Bipartisan lawmakers in the House and Senate are pressuring the Biden administration about MDMA-assisted therapy to treat post-traumatic stress disorder.
In a letter to President Biden, retired Marine Corps General Rep. Jack Bergman (R-Mich) and 60 other members of the House asked the administration to follow the science and approve a new treatment that uses MDMA – the chemical found in ecstasy or molly – with talk therapy to treat PTSD.
Bergman is the highest-ranking combat veteran in Congress. A similar letter to Food and Drug Administration Commissioner Robert Califf from 19 senators was led by Sens. Michael Bennett (D-Colo.) and Thom Tillis (R-N.C.).
More than 13 million individuals in the U.S. live with PTSD, and veterans are disproportionately affected, according to estimates from the National Center for PTSD. But current treatments are notoriously not very effective.
The FDA has not approved any new treatments for PTSD in more than two decades, and the lawmakers said continued high rates of veteran suicides means the government must do more to protect veterans.
“Despite billions of federal dollars spent on addressing PTSD and mental health, the number of Veteran lives lost to suicide has not decreased,” the House letter stated. “This is due in part to the fact that the FDA has not approved any new treatments for PTSD in nearly 25 years. This astounding lack of innovation has undoubtedly contributed to our rising Veteran suicide rates over the past two decades.”
The lawmakers said FDA’s own studies show there is significant promise in using psychedelic therapy with MDMA to treat veterans suffering from PTSD, but that the FDA needs to follow the evidence.
“The potential for groundbreaking advancements in PTSD treatment is within reach, and we owe it to our veterans and other affected populations to review these potentially transformative therapies based on robust clinical and scientific evidence,” the senators wrote.
“If comprehensive evidence demonstrates that MDMA-AT is both effective and safe when administered in appropriate settings, it is our responsibility to ensure that this treatment option is made available to those who could benefit from it.”
The FDA is set to decide this week whether to approve the application from Lykos Therapeutics. Supporters have launched a pressure campaign, as approval is far from certain.
The agency’s independent advisory board resoundingly recommended against approval during a meeting in June after raising questions about the integrity of the trial studying the treatment and missing safety data. They praised the promise of the treatment but said the risks far outweighed any benefits and expressed concern that the manufacturer’s scientific work was influenced by the psychedelic evangelism of its parent organization, the Multidisciplinary Association for Psychedelic Studies.
The committee voted 9-2 that the data doesn’t show the drug is effective in treating PTSD, and 10-1 that the benefits don’t outweigh the risks.
Advisory panel decisions are not binding, but they carry a lot of weight. The agency has gone against its scientific advisors before, but it’s a rare occurrence.
An FDA rejection of the therapy would deal a major industry-wide blow to the potential for psychedelic drugs as a PTSD treatment.
In the letter to Biden, which was copied to the heads of the Department of Health and Human Services and Veterans Affairs, the House members addressed outside criticism.
“It is not our intent to urge the FDA in any direction related to its decision, which must be based solely on the data and evidence. However, we are aware that as this application has made its way through the regulatory review process, certain groups and individuals have voiced criticism of the application,” they wrote.
“It is our understanding that while these critics may be well-intentioned, their criticism is not necessarily reflective of the science, but rather their personal ideological beliefs and biases related to the medicalization of substances like MDMA.”
