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Unfortunately this is one of those subjects that turns off people's brain and turns on their emotions. It's disappointing to see so many HN'ers with their pitc

Unfortunately this is one of those subjects that turns off people's brain and turns on their emotions. It's disappointing to see so many HN'ers with their pitchforks out on this topic. All the people on here with advanced degrees got them to kill orphans with drones right? Just like all the doctors they are accusing of killing people went to med school so they could kill people indirectly though policy. The entire reason the FDA exists is that there is only a tiny sliver of people that can offer any real medical help to a dying person. Yet there are endless streams of con artists that will enthusiastically take the money of a desperate dying person because its easy. Shut off brain forgets that. Based on my experience the actual solution is greatly expanding the FDA to allow them to be able to handle the highly increased flow of new research and create a central point for dying patients to find and get in programs. Right now they don't have the resources and have to rely on strict bureaucracy. Again the idea that the overwhelming majority of doctors would not jump at the chance to save people rather than put them in the ground slower is absurd. The FDA needs overhauled so start contacting your senators is pretty much all we can do.

A_D_E_P_T 2y ago
I don't think you understand how the process works. The FDA's job isn't to hold your hand and get you into scientific research studies. The FDA mandates certain steps -- the collection of certain data -- before it allows drugs to be marketed. Phase 1 is a safety study, Phase 2 is an efficacy study, and Phase 3 is a broader efficacy study. It is on the companies to collect this data; the FDA merely reviews it. (And then reddit-votes on which drugs to approve, with results that are sometimes funny, sometimes nakedly unethical e.g. flibanserin, and sometimes just ridiculous e.g. aducanumab.) Having more FDA employees would not speed-up the process by much, as the data collection itself is the arduous bit, nor would it reduce expenses at all. The best possible thing to do would be to simply get rid of Phases 2 & 3. That's how they did things until the early 1960s -- and, lest we forget, the 40s-60s were known as "the Golden Age" of drug development. Instead of increasingly onerous and expensive trials, allow drugs to be marketed once they're proven safe, and subject them to mandatory postmarketing surveillance. Besides, that hard-won efficacy data is often interpreted (by the FDA!) in subjective and bizarre ways, so its value is not awfully high. It's not worth the price society is paying for it.

A_D_E_P_T 2y ago

I don't think you understand how the process works. The FDA's job isn't to hold your hand and get you into scientific research studies. The FDA mandates certain steps -- the collection of certain data -- before it allows drugs to be marketed. Phase 1 is a safety study, Phase 2 is an efficacy study, and Phase 3 is a broader efficacy study. It is on the companies to collect this data; the FDA merely reviews it. (And then reddit-votes on which drugs to approve, with results that are sometimes funny, sometimes nakedly unethical e.g. flibanserin, and sometimes just ridiculous e.g. aducanumab.) Having more FDA employees would not speed-up the process by much, as the data collection itself is the arduous bit, nor would it reduce expenses at all. The best possible thing to do would be to simply get rid of Phases 2 & 3. That's how they did things until the early 1960s -- and, lest we forget, the 40s-60s were known as "the Golden Age" of drug development. Instead of increasingly onerous and expensive trials, allow drugs to be marketed once they're proven safe, and subject them to mandatory postmarketing surveillance. Besides, that hard-won efficacy data is often interpreted (by the FDA!) in subjective and bizarre ways, so its value is not awfully high. It's not worth the price society is paying for it.