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Thoughts on MDMA-AT and the FDA’s Advisory Committee Hearing

Most of you are aware of the disappointing results of the FDA's Advisory Committee hearing on Tuesday, June 4 where midomafetamine (Lykos' proposed MDMA capsule) was overwhelmingly rejected by the panel that made the recommendation to the FDA not to approve it for the treatment of PTSD.  This was after Lykos and the FDA did a pretty good job of presenting their cases and the vast majority of the public comments were positive and supportive of MDMA approval being recommended.  I was struck by the courage of the veterans and former MDMA research participants to testify in public about how this treatment saved their lives and saved their families.  It was interesting to note that most of the negative comments came from people associated with Psymposia, an organization that has a longstanding seemingly personal axe to grind against Rick Doblin and MAPS, yet they never identified themselves as such.  Of course, as soon as the Discussion portion of the meeting began following the public comment section, it became readily apparent that not only was this panel woefully ignorant about the history and nature of research with psychedelic compounds but they had seemingly already made up their minds that this medicine was not going to be recommended for approval.  It was also interesting that the panel seemed unaware that Lykos has been working very closely with the FDA for many years to address the design, conduction and interpretation challenges of this unique kind of research and have diligently implemented the recommendations from the FDA throughout this process.  It is important to note that the FDA is not bound by the recommendations of this Advisory Committee and a recent drug for Alzheimer's that had Breakthrough Therapy status (like MDMA-AT) was unanimously voted down at its Advisory Committee hearing but the FDA went on to approve there is precedent.  I also believe that the therapy component deeply confused the panel because this is the first time psychotherapy has been coupled with a drug in order to be maximally effective (which we know is essential.....otherwise there would be around 22 million likely well-adjusted adults out there just from trying MDMA at some point in their lives).

     From my experience at the Pearl Psychedelic Institute as a clinical investigator in the Lykos/FDA Expanded Access program, I have seen firsthand the ability of this compound and therapy, within months, to heal psychic wounds that conventional, evidence-based, top-down clinical approaches would have needed years to address for the 50% that may respond.  And by "respond" I mean developing the ability to manage their PTSD symptoms adequately enough that they could live relatively functional lives.  MDMA-assisted therapy has the ability to heal trauma when used under trained clinical supervision and thus provides medical and mental health practitioners a tool that has the potential to interrupt the intergenerational transmission of trauma.....which has been a silent epidemic and a major reason why our culture (and our species) is deeply threatened with increasing fear, distrust, division, anger, and aggression.  Because many of us can see how an effective, scalable trauma treatment could help potentially heal larger familial and cultural wounds (regardless of politics), we are labeled "a spiritual cult," "idealistic" and therefore "irresponsible" and "dangerous."  If people living happier, more fulfilling lives without the multilevel damage and interference of past trauma is a threat to the status quo, then we may need to seriously re-examine and explore alternatives to our existing situation.  

     Regardless of what the FDA rules on midomafetamine in August, there is ample evidence at this point that MDMA very likely has some kind of medical utility.  It would behoove us to have the ability to expand the research on how to use MDMA safely, intelligently and effectively but it is incredibly difficult to do this while MDMA remains Schedule 1.  As for the fear that midomafetamine approval in August will lead to some epidemic of illicit use and abuse, that does not really hold water in that MDMA has existed for 112 years and recreational substance users in the US have known about it since the 1980s.  If MDMA had the capacity to ignite an epidemic of abuse (like oxycontin), it would have happened many years before now. 

     As I step down off my soap box, the last thing I will say is that it is not over.  There is still a chance that the FDA (being more informed and involved than the Advisory Committee about the MDMA-AT research) will do the right thing and approve midomafetamine in August so that Lykos can begin the task of training therapists and prescribers and getting this treatment out into our communities in a deliberate, thoughtful and safe way.  If this treatment is not approved, veterans and PTSD sufferers and many others are still going to seek out this treatment.  Unlike in the 1970s when the government successfully shut down all psychedelic research, they no longer control the narrative and the internet and social media have made it so this genie is not going back into the bottle like it once did.  There will be a proliferation of "shamans" and guides of dubious skill levels, integrity, preparedness and motivations which will increase risks and negative outcomes and the suicide rate of veterans will continue to climb because the government that they fought and died to protect will not allow them legal access to something that could genuinely help them and their families.  It will also send a disheartening message to those with PTSD from childhood abuse, assault, domestic violence, mass shootings and natural disasters that although psychiatry has a possibly effective treatment for their years of suffering, they will not be permitted legal access.

   There is also ample criticism about the therapy component of MDMA-AT because it speaks of each patient having an “inner healing intelligence” which implies that each patient, deep down below their psychological damage and compensations, knows what they need to heal.  I think this empowerment of the patient may be perceived as threatening to the current medical structure.  The critics saying this therapy is “unfounded’ because it is not a current “evidence-based” approach do not know their psychedelic history.  Going back to the early LSD research in the 1950s and 1960s, this supportive form of therapy where the patient essentially guides the process happened to be the form of therapy that was most amenable to working with psychedelics.  However, regardless of the approach, when healing from serious trauma histories, it is essential that the person providing in-session support have some clinical knowledge and experience to  understand the dynamics of transference, countertransference and potential trauma re-enactment. 

     My 27yo daughter, who is a therapist working on her license in Boulder, CO, called me the night after the Advisory Committee meeting and was dejectedly asking me if she needed to abandon this idea of one day becoming a legal psychedelic therapist.  I told her in no uncertain terms that if this was her chosen path to stay on it because this is going to pass in her lifetime.  It is coming.  MDMA is only the first of several psychedelics (psilocybin, 5-MeO-DMT, even LSD) that are slowly wending their way through the FDA’s enormously expensive and labyrinthine approval process.  The pharmaceutical companies that are out there furiously trying to engineer out the psychedelic component are only doing so because they deeply misunderstand the healing power of the psychedelic experience and they are desperately trying to come up with a pill one must take every day because that’s where the money is.  Psychedelics are potentially forcing a seismic paradigm change in psychiatry, psychology, medicine, and the pharmaceutical industry and this takes time, persistence and patience.  But it is coming…….and is needed.

Raymond C. Turpin, Psy.D.

Executive Director/Clinical Director




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