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FDA grants Breakthrough Therapy designation to MDMA for treatment of PTSD

428 pointsby anythingnonidinover 7 years ago

13 comments

arikrover 7 years ago
To 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: <a href="https:&#x2F;&#x2F;www.inverse.com&#x2F;article&#x2F;32376-mdma-ptsd-therapy-dr-bronners-soap" rel="nofollow">https:&#x2F;&#x2F;www.inverse.com&#x2F;article&#x2F;32376-mdma-ptsd-therapy-dr-b...</a>, <a href="https:&#x2F;&#x2F;www.vice.com&#x2F;en_us&#x2F;article&#x2F;j5x748&#x2F;the-refugee-funding-americas-psychedelic-renaissance" rel="nofollow">https:&#x2F;&#x2F;www.vice.com&#x2F;en_us&#x2F;article&#x2F;j5x748&#x2F;the-refugee-fundin...</a>, <a href="http:&#x2F;&#x2F;www.newyorker.com&#x2F;magazine&#x2F;2015&#x2F;02&#x2F;09&#x2F;trip-treatment" rel="nofollow">http:&#x2F;&#x2F;www.newyorker.com&#x2F;magazine&#x2F;2015&#x2F;02&#x2F;09&#x2F;trip-treatment</a>, or encourage them to read the book&#x2F;audiobook called &#x27;Acid Test.&#x27;<p>I believe there&#x27;s a case that funding MDMA research has very high dollar&#x2F;impact returns - or at least that it&#x27;s likely enough that it&#x27;s worth a thorough exploration.<p>It sounds like they still need to raise about $12 million, which is shockingly small compared to the ~$1.5bn&#x2F;yr NIMH budget - and all of it will come from private philanthropists, as governments aren&#x27;t yet willing to fund the work and for-profit companies don&#x27;t see much profit yet due to the lack of patentability.<p>If you&#x27;re on HN and this is the first you&#x27;re hearing about this research, some resources:<p>- A short video excerpt from a documentary on MDMA therapy - <a href="https:&#x2F;&#x2F;www.youtube.com&#x2F;watch?v=W9iKx2MKS70" rel="nofollow">https:&#x2F;&#x2F;www.youtube.com&#x2F;watch?v=W9iKx2MKS70</a><p>- NY Times article - <a href="https:&#x2F;&#x2F;www.nytimes.com&#x2F;2016&#x2F;11&#x2F;29&#x2F;us&#x2F;ptsd-mdma-ecstasy.html" rel="nofollow">https:&#x2F;&#x2F;www.nytimes.com&#x2F;2016&#x2F;11&#x2F;29&#x2F;us&#x2F;ptsd-mdma-ecstasy.html</a>
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DaiPlusPlusover 7 years ago
I know MDMA is frequently defended as being a &quot;safe&quot; drug insofar that there&#x27;s no physiological health risks (e.g. alcohol&#x27;s liver damage, cocaine&#x27;s cardiotoxicity) but I understand the MDMA is neurotoxic (e.g. <a href="https:&#x2F;&#x2F;www.ncbi.nlm.nih.gov&#x2F;pubmed&#x2F;28801175" rel="nofollow">https:&#x2F;&#x2F;www.ncbi.nlm.nih.gov&#x2F;pubmed&#x2F;28801175</a> and <a href="https:&#x2F;&#x2F;www.ncbi.nlm.nih.gov&#x2F;pubmed&#x2F;16499508" rel="nofollow">https:&#x2F;&#x2F;www.ncbi.nlm.nih.gov&#x2F;pubmed&#x2F;16499508</a> ) - much like methamphetamine and amphetamine, which are both similar drugs, chemically and psychoactively. I&#x27;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&#x27;ve read on Erowid.<p>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&#x27;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.<p>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.
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refurbover 7 years ago
Hats 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&#x27;t support it.<p>What will be interesting is if the phase 3 is successful. The DEA won&#x27;t have any choice but move MDMA from schedule 1 to a lower schedule, as schedule 1 is defined as &quot;no currently accepted medical use in the United States&quot;.<p>The hilarious part is MDMA is given as an example of such schedule 1 drug on their website.[1]<p>[1]<a href="https:&#x2F;&#x2F;www.deadiversion.usdoj.gov&#x2F;schedules&#x2F;" rel="nofollow">https:&#x2F;&#x2F;www.deadiversion.usdoj.gov&#x2F;schedules&#x2F;</a>
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asteliover 7 years ago
Breakthrough therapy, huh?<p>Let&#x27;s remember that the DEA head (John C. Lawn) in the 80&#x27;s <i>forced</i> 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.
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notadocover 7 years ago
Source link<p><a href="http:&#x2F;&#x2F;www.maps.org&#x2F;news&#x2F;media&#x2F;6786-press-release-fda-grants-breakthrough-therapy-designation-for-mdma-assisted-psychotherapy-for-ptsd,-agrees-on-special-protocol-assessment-for-phase-3-trials" rel="nofollow">http:&#x2F;&#x2F;www.maps.org&#x2F;news&#x2F;media&#x2F;6786-press-release-fda-grants...</a>
hoodoofover 7 years ago
Ugh. Does the U.S. have to go through this phoney &quot;it&#x27;s really good for medicine!&quot; process to legalize every drug?<p>Is that the only community acceptable path to changing long standing beliefs about these <i>terrible</i> <i>terrible</i> drugs?<p>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.<p><i>People of the U.S.A.</i> - it&#x27;s not necessary for every formerly demonized recreational drug to go through a &quot;hey it&#x27;s medically valid&quot; process. Unless of course yuour goal is to prop up the system of handing out &quot;legal to use marijuana&quot; certificates that the medical profession now depends on.
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altotreesover 7 years ago
Long 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.<p>Glad to see this is slowly being taken seriously.
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alicegutover 7 years ago
Same news peg, first-person account of how&#x2F;why MDMA for PTSD saves lives...<p><a href="https:&#x2F;&#x2F;medium.com&#x2F;@AliceGut&#x2F;mdma-for-ptsd-saves-lives-66f785de1d1f" rel="nofollow">https:&#x2F;&#x2F;medium.com&#x2F;@AliceGut&#x2F;mdma-for-ptsd-saves-lives-66f78...</a>
pmiller2over 7 years ago
Does anyone know where these trials might take place and whether non-veterans might be eligible?
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honestoHeminwayover 7 years ago
This may be able to reduce systomps, but i sincerely doubt that it can heal scared neuronal tissues, where the pressure wave induced micro-bleeding.
dolzenkoover 7 years ago
Bit 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)?
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sharp11over 7 years ago
Here&#x27;s a better write-up (in Science), to avoid the hassle of Forbes&#x27; web site: <a href="http:&#x2F;&#x2F;www.sciencemag.org&#x2F;news&#x2F;2017&#x2F;08&#x2F;all-clear-decisive-trial-ecstasy-ptsd-patients" rel="nofollow">http:&#x2F;&#x2F;www.sciencemag.org&#x2F;news&#x2F;2017&#x2F;08&#x2F;all-clear-decisive-tr...</a>
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jarmitageover 7 years ago
Better to change the link to the actual press release from MAPS <a href="http:&#x2F;&#x2F;www.maps.org&#x2F;news&#x2F;media&#x2F;6786-press-release-fda-grants-breakthrough-therapy-designation-for-mdma-assisted-psychotherapy-for-ptsd,-agrees-on-special-protocol-assessment-for-phase-3-trials" rel="nofollow">http:&#x2F;&#x2F;www.maps.org&#x2F;news&#x2F;media&#x2F;6786-press-release-fda-grants...</a><p>Also better for anyone who supports this to donate to MAPS or another psychedelic research institute of your choosing!
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