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posted by janrinok on Saturday June 08, @05:08PM   Printer-friendly
from the party-time dept.

What's next for MDMA:

MDMA, sometimes called Molly or ecstasy, has been banned in the United States for more than three decades. Now this potent mind-altering drug is poised to become a badly needed therapy for PTSD.

On June 4, the Food and Drug Administration's advisory committee will meet to discuss the risks and benefits of MDMA therapy. If the committee votes in favor of the drug, it could be approved to treat PTSD this summer. The approval would represent a momentous achievement for proponents of mind-altering drugs, who have been working toward this goal for decades. And it could help pave the way for FDA approval of other illicit drugs like psilocybin. But the details surrounding how these compounds will make the transition from illicit substances to legitimate therapies are still foggy.

[...] However, for drugs that carry a risk of serious side effects, the FDA can add a risk evaluation and mitigation strategy to its approval. For MDMA that might include mandating that the health-care professionals who administer the medication have certain certifications or specialized training, or requiring that the drug be dispensed only in licensed facilities.

For example, Spravato, a nasal spray approved in 2019 for depression that works much like ketamine, is available only at a limited number of health-care facilities and must be taken under the observation of a health-care provider. Having safeguards in place for MDMA makes sense, at least at the outset, says Matt Lamkin, an associate professor at the University of Tulsa College of Law who has been following the field closely.: "Given the history, I think it would only take a couple of high-profile bad incidents to potentially set things back."

What mind-altering drug is next in line for FDA approval?

Psilocybin, a.k.a. the active ingredient in magic mushrooms. This summer Compass Pathways will release the first results from one of its phase 3 trials of psilocybin to treat depression. Results from the other trial will come in the middle of 2025, which—if all goes well—puts the company on track to file for approval in the fall or winter of next year. With the FDA review and the DEA rescheduling, "it's still kind of two to three years out," Nath says.

Some states are moving ahead without formal approval. Oregon voters made psilocybin legal in 2020, and the drug is now accessible there at about 20 licensed centers for supervised use. "It's an adult use program that has a therapeutic element," says Ismail Ali, director of policy and advocacy at the Multidisciplinary Association for Psychedelic Studies (MAPS).


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  • (Score: 3, Informative) by krishnoid on Saturday June 08, @05:22PM (12 children)

    by krishnoid (1156) on Saturday June 08, @05:22PM (#1359850)

    Michael Pollan, who wrote "The Omnivore's Dilemma", wrote "How to Change Your Mind" and did a 4-episode Netflix series on it. There are also talks and podcast episodes [youtube.com] on his research on the history and individual experiences with psychedelics as therapeutics. It's not the whole story, but a very solid introduction on psychedelics as clinical therapies.

    One question it left me with, is why socialized medicine countries that would benefit from an inexpensive, plentiful first-pass therapy that sometimes can be curative, rather than a recurring treatment for some of these conditions -- without having to involve pharmaceutical companies -- didn't move forward on research into these therapies for the last 50 years. Even if the US may have tried to prevent people from "turning on, tuning in, and dropping out".

    • (Score: 2, Disagree) by khallow on Saturday June 08, @06:11PM (10 children)

      by khallow (3766) Subscriber Badge on Saturday June 08, @06:11PM (#1359854) Journal

      One question it left me with, is why socialized medicine countries that would benefit from an inexpensive, plentiful first-pass therapy that sometimes can be curative, rather than a recurring treatment for some of these conditions -- without having to involve pharmaceutical companies -- didn't move forward on research into these therapies for the last 50 years. Even if the US may have tried to prevent people from "turning on, tuning in, and dropping out".

      Resistance from the for profit sector is obvious. Recurring treatments are easier and more profitable. Actually coming up with a one-time treatment would destroy established pharm business models.

      The socialized medicine business models might not be quite as obvious, but it's about providing healthcare theater not better health outcomes. They too would be fine with healthcare that never evolved or improved.

      My take is that long term improvement in human health will only come from removing barriers to entry. That includes the war on drugs BTW.

      • (Score: 5, Insightful) by krishnoid on Saturday June 08, @06:41PM (9 children)

        by krishnoid (1156) on Saturday June 08, @06:41PM (#1359858)

        The socialized medicine business models might not be quite as obvious, but it's about providing healthcare theater not better health outcomes. They too would be fine with healthcare that never evolved or improved.

        [citation requested]

        • (Score: 2, Interesting) by khallow on Saturday June 08, @11:28PM (8 children)

          by khallow (3766) Subscriber Badge on Saturday June 08, @11:28PM (#1359887) Journal
          Where's the incentive for a public health care system to improve?
          • (Score: 5, Insightful) by jelizondo on Sunday June 09, @12:32AM (7 children)

            by jelizondo (653) Subscriber Badge on Sunday June 09, @12:32AM (#1359894) Journal

            Not everyone is inspired by making money. As a lawyer, most of my cases are pro bono; the satisfaction I get from helping people who can’t afford a lawyer makes me happier than a larger balance in my bank account.

            Organizations are made of people, if the people in a public health care system are devoted to making the world better by reducing suffering, the system will improve without financial incentives.

            Not everyone is a whore turning tricks for money, you know.

            • (Score: 0, Troll) by khallow on Sunday June 09, @01:36AM (2 children)

              by khallow (3766) Subscriber Badge on Sunday June 09, @01:36AM (#1359899) Journal

              Not everyone is inspired by making money.

              Indeed. Some are inspired by status, security, or power.

              Organizations are made of people, if the people in a public health care system are devoted to making the world better by reducing suffering, the system will improve without financial incentives.

              And we have fifty years of history of global public healthcare systems not doing this for the topic of this thread. I guess they're devoted to something else.

              Not everyone is a whore turning tricks for money, you know.

              Other things than money to whore for.

              • (Score: 2) by krishnoid on Sunday June 09, @07:33AM (1 child)

                by krishnoid (1156) on Sunday June 09, @07:33AM (#1359918)

                Other things than money to whore for.

                Like better public health outcomes.

                • (Score: 1) by khallow on Sunday June 09, @07:44AM

                  by khallow (3766) Subscriber Badge on Sunday June 09, @07:44AM (#1359919) Journal

                  Like better public health outcomes.

                  Did you forget what you originally wrote?

                  One question it left me with, is why socialized medicine countries that would benefit from an inexpensive, plentiful first-pass therapy that sometimes can be curative, rather than a recurring treatment for some of these conditions -- without having to involve pharmaceutical companies -- didn't move forward on research into these therapies for the last 50 years.

                  I provide a hypothesis that answers your question.

            • (Score: 2) by krishnoid on Sunday June 09, @07:09AM (3 children)

              by krishnoid (1156) on Sunday June 09, @07:09AM (#1359913)

              One key argument that slipped my mind is practice and exposure through case volume. If your organization attempts to gatekeep or maximize income, you may get better training but less practical experience -- trauma surgery in gang-violence heavy areas and war zones, travelling dental and vision vans through poor rural areas, construction experience via Habitat for Humanity, etc. Internships [youtu.be], of a sort.

              You can also consider the Linux kernel. It (and the compiler) is free of cost, but the sheer volume of server-side use provides a breadth of testing you couldn't get from a proprietary kernel. The ability to freely examine the source code also means it's exposed to altruistic sorts, "you missed a spot" types, and malicious actors and flushes out bugs quickly. So you trade off income for testing and quality, and the confidence that comes from that.

              It also provides experience, both for keeping one's skills up-to-date (e.g., pro bono work), and to to display a visible, active presence in the field, and keep one's resume current.

              To argue otherwise is to say that the spirit and reality of "volunteering" doesn't exist, either for free or at below market costs. And you have leverage to complain loudly about what's broken when you're not in it for the paycheck. What are they going to do, dock your pay?

              • (Score: 1) by khallow on Monday June 10, @04:25PM (2 children)

                by khallow (3766) Subscriber Badge on Monday June 10, @04:25PM (#1360045) Journal

                If your organization attempts to gatekeep or maximize income, you may get better training but less practical experience -- trauma surgery in gang-violence heavy areas and war zones, travelling dental and vision vans through poor rural areas, construction experience via Habitat for Humanity, etc. Internships [youtu.be], of a sort.

                What makes that experience practical? /if you're some peculiar specialty like plastic surgeon or cancer treatment, then such experience is mostly irrelevant - which makes it not practical.

    • (Score: 0) by jdoe on Saturday June 08, @06:14PM

      by jdoe (18471) on Saturday June 08, @06:14PM (#1359856)

      "they" would benefit? the people/tax payers would benefit, but the corrupt politicians would not. How would they get their kickbacks, industry jobs, or other pay offs?

  • (Score: 2) by looorg on Saturday June 08, @05:52PM (5 children)

    by looorg (578) on Saturday June 08, @05:52PM (#1359852)

    If it is a problem then the problem will be that to many people will want to self-medicate for recreational reasons and not medical ... Like they do with almost every single drug (from weed to drink to pills to whatever floats your boat) on the planet already. So nothing new there.

    There should be an interesting Venn diagram of the medical and recreational use and how they overlap. Ohh I feel my PTSD coming on, time for some healing magic mushrooms .... Sort of like when you could get medical marijuana but not recreational and you had many people suddenly developing acute anxiety or whatever it was that they totally needed a prescription for. Cause now they were healing themselves and not just potheads.

    • (Score: 3, Informative) by jdoe on Saturday June 08, @06:16PM (1 child)

      by jdoe (18471) on Saturday June 08, @06:16PM (#1359857)

      mushrooms are not like other substances when it comes to abuse and dependency. try them for yourself and you will see(many truths that were hidden from you before).

      • (Score: 2) by krishnoid on Sunday June 09, @07:19AM

        by krishnoid (1156) on Sunday June 09, @07:19AM (#1359915)

        And if you don't want to try them for yourself without doing the research first because you're a huge nerd, watch Michael Pollan's Netflix special or some of the YouTube videos. I felt he did a very good job of laying out the history and facts without judgement or too much drama.

    • (Score: 2) by krishnoid on Saturday June 08, @06:44PM (1 child)

      by krishnoid (1156) on Saturday June 08, @06:44PM (#1359860)

      Nooo ... MDMA is for PTSD. You *could* say, my PTSD feels like it's flaring up. Oh hey, Paul Oakenfold is coming on stage next.

      • (Score: 2) by sgleysti on Saturday June 08, @09:29PM

        by sgleysti (56) Subscriber Badge on Saturday June 08, @09:29PM (#1359876)

        Oh hey, Paul Oakenfold is coming on stage next.

        Gives new meaning to "Perfecto presents another world". Oakenfold introduced me to Lisa Gerard from his mix of The Host of Seraphim, for which I am grateful.

    • (Score: 1) by khallow on Saturday June 08, @11:45PM

      by khallow (3766) Subscriber Badge on Saturday June 08, @11:45PM (#1359891) Journal

      If it is a problem then the problem will be that to many people will want to self-medicate for recreational reasons and not medical ...

      While I don't consider this to fall on the problem side, it's worth noting that the people exploiting these rules didn't make the rules. They would be fine with straight up legalization. It's the political leaders who can't be seen to support potheads who are the problem here. Just make these drugs legal with straight-forward markets and regulation. The games around medical use and such create broken markets with huge opportunity for subjective enforcement of law and official criminal activity.

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