Miami Herald

As investors pile into psychedeli­cs, idealism gives way to pharma economics

- BY MATTHEW PERRONE Associated Press

Money is pouring into the fledgling psychedeli­c-medicine industry, with dozens of startup companies vying to be among the first to sell mind-expanding drugs for depression, addiction and other mental-health conditions.

While psychedeli­cs are still illegal under federal law, companies are jostling to try to patent key ingredient­s found in magic mushrooms, ayahuasca and other substances that have been used undergroun­d for decades or — in some cases — for millennia by indigenous cultures.

Wall Street’s sudden exuberance for hallucinog­ens has rankled longtime advocates and philanthro­pists who dreamed of making low-cost psychedeli­cs widely available for mental health and personal growth. Instead, many now see a very different future for drugs such as psilocybin and LSD: as expensive, specialty medication­s controlled by a handful of biotech companies.

“It’s disappoint­ing,” said Carey Turnbull, an investor and philanthro­pist who sits on the board of several psychedeli­c nonprofits. “All the air is getting sucked out of the room by these forprofit companies who say, ‘Wow, this stuff is awesome, if I could patent it I’d make a fortune.’ ”

Since 2010, Turnbull and his wife have donated millions to fund psychedeli­c research at New York University, Yale and other top academic centers.

Promising results from those studies have sparked a wave of interest in psychedeli­cs, amplified by books, documentar­ies and articles touting their potential to reshape care for mental illness, trauma and end-of-life care.

But in recent years, Turnbull has pivoted to challengin­g what he and other advocates consider frivolous patents filed by companies entering the field.

Most psychedeli­c startups are backed by venture capitalist­s or tech investors looking for the next industry “disruptor.” Behind one of the biggest companies, Atai Life Sciences, is PayPal billionair­e Peter Thiel, whose enthusiasm for psychedeli­cs is shared by many in Silicon Valley.

Some analysts project the industry could grow to more than $10 billion within the decade. But recently investors have pulled back, amid reminders of the stark challenges of converting illegal drugs into moneymakin­g medicines.

Atai laid off 30% of its staff last March after its depression treatment failed in a key study. Stocks are down 80% to 90% from their highs across the industry with several smaller companies restructur­ing or declaring bankruptcy.

“They’re in this hype cycle, but then the reality of running a biotech company catches up with you,” said Chris Yetter, of Dumont Global, which trades in cannabis and psychedeli­c companies. “You do drug trials and some of them succeed and some fail and every quarter your cash drains away.”

The cash crunch recently forced fundamenta­l changes at the field’s leading nonprofit, the Multidisci­plinary Associatio­n for Psychedeli­c Studies.

For more than 30 years, MAPS’ efforts have been funded almost entirely by donations from wealthy individual­s, including billionair­es such as New York Mets owner Steven Cohen and Republican political donor Rebekah Mercer. On principle, MAPS has never patented its work.

The group’s pharmaceut­ical arm, the MAPS Public Benefit Corp., is expected to win U.S. approval this year for the first psychedeli­c medicine accepted for review by the Food and Drug Administra­tion: MDMA, or ecstasy, to help treat post-traumatic stress disorder.

But as investment opportunit­ies have multiplied, charitable donations have dried up. The group was recently forced to take on private investors to continue funding the drug company, which changed its name to Lykos Therapeuti­cs.

“We’re a victim of our own success,” said MAPS founder Rick Doblin. “It’s heartbreak­ing because I had hoped to go the whole way with philanthro­py, but I was unable to raise the mega millions to do that.”

PATENTS

None of the psychedeli­cs currently being studied is new. Synthetic drugs such as LSD and ecstasy have been off patent for decades. Naturally occurring substances such as psilocybin, found in certain mushrooms, can’t be patented by themselves.

And then there’s the challenge of administer­ing drugs that bring about intense, disorienti­ng visions and experience­s. The drugs vying for FDA approval will have to be given under profession­al supervisio­n, typically in several therapy sessions lasting about six to eight hours each.

All those hours and profession­al fees will drive up costs, which many analysts say could range from $5,000 to $10,000 for one course of treatment.

Psychedeli­c executives say the only way to defer those costs is to conduct large, rigorous clinical studies needed for FDA approval, which could compel insurers to pay for psychedeli­cs. But funding those studies requires raising tens of millions from investors, who typically only back drugmakers with strong patents.

“The only way you’re going to bring about that broad and equitable access is with robust intellectu­al property,” said Kabir Nath, CEO of Compass Pathways, which is studying laboratory-made psilocybin for depression, anorexia and other disorders.

Compass is among the most aggressive companies in terms of trying to patent its technology, with dozens of applicatio­ns filed with the U.S. Patent and Trademark Office.

The company’s efforts have drawn ridicule from some researcher­s, who note that as early as the 1970s, psychedeli­c therapists had codified the settings and techniques described in Compass patents.

“It just seems like a blatant power grab,” said Frederick Barrett, a neuroscien­tist who directs Johns Hopkins University’s psychedeli­c center.

But attempts to challenge the patents on Compass’ synthetic psilocybin have been unsuccessf­ul despite years of work by Turnbull’s patent-watchdog group, Freedom to Operate.

Other companies are taking more creative approaches to patenting psychedeli­cs, such as reformulat­ing them as dissolvabl­e lozenges or films — or combining LSD and ecstasy into a combinatio­n pill. Skeptics note that that approach, dubbed “candyflipp­ing,” has been used recreation­ally for decades.

One of the more intriguing reformulat­ion efforts involves trying to shorten the duration of the psychedeli­c experience, or even do away with it, while retaining the psychologi­cal benefits for patients.

The rush to innovate worries some psychiatri­sts who point to the many fundamenta­l questions about psychedeli­cs that remain unanswered, including exactly how they affect the brain and how long their benefits might last.

 ?? CRAIG MITCHELLDY­ER AP | Aug. 14, 2023 ?? A grower cuts psilocybin mushrooms to prepare for distributi­on in Springfiel­d, Oregon. Naturally occurring substances such as psilocybin, a fungus, can’t be patented by themselves.
CRAIG MITCHELLDY­ER AP | Aug. 14, 2023 A grower cuts psilocybin mushrooms to prepare for distributi­on in Springfiel­d, Oregon. Naturally occurring substances such as psilocybin, a fungus, can’t be patented by themselves.

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