Opinion: A rejection of MDMA therapy does not mean it is completely useless in a mental health context

Post-traumatic stress disorder can be a debilitating illness. There are very few effective treatments.

Much hope has been placed on the psychedelic drug MDMA, commonly known as ecstasy or molly – a treatment that many PTSD sufferers have touted as being effective.

But last week, a U.S. Food and Drug Administration advisory committee flatly rejected a request to approve the first MDMA-assisted therapy. (The final decision will be made on August 11, but the regulator generally follows the recommendations of expert advisers.)

The question now is whether this rejection will be a setback for psychedelic drugs in general, or whether the results of some unusual research by an unusual company are just an outlier.

At first glance, the research results carried out by Lykos Therapeutics seem impressive. Two clinical trials, involving nearly 200 patients, showed that the combination of MDMA and psychotherapy was very effective. (Some of the study participants were in Canada.)

In the first trial, 67 percent of participants experienced a reduction in PTSD symptoms to the point where they no longer had a diagnosis; the second trial had similar results, with 71 percent of participants no longer meeting criteria for PTSD after treatment.

But the FDA advisory panel expressed serious reservations about the methodology, making them doubt the results. Nine out of 11 committee members voted that the Lykos trials did not prove the therapeutic effectiveness of MDMA. Additionally, 10 people voted that its benefits do not outweigh the risks of using it.

The committee’s conclusions are understandable. First, 40 percent of study participants had previously used MDMA, suggesting they were predisposed to finding the treatment beneficial.

There were also concerns about bias among the therapists involved in the study. Some told their patients that they were participating in “historical” research. There was also a case of sexual misconduct.

The company did not help its cause by failing to collect FDA-required data on potential harm. MDMA can cause heart problems and, in some cases, increase the risk of suicide.

Finally, there remains the thorny question of blindness. In typical randomized clinical trials, half of the participants receive the test drug and the other half receive a placebo. But with a psychedelic drug like MDMA, it’s pretty obvious to the participant whether they’ve been given a sugar pill. This is a significant challenge for any psychedelic research.

Lykos Therapeutics is a pharmaceutical company owned by the nonprofit Multidisciplinary Association for Psychedelic Studies. MAPS’s evangelism in favor of psychedelics is well known. Its founder, Rick Doblin, has for years touted MDMA as a revolutionary tool, claiming it can eliminate all trauma in the world and bring world peace.

This kind of rhetoric is useless.

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 effective 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 robust, regular research to test theories and treatments, as well as nuanced analysis of risks and benefits.

A distinction must also be made between recreational and therapeutic use of these drugs. MDMA has been a staple at raves and dance parties since the mid-’80s. As far as drugs go, they’re relatively safe.

But if we want to use MDMA as a treatment for mental illness, it must be done systematically, with standardized doses and appropriate monitoring.

Currently, MDMA treatment is quite expensive. A patient takes a 125-milligram dose and stays in a quiet, dark room for four to six hours, accompanied by a therapist who performs talk therapy. (People with PTSD shut themselves down and treatment forces 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 must apply on behalf of a patient and the process is not easy. Only dozens of applications have been approved, most on behalf of former soldiers suffering from PTSD.

More and more patients are self-medicating without going through official channels – which is quite easy given that psychedelics are sold openly in major Canadian cities.

We need to incorporate the real-world experiences of these individuals into research – not as a substitute for appropriate trials, but as a complement.

The rejection of early MDMA-assisted therapy is not necessarily a major setback for psychedelics. If nothing else, it would break the hype bubble and serve as a reminder that we will never get effective drugs without high-quality research.