▲ | liquid_thyme 3 hours ago | |||||||
>The problem was that it wasn't more effective than the existing standard of care; it was only equally effective. That is misleading. When a clinical trial is designed for non-inferiority, it doesn't say anything about being superior or equal. Just as legally, a defendant is either guilty or not guilty - there is no legal adjudication of being "innocent". These drugs are not comparable (different stability profiles, different mechanisms of action, etc) and to say they're equal is highly misleading. >and the absence of the drugs that would have been discovered since then has surely killed many more people than the inadvertent use of harmful drugs ever could have. There is no evidence that safety regulations have denied us some miracle drug. I don't want the FDA approving drug products that are harmful to the general population. You haven't made a good argument for "the greater good" besides a reference to magainin, a product for topical treatment of foot ulcers. There are thousands of known anti microbial peptides. | ||||||||
▲ | kragen 2 hours ago | parent [-] | |||||||
"There is no evidence that safety regulations have denied us some miracle drug." Well, of course we don't know of a specific miracle drug they've denied us, because it isn't until after a drug is in wide use that you find out whether it's a miracle drug or not. But we can see that there were enormous numbers of miracle drugs in the 20 years immediately preceding the safety regulations, and almost none in the 63 years since then. There have definitely been some† but a very large slowdown is clearly evident if you look at the history. Most of even the important new drugs since then are slight variations on previously known molecules. A reasonable inference from these observations is that safety regulations have denied us a lot of miracle drugs. ______ † zidovudine, Paxlovid, oral rehydration therapy, ivermectin, propofol, SSRIs, sildenafil, acyclovir, misoprostol, ritonavir, and arguably buprenorphine come to mind; and time will tell whether lovastatin and semaglutide belong on this list or on the failures list with fen/phen and heroin. | ||||||||
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