It was only a few short months ago that excitement about the use of psychedelics to treat mental disorders vaulted to meteoric heights. Lykos Therapeutics , the company sponsoring MDMA, had recently applied to the FDA for approval of MDMA as a medical therapeutic agent. The FDA granted it “priority review”, signaling it would be a smooth process. Lykos was run by Dr. Rick Doblin, the head of the advocacy and licensing group for therapists called MAPS (Multidisciplinary Association for Psychedelic Studies).
MDMA was widely expected to gain FDA approval, given the Lykos communications and the MAPS expectations.
On August 9, the FDA decision came through: rejection. Prior to this decision, there had been increasing concerns about the lack of rigorous controls in the studies, particularly with respect to administration of these drugs.
One major flaw in the case, and what reached the headlines, was a “therapist“ who reportedly had sexual relations with a patient who was in an MDMA experience.
As it turns out, this therapist had no mental health training, except for that offered by MAPS. Contrary to accepted professional standards, the treatment manual for MAPS therapists includes recommendations such as the use of “nurturing touch” and “suggestion” during the MDMA experience. The “therapists” involved in the study need not to be licensed psychiatrist, psychologist, or mental health providers. In fact, it is implicitly encouraged that the practitioners themselves be personally familiar, and on a recreational level, with the effects of MDMA.
One of the physicians in charge of MDMA use in Australia was quoted on a podcast saying “we need everyday people to say ‘I take acid a few times a year’ and ‘I’ll take MDMA every now and then with my wife, and it brings us close together, you know?” continuing, “I think the government will find that even harder to resist“.
In fact, Dr. Doblin himself has said that MDMA could be used by individuals with the help of a “trusted friend“ or alone in order for people to be able to “heal themselves“.
In my opinion, this has been an exercise in hubris and folly. We cannot have the leaders of such an important potential breakthrough in the treatment of mental health disorders, encouraging people to use them as recreational agents. Scientist must be objective observers and reporters of drugs, especially as powerful as the psychedelics, not as overly excited personal advocates.
Many scientist have now pulled their articles regarding psychedelics from journals where they were published, and Dr. Doblin has since stepped down as the head of Lykos.
I would argue, however, for continuing deeper research and clinical trials on these powerful agents. There is much promise in them, but they must be used with the utmost care by people trained in psychotherapy. They must adhere to the standards, ethically and scientifically, established by their organizations.
In our clinic, we administer ketamine. This is an also a dissociative drug, with occasions of abuse leading to terrible consequences (Matthew Perry’s death is a notable recent example). However, our approach is far different from that of the MAPS program. We approach ketamine as a messenger rather than a “high”. We use a rigorous and controlled IV approach that is constantly monitored by a skilled, experienced nurse practitioner. Everything that happens within that treatment setting is carefully recorded. In this process, ketamine can open a door into some of what has been suppressed or repressed in a patient’s unconscious mind. However, this can only be accomplished in follow-up sessions embedded in strict psychotherapeutic techniques and practices.
It should never be used in a recreational sense in hopes of achieving some mental health “breakthrough”. I’m sure that it will continue to be used as a “party drug“ by those inclined to do so. However, I draw a very firm line between recreational use and the use of ketamine to treat the mental pain endured by my patients.
I highly recommend the @NYT article by Caty Enders, who published a thorough and well researched history of this. (https://www.nytimes.com/2024/08/23/opinion/psychedelics-mdma-mental-health.html?smid=url-share)
The FDA rejection was prompted by the structure and content of the study, and was not a rejection of the efficacy of the substance itself. Psychedelics are worthy of continued research. We must work diligently to develop protocols that unlock the potential of these drugs to treat the devastation of PTSD, trauma, and depression.