FDA opening up to magic mushrooms to treat major depressive disorder

The normally rigid US drug regulator has designated psilocybin, the active ingredient in magic mushrooms, as a “breakthrough therapy”

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While the possibility of federal medical cannabis legalization is still a giant question mark in the US, the Food and Drug Administration (FDA) is slowly opening up to the medical potential of magic mushrooms.

Twice over the past year, the FDA has designated psilocybin, the active ingredient in magic mushrooms, as a “breakthrough therapy” for major depressive disorder.

That classification fast-tracks the development and review of a given treatment that the FDA has deemed “may demonstrate substantial improvement over available therapy.”

That the normally rigid FDA is having an epiphany when it comes to the magic of mushrooms has generated a lot of excitement among researchers.

“What is truly groundbreaking is the FDA’s rightful acknowledgement that major depressive disorder, not just the smaller treatment-resisted depression population, represents an unmet medical need,” says Charles Raison, director of the Usona Institute. It’s one of two research institutes now conducting clinical trials. The other is Compass Pathways, which counts the billionaire Peter Thiel among its investors.

If that research pans out, it could be a paradigm-shifting development in the way depression is treated.

As many as 100 million people worldwide suffer from treatment-resistant depression. And it’s psychedelics – mushrooms for one, but also ketamine and MDMA – that have shown the most promise for treatment.

“Depression is the leading cause of ill-health and disability worldwide,” says George Goldsmith, co-founder of Compass Pathways. “It is a huge unmet need.”

Proponents have long contended that mushrooms have a more long-lasting impact than traditional anti-depressants in the treatment of depression.

That’s because of the nature of psilocybin, which opens unused pathways in the brain that allow people to confront traumas without fear.

The UK-based Beckley Foundation, one of the world’s leading researchers of psychedelics, conducted a study in 2017 with 20 patients experiencing depression.

It found that “all patients showed some reductions in their depression scores” after only one week of treatment. And that “maximal effects were seen at five weeks, with results remaining positive at three and six months.”

The kicker: psilocybin may effectively “reset the activity of key brain circuits known to play a role in depression.”

Many of the patients who took part in the study attributed the effectiveness of the treatment to “a greater willingness to accept all emotions. The psilocybin experience itself, had precipitated an emotional confrontation: a challenging return to old traumas that had led to emotional breakthrough and resolution.” 

Another well-known study by researchers at New York University in 2016 found similar results in cancer patients. It found that mushrooms “had the potential to produce a paradigm shift in the psychological and existential care of patients.”

Researchers recently followed up with some of the 29 patients who took part in that study. They found that many had experienced profound decreases in their depression, even years later.

“The drug seems to facilitate a deep, meaningful experience that stays with a person and can fundamentally change his or her mindset and outlook,” says Gabby Agin-Liebes, one of the lead researchers.

While there’s a lot of promise, psilocybin also faces a lot of the same hurdles faced by cannabis. Psilocybin is still heavily criminalized in both Canada and the United States. In the case of Canada, claims to use psilocybin as medicine are working their way through the courts.

But psilocybin is still classified as a Schedule 1 drug in the United States (along with heroin and cocaine).

A handful of places in the US – Denver, Oakland, and Santa Cruz, among them – have decriminalized mushrooms over the past year. That’s as more evidence surfaces that psilocybin could have a wide range of other medicinal benefits.

But as long as a drug remains in Schedule I, the barriers and costs to research remain onerous, says the Multidisciplinary Association for Psychedelic Studies. The advocacy group has been calling for the decriminalization of mushrooms.

A team of doctors from John Hopkins University recently laid out their argument to ease restrictions on funding for research.

They point out that psychologists, psychiatrists, pharmacologists and neuroscientists have been interested in therapeutic properties of psilocybin for half a century. But that, “Research has been and continues to be limited by the provisions of the CSA (Controlled Substances Act).”

A less restrictive regulatory approach could be the final piece of the puzzle to unlocking psilocybin’s medical potential.

Several Democratic candidates for president in the U.S. have talked about decriminalizing various drugs. Long-shot candidate Andrew Yang has even supported magic mushrooms for veterans struggling with PTSD.

With mounting political will, supported by a growing body of medical evidence, medical mushrooms may not be as much of a fantasy as we think.

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