How medical research changed after thalidomide
Lack of oversight Even if the results of clinical trials had been available, however, they would not have been reliable, because trials at the time did not require either FDA approval or oversight. In fact, unbeknownst to the FDA, the company had already distributed 2.5 million thalidomide pills to doctors across the U.S. The doctors had administered them to around 20,000 patients, including 207 pregnant people. More than 1,000 doctors took part in these “clinical trials,” though few monitored the effects of the drug on their patients. According to the FDA, during this period, there were ...