Should Psychedelics Stay Underground?
Maybe we've been thinking about this all wrong
We need FDA approval for psychedelic therapy if we want more people to benefit from it. To achieve that, we need to bring it out of the underground and into the medical mainstream … right?
That's what I thought.
I even donated money to the Multidisciplinary Association of Psychedelic Studies (MAPS), the nonprofit led by Rick Doblin, which for decades has been pushing MDMA therapy through the federal approval process. It was a grassroots effort, and it felt good to be part of what seemed like history.
Then an odd thing happened.
MAPS ran into financial trouble as it reached the expensive final stages of FDA approval. So, it spun out a for-profit pharmaceutical company called Lykos Therapeutics and raised over $100 million from venture capital firms and other private investors to help push it over the finish line.
Lykos hired 154 employees, including two seasoned executives from the pharmaceutical industry. Its focus shifted from decriminalization and therapy—concepts that are difficult to monetize or scale—to developing and patenting new versions of MDMA, which could generate billions. Doblin’s influence waned.
And then, earlier this year, the whole thing imploded. The FDA roundly rejected Lykos' application for MDMA therapy. Doblin was ousted from the very mission he had single-handedly championed. Lykos laid off 75% of its staff.
It’s not the end of the road for FDA approval, but it’s a huge setback. And it’s made me question everything I once assumed about the path forward for psychedelic therapy.
Maybe pushing psychedelics through our totally broken for-profit pharmaceutical system was never such a great idea?
Fuck the Pharmaceutical Industry
I know it’s a controversial stance, but I sometimes think the pharmaceutical industry might not have our best interests at heart. In fact, I might go so far as to say it’s a corrupt, broken system that manipulates questionable science to maximize profits.
Take Oxycodone. (Actually, don’t—ever.) The FDA approved this epidemic-causing drug in 1995 despite scant evidence of its long-term safety. How did it get approved despite its obvious risks? Good ol’ revolving-door corruption. According to a report from the American Medical Association Journal of Ethics:
… the two principal FDA reviewers who originally approved Purdue’s oxycodone application both took positions at Purdue after leaving the agency. Over the past 20 years, several other FDA staff involved in opioid approvals also left the FDA to work for opioid makers.
Most galling, the FDA has failed to overhaul its approval process despite the obvious and persistent conflicts of interest that sparked the opioid crisis (and the forthcoming benzodiazepine crisis — stay tuned!).
A 2018 study found that 11 of 16 FDA medical reviewers involved in approving 28 products now work for the companies whose products they regulated.
Doblin knew he was wading into a viper’s nest by seeking FDA approval for MDMA therapy. Yet he underestimated the difficulty of achieving approval without resorting to wholesale bribery. MDMA isn’t patentable. Therapy doesn’t scale. So the palm-sweetening money was never going to be there.
The FDA’s rejection of MDMA therapy isn’t about the science. It’s not about study design. It’s about how no new medical treatment can be approved if it doesn’t stand to make gobs of money for someone who can leverage the FDA’s insultingly corrupt process.
The Broken-Car Theory of Mental Health
So yeah, the pharmaceutical-industrial complex is real. But it’s not the only reason we should be skeptical of efforts to bring psychedelics into the medical mainstream.
Mainstream psychology and psychiatry treat mental health problems the way a car mechanic treats a broken car. The Bible of psychiatry—the Diagnostic and Statistical Manual—reads like the user manual for a Rav4:
If the check engine light comes on, check these fluids.
If the patient exhibits despondency, increase serotonin reuptake.
In this model, the human brain is a machine, and mental illness reflects a breakdown in the smooth functioning of that machine.
We’re fed such a steady supply of media bullshit based on this model of mental health that it’s basically the water we swim in. But it’s not the only way to understand mental well-being. In fact, as a scientific model, it has failed by every metric.
According to a 2018 analysis by the New York Times :
Some 15.5 million Americans have been taking antidepressant medications for at least five years. The rate has almost doubled since 2010 and more than tripled since 2000.
That number has only increased since the pandemic. And, damningly, rates of depression have continued to rise.
We’re taking more antidepressants and anti-anxiety medication than ever (by a lot), and we’re more depressed and anxious than ever (by a lot). Maybe it wasn’t as simple as topping up our serotonin.
I’m not anti-science. I have a master’s degree in biology! But the psychiatric model of mental health is flawed. Yet it makes a lot of people a lot of money.
MDMA therapy doesn’t fit into the psychiatric/pharmaceutical box because it’s not about fiddling with neurotransmitters. It’s about reconnecting with love, purpose, and meaning. And that doesn’t show up very well on brain scans.
Keep Psychedelics Weird
So the FDA takes bribes to approve medications that function based on a demonstrably faulty framework of mental health, and MDMA therapy, which actually helps people but doesn’t make a lot of money, was rejected by the FDA.
Checks out.
To me, the question is not how to contort the life-altering potential of psychedelic therapy into our fucked up model of mental health. It’s about how to bring this life-changing experience to as many people as possible. I’ve become convinced that seeking FDA approval for what is, at its heart, a question of meaning, is like seeking approval from the NSA for your wedding vows.
That is, it doesn’t make any fucking sense. The best possible path forward for the medicalization of psychedelic therapy involves stripping it of everything but the substance itself. And the substance that gets approved will likely be patented by some venture capital asshat who took ayahuasca once at his mistress’s Topanga ranch.
Maybe we should stop idealizing medicalization. Maybe we should stop making Faustian bargains with corrupt bureaucrats. Maybe we shouldn’t treat psychedelics, which are deeply fucking weird after all, as just another medication.
What Would This Mean for the Future of Psychedelic Therapy?
If psychedelics were broadly legal, they could evolve organically as a therapy rather than a pharmaceutical. That would allow small-scale guides and therapists to continue developing best practices, rather than relying on a few for-profit players.
Even though the current unregulated underground is rife with problems, I would still trust a local guide more than a venture capital firm to, say, choose the best music for a psilocybin journey.
These therapies are about transcendent reconnection. They’re often about releasing ourselves from the constraints of our toxic culture. So maybe mediating them through one of the most toxic aspects of our culture—the pharmaceutical industry—was never the right path.