Washington's challenge as lawmakers warm to psychedelic medicine: not letting hype outpace science

There's a new cause in Washington that's uniting Republicans, Democrats and Biden health officials: psychedelics as a cure for America's mental health crisis.

Long derided as counterculture party drugs, psychedelics are gaining new resonance 56 years after psychologist Timothy Leary urged 30,000 hippies in San Francisco’s Golden Gate Park to “turn on, tune in and drop out.” This time, it’s not about breaking free of staid convention, as Leary urged, but healing intractable psychic wounds.

The Food and Drug Administration has already approved one psychedelic to treat depression. The nation’s top drug regulator and Congress are pushing for more study of psychedelics’ potential to treat mental illnesses that now afflict more than a quarter of Americans. Advocates still must overcome stigma associated with 1960s drug culture and concerns about side effects, but they’ve never enjoyed such strong support inside government.

“The results that are coming out are just groundbreaking — earth-shattering,” said Rep. Morgan Luttrell (R-Texas), a former Navy SEAL who credits therapy and two psychedelics, ibogaine and 5-MeO-DMT, with helping him overcome the trauma he suffered after his Black Hawk helicopter went down during a 2009 training mission. "D.C. actually is getting their head around it.”

Luttrell was reluctant at first to try ibogaine, an extract from an African root, and 5-MeO-DMT, derived from desert toads, that like other psychedelics change a user’s perception of reality. "I'm a very anti-drug guy," he told POLITICO. But ultimately, he traveled to Mexico’s Baja California coast to use the drugs, because they’re illegal in the U.S. He said it saved his marriage.

Elected last year to represent Houston’s northern exurbs, he now wants to change the drugs’ legal status.

Federal agencies are signaling a willingness to cooperate.

The FDA, the nation’s drug regulator, has approved a version of ketamine for treatment-resistant depression.

The agency has also granted two other psychedelics — psilocybin and MDMA — breakthrough therapy status, geared at speeding up their development. In June, it offered advice for manufacturers testing psychedelic drugs in clinical trials.

In the House, Democrats including Alexandria Ocasio-Cortez of New York and Lou Correa of California, and Republicans led by Dan Crenshaw of Texas and Jack Bergman of Michigan have emerged as early champions. The House’s appropriations bill for the Department of Veterans Affairs includes an amendment that would require the VA to conduct a clinical study on psychedelics. The House’s version of the annual defense policy bill calls for similar research on troops.

Impediments could arise. The Drug Enforcement Administration says most psychedelics pose a high risk for abuse and have no accepted medical use.

But a spokesperson for the agency said the DEA has nonetheless approved applications from universities and companies to study the drugs.

“We definitely need some movement out of Washington if we're really to open up the floodgates and talk about a commercial, therapeutic class rather than a hypothetical more research-based possibility,” said Jonathan Havens, a partner at law firm Saul Ewing who works with psychedelics companies.

If Washington assents, manufacturers are poised to deliver. After decades of psychedelics research and advocacy, the California-based Multidisciplinary Association for Psychedelic Studies (MAPS) plans to file for regulatory approval of MDMA, commonly called ecstasy, by the end of the year. That could put the drug on track to get the FDA’s endorsement as a treatment for PTSD in 2024.

Big business

MDMA isn't a classic psychedelic like psilocybin or LSD, which cause hallucinations. Rather, it’s an entactogen that promotes emotional openness.

In a Phase 3 trial run by MAPS and published in Nature in 2021, 67 percent of study participants who received MDMA combined with therapy no longer met the diagnostic criteria for PTSD, compared to 32 percent in the group that received therapy and a placebo.

Psilocybin, the psychedelic compound in magic mushrooms, is in Phase 3 trials for treatment-resistant depression. A study run by the biotech company COMPASS Pathways and published in the New England Journal of Medicine last year found that a third of patients with treatment-resistant depression who took the highest dose of psilocybin saw their symptoms diminish — although those results were not as long-lasting as earlier studies.

"The data look really promising in terms of treating depression, treating PTSD, treating addictions, and also for palliative care settings," Albert Garcia-Romeu, a psychopharmacology researcher at Johns Hopkins University who was not involved in the MAPS or COMPASS Pathway studies, said of the psychedelic research landscape.

There's already a large body of smaller studies with encouraging results, he explained, and now bigger studies are building on them.

"MDMA with PTSD is furthest along the regulatory pipeline, so that seems to be poised to be the first out the gate, and then probably psilocybin for depression will be a couple years after that."

Still, he added, there are caveats: The trials have not been diverse enough. The workforce to deliver psychedelic treatments is too small. And using psychedelics is not as simple as taking a pill.

"We're talking about two to three months of talk therapy and maybe between one and three doses of the drug interspersed in that time. The people who just come and take the drug aren't necessarily going to get the benefits," he said.

There are at least 245 studies in the U.S. related to psychedelics listed on ClinicalTrials.gov, as well as dozens of publicly traded psychedelics companies. It amounts to big business. And while the biotech sector as a whole, including psychedelics companies, has struggled in 2023, the psychedelics market is projected to be valued at $11.8 billion by 2029, up from $4.9 billion in 2022.

The money flowing into psychedelics and the hype around the drugs has some physicians concerned that patients are being misled about the medical potential.

"It's reckless at best and potentially harmful at worst," said Dr. Jeffrey Lieberman, a psychiatry professor at Columbia University who coauthored a paper in JAMA Psychiatry last year about rapid investment in psychedelics. "People see this as the next gold rush," he said of investors.

While the first wave of psychedelics was brought down by a clash between culture and politics, his paper says, this one could be doomed by "entrepreneurial enthusiasm" getting ahead of the scientific process.

Dr. Nora Volkow, director of the National Institute on Drug Abuse, expressed similar concerns in a JAMA Psychiatry opinion piece in July. "Despite the promising early results, it is clear that psychedelics are not wonder drugs, but the hype has gotten ahead of the science," Volkow and her coauthors wrote.

Treating veterans

As Washington considers what to do about psychedelics, the drugs are going mainstream. Everyone from Prince Harry to New York Jets quarterback Aaron Rodgers is talking publicly about using psychedelics to improve mental health.

“In this country, we’re doing catch-up,” Rep. Correa told POLITICO. “[Approving psychedelic therapies] the good-old-fashioned way can sometimes get in the way of really advancing some public health treatments that may be here now.”

In the House, psychedelics have gotten more backing than in the Senate. The House appropriations bill for the VA and the House version of the National Defense Authorization Act both contain language that would require agencies to study psychedelics as treatment for certain mental health conditions, including PTSD. In these trials, participants would take supervised doses of psychedelics like MDMA and undergo therapy sessions.

“These breakthrough therapies represent hope for tens of thousands of Veterans every day suffering from the invisible wounds of war,” Bergman, the author of the appropriations provision, said in a statement.

Psychedelics have lingering stigma attached to them because of their association with 1960s counterculture, and because of the decades-long drug war targeting their recreational use. But today’s advocates are hopeful that focusing on the medical needs of veterans served by VA hospitals can help shift the narrative.

“If the largest health care system in our nation figures out how to roll [psychedelic therapies] out, other health care systems are going to be able to use that model,” said Juliana Mercer, the director of veteran advocacy and public policy at Healing Breakthrough, a group that advocates for MDMA-assisted therapy for veterans with PTSD.

The difficulty will be overcoming hurdles in the Senate, Correa said: “The challenge here is the stigma around drugs.”

Those hurdles may not be as high as Correa worries. Senate appropriators adopted language accompanying the chamber's Labor, Health and Human Services, Education, and Related Agencies spending bill noting their concern about barriers to research for psychedelics and encouraging the National Institutes of Health to expand its psychedelic research agenda and to "work with FDA in developing and supporting public-private collaborations to advance all forms of psychedelic research for therapeutic purposes."

Not just “Jell-O at the wall”

While some psychedelics, like psilocybin and LSD, aren't believed to be addictive for most people, ketamine, a dissociative anesthetic rather than a classic psychedelic, may cause dependency.

Short-term side effects of psychedelics can include symptoms like headache, abdominal pain, nausea or vomiting, high blood pressure, rapid heartbeat, trembling and diarrhea, as well as feelings of fear, confusion or panic.

Since people's thought processes and perceptions of reality are altered, there's risk for injuries or dangerous out-of-the-ordinary behavior, particularly for those taking the drugs outside of a medical setting.

Using MDMA may be associated with mild or moderate heart valve disease, while the long-term effects of using ketamine include uropathy, a serious, but reversible kidney condition.

Allegations of overprescribing have dogged the growth of ketamine clinics since the FDA’s 2019 approval of the drug for treatment-resistant depression, and some patients say they’ve suffered for trying it.

There's also the risk that therapists could take advantage of patients who are in a vulnerable and altered state. Already there have been reports of alleged sexual and ethical misconduct by a MAPS investigator, as well as a STAT News investigation into a psychedelic therapist who allegedly stole millions of dollars from her octogenarian patient.

Those dangers are all the more reason for Washington to move assiduously, said Luttrell.

"My biggest concern is that it comes off the rails and people take advantage of it — and we lose it," he said. With rigorous oversight, "We can show the American public that we're not just throwing Jell-O at the wall.”