Comment by chroma | Hacker News Reader

Comment by chroma | Hacker News Reader

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It seems that if the Canadian and European regulatory bodies are incompetent or too quick to approve meds, it would show up in some statistics, right? Maybe their life expectancies would be lower or they would have higher rates of certain kinds of deaths. Yet if anything, it’s the US that lags in those areas.

There are tons of examples of the FDA failing to approve things, resulting in Americans dying unnecessarily. A more recent example was Omegaven, an IV nutritional fluid.[1] The FDA took 14 years to approve it, resulting in hundreds of infant deaths. Before its approval, only a few infants at Boston Children’s Hospital managed to get it. The staff there had to get FDA approval to import the fluid from Europe for every infant they wanted to treat, resulting in a lag time of several days. Even though it was clear that Omegaven was much more effective than previous IV nutrition, the FDA’s bureaucratic hurdles prevented it from being adopted sooner.

1. https://astralcodexten.substack.com/p/adumbrations-of-aducan...

Maybe part of the reason that the Canadian and UK drug regulators are competent, is because we haven't created a sufficiently large system of incentives to undermine them. Maybe if approving a drug in Canada got you access to the entire world, we would have a very different scenario.

A rubber stamping scheme removes redundancy from the system. Approving drugs faster sounds like a great idea, but there was a reason someone put up that fence you want to tear down, and your arguments haven't addressed it. Furthermore, the fence doesn't need razing to accomplish your goal - I don't see why advocating for the FDA to approve drugs faster should be synonymous with turning them into a rubber stamp.

No one (or at least not me) is contesting the assertion that approving drugs faster may save lives. But I don't want pharmaceutical companies to be able to undermine a single regulatory body and then be able to distribute their drugs everywhere.

There is no reason because it wasn’t a deliberate choice. Different countries created their own standards bodies and didn’t try to coordinate until later. The same thing happened with safety regulations around automobiles and aircraft. Fortunately in those cases, most countries have coordinated and manufacturers can sell the same vehicle in different countries with little extra effort. But for rare diseases with cheap treatments (such as in the case of Omegaven), nobody has the both the resources and the desire to overcome the FDA’s bureaucratic hurdles.

Again, this is a fine argument for making the FDA more effective and for coordinating with international partners, but full of holes as an argument for rubber stamping. And I still don't see why a rubber stamp serves your purposes better.

If you think the UK, European, and Canadian regulators are competent, then you must believe in the possibility of a competent regulator, right? Let's just have one of those, instead of a differently-incompetant regulator who serves as a rubber stamp.

And if we can't, then I'd rather they were too conservative than that they allowed too many drugs on the market.

At this point I don’t know what could change your mind. Your response to any criticism of the FDA or any proposed fix is to say that we need to make the FDA more competent, as if that’s not what people have been trying to do since the FDA was created. Unless you provide details about what would be different from what we’re already doing, you’re just arguing for the status quo.

It’s as if I were pointing out the uselessness of most TSA screening and someone replied that the solution is to make the TSA more competent.

I’d change my mind if there were more examples of harmful drugs in Europe or Canada that the FDA blocked in the US. The thalidomide scandal was over 60 years ago and caused around 4,000 deaths and 6,000 birth defects. You’d need a dozen thalidomide scandals to equal the FDA’s delays in approving beta blockers.

> Your response to any criticism of the FDA or any proposed fix is to say that we need to make the FDA more competent... [Emphasis added]

You've only proposed one fix. I'm only opposed to one idea.

You aren't under any obligation to try and convince me of anything, but surely you don't have to put words into my mouth.

What hypothetical evidence would cause you to change your mind about allowing American doctors to prescribe drugs approved by the EU?

I haven't made the counterclaim to that. That's not the same as saying that the FDA should rubber stamp all European approvals.

Should doctors be able to prescribe drugs approved elsewhere? When we're talking about lifesaving treatment that isn't available in the US, yeah probably there should be some process to do that. I imagine insurance companies will make this next to impossible, but that's not a reflection on your argument, just a shitty reality.

What would convince me that the FDA should rubber stamp European drug approvals? I don't know, but it would be evidence about the structure of the pharmaceutical market and the incentives in place, not a recitation of misses by the FDA.

Your evidence they aren't approving drugs fast enough is convincing, I absolutely buy that a problem exists. But that evidence doesn't address my separate concerns.

Let's say we do go ahead and rubber stamp everything coming out of Europe. What is going to happen?

There's going to be more pressure on European regulators. How are they going to respond to it?

Possibly by being corrupted and subverted and failing open. That would be bad.

The alternative is that they becoming more careful, more plodding, they start taking into account the views of stakeholders the FDA would otherwise have represented, and the process gets gummed up anyway.

I'm sorry if I came off as like, an unreasonable FDA bootlicker or as being callous to the people dying or suffering reduced quality of life due to bureaucratic incompetence, I do think that's terrible.

If what you wanted me to agree with is that doctors should be able to get people drugs that there's excellent reason to believe are safe and effective, regardless of whether the FDA has finished approving them, then yeah, I see how that makes sense.

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