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APA concerned about MDMA study standards

The APA is concerned about the inability to have real placebos in MDMA tests.
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As the Food and Drug Administration prepares to host a public advisory committee meeting to evaluate a drug application for MDMA as a treatment for post-traumatic stress disorder, a major scientific and professional organization isn’t sold on the move.

The American Psychological Association, which represents 38,900 psychiatric physicians, wrote a letter to the FDA expressing concerns about the clinical tests conducted for the drug and its use in therapy.

“APA cautions that decisions should not be made based on headlines, but rather with unbiased evidence that meets the scientific integrity and regulatory standards that patients and medical providers expect,” the group said in the letter.

It also noted that conclusions drawn from the recreational use of MDMA is limited and expressed a need for more data on long-term follow-up among participants receiving MDMA, as well as use among diverse groups of patients.

Study challenges

One key challenge of the trials: It’s almost impossible to have a placebo in such a study.

“MDMA is difficult to blind (for both researchers and participants). Because the effects of MDMA are acute, intense, and idiosyncratic, it can be relatively easy for participants and researchers to recognize whether they have received the placebo or active drug, as shown by the available data from the Phase III trial article published in Nature Medicine (75% participants in the placebo with therapy group were certain or thought they received placebo),” the letter said.

“‘Functional unblinding’ may have been more likely in the Phase III trials reported as approximately 40% of participants had prior experience with MDMA. In many pharmacological trials, individuals with prior exposure are excluded from participation. The advisory committee must consider whether the current regulatory framework for clinical trials for psychedelics is ensuring the highest quality results or if it is creating bias in expectancy effects.”

The APA also warned than many patients in the study likely read about the promising effects of MDMA, which could affect the study outcome.

Another shortcoming of the study, according to the organization, is that it incorporated many hours of psychotherapy, as well, which might not be possible in a real-world setting. The cost of this many hours of intense psychotherapy might be out of reach for many patients and their insurers.

Ultimately the APA suggested that to the advisory council that the studies may be too limited to approve the therapeutic use of MDMA at this point. The group urged caution about any new treatment for PTSD inadvertently leading to adverse consequences for individuals and society as a whole if rigorous standards are not employed in the clinical trials.

Weighing the risks, benefits

As previously reported on Green Market Report, the FDA’s Psychopharmacologic Drugs Advisory Committee will meet on June 4 to discuss the overall benefit-risk profile and potential public health impact of Lykos Therapeutics‘ application for MDMA capsules. The committee provides nonbinding recommendations to the agency.

Lykos Therapeutics was previously known as MAPS Public Benefit Corp.

The committee’s expert advisers will weigh clinical data on the drug’s safety and efficacy. Presentations from FDA staff, the company, and public comments are expected before the panel votes on a recommendation regarding approval.

So far the only public comment received on the issues is from the American Psychiatric Association.

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