With the FDA poised to decide whether to approve an MDMA-based psychedelic medicine later this year and multiple states taking steps toward potentially legalizing their therapeutic use, psychedelics are becoming increasingly popular within healthcare. But with that increased popularity come concerns that patients won’t get equal access to the therapies.
Most psychedelics are still classified as Schedule I drugs (the Drug Enforcement Agency’s strictest classification) and thus illegal at the federal level, with the closest thing to an FDA-approved psychedelic medicine being Spravato, a nasal spray made from ketamine that is designed for treatment-resistant depression—though there’s some debate over whether ketamine qualifies as a psychedelic.
But the FDA has granted psilocybin, MDMA, and a form of LSD breakthrough therapy status, a designation it uses for drugs that treat a “serious or life-threatening condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.”
The designation allows drug companies to run clinical trials of the drugs for potential therapeutic uses. Psilocybin is currently being studied to treat depression; MDMA is being studied to treat post-traumatic stress disorder (PTSD); and LSD is being studied to treat generalized anxiety disorder, according to Lynn-Marie Morski, president of the Psychedelic Medicine Association, a professional association “bridging the gap between the advances taking place in the psychedelic research world and medical practitioners.”
Some advocates see great potential for this therapy to come to market. “In general, medicines that you take daily are aimed at treating the symptoms of a disease, whereas psychedelic medicine is aimed at treating the source,” Morski told Healthcare Brew. “That’s what’s so impactful about psychedelic medicine, because if you can get to the core of the condition…then you can work with that core.”
A state-by-state approach
According to a study published in JAMA Psychiatry, 25 states considered 74 bills “proposing reform of existing laws restricting access to psychedelic drugs or proposing further research into reform legislation” between January 2019 and September 2022, and in the first nine months of last year, 50 bills introduced in 20 states included the word “psychedelic,” per LexisNexis State Net data.
In 2019, Denver, Colorado, became the first city to decriminalize psilocybin. In 2020, Oregon became the first state to legalize psilocybin for therapeutic use.
Both Colorado and Oregon have released preliminary frameworks for regulating psychedelics, including requirements for clinics to obtain a license to distribute psychedelic medicines. As of May 22, the Oregon Health Authority had issued licenses to 27 clinics to administer psilocybin.
Colorado also created a Natural Medicine Division within the state’s department of revenue that will oversee, license, and regulate centers providing psychedelic therapies.
Earlier this year, Utah Governor Spencer Cox allowed a bill that lets private, nonprofit health systems with at least 15 hospitals to test treating mental health patients with psilocybin and MDMA to become law.
“I’m very encouraged by how many states have either voted to legalize or at least voted to start research…because it shows a growing acceptance of psychedelic medicine, and what is going to further psychedelic medicine is more research,” Morski said. “Even if the state hasn’t yet legalized but they are supporting research, that still helps us move along the field of psychedelic medicine as a whole.”
Concerns around equity
With states considering or passing legislation that allows various levels of use, psychedelic medicine access currently varies widely across the country, leading to equity concerns, according to Folasade Falana, a psychology resident at the Behavioral Wellness Clinic in Tolland, Connecticut.
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“You see the communities that are really able to join in on the [psychedelics] studies, or able to just have access to [psychedelics], it really includes a very specific group, and I’ll just say it flat out: it doesn’t include people of color,” Falana said.
In 18 clinical trials of psychedelic medicines that took place from 1993 to 2017, 82.3% of the participants were white, according to a 2018 research paper.
David E. Olson, director of the UC Davis Institute for Psychedelics and Neurotherapeutics, told Healthcare Brew that the high cost of administering psychedelic medicines remains a barrier to access.
“At least for the classic psychedelics…they have to be administered in the clinic under the supervision of usually multiple healthcare professionals, which drastically increases the cost and the complexity of the treatment,” Olson said.
In a 2022 study, MDMA-assisted therapy was found to cost more than $11,000 per patient. It’s unknown as of yet how much insurance coverage psychedelic therapies will receive if approved, but health benefit plan Enthea said in November 2023 that it will offer psilocybin-assisted therapy as a workplace benefit starting this year.
One way to potentially lower the cost of psychedelic medicine could be by developing non-hallucinogenic variants of the drugs that wouldn’t require as much clinician oversight, Olson said.
That could “allow [psychedelics] to be effective for a variety of different conditions, but would lead to an increase in the scalability of the treatments so that we can democratize access and get these compounds in the hands of a greater number of patients,” he added.
Falana added that she’s concerned that the psychedelic medicine industry could be following a similar path as cannabis, which she said went from “persecuting certain groups to now being a cash cow for other groups.”
“There’s this idea that if psychedelics are so great to treat all of these concerns, then people of color who have historical and generational traumas in addition to continuous and ongoing traumas that are racialized, who better to use these medicines than people of color?” Falana said. “But the access is just not there.”
Steps forward
One of the first steps to making psychedelics more accessible and equitable is getting clinicians on board with the idea of even using the drugs in the first place, as there is still stigma around psychedelics, according to Morski.
Educating clinicians on the proper uses of psychedelic medicines is one of the Psychedelic Medicine Association’s missions, which offers continuing medical education courses for providers interested in the field, she said.
If Lykos Therapeutics’ MDMA-based drug for PTSD treatment is approved by the FDA in August, that would “go a long way to opening people’s minds to the safety and efficacy of at least MDMA,” Morski said.
“We’re not advocating the use of psychedelics with no oversight and no safety measures,” she added. “We’re advocating the safe use of psychedelics where you have the proper preparation beforehand, integration afterward, the proper safe setting, and you have trained facilitators.”
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