Industry-Funded Postmarket Studies May Not Appropriately Measure Safety

A recently published study suggests that due to small sample sizes and potential conflicts of interest among participating physicians, manufacturer-funded studies of approved drugs may not be accurately detecting and reporting unanticipated adverse events.

“Post-marketing studies are a major activity in the life cycle of a licensed drug/medicinal product and are regularly conducted by pharmaceutical companies and contract research organizations,” Angela Spelsberg, MS, DM, of Transparency International Deutschland and the Comprehensive Cancer Centre in Aachen, Germany, and colleagues wrote in The BMJ.  “Regulatory agencies rely on such industry-funded studies for surveillance of drug safety. In particular, the detection of “rare” (1 in 1000) and “very rare” (1 in 10000) adverse drug reactions is often possible only with post-marketing studies.”

Postmarket studies are required in Germany and to some extent the United States, Dr Spelsberg and colleagues wrote, but not much is known about their conduct and nature. To investigate, the researchers sent out requests to German regulatory agencies for study notifications received between 2008-2010. 

Dr Spelsberg and colleagues collected information from 558 eligible studies, which comprised a median 600 patients and 63 physicians each. Approximately one-third of the studies examined recently approved drugs. 

On average, physicians received $215 (range, $0-$7820) in compensation per patient, for an average of $20,513 (range, $0-$2,196,605) in compensation per physician. In a substantial number of the notifications, study sponsors required information such as study results to remain confidential. The researchers could not find reports on adverse drug reactions across all of the studies, and only five of those examined were accompanied by publication.

“We found evidence that drug safety could be jeopardized by the current practice, as post-marketing studies are expected to contribute to pharmacovigilance, but in reality their data and results are treated as business secrets,” the researchers  wrote. —Dave Muoio