MDMA Expanded Access is almost here. What’s it all about?

What does the future hold for MDMA? This is the final part of a 4-part series on the future of MDMA. The series explores the Multidisciplinary Association for Psychedelic Studies’ (MAPS) ongoing FDA phase 3 clinical trials, rescheduling, health insurance, and the FDA program known as expanded access. 

Expanded access and Right to Try are two programs put in place by the United States government to get treatment-resistant patients access to unapproved medications. These programs have been floated as ways to obtain MDMA-assisted psychotherapy before it is potentially approved for use by the Food and Drug Administration (FDA).

MAPS is currently pending approval from the FDA for their MDMA PTSD expanded access protocol—which they submitted on January 14, 2019. Assuming they receive approval from FDA, the Drug Enforcement Agency (DEA), and the Independent Review Board, MAPS will move forward with establishing MDMA clinics and more therapist trainings.

 

Expanded Access

Expanded access—also referred to as “compassionate use”—is a policy which provides a pathway for patients to gain access to investigational drugs through the FDA.  

Expanded access was conceived in 1978 for medical marijuana, after Robert C. Randall sued the U.S. government for the right to use marijuana for his glaucoma. FDA regulations did not specifically describe expanded access as a pathway for access to unapproved drugs until 1987. These regulations were updated in 2009, further clarifying the expanded access process.

In short, expanded access means you can apply, through the FDA, to use drugs which are still undergoing clinical trials.

 

Right to Try

The Right to Try bill was signed into law in the United States on May 30, 2018 to protect the rights of terminally ill patients to try medications that have not been approved for market by the government.

One big difference between expanded access treatment and Right to Try is that the FDA only facilitates the expanded access process. You are not required to go through the FDA for treatment under Right to Try.

The Right to Try bill received bipartisan support, but is not without skeptics. Some include the American Cancer Society Cancer Action Network and nearly 40 other patient advocacy organizations who wrote a letter stating their disapproval before the bill was passed. They claim the Right to Try bill does little to effectuate policy change that would “afford [their] patients greater access to promising investigational therapies.”

Many critics also argue that Right to Try basically does the same thing as the FDA’s expanded access program. But, the whole point of Right to Try is to bypass FDA permissions, so supporters of the policy argue that it saves terminally ill patients precious time.

 

What does this mean for MDMA?

Although there was some buzz about Right to Try when it was initially passed,  MAPS is not planning on utilizing the policy. According to MAPS’ Executive Director Rick Doblin, this is partly because Right to Try is only for terminal illnesses—which PTSD may or may not qualify as.

“But more importantly, [Right to Try] cuts the FDA out of the process, which FDA doesn’t like,” Doblin said. “We’re starting to train therapists for [expanded access] and expect to set up about 50 [expanded access] sites over the next several years.”

As mentioned in Part 1 of this series, MAPS’ expanded access clinics would have to be opened by or in collaboration with therapists who have received the MAPS’ training with MDMA: about 84 people throughout the country, currently. It is going to be a very small market in the beginning, which is often a detriment to affordability for patients.

 

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What are the costs?

For one person to become certified to conduct MDMA-assisted psychotherapy through MAPS 100-hour training program, the minimum cost—before lodging and payments for required supervised sessions—will be around $7,500, according to The MDMA Therapy Training Team’s newsletter. Add in additional supervision costs, travel, and lodging, and certification costs exceed $9,000.

This is looking like the standard rate for psychedelic-assisted therapy training. The Psychedelic-Assisted Therapy and Research Certificate at the California Institute of Integral Studies—one of the only other structured psychedelic training programs—clocks in right around $10,000 for 180 hours of training.

Because training with MDMA is so new, it is unclear if costs will continue to rise, or fall to reflect other specialized therapy trainings like Eye Movement Desensitization Reprocessing (EMDR) and Dialectical Behavioral Therapy (DBT) trainings, which cost around $2,550 and $500 for 40 required hours of instruction, respectively.

Running an MDMA-assisted psychotherapy clinic will require a treatment facility that is “conducive to MDMA-assisted psychotherapy;” at least two therapy providers who have completed the MAPS training protocol; a medical doctor or prescribing physician who can obtain a DEA Schedule 1 license for MDMA, and for patient medical screening; access to a lab for bloodwork; and a cardiologist.

Would-be clinics must be established businesses with medical record storage and billing functions; must have a comfortable therapy room with sofa for reclining; a plan for overnight stays; space for music; must meet zoning requirements; the ability to install audio visual recording equipment to record therapy sessions for supervision; and, the facility must be able to pass a DEA security inspection (alarm system, drug storage room or closet with keypad entry and locking steel cabinet).

Open Society Foundations is providing a $70,000 grant for eight full-tuition therapist scholarships to people of color to help remedy the low numbers of people of color in MDMA clinical trials.

MAPS estimates $15,000 as the standard price estimate for treatment with MDMA-assisted psychotherapy once it is legalized. Doblin has suggested that, for some patients in expanded access, costs could be much lower, depending on how much care a patient requires. But, Doblin also admits, “prices will be all over the place.” This would presumably mean that prices could end up significantly higher than $15,000 for some. Expanded access treatment would be paid out of pocket, as MDMA-assisted psychotherapy is not currently covered under insurance.

(For more on insurance coverage, see Will MDMA-assisted psychotherapy be covered by health insurance?)

With an expensive and resource-intensive overhead for opening clinics under expanded access, entrepreneurs and established clinics—looking at the $15,000 price tag—may start out with an advantage over community-based clinics.

There will always be those looking to make the biggest profit possible. And, a small market of providers for a radically effective — but expensive — new therapy could be a market for overpriced services. Whether or not costs could be lower than this, or prices will drop after FDA approval remains to be seen.

 

Expanding Access Means Expanding Expectations

From expanded access approval forward, MAPS will have to onboard more therapists—which begs the question, how will they all be screened and trained?

According to the MAPS’ Therapy Team Requirements, “Providers qualified to offer MDMA-assisted psychotherapy under a MAPS protocol will be experienced, competent, ethical, and compassionate mental health care providers, with either a valid license to practice psychotherapy in that jurisdiction, or sufficient training in therapeutic communication, ethics, PTSD, and trauma-informed care.”

As the medicalization of psychedelics races forward, the conversations surrounding the ethics of therapists administering MDMA is heating up.

A recent study in The Journal of Neuroscience found that, following administration of MDMA, participants behave more cooperatively with trustworthy partners. What are therapists, if not “trustworthy partners” in a patient’s therapeutic process?

Pair this information with a paper by Torsten Passie, The early use of MDMA (‘Ecstasy’) in psychotherapy (1977–1985), where therapist Deborah Harlow interviews other therapists who have worked with MDMA. Some therapists describe seeing people open up and show their true beauty — some for the first time in years. Therapists describe the patients associating the good feelings to them: “this is about you, you gave me this, you are a goddess.” Some therapists even describe falling in love with a patient in a moment of true breakthrough.

A therapist working with a patient under the influence of MDMA will see them at their most vulnerable. This is where there is the most potential for healing, but also for abuse. Passie outlines some cases which have already emerged of therapists using MDMA to take advantage of their patients (Francesco DiLeo F v. Catherine D. Nugent, or Rick Ingrasci).

These cases spurred the male-female co-therapist teams which are now part of MAPS required protocol. But, it remains to be seen to what extent heteronormatively gender-balanced therapy teams add meaningful protections, beyond an additional observer in the room.

The facility must have the ability to install audio visual recording equipment in the therapy room to record therapy sessions for supervision. This is obviously done with patient well-being in mind, and will likely prevent abuse. However, it also raises data privacy concerns down the road. It is unclear how conversations about recording therapy sessions will be addressed with patients.

 

Will expanded access really expand access?

In the past, politics have played a large role in accessibility to psychoactive drugs through the expanded access program.

MAPS is anticipating that between 250 to 1,000 people will enroll for expanded access treatment throughout the country. But, when it comes to medical marijuana — the drug that expanded access was tailored for — only about 43 people were ever approved for use. And, of those people, only 15 ever received marijuana. This is due in large part to the George H. W. Bush administration ceasing to accept new patients in 1992.

In reality, the FDA approves most expanded access requests. In 2017, only nine expanded access patient applicants out of 1,692 were turned down. So, MAPS’ numbers, though optimistic, are not completely unrealistic estimations — as long as MDMA stays in favor with the people making the rules.

 

Getting In Position

In part 2 of this series, How Will MDMA Be Rescheduled In The Future? You May Be Disappointed we reported that, if approved by the FDA, only MAPS’ specific GMP (Good Manufacturing Practice) MDMA will be rescheduled after the successful completion of Phase 3.  Assuming this GMP MDMA is rescheduled, some of the approved expanded access sites will most likely convert into regular therapy sites. Some states do not automatically reschedule everything that the DEA reschedules, so legislative and administrative procedures will have to be initiated to officially reschedule GMP MDMA in those states, according to Doblin.

In those states, though, clinics will be able to continue to operate under expanded access until/if/when rescheduling happens.

As it stands, there seems to be an incentive for prospective MDMA clinics to get expanded access approval.

Only 250 to 1,000 potential expanded access patients spread across the country means there’s not a lot of money to be made for early expanded access clinics. But, even if they don’t see many patients at the outset, these clinics will presumably be the first to market when MDMA is eventually rescheduled. And, in a new and potentially strict regulatory terrain, there’s a lot to be said for developing experience, patient lists, and other connections before the competition really takes off.

 

Concluding thoughts. Looking to the future

These early mover advantages don’t necessarily mean initial investors are only interested in profiting down the line. Perhaps they are just smart and on a mission to provide MDMA to the world as soon as possible.

But, as more and more clinics begin to offer MDMA-assisted therapy, let’s not lose sight of the experience the drug catalyzes. MDMA has the invaluable ability to introduce people to the ingredients for a better society—what it is like to trust and be trusted, be vulnerable in the presence of others, love yourself and the world around you.

Legalization may bring with it the undeniably positive outcomes of wider exposure to these ingredients. Or not.

Clearly, there is more to MDMA-assisted psychotherapy than just swallowing a pill. But, I have to wonder who is profiting when a drug with a street price of around $15 a pop may end up costing over 1,000x more after approval and regulation.

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