Psychedelic drug company Lykos already slashed staff and overhauled leadership.
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Things are going from bad to worse for the company behind an experimental MDMA therapy for PTSD, which the FDA rejected earlier this month.
According to The Wall Street Journal, the FDA is now digging even deeper into the clinical trials for this psychedelic therapy, despite already turning it down. Last week, FDA investigators reportedly interviewed four more people, asking whether the trials downplayed side effects. Some participants in the trial had previously claimed that serious side effects—like suicidal thoughts—were not properly documented, and that they were even discouraged from reporting them to increase the chances of FDA approval.
The MDMA trials have faced intense scrutiny, with experts and FDA advisers highlighting issues like allegations of sexual misconduct at one trial site, biased trial designs, and accusations that Lykos, the company behind the therapy, promoted a near "cult-like" belief in the power of psychedelics.
In addition to the FDA’s investigation, things got worse for Lykos this month when they announced layoffs of 75% of their staff and a leadership shakeup in response to the FDA rejection. On top of that, a scientific journal retracted three of the company’s MDMA studies, citing “protocol violations amounting to unethical conduct”—basically echoing what was brought up during the FDA review.
The roots of the controversy
Part of the problem may lie in Lykos’ origins. The company is a commercial spin-off of the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit dedicated to legalizing psychedelics and exploring their potential as treatments for conditions like PTSD, anxiety, and substance abuse. MAPS was founded by Rick Doblin, a long-time advocate who believes psychedelics could even bring about world peace. Doblin recently stepped down from Lykos’ board as part of the company’s leadership overhaul.
“After 38 plus years of work, I’m profoundly saddened by the FDA decision around this critically needed therapy, but I’m heartened that Lykos will still move forward with clinical research to address the FDA’s concerns,” Doblin said in a statement. He added that by stepping down from Lykos, he can be a more vocal advocate through MAPS to push for global legal access to MDMA and other psychedelics.
Lykos hasn’t commented directly on the FDA’s investigation but told The Wall Street Journal that they’re committed to working with the FDA and addressing any questions. They’re also appealing the FDA’s rejection.
Still, trial participants and other critics have raised serious concerns about Lykos.
“The idea of a therapy cult guiding a drug through clinical trials is a huge red flag,” said Neşe Devenot, a senior lecturer at Johns Hopkins University, in public comments before the FDA’s rejection. “It’s like if Scientology or NXIVM had submitted a new drug application to the FDA.”
Devenot’s comments were included in a report from the Institute for Clinical and Economic Review, which concluded that there wasn’t enough evidence to support MDMA therapy. She was also one of the people recently interviewed by the FDA as part of its investigation.
Lykos’ troubles have sent shockwaves through the psychedelic community, especially among patients—many of them veterans—who have reported benefits from using MDMA to treat PTSD, a condition desperately in need of new treatments.
In the midst of all this, Lykos has brought on David Hough, a former vice president at Johnson & Johnson, to serve as a senior medical adviser. Hough played a key role in developing Spravato (esketamine), a drug related to ketamine, which was approved in 2019 for treatment-resistant depression.
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