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rbet win How Psychedelic Research Got High on Its Own Supply
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.
First synthesized by the drug company Merck in 1912, MDMA, also known as the party drug Ecstasy or molly, has both stimulant and hallucinogenic properties. It also has the ability to foster feelings of connectedness and to seemingly dissolve a person’s mental boundaries, which advocates say can help patients revisit their trauma more comfortably during psychotherapy sessions in order to heal from it. Lykos has spent years conducting clinical trials testing whether MDMA-assisted psychotherapy could alleviate the symptoms of PTSD. Its most recent drug trial showed that more than 86 percent of people treated had a measurable reduction in symptom severity. Even more impressive, the effect seemed to be lasting. Had the therapy been approved, it would have become the first new treatment for PTSD in decades and would have handed over administration and control of prescription MDMA to Lykos for at least five years.
More broadly, proponents hoped a green light from the F.D.A. would open the door to regulatory approval for other psychedelics in mental health treatment, an area of medicine that has been desperate for innovation. Mental health disorders are surging, with rates of depression, anxiety and PTSD all on the rise, and current drugs don’t work terribly well. The majority of patients diagnosed with depression do not benefit from the first medications they are given. Conditions like PTSD are challenging to treat, and veterans’ groups have been especially supportive of the potential for psychedelics to address the mental trauma suffered during combat. Amid growing enthusiasm, drug companies, clinicians and patients had enormous hope that psychedelics could relieve the symptoms of millions.
But that hope began to fray in June, when an advisory panel to the F.D.A. voted almost unanimously against recommending Lykos’s MDMA treatment. With what seemed to be audible irritation, the chair of the F.D.A. review panel, Dr. Rajesh Narendran, called Lykos’s study so poorly conducted as to be “meaningless,” adding that he was “not convinced at all” that MDMA could effectively treat PTSD.
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