“Definitely part of their fundraising strategy is ‘Meet rich people at Burning Man, do psychedelics with them and get Maps money.’”
Antonio Gracias, Elon Musk’s close ally and Tesla (TSLA) board member, has pivoted to a controversial takeover of Lykos Therapeutics, a biotech firm developing MDMA-based therapies once rejected by the FDA for safety concerns, The Guardian reports.
As the psychedelics industry inches toward mainstream acceptance, new developments reveal how politics, science, and industry interests are shaping the future of mental health treatments.
But Gracias’ involvement in the regulatory body of the company he is now boosting is raising eyebrows, The Guardian reports.
Lykos, which announced a $50 million recapitalization earlier this year, has been at the front of pioneering some of the most promising research into MDMA-assisted therapy. But the firm’s recent FDA rejection of its clinical trials, which cited flaws linked to bias and trial design, has cast doubt on its prospects for approval.
Thanks largely to debates about scientific rigor, the agency ordered new Phase 3 testing, a process likely to take several years and cost millions.
The company’s opponents argue that flawed science led to the rejection, while supporters believe in the therapeutic potential of MDMA under proper regulation.
Neither Lykos nor Gracias responded to a request for comment.‘Greasing the wheels’ for regulation?
Gracias’s recent leadership of Lykos, financed with a $50 million infusion backed by wealthy investors including hedge funds and veteran executives, arrives as Republican and Democratic officials alike are warming to the idea of faster approval for psychedelic medicines.
Some top Trump-era health officials, such as former officials and lawmakers, have publicly supported reevaluating the regulatory process, citing promising early results and patient demand.
This is raising alarm bells with ethics experts.
“You can’t be greasing the wheels and then say, ‘OK, now I’m going to quit and go pursue that approval,’” said Cynthia Brown, senior ethics counsel at the non-profit watchdog group Citizens for Responsibility and Ethics in Washington, told The Guardian.
