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Promise and proscription: Regulations tie up access to psychedelics

Novel psilocybin and MDMA therapies tend to be more available overseas, but advocates note that this cuts out a critical data point for researchers.

WASHINGTON (CN) — Advocacy isn’t just a job for Brett Waters; he’s experienced the therapeutic use of psychedelics firsthand.

Back in college over a decade ago, Waters struggled to eat anything beyond a small set of plain foods from his childhood. Research on ARFID, short for adult restrictive food intake disorder, is still growing, but Waters saw about 80% of his anxiety and aversions evaporate over a six-month period after he tried mushrooms recreationally.

“I was able to change the course of my life,” he said.

For the past two years, Waters has served as executive director of the organization Reason for Hope, which he co-founded while working as an associate at Winston & Strawn.

The group is among several that are lobbying the federal government to support expanded access and research into psychedelic-assisted therapy using MDMA, a synthetic drug colloquially known as ecstasy, and psilocybin, the psychedelic compound that occurs naturally in several species of fungi, giving magic mushrooms their name.

Veterans have emerged as a surprising ally of the effort as well, pioneering research into the drugs as a treatment for post-traumatic stress disorder. 

Because these drugs are labeled Schedule 1 under the Controlled Substances Act, however, they are considered not only illegal under federal law but difficult to study since medical exemptions do not exist. The scheduling also means treatments or medicines can’t be patented, so drug companies have no financial incentive to pursue them.

Jesse Gould, president of the Heroic Hearts Project, spoke about the expense and time that goes into getting studies federally approved. MDMA has received expanded research approval, but Gould said it took hundreds of millions of dollars over a few decades.

Legislative efforts and recent announcements from federal agencies have provided a potential light at the end of the tunnel for advocates, but there’s no solid plan or timeframe on expanding access to the treatment.

The first step forward came when the Food and Drug Administration marked MDMA as a breakthrough therapy in 2017, which put it on the fast track for review. Psilocybin received the designation in 2019. 

In Congress, the effort has found bipartisan support, with measures introduced in March to remove regulatory hurdles for research and use of substances that are listed as Schedule 1 drugs.

Senators Cory Booker and Rand Paul sponsored a bill in the Senate, and Representatives Nancy Mace and Madeline Dean introduced a companion effort in the House of Representatives

The legislation would expedite the transfer of substances that receive breakthrough therapy designations from Schedule 1 to Schedule 2, which loosens federal regulations and makes it easier to conduct research. 

"Breakthrough therapies give us the opportunity to improve the lives of all those suffering from treatment-resistant mental illnesses,” Mace said in a press release. “It is our duty to make sure veterans have access to every possible treatment option that shows promise, including MDMA- and psilocybin-assisted therapies.”

The Biden administration has indicated it expects the FDA to sign off on MDMA as a medical treatment by 2024, but no action has been scheduled on the legislation.

In the meantime, the obdurate federal regulations leave organizations like the Heroic Hearts Project as the only means for veterans to pursue psychedelic-assisted treatments in other countries and cutting out U.S. researchers. 

“It’s just a completely absurd situation,” Waters said. “We could be treating these people in the United States and getting that long-term data.”

Heroic Hearts, which partners with researchers to gather data that could change federal laws, assists about 200 people a year, focusing on veterans who have exhausted treatments options approved by the Department of Veterans Affairs. The organization sends people to places like Mexico, Costa Rica, Peru, Columbia and Jamaica.

Psychedelics have helped veterans, but Gould stressed it’s not a one-size-fits-all approach. Heroic Hearts conducts a risk assessment before facilitating treatment because the drugs appear to work best for those who are suffering from trauma, but isn’t a recommended treatment for those with extreme symptoms and doesn’t help bipolar disorder or schizophrenia.

A psychedelic session is conducted in a controlled environment. Typically, a therapist who has previously worked with the patient will be present to help process trauma during the experience.

“Normal barriers that we have in a talk therapy situation that prevent us from going deep to understand what’s going on, psychedelics allow people to go past that,” Gould said. “It’s essentially just making therapy more effective.”

Gould said psychedelics dampen a portion of the brain that is triggered by those suffering from trauma. This allows some people to contend with the trauma by seeing it from a different perspective.

Some research has suggested that psychedelics can help treatment of certain brain injuries by reducing inflammation caused by concussions or concussive blasts, Gould said. Those injuries can cause symptoms that manifest as depression and post-traumatic stress disorder. 

Some states have approved limited medical use of the drugs, but with it remaining illegal at the federal level, banks aren’t taking money tied to the industry and the specter of a raid by the Drug Enforcement Administration looms. At the end of the day, there’s only so much that can be done on the state level without changes to federal laws.

Representatives Lou Correa and Jack Bergman launched the Congressional Psychedelics Advancing Clinical Treatments caucus in November to push legislation supporting psychedelic science and research of psychedelics in treating brain health conditions.

“[I]f psychedelic-assisted therapy can help treat or even fully cure someone of their PTSD, we need to take a closer look at these potential life-saving therapies,” Bergman, a Michigan Republican, said in a press release.

Correa, a California Democrat, said research can determine what diseases and disorders could be better treated with psychedelic compounds.

“If these treatments can save the lives of my constituents and fellow Americans, and are safe to receive in clinical settings, why would we not want to research them?” Correa said in a press release.

Waters, who has lost two family members to suicide, feels psychedelics can potentially transform mental health treatment.

“The research shows that there’s an unbelievable amount of potential here,” Waters said. “The current regulatory landscape is so backward and really holding back progress.”

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