If you believe that than I have a little bottle of thalidomide. Perfect for morning sickness in women.
Drug design and testing is HARD. It's not uncommon for a very promising drug to fail the first or the second phase of the clinical trials, even though drug designers sincerely believed that it should work. No amount of transparency can fix this, alas.
Posted Feb 8, 2012 12:16 UTC (Wed) by nix (subscriber, #2304)
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Quite. Things which can kill people if insufficient care is taken need to be regulated, simply because if they're not, sharp operators will exploit the fact that the man in the street knows little about the subject (inevitable: nobody can be an expert in everything), and will exploit their lack of knowledge to sell them things that will, sooner or later, kill them. They'll do that *even if they know it is lethal*.
We know this because we see it happening in countries where regulation of pharmaceutical sales is relatively unregulated. Heck, if it happens with *alcohol*, whose imbibing is never a life-or-death matter, and which is a heck of a lot easier to manufacture ("no open flames, keep the methanol out" being the only real human-safety rules), it sure as anything would happen with pharmaceuticals too.
Software routinely critical for life and limb needs regulation too, and is regulated (e.g. medical device software, avionics software).
Most patents are drag on the innovation
Posted Feb 9, 2012 1:17 UTC (Thu) by rahvin (subscriber, #16953)
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You can do better than thalidomide. There's so many drugs every year that make it to the phase 3 clinical trial and they find out that it just doesn't work but actually kills X% of people that take it that you would have an impossible time even listing them.
And that's AFTER computer models, rat studies, primate studies and early human testing, a process that typically takes a decade to even get to the phase 3. Current estimates are that including the Phase 3 clinical trial a drug from discovery to post phase 3 costs $250 million (yes a quarter billion dollars). This doesn't include factory certification, production line certification, ongoing inspections and quality control or long term studies (becoming far more common due to the Vioxx scare).
And that's just the US. Then you do the same thing for Europe, Japan and pretty much every other country in the world if you want to sell the drug there.
Getting a drug to market is HARD. Last numbers I saw said less than 1% make it to market. So on top of that $250 million dollars you probably have another billion or two in failures that also has to be recouped by the successful drug.
As others have said, drug patents make sense. They make a LOT of sense given the government regulation. Now if you want to suggest that companies can drug test on the unsuspecting population I suggest you line up first.
Most patents are drag on the innovation
Posted Feb 9, 2012 18:54 UTC (Thu) by dmarti (subscriber, #11625)
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There's no clear-cut division between drugs that work and drugs that create risks. Example: Tegaserod (Zelnorm®).
Yes, it might kill you, and it's risky enough that the FDA had it pulled from the market. But for some people it was the only thing that ever let them go anywhere without an immediately available toilet. Would you take it? Would you give it to someone without informed consent? Should an informed adult be able to take it?
Most patents are drag on the innovation
Posted Feb 9, 2012 19:46 UTC (Thu) by Wol (guest, #4433)
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And actually, the tests PROVED that thalidomide was perfectly safe. Which the VERSION BEING TESTED was.
When they manufactured thalidomide for testing purposes, they got pure L-thalidomide. Which is safe. When they scaled up, the process made 50/50 L- and R-thalidomide (which are chemically identical). It was the R-thalidomide that did the damage.
So if you gave me a "bottle of thalidomide, perfectly safe for pregnant women" it's quite possible you're telling the truth ...
Cheers,
Wol
Most patents are drag on the innovation
Posted Feb 9, 2012 22:46 UTC (Thu) by Cyberax (✭ supporter ✭, #52523)
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No, thalidomide is racemic - it spontaneously flips between L- and R- forms.
However, it's a great and simple example of reasons beyond the extensive drug testing which begins with the toxicity tests, and with the compound which will later be certified and sold.
Most patents are drag on the innovation
Posted Feb 10, 2012 13:23 UTC (Fri) by Wol (guest, #4433)
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Exept that's not what "racemic" means. All racemic means is "50/50 L and R", not "L and R spontaneously flip". Actually, that flip is pretty much impossible without something there to catalyse the reaction.
But it's normal to get a pure L or R isomer or a racemic mix, depending how you produce it. And it's quite likely, similar to what you assert, that when they produced commercial quantities one of the production steps contained a catalyst that converted from "all L" to "racemic mix". Which they wouldn't have picked up unless they were actively looking for it.
Cheers,
Wol
Most patents are drag on the innovation
Posted Feb 10, 2012 13:41 UTC (Fri) by Cyberax (✭ supporter ✭, #52523)
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>Exept that's not what "racemic" means. All racemic means is "50/50 L and R", not "L and R spontaneously flip". Actually, that flip is pretty much impossible without something there to catalyse the reaction.
Posted Feb 13, 2012 11:54 UTC (Mon) by nye (guest, #51576)
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>Exept that's not what "racemic" means. All racemic means is "50/50 L and R", not "L and R spontaneously flip". Actually, that flip is pretty much impossible without something there to catalyse the reaction.
I think it's quite common for enantiomers to flip. For example, get some fresh caraway, and note that it smells *very slightly* like spearmint. Then leave it in a jar for a year or two, and note that it now smells rather *strongly* of spearmint as some of the s-carvone has become r-carvone.
Most patents are drag on the innovation
Posted Feb 13, 2012 11:55 UTC (Mon) by nye (guest, #51576)
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And now I notice somebody else has posted the same link. That's what I get for not refreshing the page after the weekend.