EXCLUSIVE: Close Up On Reason For Hope's Advocacy & Congressional Breakthrough Therapies Act

Psychedelic-assisted therapies are increasingly becoming a new hope horizon for many veterans and nonprofits are helping them access these treatments. Co-founders of national veterans organization Reason for Hope, Brett Waters and Ret. Marine LtGen Martin Steele spoke with Benzinga on their work promoting drug reform and educating officials and stakeholders on this important matter.

See conversation's Part 1.

State-Level Initiatives

Kentucky’s proposed budget allocation for ibogaine research toward treatment of Opioid Use Disorder would establish public-private partnerships to advance aspects including drug development, clinical infrastructure, protocol and training, harm reduction and education.

For Waters, “the need for more research is really the point.” He acknowledges the “very real” physical safety concerns on ibogaine, yet believes those risks could be managed and somewhat neutralized with standardized protocols considering the treatment’s “enormous” potential. 

“The ability to help people get through that withdrawal period is profound. There's nothing else really like it existing right now, certainly no placebo that could possibly be driving that withdrawal effect,” says Waters. “So we're really optimistic, Kentucky is at the forefront but certainly won’t be the last.”

On psilocybin, Arizona’s approved bill stipulates a $5 million research budget. With studies yet to begin, Waters says the state is another unique case as the money is going to natural mushroom research and thus linked to natural cultivation, which must be both FDA- and DEA-compliant.

Considering most people using psilocybin outside the clinic are taking natural mushrooms rather than synthetic products, this research’s importance also touches on public health.

Federal Bill

Waters helped in the writeup of the “Breakthrough Therapies Act.” Submitted during the last session once the new Congress resumed, a different version is ”not technically amended but rather a new bill” was introduced.

Removing the initial's broader language on Schedule I research reforms and following the DEA’s comments, the bill sticks to the narrowly tailored component of rescheduling therapies.

“We came into this specific-needed framework and saw this specific opportunity based on barriers to research with Schedule I drugs,” Waters told Benzinga. 

Because states are funding research programs and real-world clinical treatments, but the current legislation makes the process “overly burdensome.”

Additionally, the Schedule I status blocks access to the Right To Try (RTT) Act. That is, “compassionate use” for people who have tried everything else does not qualify for clinical trials and scheduling licenses cannot prescribe it. “So there's a very clear need to solve both issues,” Waters says.

HR1393 is getting ahead of FDA psychedelics’ approval, requesting a change from Schedule I to II through an existing expedited process under the Controlled Substances Act (CSA) states that, post-FDA approval, a substance must be rescheduled within 90 days. 

Further, if the FDA does basic Breakthrough Therapy or approves expanded access, the bill would automatically trigger the process, rescheduling to categories III or IV as corresponds. 

Rescheduling could also help another pressing issue: The expected demand spike and consequent bottleneck of qualified professionals. 

At the moment, the only way to treat people legally is through clinical research or expanded access programs, most people getting trained on the educational component have been unable to work with patients.

“So that’s also the reason for this bill, to make it easier to set those programs up; for instance, treating people in a research program under the RTT Act,” Waters says. A "very small but significant step” to help open up the bottleneck.

Next Up - EXCLUSIVE: Reason For Hope On Veteran Group Efforts, Comments To FDA & 2023 Expectations

Photo by Tim Mossholder on Unsplash