Company-funded studies of approved drugs may not catch safety issues

Research results published in the BMJ suggest that post-marketing studies funded by drug companies may be too small to detect rare side effects, as reported in Yahoo!Finance.

• Further, even if the studies do uncover previously undetected adverse events, physicians conducting the trials are often required to keep results confidential, limiting the potential for regulators or patients to learn about safety issues, researchers found.

• For the study, investigators made freedom-of-information requests to three regulatory authorities responsible for registering post-marketing studies in Germany and obtained data on 558 studies. On average, these studies had about 2300 patients and 270 physicians.

• The studies analyzed included a wide variety of drugs, and only one third examined recently approved medicines. Roughly 12 percent of the studies evaluated non-prescription drugs, while about 15 percent looked at biotechnology medicines and 11 percent assessed cancer treatments.

• Results showed that not one adverse event report could be identified from any of the 558 post-marketing studies, while less than 1 percent of the studies could be verified as published in scientific journals.

• "The fact that many physicians are obliged by contracts to handle adverse drug reactions as confidential business information rather than reporting them is very disturbing," commented lead author Angela Spelsberg, adding that given the role doctors play "in detecting, diagnosing and publicly reporting adverse drug reactions, this means a very big threat to public safety."