Where Does MDMA Psychotherapy Go From Here?

On June 4, 2024 an FDA advisory committee recommended that the FDA do not give approval for MDMA assisted psychotherapy (MDMA-AT), with the final ruling coming by August 11, 2024. Since then the psychedelics world has erupted with chatter about the unexpected setback. After reading articles, social media posts, and blogs over the following weeks, only one thing can be certain- uncertainty.

People far and wide have chimed in following the ruling’s reverberations. The “new drug application 215455, for midomafetamine (MDMA) capsules, submitted by Lykos Therapeutics, for the proposed indication of treatment of post-traumatic stress disorder,” no longer can be expected to be a sure thing. More than a few people seemed to have counted their chickens too early, igniting a flurry of volleys both in support of, and against the novel treatment. Now with more questions arising than answers, let’s take a look at some broader topics that may deserve more consideration, rather than discuss if Lykos is a “therapy cult” or if MDMA leads to cocaine and alcohol use.

Is Peer Pressure MDMA-Assisted Therapy’s High School Moment?

MDMA’s irony runs deep and rich. Often young people face peer pressure while in high school to do psychedelic compounds. The United States may now find itself on the same stage, getting pressured by MDMA. Other countries and more American organizations continue to join the MDMA movement which may increase external pressure on the U.S. government to join the cool kids, and not be sitting at the lunch table alone.

Australia already approved MDMA-AT in 2023, and by no stretch of the imagination is Australia alone. Both Canada and Switzerland are making moves to pave the way for further MDMA-AT research, if not, outright legalization. The Netherlands is also striding towards therapeutic use of MDMA.  But the two latest entrants to the MDMA-AT wave rolling across the globe come from war torn countries.

For years now Israel has been studying MDMA, backed by the efforts of MAPS Israel. However, Israel is now setting up a groundbreaking MDMA study for soldiers, civilians and hostages, in the wake of the October 7 attack in 2023. Another war torn country courts MDMA as Ukraine now also plans to investigate MDMA’s efficacy for its soldiers and veterans. Facing collective traumatization during their brutal war with Russia, MDMA may not be enough, so Ukraine is exploring ketamine therapy too. American soldiers need just as much help, if not more.

Many American military veterans have championed psychedelics for PTSD in recent years, so much so that they’ve recruited the most unlikely of supporters to their side, like former Texas governor, Rick Perry, for example. Their efforts seem to be paying off as “The VA is quietly fast-tracking MDMA therapy for veterans.” Not wanting to be left without treatment of their own, police officers in the United States are now asking for MDMA to treat their PTSD. Thirty years ago ravers weren’t imagining the unity in P.L.U.R. included soldiers and police officers. Welcome to 2024.

Despite the FDA advisory committee’s disparaging ruling, how long can the U.S. government and FDA resist this kind of growing global and national pressure? A better question might be, how long can science itself stand up to newfound pressure?

Science Can’t Science?

“May you live in interesting times,” is an old Chinese phrase that acts as a blessing and a curse at the same time. This couldn’t be more true for our current era. More than ever, science is learning about these “interesting times.” Evidence keeps surfacing which suggests that the problems of current reality have outstripped our epistemological, scientific framework.

One of the main issues of the FDA advisory committee ruling is the Lykos trial’s problem with “functional unblinding.” That is to say, the trial participants who weren’t supposed to know if they were given a placebo or MDMA, knew they didn’t get MDMA. This is the trickiest problem with psychedelic research. How does a study maintain veracity and integrity when participants know they aren’t on the psychedelic compound? The integrity of science goes beyond just psychedelics however.

The inability of science to replicate identical results often goes under the radar. Discovered in the early 2000s, the term “replication crisis” was coined in 2010. The replication crisis refers to the inability of many scientific studies to reproduce the same results as previous investigations. Again and again, scientists fail to replicate the same results, especially in soft sciences, namely psychology. Why is psychology called a “soft science?”

Psychology is a “soft science” due to it being “… more difficult to establish measurable criteria when working on the analysis of how the mind works, these are less rigidly required to follow the scientific method, making them “soft” subjects.” Thus, it’s not difficult at all to see how this creates a big problem for psychedelic research.

Opponents of MDMA-AT have lodged complaints about a fundamental piece of the psychotherapy involved- the “inner healing intelligence.” It’s hard to prove or disprove, when the mind, soul, psyche and spirit is involved, as we begin to reach the limits of empiricism. How does science respond to a challenge to its…soul? In the U.S., you throw money at the problem and turn up the influence.

Does Big Money Get What it Wants?

Let’s be honest, big money gets what it wants in the United States, right? During the Gilded Age, corporate titans like Rockefeller, Carnegie, Morgan and others set the agenda for decades to come. Not much has changed since. The “whales” splash money when they know they aren’t getting beached. So who has made moves in the psychedelics field?

Foremost among the whales funding MDMA research are Bob Parsons, the billionaire founder of GoDaddy and billionaire hedge fund manager and Mets owner, Steve Cohen. Parsons donated $5 million to Mount Sinai’s psychedelic research center, along with $2 million to MAPS. While Cohen gave a $5 million grant to MAPS. This doesn’t even include the lineup of other high profile names funneling money into various psychedelic avenues.

Back in 2017, Tim Ferriss, WordPress co-founder Matt Mullenweg, investor Craig Nerenberg and TOMS shoes founder Blake Mycoskie pledged $17 million to John Hopkins to launch a Center for Psychedelic and Consciousness Research. Don’t forget major plays by PayPal founder Peter Thiel investing in ATAI Life Sciences and OpenAI CEO Sam Altman’s bet on Journey Colab. Last but not least, David Bronner by way of Dr. Bronner’s, “…committed $1 million to MAPS in 2020, in fulfillment of the fourth year of a commitment of $10 million over ten years.”

Bronner also sits on the board of the Psychedelic Science Funders Collaborative (PSFC). The PSFC is a “…group of American millionaires and billionaires who fund roughly 70% of psychedelic research and charities (that’s a guesstimate)…” The PSFC has caused another psychedelic stir, after hiring 4 public relations companies, who are working in tandem with veterans and veteran organizations to do political damage control in the wake of the FDA advisory committee disappointment.

With whales tossing this kind of money around combined with pharmaceutical analysts predicting “FDA-approvedpsychedelic-assisted therapy could seize $10 billion in annual sales by targeting the treatment-resistant depression subcategory alone” it’s hard to see how MDMA-AT won’t be federally approved sooner than later. Furthermore, with public relations campaigns kicking off, and generous donations and grants flowing into newly founded psychedelic research institutions and universities, how long can the FDA hold out?

Will MDMA-AT Cost Create “Haves” and “Have Not’s”?

With all the support and enthusiasm for MDMA-AT, we might be led to believe that MDMA capsules will be thrown to the masses like candies from a Mardi Gras float. This is far from the truth, because MDMA-AT’s cost makes it prohibitive for most.

MDMA is cheap to produce. For illegal, recreational use, MDMA costs as little as $0.50 per pill to manufacture. Legal production of MDMA might be even cheaper, but this is where “cheap” and MDMA part ways. For a person seeking treatment, the initial price estimate of MDMA-AT is $11,000. This MDMA-AT pie chart itemizes each cost. However, expanded health care insurance requires something- FDA approval.

The Institute for Clinical and Economic Review (ICER) exerts influence on the FDA and ICER made approval of MDMA much harder. In its final report, ICER found that the mean medical cost to treat severe PTSD with MDMA-AT would cost $19,720, almost $9,000 more than previous estimates. Considering insurance companies cover less and less, how does this land with corporate healthcare giants?

Even if MDMA-AT receives FDA approval and access widens thanks to expanded health insurance coverage, millions of people will still be left behind. Millions of Americans lack health insurance, and many more rely on the Affordable Care Act which still makes people afraid to see a doctor or go to the hospital. Moreover, most people won’t be able to afford this out-of-pocket, so they will have to rely on their health insurance. Worse yet, the likelihood that people without robust health insurance need MDMA-AT the most, runs high.

To the dismay of those in pain and suffering, the link between socioeconomic class and trauma isn’t anything new. Family socioeconomic status has been linked to childhood trauma and evidence shows “…that low socioeconomic positions are overrepresented in trauma populations.” Even if people of low socioeconomic positions seek alternatives, underground MDMA-AT can still cost between $3,000-$5,000, which is a non-starter in the current economy.

MDMA’s Near Future is a Roll of a Dice

Where the FDA goes from here is anybody’s guess. The FDA has voted contrary to the advisory committee in the past, but only around 20% of the time. This means that MDMA-AT has a 1 in 5 chance of getting approved. But there’s a bigger issue here.

Does the FDA approve a treatment that includes psychotherapy which poses a fundamental challenge to empirical methods of science? Does the FDA acquiesce and admit the limitations of contemporary science? Or as government bureaucracies often do, does the FDA remain rigid, inflexible and maintain the status quo despite growing pressures from various angles?

Does anyone else get the feeling that there’s more at stake here than MDMA alone? The coming ruling is a crapshoot and betting on it isn’t recommended, unless you’re a whale.