 I'll start by saying that I've got two sorts of training. One is learning about working with people in non-ordinary states of consciousness, where I've been trained by Stanislav Prof in the whole group at breath work. And then the other training I've gotten at Harvard at the Kennedy School of Government, where I have my master's in Ph.D. and the regulation of the medical use of psychedelic drugs and marijuana. And so basically, I'm going to talk to you about the way in which we need to think about developing psychoactive substances into prescription medicines. This is not to say that they are only or best used in that way, but that under certain circumstances with people that are experiencing different sorts of emotional issues and traumas that therapeutic use through supportive psychotherapy can be profoundly beneficial. And why is this important? According to Stanislav Prof, he said LSD is the study of the mind, but the telescope is to astronomy and the microscope is to biology. These are incredible tools for the study of consciousness and to have banned them for so long as a tragedy. Albert Hoffman, who invented LSD and also was the first to synthesize psilocybin, said, I believe that if people would learn to use LSD's vision-inducing capability more wisely under suitable conditions in medical practice and in combination with meditation, then in the future this problem child could become a wonder child. I think that's overall what we're trying to do is to take these psychoactive substances that have been suppressed and demonized through the psychoactive law and others to try to bring them up from the underground so that we can really both reduce harms and also something that's not talked about quite as much which is to maximize the benefits. Now, on March 4th, there was an article published in The New York Times about the first study of the therapeutic use of LSD conducted in over 40 years. This was a map of the Multidisciplinary Association for Psychedelic Studies, the nonprofit that I started in 1986. This was a map sponsored study published in the Journal of Nervous and Mental Disease and simultaneously reported on in The New York Times. And what they're talking about is LSD reconsidered for therapy. So the LSD, which is the quintessential symbol of the psychedelic sixties and a symbol of cultural rebellion, if we can now bring LSD back in research and also starting to show therapeutic potential, I think there's hope for a whole range of psychoactive substances. What I'm going to mostly speak to you today about is MDMA. And just to give you a sense of the range of applications, psychedelics have scientific potential for understanding how the brain works, therapeutic potential, spiritual potential these drugs have been used for thousands of years for spiritual purposes, they're used for creativity. Steve Jobs talked about how LSD was really important to him and a lot of people in Silicon Valley have used psychedelics for creativity and Beatles for recreational purposes, for party drugs, for helping people die, dealing with the anxiety related to end-of-life issues, neuroscience for athlete, athletic performance sometimes, relationships, and there's political implications. But the part that I'm going to narrowly focus on is the medical applications for therapeutic purposes. And MDMA, many people are not quite aware of that in the middle 70s to the early 80s, MDMA was used as a secret therapy drug. That it was similar to MDA, which had been criminalized, and when MDMA was developed, it was first developed by Burke in 1912, but they didn't know what they had. It was researched by the Army Chemical Warfare Service in the 50s. They didn't really know what they had. They only did tests of animals as far as we know. And then it was rediscovered by this psychedelic community who realized that here was a legal tool that would be something that could be widely and effectively used in therapy, but it should best be kept secret for fear that it would become criminalized. And some of the people that used MDMA in these therapeutic settings, there were about half a million doses that were used from the middle 70s to 1985. Some of these people realized that this was something that they could both make a lot of money on and that a lot of healing could be done if it were more widely distributed, but they focused more on recreational use and so it became ecstasy. And this is a scene from the nightclub, the Stark Club in Dallas, and this is really where MDMA became ecstasy. And once it was clear that the use was taking place in public and recreational settings, it was clear that as the Reagan, Nancy Reagan and the escalation of the Warren drugs in the early 80s was taking place that MDMA would also inevitably be criminalized. And so unfortunately that happened. In July 27, 1984, the DEA announced that they were going to put ecstasy in Schedule 1, but the way the regulations work, there's a 30-day period where people can file objections. And since the therapeutic community, we were anticipating this. I started a prior non-profit with Elise Agar and Debbie Harlow in 1984, and we were prepared and had introduced a lot of people to MDMA who could be potential witnesses. We'd worked with politicians. I'd worked with Robert Mueller, who was the Assistant Secretary General of the United Nations, who was sympathetic to this. And so we were able to file for a hearing. So this is a picture of me in the background spying on the DEA. This is the... right before I walked in the DEA headquarters within this 30-day period and filed for a request for a hearing. And through some friends of Sasha Shilgen, we had tremendous pro-bono legal services from one of the top Washington, D.C. law firms. And we were actually able to win the case initially, but the DEA rejected the recommendation, and then they proceeded to demonize MDMA. This is Dancing with Darkness, Ecstasy and Predatory Drugs. So we went from this to... Oprah, in 2000, showed a completely fake brain scan that pretended to show that MDMA caused holes in your brain of a major magnitude like this. The irony was that they had the woman whose brain this was on the TV show and she looked completely normal. She was walking, she was talking, she would be dead if this was her actual brain with all these holes, but she was completely literate and she was unfortunately soon to become a spokesperson for the Partnership for a Drug-Free America about the evils of drugs. But then, 10 years later, about 11 years later, Oprah and her magazine, O Magazine, had an article about MDMA in which the reporter, at the end of it, described her own experience with underground psychedelic psychotherapists giving her MDMA and how valuable it was. And in the article, they didn't make it out to be something very controversial. They just said this was her experience. And so they portrayed MDMA as this magic pill where one dose and you're cured. So this is propaganda in the other direction. You know, it's not actually a completely magic pill, but this is where we're trying to head to the prescription use of the sale of GMP good manufacturing practices, MDMA. And so I'm going to talk to you about the regulations and how we managed to get to this place, to where we have psychedelic clinics set up throughout the world. And I think the model here is the hospice centers. So that in the 60s, when psychedelics really came into public consciousness, people were not really comfortable talking about death. People were not comfortable with meditation, with spirituality, with yoga. And shortly thereafter, in 1974, was the first hospice center where people could have more of a humane death. And by 2004, 30 years later, there was over 35 hospices in the United States. Most every community had one. So once we do manage to make MDMA into a prescription medicine, I believe that we will do it probably initially in these psychedelic clinics where people are specially trained to administer psychedelics and then we'll have a 20-30-year roll-out in society so that we'll have widespread distributed psychedelic clinics where people can go for therapy. Now, how do we get from here to there? In terms of regulations, in order to do research for psychedelics, you need approval from the FDA or from whatever the appropriate national regulatory agency is in this particular country. We have to have approval from institutional review boards or ethics committees, and then we need approval from the police authorities because these are highly controlled substances. With marijuana, it's the same, but in the United States, there's an additional hurdle which is because the federal government has a monopoly on the supply of marijuana that can be used in research. We have our own independent sources of supply of MDMA, LSD, psilocybin, and in fact, the MDMA that we're using in our research was manufactured by Dr. Dave Nichols in 1985 at Purdue University. So the MDMA being used in 2014 was manufactured 29 years ago and it's still among the world's purest MDMA. Every few years, we have to reanalyze it, but MDMA is an extremely stable molecule. But with marijuana, there's this monopoly, and on Friday, MAPS has been trying for over 22 years to do drug development research with marijuana and because of the 20 medical marijuana states and the two legalization states and the maturation of the drug policy reform community, what has happened is that the Obama administration has finally decided to release some of their monopoly supply of marijuana for us to do research and we have a study of marijuana for post-traumatic stress disorder in U.S. veterans from Iraq and Afghanistan and Vietnam. Yeah, it's astonishing. And I think the concern has been in the past that by the regulatory agencies that if they permit the research, it might actually work and these drugs might actually be able to be demonstrated safe and effective, sufficient to be approved for medical use and that would impact the 100 years of propaganda that Brian Emerson had mentioned. So I think that's unfortunately the resistance that we've faced, now we're overcoming it. Now the key point here is that our whole strategy is based on the FDA and regulatory agencies and we need to look at their institutional mission. The FDA's mission is to develop drugs to treat illness. They are not bought into the drug war but they're not supporters of psychedelics or supporters of marijuana. What they are is supporters of science over politics and so far the FDA has been successfully able to resist politicization and has prioritized science over politics. So that's the wedge into the U.S. government that we've been able to expand. And to give you a bit of history, once MDMA was criminalized in 1985, we tried for four different times from four different highly reputable institutions and one individual psychiatrist to get permission to work with MDMA and all were rejected. And the most outrageous was Dr. George Greer had a single patient who was a cancer patient who had been administered MDMA when it was legal and it helped reduces pain and reduces anxiety. And it was very helpful and there was no adverse reactions. And then once MDMA was criminalized, George applied to continue the work with this particular patient before he died. And what the FDA wrote back was that even the dying deserved the protection of the law and they refused to permit him to have access to the MDMA. So you can see how these decisions about risk benefit have a certain arbitrary aspect to it and from 1970, basically starting in 1966, the FDA started shutting down psychedelic research and it didn't change until 1989 when a new group at FDA was assigned the authority to regulate psychedelics in marijuana. And this was a group that was responding to the pressure to speed drug development because a lot of the concern was about AIDS drugs, about people suffering from AIDS and that this was fatal and the FDA had sort of seen its mission as preventing harmful drugs from getting approved and they ended up not really helping helpful drugs to get approved. So this was a new group that was set up to do this and it was set up without any portfolio. So they had to take some drugs and they got the Schedule I drugs and so they wanted to see research. And since 1990, the FDA has approved human studies with DMT, MDMA, LSD, psilocybin, mescaline and marijuana. So this is the core of our strategy and the FDA will still put science over politics. Here in New Zealand this would be the regulatory agency we need to work with and the Nuremberg Trials of the Nazis based on the human experiments where the Nuremberg Trials created the system of institutional review boards also known as Helsinki Committees or Ethics Committees and they have to also review studies but they're regulated by the Health and Human Services by the national agencies and also the DEA is required to look at diversion control. That means making sure that the drugs used in the research are not diverted to non-medical purposes. And this is also regulated by international treaties with set quotas for the amount of drugs that can exist and set up policies for how national governments can have to set up rules for regulating the research with Schedule I drugs. And the DEA and NIDA they have their major strategy in the past has been delay. As I said it's been 40 years to start marijuana research. They have no timetables for their reviews. So that's a big problem when we have to get regulatory permission and in order to do that you need countervailing forces. So we have sort of made a political assessment and realized that the military has more guns than the DEA. And if we can align ourselves with the military with all of their soldiers with post-traumatic stress disorder then the military can actually help us overcome the resistance of the DEA. And that's actually what's happened. This is Dr. Lori Sutton who was the highest ranking psychiatrist in the military, Brigadier General. And she said when it comes to the health and well-being of those who serve we should leave our politics at the door and not be afraid to follow the data. There's now an evidence base for this MDMA therapy and a plausible story about what may go on in the brain to account for the effects. And we've also worked with Senator Jay Rockefeller from West Virginia who is on the Senate Veterans Affairs Committee and he's written to the Assistant Secretary of Defense for Health Affairs and encouraged him to get involved with MDMA research and he also met with the Secretary of the Veterans Administration. And this is Dr. Michael Midhofer, our lead psychiatrist and Richard Rockefeller who was the chairman of the Board of Advisors of Doctor Without Borders. And he became sensitized to whole populations that were traumatized and has tried to help us with the military and I took this picture inside the Pentagon which is shocking for me because I was a draft resistor from Vietnam so to be actually in the Pentagon was kind of a healing experience for me. Now here's our timeline. We're now predicting that it's going to be two and a half years to what's called the end of phase two meeting at FDA and phase two studies which I'll get into in a minute are your pilot studies to learn various scientific and methodological facts in order to prepare for the large scale phase three studies which we think are going to take about three to four years and then the FDA reviews the data for six months or so. So we're currently predicting 2021 when we will have MDMA approved as a prescription medicine. So this is our drug development plan. What's really great is that we've hired a woman who used to work with Novartis which is one of the world's largest pharmaceutical companies and interestingly enough Novartis is the one that bought Sandos and Sandos is the pharmaceutical company that Albert Hoffman worked with when he developed LSD and synthesized psilocybin. So we have sort of the legacy of big pharma psychedelics and she's now helped us Amy Emerson as her name and she is in charge of our clinical research and has developed this drug development plan and there's a series of policies that the FDA has where you can accelerate the development. Our plan assumes that we're not going to get any of these but if we do get them it could speed up our process by several years and reduce the cost by many millions of dollars. This is the main thing here is the top numbers. To finish phase two we're estimating it's going to be about two and a half million dollars. It is about 1.9 million in the actual studies and then about 600,000 in these associated projects. How do we train the therapists reviewing the scientific literature developing training modules? How do we assess the therapists things like that? And then here we're predicting 16 million for the phase three studies. So we're more or less about 19 million dollars. One of our board of directors was a tech wizard and died at age 62 and left us 5.5 million dollars in a bequest which we've reserved for phase three for MDMA for PTSD and we're just about to receive another bequest of 1.9 million. So I think that over time we can raise several millions of dollars per year our budget is already 2 million a year and these are not out of the question that we'll be able to do this. We started in 1992 actually with the first study. First off you need to do phase one safety studies not in patients but in normal humans and then you end up getting a sense of what the side effects are what the doses are and then in phase two you can go into patients. So there's a whole series of things that you need to do in phase two. The first thing is figure out what is your treatment. For us psychedelics are not a treatment by themselves. It's psychedelic assisted psychotherapy and that's how we maximize the benefits and minimize the harms. So we have to standardize and describe our therapy and we've done this in this treatment manual and all of this stuff is up on our website and then we videotape and audio tape all of the therapy sessions and we have trained raiders that evaluate the therapists on how well they are complying with the treatment manual and we give them feedback about ideas about how they can maximize the patient outcomes. So first off this is what we're refining and we've developed this is our team from Boulder Colorado and then we have training programs and to give you a sense of how open the FDA is to this we said to the FDA that in order to train therapists they would be more effective if they actually had done MDMA themselves or LSD or whatever the drug is in question but because it's a schedule on drug the only way we can do that is to administer it in the context of a clinical study and we said would you give us permission for a study and the FDA said no we can't just give you permission to give drugs to therapists but if you design it as a scientific experiment to learn something and we don't care what it is you learn we'll let you limit it who can be in the study to therapists in your training program. So now we can take therapists from all over the world and bring them to Charleston, South Carolina where our lead therapists are and we can give them legal MDMA as part of their training so the FDA was really amazingly sensitive to our need to have there's only a limited number of people that have underground credentials and above ground credentials and so we're wanting as part of this mainstreaming is to work with people that don't have underground roots and for that now we can train them. We also need to figure out how to do a double blind and that's one of the key issues and one of the key criticisms is very psychedelic research from the 50s and 60s which is that the therapists and the patients could tell. Now imagine all of you are aware that if you take a psychedelic drug chances are you would notice it and if you take an inactive placebo you would probably tell nothing is happening so it's very hard to do this and we have spent years and lots of money trying to figure out what is the scientific approach to dealing with the double blind the inactive placebo at the top doesn't produce a successful double blind active placebos of methamphetamine or tranquilizers would also not really fool the therapists probably would fool the patients maybe at lower doses but could have anti therapeutic properties and so we've been working on what's called dose response where we give low doses of MDMA but we're trying to find out at what dose we've tried 30 milligrams, 25 milligrams, 40 milligrams, 75 milligrams at what dose would people confuse it with the full dose but that there wouldn't be so much therapeutic benefit and we just recently hired a consultant who used to work at the FDA who was in charge of the research that we're actually doing and what he said is that from a regulatory perspective the FDA realizes that in practice double blind even with Zolopaxil traditional SSRIs often doesn't work and so he said that as long as we have independent raiders and a robust effect we can compare MDMA versus an inactive placebo so that's the way that we're now proceeding with our studies we also have to figure out who are our patients for the drug and so the question is is the cause of the PTSD the differing causes would that require a different treatment basically would women survivors of childhood sexual abuse and adult rape and assault and men as well would they require a different treatment than combat related trauma and so we've done studies in different patient populations and now it's pretty clear that the MDMA assisted therapy works the same regardless of what the cause of the trauma was the changes in the brain if it's an accident a natural disaster whatever the cause we've been able to figure out that it's actually the same treatment the same disease and so we're able to in our phase 3 studies open it up to everybody then you have to figure out the treatment effect the magnitude and the variance and this is called effect size and this is to try to help you size the phase 3 studies so just to show on the left is our US data that's group averages that's the magnitude and the right hand side is our SWES data and that's the per patient data so you need the variability and the magnitude and then you can size and so we're now thinking we're going to need 200 patients in each of two phase 3 studies based on this data and then you also have to figure out cultural differences and whether that matters because we're doing MDMA PTSD research all over we're hoping to start a study in Australia as well perhaps Melbourne more likely but so far we don't have permission there in Spain was our first study and unfortunately at the time we were not very politically powerful and the study was started it was the first one ever and in 2002 there was positive media about it and the Madrid anti-drug authority decided that this was bad this is starting to look like MDMA might be a medicine so they shut the study down and we could not reopen it but we published the paper of the partial data this is our treatment room in the United States in Charleston you can see it's very comfortable people spend the night there we were able to get this study approved by... we had seven IRBs institutional review boards we had FDA approval but seven IRBs refused to approve the study there's 28 of these and I noticed that one of them the name was Copernicus and I figured if any IRB is sensitive to politics over science or religion over science it would be Copernicus and so I just ran and sort of picked them and they ended up being true to their name and they approved the study we've done the first study was 20 people and they ended up having PTSD in average of 19 years and after our treatment over 80% of them no longer had PTSD it was fantastic these were mostly women survivors of childhood sexual abuse and adult rape and assault but then we did a long term study an average of three and a half years after treatment and found that the results were durable over time and so something has fundamentally changed and it lasts doesn't mean it lasts for everybody, few people relapsed but life keeps presenting trauma but on average it lasts and then we did a study in Switzerland that we also published and while the Swiss results were more about reduction of symptoms and about cures as in the US someone who we didn't even know analyzed the data and sent in a letter saying that if you look at effect size which is a different statistical method than statistical significance which is the one what we really need at this stage that it had a large effect size and it was the same as our US study and this is the results from our study with veterans and the surprising thing here this is at the midpoint 12 out of 24 subjects we're getting tremendous results the low one on the right hand side is the 30 milligrams so that's showing that at 30 milligrams there's not much confusion but there is virtually no therapeutic effect and the big surprise here is that the middle group that had the most reductions was the 75 milligrams doing better even than the 125 so there may be something about the feelings of euphoria the good feelings that people get that might be slightly distracting from the actual work of therapy we're not so sure if this is going to hold up once the whole study is done but that's been the surprising finding now why does this all matter I've only got three slides left and you know Ethan talked about support for marijuana legalization this is a chart of the last 40 years and this is public opinion about the legalization of marijuana and I don't have a pointer that there was a lot of support high up in the 70s right after the psychedelic 60s and then it diminished it stayed the same the 70, 73, 73 the line on the top is against that's okay okay great so right here is where the drop starts the drop of opposition and this is where the support for legalization about a year and a half ago two years ago is where it crossed the 50% mark so what happened right here in 1996 that was California and the state of Arizona passed medical marijuana bills and in the current elections with legalization of marijuana in Colorado and in Washington there was a poll that was done preparing for these and it showed that the most important factor that would predict whether somebody was in favor of legalization was not whether they used marijuana themselves that's what you would think it was whether they knew a medical marijuana patient and that's direct information about something that they would trust rather than all of this propaganda that they've heard so I think the medicalization will in effect contribute to changing attitudes sufficient to move us forward in other policy reforms and there's also a human rights issue this is the Nick and Susan Pritzker have of the Libra Foundation and they have their focus on human rights and they decided would ending the drug war fall into their human rights mission and through discussions with Ethan and myself and people from LEAP the law enforcement against prohibition they decided that ending the drug war was part of their human rights mission and I think the long term reason why I've committed my life to this since I was 18 years old to become a psychedelic therapist and researcher is the political implications of the mystical experience and I think that's really why this is for me so important this was a book by Robert Bueller who as I said was the assistant secretary general of the UN he was like the mystic of the UN and what he said was that we have the UN to help mediate conflicts between countries but a lot of those conflicts are religious based and if we can help people move from fundamentalism towards mysticism and he noted that the mystics of the religions have more in common with each other than they do with the fundamentalists of their own religion that then we'll have more tolerance more appreciation for the other less demonization, less scapegoating and then we can have a more peaceful world so that I think is the vision beyond medicalization into sort of widespread cultural mainstreaming of psychedelics is that hopefully we will build a base of consciousness of people that will then support the continued and growing globalization of the world and hopefully this global mysticism so that's our process thank you very much