The first line in this editorial adequately summarizes the problem that leads to unsafe drugs and medical devices:
What would your reaction be if the results of a football match were reported as 5:0 by one of the teams and as 3:1 by the other team?
This editorial underscores a point that I think the “FDA approval is the gold standard” crew completely ignores: it is painfully easy to rig drug testing to get the desired results at any stage of the research and testing process. Most of the injuries were at the end of the study? Change the endpoint. Most of the adverse effects were in patients with blonde hair? Take them out of the study.
Okay, that is a bit of hyperbole. But you get the point. No doubt there are a lot of good, decent people at the world’s largest pharmaceutical companies, and most make the right decisions. There are also some pharmaceutical executives who would shoot their own parents in the head before not pushing what they believe will be a profitable drug to market. There is no doubt about this either. By the time the lawsuits that will kill most of the profitability hit, that executive will have gotten a promotion out of that division (or off to another company). We can debate how often this happens, to be sure. But we really can’t debate that this happens.