The European Medicines Agency said on June 21 that it was investigating Swiss group Roche Holding AG after a routine inspection found it had failed to properly assess 80,000 cases of possible adverse drug reactions dating from 1997 to the present. Among that alarming number of failed assessments were 15,161 deaths, which may have been due to the progression of natural diseases, but may have included deaths connected to Roche drugs.
Roche said that despite its failure to properly investigate the 80,000 adverse event reports, there is no evidence (regarding that failure) of a negative impact for patients. Neither, of course, is there any evidence that the company’s failure to investigate the 80,000 has NOT resulted in a negative impact for some patients.
The European Medicines Agency is the European equivalent of the U.S. FDA. The agencies both review adverse event reports very carefully to keep the public abreast of the safety of medications. The FDA told The Wall Street Journal that it is working with the EMA to assess the impact. In a statement provided to Pharmalot, Roche acknowledged the huge “oversight,” said it understands how the news might worry consumers, and said it was working to address the mistake. Roche said some of the reports can be traced to a Genentech “Patient Reimbursement Program in the U.S., which were not sent to the safety department for full evaluation, hence were not reported to the health authorities according to the applicable regulation.”
The issue relates to medicines from across the Roche product range that were part of a financial reimbursement system in the United States.
Roche is the world’s largest maker of cancer medicines and it also produces drugs for viral infections, central nervous system disorders and inflammatory diseases. It also produces Accutane, an acne drug implicated in serous bowel problems.
One can’t help but to wonder how many other adverse drug events occur that are also not reported by Roche or other pharmaceutical companies.
The EMA also said that the 80,000 or so cases tied to the PRP were not the only adverse reaction complaints that went unreported by Roche. It says it also discovered another 23,000 unrelated reports in their reporting system and about 600 tied to clinical trials.