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.
This political backing fuels concerns about politicizing the science. Critics warn that relaxing FDA standards or fast-tracking approvals under the influence of industry insiders could undermine the integrity of scientific research, risking future setbacks if safety is compromised.
“The challenge is ensuring that enthusiasm doesn’t outpace the evidence,” As Mason Marks, a Harvard law professor specializing in drug policy, told The Guardian. “Science must remain independent from politics to avoid bringing the entire industry into disrepute.”
Meanwhile, Gracias’s ties to Musk and the military, along with his past work in government, have raised questions about conflicts of interest amid the push for regulatory reform.
So will the FDA now reconsider?
The FDA now has broad discretion to reconsider its previous decisions, potentially issuing emergency authorizations or expedited reviews, creating opportunities for firms like Lykos to accelerate their path to market.
“Maps and Gracias are going to try to seize the moment that we’re in,” Ifetayo Harvey, a former Maps employee and executive director of the People of Color Psychedelic Collective, said. “I think the aim is to get MDMA-assisted psychotherapy approved by the FDA by any means necessary.”
Gracias’ involvement raises quite a few questions for the burgeoning psychedelics industry.
It stands at a crossroads: Whether to forge ahead under politicized but promising conditions or to proceed cautiously to ensure long-term safety and efficacy. As political figures harness deepening public interest in mental health and wellness, industry insiders and regulators face a delicate balance between hope and harm, progress and prudence.
“With the lack of transparency, it leaves us really grasping at what it even means to be Doge,” said Faith Williams, a policy director at the Project on Government Oversight, a non-profit watchdog group, told The Guardian.. “We have seen so many, if not outright conflicts of interest then potential for conflicts of interest, and if not outright corruption, potential for corruption.”
The magic of Burning Man
Rick Doblin, founder and president of the Multidisciplinary Association for Psychedelic Studies (MAPS) and a prominent, longtime advocate for the research and therapeutic use of psychedelic drugs. Doblin said he immediately saw a partnership.
“It was the magic of Burning Man,” Doblin said. “I was sort of looking for a white knight that would come in and would be more focused on healing and on public benefit.”
That spring, Lykos Therapeutics has announced a major leadership shakeup, appointing a new CEO and chief medical officer and restructuring its board of directors. These moves arrived as Gracias and investor Christopher Hohn assumed control.
“Gracias is actively involved in the company’s day-to-day operations,” an unnamed Map director and industry insider, told The Guardian. They said that was emphasizing the influence Gracias now wields over the firm’s strategic direction as it aims to regain regulatory confidence and accelerate clinical trials.
This leadership shift underscores the high stakes and intense industry interest in psychedelics, with supporters and critics alike watching closely as the company navigates complex regulatory and scientific hurdles.
But even more unusually, backers of the the company have been accused of a fundraising effort that allegedly involved doing drugs with investors.
“Definitely part of their fundraising strategy is ‘Meet rich people at Burning Man, do psychedelics with them and get Maps money,’” Harvey, who was Doblin’s executive assistant in 2015, told The Guardian.
Maps addresses allegations of drugs with investors
Maps denied that it used drugs to as a means of drumming up investment.
“MAPS conducts all fundraising activities with the highest integrity and maintains strict ethical boundaries in all donor relationships and fundraising activities. MAPS does not supply controlled substances at any events or gatherings, nor do we use substances as a fundraising tool or strategy,” Maps said in a statement.
Doblin also told Business Insider last year that giving drugs to donors was “not common”.
