Mindbloom’s Founder & CEO Breaks Down the FDA’s decision to reject MDMA Therapy

When you work in psychedelic medicine, optimism for the future comes naturally.

You see study after study showing the indisputable effectiveness of psychedelics to improve mental health.

You hear story after story about real people whose lives have been saved or transformed.

You read statistic after statistic showing how hellacious the legacy mental health paradigm has become.

• 13 Million: Americans suffering from PTSD
• 2: Medications approved for PTSD
• 22: Years since last PTSD drug was approved (Zoloft)
• 123: US soldiers killed in the Afghanistan War annually
• 573: US soldiers killed in the Iraq War annually
• 6,205: US veterans killed by suicide annually

My optimism got a wake-up call over the past three months as the public battle over the approval of MDMA-assisted therapy (MDMA-AT) reached a fever pitch.

On August 9th, the FDA shockingly decided not to approve MDMA-Assisted Therapy, indicating it still has “no accepted medical use.”

As the Founder & CEO of a psychedelic medicine healthcare company, I felt disappointed.

As someone who suffered from PTSD due to childhood abuse from a mother with severe mental illness, I felt saddened.

As someone who attributes MDMA as the #1 reason he moved past PTSD and became a better person for himself, his family, and his community, I felt outraged.

When MAPS’ Phase 3 clinical trials for MDMA concluded, the results were celebrated. Approval was widely believed to be inevitable. 

The FDA rejecting MDMA feels like a plot twist as surprising and gut-wrenching as Bruce Willis being dead at the end of The Six Sense and Ned Stark getting beheaded in Game of Thrones.

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How could the FDA reject the application for MDMA-AT after designating it a Breakthrough Therapy, helping Lykos design the clinical trials, and granting Priority Review? 

How could the FDA deny 13 million Americans the most effective PTSD treatment in history?

The deeper you examine it, the more dubious the questions that arise. 

Why was an exec from Big Pharma – the people with the most to lose if MDMA is approved – sitting on the FDA’s Advisory Committee that blocked approval?

And why did the journal that published three of the Phase 2 studies mysteriously retract the studies only two days after the FDA’s decision?

It seems like the FDA and this journal were influenced by something other than the data. But don’t take it from me – listen to Congressman (and retired Marine Corps Lt. General) Jack Bergman and 60 other bipartisan members of the Congress asking President Biden to support the approval of MDMA:

We are aware that as this application has made its way through the regulatory review process, certain groups and individuals have voiced criticism of the application. It is our understanding that while these critics may be well-intentioned, their criticism is not necessarily reflective of the science, but rather their personal ideological beliefs and biases related to the medicalization of substances like MDMA.

‍While all Americans are free to voice their views on this and other topics of public interest, scientific evidence should not be ignored in favor of those who have been on a mission to discredit this promising treatment at all costs – especially when that would come at the cost of our servicemembers and Veterans.

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49,000 Americans commit suicide annually. 

Studies suggest 25% of those victims have PTSD.

Meaning over 12,000 Americans suffering from PTSD die by their own hand every year.

And it could take 3 or more years to get MDMA-AT through another round of Phase 3 trials.

Let’s unpack how bias and questionable outside influence convinced the FDA to say no to the most effective PTSD treatment in history and yes to up to 36,000 suicides.

How Did We Get Here?

• 1912: MDMA first synthesized by Merck in Germany
• 1970: Therapists begin using MDMA with PTSD patients
• 1985: DEA classifies MDMA as a Schedule I drug, indicating it has “no accepted medical use”
• 1986: The Multidisciplinary Association for Psychedelic Studies (MAPS) is founded 
• 2010: MAPS publishes first study of MDMA-AT for PTSD
• 2021: Lykos (f/k/a MAPS) publishes first Phase 3 study results
• 2023: Lykos publishes second Phase 3 study results
• February 2024: FDA accepts new drug application for MDMA-AT 
• June 2024: FDA holds Advisory Committee hearing, which votes against approval
• August 2024: FDA declines to approve MDMA-AT

Notice anything interesting?

The FDA consistently supported MDMA-AT. 

They green-lit every clinical trial.

They helped Lykos develop the Phase 3 study protocols that would provide the basis for approval.

They granted Breakthrough Therapy designation and Priority Review both of which accelerate development for medicines that, as the FDA states, “would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.”

Why would the FDA consistently provide such strong support of MDMA-AT? 

Because while MDMA is currently a Schedule I drug, meaning it’s supposed to have “no accepted medical use,” the evidence shows it’s stunningly effective.

The Phase 3 trials showed the below results for study participants after just 3 MDMA sessions paired with talk therapy:

• 87% experienced “clinically significant” improvements
• 71% no longer qualified for a PTSD diagnosis
• 46% achieved full remission

“These results are nearly double those of existing PTSD treatments, rendering MDMA-AT the most effective PTSD treatment ever developed.”

That line is a banger, and I wish I wrote it. It was written by 61 Members of Congress who pressed President Biden to approve MDMA-AT. The results of MDMA therapy aren’t just numbers to me—they’re a reflection of my own transformation. Like so many others, after just a few sessions, I experienced life-changing results that altered the course of my life.

It’s no wonder the FDA saw the evidence supporting MDMA-AT and wanted to fast-track its approval. And the FDA wasn’t alone: The U.S. Department of Veterans Affairs was already working to roll out MDMA-AT for veterans.

The FDA Advisory Committee Meeting

In May 2024 the FDA announced that they would convene an “independent” advisory committee to hold an open hearing on MDMA-AT.

The AdComm would review results from studies of MDMA-AT, including the Phase 3 trials, and hear from Lykos, the FDA, and other interested parties, before voting on whether to recommend approval.

Unfortunately, the hearing was doomed from the get-go.

As the AdComm members introduced themselves, I was shocked to see an executive from Johnson & Johnson identified as an “Industry Representative.”

What industry does she represent? Certainly not the psychedelic medicine industry.

She works for J&J, the 24th most valuable company in the world with a market cap of $386 Billion. J&J manufactures Spravato AKA esketamine (one of the two isomers found in regular ketamine), as well as other mental health drugs that bring in billions of dollars in sales each year.

Big Pharma has more to lose than anyone if MDMA-AT is approved: their business model depends on not curing patients so they have to take pills every day for the rest of their lives. 

As my friend Calley Means, former lobbyist and now founder of healthcare financial accessibility company TrueMed has spoken about extensively, Big Pharma profits from keeping people sick. There’s nothing more threatening than a treatment that cures patients after only three sessions. 

But the J&J rep sitting at the table wasn’t the only problem – only one of the 11 members had any experience in psychedelic medicine.

Imagine creating a breakthrough in your field, only to have it judged by those who don't understand it — and profit from its failure.

Horrifying, right?

Meanwhile, the FDA’s presentation highlighted the massive need for better PTSD treatments, and acknowledged the strong data supporting MDMA-AT. 

They even laid out the elements of a Risk Evaluation and Mitigation Strategy (REMS) that they believe would assuage concerns about safety and misuse of MDMA after approval.

In addition, a number of veterans and other trauma survivors whose lives were transformed by MDMA-AT shared their moving stories.

Yet, the panel’s criticisms ranged from squint-and-it-might-look-reasonable to preposterous.

Concern #1: Functional Unblinding 

The main concern from the FDA and others was that study participants were functionally unblinded – in other words, they knew whether they received MDMA or the placebo.

The standard in drug development is a double-blind, placebo-controlled study where neither the patient nor the provider knows whether the patient is given the medicine or a placebo. The fear is that if a participant knows they’re getting the medicine, expectation bias will cause them to overstate the benefits of the treatment.

Double-blinding works well in most cases, but not with psychedelics, obviously.

Unblinding isn’t a new concern: it was explicitly taken into account – and protected against – when Lykos and the FDA designed the Phase 3 trial protocol. It’s also acknowledged as a concern, but not a blocker, in the FDA’s 2023 draft guidance for clinical investigations of psychedelics.

Unblinding also was an issue in J&J’s trials of esketamine, and a number of other drugs whose effects you can feel. This isn’t limited to drugs that alter consciousness – it’s come up in trials of other drugs for sleep, anxiety, and other issues. 

Unblinding didn’t stop those drugs from being approved, but it was cataclysmic for the AdComm.

The concerns seem especially dubious given testimony from others at the hearing. Researchers argued persuasively that the positive impact of MDMA-AT was so strong that even if you discounted by 50% for unblinding and expectation bias, the outcomes would still be stronger than psychotherapy and SSRIs for PTSD. 

Concern #2: Effects of the Medicine vs. Psychotherapy

Members of the AdComm expressed concern that the studies didn’t adequately distinguish the contribution of MDMA from the contribution of psychotherapy to the benefits of treatment. 

So what? 

The treatment is MDMA-assisted therapy, and the evidence shows it’s effective – why would it be necessary to tease out the contributions of each component?

In any event, the participants who received MDMA plus therapy had significantly greater improvements from treatment than the participants who received a placebo plus therapy, so it’s hard to understand how the data could be insufficient on this point.

Concern #3: Safety 

The AdComm found that the Phase 3 trials didn’t adequately address concerns about the safety of MDMA, particularly its impact on cardiovascular health.

Most commentators have found this concern to be totally unfounded. While about 46% of participants did have an increase in blood pressure during treatment, that increase was short lived (it resolved by the time the medicine wore off) and didn’t have any serious impact on the participants. It appears this would only be a concern for patients with pre-existing heart disease – which can be screened for before treatment. We do this at Mindbloom. It’s not hard.

AdComm members also raised concerns that the Phase 3 studies didn’t evaluate liver function. But liver function was addressed in the Phase 1 and 2 studies, and didn’t raise serious safety concerns.

Overall, it feels like these concerns amounted to speculation that MDMA could be dangerous in some way that hadn’t been evaluated. But I haven’t seen any evidence among any of the MDMA trials that this medicine presents serious safety risks that cannot be mitigated by standard clinical measures.

Concern #4: Abuse Potential

It’s no secret that MDMA is used recreationally. But the risks of misuse are well-known, and researchers agree that the abuse potential of MDMA is lower than common drugs of abuse in Schedule I.

The issue at the AdComm wasn’t specific evidence of abuse – it was missing evidence. Apparently, the FDA told Lykos to collect data on “positive” adverse events related to abuse like “elevated mood,” and Lykos didn’t do so.

Let’s be clear: if the FDA told them to collect this data and they didn’t, that’s a mistake.

But let’s also be clear: calling “elevated mood” an “adverse event” in the treatment of PTSD is absurd.

These people are suffering, and killing themselves at a terrifying rate – we’re worried that they’ll feel too good?

In any event, others at the hearing pointed out that the risk of misuse could easily be controlled, for example, by only administering MDMA in licensed clinics – just like Spravato, the psychedelic medicine FDA approved and manufactured by J&J. 

Concern #5: Attacks Against Lykos

One of the most surprising parts of the hearing was the attacks leveled against Lykos.

To start, there is a well-documented case where one of the study participants was abused by one of her therapists. This is absolutely wrong, and should never have happened. But it was known long before the AdComm, and there was no indication that it made the study data any less reliable.

But the attacks against Lykos went far beyond that incident. They were accused of being a “therapy cult” (whatever that means) and agreeing with therapy practices of researcher (and legend) Stanslav Grof who they accused of being homophobic, among other allegations that had no relationship to the effectiveness and safety of MDMA-AT.

It was bizarre to hear these ad hominem attacks repeated over and over – it seemed like members of the AdComm and invited speakers didn’t want Lykos/MAPS to receive approval for MDMA-AT, irrespective of the merits of the treatment itself.

At the end of the hearing, the AdComm voted 9-2 that the available data does not show that “the drug is effective" for PTSD, and voted 10-1 that the benefits of MDMA do not outweigh the risks.

Unsurprisingly, the only member of the AdComms who had experience researching psychedelics – a psychiatrist with the U.S. Department of Veterans Affairs – voted yes

The FDA’s Decision and Aftermath

After the hearing, criticisms of the AdComm grew. 

Dr. Franklin King, a psychiatrist at Harvard Medical School, said:

"Advisory committee members really showed a kind of astounding lack of knowledge about the subject matter."

Congressman Bergman said:

"I’m disappointed that the FDA advisory committee chose to ignore the voices and testimonies of Veterans whose lives have been forever improved by MDMA-assisted therapy, and instead voted in favor of those who have been on a mission to discredit this promising treatment at all costs."

Dr. Natalie Gukasyan, an assistant professor of psychiatry at Columbia University, said:

"It’s almost like this came as a total surprise that this was the study design, when in fact the FDA approved this design."

Congressman and former Navy Seal Morgan Luttrell criticized the AdComm vote as “stemming from a lack of education and experience around the clinical use of psychedelics.”

As time went on, more evidence came out about the people behind the opposition to MDMA-AT. 

It seems that the opposition was led by an organization who labeled veterans “murderers” and “imperialists,” and claimed that treating veterans for PTSD “perpetuates the logic of white supremacism, capitalism and imperialism.” For whatever reason, this organization seemed hell-bent on preventing Lykos from receiving approval of MDMA-AT.

Encouragingly, veterans organizations mobilized to urge the FDA to approve MDMA-AT, and were joined by 80 Senators and Congressmen – a remarkable show of bipartisan support for psychedelic medicine. 

Legislators like Congressman Dan Crenshaw even went farther, calling out the bizarre accusations leveled at Lykos during the AdComm and the shadowy organizations behind them.

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But this wave of support wasn’t enough: on August 9, the FDA sent a Complete Response Letter to Lykos informing them that the application would not be approved, asking them to conduct an additional Phase 3 trial to evaluate safety and effectiveness.

Although the letter isn’t public, Lykos’s press release says that the issues expressed in the FDA’s letter echo those raised during the AdComm. 

Lykos maintains that its data is sufficient, and says it will ask the FDA for reconsideration of its decision. That process is a long-shot, but given the strength of the data – and the support from Congress, veterans, and others – they’ve got a chance to succeed.

Two days after the FDA’s decision, the journal Psychopharmacology retracted three studies of Lykos’s Phase 2 trials of MDMA-AT.

The retraction was apparently due to an incident reported in 2019 where one of the therapists in the trial had an inappropriate sexual relationship with a patient.

That relationship was undoubtedly improper. But it had no impact on the validity of the data in any of the three studies – and could easily have been addressed by a correction.

So why did the journal retract these three studies, only two days after the FDA’s decision – but five years after the incident was reported

The only thing I can conclude is that the journal gave in to the prejudice, bias, and fear perpetuated by the smear campaign against MDMA-AT and Lykos.

What’s Next for Psychedelic Medicine?

The FDA’s decision is crushing for the 13 million Americans suffering from PTSD.

This isn’t just a setback—it will result in many needless deaths, with devastating impacts on families and communities. 

If I hadn’t received MDMA therapy I genuinely don’t know who or where I would be today.

But in the big picture, I’m still a Psychedelic Optimist.

Here and elsewhere, the FDA is providing guidance to the industry about what needs to be true for a psychedelic medicine to be approved. Organizations with drugs in the pipeline are taking note, and will use that guidance to achieve approval for MDMA, psilocybin, LSD, 5-MeO-DMT, Ibogaine, and others.

If Lykos is required to conduct a new Phase 3 trial, it could be a few years before MDMA is approved. 

But Compass Pathways and Usona both have Phase 3 trials of psilocybin underway, with approval expected as soon as 2026.

This is a difficult learning process that will ultimately lead to the approval of a number of psychedelic medicines.

In the meantime, we must continue to increase access to the best treatments available today – and fight the bias against psychedelic therapies. 

Ketamine therapy is the only legal psychedelic medicine, and studies have shown it can be highly effective for PTSD treatment, offering hope to those in need of immediate treatment. That’s why Mindbloom, the psychedelic medicine company I founded, launched a PTSD program this year.

In every crisis, I remind myself of the parable of the Chinese farmer, which teaches us that it’s impossible to know in the moment whether something happening to us will be good for us or bad for us in the long term. Every obstacle is an opportunity, and I’m optimistic about how we’ll all come out stronger from this one.