Among the proposals on their agenda, the Freedom to Heal Act seems a modest step for lawmakers to consider. If passed, it would expand the 2018 federal Right To Try Law—which gave eligible patients with life-threatening conditions access to certain drugs that haven’t been FDA-approved—to include Schedule I substances under DEA jurisdiction for which Phase I clinical trials have been completed.

“As a physician, I have seen how critical Right To Try can be for patients who are running out of options,” said Senator Rand Paul (R-KY), a co-sponsor of the Freedom to Heal Act. “Yet current law leaves doctors with no clear, legal way to administer investigational therapies that fall under Schedule I. This bill creates that pathway.”

Sen. Corey Booker (D-NJ) and Representatives Madeleine Dean (D-PA) and Nancy Mace (R-SC) were the other legislators who introduced the bill on December 4. Its language was largely crafted by the Veterans Mental Health Leadership Coalition, a nonprofit advocating for expanded access to psychedelic and other emerging treatments to help end the suicide epidemic.

“The problem was that these wounds weren’t being addressed.”

Right To Try was originally intended mostly for cancer patients whose conditions meant they couldn’t qualify for experimental treatments in a clinical trial setting. For Gary Hess, VMHLC’s director of advocacy and peer support, exclusion from one such trial, of the Schedule I substance MDMA, was a devastating setback.

After 11 years serving in the United States Marine Corps, often in combat environments, Hess suffered from panic attacks brought on by shattering post-traumatic stress. After leaving the military in 2008, he spent over a decade undergoing conventional treatments without relief and searching for solutions. 

“The problem was that these wounds weren’t being addressed,” Hess told Filter of his psychological scars.

After discovering alternative therapies, especially psychedelics like MDMA and ibogaine, Hess found they were helping him to reconnect with his mind and body. So he shared the good news with his doctors.

“Many of them were taken aback by my knowledge of it,” Hess said. What’s more, “Behind closed doors, they said, ‘We believe in these things. We know they help. We know that [our] medicines aren’t necessarily the answer, but because of the institutional barriers, we aren’t allowed to talk about [psychedelics]. Don’t stop doing what you’re doing.’”

The HIV/AIDS crisis of the 1980s, which overwhelmed health care systems, had ultimately forced the Food and Drug Administration to make case-by-case exceptions for doctors giving patients new treatments. These allowances relied on extraordinary efforts on the part of the doctor and were tailored to each appeal. It took until 1987 for a formalized Expanded Access program to establish people’s right to take a chance on new drugs that were under FDA investigation. And it wasn’t until the 2018 law that doctors were able to offer patients experimental drugs without having to ask the government for permission each time. But the ban on Schedule I substances remained.

This left people seeking psychedelic-assisted therapy in an untenable position. In an effort to save his own life, Hess turned to an entheogenic church operating in secret in Austin, Texas. “I took an oath that was founded on integrity, honor, courage, commitment,” he said. “I had to become a criminal to access some of these modalities within my own community.”

“How are physicians being educated and supported? At this point, there has been very little public-facing medical education.”

With many patients in crisis already turning to psychedelics, some advocates are raising concerns about how prepared doctors are to respond in the event the Freedom to Heal Act becomes law. Melissa Lavasani, founder of the Psychedelic Medicine Coalition, is among them.

“If this legislation moves forward during an administration that has taken a different approach to scientific funding and research priorities, it raises important questions about the level of coordination between the psychedelic ecosystem and the traditional medical community,” she told Filter. “How are physicians being educated and supported? At this point, there has been very little public-facing medical education to help doctors navigate what expanded access would actually look like in practice.”

Academic institutions are increasingly responding to the resurgence in psychedelics. Columbia University now offers a psychedelic therapy training program. A UCLA program trains clinicians on screening, preparation and integration methods for various psychedelic medicines. NYU, Yale, and Johns Hopkins have teamed up train everyone from grad students to medical residents interested in psychedelic medicine. And one organization, the University Psychedelic Education Program, or U-PEP, has begun educating the educators and developing curricula.

So far, however, neither the FDA or Department of Health and Human Services has been a part of such efforts.

“From a patient safety and clinical integrity perspective, I want to see policy that fills a real gap in our health care and research systems,” Lavasani said. “With the Freedom to Heal Act, we have to be honest about what the research does and does not tell us. I would like to see the bill’s sponsors address why suicidal patients are excluded from psychedelic clinical trials, how they reconcile that exclusion with this legislation, and how they plan to convince the health care community that this approach is appropriate when the research simply doesn’t exist.”

Other concerns about the potential implementation of the Freedom to Heal Act include questions of affordability and access for the average person. Still, advocates broadly welcome it.

Ousterman feels that while the Freedom To Heal Act is a step in the right direction, there must be more equity in expanding access to psychedelic treatments.

“I think it’s great that it closes the gaps with the DEA and could make these Schedule I substances accessible, Susan Ousterman, founder of the Vilomah Foundation, told Filter.

Her son, Tyler, struggled with opioid use disorder for years. In 2019, she heard powerful stories of patients responding to ibogaine therapy. Tyler wanted to try it, but US laws meant he would have to leave the country to do so. In early 2020, passport offices were closed due to COVID. By the time they reopened, Tyler had contracted endocarditis, making it unsafe for him to use ibogaine. In October 2020, he passed away from an overdose involving fentanyl and xylazine.

Ousterman has since become a champion for harm reduction and equitable access to psychedelic therapies. She feels that while the Freedom to Heal Act is a step in the right direction, there must be more equity in expanding access to psychedelic treatments.

“I have some privilege compared to many people struggling with addiction,” Ousterman said. “In my situation, yes, maybe my son could have accessed ibogaine through Right to Try. But most people dealing with severe addiction wouldn’t be able to afford these treatments in our current system, and that’s not being talked about enough.”

“It became a logical pivot to targeting that Right To Try Barrier. The system is clearly not working the way that it’s supposed to.”

In that context, many pharmaceutical companies have their own patented formulations of psychedelics in the medical research pipeline, and may not want challenging patients to get involved in their clinical trials.

“It’s already difficult to get companies that are going through the FDA approval process to be willing to supply their investigational drugs for compassionate use,” Brett Waters, Esq., executive director of the advocacy organization Reason for Hope, told Filter.  “They often fear adverse events and things that could harm their approval prospects, even though it’s not supposed to.”

When it came to crafting Freedom to Heal, Waters and the Veterans Mental Health Leadership Coalition took a cue when the HALT Fentanyl Act, which included language making it easier for researchers wanting to work with Schedule I drugs to apply to the DEA, became law in July.

“It became a logical pivot to targeting that Right To Try Barrier,” Waters said. “The system is clearly not working the way that it’s supposed to, and now we have the opportunity to provide an important fix for an entire class of potentially lifesaving Right to Try-eligible drugs.”

Photograph (cropped) by Matthew W. Johnson via Wikimedia Commons/Creative Commons 3.0

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