An Iron Curtain Has Descended Upon Psychopharmacology • Hacker News Board

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#71

Post by cdr » Sun, Aug 17, 2014, 4:03 PM UTC

refurb wrote: post #54

Symmetry wrote: post #42

It's important to look at the FDA's job in terms of diminishing returns, or maybe as a classification problem. You have some number of drugs coming in, some of which are helpful and some of which are harmful. But you don't have any perfect means of figuring out whether a drug is good or bad. If you start from no screening it's very easy to stop a lot of bad drugs without stopping many good drugs, but as you apply tig…

You have to keep in mind the history of the FDA. When kids were being born around the world with flippers instead of arms and legs because of thalidomide, that wasn't happening in the US because of the FDA. Incidents like that breed cautiousness. The pendulum swings back and forth. A decade ago, the FDA got hammered for being too cautious. Then Vioxx happened and they got hammered for being to lenient. I think the FD…

You can't attribute thalidomide being blocked in the US to "the FDA". Frances Oldham Kelsey was practically solely responsible for stalling the drug until sufficient evidence of birth defects emerged to reject it. She was under intense pressure from within the FDA to approve it. In addition, the US benefited from being the last major market to receive the drug - if it had been developed in the US, the US would have almost certainly been hit just as badly as Europe.

The scandal did lead to FDA drug testing reforms, but that was after the fact.

(Also, there were US victims of thalidomide birth defects. There were human clinical trials and the American distributor aggressively distributed "free samples" to employees.)

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#72

Post by leonth » Sun, Aug 17, 2014, 4:08 PM UTC

davmre wrote: post #69

leonth wrote: post #34

Earlier quoted context omitted.

> One obvious solution would be a government program whose mission is to identify promising treatments for which private incentives don't line up, and shepherd them through the approval process by funding clinical trials and so on You already have this. It's called Orphan Drugs in the US. http://en.wikipedia.org/wiki/Orphan_drug > a free-market variant, in which the government just auctions off US patent rights for f…

Cool, I wasn't familiar with the Orphan Drug program. From the Wiki page it looks like it's focused on development of new drugs for rare diseases, for which the market is inherently small and thus impossible to do large clinical trials, etc. That's similar to but not quite the same as the problem here, where a drug already exists and the market is potentially quite large, but the lack of patent protection prevents an…

I see, it is indeed quite different. I'm not sure what the Orphan Drug Act specifically says though.

Actually if the market is potentially quite large, big pharmas should already be researching it. The problematic ones are those that are in-between orphan drug and market-quite-large drug. The society probably needs less of these drugs (there should be alternatives at the other ends), but if it's still needed, maybe expanding the scope of the Orphan Drug Act can be a good solution.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#73

Post by refurb » Sun, Aug 17, 2014, 4:12 PM UTC

cdr wrote: post #71

refurb wrote: post #54

Earlier quoted context omitted.

You have to keep in mind the history of the FDA. When kids were being born around the world with flippers instead of arms and legs because of thalidomide, that wasn't happening in the US because of the FDA. Incidents like that breed cautiousness. The pendulum swings back and forth. A decade ago, the FDA got hammered for being too cautious. Then Vioxx happened and they got hammered for being to lenient. I think the FD…

You can't attribute thalidomide being blocked in the US to "the FDA". Frances Oldham Kelsey was practically solely responsible for stalling the drug until sufficient evidence of birth defects emerged to reject it. She was under intense pressure from within the FDA to approve it. In addition, the US benefited from being the last major market to receive the drug - if it had been developed in the US, the US would have a…

I guess we'll have to disagree as to what constitutes "the FDA". Frances Kelsey was a physician working for the FDA, so although there were internal disagreements on whether or not to approve, the point is, "the FDA" didn't approve it.

My argument is that that situation bred a lot of cautiousness at the FDA after the fact.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#74

Post by Retric » Sun, Aug 17, 2014, 4:14 PM UTC

davmre wrote: post #20

leonth wrote: post #6

Imagine that there were no FDA Iron Curtain and doctors prescribed afobazole because "the paper was good" (or more likely because the money was good). Then people taking this drug got hospitalized left and right (or - shudder - found dead) because of side effects. FDA could not do anything to protect her dear US citizens. She couldn't sue the manufacturer or ask them to do further research or impose black box warning…

You're right that the solution shouldn't be automatic US approval for any drug used in Russia. It's reasonable to have standards for drug testing and require that any drug used in the US is tested to those standards. The problem isn't (only) that US drug standards are strict. The problem is that the financial burden of testing a new drug, which is significant, lies solely on the manufacturer, who can only recoup thos…

You can get a patent for 'novel' treatments for existing drugs which should in theory fix this issue.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#75

Post by atmosx » Sun, Aug 17, 2014, 4:16 PM UTC

I study pharmacy in CZ. I know about the categories mentioned and the drugs any US (or western-based) Doctor should know, but also never heard about the Russian drugs that are mentioned.

Very eye-opening article. I remember coming in contact with the Chinese pharmaceutical/medical system through a discussion with a our Chinese guide. After the discussion I was left with the impression that Chinese medicine is still in the dark ages and for some reason doesn't wanna join the 21st century. Then our "History of Pharmacy" teacher let me know that Chinese medicine is as good as ours although their approach is strange to us, works extremely well for them hence there even might be many things worth to copy there. I still remember how stunned I was.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#76

Post by Symmetry » Sun, Aug 17, 2014, 4:16 PM UTC

ewoodrich wrote: post #70

dmm wrote: post #64

Earlier quoted context omitted.

Thalidomide was very effective in treating morning sickness, it "just" wasn't safe. Why does the danger of thalidomide justify giving the FDA extensive powers to regulate the effectiveness of treatments?

> Why does the danger of thalidomide justify giving the FDA extensive powers to regulate the effectiveness of treatments? ... because it wasn't safe for use by pregnant women? Am I not understanding part of what you're saying? I wouldn't consider that to be truly "effective" when the side-effects are quite serious. And by the nature of the medication, all pregnant women taking the drug are necessarily at risk of thes…

The big debate is whether the FDA should approve a drug as being "safe and effective", or whether it should just declare a drug "safe" and then leave it to doctors to decide what they use. The later is what most of the world uses and what reformers want the FDA to adopt. Moving to the later would not have done anything to prevent the Thalidomide tragedy.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#77

Post by refurb » Sun, Aug 17, 2014, 4:19 PM UTC

JoeAltmaier wrote: post #16

FBT wrote: post #13

Earlier quoted context omitted.

But we have patents, as well. If a major US drug company invents a new superdrug, and spend decades and billions of dollars to get it approved, they can at least be sure that if it gets approved they will get the royalties from its sale. But if a company spends decades and billions of dollars fighting for the approval of a drug they do not hold the patent on, they are by no means guaranteed making even a single penny…

Hyperbole. Marketing is how the rest of us sell things. Giant drug company would have many advantages there. They are likely to sell boatloads of product regardless of patents. The patent is a greedy attempt to dominate the market legally in addition to commercially by creating a monopoly.

The drug industry is very different from other industries because of generics. The FDA has an approval pathway that allows you to say "my drug is identical to that other drug". Also, many states have legislation that requires pharmacists to fill Rx with generics. Marketing won't do a whole lot to help that.

If the same thing happened to the tech industry, it would work like this... you create an awesome new gadget and a competitor creates a copy. The gov't certifies this copy as "exactly the same". When you go to purchase the fancy gadget at the store, the clerk automatically gives you the cheaper copy without even asking.

Again, not something marketing can help a whole lot with.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#78

Post by atmosx » Sun, Aug 17, 2014, 4:22 PM UTC

The problem lies in the so called social contract each society wants to endorse. Either people face drugs as social goods (social economical model) or as goods (liberal model).

If drugs are social goods then, in theory you put the well being of the masses above anything else.

If drugs are just goods to be marketed, then there's no need to bother. Either the financial aspect is lucrative (e.g. reasoned) or you can't have legal access to the drug.

ps. The fact that the US has the worst and most expensive health system in the world of course, says something about healthcare.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#79

Post by cdr » Sun, Aug 17, 2014, 4:27 PM UTC

refurb wrote: post #73

cdr wrote: post #71

Earlier quoted context omitted.

You can't attribute thalidomide being blocked in the US to "the FDA". Frances Oldham Kelsey was practically solely responsible for stalling the drug until sufficient evidence of birth defects emerged to reject it. She was under intense pressure from within the FDA to approve it. In addition, the US benefited from being the last major market to receive the drug - if it had been developed in the US, the US would have a…

I guess we'll have to disagree as to what constitutes "the FDA". Frances Kelsey was a physician working for the FDA, so although there were internal disagreements on whether or not to approve, the point is, "the FDA" didn't approve it. My argument is that that situation bred a lot of cautiousness at the FDA after the fact.

"The FDA" would be taken to mean some quality of the organization - a regulation, a standard process. It was not. It was a single stubborn person, working off little more than a gut feeling, and going against standard practices of the organization.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#80

Post by chemunc » Sun, Aug 17, 2014, 4:36 PM UTC

ajb wrote: post #28

TeMPOraL wrote: post #18

Earlier quoted context omitted.

> This article is junk science. The author opens by suggesting that Russians have discovered and use a different set of chemical elements than the ones we use in the United States, going so far as to suggest that one of them is a room temperature superconductor in ways that American scientists are uninterested in. Either I completely failed to see sarcasm in your comment, or you completely failed in Reading Comprehen…

There must be some ambiguity in the article, because GP's reading looks plausible to me. For example, "You can’t have one set of elements in Russia and another in the US, everyone would work together and compare notes. At the very least one side would have the common decency to at least steal from the other. No way anything like this could possibly go on. But as far as I can tell this is exactly the state of modern p…

It's things like this that point out that the author a) can't write effectively and b) doesn't know anything about pharmacology/medicinal chemistry. Why are people going nuts about an article written about a very advanced subject that's written by a non-expert?