The Internet of scary things

Posted Feb 11, 2017 20:40 UTC (Sat) by Cyberax (✭ supporter ✭, #52523)
In reply to: The Internet of scary things by ssokolow
Parent article: The Internet of scary things

FDA is effective. In this video they're talking here about Sarepta - the FIRST drug for muscular dystrophy (a genetic disease). It has passed toxicity tests and indicated some efficacy in preliminary tests.

And you can't really have it both ways - in this case FDA decided to approve a drug that might not be effective but it also might be helpful for some patients that have NO ways to treat their disease. If FDA denied their approval I'm pretty sure the same RT would have launched an article: "FDA is KILLING people by refusing to approve a LIFESAVING drug!111!!!"

If this drug turns out to be ineffective or dangerous, FDA can withdraw their approval (see: Vioxx).

FDA sure has warts - priority review vouchers is the most prominent one. Or companies that perform "trials" for well-known off-label use of existing drugs and get monopoly on them. Fixing them will take an act of Congress, though.

The Internet of scary things

Posted Feb 12, 2017 1:24 UTC (Sun) by ssokolow (guest, #94568) [Link] (1 responses)

Oh, and you never addressed the part about how the decision was made by focusing on the drug company's studies and ignoring conflicting results from other studies, nor the resignation in disgust as a result.

The Internet of scary things

Posted Feb 12, 2017 2:37 UTC (Sun) by Cyberax (✭ supporter ✭, #52523) [Link]

Again, FDA balances several conflicting concerns. This is a case of a drug for a disease that does NOT have any effective cures available and toxicity studies have shown no significant ill effects. Had it been a new painkiller or blood thinner you can bet they would have kicked approval application all the way to Greenland.

And are you saying that FDA is corrupt because it approves drugs? Really? Do you know that 90% of drug candidates fail the FDA-mandated trials? About 70% fail the Phase II trial and 50% of drugs fail the Phase III trials: http://www.appliedclinicaltrialsonline.com/phase-iii-tria...

Does that look like an agency that is at beck and call of pharma companies?

I recommend reading blogs of actual pharma scientists ( http://blogs.sciencemag.org/pipeline/archives/2017/01/23/... is a good place to start) to at least start to appreciate what FDA does.