Ethics of Safety Studies for Marketed Drugs
Even the Average Joe couldn’t have missed the discussions regarding the safety risks of Avandia. FDA is again in a tough spot and looking for answers. Traditionally, Industry was not to make safety claims about drugs, just a line listing of adverse events seen during clinical evaluation and after market. I agree with the Institute of Medicines assessment that, while the ethical considerations are perhaps more complex, they are manageable. The current system of oversight by FDA, IRB, Data safety management board (DSMB) and the Principal Investigator are the key. The study design needs to be scientifically sound (nothing new). The evidence threshold for stopping the study needs to be clearly defined (nothing new). The informed consent process is very important to protect the rights of the subjects (nothing new). Perhaps the issue is an increased focus on the risk benefit balance? Or is it getting used to the prospect of a safety endpoint versus an efficacy endpoint? Regardless, it all points to the need for transparency, open discussion and compliance.
IOM letter hyperlink: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM218595.pdf