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FDA Deems MDMA, Banned Since 1985, a 'Breakthrough Therapy'

The designation should speed the drug's approval as a prescription medicine, which could happen as soon as 2021.

WikipediaWikipediaTwo decades after the Drug Enforcement Administration banned MDMA, classifying it as a dangerous intoxicant with no accepted medical use, the Food and Drug Administration has deemed the same substance a "breakthrough therapy." The designation should speed MDMA's approval as a prescription medicine, which could happen as soon as 2021.

That remarkable turnaround is thanks to the hard work of a plucky and persistent organization known as the Multidisciplinary Association for Psychedelic Studies (MAPS), founded the year after the DEA banned MDMA. Last fall the FDA gave MAPS a green light for Phase III studies of MDMA as a treatment for posttraumatic stress disorder (PTSD), the last stage before approval of a new medicine. MAPS, which plans to start enrolling subjects for its first Phase III study this spring, announced on Saturday that MDMA had qualified as a breakthrough therapy.

The designation, created by the Food and Drug Administration Safety and Innovation Act of 2012, means the FDA thinks MDMA "may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development." It is not hard to see why the FDA reached that conclusion, given the very promising results of the MAPS-sponsored Phase II studies conducted by Charleston, South Carolina, psychiatrist Michael Mithoefer and his wife, Annie, a psychiatric nurse.

The subjects in the first study were crime victims, mainly women who had been raped or sexually abused. More than four-fifths of the subjects who received MDMA in conjunction with psychotherapy showed a clinical response, meaning they saw reductions greater than 30 percent in the severity of their PTSD, as measured by the Clinician-Administered PTSD Scale (CAPS). The mean CAPS score in this group fell from about 80 to less than 30. Ten of the 12 subjects, all of whom began with CAPS scores indicating severe PTSD, no longer qualified for the diagnosis. By comparison, 25 percent of the subjects who received placebos saw improvements of more than 30 percent. Seven of the eight subjects in the control group subsequently chose to take MDMA, and all of them showed a clinical response.

That study, published by the Journal of Psychopharmacology in 2011, had a small sample, and blinding probably was less than fully effective, since subjects may have surmised they were getting the real thing based on the effects they perceived. But follow-up evaluations conducted 17 to 74 months after the last treatment found that the improvements experienced by the subjects who received MDMA generally persisted. While two of the 16 subjects who completed all of the evaluations relapsed, the average CAPS score was essentially unchanged.

A subsequent MAPS-sponsored study involved 21 Iraq and Afghanistan veterans, plus three firefighters and one police officer. The results, which have been shared with the FDA but have not been published yet, were similarly impressive.

Instead of using an inactive placebo, as the earlier study did, this one randomly assigned subjects to receive either 30 milligrams, 75 milligrams, or 125 milligrams of MDMA, followed by supplementary doses equal to half the original upon request. Summarizing the results at a MAPS conference last April, Mithoefer said there was "not much improvement" in the 30-milligram group but "quite a lot of improvement with the other doses." Mean CAPS scores, which ranged from 80 to 90 at the beginning, fell to between 70 and 80 in the low-dose group, less than 50 in the high-dose group, and less than 30 in the medium-dose group.

In addition to the breakthrough-therapy designation, the FDA has reached an agreement with MAPS on the design for the Phase III studies. Among other things, the FDA agreed with Rick Doblin, founder and executive director of MAPS, that an inactive placebo, as in the first Phase II study, was more appropriate than the active one used in the veteran study.

MDMA seems to facilitate psychotherapy for PTSD by promoting trust and enabling people to confront traumatic memories without the overwhelming fear they would ordinarily experience. The idea of using a low dose as placebo was that subjects would not get those benefits but would feel some of the stimulating effects associated with MDMA (a relative of methamphetamine), making it harder for them to figure out which group they were in. But it turned out that the low dose actually had a negative effect for many subjects.

"What we discovered," Doblin says, "was that the low-dose MDMA did increase the blinding, which is what I knew would happen, but what I didn't anticipate happening was that the low-dose MDMA between 25 and 40 milligrams actually had an anti-therapeutic effect. It made people agitated. It was uncomfortable. They were activated, but they didn't have the fear reduction, so people in those low-dose groups, in some of the studies they got a little bit worse. In other studies, they still got better, but not as much as they would have [if they'd] had the therapy without any MDMA at all."

Nigel McCourry, a former U.S. Marine who served in Iraq, was part of the medium-dose group in the veteran study, which saw the most improvement. He was amazed at the dramatic effects of MDMA-assisted psychotherapy. After years of insomnia and nightmares, he was suddenly able to sleep through the night, and within two years he felt like this "huge healing event had taken place" because he finally "had this sense of separation from the experiences of Marine combat." McCourry is eager to share his "story of healing" with fellow veterans. Every day in America, he says, "veterans are committing suicide because they can't stand living with PTSD, and I think we could save a lot of these people if we just got this medicine available."

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  • $park¥ leftist poser||

    Oh good, more drugs.

  • Hugh Akston||

    We can only pray that Jeff Sessions has enough stormtroopers at his disposal to stage an effective raid of the FDA.

  • loveconstitution1789||

    Yeah, Trump will never get credit for this relaxation of drug laws because he and Sessions are the worst. The worst!

  • Robert||

    Seriously, though, something like this is hard to judge by because it was a continuation of an effort begun before the Trump administration. We'll see once we take the long view. I do think the Trump administration's going to be a lot better than predecessors on matters like this.

  • Thomas O.||

    Well, of course. The government has less of a grudge against ravegoers than they did with hippies and blacks. #whitedrugprivilege

    /sarc

  • Diane Reynolds (Paul.)||

    as a prescription medicine, which could happen as soon as 2021.

    right around the corner. We've got Glaciers melting faster than that.

  • Robert||

    Actually pretty fast as new drug applications go.

  • C. S. P. Schofield||

    Which is yet another excellent reason to gut the FDA's authority to ban anything.

  • And you believe that why?||

    But it isn't a new drug. The specific treatment is newish, if you discount all of the decades-old research.

  • SIV||

    Let me know when it's OTC

  • AlmightyJB||

    Look you can't have people just doing stuff without getting permission first. Plus some people might enjoy it which could distract them from their true purpose which is worshipping God. Why do you hate God?

  • ace_m82||

    "Behold the rain which descends from heaven upon our vineyards, and which incorporates itself with the grapes to be changed into wine; a constant proof that God loves us, and loves to see us happy." - Ben Franklin

    While Scripture does indeed say "Don't be drunk with wine, because that will ruin your life. Instead, be filled with the Holy Spirit", but even that doesn't preclude drinking at all. In fact, as those orders were for Christians and only Christians, those who insist that non-Christians live by the directions for Christians are mirroring the Pharisees Christ railed against.

    Basically, they are legalists. They are denying the word they claim (Christian, which means "little Christ", or "Christ follower").

  • AlmightyJB||

    Seems like our Puritans today are more moralistic and sanctimonious than our Puritans of old.

  • stuartl||

    Why do you hate God?

    Pain and suffering, poverty, hunger, disease, global warming, ....

  • Procyon Rotor||

    The wars he brings, the babes he drowns, those lost at sea and never found...

  • Eric Bana||

    Twinkle, Twinkle, Little Bat,
    How I wonder what you're at:
    Up above the world you fly
    Like a tea tray in the sky.

    Twinkle, Twinkle, Little Bat,
    How I wonder what you're at.

  • Robert||

    OTC would be very hard status to get, being reserved for drugs for common ailments for which it's thought unnecessary to get professional help. However, perhaps some states will license psychologists (in addition to MDs) to prescribe or dispense this one.

  • ||

    The subjects in the first study were crime victims, mainly women who had been raped or sexually abused.
    ...
    A subsequent MAPS-sponsored study involved 21 Iraq and Afghanistan veterans, plus three firefighters and one police officer.

    Not that I'm opposed to the legalization of a miracle drug, but if you started off asking, "What do a rape victim, a war vet, a police officer, and a firefighter all have in common?" I'd have said, "Being the punchline to a bad joke?"

    I'd love to believe that we're legalizing this drug to help people, but I kinda think/believe the opposite. Especially considering the fact that we're migrating to single-payer and that PTSD didn't exactly exist when MDMA was originally banned, let alone discovered, and that pretty much anything including firing a gun and being present at the site of a violent crime (not when the crime happened) can induce PTSD.

    It feels a lot more like we're implementing soma.

  • $park¥ leftist poser||

    +1 gram
    -1 damn

  • Hugh Akston||

  • Crusty Juggler||

    It was invented like four years ago by the SJWs, stupid.

  • ||

    I didn't mean to say that PTSD and/or shell shock never existed. They clearly do/did. More to the point that now that everyone knows it exists, anybody who can string four letters together can self-diagnose and any hack with a board certification who needs a paycheck can deign it so. People who once heard a car explode in Iraq are getting the same or better treatment than people who saw and committed dozens of killings in Vietnam.

    Also, I'm a bit touchy or biased on the subject. I'd rather have my government able to assassinate me outright than drug me into a compliant walking coma.

  • Zeb||

    drug me into a compliant walking coma.

    You should also probably read up more on the effects of MDMA. That's not what it does at all. Drugs that do that (largely benzodiazepenes) have been around and prescribed for a long time and are widely used already on people with anxiety disorders and PTSD.

  • Zeb||

    You should look into how MDMA is used to treat PTSD and the history of such use. It was being used therapeutically before it was scheduled, and MAPS formed largely in response to that. It's an aid to psychotherapy, not a drug you take longterm to make the bad feelings go away. I don't think soma is a good comparison. From what I've read on the subject, the therapeutic use of MDMA looks extremely promising.

  • ||

    It was being used therapeutically before it was scheduled, and MAPS formed largely in response to that.

    And I'm not against the lobbying or legalization. I don't like the notion that it's a treatment for something so poorly defined and understood.

  • Zeb||

    I'm no expert, but I don't think PTSD is all that much more poorly defined or understood than any other psychological disorder.

    And again, the MDMA, by itself, isn't supposed to be a treatment for the disorder. It's an adjunct to psychotherapy that helps people get to the point where they can think clearly about what triggers their stress reactions and how they can change thought patterns and behaviors to make the reactions less severe.

  • ||

    Yeah, I guess I am being a bit of a libertarian purist, wishing they would just legalize the drug because it's the right thing to do rather than because we think it will help people we sent into war zones that we shouldn't be in to begin with.

  • Zeb||

    That would be much better, of course. The case for scheduling it in the first place was extremely weak. Until some time in the mid-80s it was just plain legal. But people were having fun with it, so that had to be stopped.

  • Qsl||

    It's an adjunct to psychotherapy

    And this is the part that concerns me.

    As it is, there is a very grey line between treatment and court mandated treatment where the gatekeepers are a group of people I basically distrust. As ADHD is already over-medicated, I'm not certain I want these people lording over what could be a significant treatment. It may turn out there is a rash of PTSD out in the wild after.

    I would almost rather it were treated like SOMA, where people could choose psychotherapy if they wanted, but otherwise the option to imbibe or not didn't have the potential of a court order waiting in the wings.

  • C. S. P. Schofield||

    Don't kid yourself. PTSD existed. It may have been called something else, but various anxiety disorders caused by trauma have been recognized since WWI, if not well understood.

    The problem is that the FDA has every incentive in the world to NOT allow a drug that might be the nex thalidomide, and only a few incentives to permit study of what it has previously banned.

  • Headache||

    MDMA commonly known as ecstasy, available on the street since 1912.

  • And you believe that why?||

    PTSD most definitely existed, we just used different names in the past. Since we are a century removed from the Great War, I'll use the term common at the time, shell shock.

  • Diane Reynolds (Paul.)||

    Who is Joanna Gaines and why is she in every reason ad bar?

  • AlmightyJB||

    Her and her husband have a show in HGTV. I think it's Fixer Upper. It's one of their more popular shows. I only know this because my wife watched that channel all of the time. Husband is a dork and she's a milf so kind of a King of Queens dynamic going on. Not sure why so tabloidy.

  • Citizen X - #6||

    Did... did you just cite a Kevin James vehicle as if it were a universal cultural touchstone? Jesus Christ.

  • AlmightyJB||

    It's part of a larger trend in TV shows of regular guys having hot wives. It was the first thing that came to mind since I never watch TV, I just happen to catch parts of whatever my wife's watching while I'm reading. She's actually the one who pointed the trend out to me. Plus the chick is all over the place now with her scientology exposes

  • Diane Reynolds (Paul.)||

    If I want to see dumpy guys surrounded by impossibly hot women, I watch Univision, like normal people.

  • Robert||

    I prefer this Kevin James: http://http://www.kjmagic.com/

  • Diane Reynolds (Paul.)||

    She's Milfy as hell, but I refused to google her.

  • ||

    Who is Joanna Gaines and why is she in every reason ad bar?

    HGTV characters from Waco, TX. I don't recall the exact details but with the info I've given you, they write themselves; Conservative, southern celebrity couple does something modestly anti-gay/non-progressive but well within the bounds of personal taste and now every headline contains a detail about the things they do that secretly indicate that they're aligned with Hitler.

    IIRC, she's got 4-6 kids and looks like that. That alone, is worthy of a lot of praise.

  • Citizen X - #6||

    So people could have been benefiting from MDMA for over 30 years, possibly preventing untold numbers of suicides, and the FDA might finally get out of the way... in another four or so years? Yo, fuck the FDA and the unholy hybrid of precautionary principle and Puritanism that it rode in on.

  • ||

    ...the Drug Enforcement Administration banned MDMA, classifying it as a dangerous intoxicant with no accepted medical use,

    The science is settled!


    the Food and Drug Administration has deemed the same substance a "breakthrough therapy."

    The science is resettled!

  • Paul E||

    I also love how a substance they banned decades ago without knowing anything about it (because that's what government does) suddenly becomes a "breakthrough therapy" to the same people over night, as if the FDA suddenly discovered something new that people weren't trying to tell them 30 years ago. Idiots.

    We know that sciencey stuff proved this was bad before but... well thesciencey stuff is different now so now this stuff is great. The stuff didn't change, science did..... this is why no one trusts the government, medical profession or the eco-chicken little's. Cholesteral is bad, no its good, salt is bad, it's good, it's bad, it's good, global cooling, global warming, climate change, the science is settled! Don't question us!

  • Longtobefree||

    I am not shocked that the FDA was wrong (on this, too), but I am deeply shocked that they now admit they were wrong.

    Of course, twenty years ago was ol' Billy Jeff, so. . . . .

  • Crusty Juggler||

    I am not shocked that the FDA was wrong (on this, too), but I am deeply shocked that they now admit they were wrong.

    It gives you an idea about how the current PTSD treatments are so poor.

  • Robert||

    They don't admit anything. FDA was never officially asked before, so they can't have been wrong. All they told DEA previously was that nobody'd ever asked them before, so they officially knew nothing.

  • ||

    Things to ponder:

    1. I wonder how they handled the after effects - the depression caused by serotonin depletion.

    2. I don't know if this is still a thing, but back in the 90s, people would do what is called "candy-flipping", which is taking LSD and MDMA at the same time. It strikes me that such a combination would be really helpful with dealing with a bad LSD trip and by extension PTSD via flashbacks/bad trips caused by the LSD. I.e. The LSD causes the traumatic memory to resurface but the MDMA turns the experience into a theraputic one by making them not feel the terror and trauma which in turn results in associating the experience with feelings of acceptance and calm.

  • Uncle Jay||

    RE: FDA Deems MDMA, Banned Since 1985, a 'Breakthrough Therapy'

    "Two decades after the Drug Enforcement Administration banned MDMA, classifying it as a dangerous intoxicant with no accepted medical use, the Food and Drug Administration has deemed the same substance a "breakthrough therapy." The designation should speed MDMA's approval as a prescription medicine, which could happen as soon as 2021."

    I don't know about all you wonderful people out there, but this certainly replenishes my faith in our ruling elites who micromanage our meaningless lives.

  • Rockabilly||

    Another permission slip from central committee to put something you choose into your own body. Disgusting commie government rats.

  • contrarian||

    Three decades*
    Hope that doesn't depress you too much.

  • Hank Phillips||

    I might've known... Here I was thinking Grace Slick had figured a way to dose some of the prohibition nazis and bring 'em around. Now it's looking more like bait to re-enlist shellshocked kids for another tour as Opium War cannon fodder in Afghanistan.

  • Larper||

    >it turned out that the low dose actually had a negative effect for many subjects

    Can I get a definition of the "low dose"?

    Was that 40 mg, 60 mg, 80 mg?

  • nicmart||

    Written by the same Jacob Sullum who won the Szasz award?

  • jjjjj||

    Which pharma company is going to get the (legal) monopoly on this and make a shit-ton of money?

  • Storm Damage Repair Tulsa||

    Yes, I think it will help people we sent into war zones that we shouldn't be in to begin with.

  • mysmartstuffs||

    Well, of course. The government has less of a grudge against ravegoers than they did with hippies and blacks. #whitedrugprivilege

    /sarc

    My recent post: ConvertProof Review
    Sent from Internet Marketing tips

  • ||

    It would have been helpful if the article had indicated what the acronym "MDMA" stands for.

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