In June the pharmaceutical company Roche came under fire. Fierce Pharma reported that the European Medicines Agency is working with national medicines agencies to investigate deficiencies in the medicine-safety reporting system of Roche. According to the report this includes looking at whether the deficiencies have an impact on the overall benefit-risk profile for any of the products involved. Fierce Pharma state:
“The deficiencies are identified in a May 2012 report from the UK medicines regulatory agency (MHRA) following an inspection at Roche. This was part of a coordinated European program of routine inspection of safety reporting systems.
At the time of the inspection the company identified some 80,000 reports for medicines marketed by Roche in the USA that had been collected through a Roche-sponsored patient support program, but which had not been evaluated to determine whether or not they should be reported as suspected adverse reactions to the EU authorities. These included 15,161 reports of death of patients and it is not known whether the deaths were due to natural progression of the disease or had a causal link to the medicine. More recent information from the company indicates a smaller number of reports, but this information needs to be verified by the authorities!”
After 15,161 deaths someone would bother to investigate the drugs involved! Whether it is negligence or fraud this should be checked and verified surely!