4 ms·
Do you realize the irony in providing a list of FDA recalls while bemoaning their lack of rigor? Lots of these "drugs" were unapproved dietary supplements that
by mmmrtl 6y ago
Do you realize the irony in providing a list of FDA recalls while bemoaning their lack of rigor? Lots of these "drugs" were unapproved dietary supplements that the FDA found to actually contain drugs, or drugs that failed QC while on the market, not the pristine batches and data that would have gotten the drug approved in the first place.
To me, it's similar to having more trust for media outlets that post corrections rather than pretending that nothing ever goes wrong. It's a point in their favor that a stamp of approval can be rescinded.
You might have an argument that the companies need to be taken out of the drug approval process entirely, due to issues of hiding data to avoid giving the FDA a hint of anything wrong (or making them "confused" as you say), or maybe we need much stricter rules on data withholding. I'm with you there.
- abfan1127 6y agoThe irony is specifically why I posted it. FDA approval is treated as a "gold standard" yet we have lots of evidence that it isn't. Companies lie, make non-intentional mistakes not caught by the FDA, there's all sorts of issues with it. The FDA review process is more like an editor checking spelling than actual rigorous analysis. I don't think your media analogy is accurate. It would be like the government censoring media companies, but having a poor biased criteria which then changes later, but is also subject to lies, etc. I don't think its a good analogy. I think drug companies should be rated on their data openness, with enough information to reproduce results. I think approval processes should be replaced with levels of confidence certifications. For example: Gold is independent labs find similar results to internal labs (verified) Silver is only internal labs produced results, not reproduced elsewhere etc.