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On Feb. 4—the same day that Robert F. Kennedy Jr.’s nomination for secretary of Health and Human Services advanced out of the Senate finance committee—the New York Times published a story with the headline “How a Leftist Activist Group Helped Torpedo a Psychedelic Therapy.” The story claims that Psymposia, a psychedelic-science and harm-reduction nonprofit consisting of five unpaid volunteers, used baseless and misleading accusations to thwart Food and Drug Administration approval of MDMA-assisted therapy, or MDMA-AT. Without the efforts of this “small band of anticapitalist activists,” the authors argue, Lykos Therapeutics’ “$250 million investment” in MDMA-AT may have paid off by being the first psychedelic therapy to get federal approval—potentially establishing the company as a multibillion-dollar enterprise.
As a journalist who has followed the psychedelics movement for years and attended hearings during the FDA approval process to write about them for Slate, the story was stunning. It was largely divorced from the events as I witnessed them, misleading in crucial ways, and journalistically bewildering. But what the story lacks in fully recounting why Lykos’ application tanked, it makes up for in fostering outrage, scapegoating a fringe group, and establishing a useful narrative should the new HHS secretary want to reverse the FDA’s decision.
The core argument about Psymposia outlined in the New York Times article—that individuals from the organization deliberately raised baseless, inflammatory allegations in a vendetta against Lykos and veterans—isn’t new. It’s an allegation initially posited by the Heroic Hearts Project, an organization that advocates for veterans’ access to psychedelic therapy. RFK Jr. retweeted that statement, and proponents of Lykos’ therapy later echoed the narrative in a video posted on the social media accounts of Lykos’ parent company, MAPS—the Multidisciplinary Association for Psychedelic Studies.
Veterans speak out on FDA advisory committee's rejection of MDMA therapy on spurious grounds. Not surprised that drug industry funding is behind the anti-MDMA campaign. https://t.co/VPzOUe4Iwa— Robert F. Kennedy Jr (@RobertKennedyJr) June 25, 2024
To understand how we got here, though, it’s worth stepping back. The first domino fell in March 2024 when the Institute for Clinical and Economic Review—an independent group that evaluates the value of new medical treatments—published a draft review of the Lykos trials. The authors of the report said they had “substantial concerns about the validity of the results,” noting poor experimental design choices and potential misconduct.
The FDA’s Psychopharmacologic Advisory Committee—which reviews drug applications for safety and efficacy, voting on whether they should recommend approval to the FDA—met on June 4 and lamented that Lykos failed to collect important patient safety information, like liver and heart function; declined to record elevated mood and euphoria as they’d explicitly been instructed to do; and neglected to use a placebo per department recommendation. The list goes on and has expanded considerably with further reporting in the wake of the FDA’s decision. The NYT story glosses over these data collection missteps, failing to mention mishaps like Lykos’ failure to take study participants’ lab work or EKG data.
The article and advocates for Lykos are quick to note that the FDA approved the study design. But Michael Ostacher, a professor of psychiatry behavioral sciences at Stanford University who has worked on esketamine studies, told me that’s misleading. “Just because the FDA accepts a trial design doesn’t mean they approve the application if the trial gets positive results,” he said. “Plus, Lykos ignored things the FDA had asked them to do.”
The NYT story also begins with a strange and misleading characterization of Psymposia’s role at the public comment period of the advisory committee meeting, claiming that seven members connected to Psymposia “presented themselves as experts in the field of psychedelics, but none had expertise in medicine or therapy.” It goes on to assert that none of these speakers disclosed their connection to Psymposia, “a leftist advocacy group” with a vendetta against MAPS.
Only three of Psymposia’s five members spoke during the public comment period, and none presented themselves as having expertise in medicine or therapy or suggested that expertise in psychedelics translated to expertise in medicine or therapy.
First to speak was Neşe Devenot, who the story refers to as a “self-described expert in psychedelic bioethics who uses gender neutral pronouns.” Indeed, Devenot introduced themself as an expert in “psychedelic bioethics,” but their credentials aren’t merely “self-described.” Devenot completed a postdoctoral fellowship in the department of Bioethics at the Case Western Reserve University School of Medicine and is an affiliate researcher with the Project on Psychedelics Law and Regulation at Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics.
The other speakers included Brian Pace, who introduced himself as a lecturer teaching psychedelic studies in the Department of Plant Pathology at Ohio State University, and Russell Hausfeld, who stated that he was there in his capacity as a journalist who reports on psychedelics and never claimed expertise in the psychedelic field.
While it’s true that none of the members of Psymposia disclosed their affiliation to the organization during the public comment portion of the hearing, they didn’t have to. The FDA guidelines given to all speakers during the public comment period were “to advise the committee of any financial relationship that you may have with the applicant,” which Devenot, Hausfeld, and Pace do not have.
The day before the hearing, the three speakers published a press release stating their affiliation with Psymposia, and Hausfeld had previously disclosed his affiliation with Psymposia in a May 30 email to the advisory committee, clarifying that he would be speaking on behalf of himself, not the organization.
When the advisory committee declined to recommend acceptance of Lykos’ application, the Heroic Hearts Project veterans group published a statement claiming “ICER relied on” Devenot and Psymposia while drafting the report. However, Devenot told me that neither they—nor, to their knowledge, anyone from Psymposia—was even aware that ICER was working on a draft report before its publication. In a transcript I reviewed of an interview between the reporters and three Psymposia members, Devenot said, “We found out about the draft the same time the rest of the field found out about it.”
The published story seems to suggest otherwise, arguing that “Psymposia ramped up efforts to thwart Lykos’s application,” adding that the group eventually “found an audience” with ICER, resulting in the report echoing many of Psymposia’s ethical concerns.
Perhaps one of the most egregious parts of the story, though, occurs when describing a documented case of a MAPS facilitator sexually assaulting a patient during and after the Phase 2 trials. The NYT authors write of “an ethical violation that occurred in an early Lykos trial that was not part of the company’s F.D.A. application, when a husband-wife therapy team in Canada spooned and cuddled a participant, Meaghan Buisson, during her MDMA session.”
The story neglects to mention that Buisson, who was there in part to address sexual trauma she’d previously experienced, immediately started crying and curled into a ball when the male facilitator, Richard Yensen, asked her if she wanted to “lie down and spread her arms and legs.” When Yensen tries to put a hand on her shoulder, she shakes it off. Later in the video, she’s sobbing and saying “Stop” as Yensen lays on top of her, restraining her movement.
The article continues to minimize the sexual assault by pointing out that Yensen “began a sexual relationship” with Buisson “after the trial concluded.” Several crucial facts are left out of this description. Most obviously: Legally, and ethically, a patient cannot consent to a sexual relationship with their therapist, which MAPS notes in a statement it made about the incident in 2019. (Yensen’s defense in the civil suit Buisson brought against him? He was an unlicensed therapist and thus had no “duty of care” to her.) Additionally, the trial was not over when the sexual abuse began.
I contacted the journalists who wrote the NYT story with detailed questions about these exclusions. A spokesperson for the publication responded with the following statement: “This piece of independent journalism was thoroughly reported and fact-checked, and The Times stands behind its publication.”
RFK Jr. has a long history of ignoring the minutiae and nuances of clinical data in favor of a zealous belief in unproven remedies with dramatic anecdotal evidence.
The NYT story hints at this connection. After mentioning the FDA’s ongoing review of Lykos’ data, the authors write, “Some advocates hope that the Trump administration will take a friendlier approach,” specifically noting Elon Musk and RFK Jr. as “vocal supporters of psychedelic medicine.”
Kennedy made his position clear. In October, after Trump announced that he would nominate the anti-vaccine activist for the position, Kennedy tweeted, “FDA’s war on public health is about to end. This includes its aggressive suppression of psychedelics … and anything else that advances human health and can’t be patented by Pharma.”
FDA’s war on public health is about to end. This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything…— Robert F. Kennedy Jr (@RobertKennedyJr) October 25, 2024
Lykos is a pharmaceutical company and has filed several patents related to MDMA formulation. Investors know this even if the new HHS secretary doesn’t—after Kennedy’s nomination advanced out of committee on Feb. 4, shares in biotech companies making psychedelic therapies soared.
Now a newly confirmed Health and Human Services secretary, Kennedy has the power to reverse what he calls the FDA’s “scandalous” decision or otherwise influence the ongoing FDA review of Lykos’ Phase 3 data. When vague accusations of “DEI” and “wokeness” are already being used to gut government programs, it might not be a bad time to blame the FDA’s decision on “a small band of anticapitalist activists.”
Michael Abrams, a senior researcher in Public Citizen’s Health Research Group, told me he thinks it’s unlikely that Kennedy would completely reverse the decision, but it’s possible that “the next time it goes through review, we might see the standards lowered, and the process goes a bit smoother for the sponsor.”
Kennedy is already implementing changes at HHS that limit public input. On Feb. 28, he placed a statement in the Federal Register rescinding the public comment period where members of the public can argue for or against proposed HHS plans. Although the mandate doesn’t necessarily affect FDA decisions, it’s a troubling sign for transparency from the agency that oversees the FDA and the Centers for Disease Control, among other federal health bodies.
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The public narrative about what happened with MDMA-AT is important, as more potential psychedelic therapies are certainly in the pipeline. Painting the final stages of the FDA approval process as unnecessary and easily corruptible—as the NYT article did—may serve a larger “MAHA” agenda of eliminating or severely restricting vital oversight.
Kennedy—perhaps best known for his anti-vaccine advocacy—has spent decades suggesting that the decisions of federal oversight committees and medical associations can’t be trusted due to conflicts of interest and corruption, an assertion some advocates for MDMA-AT also made after the FDA’s decision. The NYT story seems to underscore this narrative by claiming Psymposia “derail[ed] the approval of MDMA-assisted therapy” by committees like ICER that would otherwise have supported the application.
In lieu of rigorously conducted clinical trials, Kennedy often cherry-picks dramatic and heart-wrenching anecdotal evidence to support his claims. For example, last year, he reposted an image of school shooters with the antidepressants they were allegedly taking. There is no evidence to suggest that SSRI drugs are a cause of school shootings.
There is plenty of anecdotal evidence to support the efficacy of MDMA-AT on post-traumatic stress disorder. It has undeniably helped people who were struggling, many of whom are veterans and spoke at the FDA advisory committee. The unmet need for PTSD treatment has made psychedelic-assisted therapy a more bipartisan subject than it might be otherwise. (In 2024, Kennedy said that veterans are “the most deserving of benefiting from psychedelic therapy.”)
The NYT story highlights this angle as well. It quotes Jonathan Lubecky, a retired U.S. Army sergeant and a psychedelic medicine policy advocate, who notes that many of his friends have “fallen into despair” since the FDA’s decision and that “‘Some, quite frankly, are trying to decide whether they should stick around long enough to see it happen.’” It’s a heartbreaking quote. Given the reporters’ emphasis on Psymposia’s disclosures, however, it is curious that the story doesn’t mention that Lubecky was employed by MAPS from 2018 to 2023.
Public health experts largely disagree that Psymposia could have such a dramatic effect on the FDA approval process. “It’s absurd, absolutely silly to say that five or six people undermined the success of Lykos’ application,” said Ostacher. “I’m really concerned that the true believers are driving the narrative about [psychedelic-assisted therapy] in a way that will make it very difficult for people not to believe the results of flawed trials.”
Abrams agreed, adding that the committee didn’t need to be experts in psychedelics to understand the application before them. “The committee is smart, they understand things like bias, they understand things like liver toxicity, and reporting adverse events,” he said. “But that’s more nuanced than the rather provocative ‘Leftist anticapitalist activists torpedoed multimillion-dollar case for veterans and cops’ narrative.”
But if anyone likes a “provocative” theory that contradicts the medical establishment and paints the FDA as easily corruptible, it’s RFK Jr.—and he doesn’t need help from the Gray Lady to do it.