Slowly but surely, we may be reaching success in a determined and long-time legal effort to unleash the curative powers of psychedelic drugs in America. There is a tremendous need for alternative approaches to the existing models of drugs and therapy. Tens of thousands of soldiers have returned from wars in Iraq and Afghanistan with symptoms of PTSD. Many alcoholics and drug addicts fail to find success in 12-step programs. Research shows that psychedelics have the potential to help many of them, as well as the victims of rape, molestation and family violence.
But for years, scientific inquiry into the curative powers of psychedelic drugs has been blocked by political fears, the result of drug hysteria generated by anti-drug forces, law enforcement and Nancy Reagan's "Just say no" campaign. Many industries, particularly the pharmaceutical and alcohol industries, and in some cases the prison guard unions, have employed a phalanx of well-connected lobbyists to protect the financial interests of their clients, regardless of the negative effects on the rest of us.
There was a time in America when scientific research was not so hindered by politics; when elected officials didn't constantly look over their shoulders, fearing conservative attacks of the lowest common denominator. Those "good old days" were the 1960s, when relatively unfettered research begin to tell the promising, occasionally startling story of the profound potential of drugs we refer to as psychedelics, or hallucinogens. Some are part of natural ingredients, while others are a product of creativity in the laboratory.
Most of these drugs we recognize by their common names: LSD, psilocybin, MDMA or ecstasy, ayahuasca, Ibogaine, and other lesser known concoctions. And we shouldn't leave out cannabis, as there is much research as well as anecdotal evidence of how marijuana can help users.
Back in the '60s, thanks to lab workers, doctors, chemists, and adventurers, many psychedelic drugs escaped from the labs and found their way into wider use. These drugs moved into the culture because they were mysterious, pleasurable and caused profound introspection. They spread first to elites around universities and in urban areas, and then to artists and musicians and then to the kids, who rolled them out far and wide like a huge tribe of Johnny Appleseeds. They created an influential niche in the culture.
There was an explosion of creativity, cultural change, and of course, a few bad trips. Steve Jobs, the Beatles, John Coltrane, Jack Nicholson, Ram Das, Andrew Weil and many others experienced and shared their own personal magical mystery tours.
I came of age during this period. I experienced the excitement and the often eye-opening insights of the culture of drugs, music, and yes, social change. Like many, I thought we had seen the future, and it looked very bright. But we were so wrong.
This explosive cultural shift scared the shit out of the rest of the country. Scare stories and anti-drug propaganda were cranked out, excess highlighted, and before long virtually every one of these drugs was declared not only illegal, but profoundly so; drugs labeled Schedule 1, categorized as very dangerous and with no redeeming medical benefit, despite research that showed the contrary. Even pot, far less harmful than alcohol and most prescription drugs, was defined a "hard drug" in many parts of the country. In the past few decades millions of Americans have been arrested or thrown in jail for weed.
These drugs were pushed far underground, and some, like LSD, become almost impossible to find. Research into the properties of these drugs came to a halt. And that is the way it has stayed for close to 40 years, the so-called war on drugs dominating the American psyche, sowing fear and misinformation, and not incidentally, filling the prisons, helping to create the prison-industrial complex and protecting various vested interests as millions of people suffer.
But well below the radar, a small group of committed researchers, doctors and advocates did not give up on the potential of psychedelic drugs. Slowly but surely, over decades, they were able to convince the right people, at the right time, to embrace scientific values and fight against political hysteria. As a result, there has been tremendous progress toward bringing these drugs closer to legal availability, though the hurdles that remain are formidable.
Scientists in the US and other countries have been coming up with impressive findings. Sarah Seltzer, writing for AlterNet in late April, cataloged a number of success stories in treating alcoholism (in Norway), depression and anxiety. Research showed psychedelics may shut down active regions of the brain associated with depression. Ecstasy has been shown to help women who were abused or raped. It may help cluster headaches, which are so painful they are sometimes called "suicide headaches." Other scientific work has shown hallucinogens can give the dying a profoundly calming experience as they prepare for the end of life.
What follows is the transcript of a highly illuminating panel discussion from the bi-annual conference of the Drug Policy Alliance in Los Angeles late last year, where some of the world's foremost researchers in psychedelics described the history, process and results of their work thus far. I attended this workshop, and came away thinking how important it is for more people to know what is happening, so I decided to get a transcript of the proceedings for your reading pleasure.
Ralph Metzner: Welcome to this panel on review and update on current clinical psychedelic research. I’m Ralph Metzner. We’re going to hear from four people who are currently actively involved in various aspects of research on these fascinating and unusual substances.
First, we’ll hear from Rick Doblin, founder and executive director one of the most effective advocacy and public health education organizations that exists in this field, the Multidisciplinary Association for Psychedelic Research Studies (MAPS). He's been a friend and colleague of mine for many, many years.
And, then we will hear from Amanda Feilding, the executive director of UK-based Beckley Foundation, who sponsors research projects and meetings and policy initiatives in the United Kingdom. And then, we’ll hear from Dr. Charles Grob, a psychiatrist in the Division of Child and Adolescent Psychiatry at Harbor-UCLA. He's done some of the most interesting and progressive far-out research on psychedelics, including groundbreaking studies in the use of psychedelics in the final stages of terminal illnesses, as a preparation for the life beyond which, in my opinion, is one of the most significant areas of application, because it fulfills, meets a need in society that’s not addressed at all in any other way, because it touches into the spiritual dimensions, which science doesn’t want to recognize.
And it’s very significant to me, politically, that he’s been able to obtain official government approval and funding to conduct these studies, because these drugs normally are not approved. You only get to approve a drug for the cure of an illness, and these drugs do not cure this population's illness. These people are dying, and they’re going to be dead within a few months. So it represents a significant opening up of the medical establishment to recognize that certain drugs can be used to help prepare for something, and it’s not a designated cure of anything.
And finally, Bob Wold, who has made some startling and unexpected discoveries in the use of LSD and the treatment of cluster headaches and migraines.
So, we will start with Rick Doblin.
Rick Doblin: It’s really a pleasure to be here with Ralph. MAPS took its name in part from “Maps of Consciousness,” a book that Ralph wrote. Luckily, it had a P in it, so I could put in the word “Psychedelic.” But I thought of it, as far as maps of consciousness, maps of therapy, maps for social change, in a way, of how we integrate psychedelics into our culture.
I’m going to be speaking today about our drug development efforts. So, the best way to think about MAPS is as a non-profit psychedelic and medical marijuana pharmaceutical company. Our goal is to develop these medicines into legal prescription medicines.
And our role model … and I’m a little reluctant to talk about it, because it’s another controversial area … is the development of the abortion pill, RU-46, into a prescription medicine. Because that’s the first example of a drug being developed by a non-profit organization. And the reason for that was because all the for-profit pharmaceutical companies were scared of consumer boycotts that would affect their other products. So it was the Population Council that was started by John D. Rockefeller III, and funded in part by Warren Buffett, and by the Pritzker family and others that raised the money to develop RU-46.
So, what we have now is a similar kind of market failure, in that the psychedelic drugs and marijuana are off patent. They’re no longer possible to be monopolized by the pharmaceutical industry. So you could have what’s called composition of matter patents, which is when somebody originally creates the drug, and then you control all of its uses. MDMA, for example, was first developed by Merck in 1912, and patented in 1914, and has long since expired. LSD was developed in 1938, psychedelic properties discovered in ’43. And we could go on and on with psilocybin, with marijuana. All of these drugs are no longer possible to be monopolized.
Then there’s also what’s called use patents, where you can have a patent on a particular use, if you’re the first to discover it. The for-profit approach was tried with Ibogaine in the ‘80s, where Howard Lotsof patented the use of Ibogaine the treatment of opiate addiction. And, unfortunately, that has led to a whole series of lawsuits by people who thought that they had a profit potential, sued each other, and brought down the whole field of Ibogaine research. And now, fortunately, those patents have expired.
So, the market failure is that the pharmaceutical industry is not putting any money into this, because they can’t really make money. Also, these drugs are not like your normal money-making drugs, where you need to take them once a day or twice a day, and if you stop taking them your problems come back. That’s the ideal drug, from a pharmaceutical perspective.
Psychedelics in therapy are only offered a few times, and they’re not offered by themselves. They’re offered as part of the psychotherapeutic process. And all of these uses, now, are in the public domain. So, we actually have hired a patent attorney and have developed an anti-patent strategy, so that any new use that somebody comes up with MDMA, or any of these drugs, we post on our Web site, or elsewhere, so that nobody can claim a use patent.
Andy Weil sent me an account of somebody that he knew that had used MDMA, and his rheumatoid arthritis went completely away. We put that up on our Web site, so now nobody can get a use patent on that.
So, the pharmaceutical industry doesn’t see profit. The government agencies that normally fund health care research, medical research, are still stuck in the prohibition mindset, and they’re not that open to funding studies into therapeutic potential of Schedule 1 drugs. And then, the major foundations that support this research are also still a little bit too consumed by the controversy factor. So, the psychedelics and marijuana, if they are to become prescription medicines, they have to be developed in a non-profit context.
And so, MAPS is a non-profit organization that is trying to move these drugs through the regulatory system to make them into prescription medicines. It’s not to say that the medical application of these drugs is the only use. There are spiritual uses. There are personal growth uses. There are recreational uses. There are all sorts of a range of uses. But our culture is most open to the idea right now of treating medical illnesses. So, MAPS has been structured as a way to try to take the path of least resistance, and create legal context in a therapeutic setting, regulated by FDA.
And, what has been a tremendous benefit goes back to 1992, when Charlie and I were participants in an FDA advisory committee meeting, where the FDA was trying to decide whether they would open the door to psychedelic research or not.
Much work that was done in the ‘50s and the ‘60s, thousands of studies with psychedelics were conducted with very low level of harm, and with a lot of promise. But, out of the cultural turmoil of the ‘60s, there was a massive counter-reaction that both criminalized these drugs and took them out of the hands of scientists all over the world. And so, for several decades, it was impossible to get permission to do psychedelic research.
And what happened in ’89, ’90 was, a group of people at the FDA, who were experimenting with new ways to develop drugs into prescription medicines took over the responsibility for regulating psychedelics and marijuana. And they decided that they would put science over politics. So that, when we think of “the government,” it’s really important to recognize that the government is kind of like our body. There’s all these different parts of it, and some parts of our body could be doing things that other parts of our body are doing the opposite thing.
The government right now is composed of people at the FDA who, as a result of this 1992 meeting, decided that they would put science over politics. And, at this meeting was DEA, the drug czar’s office, NIDA. And it was a brilliant maneuver by the FDA, in terms of a bureaucratic power grab.
And what they basically said was that they would put the same kind of requirements that they put on the major pharmaceutical companies on psychedelics and marijuana. That there were no unique risks of psychedelics and marijuana that they didn’t already face in their work with opiates, or their work with methamphetamine, or their work with other drugs that had abuse liability. And they made it seem, to these other regulatory agencies, that if they opened the door to the research and imposed the same kind of requirements that is imposed on the pharmaceutical companies, that nothing bad would come out the other end. And so, the drug czar’s office, the DEA, NIDA, they signed off to this.
The non-profit organizations that we’ve developed have started getting more resources, more connections to scientists. And at the same time … and this is the key factor, it’s like the Aikido strategy to drug development … is that you use the opponents’ energy sort of against them. You let their own momentum, you know, turn back on them.
To the opponents, we could say here are these government agencies that have spent hundreds and hundreds of millions of dollars on what’s wrong with all these drugs. And that’s all information now in the public domain. Now, if you put in MDMA or ecstasy, you get over 3,500 studies that have been conducted at a cost of over $300 million. We’ve spent about $160,000 having someone read all of them, summarize them, and have developed what’s called an investigators brochure, so that we have phenomenal information on the risk profile of these drugs.
And, the other advantage is that these drugs have been used by tens of millions of people so that the FDA and other regulatory agencies around the world will know more about these drugs than any other drug they ever approve, because they approve drugs they’re used to having been tested with a few thousand people. And you don’t discover the one-in-100,000 risk, or the one-in-a-million risk of somebody overheating and dying. So we have a body of knowledge about the psychedelics and marijuana that is so extensive, and in many cases goes throughout thousands of years of history, that the risk profile is really well-known.
So what we mainly need to do is focus on studies into benefits in patient populations that we choose, and looking at risk profile in terms of those specific studies. So, somewhere in the neighborhood of $10 million is what we’re estimating it will be required for us to develop any psychedelic or marijuana into a prescription medicine. But that’s only because there’s hundreds of millions of dollars already spent on risk profile.
And it’s only because we have a regulatory agency that is still willing to put science over politics. The main way that the FDA has been politicized is in women’s reproductive rights. And so, once you get a drug passed through the research stage, and you’ve proven safety and efficacy, you still have to get it approved by the highest levels of the FDA. That’s where politics might come in. But we have basically a politic-free, open science for the next decade in this area. So that’s the basic context.
So then, what we need to do is pick, what is the most likely psychedelic and the most likely patient population, from a strategic point of view, that we can take through the system? And for a variety of reasons, I feel that it’s MDMA. It’s gentler. It’s shorter-acting. It reduces fear. And it has really clearly defined therapeutic potential. And, at the same time, our treatment method suggests that the therapists who would be administering these substances would be more effective if they had tried them themselves.
And to show you how far we’ve gotten in our relationship with the FDA, we have proposed that to the FDA. We said, we want to be training a bunch of therapists, and we need to be able to give them an experience with MDMA. But, because it’s an illegal drug, the only way we can do that is in the context of a protocol. And so, we said to the FDA, here’s our protocol for treating therapists.
And the FDA said, you know, you’ve made your main point, that this is important for your training. But we can’t just give you permission to give MDMA to therapists. But if you can do a double-blind, placebo-controlled crossover study that gathers legitimate information, we’ll let you limit who can be in it to people in your training program.
So, we’ve done that. And we’ve even got DEA and an Institutional Review Board to sign off for that, and we’ve already treated the first therapist, subject, who’s come over from Israel, and we’ve got another one coming in December and another one in January. So we can take people from all over the world and train them in this way.
So, what we’ve done, then, is also identified the patient population that we most want to work with, and that’s veterans. Or, women survivors of childhood sexual abuse, and adult rape and assault. So, these are patient populations that people are sympathetic with. They have post-traumatic stress disorder. It’s a national crisis. And MDMA is ideal for that. So we’ve picked MDMA for PTSD.
We’ve completed the first study that was published in the Journal of Psychopharmacology, a small pilot study with 20 subjects. And what we showed is that people who had post-traumatic stress disorder for an average of over 20 years, and who were treatment-resistant, had failed on pharmacotherapy and on psychotherapy, that, after our treatment with MDMA-assisted psychotherapy, over 80 percent of them no longer had PTSD. So it’s a remarkable situation.
And, what we’ve just done, and what I was working on the plane coming here, and yesterday a little bit, is that we have now done a long-term follow-up study of the people in our initial study. So, the results that I just proposed to you were after two months.
And, what we’ve now done is an average of 41 months … after almost three and a half years … we re-interviewed these people. We got 16 out of the 19 who got MDMA to fill out the CAPS, the Clinician-Administered PTSD Scale. And what we’ve shown is that, on average, the treatment benefits have sustained over time. They’ve actually gotten slightly better.
But something fundamental changes when they have gone through this therapy, and it lasts. Now, a few of these people have relapsed, and have PTSD again. You can’t prevent people from having lives that present them with trauma and stressors. So we’ve gone back to the FDA, and we have a new protocol now, where we can give one MDMA session open label … meaning that it’s not a double-blind study … to people who have relapsed in our study. So we’re thinking that we’ll be able to sort of help them back with just one session. That’s what we’re going to investigate.
We’ve conducted a study in Switzerland that we’re working on the results right now, and the results there were about half as powerful as the results in the U.S. We’re trying to figure out all the reasons why, but it’s still better than Zoloft and Paxil, the drugs that are approved. So that, even that study is enough to move it through the system.
And now we’re doing a study in the United States. The first study was mostly women survivors of childhood sexual abuse and rape. Now we’re working entirely with veterans, mostly from Iraq and Afghanistan, and a few from Vietnam. And we’re getting excellent results there.
And we’re about to start a study sometime soon in Canada. We’ve been working three and a half years to get permission there. We’ve got another study in the U.S. that we’re starting […] And so, we’re going to be pairing, in the male/female team, one will be a trained therapist. The other will be an intern, who’s learning to be a psychologist or a psychiatrist or a social worker or a nurse. And they have to do all these free hours. So we’re going to give them credit in working on their free hours.
So, there’s a series of questions that we need to address in these Phase 2 studies. These are all small pilot studies. And then, in a couple years, we’re going to have what’s called the end of Phase 2 meeting with FDA, and that’s where you present your design for the large-scale Phase 3 studies. And if they agree with that, then you march that out, and that takes another five, six years. And that’ll probably be about 600 subjects, we’re guessing.
We have to figure out the magnitude and the variance of the effect in order to size these studies. We have to figure out if the cause of PTSD is related to our treatment, which we think it’s not. We have to figure out how to train therapists. We have to figure out how to do a double-blind study. That’s one of the biggest issues that we’re trying to figure out. And so, that’s where these Phase 2 pilot studies are going. So our main focus is MDMA, PTSD.
We’ve just completed the first study with LSD in over 35 years, in Switzerland, which was LSD for end-of-life. And we’ve gotten good results. Eleven out of those 12 people had never done LSD before. And, so we’ve shown safety. And we didn’t get significant results, but we got a good trend toward safety.
And this is the very last thing. We’re also doing work with Ibogaine and ayahuasca in the treatment of addiction. Observational studies. And we’ve tried to do a marijuana post-traumatic stress disorder We have FDA approval. And NIDA, the National Institute on Drug Abuse, that has the monopoly on the marijuana, won’t sell it to us. So we’re still trying to work through that.
Amanda Feilding: Hello. My name’s Amanda Feilding. I’m the director of the Beckley Foundation, which is a charitable foundation I set up in 1998, with the purpose of discovering what is the neurophysiological explanation of changes in consciousness, and how, by increasing our understanding of how they work, can we use them to the benefit of ourselves and mankind. It’s a very fascinating topic, and I also concentrate on how to change global drug policy. But, of the two, I find the science very much more exciting.
So, my first move was to get 10 very distinguished scientists to come onto my advisory board. And, since then, I’ve worked in two different directions. One is in collaborating and initiating clinical study. And the most exciting one happening at present is with Roland Griffiths and his wonderful team at Johns Hopkins, which is a study, the first study, to see how, with the aid of a psychedelic … i.e., in this case, psilocybin … treatment therapy can help the overcoming of an intractable addiction. And that is, in this case, nicotine. And so far, four patients have completed the research, and all four are nicotine-free. Two of them one year later, and the other two six months later.
Now, this is a small study, without sufficient double-blind placebo. So, it’s an indication more than a strong scientific study. But the indication is quite excellent, because no addiction treatment has ever got such a high success rate. And we are hoping, by completing this study, then to go on to a much more advanced and expensive study, where we have a double-blind.
So, on the other side, my interest is in discovering how these substances work. Because I think that’s the best way of overcoming the taboo on this category of substances, and also knowing with sureness why they are useful in the different areas. And, for many years, I looked for suitable scientists to collaborate with, and had one or two efforts, which, sadly, didn’t produce fruit.
But now I’ve got an extremely good relationship with one of the top neuropsychopharmacologists in England, called Professor David Nutt. And we’ve started the Beckley Foundation Imperial College Psychedelic Research Program. And that’s been running for two years now, and we are just on our third study. And, the first two have produced some extremely interesting and unexpected results.
I, for one, always thought that the action of a psychedelic was dependent on an increase in blood supply to the brain, which is allowing billions more brain cells to function, and thereby explaining the expanded sense of consciousness. To my surprise, this research has showed exactly the opposite. It showed a decrease of blood flow to the brain.
And, what is specifically interesting is, it shows a decrease in this essential network of centers called the default mode network, which it is hub centers, which have the most connections. So they are the controlling centers in the brain, equivalent in Freudian language to the ego. And, in the psychedelic state, they are the centers, which lose the most blood supply.
And so, how does a psychedelic experience happen, then? It happens by reducing the constriction on sensation, experience. So, suddenly, we are flooded with perception, which is normally repressed. And that explains why one has novel and creative insights on a psychedelic, or can have. And also, why they’re so important in psychotherapy.
One of our most recent studies … and in these studies, we’re using the very, very latest brain imaging technology of FMRI, ASL and BOLD, and also now MEG. So, I don’t think any other studies in the world are using these technologies combined. And with this, we are really getting a wonderful map of how they work.
And what has come out of this study is clear new evidence of why psychedelics can be used in the treatment of depression, by reducing blood flow to center, which is normally overactive in depression. And also the same for cluster headaches.
Also, another study we’ve done shows why it is helpful in psychotherapy, because it gives memories more vivid visual and auditory input. So, they come to life much more than without a psychedelic. So, the subject can re-live the traumatic or happy experience in a much more deep and meaningful way, and then help clear it out.
Now, most people are rather bored by brain imaging studies. But, actually, I think they are like wonderful artworks, which demonstrate how these substances work in a way that no one can argue with. And we’re going to continue our studies. We’re just starting one with MDMA. Later on, we’re starting one hopefully with LSD, which is actually the kind of pivotal point of what we’re wanting to do. And so, that is one very pleasing aspect of where the research at Beckley has gone.
We’ve also been doing quite a lot of studies with cannabis, particularly with cannabidiol (CBD) and THC. And, showing the very high antipsychotic principles of CBD. And this, in turn, demonstrates why it is so essential that we have a regulated market, with labeled production, so that in England, the street cannabis, is extremely high in THC and zero CBD. And that’s why, in England, there has been quite a big increase in psychological problems from cannabis. So, with this research, we’re showing not only why it’s so important to have a balanced mix, but also the fact that CBD could be a very valuable medication for neurosis and psychosis.
We’ve also done a study with cannabis and creativity, using 160 participants, in which we take measures of CBD and THC and also measures of the subjects’ schizothyme and genetic makeup. And this has shown interesting results in the test of creativity, although these tests are very insufficient.
And we’re just starting one at Oxford University, with cannabis and pain. So, I hope to produce, through this research, a body of information which will back up the therapeutic use of these substances.
Charles Grob: My name is Charles Grob. I’m a psychiatrist. I work at Harbor-UCLA Medical Center. I’ve had a longstanding interest in the potential psychedelics might have to ameliorate pain, suffering, and to be incorporated as part of medical treatment models.
Long ago, when I was young, I had opportunity to become acquainted with the medical and psychiatric research literature on psychedelics, during the 1950s and the 1960s. At that time in history, psychedelics were really the cutting-edge in psychiatric research. They held great promise for understanding the brain, the mind-brain interface, helping us to understand mental illness. And they certainly held the promise of new and novel treatment models, particularly for conditions that were not particularly responsive to mainstream treatments.
Considerable advances were made, including the major pioneer work establishing the circuitry of particular neurotransmitter systems in the brain, specifically the serotonin system. So, it was very exciting, active area, which was abruptly shut down by the late ‘60s, because of the cultural reaction. The compounds got out of the labs, got out of the treatment settings, made their way into the culture, became particularly popular among young people. And, arguably, there were some mental health issues. There may have been a mental health crisis. But there was also an environment of panic and fear, and a need, the authorities, to shut down further work in these agents — these agents, which many would consider to be catalysts for change.
And so, for decades, there was virtually no investigations, at least in human subjects. Nevertheless, I went to medical school with the intention of someday being able to study these compounds. I did not anticipate that it would take as long as it did. But, around 1990, I met Rick Doblin, and we discussed our mutual interest in the potential value these compounds might have for medicine, and a need for new research.
And in ’92, I got permission from FDA to conduct the first Phase 1 study to evaluate the effects of MDMA in adult normal volunteers. Our original hope had been to conduct a terminal cancer anxiety study, but at that point, no Phase 1 study had been conducted. So, FDA redirected me to rewrite my protocol for a Phase 1, which I did, and we did successfully complete our study in 1993, ’94 and the beginning of ’95.
Psychologically, all of the subjects did quite well. In fact, extremely well. Although, I did have one problem with the chief nurse on the research unit, who came to me one day complaining that her nurses were spending too much time with my patient, or my subjects, and neglecting their other patients in the unit. I think they were picking up the contact high, and our subjects just had a phenomenal interest in the lives of the nurses, and wanted to hear their stories. They were just so empathic, it was very moving. But, the nurses had to be redirected out of the room at times.
Also, in the early 1990s, I had a remarkable opportunity to conduct a research with the Amazonian plant hallucinogen decoction ayahuasca, in the Brazilian Amazon. My friend Dennis McKenna, the ethnobotanist and pharmacologist, had made a valuable connection with some leaders in one of the Brazilian syncretic ayahuasca religions, Uniao de Vegetal, union of the plants, the UDV. And, Dennis had pitched the idea of a medical research study. The masters of the UDV were very receptive, and Dennis called me into the project, and we went down, along with James Callaway rom Finland, and our chief collaborator in Manaus, Brazil was Glaucus de Souza Brito
And we did what is really the first examination of the physiological and psychological effects of ayahuasca on long-term users, on members of this ayahuasca religion (UDV). We found these were very high-functioning individuals. Although, interestingly, they were not always that high-functioning. Many of our subjects, prior to their entry into this ayahuasca-using religion, had had serious problems with mood dysregulation, substance use and abuse, addiction, alcoholism, some antisocial behaviors, and they had all remarkably transformed after their entry into the UDV and their participation in twice-monthly ayahuasca sessions.
Now, of course, all religions can point to their success stories, their transformations. But we did think it was quite extraordinary that this particular religion had permission from the Brazilian government to utilize a very powerful plant hallucinogen decoction as a ceremonial sacrament. And we felt that this had an enormous impact on these individuals’ transformation.
I remember, one evening, I was invited to attend a ceremony, and the structure of the UDV was that, for the first hour, there’s music played. For the next couple of hours, the master will sing one of their songs, usually about the beauties of nature, or about their mythology. Then, individual members of the congregation will ask permission to sing a song. And then there’ll be a sermon by the mastery, and then questions or comments by members of the congregation.
Toward the end, there was a very active dialogue going back to the master, various members of the congregation. And my Portuguese wasn’t that good, and my interpreter had kind of lapsed off into silence. But I felt, I really need to understand what they’re talking about, because this really might help me understand, you know, the gist of this religion. And so, I asked her, “What were they saying?” And she says, “Oh, what they’re saying is how important it is that if you say you’re going to be someplace at a certain time, you be there.” And I was like, whoa. This is extraordinary. I mean, South America. You know, people … relative attitudes toward getting places on time.
And these people, you know, some had started off kind of the lower rungs of society. They were, across the board, the most functional members of the society, the pillars of the community. And I felt this was important.
I mean, when a hallucinogen is administered, individuals experience a powerful state of hyper-suggestibility, and here they were getting a message of, be responsible. Be good parents to your children, good children to your parents. Be good employers, or good employees. Be responsible out in the world. They were hearing these messages in a profoundly altered state, and they were incorporating it in their very marrow. So, I was very impressed.
In the early 2000s, I went back to Brazil with my colleague, Marlene Dobkin de Rios, and our colleague in Brazil, Duarte Da Silveira, and we conducted a study at the request of the Brazilian Judiciary, to evaluate the functional health of adolescents whose parents belonged to the UDV, and who were accompanying their parents to religious ceremonies, utilizing ayahuasca as a psychoactive sacrament.
And I can just say, these kids were extremely high-functioning. We had a match control group, and very impressive kids. Some of these kids had been actually exposed in utero, because in the UDV, the mothers often participate in ceremony during pregnancy. I was even told they sometimes take it in labor and delivery. I’ve seen babies baptized with an eyedropper full of ayahuasca. And, you might be concerned about teratogenic effects, neurotoxicity. That did not appear to be the case, at least with the kids I observed and evaluated. These were very high-functioning kids, in every parameter we looked at.
Now, in the early 2000s, I developed a new study at Harbor-UCLA. This was in collaboration with my colleagues at the Hefter Research Institute. We’re kind of a parallel process to MAPS, helping to develop research studies with psychedelics, helping to find funding.
And, with the encouragement of my colleagues, I put together a protocol design to utilize psilocybin, the active alkaloid in hallucinogenic mushrooms, to treat individuals with advanced cancer who had overwhelming anxiety. And, together with my colleague Alicia Danforth, we’ve studied a series of subjects. We’ve found very impressive response in regards to reduction of anxiety, improved mood, improved quality of life. We put together our manuscript and submitted it to the number one impact journal in psychiatry, the Archives of General Psychiatry, and we were very gratified that our manuscript was accepted for publication and was published in the January 2011 issue of the Archives of General Psychiatry.
So we feel that we’re bringing this field back into the forefront of psychiatry, and we certainly need to consider that, whereas modern medicine, modern psychiatry, has made sizable advances, there are still patient populations that do not respond well to conventional treatments. These compounds, when used wisely, when utilized under optimal conditions, I believe hold great potential to facilitate healing, to ameliorate suffering. And I think we really are at the threshold where more of this work will be possible.
I will say that I feel our studies, and other studies, have demonstrated feasibility, that we are able to get regulatory approval. And there are a number of levels of regulatory approval we have to go through. Perhaps the greatest stumbling block, and the rate-limiting factor for more research getting on board, is funding. So that is always a challenge. National Health Research Funding does not identify this as a priority area, so we have to raise everything privately. So, anyone has the urge and a handy checkbook, I’m available after the talk. We’ll talk.
Let me just mention also, with the Heffter Research Institute, some of the other very important work that’s going on. Franz Vollenweider at University of Zurich is running the world’s leading laboratory, looking at effects of psychedelics on the brain, in normal volunteers. It has some phenomenal state-of-the-art brain imaging work on a series of different psychedelics.
Let me mention also, the very, very critical work of Roland Griffiths at Johns Hopkins. Amanda mentioned Roland. Roland has done a series of studies with psilocybin, establishing that, under optimal conditions, it may reliably induce a psychospiritual-level experience, a mystical epiphany.
And this is significant because, if you go back to the very valuable research done in the late ‘50s and the ‘60s, you find that, with many of these studies, the variable that was most predictive of positive therapeutic outcome during the actual psychedelic session was that individuals had a transcendent, transpersonal, mystical level experience. This seemed to predict therapeutic outcomes. So Roland’s work is establishing that with optimal conditions, optimal preparation, optimal structures, you can reliably predict this.
So, for treatment work, Stan Grof and others in Maryland in the ‘60s demonstrated this was the case with the terminal cancer anxiety patients. Best outcomes were those with mystical level experience. Researchers going back to the ‘50s, working with alcoholics, found that the best outcomes were those who had a mystical level, a mystical-medical experience. This is extraordinary work.
Let me mention just briefly, in regards to the treatment of alcoholism, which remains one of the scourges of our culture, one of the most challenging areas in all of medicine to treat. If someone came into our office today, said, “I’m an alcoholic,” we would do the same thing our colleagues did 50 years ago. Suggest they find a 12-step group and hope it’s a good fit. Because we don’t have a whole lot else to offer.
Going back to Humphrey Osmond and Abram Hoffer’s work in Canada in the late ‘50s, they had extraordinary success in demonstrating, particularly in individuals who had this psychospiritual level experience, that they could establish and maintain sobriety for many years.
Now, to that end, let me mention a new study that has been funded by the Heffter Research Institute that’s now in the planning stage. We’ll be at the University of New Mexico with an addiction specialist, researcher, Michael Bogenschutz, designed to look at the treatment of chronic alcoholics with a psilocybin treatment model. This will be the first study looking at this patient population with a psychedelic drug in many, many decades. So this is a great advance for the field.
I think it’s really important that we also pay tribute and acknowledge and honor our predecessors, the researchers in the ‘50s and ‘60s, some of whom, like Stan Grof, are still around. Their work, I think, has been inspiration for all of us up here, and for our colleagues in the field. And it was really a tragedy that cultural conditions, political conditions, forced their valuable work to be shut down for many decades.
But now we’re getting things up and running again. We’re demonstrating feasibility. We are very importantly demonstrating effective safety parameters. You know, without safety, we really can’t move forward. But we’re establishing safety. We’re conducting them under optimal conditions. Younger investigators are expressing interest in joining this field. And it is my hope and my expectation that, as we move into the future, we’re going to see significant additional advances into this very exciting field.
Bob Wold: Hello. I’m Bob Wold. I started Clusterbusters about nine years ago, and I’m going to try to make the last nine years flash before your eyes in the next 15 minutes. First thing I want to do is thank Rick Doblin. It’s an honor to be on the same stage with him. He’s been instrumental in all the work that we did. He really helped us get going. And, without him, we probably couldn’t have done more than the entire medical community has done in the last 40 years for people with cluster headaches.
The first thing I should do is explain what it is that we’re trying to treat, so that you can see the importance of the work. We’re working with something called cluster headaches, and a lot of people probably don’t know what they are. They are similar to migraines only in the fact that they’re on one side of the head. But I think that if you see what’s going on here, you’re going to see the importance of this work, and how desperately we do need reform.
This is a short video of a friend of mine. His name is Chuck. He allowed himself to be videotaped. This was a couple of years ago. He’s in a hotel room. The only reason that he’s with somebody that’s holding him down was because the only reason he would allow to be filmed was if somebody was there with him that would stop him from tearing up the room and pounding his head on the walls, trying to knock himself out, which is what he normally does.
You see a green tank there. He’s breathing pure oxygen, which is one of the treatments that is available, which … it doesn’t stop the attack, but it may shorten it from 45 minutes or an hour down to 20 minutes, in some instances. But this is … you can see it’s a little bit different than a migraine.
There are approximately 400,000 – 500,000 people in the United States alone that have this condition. Last year, National Institutes of Health put zero dollars towards research for cluster headaches.
At one point, Chuck was institutionalized, because the doctors could not believe that anyone could have this much pain without actually faking it. So the medications that he did have, and the oxygen that he was using, was taken away from him, and he was put into a psychiatric hospital for three months, until he finally convinced them that he actually did have a physical condition that was causing this problem.
We desperately need reform. Friends of mine are dying from this condition. And one of the main reasons they are dying from it is because they do not have access to LSD or psilocybin. And I think that that’s important for the reform movement. If you’re looking for a physical ailment that is treated with psilocybin or LSD, I think you can see one right here.
It’s a little difficult sometimes to explain to people about treating something like post-traumatic stress. If they’re sitting in a room, you don’t really see it, unless you’re there and you’re talking to them. You can’t walk into a room with somebody that’s suffering from a cluster headache and not know he has a cluster headache.
This is a list of the medications that the medical community offers to people This is the list that I was on for the first 20 years that I had cluster headaches. There’s approximately 75 of them here, and I use them in many different combinations. And there’s some fairly powerful drugs here that really did nothing at all, other than dull the pain in some cases, or make me forget a week. In some cases, that actually happened.
But this was the list, and one of the interesting things on this list was, they did prescribe me cocaine drops at one point, which were used to try to deaden the nerves in the back of the sinus cavity.
We also try a lot of different alternative treatments. So, if anybody out there is thinking that, “I’ve got an acupuncturist that I think can help you,” believe me, you don’t. It’s not going to help with cluster headaches. And, last thing I want to do is walk up to Chuck and ask him if he’s actually tried the Extra Strength Tylenol rather than the normal Tylenol.
What’s available at this point right now, and where the medical community is really going is toward surgeries, because all of the medications that they’ve tried over these years do not work. And at one point, I was approved for three of these operations. But the latest one that they’re looking at right now is the deep brain stimulation, where they drill a hole in the top of your head, put electrical wires down into the deepest part of your brain, into the hypothalamus, and send electrical currents through those wires. And there’s a battery pack inserted under the skin in the back.
The biggest problem that I see with these types of treatments for people is, normally when the people go into the hospital or to see their doctor, when they’re offered these treatments, they’re told, this is the cutting-edge. This is the last thing we’ve got to try for you. The problem is that these don’t work either.
The suicide rate, it’s difficult to find good numbers on it, because there, once again, isn’t a lot of research on cluster headaches. But, the last small study that was done, looks like the suicide rate for people with cluster headaches is approximately 200 times the national average, Personally, I’ve had six friends of mine that have committed suicide in the last two years. None of them had access to psilocybin or LSD. Some of them that could have gotten it were on medications that they couldn’t stop using before they just gave up to try one more thing. I mean, if you look at a list of 75 medications that they may have already tried, just learning about one more thing, you know, it’s difficult to believe that that’s going to work, especially if somebody tells you, “Well, you ought to try some LSD next time you get a headache.” It really doesn’t work too well.
What we came up with was a treatment to treat the cluster headaches that actually was discovered about nine years ago by somebody in Scotland, who had cluster headaches. He did some recreational LSD at a concert on a summer, and his cluster headaches stopped completely and he didn’t have any clusters for six months. And that was the first time he had gone six months without a cluster in years. So he got on the Internet and started asking questions about if anybody had heard anything about LSD treating cluster headaches.
So, some of us started doing some research and found out that there was a lot of work done on this, originally by Dr. Hoffman. He was looking for migraine and cluster headache treatments when he was working with LSD And all of that was buried at that point, when LSD was banned.
What the people need to do is, the first thing is to stop all of the prescription medications that they’re on. This is the biggest hurdle for people, doing this detox from the prescription meds, because even though they may not be helping at all, to give up that lifeline that they have to try something that somebody on the Internet told them to try, it’s a big leap. But that’s the first thing they need to do, is stop those medications. Then, usually, do three treatments of LSD or psilocybin. And it normally will completely break the cycle.
If people are in between cycles and they do a couple of doses, the next cycle may not even start. I’ve been using this for nine years. I used to have two cycles a year that lasted three or four months each. And I’ve had three cycles that actually started over the last nine years, because of the treatments that I’m using. And all three of those that started, I allowed to start so that I could try a different treatment here. Somebody has to test the LSD and other things like that, so.
When I first tried the psilocybin, I was on 15 prescriptions at that point. I stopped all of them, found a package on my front doorstep that had three grams of dried mushrooms, and I tried those and I haven’t looked back since. So basically, that’s a one-year supply of medications for my headaches on the bottom picture, and that was a one-month supply, on the top picture. So you can see, I’m saving insurance companies a lot of money.
The success rate of this, that we looked at with the first 200 people that tried this — and nine had tried LSD, because it’s very difficult to find, as a lot of you probably know — but a lot of people were able to grow their own mushrooms. So we’re looking at a 95 percent success rate on LSD on those first nine people. And 80 percent of the people that tried the mushrooms broke their cycles completely.
And you have to remember that these people that tried this were the worst cases. I mean, this is the last option for people. I mean, it’s a big leap for a 50-year-old carpenter to try LSD for the first time. So, all of these people that are doing this have tried everything else the medical community has to offer, and it hasn’t helped. So, we’re really helping 80 percent of the people that the medical community has no help for at all.
And people now are using the lysergic acid amide (LSA) seeds. The success rate is a little bit less than the LSD, but I think that it’s probably because they’re using a lower dose, and it’s a little bit harder to get the right dosage with the seeds.
The kind of stuff that just keeps us going with this is like a letter from Alex in Italy. And he was reporting about himself and another person, two guys had serious improvements after seeds. And one of them is in remission for three weeks. They were both chronic, meaning that they had those headaches that Chuck had there probably six or eight times a day, every day, all year round.
There are two types of cluster headaches. There’s a chronic, where you have no breaks, and there’s an episodic that may last three or four months, and then you get a couple months break. And in this case, this was somebody that the doctors were trying to get him to use the deep brain stimulation, and once again, he tried the seeds as a last resort, prior to the operation, and it worked. So. We kept at least one person off the operating table.
This is a list, a chart, that probably most of you have seen here. But, it just shows that, you know, how safe these drugs are. And if you compare them to the medications that are prescribed for this, it’s incredible, the differences. Most people with clusters, after they’ve had them for 10 or 15 years, they’ve got quite a bit of built-up problems from the medications. They’ve used a lot of steroids, so their vascular systems are destroyed. Lot of hip replacements. Lot of broken marriages. Yeah, it’s not good.
It's important to weigh the similarity between psilocybin and LSD to serotonin, which is involved in starting off the cluster headache. Most of the treatments that are available for clusters aren’t quite as clean as LSD and psilocybin, in that they attach themselves also to the heart, where the serotonin also goes. And, psilocybin and LSD has no effect on that. And so, in most cases, there are a lot of people that can’t take things like Imitrex, which are also used to treat migraines and so forth, because of heart problems. But it would be much better for them if they were using LSD.
What our research led to was, we discovered that bromo-LSD, which has been around since 1957, is also very effective. And, we wouldn’t have been able to find this without doing research on a psychedelic. And I think that this is an important argument that reform people could make, is that, you know, if you do the research with psychedelics, it’s very possible it can lead to other things. I mean, the first chemical that you start working with may not end up being the last chemical, with the best results.
We had five people that took BOL, took three treatments, and when they finished their three treatments, the headaches were gone. All the other treatments that people are using, they’re having to use them every day, and without the breaks. What we think is going on is epigenetics. And that’s what we’re trying to find where we’re at there.
The last thing with using the psychedelics is that we found out that people are also treating post-traumatic stress that is caused by the cluster headaches, and those numbers have been cut by, like, 48 percent, and they’re no longer reaching the numbers of being diagnosed with post-traumatic stress.
Ralph Metzner: Well, that’s fantastically interesting demonstration. So, thanks very much for that, Bob. And something I have never experienced, and hope to never experience.
So, we have only a few minutes’ time left for discussion
Rick Doblin: Okay. In case everybody didn’t hear the question, it’s about what are the stages of research, and what numbers of subjects do you use at each stage? So, Charlie described how we worked with a Phase 1 study to start with. And so, Phase 1 studies can be relatively small. Depends on what other safety information you have. And they’re not in patient population. So you start out in healthy normals, and you just characterize the drug, and you characterize some of the safety issues.
Then you do the Phase 2 studies, and the Phase 2 studies normally have, you know, 12 to 40 or so subjects. Most of ours now are 12 subjects or 16 subjects or 20 subjects, something like that. And you have to answer a whole series of methodological issues.
And none of these studies actually count, in terms of making the drug into a prescription medicine. Those are only what are called the Phase 3 studies. So, the statistics will tell you if you get statistically significant results, even from small numbers. And when you do, that tends to tell you that something really profound is going on. Because a lot of the pharmaceutical company studies, they get statistical results with hundreds or thousands of patients. So the more numbers of subjects you have, the easier it is to find significance, even with a smaller kind of effect.
And so, it’s all of these series of Phase 2 studies that we need to do that will help us size the Phase 3 studies. And that’s where I’m saying before that we’re estimating. And you need two large-scale Phase 3 multi-site studies. Each of them, we predict, will have around 300 subjects, for a total of 600.
So, this is the way that the FDA wants you to do it. It makes total sense. And, you know, from a strategic point of view, you can do too many Phase 2 studies. At some point, you don’t need to do anymore. It doesn’t help you. And you can also do too large of Phase 2 studies. Because you don’t want to just get the information on, what’s the safety profile in this particular patient population? What’s your method? How do you do double-blind? How do you train your therapist? Things like that. So that’s the basic process.
And then, sometimes now, the FDA has developed what’s called Phase 4 studies. And then, what that means is that they will permit you to market the drug. So you get approval to market the drug, but then there are some questions that haven’t been addressed, like for example, if we do MDMA for post-traumatic stress disorder in adults, what does it do in children? You know, there’s childhood sexual abuse. Why wait 20 years? Or why wait ‘til they’re adults? And then, you have a series of Phase 4 studies that you can do after you’re already marketing the drug. So that’s the basic process.
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