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.
In a matter of months, the Food and Drug Administration is expected to decide whether the drug commonly known as ecstasy can be used as a treatment for post-traumatic stress disorder.
Casey Tylek, a participant in the Phase 3 trials, says he had no experience with the drug prior to the study. "Concerns have been raised by some that therapists encouraged favorable reports by patients and discouraged negative reports by patients including discouraging reports of substantial harms, potentially biasing the recording of benefits and harms," the report states.
But since then, a group of more than 70 clinicians, investigators and others involved in the Phase 3 MDMA trials have, a clinical psychologist in the Phase 3 trials, says she and her colleagues were shocked by how ICER described their work. Still, Mitchell acknowledges she doesn't have full insight into what was going on at each trial site on a given day.
It continues:"We cannot rule out the possibility that MAPS/Lykos manipulated clinical trial data to hide adverse events from regulatory agencies."
United States Latest News, United States 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 »
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 »
Study shows heightened sensitivity to PTSD in autismA new study shows that a mild stress is enough to trigger post-traumatic stress disorder (PTSD) in mouse models of autism spectrum disorder (ASD).
Read more »