5 ms·
It looks like in this case it was known to be ineffective when it was approved. I thought the FDA was supposed to protect us from snake oil like this?
by amanaplanacanal 5y ago
It looks like in this case it was known to be ineffective when it was approved. I thought the FDA was supposed to protect us from snake oil like this?
- lazide 5y agoThey are - it’s also a thing that corruption happens. There has been a lot more corruption than usual the last 4+ years in gov’t offices, and it will be a long time before it’s all identified.
- WarOnPrivacy 5y agoFDA's state of compromise goes a lot farther back than 4 years. ref: https://www.forbes.com/sites/matthewherper/2016/09/20/approving-a-muscular-dystrophy-drug-ignites-civil-war-at-the-fda/ https://www.forbes.com/sites/matthewherper/2016/09/20/approv...
- naasking 5y agoJust go back to the history of anti-depressants 20+ years ago. Technically they don't work any better than placebo.
- l33t2328 5y agoWhat evidence is there that there has been an abnormal amount of corruption? What is the normal baseline?
- kbelder 5y agoI suspect the baseline is measured in outraged Twitter posts per hour.
- Supermancho 5y agoThis is some data about corruption over the years https://trac.syr.edu/tracreports/crim/646/ https://trac.syr.edu/tracreports/crim/646/
- uvnq 5y agoIt may also just be that more corruption is being exposed.
- db48x 5y agoYea, that’s what I mean. If the evidence was merely equivocal, as in there was some evidence in favor but not as much as expected, then nobody would have resigned. In this case their last study was “halted for futility”, which makes the approval pretty egregious.
- mcguire 5y agoWhen this came up originally here on HN, the point was made that it was known to be effective in reducing plaques (IIRC; against a symptom anyway), but was not known to be effective or ineffective against Alzheimer's.
- ekianjo 5y agoreducing plaques is useless if it results in no different cognition outcome. you are supposed for actual patient benefit not for mere theoritical value.
- refurb 5y agoIt’s an Accelerated Approval by the FDA. “to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint” It’s not full approval, it’s conditional approval based on the possibility of clinical benefit.