For a while now, the Good Science Project has been sponsoring modest grants for investigative reporting on science policy, in partnership with Johns Hopkins University.
Today, the cover story for the New York Times opinion section was a story that we indirectly sponsored (to be clear, we had zero input into which writers or stories got selected):
Caty Enders, “How Psychedelic Research Got High on Its Own Supply.”
The introductory paragraphs:
Things weren’t supposed to go this way. The drug company Lykos Therapeutics had spent much of this year expecting to vault to meteoric heights. It had sent an application to the Food and Drug Administration seeking approval to use MDMA to treat post-traumatic stress disorder. Lykos expected F.D.A. approval; it was banking on it.
And then on Aug. 9, the F.D.A.’s decision came through: rejection. It was the capstone to months of increasingly loud concerns being voiced over the quality of Lykos’s clinical trials. And in the wake of the F.D.A. decision, the journal Psychopharmacology retracted three papers related to research on MDMA, citing “unethical conduct,” an apparent reference to allegations of sexual abuse on the part of an unlicensed therapist at one of the trial sites. Several of the authors of the retracted papers were affiliated with Lykos.
It is a shocking decrescendo for a drug that had been promoted for years as best positioned to lead a psychedelic mental health revolution. The F.D.A.’s rejection signals greater uncertainty for the future of psychedelic medicine. And it will take more than just additional clinical trials for advocates to get back on track — it might require changing the culture of the research community from within.
For more, read the whole thing.