A Therapist Responds to the MDMA Imbroglio
It has been a long haul for MDMA since it was criminalized in 1985. As its potential FDA rescheduling approaches, there has been a sudden hullabaloo of negativity, false claims of risks, and undeserved criticism of the studies by MAPS, the Multidisciplinary Association for Psychedelic Studies, and MAPS PBC, the independent Public Benefit Corp., now morphed for MDMA commercialization into the entity known as Lykos Therapeutics.
The sudden barrier to MDMA’s approval for prescription arose with a hearing by an FDA Advisory Committee whose ignorance of MDMA is astounding. From that testimony by multiple detractors who for various and sundry reasons challenged the 25 years of stringent FDA-supervised and approved work conducted by MAPS, a threat to MDMA finally becoming available has been generated. No doubt, the FDA will classify MDMA as a highly controlled Schedule II substance, if it decides to take it out of Schedule I.
Various criticisms of methodology, inadequate reporting, bias, and sexual misconduct were heard at the June 4th hearing. This article will examine their merits.
Of course, the media, extending to the respected Science in its June 14 issue, has clamped onto the drama and downplayed the extraordinary benefits of MDMA-assisted therapy. Studies conducted prior to its criminalization in 1985 and the MAPS research trials are a powerful demonstration of this. In fact, many millions of people do and will attest to its positive impact on their consciousness, healing, and relationships.
My Experience of MDMA and Psychotherapy
I have participated in, prescribed, and observed the MDMA world nearly since its inception. Here is the stance I came to decades ago.
MDMA fulfills human needs by releasing us from trauma, negativity, depression, and intolerance, and opening us up to kindness towards ourselves and others. It has always had these virtues since Alexander Shulgin plucked it off its 1912 German Pharma shelf, synthesized a batch, tried it for the first time ever, and lit up. We are at this current moment for one and only one reason: the political decision to make MDMA illegal and unavailable to those who wish to explore and expand their consciousness, heal their trauma and suffering, challenge their perspectives, and the qualities of being in this confusing time and culture.
The failed War on Drugs, along with the negative attitudes by pharma and psychiatric academia toward mind expansion and the pleasure and happiness potentially afforded by alternative medicines has distorted and truncated the availability of these substances.
An incalculable number of humans worldwide have experienced psychedelics in a framework of false negativity and the threat of legal punishment. That oppressive framework has inhibited education about best use and harm reduction, and the availability and quality of support for those who need that—and this applies to the overall range of substances that create dependency and addiction. MDMA is not dependency forming. Bringing MDMA out for controlled availability for prescription is a first step in rectification with what will be a limited number of patients and at a substantial expense.
The MDMA ordeal began in 1986 with the DEA’s bogus placement in Schedule I, where some of the very bad ones are located, like heroin, but most substances in this category are psychedelics and marijuana. MDMA has vast usage, hundreds of millions of experienced users over many decades–or even millennia– despite being illegal. Interestingly methamphetamine is in Schedule II, along with fentanyl with its tens of thousands of overdose deaths. Huge damage and still in Schedule II as they have medical utility. Really, no substitutes available? They are out of the box in any event. Suppression won’t help. The cartels are at it. Only dropping the price and the interest in cashing in by decriminalization and formidable education and treatment availability for users might help.
So, what has this to do with MDMA (and all the other scheduled psychedelics and marijuana). Well, in 1985, the DEA Administrative Law Judge (ALJ) conducted extensive hearings—I participated and was on TV—and found that MDMA had medical utility. We demonstrated that in spades—we had taken psychiatry and psychotherapy into new realms of healing and connection. We were very excited practitioners, pleased to give testimony. Here is a summary of his—the ALJ’s—findings.
‘Relying on the hearing testimony of experts in the health care community, the ALJ concluded that MDMA had an accepted medical use for treatment in the United States, 21 U.S.C. § 812(b)(1)(B), and an accepted safety for use under medical supervision, 21 U.S.C. § 812(b)(1)(C). The ALJ also found that the record did not establish that MDMA had a “high” potential for abuse. 21 U.S.C. § 812(b)(1)(A). The ALJ therefore recommended that MDMA be placed into Schedule III of the CSA.’
So why wouldn’t that finding still apply?
At this point, there was little evidence of abuse—MDMA was legal, and more and more people were becoming acquainted with its virtues personally, collectively and as a medicine for profound change and relationship. Of course, all that continued and expanded hugely with making it illegal.
In 1985, a CBS news story reported ‘dozens of doctors’ working with MDMA and maybe ‘a million doses of MDMA’ used. Of course, this was entirely guesswork as there was no data. The report was very positive including glowing patient testimonies. You can watch it. Another report stated 500,00 uses.
End of story–the DEA did not like the ALJ’s finding and overruled it, putting MDMA into Schedule I, making its manufacture, distribution, possession and use a felony. This made so many millions who have taken MDMA criminals and eligible for jail (there is no good data on MDMA-related incarcerations). It also created the ‘Underground’, namely those who continued after scheduling to provide MDMA for its broad therapeutic and celebratory value.
As Scheduling loomed, manufacture of MDMA blossomed. Money is the main human addiction, and it began to pollute the MDMA scene. While the data is poor, one estimate cites three million users were working with this material then despite the illegalization. Then came the Rave Scene, some casualties from misuse—dehydration, overheating, serotonin syndrome, polypharmacy. The 2016 estimate for worldwide MDMA use was put at 21 million, with a range extending to 32 million. The 2022 estimate for U.S. use was 2.1 million people, based on a survey with limited response. Surveys of psychedelic use are notoriously unreliable in a climate of illegality.
You could call the legal period of MDMA’s full availability ‘The Ground’. Between its 1977 beginnings and 1985, an ever enlarging number of practitioners, including me, practiced intensive MDMA-assisted therapy, and learned its properties, clinical use, limitations, and adverse effects. Without arrogance, what was learned clinically in the legal period, was what there is to learn. What has been added to our knowledge since Scheduling has been neuroscience, the application of newer psychotherapeutic methodologies, and the collection of data from MAPS’ rigorous studies for one of the diagnostic entities for which MDMA assisted psychotherapy is so beneficial – PTSD.
In terms of numbers of recipients and sessions, my own work exceeded the 350+ subjects in total that MAPS has studied in the Phase 2 and Phase 3 FDA studies. I had no casualties, no misuse, no hospitalizations, no ER visits. I practiced individual, couples, group, and family therapies. In fact, the only true adverse effect I have encountered was a brief episode of mild angina due to MDMA-induced tachycardia in one of the subjects in our MAPS Phase II Life Threatening Illness protocol. Increased heart rate and blood pressure are frequent with MDMA, and I was careful to exclude those who had cardiovascular conditions of concern.
I was surrounded by fellow practitioners who had similar MDMA practices going. We had a network in which we shared our work, our methods, our difficulties, and our enthusiasm. It felt and has felt as making an affirmative revolution in the nature of psychotherapy and healing. We met frequently at Esalen Institute in Big Sur, California in an informal but extensive and potent group called ARUPA—the Association for the Responsible Use of Psychedelic Agents—Sanskrit for the formless realms of meditative experience. MAPS was born of Arupa. We did not collect statistical data—no doubt a failing in retrospect. We did write papers and books, case studies, the qualitative and subjective aspects of the MDMA experience and psychotherapy with it.
My Personal Experience
For me, the personal realm with MDMA was affirming and held me and my family through the hardest time of my life. At 12, my oldest son Noah was afflicted with leukemia—ALL—and he lived for four years until nearly 17. It was a harsh and taxing struggle to keep him in remission and he was a noble and complex being putting all his energy into living and seeming normal despite setbacks, relapses and the grinding on soul and body of the chemotherapy of the 1980s. I wrote a book about us—Noah-a father/son song of life, sickness, and death. With the centripetal, entropic forces a family faces with a child’s life threatening illness, its unprecedented stresses on all members, we brought in MDMA to assist us in keeping our unity and kindness.
Practicing open awareness with our two children, we created a ritual of Family Night in which parents used MDMA to create ambience, freedom of expression, and snuggleness. MDMA, used thoughtfully and with intention, fosters communication, recognition of perspective, tolerance, and the embrace. After he died, despite our best efforts and intention, unfortunately we came apart. In our loss and its aftermath, it was hard to take refuge without our Noah. But during the four years of his and our cancer life, MDMA and Family Nights gave us togetherness, love, sharing, and the ability to go on.
My friend, Rick Doblin of MAPS, knew about this and asked me to do our Phase 2 protocol of MDMA -assisted therapy for the anxiety and PTSD of Life Threatening Illnesses. That study was certainly the most intensive psychotherapy I know of. All 18 of our subjects – and we who were the therapists – had profound life changing experiences. Our subjects were vulnerable. One had a relapse during our first phase, another three subjects later on, and two died after the conclusion of the study. In other words, we weren’t playing around. MDMA had a profound and positive impact on all our lives.
Examination and Response to the Criticisms
Positive set and setting impact a study and increase its success. To reference one of the recent critiques that has been leveled at the MAPS Phase 3 Studies, a positive expectation for success on the part of a subject who enters any study is a constant. Other than money if a subject is paid to participate, or a notion of bettering treatment for others, ‘I want this to work for me’ is an entry level expectation. In placebo-controlled studies, subjects experience anxiety about not getting the active, and some refuse to participate in the study to avoid the placebo fate. This is not confined to MDMA studies. As a metaphor, “I want the penicillin to treat my infection would certainly be the main motivation.
Contrary to another aspersion, no subjects were ever restricted from expressing their difficulties, as is true for all MAPS studies. And complaints and reactions are fundamental to the success of our work and learning the needs of our subjects. That criticism is absolutely empty.
Similarly, the critique that the setting should not contribute to the outcome is nonsense. Positive or negative settings invariably contribute to a subject’s experience. MDMA experiences last 8 hours and in our study, FDA required subjects to sleep over—and the study was conducted in my home. Certainly, the comfort contributed to outcome and could not be separated as to impact.
To be clear, all of our subjects exceeded placebo levels. A setting that was not conducive would neither be ethical and would encourage dropouts. Eight hours in a bomb shelter definitely would affect outcome—negatively no doubt. MDMA and other psychedelics being studied—psilocybin—all require comfort and attention. We are in the realm of consciousness affecting agents with immediate onset of altered states This is not waiting the weeks for recognizing an antidepressant’s effects. These are acute and intense feeling states.
The subject of using active placebos has been raised as another critique. Earlier in MAPS history, low doses of MDMA were tried and found ineffective as a comparator since while they did increase blinding, they also made PTSD patients uncomfortable. Subjects who received low doses of MDMA experienced fewer reductions in PTSD symptoms than similar subjects receiving therapy with inactive placebo. With other psychedelics, psilocybin in particular, Ritalin–methylphenidate, methamphetamine, caffeine and other substances have been used to provide a sense of altered consciousness but rarely were confused with psilocybin. The power of the psychedelic medicine would inevitably be felt by people who received it, and therefore known to the subject by comparison. Years ago, a former FDA Director of Psychiatry consulting to MAPS was persuasive for the use of an inactive placebo— therapy with nothing vs therapy with the medicine. In 2017, FDA itself selected therapy with inactive placebo as the best choice for the Phase 3 control group, successfully concluding an FDA process called Special Protocol Assessment which took 8 months to resolve.
Of interest in our MDMA study was the positive response to placebo by one subject who fully believed he had received MDMA. He was so excited to be in the study and dealing with his struggle with increasing entrapment in his scleroderma. After unblinding at the primary endpoint and having an MDMA experience, he could clearly feel the difference.
His experience goes to the heart of the nature of the psychotherapy and the influence of the setting. Our study was conducted apart from the formal MAPS PTSD protocols with somewhat greater leeway for our interactions and interventions. The two PTSD Phase 3 studies are both subject-centered and also highly choreographed for therapist methodological consistency. There is nothing woo woo about them as has been remarked by some critics. The theory of Inner Healing is an attempt to explain the inner drive to get better and improve one’s condition and if possible, to eliminate suffering. This occurs as an inherent aspect of human potentiality. MDMA and the attendant therapy are thought to reduce and/or remove the obstacles to its presence and effect. Inner Healing is a concept about who we are and not a methodology. All of us have access to it.
There is another beauty that has been unleashed—a concern that Lykos did not adequately report moments of ‘euphoria’– a feeling or state of intense excitement and happiness–and its risks for addiction, for dependence. One could remark that at last psychiatry has created the possibility for joy and happiness—and that as per the Lykos Phase 3 studies, it could be lasting. That is not to say that in my and others’ work as psychotherapists, we don’t or have not had the experience of our patients having wonderful feelings. Au contraire. It is to say that the Pharma toolbox is primarily suppressive in orientation—for symptom relief and symptom control. It has eschewed any development that makes for Dr. Feel Goods, though human cleverness may turn the tables and find ways to make a psychiatric drug relaxing and trippy. I have been hearing about this from a psychiatrist working in the prison system. And over my many decades of practice I have been surprised by some drugs that are obviously designed for other actions being turned into something like euphorogens.
Indeed, MDMA often induces a state that has been variously dubbed its aura, the bubble, bliss, and elevation. This generally occurs in the immediate period following a session and MDMA therapists need to guide their subjects/patients to give time for integration and, for the moment, eschew major life decisions. Ongoing therapy is a great concept to support integration and reality testing. For instance, during the legal period, couples therapy might lead to a marriage conceived during the bliss state that in the light of day, never had a chance. There were quite a few in my practice and some continued as permanent and satisfying unions.
Euphoria is hardly the main hazard for MDMA users. As is the case for all things, foolish behavior—foolishness—bad judgment–that is rooted in character, a bad experiment, a paranoid-making setting, a quest for relief, too much stuff, a notion of entertainment, driving intoxicated, buying drugs off the street, and so much more of how we get ourselves in trouble– is generally at the root of hazard. On its own, MDMA-specific deaths are rare and there is no good data. The few deaths that were entirely attributable to MDMA were caused by hyperthermia—in essence heatstroke. Public awareness of the need for adequate hydration reduced this risk but then a few people died from drinking too much water, hyponatremia.
Emergency Room visits related to MDMA number in the low thousands—3,000-5,000 in the current period each year. This, and some subsequent hospitalizations, are usually related to polypharmacy, especially putting MDMA together with alcohol, cocaine, meth that are dangerous combinations both physically and mentally. With those inexperienced in altered states, combining with other psychedelics that create a hallucinosis may be terrifying and disorienting. Many people come to the ER because they ‘think’ something is wrong. The neophyte user in an unsupported setting may become anxious and have a panic attack. Uncommonly, others may have had exacerbations of underlying or present psychosis or mania. Remember, this is in the general population with 3 or more million MDMA users per year in the U.S. and a multiple of this for the number of actual use events.
The point is straight forward: MDMA is a very safe medicine when used on its own and its safety has been overwhelmingly demonstrated by its use in the populations of the world at large. Within the clinical setting and explicitly for the Lykos studies, its remarkable safety has been demonstrated resting on explicit Inclusion and Exclusion criteria. Taking this into consideration as an overall safety attribute of MDMA in its 47 years of experience is obligatory.
In this respect, MAPS deserves great credit for its attention to public safety through its innovative Zendo direct care space and harm reduction programs.
Regarding the woman who was sexually abused while still a subject in a MAPS Phase 2 study at its Canadian site, it was me and my partner who discovered the sexual misconduct. We were visiting our long time friends, a female psychiatrist and her husband, an unlicensed near 70 year old psychologist of renown. Both had been leaders of the study, and both were treating the patient in their home, this being the case while the sexual relationship with the male was ongoing. We were shocked and made an immediate intervention to have them stop and insisted on the care of the patient being transferred. They did not and the patient stayed in the relationship for some time after, before breaking it off, moving away and eventually filing a complaint.
As the psychologist was not licensed, the subject’s only options were to expose and to sue. The details are available to the public, and I will not go into them here. The transgression took place during the follow-up phase of the study. They brought her to their island home, initially to support her healing and treatment. It led to the rupture of care and sexuality. The couple has been unrepentant and blamed the subject. I tried hard to reach them and was unsuccessful. They have been unfriended—sadly.
The situation was complex for many reasons and the misconduct was a serious breach of the absolute boundary between psychiatrist/therapist and patient, whether in overground or underground practice. MAPS was informed as was their and my colleagues in Canada. Initially, we formed a group of practitioners in Canada, outed the couple and created an ethics code that applied to all practitioners practicing with alternative medicines. MAPS rapidly joined with us and created its own Code of Ethics as well as supporting the subject. In my ketamine work, we have a formal Ketamine Code of Ethics.
Violations of boundaries between practitioners and patients abound throughout the history of medicine and psychiatry/psychotherapy. They occur regardless of risks to license and career. In the underground, there is no enforceability protecting recipients and no easy way to report or seek justice. The most powerful deterrent is participating in the community of practitioners and seeking support before acting out. That is an idealization. Fortunately, the frequency of sexual misconduct is not rampant. Other forms of transgression include using patients for money, fame, or from a warped sense of need and power.
The basic rule is not to need something from a subject or patient other than observation of the ground rules for participation in treatment—arrive, attend, pay the agreed upon fees. MAPS has made every effort to be clear about boundaries and to offer community and support to its practitioners. While this incident is intolerable and has ruined lives, it is a singular event in MAPS’ history. It should not mar the approval process.
In Conclusion
Approval, Approval. May it happen. I have covered what appear to be the principal criticisms raised. Examining the backgrounds of those who have jumped on the negative bandwagon, we find self-promotion for prominence; representation of insurance company interests for ICERS in its demolition derby of attack and misrepresentation; territorialism for some in academic psychiatry; and zaniness in others. Critical input is desirable and a necessary part of getting it right. The obligation of a critic is to be informed, to own its own self-interest, and to know the field, so the critique is on the mark, beneficial and constructive.
MAPS and now Lykos have done the work in concert with FDA throughout. The evidence for MDMA is overwhelmingly positive and we need it in the most accessible format for the benefit of humans—as has been its impact since inception. There are no perfect medicines, or therapeutic formats. We have plenty to learn about the application of psychedelic psychotherapies. We cannot learn if they are not available and are illegal with the attendant risks and consequences for use.
Mass public pressure for decriminalization and legality is occurring worldwide based on the mass experience of benefit that includes MDMA. Prescription is only a small part of this. The challenge with approval for Lykos will be cost and accessibility. May that challenge be granted.
The views and opinions expressed in this essay are those of the author and do not necessarily reflect the views or positions of the Lucid News editorial team.