Far-left group pushed anti-pharma-industry agenda to derail MDMA approval, according to NYT article.
Source: New York Times
According to The New York Times, the FDA’s recent rejection of MDMA-assisted therapy for PTSD was significantly influenced by a small leftist activist group called Psymposia. The treatment, developed by Lykos Therapeutics with a $250 million investment, was widely expected to gain approval given its promising clinical trial results. However, at a crucial FDA advisory panel hearing last summer, Psymposia members presented allegations of misconduct and abuse in the trials, though they did not disclose their affiliation with the group or provide evidence for their claims.
While the FDA’s official rejection letter cited concerns about the treatment’s long-term effectiveness and potential bias in the trials, seven of the eleven panel members mentioned Psymposia’s allegations in their decisions. The rejection has led to management changes and layoffs at Lykos and other psychedelic companies, while raising concerns about the future of psychedelic medicine development.
Lykos is now working with the FDA on a path forward, which may include an independent review of its data and additional clinical trials. Meanwhile, Psymposia has expanded its criticism to other organizations in the field, including veterans groups and researchers at Johns Hopkins University, leading many in the psychedelic medicine community to express concern about the group’s impact on the emerging industry.
Read the full NYT article (subscription required).