How in the world do over 15,000 drug related deaths just get overlooked and not reported? Or why did approximately 80,000 adverse events in connection with various drugs just get swept under the rug?
This is the topic of the latest investigation that Swiss-based pharmaceutical giant Roche and its US affiliate, Genentech are involved in, as The European Medicines Agency is investigating whether Roche failed to report tens of thousands of adverse events in connection with its various drugs.
The collection of buried reports was discovered last month when officials from the UK Medicines and Healthcare products Regulatory Agency visited Roche’s facilities in Welwyn, UK. The EMA revealed the lapse on June 21, 2012.
Roche and Genentech stress that their failure to report was not intentional. “We are taking steps to enhance our systems and controls for detecting and analysing safety data, and are evaluating further actions to prevent this from happening again,” said Nadine Pinell of Genentech.
The EMA is looking at whether the deficiencies in reporting adverse events are having an impact on the overall benefit-risk profile for any of the drugs involved. She said that no potential dangers to patients had yet been identified during an initial examination of the 80,000 buried reports. “Based on our assessments to date, no impact on the safety profiles of any of Roche’s products has been found.”
In response to the investigation, a Roche spokeswoman wrote this: “The inspection found deficiencies related to Roche’s global pharmacovigilance processes. In addition, Genentech identified potential adverse events from our Patient Reimbursement Program in the US, which were not sent to the safety department for full evaluation, hence were not reported to the health authorities according to the applicable regulation. We have provided initial estimates of potentially unassessed AEs to health authorities and are in the process of confirming the final number.
Roche and Genentech acknowledge we did not fully comply with regulations and appreciate the concerns that may be caused by this issue for people using our products. We are committed to actively pursuing corrective and preventative actions to address this matter expeditiously. Patient safety is of paramount importance to us and we are fully committed to being in compliance with all pharmacovigilance/safety reporting regulations and to ensuring that effective quality systems and procedures are in place for recognizing and reporting adverse events appropriately.
At the time of the inspection, Roche identified some 80,000 reports for medicines marketed in the US that had been collected through its patient support program, the EMA states, but these had not been evaluated to determine whether they should have been reported as suspected adverse reactions to EU authorities. There were also questions about 23,000 adverse events related to evaluating and reporting to national regulators and 600 pertaining to clinical trials.
For now, it remains unclear whether the deaths were due to natural disease progression or a causal link to a drug. More recent information from Roche indicates a smaller number of reports, but this information needs to be verified by the authorities. It is also uncertain whether any of the reports have already been submitted to EU authorities through other channels, for example by the healthcare providers.
In any event, the EMA is telling Roche to ensure that all known, reportable adverse events are immediately reported to the appropriate EU authorities as required by law and the drugmaker must confirm to the agency that this has been done, both for products in clinical trials and for marketed products.
On June 27, Roche sent the EMA a comprehensive action plan aimed at rectifying the situation and ensuring that all future reports will be properly submitted.