Ecstasy, the psychedelic club drug that lawmakers and the Department of Veterans Affairs hope can help veterans with PTSD, is about to have its make-or-break moment.
A Food and Drug Administration panel will decide Tuesday whether to recommend the agency grant approval. A thumbs up from the FDA could open up a massive shift to psychedelic medicine, not only for veterans, but also all Americans with mental illness. A thumbs down will upend a burgeoning industry — and crush a lot of hopes.
"MDMA is going to revolutionize treatment of mental health in this country,” said Rep. Lou Correa , a Democrat who’s traveled from his southern California district to Tijuana, Mexico, to visit a clinic there that provides psychedelic drugs to veterans who can’t get them here.
The VA cites research finding 7 percent of veterans will suffer from PTSD at some point in their lives. It can cause flashbacks, nightmares and anxiety brought on by traumatic events — like combat. Nearly one in four vets who seek care at a VA facility have the condition, had it, or will get it.
Lykos Therapeutics, whose application the FDA panel of expert advisers will consider, is making the case that MDMA, the scientific name for ecstasy, along with therapy can take the pain away. VA officials are hoping it’s right.
In May, the VA’s undersecretary for health, Dr. Shereef Elnahal, raised the expectations of psychedelic enthusiasts at a conference in New York put on by the Horizons Center Public Benefit Corp., which promotes the drugs.
“We keep proving the science. We keep surprising the folks who are skeptical,” he told the crowd.
But there’s a problem with the rosy forecasts.
Lykos has come under fire for allegedly slanting its studies to make the case for approval. The head of the National Institute on Drug Abuse, Nora Volkow, last month compared the hype for psychedelics as a cure for mental illness to belief in “fairy tales” in Senate testimony.In March, an independent, nonpartisan group that evaluates new drug applications found Lykos’ trials suspect."We have substantial concerns about the validity of the results ," the Institute for Clinical and […]
A club drug could be the next big thing in treating mental illness
