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FDA grants Breakthrough Therapy designation to MDMA for treatment of PTSD
- sharp11 9y agoHere's a better write-up (in Science), to avoid the hassle of Forbes' web site: http://www.sciencemag.org/news/2017/08/all-clear-decisive-trial-ecstasy-ptsd-patients http://www.sciencemag.org/news/2017/08/all-clear-decisive-tr...
- danharaj 9y agoThey also keep track of news about them here: http://www.maps.org/news/media http://www.maps.org/news/media
- asteli 9y agoBreakthrough therapy, huh? Let's remember that the DEA head (John C. Lawn) in the 80's forced a Schedule I classification, ignoring the recommendation of two separate hearings, and a successful federal lawsuit to do so. This was at a time when MDMA was already in burgeoning, but successful, clinical use.
- Clubber 9y agoYea, the 80s were full of crazy people in government and everywhere. I remember when D&D was honestly considered being a gateway to satanism / Devil worship, and not in jest. And not a short two week news cycle thing, but it went on for years. Oh, and heavy metal too. It all finally started to wind down when the televangelists were exposed as money grubbing perverts. Paradise Lost took place in that era. If you haven't seen the movies, they're disturbing but good. https://en.wikipedia.org/wiki/West_Memphis_Three https://en.wikipedia.org/wiki/West_Memphis_Three You millennials think you have it bad, the boomers were absolutely batshit crazy to GenXers (we were also considered lazy BTW).
- danblick 9y agoThere's an insane quote from John Ehrlichman about the origin of the war on drugs in the Nixon Whitehouse: https://harpers.org/archive/2016/04/legalize-it-all/ https://harpers.org/archive/2016/04/legalize-it-all/ "The Nixon campaign in 1968, and the Nixon White House after that, had two enemies: the antiwar left and black people. You understand what I’m saying? We knew we couldn’t make it illegal to be either against the war or black, but by getting the public to associate the hippies with marijuana and blacks with heroin, and then criminalizing both heavily, we could disrupt those communities. We could arrest their leaders, raid their homes, break up their meetings, and vilify them night after night on the evening news. Did we know we were lying about the drugs? Of course we did." I wonder, is that credible? If so, it's kind of amazing how little has actually changed since those laws were put in place. (Edit: okay, there are some reasons to doubt that quote) https://www.quora.com/Is-John-Ehrlichman-a-credible-source-when-he-claimed-that-the-war-on-drugs-was-intentionally-aimed-at-the-left-and-racial-minorities https://www.quora.com/Is-John-Ehrlichman-a-credible-source-w...
- wallace_f 9y ago>it's kind of amazing how little has actually changed since those laws were put in place. Given there's a lot of bureaucratic inertia and jobs at stake here, and: "It is difficult to get a man to understand something, when his salary depends upon his not understanding it!" ...is it really so surprising? This aspect of human nature is not isolated to the Drug War. Jaime Escalante was possibly the best teacher in America, and demoted because his success threatened the jobs of others-1 What about the never ending wars for profit? Wolf Blitzer at CNN tells us it's a moral problem for the US to stop funding war because a lot of jobs will be lost-2 The problem is that if we are to truly care about human dignity and equality, we need to fundamentally change the way in which we approve of jobs without critically looking at what they actually produce. This isn't just isolated within the economy of the War on Drugs. 1-reason.com/reasontv/2017/08/22/stossel-government-run-schools-crush-in 2-https://theintercept.com/2016/09/09/wolf-blitzer-is-worried-defense-contractors-will-lose-jobs-if-u-s-stops-arming-saudi-arabia/ https://theintercept.com/2016/09/09/wolf-blitzer-is-worried-...
- deleted 9y ago[deleted]
- api 9y agoPsychedelics and similar drugs for clinical treatment are a genuine example of a suppressed technology.
- phkahler 9y ago>> This was at a time when MDMA was already in burgeoning, but successful, clinical use. I remember seeing it on TV (Dateline or 20/20 or similar) they were talking with practitioners using it for couples therapy. It seemed really remarkable. That was well before it turned into a street drug (tainted with other stuff).
- DaiPlusPlus 9y agoI know MDMA is frequently defended as being a "safe" drug insofar that there's no physiological health risks (e.g. alcohol's liver damage, cocaine's cardiotoxicity) but I understand the MDMA is neurotoxic (e.g. https://www.ncbi.nlm.nih.gov/pubmed/28801175 https://www.ncbi.nlm.nih.gov/pubmed/28801175 and https://www.ncbi.nlm.nih.gov/pubmed/16499508 https://www.ncbi.nlm.nih.gov/pubmed/16499508 ) - much like methamphetamine and amphetamine, which are both similar drugs, chemically and psychoactively. I've never taken MDMA but I know people who have - who describe how they refuse to take it more than once every six months to prevent said neurotoxic damage, as well as taking dietary supplements that allegedly mitigate damage - which corroborates what I've read on Erowid. Obviously for certain classes of PTSD sufferers the tradeoff would be worthwhile (similar to how the negatives of stimulant therapy for ADD are a trade-off if it enables an otherwise healthy and productive life) - so I'm hoping this will enable further research into the negative side-effects of stimulant therapy for PTSD - as well as better research into supposed damage-mitigation techniques - so far a lot of published research on stimulants has been only performed on rodents whose CNS are considerably different compared to our own. Anecdotally, I have comorbid ASD and ADD with an anxiety disorder and I found that amphetamine-based drugs prescribed for my ADD (Adderall, Vyvanse, et cetera) have worked wonders for my anxiety issues - which surprised my psychiatrist because typically worsening anxiety is a side-effect of amphetamine.
- cwkoss 9y agoI would guess that MDMA neurotoxicity is highly correlated with dose. The therapeutic dose is likely a fraction of a single recreational dose (1/10-1/2). Neurotoxicity is likely most pronounced by crazy recreation drug users taking tens of doses in a single day/weekend. I'd be surprised if therapists found it useful for their PTSD patients to be 'rolling face', but I'm no expert. EDIT: Seems like I'm wrong - therapists are using roughly 1 full dose for therapy See http://journals.sagepub.com/doi/full/10.1177/0269881112464827 http://journals.sagepub.com/doi/full/10.1177/026988111246482...
- acchow 9y ago125mg. Should be "rolling face".
- refurb 9y agoHats off to MAPS! What we need for drugs like MDMA are data. The FDA has turned down other drug companies who have sought breakthrough status, because their data didn't support it. What will be interesting is if the phase 3 is successful. The DEA won't have any choice but move MDMA from schedule 1 to a lower schedule, as schedule 1 is defined as "no currently accepted medical use in the United States". The hilarious part is MDMA is given as an example of such schedule 1 drug on their website.[1] [1]https://www.deadiversion.usdoj.gov/schedules/ https://www.deadiversion.usdoj.gov/schedules/
- TheSpiceIsLife 9y agoWhat we need for [problem] are data. If only it were that simple.
- lgas 9y agoI think refurb wasn't saying "all we need for this is data" but rather "we need data for this" (so hats off to the people actually producing it).
- cvsh 9y ago>The DEA won't have any choice but move MDMA from schedule 1 to a lower schedule, as schedule 1 is defined as "no currently accepted medical use in the United States". The DEA has demonstrated pretty clearly that it doesn't give a rat's ass what the medical community thinks about a substance if the DEA has decided it doesn't want to remove it from Schedule 1 classification
- martinald 9y agoYes, this is most hilarious when GHB is in both Schedule 1 and Schedule 3 at the same time, or as Wikipedia puts it: "Schedule I but Schedule III when in an FDA-approved drug product" So it's "no currently accepted medical use in the United Sates", apart from when it is in a FDA approved medical use. wut? :D
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- notadoc 9y agoSource link http://www.maps.org/news/media/6786-press-release-fda-grants-breakthrough-therapy-designation-for-mdma-assisted-psychotherapy-for-ptsd,-agrees-on-special-protocol-assessment-for-phase-3-trials http://www.maps.org/news/media/6786-press-release-fda-grants...
- arikr 9y agoTo the extent that anyone on HN knows an active philanthropist looking for potentially highly impactful but severely underfunded causes - send them one of these articles: https://www.inverse.com/article/32376-mdma-ptsd-therapy-dr-bronners-soap https://www.inverse.com/article/32376-mdma-ptsd-therapy-dr-b..., https://www.vice.com/en_us/article/j5x748/the-refugee-funding-americas-psychedelic-renaissance https://www.vice.com/en_us/article/j5x748/the-refugee-fundin..., http://www.newyorker.com/magazine/2015/02/09/trip-treatment http://www.newyorker.com/magazine/2015/02/09/trip-treatment, or encourage them to read the book/audiobook called 'Acid Test.' I believe there's a case that funding MDMA research has very high dollar/impact returns - or at least that it's likely enough that it's worth a thorough exploration. It sounds like they still need to raise about $12 million, which is shockingly small compared to the ~$1.5bn/yr NIMH budget - and all of it will come from private philanthropists, as governments aren't yet willing to fund the work and for-profit companies don't see much profit yet due to the lack of patentability. If you're on HN and this is the first you're hearing about this research, some resources: - A short video excerpt from a documentary on MDMA therapy - https://www.youtube.com/watch?v=W9iKx2MKS70 https://www.youtube.com/watch?v=W9iKx2MKS70 - NY Times article - https://www.nytimes.com/2016/11/29/us/ptsd-mdma-ecstasy.html https://www.nytimes.com/2016/11/29/us/ptsd-mdma-ecstasy.html
- andrewtbham 9y agoOr donate yourself... I have donated money to maps. Small amounts add up. I don't often donate to charities. But this is an opportunity to contribute to something that is likely to provide a long term solution for a serious problem. https://store.maps.org/np/clients/maps/donation.jsp?campaign=11 https://store.maps.org/np/clients/maps/donation.jsp?campaign...
- arikr 9y agoYes, please. I'm the same way - I don't really donate to things, wouldn't consider myself the type of person who "donates," but I donated to MAPS last year and this year. Felt good.
- pmiller2 9y agoDoes anyone know where these trials might take place and whether non-veterans might be eligible?
- anythingnonidin 9y agoYes I believe non-veterans with PTSD will be eligible. I'd say sign up for the maps.org newsletter, they'll likely announce study sites. http://www.maps.org/news/update http://www.maps.org/news/update
- jarmitage 9y agoBetter to change the link to the actual press release from MAPS http://www.maps.org/news/media/6786-press-release-fda-grants-breakthrough-therapy-designation-for-mdma-assisted-psychotherapy-for-ptsd,-agrees-on-special-protocol-assessment-for-phase-3-trials http://www.maps.org/news/media/6786-press-release-fda-grants... Also better for anyone who supports this to donate to MAPS or another psychedelic research institute of your choosing!
- anythingnonidin 9y agoAgreed. If dang / the admins agree, feel free to change.
- hoodoof 9y agoUgh. Does the U.S. have to go through this phoney "it's really good for medicine!" process to legalize every drug? Is that the only community acceptable path to changing long standing beliefs about these terrible terrible drugs? How about taking a general position that the war on drugs has failed and has created far bigger problems than were ever presented by individual people making decisions that impact their own health. People of the U.S.A. - it's not necessary for every formerly demonized recreational drug to go through a "hey it's medically valid" process. Unless of course yuour goal is to prop up the system of handing out "legal to use marijuana" certificates that the medical profession now depends on.
- empath75 9y agoI think I'd rather GP's be handing out prescriptions for mdma than OxyContin.
- phkahler 9y ago<cynical hat> The goal is to regulate and profit from everything. Criminalizing drugs has created a huge prison industry and a large chunk of government. Since there's little money in MDMA they may as well legalize it for a specific use and regulate it.</cynical hat> But you're right of course. Blanket regulation where none is needed is the wrong way to go about it.
- chimeracoder 9y ago> Ugh. Does the U.S. have to go through this phoney "it's really good for medicine!" process to legalize every drug? While it should not be necessary tactic for ending the war on drugs, don't brandish the label "phony" when it comes to the medical benefits for marijuana and MDMA. Marijuana has been extensively studied, more so than almost any other prescription drug available today, and its medical benefits are clearly established. MDMA is not quite as over-exhaustively studied, but it's similarly been shown in a multitude of studies to have real medical benefit. Moreover, that medical benefit is for a disorder which is currently not possible to treat effectively with any other drug available, which makes it all the more important.
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- alicegut 9y agoSame news peg, first-person account of how/why MDMA for PTSD saves lives... https://medium.com/@AliceGut/mdma-for-ptsd-saves-lives-66f785de1d1f https://medium.com/@AliceGut/mdma-for-ptsd-saves-lives-66f78...
- Allower 9y agoFinally
- altotrees 9y agoLong ago I read an article about Dr.Rick Doblin in Rolling Stone. Thought his ideas on psychedelics and mental health treatment were amazing. Wrote about him and his research for my Honors high schoo English thesis. Got some looks from my teacher, but I digress. Glad to see this is slowly being taken seriously.
- cnp 9y agoRight on :)
- dolzenko 9y agoBit surprised why such news keep coming to the front page? I mean is there really much interest in psychology and especially PTSD treatment here or is it about drug use (doubt that, too)?
- anythingnonidin 9y agoI think "hackers" are generally interested in things that solve large problems. And "hackers" are also generally interested in things/interesting technologies or tools that have been stunted but now being realized.
- honestoHeminway 9y agoThis may be able to reduce systomps, but i sincerely doubt that it can heal scared neuronal tissues, where the pressure wave induced micro-bleeding.