Members of the House and the Senate from both parties are asking the Biden administration to approve the use of MDMA-assisted therapy for the treatment of post-traumatic stress disorder to address the veteran suicide epidemic.
“Thousands of Veterans suffering from PTSD continue to take their lives each year. Current treatments clearly are not working well enough, and our Veterans can no longer wait,” a group of 61 House members wrote to President Joe Biden on Monday. The signatories included outspoken MDMA advocates Reps. Dan Crenshaw (R-TX) and Alexandria Ocasio-Cortez (D-NY).
The Food and Drug Administration is slated to announce on Sunday whether it will approve the use of MDMA-AT for the treatment of PTSD, which has not had a new treatment option approved for nearly 25 years.
Separately, 19 senators also petitioned FDA Commissioner Robert Califf to review the evidence impartially for efficacy of the treatment.
“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 senators, led by Sens. Michael Bennet (D-CO) and Thom Tillis (R-NC), wrote.
Between 17 and 44 veterans die by suicide each day, with more than 150,000 having taken their own lives since 9/11. That is more than 21 times the number of people from the United States who lost their lives in active war zones since 2001.
Clinical trials conducted by Lykos Therapeutics, makers of medical-grade MDMA, found that MDMA-AT effectively eliminated the PTSD diagnosis for 71% of trial participants, almost double the rate of current medication protocols for the disorder.
Approximately 86% of participants total showed a significant improvement in their conditions.
Advocates of the treatment suggest that MDMA, known to increase feelings of empathy and social connection, allows patients to better participate in traditional talk therapy to work through trauma.
Last month, an FDA advisory panel voted not to approve the experimental treatment, citing quality control troubles with Lykos’s studies. One factor was that some patients were able to identify whether they received the placebo, a common problem in testing psychedelics.
Although advice from the advisory committees is nonbinding, the agency only acts against their advice about one-third of the time.
The House members writing to Biden, however, directly challenged some of the criticism from the committee as “not necessarily reflective of the science, but rather their personal ideological beliefs and biases related to the medicalization of substances like MDMA.”
“If the data and evidence show that MDMA-AT is safe and effective at relieving the suffering that many Veterans face, then we owe it to them and the millions of others who are living with PTSD to make this treatment option available to them,” the House members wrote.
Neither the White House nor the FDA responded to the Washington Examiner’s request for comment at the time of publication.