(New Scientist) An investigation is under way after the discovery that 80,000 reports of patient reactions to drugs were not passed on to regulatory authorities by the Swiss-based pharmaceutical giant Roche and its US affiliate, Genentech.
The focus of the probe, by the European Medicines Agency, is to find out whether patient safety has been compromised by the unreported information, which includes 15,000 reports of patients who ultimately died of their illnesses – although there is no evidence that their deaths were a result of the drugs they took.
“We need to determine what’s going on, and have asked the companies to submit an updated corrective action plan,” said a spokeswoman for the EMA.