Studies on ecstasy for PTSD called into question
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Clinical trials using the drug known as ecstasy to treat PTSD may have been tainted by investigator biases and understated possible harmful effects, the Institute for Clinical and Economic Review said in a report on Tuesday.
Why it matters: The influential nonprofit's assessment could complicate prospects for the therapy, which has been touted as a treatment for veterans with PTSD and is part of a cohort of psychedelic drugs that has shown promise for treating addictions and mental health disorders.
- Food and Drug Administration advisers will meet June 4 to review a new drug application from Lykos Therapeutics, which oversaw the clinical trials of what could become the first psychedelic-based treatment approved in the U.S.
- The FDA is expected to make a final decision on approval by August.
Zoom in: PTSD is hard to treat, and it often involves pairing medication like antidepressants with psychotherapy.
- MDMA, ecstasy's chemical name, targets multiple neurotransmitters in the brain, potentially diminishing fear responses and helping ease the way for therapy sessions.
- But a citizen's petition to the FDA last month cited shortcomings and safety risks surrounding Lykos' application.
- It came after ICER, in a preliminary review in March, said it heard numerous concerns about the way two trials on 194 adults were run — and questions about whether misconduct could have influenced outcomes.
What they found: The report Tuesday concluded publicly available evidence for MDMA-assisted therapy is insufficient, adding ICER can't determine how frequently benefits and harms were misreported or recommend a fair price should Lykos' application be approved.
- It cited concerns that some therapists involved with the trials encouraged favorable reports by patients and discouraged reports of substantial harms, potentially biasing the results.
- It cited multiple unnamed sources who said some patients exhibited a reduction in PTSD symptoms from a single trauma while their overall condition worsened.
- While some patients believe they were greatly helped by MDMA, others experienced severe side effects. Some of those were told those outcomes were a sign they were responding appropriately and would eventually improve, the report said, citing sources.
What they're saying: "We have substantial concerns about the validity of the results," the ICER report stated on Tuesday, citing multiple experts who identified "very strong prior beliefs" about the benefits of MDMA among investigators, therapists and patients involved in the trials.
The other side: Lykos, in a statement, said it stands behind the design and results of the clinical trials, adding ICER's report "is based on incomplete data from a limited source of information."
- The company pointed to comments clinical investigators, therapists and others involved in the trials made in response to ICER's preliminary review that weren't factored in the final report.
- Researchers and clinicians involved in the trials have also pushed back against the accusations that their data isn't sound.
- "I didn't feel any pressure from the sponsor to come up with anything different than what the data was providing," Jennifer Mitchell, a professor of neurology and psychiatry at the University of California, San Francisco, told NPR. "I wouldn't have continued to work with them if I had felt that."
