Clinical trials of MDMA have been promising, but concerns have emerged about the quality of the research. A June hearing scheduled by the Food and Drug Administration is likely to address them.
Research on MDMA has shown it can be effective for PTSD, but approval of the treatment isn't yet guaranteed.
By the end of the trial, about 71% of participants in the MDMA arm no longer met the diagnostic criteria for PTSD, compared to about 48% who underwent the same therapy but took a placebo instead. Those findings built on promisingin both groups — ranging from nausea and anxiety to heart palpitations — but none of them qualified as serious. The treatment was"generally well tolerated.","MDMA did not appear to increase this risk, and no suicidal behavior was observed.
Beyond that, however, the report brings up the possibility that"very strong prior beliefs" among therapists, investigators and patients influenced the results. "You have a group of people who are very upset about how these trials went," he says."We couldn't tell, even though we talked with people where this happened, whether that represents a tiny fraction of bad events or a number of bad events large enough to have rendered the trial just not believable."According to Rind, MAPS and Lykos had"very little" engagement with ICER on the draft report.
Hall says therapists"meticulously" captured any adverse events."We encouraged our participants to be very honest," she says."We're all invested in knowing how it works and what are the risks for people." "Evidence from multiple sources indicates that the sponsor has engaged in a pattern of systematic and deliberate omission of adverse events from the public record while minimizing documented harms," the petition states.
United Kingdom Latest News, United Kingdom Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
FDA panel to consider psychedelic party drug MDMA, or molly, for PTSDThe FDA's panel of independent advisers will on June 4 deliberate whether to recommend approval for the first MDMA-assisted therapy for PTSD, Lykos Therapeutics said.
Read more »
As the FDA evaluates ecstasy treatment for PTSD, questions mount about the evidenceClinical trials of MDMA have been promising, but concerns have emerged about the quality of the research. A June hearing scheduled by the Food and Drug Administration is likely to address them.
Read more »
In a first, FDA approves use of Apple Watch for clinical trials involving abnormal heartbeatsThe Food and Drug Administration has approved the use of the Apple Watch in clinical trials dealing with atrial fibrillation, a type of abnormal heartbeat.
Read more »
FDA qualifies Apple Watch’s AFib history for use in clinical studiesThe Apple Watch’s AFib detection history feature is now accepted under the Medical Device Development Tools (MDDT) program by the FDA.
Read more »
Postpartum PTSD: Right Diagnosis Can Help Mothers and BabiesMany new mothers aren’t aware that postpartum PTSD even exists, but it’s far from rare. Here's what to know.
Read more »
Grappling with trauma and PTSD one year later: Allen Mall victims can still find helpEight people were killed and six others injured at Allen Premium Outlets one year ago.
Read more »