Psychedelic Optimist: MDMA-Assisted Therapy, Why I’m Betting Big, and 3 Unanswered Questions

MDMA changed my life. 

My mom suffered from severe mental illness. As a result, I suffered from childhood abuse, neglect, and physical violence. Most likely, I had undiagnosed PTSD. 

On paper, it looked like I had it all figured out: MVP football player for 12 years, valedictorian of my high school, and a full academic scholarship to Wharton — the #1 business school in the country.

But interpersonally and intrapersonally, I was sick. My relationships with others, the world, and above-all myself were unhealthy. In college, I discovered the field of Positive Psychology, the study of happiness and human flourishing. I realized I wasn’t happy, and I was far from the path to becoming happy. This was the beginning of my personal journey of healing.

I learned I needed a radically different approach, and shortly after I tried MDMA therapy. This was the single most important decision I’ve ever made in my personal journey of healing. I wouldn’t be who I am, for myself or the people and world around me, if it weren’t for what that first experience showed me and for the journey of healing and growth it catalyzed next.

The Growing Mental Health Crisis

I’m not the only one who needed help: mental illness is the #1 public health crisis in the U.S. with 50,000 people dying from suicide, 110,000 dying from overdoses, and 8 million suffering from PTSD every year. 

Unfortunately, the crisis is growing worse because last-generation treatments like talk therapy and SSRIs simply aren’t effective enough. 

After my experience, I delved into the world of psychedelic medicines, and I couldn’t believe what I experienced firsthand and learned through research: study after study showed that MDMA and other psychedelics were the most effective and fast-acting mental health treatments available. But they were stuck on the shelf after the counterculture backlash of the ‘60s and the War on Drugs.

I wanted to help others access this medicine, and launched Mindbloom in 2018 to eventually provide MDMA-assisted therapy. But with no timeline for when (if ever) MDMA might be approved by the FDA, we started with the only psychedelic medicine that is legal to prescribe: ketamine.

Six years and over 500,000 ketamine sessions later, Mindbloom has become the largest provider of psychedelic therapy, and ketamine therapy has earned its new place in the mainstream of mental health care – but a big change is right around the corner.

FDA Approval of MDMA-Assisted Therapy

This August, the FDA will issue a decision on the approval of MDMA-assisted therapy. Many seem surprised that approval may be imminent, but it’s been decades in the making: 

• Research applications for MDMA were first submitted to the FDA in 1986
• The Multidisciplinary Association for Psychedelic Studies’ (MAPS) helped develop and submit a MDMA protocol to the FDA in 1992
• In 2017, the FDA granted MAPS Breakthrough Therapy Designation for MDMA based on the incredible results of their work. 

I’m betting that the approval of MDMA-assisted therapy will be the single biggest advance in the history of mental health. Our objective at Mindbloom is to become the #1 provider of MDMA-assisted therapy, and to transform countless lives in the process.  

But it's not as simple as flipping a switch to make MDMA available. There are a number of unanswered questions that will dictate whether MDMA-assisted therapy helps end the mental health crisis, or becomes a footnote in history.

Why I’m Betting Big on MDMA-Assisted Therapy

One word: outcomes. 

• In MAPS’ phase 3 clinical trial of MDMA-assisted therapy, 87% of patients with PTSD experienced a clinically-significant reduction in symptoms after just three sessions 
• Decades of research on MDMA demonstrate similarly remarkable outcomes 
• These outcomes are significantly stronger than the current treatments for PTSD, which show clinically significant response rates of 31-50% for medication or therapy.

In parallel with the FDA’s movement toward approval, Congress has passed legislation to fund research on psychedelic medicine, and the Department of Veterans Affairs (VA) launched an initiative to deepen research on psychedelic therapies for veterans. 

“This legislation is a historic accomplishment for our Country, our service members, and for science. This achievement, coupled with the recent actions of the VA, have shown psychedelic-assisted therapies are moving from theoretical ideas to tangible therapeutic treatments.” - Mimi Walters, former Congresswoman and Chair of the patient advocacy group Apollo Pact

I'm proud of the role Mindbloom played in supporting this effort, engaging with dozens of Senate and Congressional offices to advocate for psychedelic medicine and telehealth. 

With the support of Congress and the FDA, I’m confident that MDMA-assisted therapy will help end our mental health crisis.

3 Questions We Need to Answer

Despite this momentum, there are still unanswered questions about MDMA-assisted therapy that will determine whether it can live up to its promise.

1. Who can get MDMA-assisted therapy? 

If the FDA approves MDMA, it will be for the treatment of PTSD. 

Providers typically have the flexibility to prescribe medications off-label for conditions beyond their initial approval. However, providers may be hesitant to prescribe MDMA off-label given the stigma around it, and regulators may seek to limit prescriptions to the approved indication. People suffering from depression and other issues beyond PTSD have no idea whether they can get treatment.  

Even if MDMA-assisted therapy is approved on August 11, it won’t be available right away. Both the federal government and individual states will then need to reschedule MDMA out of Schedule I before it can be prescribed – a process that will take at least a few months. 

2. What will treatment cost?

There's concern that MDMA-assisted therapy might become another high-cost treatment option, accessible only to a few. Although the AMA has approved a CPT code for psychedelic therapy, it is unlikely that insurance companies will cover treatment from Day 1. 

The potential for substantial FDA requirements around the administration of MDMA-assisted therapy could make it prohibitively expensive, a scenario we're already seeing unfold in Australia where MDMA-assisted therapy is projected to cost $25,000 or more. 

3. What will treatment look like?

The treatment protocol being reviewed by the FDA includes three medicine sessions and 12 psychotherapy sessions. Typically, the approved dosing and treatment regimen follows the protocol used in the trials – but the FDA has never before approved a medicine-plus-psychotherapy treatment. It remains to be seen whether psychotherapy is a required part of the protocol.

At Mindbloom, we’ve seen that providing coaching, community, and other psychosocial support alongside ketamine drives greater symptom improvements than those achieved through a medicine-only approach. Requiring a therapy component to MDMA treatment could produce stronger outcomes, but would also make treatment more expensive and limit the supply of available providers.

Additionally, as part of its approval decision, the FDA may implement a Risk Evaluation and Mitigation Strategy (REMS) – a set of requirements for treatment that will be instrumental in shaping the landscape for MDMA-assisted therapy. For example, the FDA may require that treatments be conducted in licensed clinics, at least initially. This type of requirement is intended to support patient safety, but also increases costs and narrows the geographic areas in which patients can access care.

There are some within the provider community arguing that more accessible models, such as in-home or other care settings, should eventually be permitted; but it wouldn’t be surprising if the FDA took a more conservative approach with MDMA.

My (Optimistic) View

I believe that MDMA-assisted therapy is going to change the world. It’s impossible to ignore the data demonstrating its effectiveness (and safety), and the stigma around it is dissipating. Congress has made its support for psychedelic medicine clear, and I believe that the FDA understands the importance of making this medicine accessible to people in need.

It’s true that there are major barriers to broad availability – but they’re barriers that Mindbloom has already overcome in expanding access to ketamine therapy, and I’m confident that we can do it again. We’ve transformed countless lives through ketamine therapy, and I couldn’t be more excited to enter a new era in psychedelic medicine.