What I don't understand is why the FDA doesn't automatically rubber stamp approvals on medicine approved in Canada and the European Union. We all know their medicine is good - so why can't I get it?!
I've had this misdiagnosed medical condition for 25 years by multiple doctors. Nothing serious but extremely annoying. There are approved drugs in Europe for decades which are much better than the ones approved in North America. One day the company making the drug that's approved in North America decided to stop making it! You just could not get it. This was the event that finally led to the correct diagnosis for my condition because I was in so much pain I got to see the expert. Turns out my condition has a very simple non-prescription solution and for 25 years I've been taking the wrong meds that happen to alleviate this different condition as well!
So I am good but this condition is not uncommon. What are all the other people that really need this drug in North America doing?
I'm not sure what's the takeaway here. Maybe that efficient/smart organizations generally don't exist. This is just a reflection of human nature.
So if you've been diagnosed with herpes, and anti-virals don't seem to help, maybe you don't have herpes. If you do have herpes of the eye there are good drugs approved in Europe but not in the North America (though there are likely some approved drugs in the US which will still help - it's complicated).
A government issued id, like a driver's license, is often required for various services like opening bank account, a telephone connection, avail some government service etc. Thus a local driver's license can be used for deception by a foreigner who wants to pretend to be a local citizen.
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.
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...
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...
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.
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.
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.
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.
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.
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 is what is used to treat erythema nodosum leprosum (ENL) better known as just leprosy.
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."
https://medlineplus.gov/druginfo/meds/a699032.html
As with any medication there are risks and side effects but that hardly makes it "worthless".
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!
I do buy the author's assertion that people should have right to expose themselves to experimental medicines when it could save their lives though.
But the next day I come to you with an 11th task. I tell you this is the only one that matters. I give you full license to blow through your budget, harass people until they get their paperwork done, whatever it takes - this is the only priority. So you get right to work, and with all the blockers cleared you get it done in 6 months.
"Great," I say, "so you can do all them that fast right? And when I come back in 6 months, all of the original 10 tasks will be done?"
But of course they won't be, because you don't have the resources you had before, the external stakeholders aren't as motivated as they were before, and instead of putting all your effort into 1 task you're going to be spreading it across 10.
Agreed.
> USA refuses to accept rubber stamp European experimental medication. Europe pikachu face