Denver Psychedelic Conference Focuses on Regulatory Processes, Science

June 22, 2023 · Green Market Report

High costs and regulatory hurdles still need to be overcome by psychedelics industry.

Business opportunities in the world of psilocybin, MDMA, and other mind-bending substances are still limited, but that doesn’t mean the industry is standing still, as demonstrated by the 12,000 attendees from all over the world at the Psychedelic Science 2023 conference in Denver this week.

There were only cursory mentions Wednesday during the conference’s business panels of the burgeoning psilocybin trade that has cropped up in California, Colorado, Oregon, and other states. But the conference host, the Multidisciplinary Association of Psychedelic Studies, spent an hour laying out its plan for a federally backed psychedelic treatment regimen that it hopes to launch next year.

“It’s a really exciting time,” said Michael Mullette, the chief operating officer of the MAPS Public Benefit Corp.

Business-focused speakers on Wednesday primarily keyed in on the heavily regulated environment through which nonprofits and large companies can get federal approval to begin setting up large-scale and expensive treatment centers that are expected to charge patients roughly $10,000-$20,000.

Mullette described the MDMA “hub” that the MAPS PBC envisioned as playing a central role in supporting a broader psychedelics supply chain, which would also include new MDMA trainings for therapists. He said the plan currently is to submit a New Drug Application to the U.S. Food and Drug Administration within a few months, and ideally to start offering treatments by the end of 2024, as long as the FDA signs off.

With approval from the FDA, health insurance should be able to help bring the cost of treatments down, Mullette said during one of Wednesday’s presentations. The MDMA-assisted therapy that MAPS hopes to bring to the U.S. market will focus on the 13 million patients suffering from post-traumatic stress disorder, he said.

“The reality is this is going to be challenging. The devil’s in the details,” Mullette said. “It is very expensive, to bring any sort of drug … to market.”

Josh Hardman, the founder and editor of Psychedelic Alpha, estimated that many current psychedelic treatment regimens cost up to $20,000 per patient, making clinical treatments cost-prohibitive for many. Hardman also estimated it costs corporations – including the MAPS PBC – upwards of $1 billion to develop new drugs and get them approved by regulators.

“This isn’t doom and gloom. It doesn’t mean we can’t convince payors it’s cost-effective,” Hardman said, before adding that the cost “is a big challenge.”

Hardman also cited statistics showing that capital raises by psychedelics companies have dropped off a cliff since peaking in 2021.

Psychedelics advocate Natasia Poinsatte, who is working with the state of Colorado to implement Proposition 122, the psychedelics ballot measure voters approved last year, also reminded conference-goers that social equity is a major plank of the upcoming state industry. She said the psychedelics trade will be very different from the marijuana business.

“We want to make sure that equity is part of the conversation, part of the foundation from the beginning,” said Poinsatte, who is also director at the Colorado branch of the nonprofit Healing Advocacy Fund.

Poinsatte said that the Colorado psychedelics system per Proposition 122 is a “therapeutic model,” with patients who would likely only use psychedelics “once or twice over the course of a year,” whereas many marijuana consumers use daily.

“So that is a completely incomparable market system,” Poinsatte said. “The temptation is to say, ‘We’ve done this with cannabis, now let’s do it with psilocybin.’ … (That’s) not going to go well.”

MAPS founder, Dr. Rick Doblin, emphasized during a press conference that he and his nonprofit support the legalization of all drugs, and said that he believes the gray market in various U.S. states is helping push reform efforts forward. But he acknowledged that there needs to be a careful balance between the profit motive and accessibility for patients.

“The gray market is moving in the direction of legal access,” Doblin said. “Moving in this direction of commercialization is an essential step we need to make. And that will provide access, and the key is going to be the insurance coverage.”

Though the federal government is key to the approach being taken by MAPS and many other large companies to psychedelics, there’s also continued reform momentum at the state level, two lawmakers from very different states told conference-goers.

State Reps. Alex Dominguez of deep-red Texas and La Shawn Ford of ocean-blue Illinois both said their respective legislatures are seriously considering legalizing psychedelic treatments.

“There is a desire in red states to pass this type of legislation. The willingness is there, but I think the approach needs to bring a coalition to the table,” said Dominguez, a Democrat who left office in January. (Full Story)

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