Nothing Has Changed About the Healing Power of MDMA-Assisted Therapy

After decades of research and clinical trials, the US Food and Drug Administration (FDA) recently denied an application to approve the psychedelic drug MDMA, combined with talk therapy, as a treatment for Post Traumatic Stress Disorder (PTSD). The FDA rejection has called for further research.

But despite the rejection, MDMA-Assisted Therapy, as far as I know, remains one of the most powerful and promising tools for healing trauma and relationships.

“The great benefits of MDMA therapy significantly outweigh the risks.”

— Darek Dawda, PhD, CPsych

To be clear, I strictly adhere to all relevant laws and professional regulations. Regulation is a good thing, and regulatory bodies—such as the FDA—are there to protect treatment recipients from quacks and charlatans. Therefore, as a regulated professional, I am bound to respect the recent FDA rejection of MDMA-Assisted Therapy.

At the same time, as a scientifically trained professional, experienced psychotherapist, and someone familiar with psychotherapy literature and trained in MDMA-Assisted Therapy, I am very disappointed with the FDA rejection decision.

The FDA has been working closely with MAPS for years now. They were well aware of the study design and issues such as expectancy bias. (1) The FDA was also aware of a gross ethical violation that occurred in the earlier stages of MAPS research, which by the way, was not only already dealt with but also did not affect the results in question. Furthermore, during the Advisory Committee meeting, the FDA explicitly stated they believed the post-approval stage could likely address most of the shortcomings of the MAPS trials. It could do so through mechanisms such as:

• A REMS (Risk Evaluation and Mitigation Strategy)
• The accreditations of sites by medical regulatory bodies
• Specialized codes of conduct within self-regulating professions

Why, Then, Has the FDA Rejection of This Potentially Formidable Treatment Occurred?

We don’t know the exact details of the rejection. However, the reasons are likely similar to those discussed during the recent FDA Advisory Committee (AdComm) meeting. AdComm is a committee of several health professionals, most of whom, unfortunately, have minimal knowledge of MDMA Therapy. The FDA recently tasked the committee with advising it on whether or not to approve this therapy.

The AdComm meeting addressed numerous issues. The potential expectancy bias (1) caused by the failure in blinding might have some validity. However, this issue was already well-known to the FDA.

The meeting also raised questions about MDMA’s abuse potential, which is known to be low. The meeting also brought up concerns about the lack of diversity and representation. However, over 50% of participants in the Phase III study’s second part were BIPOC. The reviewers also flagged prior MDMA use among study participants as a potential problem. This issue was raised as a concern even though there was no difference in results between those who previously used MDMA and those who did not.

The discussion also quoted the unprecedentedly meager drop-out rate as suspicious rather than simply meaning the treatment was working. Even the role of psychotherapy faced questions, despite researchers generally agreeing that MDMA does not heal on its own—only in conjunction with psychotherapy.

Furthermore, the FDA asked committee members to focus on what the information package contained. Unfortunately, the meeting occasionally went off-script, especially when some motivated public commentators made unsubstantiated claims. For example, there were claims that MAPS studies harmed many people and that adverse effects and misconduct were underreported. While this may be true, we need to see the evidence to consider it. To top it all off, some commentators claimed regulators should treat MAPS and the entire psychedelic therapy community as a cult.

Did Several Small Criticisms Make a Big Impact?

While some issues raised in the AdComm meeting have some validity, none were new or unknown to the FDA. It did not help that the applicant (Lykos) had minimal opportunity to respond to claims and criticisms during the meeting.

As far as I have seen, nothing discussed in the AdComm meeting changed the basic facts. MDMA-Assisted Therapy—when properly delivered—is 1) reasonably safe and 2) far more effective than any other currently available treatment for trauma.

Instead, most topics raised seemed to have served as a distraction from the unprecedented healing that MDMA Therapy delivers. And I wonder whether the sheer number of issues raised, while carrying little to no weight, might have overwhelmed the committee members and forced the rejection vote.

The AdComm recommendation was likely the main reason for the subsequent FDA rejection of MDMA-Assisted Therapy for treating PTSD.

The Strange Turn of Recent History

I also wonder to what extent a small group of opportunistic and dishonest anti-MAPS people unduly influenced the FDA approval process by sowing enough confusion, ultimately delaying the approval of this therapy.

Interestingly, members of this motivated anti-MAPS group were allowed to present during the public comments part of the meeting. They were allowed to do so without identifying their affiliation and conflict of interest. At the same time, the FDA precluded experts in MDMA-Assisted Therapy from being on their Advisory Panel. The reason for this exclusion was precisely because they had affiliations with the psychedelic therapy community.

And what can we make of a prominent scientific journal retracting three of MAPS’ old (pre-Phase III) research papers only one day after the FDA rejection, but not before?

In other words, as far as I can see, the entire process of FDA approval—while looking very promising for the longest time—seems to have gone wrong in a few quick turns.

Safety First

Safety always comes first. It goes without saying that I fully support all current efforts to make this novel therapy as safe as possible. MDMA Therapy clearly carries some risks. But so do many treatments. Most treatments are about the balance of benefits and risks. When you have heart surgery, the pre-surgery assessment must determine whether the potential benefits outweigh the possible risks. It’s no different with MDMA Therapy.

When your heart opens, it is at greater risk of being hurt—especially if the context is not conducive to healing. Perhaps MAPS underestimated the amount of support that some individuals would require after the clinical trials were over. But anyone who knows anything about MDMA Therapy also knows that when your heart opens in the company of safe and supportive people and therapists, it has an even greater chance to heal.

The current data, as far as I can see, still shows that the great benefits of MDMA therapy significantly outweigh the risks. In my opinion, nothing that Power Trip, the ICER report, or the FDA Advisory Committee discussed so far has changed this basic equation.

The Fallout

And now the MDMA Therapy community is dealing with the fallout. I am no exclusion. I have been trained in MDMA Therapy and started a company that was getting ready to deliver this therapy locally. We have been working with local regulators to bring this therapy under the regulatory umbrella safely and in an accessible way. Unfortunately, our leap into the future of mental health treatment has not produced results. Not yet.

And then there’s MAPS. I extend my heart to Rick Doblin and all those at MAPS who have invested so much in this pioneering work to bring forth one of the most powerful psychological healing modalities humanity has ever seen. Unfortunately, MAPS’s heart-led approach, open science, and transparency have made them more vulnerable to attacks.

Above all, if we could already deliver MDMA-Assisted Therapy safely and effectively in regulated settings, then it is those who suffer from trauma—especially trauma unresponsive to existing treatments—that will pay the greatest price if this therapy remains inaccessible.

So What Now? 

The FDA is now asking for an entirely new study—possibly with many changes to the original elements and study design. If Psychedelic Alpha’s information is correct, the FDA might be asking for changes such as:

• Accounting for the euphoria MDMA causes
• More scrupulous monitoring of abuse potential
• Conducting the studies exclusively in academic research settings (no private practice)
• Better control of potential selection bias
• Better blinding of subjects by using an active placebo
• Hiring an independent research organization
• Perhaps even using an already well-established evidence-based trauma treatment modality

Implementing these changes will likely take years to complete.

As a Canadian, I hope Health Canada can take the lead here. It could review the available scientific evidence with a fresh eye—conducting its own process of regulatory approval of MDMA-Assisted Therapy. Some Canadians can already access MDMA-Assisted Therapy through the Special Access Program. Additionally, Health Canada is now in an advantageous position to gather further data on safety and gradually expand the scope of access to this therapy.

After consulting both my heart and professional ethics, I remain fully committed to my dual mission. I strictly uphold the current regulatory framework in practicing psychotherapy. I also passionately advocate for much-needed innovation in treating suffering, which at present—first and foremost—means seeking regulatory approval for MDMA-Assisted Therapy.

1. Expectancy bias occurs when patients know whether they have received a placebo, as part of a control group, or the actual medication.