The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) estimates that proposed phase 3 studies of MDMA will be completed by 2020. They and others assert that a new drug application will be submitted to the FDA shortly thereafter.
MDMA may show some promise, but a fast-track to FDA approval should give us all pause.
It seems assumed that MDMA will be moved forward by an expedited review through an FDA special protocol that is, in fact, less rigorous and will increase the likelihood of approval after phase 3 trial results. As a result, MDMA may be approved for prescription by 2021.
But why the hurry?
In the 1990’s there were a number of deaths from MDMA use at RAVES and brain injuries from bad MDMA, including Parkinson’s disease. But, most of the problems stemmed from hyperthermia and adverse cardiac events at all night dances in hot venues without water. Some suggested MDMA caused serotonergic blunting and even brain damage. It is not surprising that this interesting article notes that healthy young volunteers had not experienced any adverse effects using low, controlled dosing of MDMA. Risks still exist and additional safety-efficacy studies are warranted. The researcher suggests that that MDMA would only be used during prolonged intensive therapy sessions for couples, or for those with PTSD. Yet it is not clear who will actually be included in the next trials. Still, it is encouraging that MDMA through the process of demonstrating safety and efficacy in well-controlled FDA trials.
Why Does This Matter?
When the news of fast tracking MDMA broke, many rushed to the erroneous conclusion that MDMA was already proven safe and effective. MDMA is not the penicillin for the soul as many have touted. Although the research offers case data and theories, it lacks good, well powered double-blind, randomly assigned, placebo controlled studies. But the current FDA trials matter because we are actually studying the effects of MDMA as an adjunct to psychotherapy. We should do more than this and should also be comparing the effects of MDMA in rigorous trials among different cohorts, while assuming it will likely be prescribed off label, prescribed to unselected populations, and heavily sold and abused on the black market and the dark web. Furthermore, we still don’t know why some users of MDMA experienced adverse effects at doses comparable to those who did not. This is an important question because the cost of not understanding these adverse effects is simply too high. I recall many bright students with promising academic careers who literally lost their mind due primarily to permanent damage via destruction of central serotonergic neurons, following moderate doses of MDMA.
Rigorous FDA scrutiny has always taken the position that a new drug is dangerous until proven safe. In the case of MDMA, there is ample evidence of its abuse and harm, even for occasional or first-time users. Rigorous FDA scrutiny is the only way to assure both dose dependent efficacy and public safety.
Bedi G . 3,4-Methylenedioxymethamphetamine as a Psychiatric Treatment. JAMA Psychiatry. 2018 Mar 21. doi: 10.1001/jamapsychiatry.2018.0063. [Epub ahead of print]