Archives for posts with tag: FDA

21st Century Cures Act will distort the meaning of ‘FDA approved’

The term “FDA approved” means a lot to those of us working in health care and the patients we treat. But if the 21st Century Cures Act becomes law – the House of Representatives approved it Wednesday and the Senate will vote on it next week – this mark of trustworthy stewardship will become a shadow… (more…)

The Vegas-cavorting executives of GSK recently made news for their off-label shenanigans, promoting medications for uses which had not been approved yet by the Food and Drug Administration. Bad enough.

Is it worse or better, though, to realize that the everyday practice of medicine involves an order of magnitude more questions, and more specific questions, than can possibly be addressed by the FDA? 

I want to discuss with a patient the treatment of her reflux. Sure there are a bunch of approved medications available. We are taught in medical school that the proton pump inhibitors are more effective than the H2 (histamine receptor) blockers. But which of the PPIs are more effective? Which strike the best balance between cost, side effects, and symptom relief? And how do any of them compare to non-pharmacologic treatments?

There are precious few studies to answer any of these questions. Sure, let’s blame Big Pharma. They have blood on their money. But is it any wonder that doctors are susceptible to such inappropriate influence, when the appropriate variety is so hard to come by – not due to any venality, but due to the imperfections of our research system? Studies of one drug against placebo are valued; comparative effectiveness studies that pit drugs against each other are vanishingly rare. And forget about considering cost!

So sure, let’s blame greedy pharmaceutical companies for what they’ve done, but let’s acknowledge the difficult spots patients and doctors are in when they try to find the best evidence to answer clinical questions. If we figure it all out, we can celebrate in Vegas.