Post-traumatic stress disorder can be a debilitating condition. There are very few effective treatments.
A lot of hope has been placed in the psychedelic drug MDMA, commonly known as ecstasy or molly – a treatment whose effectiveness many a PTSD sufferer has raved about.
But last week, an advisory committee of the U.S. Food and Drug Administration soundly rejected an application to approve the first MDMA-assisted therapy. (The final decision will come Aug. 11, but the regulator usually follows recommendations of expert advisers.)
The question now is whether this rejection will be a setback for psychedelic drugs in general, or if the findings of some unusual research by an unusual company are simply an outlier.
At first blush, the outcome of the research conducted by Lykos Therapeutics looks impressive. Two clinical trials, involving almost 200 patients, showed the combination of MDMA and psychotherapy was highly effective. (Some of the study participants were in Canada.)
In the first trial, 67 per cent of participants saw a reduction in PTSD symptoms to the point they no longer had a diagnosis; the second trial had similar outcomes, with 71 per cent of participants no longer meeting PTSD criteria after treatment.
But the FDA advisory group expressed some serious reservations about the methodology, which made them doubt the results. Nine out of 11 committee members voted that the Lykos trials did not prove MDMA’s therapeutic effectiveness. In addition, 10 voted that its benefits did not outweigh the risks of using it.
The committee’s findings are understandable. First of all, 40 per cent of the study’s participants had previous experience using MDMA, suggesting they were predisposed to finding the treatment beneficial.
There were worries, too, about bias among the therapists involved in the study. Some told patients they were part of “history-making” research. There was also a case of sexual misconduct.
The company didn’t help its case by failing to collect data that the FDA had demanded about potential harms. MDMA can cause heart problems and, in some cases, increase the risk of suicide.
Finally, there is the thorny issue of blinding. In typical randomized clinical trials, half the participants receive the drug being tested, and the other half receive a placebo. But with a psychedelic drug like MDMA, it’s fairly obvious to the participant if they have received a sugar pill. This is a significant challenge for all psychedelics research.
Lykos Therapeutics is a pharmaceutical company owned by the non-profit Multidisciplinary Association for Psychedelic Studies. MAPS’s evangelism for psychedelics is well-known. Its founder, Rick Doblin, has for years touted MDMA as a game-changer, claiming it can eliminate all trauma in the world and bring about world peace.
This kind of rhetoric is unhelpful.
There is no doubt that psychedelics like MDMA, LSD, psilocybin, ketamine, DMT and others have the potential to be effective treatments for various mental health conditions.
There is no miracle drug, but psychedelics could be at least as efficacious as existing prescription drugs, especially for stubborn and common conditions like PTSD and treatment-resistant depression.
But we need more than anecdotes and hype. We need solid, by-the-books research to test theories and treatments, and a nuanced analysis of the risks and benefits.
We also have to make a distinction between recreational and therapeutic use of these drugs. MDMA has been a staple of raves and dance parties since the mid-80s. As drugs go, it’s relatively safe.
But if we’re going to use MDMA as a treatment for mental illness, it has to be done in a systematic fashion, with standardized doses and proper oversight.
Currently, MDMA therapy is fairly onerous. A patient takes a 125-milligram dose and remains in a quiet, dark room for four to six hours, accompanied by a therapist who does talk therapy. (People with PTSD close themselves off and treatment requires them to open up; psychedelics like MDMA can break down inhibitions.)
In Canada, MDMA is only available (legally) through Health Canada’s special access program. Doctors have to make a request on behalf of a patient, and the process isn’t easy. Just dozens of requests have been approved, mostly on behalf of former soldiers suffering from PTSD.
Many more patients self-medicate without going through official channels – which is easy enough given that psychedelics are sold openly in big Canadian cities.
We need to incorporate these individuals’ real-world experiences into research – not as a substitute for proper trials, but as a complement.
The rejection of the first MDMA-assisted therapy need not be a major setback for psychedelics. If nothing else, it will burst the hype bubble and serve as a reminder that we will never get effective drugs without high-quality research.