The sky is falling! The sky is falling! And Big Pharma is tearing it down.
This is what psychedelic enthusiasts everywhere would have you believe: That Big Pharma is responsible for the recent “no” vote by an FDA advisory panel evaluating MDMA as a treatment for post-traumatic stress disorder — that Big Pharma wants to protect its monopoly on psychiatric medications.
Some will say this decision had nothing to do with drug sponsor Lykos, a for-profit spinoff of the Multidisciplinary Association of Psychedelic Studies (MAPS), failing to include basic monitoring parameters within its reported dataset, such as blood tests and electrocardiograms. It apparently had nothing to do with study design flaws around participant selection, blinding or expectancy. Nor did it seemingly have anything to do with the fact that a participant in the MAPS trials was sexually assaulted by her therapists (allegedly) or that MAPS may have coerced research participants into minimizing the adverse effects of the treatment.
It was all about protecting Big Pharma’s revenue. That’s what some will say.
The FDA advisory panel raised significant concerns regarding the safety and study design of MAPS’ MDMA trials. Anyone who insists these concerns were a ruse by Big Pharma to squash a new, disruptive psychiatric therapy is mistaken.
In fact, the FDA advisory panel meeting was a promising first step toward FDA approval of psychedelic therapies. Aside from voicing their numerous concerns, members of the panel also expressed optimism about MDMA as a future treatment for PTSD.
John Hertig, a pharmacist, said, “I do believe that the therapy holds clinical promise.” Maryann Amirshahi, a medical doctor and pharmacist, claimed, “I do believe there was a signal. It just needs to be better studied.”
Paul Holtzheimer, a medical doctor, said, “I think this is a really exciting treatment. I’m really encouraged by the results to date. But I feel that both from an efficacy and a safety standpoint, it is still premature.” Melissa Barone, a psychologist, said, “I think this treatment is incredibly promising and has a lot of potential to help a lot of patients.”
Despite the optimism, the panel ultimately voted “no” on this particular MDMA new drug application, partly because of the study design flaws and missing safety data. Members of the panel appeared sincere about wanting to get this right. They want to set a good precedent for future psychedelic drug applications, and they want to make sure there are sound systems in place for adequately delivering these potent drugs.
The panel members are not alone in their optimism or their concerns. Anyone who has any experience with these drugs knows their power. These drugs have great power to heal but also the potential to do great harm. We need to ensure that proper safeguards are in place to maximize the benefits and minimize the risks of these potent drugs.
More and better research is needed to establish safeguards. Laboratory monitoring is a requirement for all FDA new drug applications — how this was missed in the MAPS/Lykos trials is truly befuddling — especially for a drug that is known to kill people via low sodium. Unblinding and expectancy effects can be better addressed by implementing models that specifically measure expectancy as a physiologic process separate from the drug effect.
Additionally, the effects of the drug can be teased out from the effects of psychotherapy by using a 2×2 factorial design. Common-sense morals and closer monitoring should prevent research participants from being sexually assaulted or coerced into minimizing adverse effects, as was alleged in the MAPS/Lykos trials.
In addition to improved study designs, we need more research teasing out the specific risks of psychedelic treatments. We need to better understand who is and isn’t an appropriate candidate for particular psychedelic drugs. Teasing out these risks starts with acknowledging that these drugs do carry significant risks (like nearly every other drug on the planet). Drug developers, researchers and psychedelic enthusiasts must be honest about this fact.
Moving forward, policymakers and other interested parties should focus on increasing funding for and decreasing barriers to psychedelic research. If we address the legitimate concerns raised by the recent FDA advisory panel, the future of psychedelic medicine remains bright.