
FDA grants Breakthrough Therapy designation to MDMA for treatment of PTSD - anythingnonidin
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
======
arikr
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: [https://www.inverse.com/article/32376-mdma-ptsd-therapy-
dr-b...](https://www.inverse.com/article/32376-mdma-ptsd-therapy-dr-bronners-
soap), [https://www.vice.com/en_us/article/j5x748/the-refugee-
fundin...](https://www.vice.com/en_us/article/j5x748/the-refugee-funding-
americas-psychedelic-renaissance),
[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
Or 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...](https://store.maps.org/np/clients/maps/donation.jsp?campaign=11)

~~~
arikr
Yes, 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.

------
DaiPlusPlus
I 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.

~~~
empath75
Anecdotally, I went to a lot of raves in the 90s and did what I would consider
to be a stupid amount of ecstasy now, as did most of my friends, and everyone
that I've kept in touch with are fully functioning members of society. Most of
us are making six figures, have families, etc. The people whose life turned
into a mess were people that got sidetracked into methamphetamines or opiates.

~~~
acchow
It's likely your "ecstasy" in the 90s was laced with something else too like
MDA, methamphetamines, etc.

But yes, MDMA anecdotally is much safer than anything else.

~~~
wavefunction
From my experience in the 90s rave scene the most common adulterants were DXM
and speed since they're cheap and press more easily than meth. Acid was the
drug of choice when I started going to parties in 94 but then ecstasy overtook
it by a long shot and acid pretty much dried up.

I think RCs as adulterants like 2cb or similar phenethylamines started to
creep into the scene in the early 2000s. Then cat was _huge_ mid 2000s until
it and the other RCs started to get prohibited.

This is just what I picked up from people I knew doing these things btw. I was
there for the music and girls.

This sort of subject matter is absolutely fascinating to me. The intersection
of pharmacology, law, society and culture and the actual evolution and changes
they all go through.

I feel like you could tie phases of electronic music to the drugs people were
taking at the time.

~~~
pcthrowaway
I'm not suggesting lacing mdma with dxm would be out of the question, and
maybe it was more common in the 90s, but it's my understanding that the
biggest adulterant of mdma (besides meth) in 2000-2013 was methylone, which
could be ordered online until recently, and is known for having a relatively
similar profile to mdma, with relatively few side effects and a low risk
profile (to the best of our current knowledge)

~~~
senorjazz
In the early 2000s I don't think it would have been methylone. MDEA was a big
one that was similar (although not legal, was less scheduled and / or was semi
legal at some point so there were big stockpiles of it. This was for the UK

------
refurb
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'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/)

~~~
cvsh
>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
Yes, 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

~~~
mrsteveman1
Well, that depends on whether CI is a logical AND, or a logical OR. No
accepted medical use AND high potential for abuse? Or can it be "any of the
above"?

21 U.S.C § 812[0] doesn't say anything at all except to give the list of
findings:

> (A) The drug or other substance has a high potential for abuse.

> (B) The drug or other substance has no currently accepted medical use in
> treatment in the United States.

> (C) There is a lack of accepted safety for use of the drug or other
> substance under medical supervision.

This is a little surprising because the "trailing AND/OR" is fairly common in
other areas of the law. Makes me wonder if it's ever been clarified in court.

There is some precedent for having a single active ingredient listed in
multiple schedules though, the one that immediately comes to mind is
hydrocodone.

Until very recently, we listed hydrocodone in both CII and CIII, depending on
which other active ingredients it was combined with.

If it was in a pill loaded with acetaminophen, which would supposedly deter
addicts from eating 20 of them at a time, it could be in CIII, otherwise it
was strictly CII. Because naturally, anyone getting ready to swallow 20
Vicodin at a time is going to know that acetaminophen can cause acute liver
failure and make the rational choice to avoid it.

That was one of the primary reasons Vicodin has been handed out like skittles
for every little injury, it's every bit as powerful as the others in CII, but
it could be prescribed with less oversight.

In that light it's not _too_ surprising to have GHB listed in more than one
schedule, but it's still absurd that one of them is CI, given that as far as
I'm aware, there is nothing particularly abuse-resistant about Xyrem.

[0]
[https://www.law.cornell.edu/uscode/text/21/812](https://www.law.cornell.edu/uscode/text/21/812)

~~~
fragmede
_> No accepted medical use AND high potential for abuse?_

That is Schedule II.

21 U.S.C § 812.b states:

(2) Schedule II.—

(A) The drug or other substance has a high potential for abuse.

(B) The drug or other substance has a currently accepted medical use in
treatment in the United States or a currently accepted medical use with severe
restrictions.

(C) Abuse of the drug or other substances may lead to severe psychological or
physical dependence.

[https://www.law.cornell.edu/uscode/text/21/812](https://www.law.cornell.edu/uscode/text/21/812)

Additional reading at wikipedia:
[https://en.wikipedia.org/wiki/Controlled_Substances_Act#Sche...](https://en.wikipedia.org/wiki/Controlled_Substances_Act#Schedule_II_controlled_substances)

------
asteli
Breakthrough 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
Yea, 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).

~~~
ekianjo
> Oh, and heavy metal too.

To be fair though Heavy Metal has been playing on the Satanist/Gore imagery
for years, and not just in graphics, but lyrics too. Not because they are
satanists, but it because it sold well.

~~~
cjslep
Because it sold well, as compared to non-Satanist/non-gore Heavy Metal?
Definitely would like to see the data you used to draw that conclusion. And
how inclusive your definition of "gore imagery" is.

~~~
_jal
To be fair, I think Slayer gets a lot more play than Stryper, but I have no
data for you.

That said, the notion that metal bands are fine-tuning lyrical content to
minimax paydays is pretty funny. I think income-maximizers generally gravitate
towards different careers. But I like picturing a bunch of corpse-paint MBAs
sitting on a conference call: "Nice, Sean, I like it, I like it a lot. What
about the next line - I think 'Demons dining on your shame' will sell better
than 'Demons know this ain't no game'. How does that grab you?"

~~~
soundwave106
This is a funny thought. But my guess is that if they were income-maximizers,
they wouldn't be writing metal with "satanic" or "gore" content.

Slayer certainly has been successful, and have built a nice consistent career.
You can do well with niches. But by one statistic, album sales... well,
they've never created an album that's gone platinum. (Stryper actually has
once!)

The "money" to "maximize" in music, if anything, is in pop. A large portion of
pop these days is written by teams of people these days. I'm not sure how it
goes down personally, but I can easily see conference calls coming up with the
best love metaphors for a teen idol to croon. :)

------
notadoc
Source link

[http://www.maps.org/news/media/6786-press-release-fda-
grants...](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)

------
hoodoof
Ugh. 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.

~~~
chimeracoder
> 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.

~~~
catshirt
i think OP is calling the process phony, not the conclusions. the government
theatre that acts like it's learning something new about the benefits of these
drugs so they can palletize their legalization. (palletize -- to make
palatable -- can i do that?)

~~~
JumpCrisscross
Re-branding past sins is an essential part of the political process and
community healing. It's also the number one reason why people who see the
world in rigid terms tend to have a tough time understanding any political
process, whether in an executive suite or Board room or Capitol building.

~~~
plaidfuji
Another way of putting it: an essential part of any successful negotiation is
achieving your desired outcome in a way that doesn't make the other side feel
like they've lost.

------
altotrees
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.

Glad to see this is slowly being taken seriously.

~~~
cnp
Right on :)

------
alicegut
Same news peg, first-person account of how/why MDMA for PTSD saves lives...

[https://medium.com/@AliceGut/mdma-for-ptsd-saves-
lives-66f78...](https://medium.com/@AliceGut/mdma-for-ptsd-saves-
lives-66f785de1d1f)

------
pmiller2
Does anyone know where these trials might take place and whether non-veterans
might be eligible?

~~~
anythingnonidin
Yes 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)

------
honestoHeminway
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.

------
dolzenko
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)?

~~~
anythingnonidin
I 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.

------
sharp11
Here'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-
tr...](http://www.sciencemag.org/news/2017/08/all-clear-decisive-trial-
ecstasy-ptsd-patients)

~~~
danharaj
They also keep track of news about them here:
[http://www.maps.org/news/media](http://www.maps.org/news/media)

------
jarmitage
Better to change the link to the actual press release from MAPS
[http://www.maps.org/news/media/6786-press-release-fda-
grants...](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)

Also better for anyone who supports this to donate to MAPS or another
psychedelic research institute of your choosing!

~~~
anythingnonidin
Agreed. If dang / the admins agree, feel free to change.

