Why? New drugs have been getting less effective over time, even though the scientific requirements to get them approved have been becoming stricter. The majority of our most effective drugs were approved before there were any requirements for demonstrating safety and/or efficacy.

Also, from that pool of drugs you're referring to, we've eliminated a number of things that had strong effects but whose side-effects were later found after careful study to not outweigh the benefits.

There is a similar effect from carefully studying devices/surgical interventions--not so much a raft of "new innovations" but rather the culling of a lot of things that were overused or actually harmful. Huge cost savings, big improvements in population health & lots of gored oxen.

I personally think FDA approval is dubious in cases like the OP mentioned.

We know from centuries of use that the plant is safe. Whether it helps their gout or not is irrelevant. Even if it's a placebo effect, who cares? Trying it out won't kill them, and if it doesn't work they can move on to something else.

Why waste tax payer money "proving" something like this?

I love the protections the FDA gives, but we need to use common sense, too.

We've known (for various confidence levels) that lithium salts are effective for some mood disorders since at least the 1870s (though there's various stories and one-off doctor recommendations that survive about lithium salts or natural water sources with high lithium levels being good for melancholy much older than that), then the FDA banned it in the 1940s due to the nasty discovery of lithium poisoning fatalities, and now we're using it again since 1970, with recurring blood tests to be sure you're not accumulating too much.

We used lead regularly in all sorts of things until, surprise, lots of people often exposed to lead turned up with nasty health issues.

We used asbestos all over the place until, decades after we started using it, we realized "hey, maybe all these easily-broken-off fibers that turn up in the shredded lungs of people might be related".

We used syrup of ipecac for hundreds of years, until we concluded "I _think_ the side effects from the ipecac are probably worse than the thing we wanted them to expel".

What do you do about all the flawed and weakly powered clinical trials of the past then? Do you consider them invalid at some point? If not, why have double standards then?

Wouldn't that get SOMEBODY to take the nigh guaranteed investment? I think what rubs people the wrong way is the limitless profits that are guaranteed by government sanctioned monopoly for things that save people's lives. It's a strange perversion of the free market that benefits the wrong people disproportionately.

As it currently stands, 60%+ of the new drugs that are developed in the world these days are for cancer or rare disease. Because for most other diseases, drug r&d is not profitable. Neuro is too risky because the biology is complex. Cardiovascular and metabolic disease is too costly because of regulatory and reimbursement hurdles. Infectious disease is a field where generics dominate, and the regulatory system is failing to support efforts to fight drug resistant strains

For-profit companies fund 3x what governments fund. We don't have the federal budgets to support a public drug industry. And we don't have the political will at least in the US to empower federal funding increases of that magnitude

It certainly isn't ideal that profit driven companies control which drugs get approved. But if profit driven companies didn't fund new drug development, no one else would

If it's so straight forward to prove, the government should just fund the studies itself. There's no reason to grant any private company anything in that case.

The top ~15 pharma companies spend over $70B a year on r&d, and VC funds $15B in the US alone

Even assuming government operates as efficiently as private industry, we are talking almost triple the NIH budget to accomplish that

So increase the budget? If we assume the government would operate as efficiently as private industry, then it would be cheaper overall. The other option is for private industry to recoup the costs plus profits from society at large.

Obviously increasing the budget is politically difficult, but let's not pretend the current method makes any real economic sense.

The Unapproved Drugs Initiative sounds much worse.