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Exposing ICER’s Anti-Veteran Campaign Against MDMA-Assisted Therapy

An Open Letter From Our Veteran Community:

For the past two decades, scientists, researchers, and veteran advocates have sought the answer to a burning question: Can MDMA-assisted therapy (MDMA-AT) provide a significantly better treatment option for PTSD than currently available treatments? 

The urgency of this question is fueled by the fact that billions of dollars and over 20 years of research have done absolutely nothing to curb, much less end, our veteran suicide epidemic. Over 6,000 veterans, most of whom suffered from PTSD, have taken their own lives each and every year since 9/11. The cumulative loss to suicide is more than 130,000 veteran lives and climbing, a number 18 times greater than the 7,054 U.S. servicemembers’ who lost their lives in post-9/11 combat zones. 

The answer to the question of MDMA-AT’s efficacy thus provides a much-needed surge of hope: Phase Three clinical trial results have demonstrated that this treatment is both safe and efficacious. Seventy-one percent of trial participants, who suffered an average of 14 years from debilitating PTSD, no longer qualified for a PTSD diagnosis, while 86.5% experienced clinically significant improvement in their symptoms. These results are “almost double” the efficacy of existing treatments. If these results hold up outside clinical studies, it would render MDMA-AT the most effective PTSD treatment ever developed. 

Over the past year and a half, MDMA-AT’s efficacy has garnered a slew of positive press, FDA “Breakthrough Therapy” designation and fast-tracked approval consideration, bipartisan support from policymakers, and government funding through both the Department of Defense and the Department of Veterans Affairs. MDMA-AT’s FDA approval, slated for August 11, 2024, thus seemed to be on the verge of materializing to the relief of millions of suffering veterans.

But earlier this spring, something changed in the media narrative. Articles with suspicious origins and strikingly similar narratives raised unfounded and almost laughable rumors, alleging that the 20-plus years of scientific research by the NIH, VA, prominent universities, and researchers were the work of a “cult.”

Surprisingly, these rumors emerged publicly at the June 4, 2024, meeting of an external FDA Advisory Committee, empaneled by the FDA to consider MDMA-AT’s merits. Rather than assess the data at hand, the Committee devolved into what one expert called a “dumpster fire.” The group strayed from analyzing the safety and efficacy of the treatment to asking bizarre questions about the diversity of the trials, the types of therapy used, and questions regarding whether MDMA-AT would lead to cocaine usage. No mention was made of the veteran suicide epidemic or the soundness of the clinical trials’ results. Consequently, the committee voted against recommending FDA approval of this FDA-designated “breakthrough therapy” that would provide life-saving relief to the 13 million Americans who suffer from PTSD today.

Leading scientists, policymakers, and veteran advocates watched the advisory committee meeting with confusion and disbelief. According to the BBC, Dr. Franklin King, a psychiatrist at Mass General Hospital and Harvard Medical School, observed that “advisory committee members really showed a kind of astounding lack of knowledge about the subject matter.” Dr. Natalie Gukasyan, an assistant professor of psychiatry at Columbia University Irving Medical Center, stated: “It’s almost like this came as a total surprise that this was the study design, when in fact the FDA approved this design.” Republican Congressman and retired Lieutenant General Rep. Jack Bergman (R-MI) said, “I’m disappointed that the FDA advisory committee chose to ignore the voices and testimonies of Veterans whose lives have been forever improved by MDMA-assisted therapy, and instead voted in favor of those who have been on a mission to discredit this promising treatment at all costs.” And former Navy SEAL, Republican Congressman Morgan Luttrell (R-TX), slammed the Committee’s vote as “stemming from a lack of education and experience around the clinical use of psychedelics.” 

The question that needs to be asked is: who influenced the Advisory Committee, and why? 

Weeks before the meeting, a group called ICER, which claims to “conduct evidence-based reviews of health care interventions,” published a draft report of a study that is critical of MDMA-Assisted Therapy and its sponsoring company, Lykos. ICER’s funders include insurance and pharmaceutical companies with a vested interest in preserving the status quo of healthcare. Its opposition to MDMA-AT is thus likely influenced by Big Pharma, which makes billions of dollars on antidepressants ($16.6Bn in 2023), which are largely ineffective treatments for PTSD.

Furthermore, one of the “experts” ICER relied on in drafting its report is an individual closely associated with a little-known group called Psymposia. This Individual has made it their stated mission to prevent MDMA-AT’s FDA approval due to their personal antipathy towards the therapy’s sponsor, Lykos. After the Advisory Committee’s vote, they publicly claimed victory as the engineer of ICER’s public crusade against MDMA-AT. 

The motivation of many of the people associated with Psymposia for opposing MDMA-AT lies in their belief that treating veterans suffering from PTSD “perpetuates the logic of white supremacism, capitalism, and imperialism.” They openly refer to veterans as imperialists, white supremacists, and murderers on their website, in public speeches, and on their social media feeds. This hateful, anti-veteran rhetoric infiltrated the media and the Advisory Committee’s psyches through ICER’s draft report, as evidenced by how often committee members raised the issue of a perceived “lack of diversity” in MDMA-AT’s Phase 3 clinical trials. Moreover, they clung to this narrative despite the fact that over half of confirmatory Phase 3 trial participants self-identified as a race or ethnicity other than white or non-Hispanic Latino.

As veterans, PTSD advocates, and Americans, it is our responsibility to expose the underlying motives for the carefully coordinated, unscientific, anti-MDMA smear campaign. The Individual and their colleagues at ICER and Psymposia have successfully manipulated the media and infiltrated the FDA’s regulatory process to the detriment of millions. Psymposia’s involvement in ICER’s report should have rendered its “findings” null and void. Instead, it may single-handedly dash the hopes of thousands of veterans who continue to take their own lives due to their suffering from PTSD. 

For this reason, and because of the overwhelming scientific evidence in favor of MDMA-AT’s efficacy, we urge the FDA and members of the media to take the Advisory Committee’s vote with a grain of salt. Too many lives are at stake for anything other than science to guide the FDA’s decision. Veterans’ lives are now dependent on the FDA’s ability to separate fact from opinion – especially ones that attack, rather than support, those who’ve risked their lives to protect and defend ours.

*Edited 06/26/24 removed individuals name per request