FOIAengine: Media Requests Signaled Issues for a “Party Drug” Going Mainstream
With 153 clinical trials to assess whether the party drug known as Ecstasy can help patients suffering from Post Traumatic Stress Disorder, optimism was high earlier this summer among investors in numerous start-ups hoping to hit it big in the medical psychedelic market.
Ecstasy, also known by the pharmaceutical shorthand MDMA (an abbreviation of 3,4-methylenedioxymethamphetamine), is used illegally by millions in the U.S. The synthetic drug has been banned since spreading across the rave and club scene in 1985.
A Drug Enforcement Administration fact sheet about Ecstasy says it acts as both a stimulant and psychedelic, producing an energizing effect, distortions in time and perception, and enhanced enjoyment of tactile experiences. According to the DEA, black-market Ecstasy sold on the street comes from clandestine labs that often combine the drug with ketamine and cocaine, which “can lead to overdose and death when the user takes additional doses to obtain the desired effect.”
But, just a few months ago, at least a half-dozen companies were so hopeful of legalizing the psychedelic drug – with apparent support from the Biden Administration – that they’d already raised more than a billion dollars in fresh capital.
There were promising signs that the federal government would soon green-light Ecstasy for psychiatric use in treating depression and PTSD. One such clue came from the Health and Human Services assistant secretary for mental health, who revealed that the feds were “exploring the prospect of establishing a federal task force to monitor” the emerging psychedelic treatment ecosystem. The Intercept called the letter “the clearest indication yet that top officials are preparing for the approval of psychedelic drugs . . . which was arguably unthinkable even five years ago.”
Importantly, the Food and Drug Administration also was thought to be close to approving what looked like a promising MDMA application from a company called Lykos Pharmaceuticals.
Then, things fell apart. In a surprise that perhaps shouldn’t have been, the Lykos application was denied by the FDA.
The FDA denial wasn’t just a momentary hallucination. Rather, it was the start of a very bad trip for the fledgling psychedelic stocks. Share prices of psychedelic start-ups have been battered; short sellers are circling.
To gain more insight into what happened, we searched PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks Freedom of Information Act requests in as close to real-time as their availability allows. In this case, multiple FOIA requests revealed the interests of some of the players involved, and also presaged the negative publicity to come.
In recent years, FOIA requests mentioning Ecstasy’s shorthand descriptor, MDMA, have periodically entered the FOIAengine database. But by early June, we noted a marked shift in focus that became a signal to watch: News media requesters suddenly were asking about Lykos. And the timing wasn’t a coincidence.
Lykos, a for-profit public benefit corporation spun out of a non-profit, had spent 10 years seeking to become the first pharma company to receive FDA approval for its Ecstasy capsules. In February 2024, the company announced that the FDA had put its Ecstasy application on a fast track for review – a sign, the company indicated, that the FDA favored the application, since the agency grants priority review only “for drugs that, if approved, would represent significant improvements” in safety or effectiveness.
The FDA even set a target date for its decision on Lykos’ Ecstasy capsule: August 11. Hope was building, along with hype. “If approved, this would be the first MDMA-assisted therapy and psychedelic-assisted therapy,” the company said in its February press release.
Lykos’ shares aren’t publicly traded. But share prices soared for pharma start-ups in the same psychedelic space as Lykos. Investors were anticipating the FDA’s decision on the Lykos application.
Within months, there were more Lykos press releases: a new chief commercial officer was brought on “to lead the potential commercial launch of MDMA-assisted therapy if approved by the FDA.” A new “vice president of market access” also came aboard, with special expertise in marketing “important medications across multiple therapeutic areas with high unmet needs and social stigma.”
On May 6, Lykos announced that the FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) would be meeting the following month to review data supporting its new-drug application for the Ecstasy capsule – “the first FDA advisory committee meeting to review a potential new PTSD treatment in 25 years.” The PDAC meeting was scheduled for June 4.
Things were about to get more interesting.
One day before the PDAC meeting was set to begin, a FOIA request came to the FDA from the New York Times. The June 3 request from the Times asked the FDA for “all inspection reports on Form 483 of clinical study sites related to the MAP/Lykos Therapeutics study of MDMA for PTSD. Please provide on a rolling basis the Establishment Inspection Reports associated with the inspections as applicable.” (An FDA Form 483 is a document, prepared by an FDA inspector, describing possible safety or other violations.)
When the FDA advisory committee met the following day, its members took a vote on whether Lykos’ clinical trials had shown that Ecstasy could be effective in treating patients with PTSD. Nine of the eleven members voted No. On a second question – whether the benefits of Ecstasy could outweigh the risks to patients – 10 of the 11 members voted No.
“We are disappointed,” Lykos’ CEO said, while also pointing out that the advisory committee’s recommendation wasn’t binding on the FDA. Still to come was the FDA’s expedited decision on Lykos’ application.
As the market caps of psychedelic start-ups began tanking on news of the thumbs-down from the advisory committee, more media requesters began weighing in. Their focus was on Lykos’ clinical study sites. On June 18, and again on July 1, the Wall Street Journal filed lengthy FOIA requests for Form 483s and other materials. That was followed by requests from Stat, the medical news website; Bloomberg News; and CBS News.
By early August, the psychedelic world was awaiting the FDA’s decision. That came on August 9, when Lykos announced that the FDA had sided with the advisory committee and turned down its Ecstasy application. The FDA asked Lykos to begin a new clinical trial, which Lykos said could be a multi-year setback.
Instead of releasing the FDA’s complete response to its Ecstasy application, Lykos merely summarized it in a press release. That led right away to more media requests from reporters seeking to learn whatever they could about the denial. There were new FOIA requests from NBC News; CBS News; the New York Times; and journalist Rachel Nuwer, author of a 2023 book titled I Feel Love: MDMA and the Quest for Connection in a Fractured World.
Soon there was more bad news for Lykos when the medical journal Psychopharmacology retracted three papers about MDMA-assisted psychotherapy due to “protocol violations amounting to unethical conduct.” Numerous authors on the three studies were affiliated with Lykos and its founding entity, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS). Within days, three-fourths of Lykos’ employees were laid off and the company’s founder resigned from the board. A few weeks later, the company’s CEO resigned. The New York Times laid out the ongoing train wreck in an article titled, “How Psychedelic Research Got High on Its Own Supply.”
As word spread, other notable FOIA requesters made their interest known. Within days of the Lykos denial, The Microdose, a twice-weekly newsletter published by the UC Berkeley Center for the Science of Psychedelics, logged a FOIA request seeking “a copy of the Complete Response Letter sent to Lykos Therapeutics regarding their new drug application for midomafetamine capsules.”
Tactogen, a company developing similar psychedelics, also jumped on the Lykos denial, filing a September 12 request seeking all the documents previously provided to the Wall Street Journal.
When Michael Pollan kicked off The Microdose, UC Berkeley’s newsletter about psychedelics, he boasted to its now-47,000 subscribers that psychedelic research “has already spawned an entirely new industry, with hundreds of startups, all with different ideas of how best to commercialize psychedelics. A handful of these companies have already gone public, with billion-dollar valuations. FDA approval of MDMA and psilocybin may be only a few short years away. Since 2018, a dozen universities—including Johns Hopkins, NYU, Berkeley, Yale, and Harvard—have launched research centers dedicated to studying psychedelics, all funded by private philanthropy. . . . If proof of the promise and legitimacy of psychedelic research were still needed, it has arrived.”
That was then. The recent New York Times article about the Lykos affair called it “a shocking decrescendo for a drug that had been promoted for years as best positioned to lead a psychedelic mental health revolution. The FDA’s rejection signals greater uncertainty for the future of psychedelic medicine.”
FOIAengine access now is available for all professional members of Investigative Reporters and Editors, a non-profit organization dedicated to improving the quality of journalism. IRE is the world’s oldest and largest association of investigative journalists. Following the federal government’s shutdown of FOIAonline.gov last year, FOIAengine is the only source for the most comprehensive, fully searchable archive of FOIA requests across dozens of federal departments and agencies. FOIAengine has more robust functionality and searching capabilities, and standardizes data from different agencies to make it easier to work with. PoliScio Analytics is proud to be partnering with IRE to provide this valuable content to investigative reporters worldwide.
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John A. Jenkins, co-creator of FOIAengine, is a Washington journalist and publisher whose work has appeared in The New York Times Magazine, GQ, and elsewhere. He is a four-time recipient of the American Bar Association’s Gavel Award Certificate of Merit for his legal reporting and analysis. His most recent book is The Partisan: The Life of William Rehnquist. Jenkins founded Law Street Media in 2013. Prior to that, he was President of CQ Press, the textbook and reference publishing enterprise of Congressional Quarterly. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Jenkins and Washington lawyer Randy Miller. Learn more about FOIAengine here. To review FOIA requests mentioned in this article, subscribe to FOIAengine.
Write to John A. Jenkins at [email protected].
