Warning of “history repeating,” researchers list ten problems with psychedelic research that make conclusions about efficacy and safety uncertain.
March 20, 2023
Drugs like ketamine, psilocybin (mushrooms), LSD, and MDMA are at the forefront of a new wave of overhyped treatments for mental health problems that may fail to deliver on their promises, according to a new article by researchers Michael van Elk and Eiko Fried at Leiden University, the Netherlands. They write that psychedelic research is plagued by methodological problems that make the efficacy and safety of these drugs uncertain.
Despite the minimal research and its limitations, the drugs have been hyped as “miracle” drugs, with some, like esketamine, even receiving FDA approval—despite failing to beat placebo in five of its six initial efficacy trials (the sixth trial reached statistical, but not clinical, significance). In fact, last year, researchers wrote that the promotion of ketamine/esketamine treatments poses “a significant risk to the public.”
In their new article, published before peer review on the preprint server PsyArXiv, van Elk and Fried focus on the top 10 methodological problems rampant in psychedelic research, how these issues undermine the evidence base, and how researchers can avoid them in the future.
“These problems threaten internal validity (treatment effects are due to factors unrelated to the treatment), external validity (lack of generalizability), construct validity (an unclear working mechanism), or statistical conclusion validity (conclusions do not follow from the data and methods),” the researchers write.
Worse, they add, most psychedelic studies feature more than one of these problems, which makes the studies far more unreliable: “These problems tend to co-occur in psychedelic studies, strongly limiting conclusions that can be drawn about the safety and efficacy of psychedelic therapy.”
Also see LOBBYING FOR MEDICINE – AROUND WE GO AGAIN (THIS TIME IT’S PSYCHEDELICS)
