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Comment by QuantumGood | Hacker News Reader

The FDA does not take information from other countries into account much. EDIT: Foreign approval and use history can be supportive information in an FDA review process, but are not determinative factors for U.S. approval.

For example, Promethazine has been popular in the UK for a very long time (ingredient in UK Sominex), but its not approved in the U.S. as a sleep aid.

InHousePharmacy.vu/search.aspx?searchterm=promethazine

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> The FDA does not take information from other countries into account.

The FDA doesn't care where data comes from. Much of drug testing in the US is done overseas in CROs.

> but its not approved in the U.S. as a sleep aid.

Approval is not automatic just because another country did so. Someone needs to take responsibility and formally apply.

The issue is that foreign approval and use history are not allowed to be determinative factors for U.S. approval in an FDA review process, but rather as supportive information only.

Seems rather myopic to me.

We already share critical intelligence with the Five Eyes countries; why not share medication safety/efficacy information with them too?

Because then you can’t sue someone as easily in the US when you find out the drug popular in Europe actually caused cancer 50 years later.

The US has to be sure it’s completely safe. Or that it will make enough money to outweigh the lawsuits later…

> The US has to be sure it’s completely safe.

That doesn't make sense to me, who does US refer to in this case?

The manufacturer is the one that would be sued and they generally only want to expediate process.

FDA is one that aproves/denies application. They wouldn't get sued for using data from other countries (or at least no more that they already are).

The "Five Eyes" countries are the United States, Canada, the UK, New Zealand, and Australia.

Of the four countries that aren't the US, I'm sure that all have regulatory safety standards that would satisfy the safety and efficacy expectations of the American public.

I remember a blog post of an MD or psychologist about Russian/Soviet psychotropic drugs that are not used or unknown in the west and used as an analogy that if Russia had found new elements in the periodic table, and we would not use them.

It might be worth considering that until very recently, Russia's military was definitely supremely capable and on-par with NATO.

Russia lies. About everything. And culturally Russians have been immersed in a narrative that they're the absolute best in the world at everything, that all good ideas were originally Russian ideas (see how the narrative of LK-99 started getting modified before anything was verified).

So do they have processes or techniques not used in the West? Sure it's possible: but it's also far more likely that the reason we don't use them is that the actual investigation of their effectiveness can't reproduce the results.

Because no one looks up the clinical studies: they just repeat the fun narrative about big mysterious super-technology from behind the Iron Curtain. Which itself was essentially an invention of interest groups looking for funding in the West (i.e. there's was never a "missile gap" the US was going to lose).

Like as noted here: you remember the story, but not any actual specific drugs or processes? Why?

EDIT: Someone found the link: https://slatestarcodex.com/2014/08/16/an-iron-curtain-has-de...

I did not find the blog post anymore. But the blog linked to a pharmacy website that had tons of stuff available.

A few links:

https://en.wikipedia.org/wiki/Phenazepam

https://nah.sen.es/vmfiles/vol9/NAHV9N2202155_68EN.pdf

https://cosmicnootropic.com/blog/popular-nootropics/

https://medicine.umich.edu/dept/psychiatry/news/archive/2020...

"It might be worth considering that until very recently, Russia's military was definitely supremely capable and on-par with NATO."

I think Russia was not on-par with NATO after it collapse, at least not in conventional warfare. They missed the electronic revolution in warfare (See US-IRAQ Gulf War I). But they are now back on par, possibly better. Their jamming, air defense and rockets are top-notch, possible better than NATOs. They can disrupt our GPS System, we can't disrupt theirs since it is much younger, speak better.

As a comparison: Germany had 3000 tanks during the cold war. Now they have 300, 200 operational. Russia looses so many tanks every month, and actually builds 100-200 new ones every month. Germany had ammunition for two days of warfare. After they gave some to Ukraine, they have ammunition for one day left.

Russia has been underestimated. They are back and their future looks pretty good, even with a dubious leader. They won their war:

Defeat of the West? Emmanuel Todd and the Russo-Ukrainian War https://www.thearticle.com/defeat-of-the-west-emmanuel-todd-...

They have energy, they are not overpopulated, they have fewer problems with immigration. In fact, they're even looking for immigrants: https://movingtorussia.ru/ru

In the US I can smell the recession and banks will go belly up very soon: https://www.visualcapitalist.com/which-big-u-s-banks-have-th...

In Germany too. Without Russian Energy their manufacturing heavy country will deindustrialize.

At the same time, Russia is actively trying to replace the US Dollar as the world reserve currency, together with BRICS+. If successful, this will have a tremendous impact on the US.

I am not a Putin troll, and I hope that I am wrong. But the future has the nasty habit of taking unexpected turns.

They have not "won the war". Not by any stretch. That's just a pundit's plainly ideology-driven projection.

The fact that this author chose to call their book The Defeat of the West, and that its main thesis is that this defeat is due to the “vaporisation of Protestantism" should give one serious pause.

Perhaps not the best source to turn to for a serious, impartial military analysis.

"Perhaps not the best source to turn to for a serious, impartial military analysis."

Fair point. But it is from Emmanuel Todd. Who the f. is Emmanuel Todd?

"Todd attracted attention in 1976 when, at age 25, he predicted the fall of the Soviet Union, based on indicators such as increasing infant mortality rates: La chute finale: Essais sur la décomposition de la sphère Soviétique (The Final Fall: An Essay on the Decomposition of the Soviet Sphere)."

It doesn't matter who he is, or what he said when he was 25. His perspective this time around is plainly warped, and his analysis is just as plainly flawed, given the current reality of what's happening on the ground in Ukraine. You can tell that all by yourself, without having to take some supposed visionary's word for it.

That's what happens when people get lucky early in their careers. Sadly, it tends to go to their head.

What’s currently going on in Ukraine is they are slowly losing a war of attrition that eventually their allies will lose interest in funding.

We don’t have to like that outcome to see that it’s inevitable and has been from the very start.

One entirely possible outcome I haven’t seen discussed much is Poland turning on the Ukrainian rump state once Russia finishes annexing the ethnic Russian east.

The current situation can only be regarded as a stalemate. In the service to which Russia is devoting 10 percent of its GDP, while Western countries are spending 1 percent.

We don’t have to like that outcome to see that it’s inevitable and has been from the very start.

It's not at all inevitable. Russia has lost many of its optional wars of aggression and foreign intervention, in the past.

Putin will also be dead or starting to lose his marbles in a few years, and Russia's overall prospects for stability (even if there were no war at all) do not look particularly good after that.

> As a comparison: Germany had 3000 tanks during the cold war. Now they have 300, 200 operational. Russia looses so many tanks every month, and actually builds 100-200 new ones every month.

New production is 10 tanks a month at best, which is indeed how many Ukraine destroys sometimes in a day. The rest are refurbishments of rapidly declining USSR's stock without anything to replace it. I think it would be appropriate to call it Soviet Union's last stand.

> But they are now back on par, possibly better. Their jamming, air defense and rockets are top-notch, possible better than NATOs.

That is a wild stretch considering that Russian navy has run away from Crimea at the risk of getting sunk in entirety, Russian air force cannot come even within a hundred kilometers of Crimea without getting shot down, and ground forces are regularly hammered by drone and missile strikes, all while Ukraine has less of everything and is under severe restrictions what it can do with military aid provided to them. I cannot imagine any major NATO country in such a poor position that they cannot fly airplanes over the territory they hold. Claiming victory in such position - as you do - would be downright ridiculous.

Russia doesn't produce any new tanks, not since the dozen or so T-14s. Remanufactured T-90s are probably close to 10/month while refurbishing t55 and t62 are at 100-200/month.

https://www.ukrinform.net/rubric-ato/3820768-russia-can-prod...

> At the same time, Russia is actively trying to replace the US Dollar as the world reserve currency, together with BRICS+. If successful, this will have a tremendous impact on the US.

I would happily take the other side of this bet.

> but it's also far more likely that the reason we don't use them is that the actual investigation of their effectiveness can't reproduce the results.

Or, passing a novel approach through FDA, who are previously not familiar with it, is so prohibitively expensive that nobody wants to invest in it. And since it already has prior art, it's probably also not patentable so you can't even get back the money after you get the approval. Unless such drug can make billions as generic - which is quite rare - there's no point in investing in it, even if it works.

Link to blog post being described:

https://slatestarcodex.com/2014/08/16/an-iron-curtain-has-de...

who cares what a blog post of an MD or psychologist says? If a new element had use, of course we would use it. Are you seriously telling me that if they discovered copper, we won't use copper?

https://slatestarcodex.com/2014/08/16/an-iron-curtain-has-de...

> If a new element had use, of course we would use it.

If we had FDA for elements, then we wouldn't because FDA for elements wouldn't approve it. That's the point of the analogy.

Weird analogy. The USSR/Russia did discover new elements, and while there was a certain amount of arguing over names (as it wasn't always clear who discovered them first), there was no "not using" them because they were Russian. That isn't how science works.

That’s the point of the analogy. Even though scientists in the USSR discovered certain elements, the US did not refuse to “use” them. But for pharmaceutical compounds like bromantane, this isn’t the case. An anxiolytic stimulant discovered and approved in Russia, it cannot be prescribed in the US.

"In 1996, it was encountered as a doping agent in the 1996 Summer Olympics when several Russian athletes tested positive for it, and was subsequently placed on the World Anti-Doping Agency banned list in 1997 as a stimulant and masking agent.[10][42]"

Many nootropics and Phenibut comes to mind. Not used is relative. FDA occasionally cracks down.

There is the famous example of Thaladomide, which was approved by the regulators in the Germany and caused a disaster in birth defects:

https://en.wikipedia.org/wiki/Thalidomide_scandal

US FDA however was skeptical of the safety of the drug and never approved it for sale in US.

It doesn't look like FDA - or, specifically, Frances Oldham Kelsey - had any data or any evidence to suspect something was wrong with thalidomide. Partly it was because the manufacturers hid whatever suspicious data they had, but Kelsey had no way of knowing it - she basically just run out the clock until it so happened that the news about birth defects caused by it started coming in. That seems to have validated the idea that the strategy should be "delay approval as long as possible and request more and more tests for as long as possible". Which, of course, technically makes it safer for the drugs that manage to pass - but the cost is hugely inflated costs and absence of access to many drugs.

Wrong: FDA was approved in the US and is used as an effective cancer drug. We just don't give it to people who would be at risk.

It's still prescribed in the US for other uses though. I fucked up once and took one as an antiemetic, forgetting it was a sedative... right before I had an important meeting. Lesson learned :P

But for that kind of thing it would seem to be much easier and probably cheaper just to mail order the drug from overseas, or even book an inexpensive flight and buy some. For example, bromhexine and ambroxol are cold remedies that many people find effective, are not available in the US, but are easy to mail order from any number of Japanese sellers. The difficulty of hiring a lab or setting one up yourself would seem to be worthwhile only for new or unusual medicines that could not be obtained this way.

gettong those drugs are legal? and do you know someone in japan willing to do this ? sounds pretty specific.

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