A study in the Journal of the American Medical Association finds that, although “many patients and physicians assume that the safety and effectiveness of newly approved therapeutic agents is well understood,” in reality the quality of evidence for new drugs’ safety and efficacy varies widely, with about a third of new drugs winning approval on the basis of a single clinical trial. “Not all FDA approvals are created equally,” explained the study’s lead author.
Downing, N., Aminawung, J., Shah, N., Krumholz, H., Ross, J.; Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012. JAMA. Online January 22, 2014. 311(4):368-377. doi:10.1001/jama.2013.282034.
Of further interest:
FDA’s ‘Safe and Effective’ Drug Approvals Based on Widely Varied Data, Study Finds (Washington Post)
Cannabis Has Been Studied More Than Many FDA Approved Pharmaceuticals (High Times)