Comment by maxbond | Hacker News Reader

Comment by maxbond | Hacker News Reader

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If you think the fact that thalidomide, a deadly and basically worthless medication, being successfully blocked by the FDA is an example of a problem, then I'm a bit baffled?

If you think that regulatory bodies make mistakes - then surely you want them checking each other's work?

It's very frustrating to feel you are dying just shy of a breakthrough that can save you. I get that. And the author's contention, that they have a right as a human being to join studies that can potentially save them, is entirely reasonable.

But that's an entire universe apart from rubber stamping medications. We should not give the pharmaceutical industry that much credulity.

If pharmaceuticals have improved the length and quality of our lives, it's because they've been kept on the straight and narrow. This isn't a self regulating industry, they have a desperate base of customers and their "sales people" (doctors) are trusted implicitly - they hold a tremendous amount of power and would abuse it at the drop of a hat.

I’m saying that the FDA’s strictness cuts both ways. My beta blocker example was not a hypothetical.

Europe approved the use of beta blockers to prevent heart attacks a decade before the US. Although the FDA approved propranolol in the 1960s, and timolol for glaucoma in 1978, they didn’t approve beta blockers for prevention of second heart attacks until the 1980s. This resulted in the deaths of over 80,000 Americans. Amusingly the New York Times article about this approval brags about how many people will be helped by the previously-banned medicine.[1] Nowhere is it pointed out that so many more people could have been saved if the FDA fast-tracked drugs approved in Europe.

1. https://www.nytimes.com/1982/02/02/science/new-class-of-drug...

It's one thing to say they should approve drugs faster and another thing to say they should rubber stamp anything that Europe and Canada approve.

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.

> thalidomide, a deadly and basically worthless medication,

Thalidomide is what is used to treat erythema nodosum leprosum (ENL) better known as just leprosy.

It used to be regarded as a miracle drug that could be used over the counter in many circumstances, and as they looked into it they discovered it just couldn't be used safely.

That they've narrowed it down to some use case is more of a testament to the thoroughness of the investigation, I'm sure there are many chemicals that could treat leprosy this just happens to be the one we understand how to manufacture and when it is safe to use.

I'm sure it's very meaningful for the people who do take it, but that is what I meant by "basically worthless."

You are obviously deeply and aggressively ignorant about pharmacology. Thalidomide is an effective immunomodulator which is prescribed for multiple conditions beyond just leprosy.

https://medlineplus.gov/druginfo/meds/a699032.html

As with any medication there are risks and side effects but that hardly makes it "worthless".

Hey, please omit personal attacks and swipes from your comments, as the site guidelines ask: https://news.ycombinator.com/newsguidelines.html.

Your comment would be just fine without that first sentence.

Edit: it looks like we've had to warn you about this many times in the past—for example:

https://news.ycombinator.com/item?id=32737135 (Sept 2022)

https://news.ycombinator.com/item?id=30120252 (Jan 2022)

https://news.ycombinator.com/item?id=29598017 (Dec 2021)

https://news.ycombinator.com/item?id=25935223 (Jan 2021)

We end up having to ban accounts that keep doing this and don't listen to warnings. I don't want to ban you, so please fix this!

That's true, though I'll note that treatment options seem to have broadened a bit [0]. Thalidomide is effective, but suffers from cost and limited availability (in addition to the teratogenic effects).

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7413435/

It's not been recommended in decades.

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