How the "War on Drugs" hurts pharmaceutical development
June 6, 2017 9:56 AM Subscribe
What can drugs-of-abuse teach us about discovering psychiatric drugs? "[The experience with ketamine and MDMA] suggests a new direction pharmaceutical companies might take: look for the chemicals that have the strongest and wackiest effects on the human mind. Then see if any of them also treat some disease. I think this is impossible with current incentives."
So there's also the issue that pharma researchers work on animal models, study the absorpion, diribution, metabolism, and elimination of the molecules, look at drug-drug interactions and not-short-term adverse effects, and so forth. At least Alexander Shulgin tried nanoscopic doses and worked up, noting effects at each order of magnitude. I don't know what modern underground analogue chemists do. IRB approval isn't one of the things they do.
But I think it's weird the pivot in his piece is What if there was no illegal and they just hadn't found these things? which is an odd counterfactual base to the next series of suppositions about drug discovery. Especially when it seems awfully clear that the CSA-DEA-FDA-HHS apparatus's approach to psychotropic drugs absolutely stifled research. They even stifled existing practice, as when lysergide-assisted and MDMA-assisted psychotherapy were ended by legal fiat in the 60s and 80s, respectively. (I don't think I can blame Reagan for the latter, but absolutely screw Nixon for the former.)
Hell, even though the environment for research and development is looser today, stronger rules on drug scheduling are still causing minor headaches even among drugs that seem not-very-abusable. Almost all the new antiepileptic drugs (AEDs) on the market since 2005 are controlled substances, schedules III to V. Requires more stringent prescriptions, restrictions on number of refills, restrictions on electronic transfer, and restrictions on storage of samples. AEDs, which patients generally hate and want to get off of as soon as possible.
Because why? Because human abuse potential studies, required by the FDA now for any drug which might affect the CNS, consist of a wacky protocol of administering study drugs along with arbitrarily-chosen active controls to "experienced recreational drug users." A protocol which appears to have the support of a large but pretty quiet base of human abuse potential drug researchers but whose validity in predicting drugs of abuse has not been established as far as I have been able to read.
And then the DEA. That takes $750 from every physician every 3 years just so they can prescribe medication. With the raids and stuff. The relentlessly old-fashioned view of drug possibilities. The DEA, whose extended dilly-dallying on a scheduling recommendation for perampanel (Fycompa--and in disclosure I speak for Eisai on Fycompa) was apparently so egregious Congress decided to limit the time they could consider future drugs. The DEA which is such a fundamentally disjaskit sort of an organization that I am inclined to skepticism on its opioid epidemic pronouncements (except there's actually data there). Seriously, screw those guys.
At least ketamine is, in fact, not illegal. No new scheduling decision needed. Esketamine will get a strong look from them, as will MDMA. As will cannabidiol, which in formulation as Epidiolex just showed promise in a phase III study. Won't it look funny that marihuana [sic] and "all its derivatives" will remain in Schedule I (forbidden, no medical use, high abuse potential) while its main ingredients are in Schedule III (synthetic THC, brand name Marinol) and Schedule Whatever But I'm Guessing III (cannabidiol)? Like how GHB is Schedule I but GHB in a special formulation by just one company (sodium oxybate, or Xyrem) is legal and in fact quite useful as a treatment for narcolepsy?
So anyway although it's a clickbaitey thing to say I think I basically agree wholeheartedly with TFA's choice of ketamine and MDMA as the most exciting psychotherapeutic developments.
posted by adoarns at 5:40 AM on June 7, 2017 [1 favorite]
But I think it's weird the pivot in his piece is What if there was no illegal and they just hadn't found these things? which is an odd counterfactual base to the next series of suppositions about drug discovery. Especially when it seems awfully clear that the CSA-DEA-FDA-HHS apparatus's approach to psychotropic drugs absolutely stifled research. They even stifled existing practice, as when lysergide-assisted and MDMA-assisted psychotherapy were ended by legal fiat in the 60s and 80s, respectively. (I don't think I can blame Reagan for the latter, but absolutely screw Nixon for the former.)
Hell, even though the environment for research and development is looser today, stronger rules on drug scheduling are still causing minor headaches even among drugs that seem not-very-abusable. Almost all the new antiepileptic drugs (AEDs) on the market since 2005 are controlled substances, schedules III to V. Requires more stringent prescriptions, restrictions on number of refills, restrictions on electronic transfer, and restrictions on storage of samples. AEDs, which patients generally hate and want to get off of as soon as possible.
Because why? Because human abuse potential studies, required by the FDA now for any drug which might affect the CNS, consist of a wacky protocol of administering study drugs along with arbitrarily-chosen active controls to "experienced recreational drug users." A protocol which appears to have the support of a large but pretty quiet base of human abuse potential drug researchers but whose validity in predicting drugs of abuse has not been established as far as I have been able to read.
And then the DEA. That takes $750 from every physician every 3 years just so they can prescribe medication. With the raids and stuff. The relentlessly old-fashioned view of drug possibilities. The DEA, whose extended dilly-dallying on a scheduling recommendation for perampanel (Fycompa--and in disclosure I speak for Eisai on Fycompa) was apparently so egregious Congress decided to limit the time they could consider future drugs. The DEA which is such a fundamentally disjaskit sort of an organization that I am inclined to skepticism on its opioid epidemic pronouncements (except there's actually data there). Seriously, screw those guys.
At least ketamine is, in fact, not illegal. No new scheduling decision needed. Esketamine will get a strong look from them, as will MDMA. As will cannabidiol, which in formulation as Epidiolex just showed promise in a phase III study. Won't it look funny that marihuana [sic] and "all its derivatives" will remain in Schedule I (forbidden, no medical use, high abuse potential) while its main ingredients are in Schedule III (synthetic THC, brand name Marinol) and Schedule Whatever But I'm Guessing III (cannabidiol)? Like how GHB is Schedule I but GHB in a special formulation by just one company (sodium oxybate, or Xyrem) is legal and in fact quite useful as a treatment for narcolepsy?
So anyway although it's a clickbaitey thing to say I think I basically agree wholeheartedly with TFA's choice of ketamine and MDMA as the most exciting psychotherapeutic developments.
posted by adoarns at 5:40 AM on June 7, 2017 [1 favorite]
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The reason some drugs are legal and some are illegal has absolutely nothing to do with whether they cause harm or not and while I appreciate the point the author is making, they could dig a little bit deeper on those barriers.
posted by gingerbeer at 11:52 AM on June 6, 2017 [7 favorites]