Trevor Burrus: Welcome to Free Thoughts.
I'm Trevor Burrus.
Aaron Powell: I'm Aaron Powell.
Trevor Burrus: Joining us today is Rick Doblin, he's the founder and Executive Director of
the Multidisciplinary Association for Psychedelic Studies.
He received his doctorate in Public Policy from Harvard's Kennedy School of Government.
Welcome to Free Thoughts, Rick.
Rick Doblin: Trevor, thank you for having me.
Trevor Burrus: What is MAPS?
Rick Doblin: MAPS stands for the Multidisciplinary Association for Psychedelic [00:00:30] Studies.
In its essence, it's a nonprofit pharmaceutical company focused on developing psychedelics
and marijuana into FDA approved prescription medicines.
Then, also we're starting to really think globally.
It'll be about really trying to develop MDMA-Assisted Psychotherapy for PTSD, first through FDA,
with our America First plan, then through the European Medicines Agency, then the rest
of the world.
Then expand to other [00:01:00] indications for MDMA, and also other psychedelics and
marijuana.
Aaron Powell: What led you to start an organization like this?
Rick Doblin: What led me to start it was that I was totally as a young man, freaked out
by the world, and scared of the world being destroyed through ... I was almost 10 when
we had the Cuban missile crisis.
I grew up on stories of the holocaust, I'm Jewish, and had distant relatives killed.
Then, [00:01:30] I was the last year of the lottery for Vietnam.
All of that just made me realize that the essence of the psychedelic mystical experience,
which has been used for thousands of years in all different cultures, is this sense that
we're all connected.
We're connected to nature, we're connected to others, and we're essentially, we're more
the same than different, and I thought that the political implications of that were profound.
We saw that a lot during the '60s, that a lot of [00:02:00] the people that were using
psychedelics were finding them to be very educational, and instructive, and also motivated
them to get involved in a lot of the social justice causes of the era, which increased,
of course, the controversial nature of these drugs.
But also, for me, really confirmed the sense that there were important political implications
of having this sense of connection, and [00:02:30] knowing it is one thing intellectually, but
feeling it experientially is another.
That led me to just focus on psychedelics as what I thought would be a valuable contribution
that I could focus my life on to bring them back up from the underground into mainstream
acceptance.
Aaron Powell: I'm curious on the psychedelic's approach, specifically, because what you're
describing that kind of [00:03:00] those mystical experiences, then the benefits of that feeling
of connection, is popular or comes about another ways too, right?
Like right now we're going through a period where mindfulness is on the rise, and Buddhism
is on the rise.
The Buddhists did their love and kindness meditation, which gives you similar sorts
of effects.
Why approach this kind of thing from the pharmaceutical's perspective?
Rick Doblin: I would say that mindfulness [00:03:30] has arisen out of a lot of this
mystical experience.
There's many, many different ways to do it.
You can go to a monastery and meditate for 30 years, or you can try to do yoga for a
long time, or you could practice mindfulness.
There's many ways to do it, and I think that's a really important point, is that these are
not drug induced experiences, essentially, these are human experiences catalyzed by drugs,
by psychedelics, but also available in many other ways.
The reason I [00:04:00] chose psychedelics is because I think they're more reliable,
more consistent, have been used for thousands of years for those reasons.
Given the fact that a lot of people are not going to meditate for 20 years, or that mindfulness
is hard for people, and that yoga is hard, you can have these experiences just walking
in nature.
But I just felt like the psychedelics were an efficient tool, that's what we saw during
the '60s, that's what influenced me.
I felt like time was pretty limited, we've got [00:04:30] incredible technology that's
impacting the climate, we've got nuclear weaponry that could be explosive in a terrible way
at any moment, I just [inaudible 00:04:42] for an efficiency point of view, I focus on
psychedelics.
Trevor Burrus: Is it accurate to conclude that if we say that the Counter-cultural movement
in the '60s and a lot of people doing psychedelics, and they became more worldly minded in social
justice causes, but is it accurate to conclude that psychedelics [00:05:00] caused that or
that the kind of people who would take psychedelics are the kind of people who might be more open-minded
to new experiences and things that actually predict more social justice left-wing to some
extent, anti-war, those attitudes might predict those opinions more than being caused by psychedelics?
Rick Doblin: I think it's both of those things.
I think it's both accurate.
The psychedelics don't inherently, under any circumstances, [00:05:30] produce these kind
of experiences, we have all sorts of information about people that take psychedelics at parties,
or elsewhere for recreational purposes, and then end up feeling a lot worse off, and scared,
and panicked, and emotional breakdowns.
It's about the context, what Timothy Leary now they started calling the set and setting,
that has a big impact on what's going to happen from the experience.
It's not inherently in the drug, [00:06:00] it's this combination of drug set and setting.
I think that there are suggestions of people that are predisposed to these kind of experiences
are more questioning, more willing to explore novelty, more open to this kind of experiences,
that in fact are seeking them.
I think it's a combination.
There was just a study that came out of Imperial College in London that looked at people [00:06:30]
who were experiencing psilocybin for reasons of depression.
These are not people that are looking for a mystical experience or anything.
But they're willing to volunteer for a study in which psilocybin could be used to help
them with their depression.
What the study showed is that those that had a mystical experience, and that the depth
of the mystical experience was linked to experiences of what they called natural [00:07:00] relatedness
and openness, and anti-authoritarian views, that they were correlated between the depth
of the mystical experience and this outcome.
I think it's something that happens in people naturally if they're open to whatever it is
about to emerge, whether they come it for personal political reasons, or they come to
it for trying to get out of depression, or alcoholism, or nicotine addiction, or other
clinical conditions that they might seek out therapy.
Aaron Powell: I'm curious how you go about doing [00:07:30] studies of this kind when
the materials you're studying are illegal.
Rick Doblin: Yes.
That's why I got my Master's and my PhD from the Kennedy School of Government on the regulation
of the medical uses of psychedelics and marijuana.
The drugs are illegal, unless you can have approval from the FDA, the DEA, and Institutional
Review boards to conduct scientific research.
They're only legal in research contexts.
[00:08:00] Although, I guess, I'll make an exception that some of the psychedelics, like
Ayahuasca, and Peyote, have been approved by the US Supreme Court for legal use in certain
religious contexts.
For example, there's roughly half a million members of the Native American Church, who
can legally use peyote throughout America.
There's also members of the União do Vegetal, the UDV, which is an ayahuasca [00:08:30]
church, and the Santo Daime, which are also another ayahuasca church that can use the
ayahuasca within very specific religious contexts that in one case, with the UDV, went all the
way up to the Supreme Court, and with the Santo Daime, it went up to the Ninth Circuit,
and they affirmed their religious use.
But, basically, it's very difficult to do research with these drugs, because they're
illegal.
It takes a great deal of negotiations with regulatory authorities.
[00:09:00] But, it's not unknown that drugs that have been in Schedule 1, the most illegal,
have emerged out of that and then had medical uses accepted.
Most people, I think, would be aware of the oral THC pill, Marinol, for nausea control,
for cancer chemotherapy, and for appetite ... for AIDS Wasting, that that's been approved
as an extract of marijuana.
Then, also, more recently, GHB, [00:09:30] which was a Schedule 1 drug, sometimes known
as the date rape drug, it's been approved as a medicine for narcolepsy, for people that
fall asleep during the day, so they take GHB at night, and then it helps them sleep better
through the night, so they're not sleepy during day.
It is possible for a drug to move from Schedule 1 into other Schedules, meaning that the medical
use is approved.
It's also possible to do research with these drugs.
Trevor Burrus: When it comes to trying to get permission from [00:10:00] the government,
and the DEA as you said, and the FDA, do they seem to not want to give you permission?
I mean, the DEA is not the drug study administration, or whatever, the drug education administration,
its job is to stop the use and flow of these drugs, especially Schedule 1 drugs.
I feel like they wouldn't be totally happy about giving people licenses to study these
and possibly make people believe that they have beneficial effects and make the [00:10:30]
DEA's job harder.
If you discover that marijuana helps cancer patients, then cancer patients are going to
try and get marijuana, and now we got to go burn down more fields in Northern California.
Rick Doblin: I think the Riders in Congress, when Congress created the Controlled Substances
Act in 1970, they did so with a healthy suspicion that police authorities would want to shut
down research, that produced [00:11:00] evidence that was contrary to the propaganda of the
drug war, which was now just starting to be escalated at that time by Nixon.
The members of Congress limited the ability of DEA to block giving Schedule 1 licenses
to very specific reasons.
None of those have to do with "Oh, they don't like the politics of the study."
If the person applying for a Schedule 1 license has had a criminal record related to drugs,
they're not going [00:11:30] to get a Schedule 1 license.
But if they don't, and if the protocol has been accepted by the FDA, and by an Institutional
Review board, and DEA always wants to go last in this process, but if you have the proper
approvals, DEA is pretty limited in how they can say no.
They have said yes.
Sometimes we've had [inaudible 00:11:51] them, they've done nothing for a long time, as a
way to show that they weren't so happy.
We've had to sometimes get members of the Senate [00:12:00] to call the DEA to say "What's
taking so long to get these approvals?"
But, in the end, the DEA has been giving these approvals.
We just had a meeting with DEA December 19th, with DEA Headquarters.
It was precisely to talk about the issuing of Schedule 1 licenses to researchers.
It actually was a cordial and collaborative discussion.
We now have our first senior retired DEA official [00:12:30] working as a consultant for us.
The reason is because his son went off to the military, and went to Iraq, and has PTSD,
and uses marijuana for PTSD, which changed the ideas of his father.
His father is now working for us as a consultant, Tony [Coulson 00:12:53] is his name, and we
ended up ... he arranged these meetings December 19th at DEA Headquarters.
There was one [00:13:00] moment that was so particularly illustrative, which was, we get
in the elevator, we're going up to the sixth floor of the DEA building.
For whatever reason, the elevator opens up on the second floor, nobody got in, nobody
got out, I don't know if anybody actually pressed the second floor.
But the second floor is where the Administrative Law Judges courtroom is.
The last time that I was in the DEA Headquarters was 2005, when we were suing the DEA to try
to enforce them [00:13:30] to issue licenses to professor Craker at UMass-Amherst for growing
marijuana for drug development purposes, because there's been this monopoly since 1968, that
they federal government has on the production of federally legal DEA license marijuana that
can only be used in FDA approved trials.
The elevator opened up on the second floor, nobody got in, nobody got out, it closed.
That just reminded us that that was our past experience with DEA, we had been suing them
on that [00:14:00] floor, and then we went up to the sixth floor, and we had our collaborative
meeting about Schedule 1 licenses.
I think the other part of this is that the police are among the first responders in our
society that most need help with Post-Traumatic Stress Disorder.
When you think about it, we talk a lot about veterans with PTSD, or women and men even
survivors of childhood sexual abuse, and adult rape and assault.
But, I've lately become more sensitized [00:14:30] to the difficult job that the police have,
and how often they see horrific things, and can be easily traumatized by that.
There was a hint of that, that what we're trying to do is not completely against the
best interest of the DEA, or police authorities.
We're trying to bring in tools that can help their own members who are suffering from the
challenges of the job that they have.
Trevor Burrus: When you mention the marijuana source, [00:15:00] tie a little bit more about
that in the ... There is another level for that, it's the NIDA to get this marijuana.
I've heard it's not very good on top of that.
Aaron Powell: Yeah, I was going to ask about that.
Does the government grow good pot?
Rick Doblin: The issue is right now, will science, in this case drug development in
science for marijuana, be blocked by politics?
With psychedelics, because so many manufacturers [00:15:30] have DEA Schedule 1 licenses, or
Schedule 1 licenses from their one countries to produce these drugs for research, we have
an independent source of psychedelics.
We have an FDA that's willing to put science before politics of the drug war.
That's why we're making so much progress with psychedelic research, that we're about to
start these three studies with MDMA-Assisted Psychotherapy for PTSD.
FDA has declared that a breakthrough therapy, [00:16:00] which is absolutely tremendous.
But, with marijuana, we're way behind.
Years, and years, and years behind.
That's because of this monopoly that the federal government has on the production of marijuana.
It's [inaudible 00:16:14] license of the University of Mississippi.
They grow under contract to the National Institute on Drug Abuse.
The National Institute on Drug Abuse can only provide it for research, not as a prescription
medicine.
What that means is, [00:16:30] that as long as there's only one source, which is NIDA,
we can never do phase three studies.
Because the phase three studies, the crucial, pivotal studies that are necessary to prove
safety and efficacy, to get approval by the FDA for marketing, those phase three studies
have to be done with the exact same drug that the sponsor is seeking permission to market
if the study is prove safe and effective.
The [00:17:00] NIDA marijuana is not just bad quality, which it is, it's low potency.
It's all ground up, and it's dry, and it's not at all what you'd want to smoke if you
had a choice.
But the most important problem is that, that marijuana can only be used in academic research,
not in phase three drug development research.
This has been a problem since 1968.
Starting in 2000, I started working with professor Lyle Craker [00:17:30] to sue the DEA to apply
for licenses that had led to that lawsuit in 2005, where the Administrative Law Judge
agreed with us, that it would be in the public interest to end the NIDA monopoly.
But the administrator of the DEA rejected that recommendation.
We were tied up in the courts, that didn't work.
But, under Obama, in 2016, in the summer of 2016, the DEA agreed that they would end the
monopoly.
[00:18:00] They put in a couple paragraphs in a Federal Register Notice that explain
how they could do this consistent with US International Treaty obligations.
That had been the big argument for decades, that US International Treaty obligations prevented
DEA from licensing anybody other than NIDA.
In two short paragraphs they showed how that was a totally bogus argument, and how they
could do this in accordance with their treaty obligations.
Then, since then, roughly 26 [00:18:30] companies, or individuals, have filed for licenses to
grow marijuana exclusively for federally regulated research.
But then, what happened is, we got Trump and Sessions.
They're ending up, Sessions is now blocking DEA from issuing any of these licenses.
Senator Orrin Hatch, in October, had Sessions in front of him in a Senate hearing, and he
questions Sessions about this.
Sessions agreed that the monopoly should end, that [00:19:00] it would be good to have competition,
and that he just didn't want to license all 26 of them.
That was over three months ago, and nothing has happened since.
What's even the most egregious is that last week, word came out that President Trump called
Prime Minister Netanyahu in Israel and said "Do not permit the export of medical marijuana."
The entire Israeli establishment, political [00:19:30] establishment, the Ministry of
Health, the Ministry of Justice, they had all decided that they would finally permit
the Israeli medical marijuana producers to export their product.
We would be interested in importing it, into the US, for research, because their marijuana
can be used for prescription sales, and it can be used for phase three, but President
Trump called Netanyahu and said "Don't permit it."
He reversed the policy in Israel, and blocked [00:20:00] the export.
Now, we have a situation where the Trump administration is blocking importation of medical marijuana
from abroad, and through Sessions, is blocking the DEA from issuing any licenses to domestic
producers.
Meanwhile, we have a company called GW Pharmaceuticals that was approved by the Home Office in 1998.
20 years ago, to produce marijuana [00:20:30] for medical research.
That company is now worth in excess of $3 billion for blocking domestic production.
It's all because it's hard to say why it is.
Because we've got a majority well over 85% of Americans are in favor of medical marijuana,
and over 60% of Americans are in favor of marijuana legalization.
This is the last holdout, and we are really focusing, MAPS is focusing a lot of effort
on trying to change [00:21:00] this, because this is now drug war politics blocking science,
and we need to undo that.
Aaron Powell: Along those lines then, how much damage to the future of this field can
Sessions do, and how worried are you about him taking further steps to inhibit things,
make it harder, re-criminalize stuff than he already has?
Rick Doblin: I'm not that worried about what [00:21:30] Attorney General Sessions can do
in terms of trying to slow down the research that we're doing with MDMA-Assisted Psychotherapy
for PTSD.
There's a couple of reasons for that.
First off, we have approval from FDA to move forward into phase three.
[inaudible 00:21:51] cooperation from DEA giving the Schedule 1 licenses to the researchers,
and that's really the only point of leverage that the Attorney General [00:22:00] has.
There's also a law that's been passed not too long ago that says that once the FDA decides
that a drug has been proven to have safety and efficacy, the DEA must reschedule within
60 days to permit the medical use.
Now, whether it goes in Schedule 2, or Schedule 3, or Schedule 4, Schedule 5, that's a discussion
between the DEA and the FDA's Controlled Substances staff.
There is some influence that the attorney general [00:22:30] could have through the
DEA on the Schedule, that MDMA ends up with, if it's approved by the FDA.
But, if it's approved by the FDA, it must become a medicine within 60 days.
The other thing that we've done was we've negotiated with FDA in what's called a Special
Protocol Assessment process.
That's one of the newer innovations at FDA in terms of regulatory science.
Once you've been given permission for moving to phase [00:23:00] three, as a sponsor, you
can just go ahead and do your phase three studies.
Or, if you elect, you can enter into a Special Protocol Assessment process, which negotiates
every aspect of the phase three design with the FDA.
That delays things sometimes six months to a year, and a lot of pharmaceutical companies
don't want those delays, because they've got patents that they think are expiring, and
they think that they know how to design the phase three [00:23:30] studies.
But in such a controversial issue, of MDMA-Assisted Psychotherapy for PTSD, we elected to go through
the Special Protocol Assessment process.
On July 28th, 2017, we've reached an agreement and received an agreement letter from FDA.
What that means is that FDA is now bound, legally, to approve MDMA-Assisted Psychotherapy
for PTSD.
If the studies, as we've agreed to design them with FDA, if we get evidence statistically
significant evidence in efficacy, and [00:24:00] no new safety problems arise.
I'm pretty confident that we're on a really good track that cannot be interrupted.
Plus, the other thing is that we have bipartisan support for what we're doing.
Just today we released a press release of a $1 million donation for veterans going through
phase three from Rebekah Mercer, the Republican funder.
We've got a lot of support from veterans communities, from the military, from all the military newspapers,
[00:24:30] and media outlets.
I think we're in good shape.
I think the big issue for me with Sessions is how he's blocking drug development research
with marijuana.
That is a major concern.
Trevor Burrus: He also doesn't like medical marijuana on top of that, I mean, anything.
He would like to go after medical marijuana.
Rick Doblin: He's very interested in, yeah, doing what he can to hinder state medical
marijuana laws, and also state marijuana legalization laws.
But MAPS is focused [00:25:00] on federal, and trying to do the federal research.
We have a study right now, which is four different kinds of marijuana for Post-Traumatic Stress
Disorder in 76 US veterans.
This study is taking place in Phoenix, Arizona, and it's being funded with a $2.1 million
grant that MAPS has received from the state of Colorado, from their marijuana taxes.
Even though this study is not taking place in Colorado, the state of Colorado has funded
it.
[00:25:30] We're moving forward with that study with marijuana from NIDA.
This is a phase two study, it'll take us another year, year-and-a-half to get all the data.
Then we'll be ready, perhaps, depending on the results, to move to phase three.
We can't move to phase three with NIDA marijuana.
Hopefully, between now and a year and a half from now, we'll be able to break the NIDA
monopoly and force Sessions to permit the DEA to issue some licenses.
But [00:26:00] that's really where Attorney General Sessions can impact our work on a
federal level ... He can certainly try to crack down on states, but that just puts a
lie to all the state's rights [inaudible 00:26:14] that we've heard from Republicans, and it
also is meeting with incredible resistance among various states, even in the Republicans.
Senator Cory Gardner, from Colorado, has gone on a warpath against Sessions, now that Sessions
has talked about cracking [00:26:30] down on marijuana legalization states, in medical
marijuana states, which Colorado is.
Sessions is trying to do what he can to slow down the acceptance of the medical use of
marijuana, and marijuana legalization, but it's a losing battle that he's got, and he's
got a lot of Republican opposition.
I think from a political point of view, it's foolish, because they're going to be losing
supporters who [00:27:00] care about liberty, and ending the drug war, and freedom to access
medical marijuana, they're going to lose support from those voters who might otherwise have
voted Republican.
Trevor Burrus: You mentioned a few times the MDMA-Assisted therapy for PTSD.
MDMA for those listeners who don't know is ecstasy in the street world.
But, talk a little bit about those studies, because it's quite shocking [00:27:30] how
effective the preliminary results are for PTSD treatment through ecstasy, which everyone
always associates with going to a rave.
But, for a very long time, before they was even prohibited by the DEA, ecstasy had been
used by psychologists too to treat these kinds of things.
Rick Doblin: Yeah, Trevor, it's very good you mentioned that, because most people are
not aware that MDMA, which I prefer to use, because ecstasy now refers to a street drug
[00:28:00] that is often impure, and adulterated with other things, but it was originally intended
to be pure MDMA, and that's what it was in the '80s.
From the middle '70s to the early '80s, MDMA was used under the code name Adam.
Sort of a scramble of MDMA, and sort of reminds one of the garden of Eden and a certain state
of innocence that MDMA can help people feel.
Around half a million doses were used in therapeutic settings, personal growth settings, private
[00:28:30] settings, homes, and this was completely out of the view of the DEA, there were no
significant problems from these views.
It was only that some people who had used Adam in these settings decided that a larger
group of people would benefit from this, and that they could make a lot of money, and that
people would be wanting this drug in other context.
They turned it into ecstasy.
Then, it became sold in bars in Texas, the Starck club, in [00:29:00] particular, in
Dallas and others.
It became known as the party drug.
When the DEA moved to criminalize MDMA in 1984, I had organized a group of therapists
and researchers into psychedelics, and we ended up anticipating the DEA move, because
this was during Nancy Reagan "Just say no" era, and the fact that ecstasy was being used
in a public setting, it meant that it was doomed.
We ended up filing for [00:29:30] a DEA Administrative Law Judge hearing in the summer of 84 and
got that hearing.
Then, actually, similar to the marijuana Administrative Law Judge hearing, we won the case.
The Administrative Law Judge said that MDMA should be Schedule 3, and available still
to therapists.
The administrator of the DEA at the time, John Lawn ignored that recommendation and
put it in Schedule 1.
Then I realized that the only way to bring it back was going to be through the FDA, [00:30:00]
and that's where I created MAPS in 86.
If you were to design a drug for Post-Traumatic Stress Disorder, MDMA would be it.
The results are remarkable, but at the same time, it was well-known in the therapeutic
circles, where Adam was used, that MDMA had remarkable potential for Post-Traumatic Stress
Disorder.
What it does, briefly, is that it reduces activity in the amygdala, the fear processing
center [00:30:30] of the brain.
It increases connectivity between the hippocampus and the amygdala, which is where memories
are processed.
What happens with PTSD is people have such scary, traumatic experiences that they can't
fully process it, and it comes back to them all the time.
They're hyper vigilant, and hyper-sensitive to fears and anxieties.
These memories are never really fully processed and turned into long-term memories, they're
always sort [00:31:00] of hovering there, on the surface, they come back in nightmares,
they come back in dreams, they come back in triggering events, somebody sees something,
or hears a noise.
Also, MDMA enhances activity in the frontal cortex, which is where we put things in context,
and where we can store memories, and long-term memory.
Also, MDMA stimulates oxytocin, and prolactin, which are hormones of nursing mothers, and
love, oxytocin, the love hormone.
It produces [00:31:30] a sense of safety, sense of connection, it enhances the therapeutic
alliance between the patient and the therapist.
MDMA stimulates serotonin, dopamine and norepinephrine, neurotransmitters that end up in this kind
of unique way producing a state whereby people are able to process powerful and painful negative
emotions in ways that they have not been able to do before.
We've actually worked with Vietnam veterans, [00:32:00] who had been stuck for 40, 50 years
with Post-Traumatic Stress Disorder, and they're able to heal under the influence of MDMA,
even after all that much time.
Trevor Burrus: [inaudible 00:32:10] I think in one of the ... was in the 80%, in the sense
of five years out having substantial treatment of patients, which is an incredible-
Rick Doblin: Yeah, the very first study that we did was mostly women survivors of childhood
sexual abuse.
[00:32:30] 83% of them no longer had PTSD after the treatment.
Then, at the three-and-a-half year followup, it actually was increased slightly, not decreased.
So that, on average, the benefits last over time.
Some people do relapse, and new things happen to them in their lives, but in general, it
lasts.
But, when we did all of the studies, we did studies in the US, in Israel, in Switzerland,
and in Canada.
When we put them all together, [00:33:00] we had 107 people.
The results were that after 12-month followup after the last MDMA session, two thirds no
longer had PTSD.
These were people that had chronic treatment resistant on average severe PTSD.
For two thirds of them, at a year later, no longer they have PTSD is pretty remarkable.
The one third that still had PTSD, many of them had significant reductions in symptoms,
but [00:33:30] they still had PTSD.
The question is maybe if a [inaudible 00:33:33] session were available to them, they might
continue to make progress.
That's why the FDA declared it a breakthrough therapy.
That's another, get back to the political question that you asked before about what
Sessions could do.
I was very concerned whether the FDA would give us breakthrough therapy designation because
it's a very public demonstration of FDA's support for the research.
They're actually [00:34:00] evaluated by Congress on how quickly breakthrough therapy drugs
move through the system.
The FDA provides extra meetings with the sponsor in the FDA, they try to help that whole process
move forward.
I was concerned, I felt we met the criteria, but now under President Trump, and Sessions,
I just wasn't sure how it would turn out.
But, on August 25th, 2017, FDA granted us breakthrough therapy.
That was really, for [00:34:30] me, the final point of FDA prioritizing science over politics,
being willing to stand behind the evaluation of our phase two data, and say that they want
to help us.
I really think that we do have bipartisan support, I don't see any significant opposition
coming from drug warriors, because that would put them against the warriors that we have
in the veterans community, and others.
I believe we're going to be able to move forward [00:35:00] with MDMA-Assisted Psychotherapy
for PTSD without encountering major objections from any political sources.
I think this latest $1 million donation from Rebekah Mercer, the Mercer Family Foundation,
will help in that regard.
Aaron Powell: Given a drug that seems this effective, that seems to work that astonishingly
well for people who are desperate for something that can work that astonishingly well, what's
[00:35:30] the drive to criminalize drugs like MDMA?
What are the arguments that, I mean, you said that aren't really any major objections, but
there are still, obviously, objections people make to legalizing, or freeing up in some
way these kinds of drugs, where are those people coming from?
What sorts of arguments are they making to you that we should keep something like this
off the market, that we shouldn't allow people to use it?
Rick Doblin: The main argument that we get [00:36:00] is that the medicalization of MDMA
"Sends the wrong message" to young people.
The message is supposedly that "Oh, this drug is safe, therefore go ahead and take it, even
if it's impure, and take it under any circumstances."
People are not really capable of looking at our data and saying "This drug is unsafe under
medical supervision."
Or "This drug is not [00:36:30] helping people tremendously with PTSD."
What they're able to only say is "Oh, we don't like the messaging, and it's going to get
in the way of the anti-drug message."
I think what we really need to acknowledge is that we need honest drug education.
When you exaggerate the risks of drugs, and deny their benefits, you may be able to persuade
fifth grader in D.A.R.E. program run by the police that drugs [00:37:00] are bad.
But once they get a little bit older, and they start learning more, you've lost all
credibility, because they see that they've been given any accurate information.
I think we really need honest drug education, and I think the message, anyway, that comes
to kids with the medicalization of this drug, is a different message than people are saying.
It's not that "Oh, go ahead and do it under any circumstances."
What they're hearing is ... we have a male/female co-therapist team, we have two [00:37:30]
therapists for every one patient.
The drug is only administered under direct supervision in an eight-hour session where
the subjects, in almost all of our sites, end up spending the night at the treatment
center, and then have more psychotherapy the next day.
We only do the therapy during the day, not at night.
It's only pure drugs, and it's only limited doses, and people have adequate fluid replacement.
People's temperatures don't have any kind of dangerous rise, people don't have [00:38:00]
problems with blood pressure increases.
Under those circumstances we're able to demonstrate safety and efficacy, but it's not the same
as just saying "This drug is safe for people to take under any circumstances, and any context."
I really think a lot of times people take these drugs for parties, they're only looking
for a good time, and then something emerges from their own unconscious, some prior trauma,
and if they know that this drug is a therapy drug, they're more likely to [00:38:30] process
the trauma, meaning to focus on it, to let out the emotions, to [inaudible 00:38:35]
to run away from it, or consider a bad trip, and then start trying to tranquilize themselves,
or whatever.
I actually think the medicalization is going to have a beneficial effect on non-medical
use rather than a harmful effect.
But that's the argument, [crosstalk 00:38:53].
Aaron Powell: The "sending the messaging" is such a frustrating argument too, because
on the one hand, if we medicalize [00:39:00] it, then it's like saying if we medicalize
chemotherapy all the kinds are going to go out and want to do it.
But then, on the other hand, the sending the wrong message, like here's a thing that you
know they're going to misuse, is odd in light of say "All of the beer commercials I saw
during the Super Bowl" the complete disconnect we have, we glamorize certain drugs, and send
the message that all the cool people do [00:39:30] it.
But then think that if we let a handful of doctors administer something, it's profoundly
frustrating.
Rick Doblin: It's really not a very logically consistent argument about sending the wrong
message.
I also think it's logically inconsistent, in fact, that the message that people get
is that under therapeutic controlled circumstances this can be helpful.
If you look at what's going on in medical marijuana states, they have not seen this
dramatic increase [00:40:00] in adolescent drug use with marijuana.
In fact, in some states they've seen a decrease.
It sort of takes it away the rebellious nature of doing these drugs once they're approved
as medicines.
We don't see in the Netherlands, for example, young people in the Netherlands where you
can get marijuana in coffee houses, they have a lower adolescent use of marijuana than we
do here in the US.
It sort of takes it as a symbol of rebellion, and it kind of reduces the symbolic value
of it once you've [00:40:30] mainstreamed and medicalized it.
Trevor Burrus: There's a strange aspect to psychedelics too, kind of going off of Aaron's
question about the drugs that we legalize, have legal, and also encourage in commercials
and the drugs we don't.
But with psychedelics, you were [inaudible 00:40:47] '60s as you said, it seems a little
bit different of what scares people about them than, say, cocaine or things that are
supposed to turn people into stark raving lunatics.
Psychedelics, it's like you're messing [00:41:00] with your brain, and I always got these ideas,
I think maybe in dare or someone told me on the playground, this rumor of if anyone's
ever taken LSD five times, they're declared clinically insane by the government.
Rick Doblin: [crosstalk 00:41:15] the same thing, yeah.
Trevor Burrus: My ideas of people jumping off a roof, that's why, you see, why is LSD
illegal?
Well, it makes people live in a different reality and it's really-
Aaron Powell: They said the same thing about Dungeons and Dragons.
Trevor Burrus: This is true.
I guess in that regard, like [00:41:30] why do you think psychedelics, how do you think
people, the public in general, thinks about psychedelics?
What mistakes do they make about that?
Rick Doblin: Okay, this is now, I think, a really key point, which is that in the '60s,
the psychedelics, because of the turmoil of the times, and because this was sort of the
first emergence of psychedelics into really widespread public consciousness, they got
lumped in as psychedelics produce counterculture rebels, who are going to protest [00:42:00]
everything, and drop out of society.
Tim Leary was talking about "Turn on, tune in, drop out."
I think that now, here we are, 50 years later, and that kind of fear, the fear that psychedelics
are going to inherently produce social turmoil, I think is not true anymore, we have to look
at all those people from the '60s who did psychedelics at a young age, and how many
of them have gone on to have families, to have careers, [00:42:30] to make positive
contributions in America.
One of the ones that we all love to point to is Steve Jobs, who talked about LSD as
being among the three most important experiences of his whole life.
He produced the most financially, wealthy company in the entire world, from Apple Computer.
So the association of psychedelics with the counterculture is still alive in the mind
of Attorney General Sessions, and a few [00:43:00] others.
But it's not really true, nor is it produced by the evidence of what people have done in
the last 50 years.
Our whole message now is about mainstreaming psychedelics, and making them something that
people can have access to, and they don't drop out of society.
In fact, it enhances their life, it enhances their participation in society, it can address
PTSD, depression, [00:43:30] anxiety, fear of dying, alcoholism, nicotine addiction.
These psychedelics, when combined with psychotherapy can be tremendously helpful for treating substance
abuse.
I think what's mostly now concerning people is this idea of parents worrying about their
children, and this idea that you take it five times, and you're clinically insane, or you
take MDMA and you get wholes in your brain, or any number of these fears that have no
basis in reality.
But I think we've [00:44:00] now got to this point where it is about sending the wrong
message to kids, or how do we protect the kids as the issue?
I think that the current system of prohibition endangers children, and adolescents more than
it protects them.
I think we're making that message, we're seeing that happening with marijuana, as we move
towards legalization in multiple states.
I think the thing that's been surprising to me, and this is where I've been very much
appreciative [00:44:30] of Cato, is this idea of personal freedom, and human rights to explore
consciousness that many, many Democrats, and Republicans don't really value as highly as
they should.
But the Cato Institute has been one of the pioneers in really talking about the infringement
of liberty represented by prohibition, and that we should have a whole different approach
towards drug abuse, and that it should involve honest drug education, open access [00:45:00]
to treatment, de-stigmatize people that run into problems.
That's what we're trying to see with alcoholism, and drug abuse, where people talk about it
at NIDA, and elsewhere, it's a brain disease.
It's not a moral failing necessarily completely, it's, in some sense, a brain disease, people
are trying to de-stigmatize it, and help offer treatment to people, particularly now what
we see with the opiate epidemic.
These are people that used opiates a lot of times for pain, and then got addicted to it.
Now that [00:45:30] it's more of a white kind of a problem, they're not demonized as much.
I really think that we're at a transition point in our culture, and that the Cato Institute
and others that really believe in personal liberty are leading the way to trying to come
up with a more effective and less costly, and more humane, and more pro-freedom, pro-liberty
drug policy.
Trevor Burrus: It is interesting how much [00:46:00] the stigma affects this view of
what psychedelics do when you have this question.
I always tell students that it's more profound than they usually think, which is what's the
difference between a drug, like an illegal drug, and a medicine when it sort of affects
your brain?
They say "LSD is really bad, it's a drug."
But then, there are so many psychotropic drugs out there, Xanax and all the anti-depressants,
and things that radically affects your brain, and [00:46:30] that's medicine.
But these things that have been used for thousands of years, of people use in different ways
to solve all these problems in their life, or have spiritual experiences, that's a drug,
and that's not okay.
It seems that sort of not a very fair way to classify these things.
That's of course what you're trying to fix.
Rick Doblin: Yeah.
It's completely unfair.
The ultimate irony is that what we're talking about when we talk about therapy with psychedelic
drugs is an administration of these drugs only a few times [00:47:00] in a therapeutic
context to help people be drug free, and to sort of address their emotional issues, and
be drug free.
In contrast to all these pharmaceutical drugs, which are many times meant to be taken on
a daily basis for years, or decades.
Then, if you stop taking them, your problems come back.
We're actually talking in some ways about an anti-drug strategy through the use of psychedelics
to go deep into people's unconscious, [00:47:30] and their psyche, with support, with therapeutic
surrounds, and try to make it so people become independent of drugs, and also free of the
psychological burdens that they've carried before.
Trevor Burrus: Here's something that strikes me, just now, I hadn't thought about this,
but MDMA is, I think it was discovered in 1913 or something, it's not patentable.
If you get FDA approval, will any drug company want to produce it?
Rick Doblin: MDMA was [00:48:00] invented in 1912 by Merck Pharmaceutical Companies,
the patents have long since expired.
Then, in the 80s, I actually hired a patent attorney to develop an anti-patent strategy
for used patents, so nobody could ever patent the use of MDMA, which basically meant putting
potential uses in the public domain, so nobody could say they discovered them.
What we're really trying to communicate to people is that [00:48:30] once it becomes
a medicine, MAPS is in an unusual circumstance, and to this we have thank Ronald Reagan.
In the 1980s, under 84, there was a law that was passed that provided incentives for the
development of drugs that were off-patent.
Once MDMA becomes a medicine, the FDA has a policy that they automatically give sponsors
of drugs that have no patent protection what's called data exclusivity.
[00:49:00] What that means is that nobody can use your data for five years to market
a generic.
It's less than a patent, because if some other sponsor wanted to make MDMA into a medicine
for PTSD, they could do so, and we'd be glad if they did, because that's just further part
of mainstreaming.
If somebody wanted to make MDMA into a medicine for something else, other than PTSD, they
could do that.
There's no composition of matter patent, there's no [00:49:30] used patents, but there is this
data exclusivity.
What MAPS has done is we've created a Public Benefit Corporation that will market MDMA
during this period of data exclusivity and beyond once MDMA becomes a medicine.
Whatever profits are made from the sale of MDMA by the MAPS Benefit Corporation will
be used for the mission of MAPS.
The MAPS Public Benefit Corporation is a for-profit company, but it has [00:50:00] only one investor
in it, which is the nonprofit.
What we're trying to demonstrate is a new mechanism, a new corporate mechanism for marketing
drugs.
One could argue that probably the whole pharmaceutical industry should be transformed into public
benefit corporations instead of profit maximizing corporations.
You have a lot of people who say "I'm against the legalization of marijuana, not because
I think marijuana is so terrible, but because we're [00:50:30] going to have big alcohol,
and big tobacco, and they're going to get involved in marketing marijuana, and they're
going to market to kids, and they're going to market to heavy users, and they're going
to advertise just the way you described these beer commercials, and that's going to have
a pernicious effect on society, and we don't like that unbridled corporate capitalism maximizing
profits to disregard public health."
That's where the public benefit corporation, and there's thousands of them now approved
in Delaware, [00:51:00] and also California, that you maximize public benefit, not profits.
I think we're trying to demonstrate, also, to regulators, to DEA, to people concerned
about abuse that once MAPS obtains approval from FDA for marketing MDMA, we're not going
to be just trying to get it out there to as many people as we can, as quickly as we can,
regardless of the outcomes, that we're going to be focusing on maximizing public benefit,
and I think that's a really incredible opportunity [00:51:30] that this data exclusivity process
has created.
Aaron Powell: We have spent most of the last hour talking about the ways that these drugs
could be used in specific therapeutic situations.
People suffering from particular ailments that can be solved with them.
But, I want to bring it all the way back to the beginning, because we started the conversation
by you saying you founded MAPS in part because you thought that there was something [00:52:00]
that could come out of the psychedelic experiences of the '60s, a connection, a feeling of oneness,
a feeling of a shared humanity, spiritualism that you saw as necessary for protecting us
against a lot of the great horrors that might come down.
That's a very different thing from specific therapeutic context.
Going forward, do you think that we should be taking these drugs and moving them into
a broader [00:52:30] usage, that people should simply be taking them in order to establish
that shared humanity that you saw back in the '60s?
Rick Doblin: I'm so glad you raised that point.
It's a really important point.
The medicalization of these drugs is a stepping stone to, I think, broader drug policy reform.
I do believe that we need to have legal access for people [00:53:00] to these drugs for those
spiritual purposes without them having a clinical condition that's being treated.
But if we look at the history of marijuana regulation in America, what I like to point
out is there's a Gallup poll or chart that looks at the attitudes of American voters
towards the legalization of marijuana from 1970 to around 2014.
What you see is an increase in support [00:53:30] for legalization through the '70s, this was
the Jimmy Carter era, been around 78 or so, where we started having the rise of the Parents
Movement.
Then in 80, where we get Ronald Reagan.
That the things [inaudible 00:53:42] for about 20 years.
It was somewhere on 20%, 22% or so that were in favor of legalization.
Starting around 96, 97, 98, there was a gradual increase until around 2012, when it crossed
the 50% mark in favor of legalization of marijuana.
[00:54:00] What happened during that time of increasing attitudes towards legalization
was the medicalization of marijuana.
Medicalization leads to legalization.
Medicalization is the only and the best way that we have to educate people honestly about
the actual risks and benefits of these drugs under certain conditions, and that is what
helps people try to sort through all the propaganda and exaggerated [00:54:30] information they've
seen about, and been given about the risks that have been put out there to justify prohibition.
Strategically, making psychedelics into medicines, it has to be looked at in and of itself, on
its own merits, through the most rigorous science possible, proving safety and efficacy
to the satisfaction of the most rigorous regulatory agency in the world for this, the FDA.
It has to make sense in and of itself [00:55:00] as a medicine.
But, that process, I think will change public attitudes so that we can have broad based
legal access, anticipating, that'll be 2035, that we're going to medicalize MDMA, other
groups are working to medicalize psilocybin by 2021.
Then we will have 10, 15 year roll out of psychedelic clinics.
Right now there's 14,500 drug abuse treatment centers in America, and you could [00:55:30]
imagine everyone of them could have somebody that's able to work with psychedelics to help
people deal with the trauma, and deal with the problems that addiction have caused.
There's 6,000 hospice centers now in America where people go when they're facing death,
they have a more humane approach to death instead of dying super medicalized in a hospital
bed.
Everyone of these hospice centers could have a psychedelic therapist, or two, associated
with them.
I think we're going to have through the [00:56:00] 2021, through 2031, 2035, we're going to have
broad-based distribution of medical use of psychedelics.
Eventually, we'll have family members be able to join in, and eventually I think people
will go to these clinics for initiation experiences, and then they'll have the ability to buy them
on their own, and use them in whatever settings they want.
But I think your point, of your question, is exactly right, is that the kind of [00:56:30]
broad-based spirituality that I think the world needs has to go beyond just medical
applications.
Aaron Powell: Free Thoughts is produced by Tess Terrible.
If you enjoyed today's show, please rate and review us on iTunes.
If you'd like to learn more about libertarianism, find us on the web at www.libertarianism.org.
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