The psychedelic medical industry faced a major setback when the FDA rejected a cutting-edge MDMA-based therapy in late 2024, but medical practitioners have not given up on psychedelics just yet.
In fact, AbbVie, one of the largest drug companies in the United States, announced in August that it plans to spend more than $1 billion to acquire a psychedelic drug in development from Gilgamesh Pharmaceuticals.
As states continue to introduce and pass bills to research or legalize psychedelic drugs, Healthcare Brew asked leaders across the industry for their thoughts on psychedelic drugs, how they are being integrated into the healthcare system, and what still needs to be done.
hospital
Rachel Yehuda, endowed professor of psychiatry and trauma neuroscience at Mount Sinai in New York, said the medical industry is “in transition with psychedelic medicine.”
“We're seeing increased interest from academic medical centers, government agencies like the Department of Veterans Affairs and the National Institutes of Health, and traditional institutions like pharmaceutical companies,” Yehuda said.
But clinical trials for psychedelics are difficult to conduct and there are still “too few”, she added, so it's still in the early stages.
Mount Sinai Hospital opened its Psychedelic Research Center in 2021, which was renamed the Parsons Research Center for Psychedelic Healing in 2024, because the hospital believes it is “essential to bring scientific rigor, clinical safety and ethical clarity to this emerging field,” Yehuda said.
Ensuring that clinicians are properly trained, ensuring that historically underserved communities have access to treatment, and conducting continued research should be key priorities to safely incorporate psychedelics into healthcare, she added.
Jerry Rosenbaum, founder and director and chief psychiatrist emeritus of the Massachusetts General Brigham Center for Psychedelic Neuroscience in Boston, told Healthcare Brew that although there is uncertainty about how psychedelic drugs will be delivered and reimbursed, he believes it is very likely that some drugs will ultimately gain FDA approval.
Rosenbaum said this is because some research suggests that psychedelics can be effective in treating and reversing many mental illnesses without the need for daily medication, and that they often work for patients who have not responded to existing treatments.
Psychedelics are best suited to treat mental illnesses such as treatment-resistant depression, generalized anxiety disorder, PTSD, obsessive-compulsive disorder and substance use disorders, he said.
For example, Lykos Therapeutics' Phase 3 study of MDMA as a treatment for PTSD found that 71% of 104 patients no longer had symptoms that met PTSD criteria after treatment. And a phase 2 study from psychedelic drug company Usona Institute found that psilocybin treatment was associated with “significant and sustained reductions” in symptoms of depression.
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Gen. Brigham established the Center for Psychedelic Neuroscience in 2021 with the goal of “understanding how psychedelic molecules work to produce changes in the brain, which we hope will advance our understanding of psychiatric conditions and facilitate the discovery of new treatments,” Rosenbaum added.
pharmacy
Andrew Whitman, a clinical pharmacist in hematology and oncology at UVA Health in Charlottesville, Virginia, said Healthcare Brew psychedelics can be particularly impactful for cancer patients.
“Many patients are dealing with the pain of a cancer diagnosis and pre-existing depression (or) anxiety. Cancer diagnosis involves a trauma response,” he said.
In Whitman's experience, oncology practitioners are generally open to exploring psychedelic drugs because they work with such a vulnerable patient population.
A 2016 study from Johns Hopkins University found that psilocybin therapy can help cancer patients fight depression and end-of-life anxiety.
A potential benefit of psychedelic drugs is that they allow health care providers to stop prescribing other drugs and prescribe them more minimally, Whitman said. Then the patient does not need to take medicine every day.
“We're serious about solving the root causes, so the focus shifts from routine use to a more holistic approach to making sure patients are taken care of,” Whitman said.
However, hallucinogens don't work for everyone. Whitman added that psychedelics are a concern for people with conditions such as bipolar disorder and schizophrenia because they can make their symptoms worse.
health tech
Leonard Band, medical director of Mindbloom, a telemedicine company that offers ketamine therapy, told Healthcare Brew that while there is still a stigma against psychedelics, the medical system is beginning to embrace the treatment.
“Academic medical centers are leading clinical trials, and health systems are increasingly exploring what it looks like to responsibly integrate psychedelic care. Even insurance companies are starting to pay close attention,” he said. “We are still in the early stages, but momentum is building.”
Band said the three areas to focus on to make psychedelics more mainstream are research, access and education.
He said the industry needs to continue rigorous research on psychedelics and ensure that the drugs are “affordable, scalable, and available to people from all walks of life, not just the privileged or those close to major research institutions.”
And education is needed to combat the misconception that psychedelics are experimental and dangerous, Band added.
“If we can deliver these treatments with compassion, structure and integrity, they will not just join the mainstream, they will help reshape the mainstream,” he said.
