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Medicine

The Law Isn't Ready For Psychedelic Medicine (scientificamerican.com) 185

Posted by BeauHD from the ready-or-not-here-it-comes dept.
Matt Lamkin reports via Scientific American: In March, the Food and Drug Administration approved esketamine, a drug that produces psychedelic effects, to treat depression -- the first psychedelic ever to clear that bar. Meanwhile the FDA has granted "breakthrough therapy" status -- a designation that enables fast-tracked research -- to study MDMA (also called "ecstasy") as a treatment for post-traumatic stress disorder and psilocybin as a treatment for major depression. While these and other psychedelic drugs show promise as treatments for specific illnesses, FDA approval means doctors could also prescribe them for other, "off-label" purposes -- including enhancing the quality of life of people who do not suffer from any disorder. Hence if MDMA gains approval as a treatment for PTSD, psychiatrists could prescribe the drug for very different purposes.

Yet while the FDA generally does not regulate physicians' prescribing practices, a federal law called the Controlled Substances Act bars them from writing prescriptions without a "legitimate medical purpose." Although this prohibition aims to prevent doctors from acting as drug traffickers, the law does not explain which purposes qualify as "legitimate," nor how to distinguish valid prescriptions from those that merely enable patients' illicit drug abuse. Would prescribing a psychedelic drug simply to promote empathy or increase "life satisfaction" fall within the scope of legitimate medicine -- or would these practices render the physician a drug dealer? To many the answer may seem obvious: to qualify as a "medical" use, a drug must be prescribed to treat an illness. But in fact, medical practice has always included interventions aimed at promoting the well-being of healthy individuals. "At a time when 'lifestyle drugs' are marketed as consumer products, it is increasingly difficult to draw a bright line that distinguishes legitimate medical practices from their illicit cousins," adds Lamkin. "If prescribing mind-altering drugs to help healthy people achieve desirable mental states falls within the bounds of legitimate medicine, what is left of the concept of recreational use?"
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The Law Isn't Ready For Psychedelic Medicine More

The Law Isn't Ready For Psychedelic Medicine

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  • or, here's an idea (Score:5, Insightful)

    by Anonymous Coward on Thursday August 01, 2019 @05:34AM (#59022022)

    legalize weed, E and shrooms. shoot meth dealers on sight.

    • That's crazy talk! How do you think we could fuel the war on drugs that way?

      • That's crazy talk! How do you think we could fuel the war on drugs that way?

        Taxes (when used for recreation)

        • But...but taxes are bad! Besides, the money can be traced, other than the drugs that we "destroy" after a raid.

    • Re: or, here's an idea (Score:4, Insightful)

      by Type44Q ( 1233630 ) on Thursday August 01, 2019 @08:14AM (#59022482)
      Meth is like Godzilla: reality's "autoimmune response to stupidity."

    • Mod parent up.

    • legalize weed, E and shrooms. shoot meth dealers on sight.

      The US government got my dad hooked on uppers in Korea. Are you saying we should bomb the Pentagon?

    • What the A.C. siad.

    • "legalize weed, E and shrooms. shoot meth dealers on sight."

      Wot? How would truckers then drive 18 hours a day?

      • How would truckers then drive 18 hours a day?

        This isn't a thing since states started requiring e-logs. If you know of someone that is doing it then let your local DOT know. They take that seriously.

    • Repealing the Controlled Substances Act in full might be simpler, because then you don't have to worry about your accuracy in identifying meth dealers.

      Your policy, on the other hand, might end up with innocent people shot and Walter White still acting with impunity so that the collateral deaths don't even help solve anything. Why bother with all that?

    • Legalize everything (Score:5, Interesting)

      by rsilvergun ( 571051 ) on Thursday August 01, 2019 @10:50AM (#59023178)
      treat the hard stuff as a medical condition. Have government run clinics where hard drugs are free and as soon as you come down off your high you go right into addiction treatment. Nordic states do this and it works. It's more human, keeps addicts from turning into criminals and the only thing cheaper is death camps for addicts.

      Shooting dealers doesn't do any good. Large swaths of America are blasted out hell holes with no jobs. And addicts are often treating mental illnesses with hard drugs due to a lack of medical care. Unless you're willing to take every addict and kill and/or send to work camps until they die from over work you're wasting your time. Yes, you can make the problem go away with overwhelming brutality. I'd like to think most of us aren't OK with that.

      So I say again: Legalize all drugs, treat the hard stuff as a medical condition. And yes, this means a Medicare for All universal healthcare system.

      • Legalize everything and take all the users out of jail, but impose harsh criminal penalties for those who sell to under-age, and for addictive hard stuff like Heroin I'd make it a misdemeanor to give somebody their first dose, and a felony to give somebody H for the purpose of commercially hooking them. Although we can't apply such laws retroactively, we should have a new law that would send executives to prison for doing things like shipping enough opiates to a town to keep every man, woman and child fixe

    • They keep trying, but they don't have the technology to shoot down our Jets.

  • Woo (Score:1)

    by R0UTE ( 807673 )
    Hoo

  • when it is prescribed by a doctor the drug is used in a controlled matter, one would assume the doctor knows what he's doing and have the best interest of his patient in mind. recreational use, without any control on the usage, might be dangerous and grow into an addiction.
    ofcourse, the same could happen when the drugs are used in a legal way, but early signs of addiction might be noticed to prevent the addiction getting worse.

    • The widespread distribution of synthetic opiates is blamed by many, and especially by the governors, of creating addictions where they didn't previously exist. Perhaps a more realistic viewpoint is that these people were going to end up self-medicating with some substance, and prescription pain pills are not the worst outcome.

      "Be careful. Life is habit-forming."

      • "Be careful. Life is habit-forming."

        Life is a very dangerous activity, and eventually leads to death. No one seems to have survived it yet.

  • Off-label? Yeah right (Score:5, Informative)

    by fafalone ( 633739 ) on Thursday August 01, 2019 @05:50AM (#59022066)
    Cocaine, methamphetamine, morphine, etc, all used currently, and not a doctor in the country dares to prescribe them for off label use for medical reasons, let alone to healthy people. Esketamine isn't even legally allowed to be prescribed to take home; patients have to take it at the doctor's office. The DEA throws criminal charges at doctors for relieving pain too well, and for death of people who take a week's worth of meds at once and OD (No, they absolutely do not only prosecute nonmedical prescribing or to known abusers). People are killing themselves because doctors won't treat severe chronic pain anymore. Not one would ever dare step out of line and try to give esketamine, MDMA, or any other addictive and recreationally used drug to someone healthy for "life satisfaction", not as long as medical treatment is subject to approval by drug cops.

    • Re: (Score:2)

      by gweihir ( 88907 )

      The evil done by the anti-drug fuckups is truly amazing...

    • Comment removed (Score:5, Insightful)

      by account_deleted ( 4530225 ) on Thursday August 01, 2019 @06:37AM (#59022194)
      Comment removed based on user account deletion

      • Re:Off-label? Yeah right (Score:4, Insightful)

        by Mashiki ( 184564 ) <mashiki@gmail.cBALDWINom minus author> on Thursday August 01, 2019 @08:20AM (#59022498) Homepage

        Don't worry about them not prescribing marijuana. Doctors are now cutting chronic pain patients off of their meds with no tappering, and refusing to refer them to any clinic. Sit back, enjoy the shitshow, watch the people on tramadol(weak synthetic opioid) have psychotic episodes from serotonin syndrome, [nih.gov] because it was an unknown side effect when they were prescribing it. But decades later they find out it acts in a similar way to SSRI's.

      • Comment removed (Score:4, Insightful)

        by account_deleted ( 4530225 ) on Thursday August 01, 2019 @08:24AM (#59022516)
        Comment removed based on user account deletion

        • Re: (Score:3, Insightful)

          by bill_mcgonigle ( 4333 ) *

          > Federal supersedes state law. That's all there is to really know.

          Uh, no, not if you've moved past seventh-grade civics.

          Federal supersedes State law *for the powers enumerated in the Constitution*. See Amendments 9&10 or the Federalist Papers if these are in question.

          Which is precisely why Ethanol Prohibition was enacted as an amendment.

          Now, they have more guns and are happy to kill innocents to enforce their illegal statutes, but the Supremacy Clause is not a valid justification from a Rule-of-Law

          • Pro-tip: we found out Constitutional limited government isn't a reliable check on power. No need to revisit that mistake.

            We found that out because we insisted that the Government Needs to Fix That (for assorted values of "That"). Whenever people call for the government to "Fix That", they're calling for the government to take on new powers...

            And, for the record, there's nothing in the Constitution that could conceivably be stretched to making marijuana illegal. Or any other of the current "illegal drugs"

            • Re: (Score:3)

              by sconeu ( 64226 )

              This sort of of stuff is usually hung off of the Commerce Clause.

            • Re: (Score:2)

              by Nidi62 ( 1525137 )

              And, for the record, there's nothing in the Constitution that could conceivably be stretched to making marijuana illegal. Or any other of the current "illegal drugs".

              Interstate commerce. Illicit substances are usually imported into a state from another or produced in one state to be sold in another in rates high enough that it is safe to assume all illicit substances have or will cross a state border. Therefore, the federal government has jurisdiction over it.

              • The judgement in Wickard v. Filburn was bullshit and so is every case that cites it.

                The justices cannot read the plain text of the commerce clause -- they keep inserting the word "affects", which is not present.

                So much for the "Originalists". It's bullshit all the way down ...

          • Comment removed based on user account deletion
        • Except that's not how it works. The government dosent positively grant freedoms, those are inherently granted by the constitution, they can't "make weed legal" for example. They can, however, take away freedoms such as making drugs illegal and then later can remove those restrictions - all drugs were legal if you go back a hundred and fifty years. States have the same right, they just can't supersede the government so if the federal law dosent cover it, a state can. A state could ban alcohol, guns, or an
          • Comment removed based on user account deletion
            • Except the political movement by states is winning. Also you have the "supersedence" wrong. It's really $$$$ --> US Constitution --> Treaty (between nations) --> Federal law --> Local Law and there is so much $$$$ even republican politicans are getting high on the cash and giving in. Before it used to be $$$$ for private prisons and the police force, but there are getting outspent as the market for legal cannabis is dozens to hundreds of times larger.

            • But again, until scheduled drugs aren't criminalized at the federal level, passing these laws at the state level is just a political movement. Currently as it now stands, there's nothing preventing the FBI for busting your ass in Colorado.

              It's more than just a political movement. The federal government doesn't really directly enforce these laws and rely on states. States have the executive power of selective enforcement. Effectively, the federal laws don't apply in those states.

      • They didn't threaten to kick the door down and try to arrest people at the hospital, it's far far worse. They officially threatened to cut all government funding [nih.gov] which has a far higher monatary penalty and absolutely no due process at all.

      • Comment removed (Score:4, Informative)

        by account_deleted ( 4530225 ) on Thursday August 01, 2019 @09:10AM (#59022720)
        Comment removed based on user account deletion

        • CBD is just as half-assed as Marinol. There's hundreds of active compounds in the plant, and it's been shown time and again to be most effective when used whole.

          Nevada actually seems to have law protecting you from being fired (or not hired) for medical marijuana use, that's some ACTUALLY USEFUL legislation. We don't have that here in California.

          The other thing we don't have in California is voters with a lick of sense. They didn't vote for legalization the first time, when it was good legislation. Instead

          • Arizona also has a medical marijuana law that protects workers. However, the law has been neutered as the disability office and state attorney general refuse to enforce the law. This should be illegal.

        • Re: (Score:2)

          by Zorro ( 15797 )

          No.

          It was soldiers being unfit to fight in the Vietnam war because of drugs and soldiers coming back from Vietnam as junkies.

      • I live in NY and my doctor's office will prescribe medical marijuana. However, you're right that the prescription of and use of medical marijuana is limited thanks to the federal government still considering it illegal. If the federal government decriminalized it (even if they just left it to the states), medical marijuana would take off even more than it has.

      • outside of CA and maybe CO I bet you won't see ... (Score:4, Interesting)

        by charlie merritt ( 4684639 ) on Thursday August 01, 2019 @09:46AM (#59022898)

        I disagree. Drs are less scared of the big bad DEA than in the past _excluding narcotics_.

        I live in New Mexico, a medical Cannabis state. I know Drs that recommend 'those drugs'. Recommend, not Rx, but that is just a legal distinction.
        My Dr. recommends Cannabis for patients that need it, No Extra Charge. I am 65+ and I think that 1/3 of my friends are legally consuming cannabis for chronic pain, insomnia, ptsd. Most of the legal users I know got their recommendation letters from their regular Dr, a few had to go to a "pot Dr". Even those that had to go to a cannabis consultant had Drs that carefully described their qualifying condition so that it qualified easily.
        I have met a local psychiatrist that recommends psilocybin for depression, right down to exactly how much dried mushroom to take [a micro dose every three days]. I presume he knows where to get it...

      • We need to change who we vote for (Score:5, Insightful)

        by rsilvergun ( 571051 ) on Thursday August 01, 2019 @10:34AM (#59023110)
        I keep saying this, but we should show up to primaries (where career politicians are most vulnerable) and vote anyone out who accepts corporate PAC money. The Democrats have a wing (called "Justice Democrats") who do just that (I'll confess I don't know a Republican equivalent, I don't think there is one... yet).

        Keeping drugs illegal servers several purposes. First, voter suppression. Florida has 1 million convicts who can't vote, mostly due to minor drug charges. It's well documented [youtube.com] that our drug policy started as an attack by Nixon on the left. It sounds crazy, but, well, it's true, crazy or not.

        Also, private prisons are extremely profitable and the prison guards union may not get their employees good wages but they sure as heck make sure they've got prisoners to guard. Again, we need to get PAC money out of politics.

        The good news is that with Millennials drinking less and less booze the alcohol industry is looking at legal marijuana as a new product. There's big money lobbying for legal weed and the end of the drug war. There's also a good chance that Trough on Crime guys like Joe Biden's careers are over paving the way for folks like Tulsi Gabbard, Liz Warren and Bernie Sanders.

      • Likewise outside of CA and maybe CO I bet you won't see a doctor come within 200 miles of these drugs, approved or not, they don't want the feds kicking down their door.

        Please explain why it is different in CA and CO. Last time I looked, Federal laws and the jurisdiction of the DEA also applied in these states.

        What your state needs is another ballot initiative. One that would prevent state and local law enforcement from enforcing Federal laws on marijuana possession and supply.

    • Re:Off-label? Yeah right (Score:4, Interesting)

      by bill_mcgonigle ( 4333 ) * on Thursday August 01, 2019 @09:14AM (#59022742) Homepage Journal

      > People are killing themselves because doctors won't treat severe chronic pain anymore

      The number of suicides caused by PTSD alone (due in large part by illegal supression of psychiatric drugs like MDMA by the DEA) eclipses by several orders of magnitude the number of accidental deaths that would be expected under a full repeal of the Controlled Substances Act.

      Most of the OD's are "bad product" which would almost entirely vanish, and the Portugal model predicts an 80-90% reduction in both addiction and drug-related crime.

      But EVERYTHING above is sophistry because none of those are real reasons for the Drug War. Expansion and imposition of Federal power, targeting of political enemies, and funding of CIA black ops, both domestically and overseas, are the real motivations for the Drug War and all of those have mountains of evidence. Not that the politically-controlled media will cover the through story.

      It's up to the States, or the People independent of the States (oh, hai, cypherpunks) to take down these illegal and immoral institutions. After you're done binge-watching Netflix, of course.

    • Re: (Score:2)

      by epine ( 68316 )

      People are killing themselves because doctors won't treat severe chronic pain anymore.

      Ah, the cry of the great blue-collar loon. I recognize that sound anywhere.

      Eben Byers [wikipedia.org]

      The son of industrialist Alexander Byers, Eben Byers was educated at St. Paul's School and Yale College, where he earned a reputation as an athlete and ladies' man. He was the U.S. Amateur golf champion of 1906, after finishing runner-up in 1902 and 1903. Byers eventually became the chairman of the Girard Iron Company, which had been crea

  • "Yet while the FDA generally does not regulate physicians' prescribing practices..."

    Well, the FDA doesn't, but the States do. It's called a medical license.

  • Let's Make A Dope Deal (Score:1)

    by Anonymous Coward

    This is why you must vote for DEMs in 2020. They want you high so you keep voting for their corrupt swampy cesspool of neverdowells. Yes. I got that right. You are wrong!

  • Yep (Score:5, Interesting)

    by burtosis ( 1124179 ) on Thursday August 01, 2019 @07:55AM (#59022416)
    People may have missed it, but cannabis was federally legalized with the 2018 farm bill [brookings.edu] as long as it's below 0.3% thc (note precursors like thca aren't regulated so if you heat it you can easily go over this 0.3%). This has fueled CBD sales across the nation, and even legalized the interstate transport of material that looks, smells, and tests positive for marijuana because it is in fact the same thing. It has also effectively legalized or made heavily grey the sale of cannabis flowers in many states that don't have specific laws against hemp. CBD won't get you high, has numerous scientifically proven medical uses, and is less addictive than caffeine which we give to children which does get them high.

    This has created a patchwork of conflicting laws and the poorly educated police force and DAs who desperately cling to the failed war on drugs are arresting anyone and everyone from truck drivers [freightwaves.com] To people with CBD extracts [mashable.com] to people in possession of hemp [newsobserver.com] to the stores that sell hemp products [theadvocate.com].

    The entire war on drugs needs to end, its foundation in racism, bigotry, and attempts to control the "undesirable" population and complete denial of reality needs to be addressed and the entire system overhauled. It would likely be best to legalize all drugs that are not extremely addictive and decriminalize the rest and use the taxes from the sale to create jobs and fund treatment centers and other public policies like education.

    • /Oblg. US Dept. of Agriculture Hemp for victory [youtu.be]

    • Re: (Score:2)

      by geschild ( 43455 )

      My sentiment, too. However there are some tweaks and extensions to make to your proposal:
      - Legalise all 'recreational drugs' but tax them according to the cost to society (this must include nicotine, alcohol and even NOx, too.) The tax levied should compensate for medical costs (such as for OD treatment), damages, cost of policing/monitoring the chains of production, quality control, education, other prevention measures etc.
      - Make production of drugs something you have to get a license for. Preferably, the

      • Mostly with you but didn't want to post a dissertation. For drugs and simple extracts from natural plants there should just be consistent and professional testing of the product required, since it grows itself. That way the consumer still knows exactly what they are getting.

        On the conservative angle, you are failing to not apply logic. Conservative politicans don't care about conservative values, they simply want a way to enforce the bigotry of the base upon the population. Thus the abortion laws agai

      • I completely agree.
        We all know pot isn't is bad as smoking or drinking.

    • Re: (Score:2)

      by PPH ( 736903 )

      legalize all drugs that are not extremely addictive

      By far, the most addictive drug around is alcohol. We tried outlawing that. It didn't work. Its addictive properties may have been what drove the creation of a large underground market. If you are hooked on booze and you stop consuming it, you can die.

      But forget the causation/correlation links and look at what was another huge illicit market. Pot. In the face of serious negative social and economic impacts, people continued to obtain and use it. That's the clinical definition of an addiction. So pot is add

    • CBD oil = snake oil! It really annoys me when I see big business moving in to exploit dumb customers...

  • State / Federal Jurisdiction Split (Score:3)

    by Aero77 ( 1242364 ) on Thursday August 01, 2019 @08:21AM (#59022500)
    State Law Governs Doctors (Medical Practice), Federal Law Governs Drug Distribution. So the federal government can't prohibit doctors from prescribing specific medicine, they can only limit access to those drugs and investigate cases of suspected drug distribution (pill mills).

  • ... the law's kids are going to love it!

  • It is my understanding that the administration of esketamine must be done under close clinical observation. There is no 'pop a pill and go on about your business'. In such cases, I can see a place for the use of such drugs. But what we don't need are a bunch of people high on these substances jumping off buildings because they think they can fly. Or murdering random people on the street because they see lizards. You need the drug, you check yourself into a facility that administers it and then keeps an eye

  • The law's fine. These substances shouldn't be outlawed in the first place. I look forward to pharmaceutical grade psilocybin and MDMA.

  • The law may be out of touch with reality (Score:3)

    by Chromal ( 56550 ) on Thursday August 01, 2019 @12:24PM (#59023730)
    I believe that we need to be very careful not to conflate topics that are actually quite nuanced. For example, while it's true that ketamine is a psychoactive, it specifically dissociative and not a psychedelic like a tryptamine. It's not an entheogen by any stretch. It's a strong psychiatric medicine and an intervention for non-responsive depressive symptoms, but it will not necessary help its patients construct sustainable lives. For that, they want spiritual awakening, self-reconnection and self-realization, and ultimately a balanced wellness. In great acts of over-reductionism and arrogance, most of medical science rejected spirituality long ago, and yet spirituality can be thought of as a metaphor for one's integrative being as a mind-body-spirit. For deeper healing, help with the wellness needs that western doctors are not ever going to ask you about (not even after decades of malaise), one should look within or consult with a sensitive and qualified shaman. Asking the government to get involved in your spiritual being would be like asking Donald J Trump to teach your daughter civility.

    • Re: (Score:2)

      by GuB-42 ( 2483988 )

      The problem is that doctors are overworked. They won't spend hours talking to you, getting you comfortable and slowly get you to change your habits for the better. So you eat healthy, sleep well, stop overworking yourself, etc... They have a lot of people to treat and they simply don't have time.

      That's what alternative medicine has that western medicine doesn't. Someone to talk to. Call it spirituality, I call it a healthier lifestyle. Besides some crazy ass beliefs, "spiritual" lifestyles are usually healt

      • Re:The law may be out of touch with reality (Score:4, Interesting)

        by Chromal ( 56550 ) on Thursday August 01, 2019 @04:36PM (#59025242)
        Then they aren't good doctors, or the system isn't permitting to practice good medicine. Either way, it's a medical system worthy of condemnation and replacement with a model whose outcomes are better. Many other countries demonstrate this by creating better outcomes at less cost. Nobody should put up with social, medical, political, or economic dysfunction; these are modern forms of oppression. Saying people should 'eat healthy' (which for many is expensive), sleep well (in light and noise polluted communities), stop overworking themselves (even though they aren't being paid a living wage), or be their own doctors--- is missing the point. It's a statement of "let them eat cake," in functional terms.
    • 'Dance of Stones' type deal? I for one am both pleased and sad that I can't find a shaman in the yellow pages. Mostly pleased because I can guess the type of clueless hippy that might be drawn to unregulated shamanic healing. Sad because there are loads of countries that us Westerners look down on that don't have an epidemic of depression and spiritual emptiness and we'll probably never really get the point.

  • But in fact, medical practice has always included interventions aimed at promoting the well-being of healthy individuals.

    No.... medical practice is never just "any intervention someone would like" to improve their general well-being --- an example of what's not really medical would be cosmetic plastic surgery when done for purely vanity purposes. Try appropriate interventions and therapies that are directed to cause no harm and also aimed at preventing illness or improving health as well as treating

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