An expert panel in the United States, organized by the Food and Drug Administration (FDA), recently cast a major vote against the use of the drug MDMA, known colloquially as ecstasy, for treating individuals with post-traumatic stress disorder (PTSD).
PTSD is a severe mental health issue that can manifest after someone has experienced or been exposed to traumatic occurrences, such as the threat of death, warfare, or sexual violence. This condition is believed to affect roughly five percent of the American population annually.
Current pharmaceutical remedies for PTSD are limited primarily to a pair of antidepressants, necessitating up to three months of consistent dosage for effectual treatment, with varied responses among patients.
Lykos Therapeutics, a California-based company, sought the FDA’s approval based upon the results of two clinical trials. These trials, with near 100 participants each, examined the combination of MDMA and psychological therapies, including talk therapy, in contrast to a placebo combined with talk therapy.
As documented in the influential Nature Medicine journal, the research studies suggested that MDMA was not only safe but also highly potent in curbing symptoms of PTSD. Furthermore, subsequent findings indicated its safety and significant effect in treatment.
Despite these promising studies, the panel was not convinced by the available data, with nine out of 11 experts opining that there wasn’t enough proof of efficacy and 10 out of 11 believing the risks outweighed the benefits.
“I think this is a really exciting treatment. I’m really encouraged by the results to date,” said Paul Holtzheimer of the National Center for PTSD. “But I feel that both from an efficacy and a safety standpoint, it is still premature.”
Although the expert panel’s decision is not obligatory, it is rare for the FDA to contradict their recommendations.
Lack of Comprehensive Data on Side Effects
MDMA, a Schedule 1 substance under the Controlled Substances Act, has never been approved for medical use, and authorization would mark a significant change in its legal status.
FDA staff highlighted concerns in a pre-meeting briefing document, pointing out that the supposed double-blinded nature of the studies might have been compromised as many participants could correctly guess whether they received MDMA or a placebo, potentially introducing bias.
Additionally, there were criticisms voiced about insufficient data collection by Lykos on potential side effects such as “euphoria” or “elated mood,” which they indicated would be relevant to evaluate abuse potential or to characterize expected drug effects.
Existing recreational use reports of MDMA indicate negative effects on the heart and liver, but the company reportedly failed to gather ample data in these crucial areas, according to the FDA.
Questions of Research Integrity
Compounding the controversy, allegations of research misconduct connected to the trials arose in a draft report by the Institute for Clinical and Economic Review, raising alarm.
It was suggested that the trials recruited participants already engrossed in the psychedelic community, which might be predisposed to positive outlooks regarding psychedelics’ psychological benefits. Moreover, some participants alleged exclusion from follow-up studies, supposedly to prevent negative data from influencing outcomes.
“We certainly take those allegations very seriously and are quite concerned by them,” said Tiffany Farchione of the FDA, with an investigation reported to be in progress.
The final verdict from the FDA regarding the drug’s approval is expected by mid-August. If MDMA is authorized against the advisory panel’s recommendations, it may come with stringent conditions, such as restricted dispensation in healthcare environments, close monitoring of patients, and mandatory registry enrollment for documenting any adverse effects.
© Agence France-Presse
Frequently Asked Questions (FAQ)
Why did the expert panel reject MDMA for treating PTSD?
The panel was not convinced by the evidence provided, indicating that there was not enough proof of efficacy. Additionally, they raised concerns that the risks involved might not justify its use for treatment.
What is PTSD and how common is it?
Post-traumatic stress disorder (PTSD) is a mental health condition that can occur after experiencing or witnessing severe trauma. It is estimated to affect around five percent of Americans in a given year.
What were the main concerns about the MDMA studies?
Concerns included potential biases due to functional unblinding, insufficient side effect data, and claims of research misconduct.
What happens if the FDA approves MDMA despite the panel’s recommendations?
If approved, restrictions might include only dispensing the drug in healthcare settings, careful patient monitoring, and maintaining registries to record side effects.
When is the FDA expected to make a decision on MDMA for PTSD treatment?
The FDA decision is anticipated by mid-August.