conflicts in a timely manner, the agency says.
Cardiac Risks Of Propoxyphene Raced Out Of Control As FDA Moved For Immediate Withdrawal
In deciding that the pain drug propoxyphene should come off the market, Center for Drug Evaluation and Research officials went from believing there was insufficient evidence of cardiac harm at therapeutic doses to concluding there was no way the risks of heart arrhythmia could be managed and mitigated.