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An Iron Curtain Has Descended Upon Psychopharmacology

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21–30 of 118 posts

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#21
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…

Overthinking it. The Russian regulations presumably are adequate to protect her own citizens; its not necessary for US sufferers to sue in Russia to correct manufacturing problems there.

Its hubris, American regulatory groups sticking their fingers in the affairs of other countries. And its beyond their charter to try to regulate what Americans do; they're supposed to regulate what American manufacturers do, not private citizens?

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#22
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…

The primary issue here is extremely well understood drugs for which the patent opportunity has expired. The only problem is profit incentive, not any serious question marks about safety or efficacy. There are European drugs in wide use for decades with reams of great research that nobody is ever going to bother pushing through approval in America because ultimately no profit would be made.

But the argument still stands, right? Who will be responsible if the "extremely well-understood drugs" have some problems in the US? They don't care about US population because it is such a small market for them. Let's say we lower teh barrier of entry by waiving these "extremely well-understood drugs" from proper research in US. There are instances of drugs that exhibit different side effect profile due to genetics in different population, and this sometimes tip off the risk-to-benefit balance, how do you account for that?

The more barrier you place for drug approval, the safer it will be. It is a classical risk-versus-benefit trade-off. If there is an option that may be slightly more effective than current practice but has unknown (or perceived less certain) side effect profile, healthcare industry mindset prefers the status quo.

"First, do no harm." http://en.wikipedia.org/wiki/Primum_non_nocere

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#23
post #5

The analogies with room temperature superconductors and antigravity suggest that bromantane is some kind of super drug. But the only thing the author bases this on is the summary of a study in russian that the author can't even read.

> But the only thing the author bases this on is the summary of a study in russian that the author can't even read.

Not true. He said that "they seem to have pretty good evidential support", and that russian study was used only as an example. Also while comparison tu room temperature superconductivity might be a hyperbole, apparently drug having "both stimulant and anti-anxiety properties" that "millions of Russians have been using for decades and are by and large still alive" is something really big in the field of medicine.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#24
Maybe the FDAs mandate could be changed to regulate drugs to maximise the benefit to society. That way things like Melatoin should be allowed and the shenanigans detailed in Bad Pharma (book by Ben Goldacre) should be dealt with. There seems a lot of stuff that is not entirely in the public interest at the moment.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#26
post #14

[deleted]

> 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…

OP described exactly how the author began his article. Your apologetics are tendentious. I hate to break this to you, but the author you have gone out of your way to praise is a very shallow thinker who darts around to create the illusion of a solid argument. It's just sad that you find him thought-provoking. I suggest Critical Reasoning 101 for you.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#27

so is this article about drugs, presumably a complex molecule involving many elements, or actual new chemical elements?

About drugs that work well, are deployed around the world and US has no equivalent of, that somehow still don't get imported to America.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#28
post #14

[deleted]

> 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 psychopharmacology."

It's not obvious whether the author really thinks that the Russians have found some new elements, or is just using the term 'element' to mean 'chemical', but either is erroneous.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#29
post #22

Earlier quoted context omitted.

The primary issue here is extremely well understood drugs for which the patent opportunity has expired. The only problem is profit incentive, not any serious question marks about safety or efficacy. There are European drugs in wide use for decades with reams of great research that nobody is ever going to bother pushing through approval in America because ultimately no profit would be made.

But the argument still stands, right? Who will be responsible if the "extremely well-understood drugs" have some problems in the US? They don't care about US population because it is such a small market for them. Let's say we lower teh barrier of entry by waiving these "extremely well-understood drugs" from proper research in US. There are instances of drugs that exhibit different side effect profile due to genetics…

I would be on the same page as you if the FDA and the American medical establishment had a great track record of protecting Americans from harm. As it is there's massive over-prescription of dangerous chemicals doing serious harm. Remember Vioxx? Remember estrogen hormone replacement therapy? There's currently massive, dangerous over-prescription of statins, amphetamines for kids, female hormones, and SSRIs.

Consequently I take a bit of a more libertarian perspective on pharmaceuticals. You can't really trust the government or most doctors anyway. So people might as well be more free to find helpful chemicals.

Re: An Iron Curtain Has Descended Upon Psychopharmacology

#30

> It doesn’t count if some foreign scientists already did a bunch of studies. It doesn’t count if millions of Russians have been using the drug for decades and are by and large still alive. Um, no, it doesn't. What's the FDA going to do if they have additional questions or want additional studies done? The FDA doesn't approve these drugs for the exact same reason the author doesn't prescribe them. Lament the situatio…

The author doesn't prescribe them because they don't want to get sued.

The fda doesn't allow them because they are (argues the author) run by big pharma.

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