There’s more bad news for the company behind an experimental MDMA treatment for post-traumatic stress disorder that was rejected outright by the U.S. Food and Drug Administration earlier this month.
According to Wall Street Journal reportDespite already rejecting the experimental psychedelic therapy, the FDA is now expanding its investigation into the clinical trials behind the drug. FDA investigators reportedly interviewed four more people last week, asking questions about whether side effects were underreported in the clinical trials.
Trial officials have previously claimed that adverse effects, such as suicidal thoughts, went unrecorded and that trial participants were encouraged not to report them in order to improve the chances of FDA approval. Overall, the MDMA trial faced intense criticism during the FDA’s review, with outside experts and the agency’s advisers blasting allegations of sexual misconduct at one trial site, flaws in the overall trial design, multiple sources of bias, and allegations that Lykos, the company behind the treatment, fostered a cult-like belief in psychedelics.
According to The Wall Street Journal, the recent interviews were conducted by the FDA’s Office of Regulatory Affairs, which oversees the testing, and the agency’s Biomedical Research Oversight Program, a division that works to ensure the quality and integrity of data submitted to the FDA. Notably, when the FDA rejected MDMA, it advised Lycos to conduct new testing.
The FDA’s refusal and expanding investigation are bad enough for Lycos, but the company said earlier this month that Laying off 75% of its workforce and replacing its management teamThe company said the move was in response to the FDA’s refusal. Additionally, a scientific journal retracted three of the company’s MDMA studies, citing “protocol violations amounting to unethical conduct” in the trials, repeating allegations raised during the FDA investigation.
The troubling roots
At the heart of the accusations and criticism of Lycos is its drug advocacy. Lycos is a commercial spinoff of the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit psychedelic advocacy group. MAPS has been a vocal supporter of the legalization and pro-psychedelic drug movement for decades. Investigating its potential therapeutic usespecifically dedicated to treating mental illnesses such as PTSD, anxiety, and substance use disorders. MAPS was founded by longtime psychedelic activist and advocate Rick Doblin. I believe that the use of psychedelics will lead to world peace.Doblin stepped down from Lycos’ board of directors amid a management shake-up this month.
“After more than 38 years of service, I am deeply saddened by the FDA’s decision regarding this critically needed treatment, but encouraged by Lycos’ continued progress in clinical studies that will answer the FDA’s questions,” Doblin said in a statement. “Stepping down from the Lycos board will allow me to speak out more freely as a public interest activist. The FDA’s delay makes it more important than ever for me to work at MAPS to develop global legal access to MDMA and other psychedelics for the public good through MAPS’s multidisciplinary research, education, and drug policy reform.”
Lycos did not immediately respond to a request from Ars for comment on the FDA’s investigation. In response to The Wall Street Journal, a company spokesperson said, “Lycos is committed to working with the FDA to address any questions that may be raised.” The spokesperson also said the company plans to meet with the FDA about the denial, which it is appealing.
But the company has been harshly criticized by participants in the trial and outsiders alike, which may be difficult to overcome.
“The prospect of a therapy cult directing a clinical trial of a suggestibility-enhancing drug highlights unique risks that have not previously been discussed publicly,” Neche Devenot, a senior lecturer in the writing program at Johns Hopkins University who works on drug issues in society, said publicly before the FDA’s rejection. “This clinical trial should be subject to the same scrutiny as if Scientology or NXIVM had submitted a new drug application to the FDA.”
These public comments were published in a scathing report by the Institute for Clinical and Economic Review, Insufficient evidence to support MDMA-based treatmentsDeBenot was among those recently questioned by FDA investigators, the Journal reported.
The Lycos case is a blow to the entire psychedelic community and to the many patients, particularly veterans, who have reported success with MDMA to treat PTSD, a condition that is in desperate need of effective treatment.
Amid Lycos’ woes, the company has brought on David Huff as senior medical adviser to oversee clinical and regulatory affairs. Huff is a former vice president at Johnson & Johnson, where he is known for helping develop Spravato (esketamine), a ketamine-related compound approved in 2019 for the treatment of treatment-resistant depression.