This KY commission will choose whether or not to fund research of experimental psychedelic

Last summer, Kentucky’s 11-member Opioid Abatement Advisory Commission met for the first time in a fluorescent-lit room in Frankfort, introducing themselves around a horseshoe of plastic folding tables.

Their task was enormous: Together, they were to distribute roughly half of the $842 million acquired by the state in opioid settlements over the next several years. The other half would be given directly to counties and local governments.

Defined in Kentucky statute, part of the commission’s charge is to dole out abatement funds to groups and organizations who apply with evidence-based proposals for combating opioid use that needs funding. Members discuss the applications at length and then vote on who gets what amount of money.

In May, Republican Attorney General Daniel Cameron and Bryan Hubbard, chairman of Kentucky’s Opioid Abatement Advisory Commission, called a news conference to publicly announce a lofty proposal Hubbard spearheaded research for but hadn’t yet presented to the commission: invest up to $42 million over the next six years to conduct research by way of clinical trials using ibogaine in hopes of receiving FDA approval to distribute it as a medication to treat opioid addiction.

Ibogaine is a psychedelic that has been studied in other countries and found to treat anxiety, depression, post traumatic stress disorder and opioid use disorder. There are risks associated with the drug — which is not FDA approved in the United States — including fatal heart arrhythmia.

The way Hubbard presented his proposal in May was unorthodox. Hubbard told the Herald-Leader that his own interest in finding a “Manhattan Project-style solution” to help Kentucky recover from the drug epidemic led him to ibogaine.

Some commission members weren’t aware of the proposal until it was presented to the public May 30. Also absent on stage at the event were leaders in Kentucky’s recovery community, medical experts and University of Kentucky researchers involved in the state’s multi-million dollar efforts to expand access to FDA-approved opioid treatment options at the community level.

Commission members include Republican Rep. Danny Bentley, a pharmacist; Eric Friedlander, Cabinet for Health and Family Services secretary; Van Ingram, Office of Drug Control policy director; and Dr. Sharon Walsh, director of UK’s Center on Drug and Alcohol research and principal investigator for the HEAL study. Some members are appointed by Gov. Andy Beshear, like Friedlander and Ingram. Some are appointed by Cameron, like Hubbard.

‘This was never the way the money was meant to be spent’

Like some commission members, Beshear said in a press conference later that same day he had no idea about the proposed hopes to study ibogaine as a treatment for opioid use.

Beshear told media he immediately spoke with some commissioners following the press conference, who said they didn’t take a vote or even discuss the ibogaine proposal before the public announcement.

“I have some questions about how that procedure did, or did not, go,” Beshear said.

“Now the other thing I mention is, this is a huge amount of money. Thus far they have only put out $18.5 million and that is for law enforcement, treatment, recovery altogether,” the governor said. “So, I think the attorney general’s going to have to explain to every treatment center why they have received about $10 million total ... and what they are doing.”

Cameron, who was the lead speaker at the May news conference, is running for governor to unseat Beshear.

At the commission’s June 13 meeting, Hubbard asked to set two public hearing dates on ibogaine and whether the commission should invest in its research. Before the vote, Walsh said the statutory charge of the commission was to allocate money toward proposals that are “evidence-based.”

“For any medication in the U.S., the ‘evidence-based’ is that it’s FDA approved,” she told Hubbard. “How does that fit into doing something exploratory, if it’s not approved?”

Hubbard said the commission was “well within our legal ability to explore, and that’s the only thing we’re seeking to do is explore, at this stage.”

Walsh pressed further.

“If the focus is (diminishing) opioid withdrawal, we have medications that are already approved for (that),” she said. “Those are very effective drugs. I’m not sure why we need other drugs to target opioid withdrawal.”

Hubbard replied that “there are others who would seem to believe this is worth exploring, individuals who are scientifically credentialed who believe it has breakthrough therapeutic potential. I want to know if that’s true. That’s why we’re having this exploration.”

The time for commission members to more fully discuss the proposal was reserved for the public hearings on July 17 and August 16, Hubbard said. Friedlander and Bentley were the only two to vote against scheduling the public hearings.

“It feels like, if we can have a press conference, surely we can have a discussion,” Friedlander said at the meeting.

Despite Cameron’s attendance touting the proposal, Cameron’s office, in response to an open records request, said it had no written documentation to or from the attorney general regarding ibogaine, or the clinical trial proposals.

During the May 31 news conference, which commission members were invited to, Hubbard and Cameron said the tools Kentucky is currently using to remediate the vast impact of opioid addiction weren’t enough.

“We need to explore a new approach,” Cameron told the crowd.

But Beshear’s office said with a decrease in overdose deaths and high seizure amounts of fentanyl, the work being done in Kentucky is making a dent in beating back the epidemic.

“These wins are proof that the work being done in Kentucky is succeeding. But instead of investing more in our police and care providers, the attorney general is betting $42 million on an experimental drug trial,” said Crystal Staley, spokesperson for Beshear’s office. “This was never the way this money was meant to be spent.”

‘Exploring the possibility’

Despite the political controversy surrounding the funds and how they could be spent, some in the recovery community feel there is potential for ibogaine research to be success.

Isaiah House, a faith-based treatment facility, is one of several recovery centers that has been awarded a grant through this opioid abatement money for a new facility. When specifically asked about ibogaine, CEO Nick Wren said when people are suffering and dying, every tool needs to be used to help, as long as it is safe.

“Ibogaine has shown some promise and if it will help save lives, it needs to be studied. Our people in Kentucky deserve no less,” Wren said.

Alex Elswick, a founder of Voices of Hope, a non-profit which provides resources to those in recovery, was surprised that opioid abatement grant money could be used for experiential clinical trials. However, he said the core values of Voices for Hope are to appreciate all pathways to recovery.

“We are not here to say what is good or bad, we just want to see you get well,” he said.

Elswick said to his understanding of psychedelic therapies, if monitored and dosed properly, the treatment could provide a real benefit in the plasticity of the brain.

While he was intrigued by the announcement of ibogaine trials, he said he did think those in the recovery community need to have a seat at the table in future discussions.

“A principle of harm reduction is that people who use drugs should have a voice in policy and change that can impact them because they understand the issue better than anyone else through their lived experience,” Elswick said.

He said he felt it would be a mistake if recovering individuals are not included. However, people in recovery have different modalities which they do and do not support.

Some believe recovery is only possible through total abstinence. Others support the use of medications for opioid use disorder including Suboxone and methadone.

“There’s disagreement among folks that prefer abstinence and those that prefer (medication assisted treatment),” Hubbard said. “And then there’s a third group of folks who say recovery is an individualized journey. The issues that lead to addiction are unique and therefore whatever works for the individual is what should be made available.”

Hubbard, an attorney, said he is not looking to supplant or attack any of the models, but wants to look at adding another “weapon to the arsenal.”

“That’s the bottom line when it comes to any potential related to ibogaine,” Hubbard said. “This is an additional option that shows great promise. Insofar as it shows great promise, it is only fitting that this state above and beyond all the other 49 should take the lead in exploring the possibility of helping develop a breakthrough.”