Commissioner of the FDA Dr. Robert Califf testifies before the the House Oversight and Accountability committee in the Rayburn House Office Building on April 11, 2024, in Washington, D.C. Califf answered a range of questions from members of the committee on topics pertaining to several drug related crises in communities across the the country, and how U.S. President Joe Biden’s administration is handling them. (Anna Moneymaker/Getty Images/TNS)
In an effort to help veterans struggling with post-traumatic stress disorder, 80 members of Congress, including Virginia Sen. Tim Kaine, recently highlighted the need to consider MDMA-assisted therapy as a treatment.
MDMA is a psychedelic drug currently illegal under federal law. The U.S. Food and Drug Administration is weighing whether to approve it for medicinal purposes.
Kaine, a Democrat, and 18 other senators sent a letter Monday to FDA Commissioner Robert Califf, pointing out that about 6,000 veterans die by suicide each year — many suffered from trauma while serving in the military.
“Existing treatments and medicines for PTSD, the last of which FDA approved nearly 25 years ago, have not decreased the frequency of suicide within the veteran community,” the letter states. “As a nation, we cannot allow our veterans to continue to suffer in silence and must identify treatments proven to drastically decrease the adverse effects of PTSD.”
The senators said advancements in scientific research were offering new hope and described MDMA-assisted therapy as a promising potential option.
“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 letter states.
Meanwhile, 61 representatives, including Yorktown Republican Rob Wittman, sent a similar letter Friday to President Joe Biden. Representatives said they understood the agency had to carefully weigh the risks of any new drug and explained they were not urging the FDA in any direction.
“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,” the representatives 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.”
The representatives said scientific evidence should not be ignored by those “on a mission” to discredit the treatment.
The FDA is expected to make its final decision this month.
In the agency’s initial assessment released in May, FDA scientists said patients who received MDMA and talk therapy showed rapid and meaningful improvements with their PTSD symptoms. But they questioned how long the benefits would last and said it was difficult to determine how much of the improvement came from MDMA versus the intensive therapy alone, the Associated Press reported.
The scientists also noted safety concerns about serious side effects, including heart palpitations and elevated blood pressure, which they said had the potential to trigger life-threatening heart problems. They further noted concerns regarding the potential for patients to abuse MDMA.
Katie King, katie.king@virginiamedia.com
Originally published at Katie King