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?!
Money and politics. Why can someone drive for 6 months in a country with a foreign driver's license but can't get a local license?
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.
If you're okay with it, could you expand/name the condition you thought you had, the actual one, and the medication(s)? Never know, might help someone else out
I'm a bit concerned about my privacy but the condition is herpes virus infection of the eye. The similar condition is Thygeson's disease. The drug in question (that I could not get) is called Viroptic which for some reason helps with both conditions (despite them not being related). Thygeson's is thought to be more of an immune system issue.
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).
Why can someone drive for 6 months in a country with a foreign driver's license but can't get a local license?
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.
Because it then becomes a kind of race to the bottom, where all manufacturers will approve medecine in the easiest country, a bit like flag on convenience for ships
They already do that. Having approval and data in another country makes it much easier to get FDA approval. But it's still a lengthy process, costs a lot of money, and often puts you in competition with other options that are approved. There are drugs that have been used for decades in Europe, are perfectly safe and proven to be more effective, and are not available in the USA (and likely the other way around, I'm just aware of specific examples there).
But that’s the problem. No regulatory body has perfect judgement, so they’ll all approve some harmful things and ban some helpful things. If you’re so strict that you don’t allow thalidomide, you’ll also ban stuff like beta blockers for an extra decade, causing 80,000 deaths. The argument in favor of loosening restrictions is that it would reduce overall death and suffering.
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.
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.
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.
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.
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.
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).
Sure, but they did rubber stamp Fen-phen and Vioxx despite plenty of people within the FDA understanding it should come with a black box warning. The FDA needs a win that's more recent than 1971 if they want to demonstrate their efficacy as regulators.
They approved one drug in under a year in a literal emergency (and it's deeply controversial that they did even that). That doesn't mean they can do that with everything that crosses their desk.
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.
Let's say I give you 10 tasks. You're going to have to go back and forth with external stakeholders, and a given task will be blocked much of the time waiting for a response. So you can do each of them concurrently, but it's gunnuh take a year to do each of them.
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.
The external stakeholders in the FDA are extremely motivated to get approval quickly. If this is a resource problem then the case for increasing the budget is clear.
I guess we know that, but why doesn't the EU rubber stamp medicine that's approved in the US? In my opinion it's actually good for there to be independent bodies reviewing things.
There are many divergent if not contradictory regulatory findings levels and limits between the US Canada and Europe.
eg. Tolerable total cholesterol levels US:200 Euro: 240 (last I checked, these move around quite a bit. In the 70s the US banned Cyclamates as an artificial sweetener, but approved Sacharine while Canada approved Cyclamates and banned Sacharin.
For Glaucoma treatment Europe is "Laser first, drugs second" while the US is Drugs first, laser surgery second.
etc etc.
Somewhat famously the US not doing this stopped Thalidomide being such a large issue in the US, but of course one example of it failing doesn't mean it is inherently bad policy.
So all drugs will always be trialed at the most lax country and get approved at a stricter one? Then why make rules because the laxest country will be the one used and in control of approvals
