An Iron Curtain Has Descended Upon Psychopharmacology
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An Iron Curtain Has Descended Upon Psychopharmacology
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Re: An Iron Curtain Has Descended Upon Psychopharmacology
#2Even out of patent drugs that have effective off label uses get ignored.
Re: An Iron Curtain Has Descended Upon Psychopharmacology
#3This is one of my favourite blogs I read. There are many interesting and thought-provoking things there, and the author's style of reasoning makes me regain faith that there is still some level of sanity to be found on this planet.
Re: An Iron Curtain Has Descended Upon Psychopharmacology
#4The original article says the curtain has descended on Psychopharmacology, which seems an important distinction vs Pharmacology used in the submission here.
Re: An Iron Curtain Has Descended Upon Psychopharmacology
#5The 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.
Re: An Iron Curtain Has Descended Upon Psychopharmacology
#6Imagine 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 or pull the drug out of the market because it was simply beyond their jurisdiction. Doing any of that would constitute a version of the Iron Curtain.
So FDA is doing the right thing to prevent this from even happening by requiring the manufacturer to have everything in place before the drug sees the market.
Furthermore, a randomized controlled trial is no synonym of "drug is good to use". Do they work on US populations? How big is the sample size? Is the methodology sound? What is the side effect profile? Is there any long-term data (like 1 year after using the drug)? These are answered for FDA-approved drugs, but not necessarily for non-approved ones, especially if you are not a healthcare professional that speak Russian (even then, they have teams of professionals looking at drug applications, are you sure you're not overlooking anything?).
Re: An Iron Curtain Has Descended Upon Psychopharmacology
#7The author is talking about a market category in which successful drugs are worth billions. If these Russian drugs are so effective, why isn't some pharma firm in the US driving them through testing? The answer can't be "because the FDA is capricious and rejects drugs at the last minute", because that problem applies to all drug research, and we obviously have a lot of drug research.
Re: An Iron Curtain Has Descended Upon Psychopharmacology
#8Isn't this the normal case of drugs having different names in different countries? I thought this is why the drugs also have a secondary, chemical, name that describes the actual molecules. Even the most popular drugs have different names - Tylenol isn't named like that in Europe or Russia, AFAIK.
Re: An Iron Curtain Has Descended Upon Psychopharmacology
#9The 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.
Believe it or not there is a respectable number of scientists, physicists no less, who make a living doing nothing but bringing 80 year old Soviet Science to the west.
Every so often they get the front pages of nature for essentially finding anti-gravity: http://www.nature.com/news/2008/012345/full/news.2008.1185.h...
Or you find actually build computer architectures and languages which American theoretical computer scientists rediscovered 30 years later as the most efficient possible: https://en.wikipedia.org/wiki/Setun
Re: An Iron Curtain Has Descended Upon Psychopharmacology
#10Imagine 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.