Hacker News Reader

Comment by vips7L | Hacker News Reader

I write software for this industry, the thought of not involving the FDA genuinely scares me.

I do admin work for a pharma-related company. I would never want to be in charge of verifying with my own body what treatment is safe and/or effective.

Drug development and clinical trials are expensive for a reason. Not doing them in an orderly manner is more expensive.

One far less scary version is to allow drugs approved by other reputable agencies (EU, Japan, UK, maybe) to be used in some limited capacity in the US.

From what I've heard from some friends working with regulatory agencies worldwide, this is currently the case or is about to happen. FDA-EMEA-(whatever the japanese regulatory agency's called) have agreements for treatments approved in one of the other two agencies to be easily approved.

There is a history of these agencies later withdrawing approvals and FDA conservatism protecting US healthcare consumers. The same pattern applies with these other agencies not basing decisions on FDA approval. Overall, the combination of approval authorities and global surveillance delivers the best results by ensuring the broadest coverage and continued research.

The rarely understood tradeoff in this arena is that no matter what you do, your decisions kill people!

Everyone understands the case when (A) you approve something that later turns out to kill people.

The other case (B), when you don't approve something that would have saved lives is much less understood, but those people are just as dead as those from case A.

One famous case B is when the FDA only approved beta blockers 17 years after other major countries. This cost ~10k US lives per year, or ~170k lives total.

Because A errors produces headlines and scandals, while B errors are just the normal deaths we are used to, the FDA is heavily incentivized to minimize A errors, regardless of the B error rate.

The incident around thalidomide is basically FDA mythos at this point.

We all love a good trolley problem

https://web.archive.org/web/20210125231725/https://blog.jaib...

Not just lives also DALYs from glaucoma.

An important thing to remember when thinking about this thing: the downside of approving a drug that was dangerous is bounded: it kills people or causes some unexpected side effect and then it gets pulled. Meanwhile, the downside of failing to approve something that could have saved/improved lives is at least potentially unbounded: if it never gets approved that's the entire futures worth of humanity who is unable to take advantage of it (although admittedly I'd like to imagine that _eventually_ tech will improve to the point that we either figure out we should approve the drug and/or invent something else that obviates the need).

The point is that case B is both harder to notice and at least potentially _much_ worse than case A. And it's the case that the FDA currently errs towards.

And I hope we've all seen Dallas Buyers Club which showed the real, historical problem of drug approval being slow-rolled because it was killing a controversial minority

I believe European regulators approved Boeing 737 Max on this principle. And in turn FAA approved it because Boeing said it's safe an compliant.

This is exactly what I'd do if I was an accredited ingestor. I'd look if I trust countries that already approved it and decide based on that.

Fortunately, the position would be voluntary.

You might be a big fan of the work the FDA does to keep us safe in light of past industry abuses, but keeping good drugs off the market - whether by outright fiat or by making them too expensive to develop, test, and deploy -- also has a terrible human cost. It's not clear that the FDA has found the right balance between risk reduction and upside potential.

Drug development is a conservative industry. Even with researchers/companies/FDA all doing their best to develop good treatments, there are still many drug failures due to efficacy or safety.

Being more lassiez faire is going to lead to direct harm of some patients. Is it a worthwhile tradeoff vs potentially addressing some unmet need is a tough calculus.

What criteria would you suggest to measure in an effort to make it clear that the FDA has >found the right balance between risk reduction and upside potential?

I don't think there's a good answer to that question, unfortunately. What we're doing now seems to be working for most people most of the time, but it'd be absurd to think there's no further room for optimization. And it seems unlikely that the best approach is more restrictive regulation, given that extremely-useful drugs are going undeveloped for decades.

So... that leaves more flexible regulation as a worthwhile approach going forward. I like the idea of making limited human trials easier to carry out and less costly in general.

Not OP, but it's certainly not by leaving drugs unapproved in the US that have been in wide use in Canada, England, Japan, etc for years (and in some cases decades). The incentives are so misaligned for the FDA that the bias for inaction is enormous.

I also find it a bit patronizing that a federal agency determines whether or not a drug they've deemed safe has enough upside potential for me. That's a value judgement I'd like to make for myself.

Sorry if this sounds harsh, but the FDA's inability to approve drugs inside of a decade has personally impacted me quite a bit.

Reply on news.ycombinator.com