Opioid panel leader cites support for government-funded research into psychedelic drug; members have robust discussion of idea

By Melissa Patrick
Kentucky Health News

The commission that spends the state's half of opioid settlements with drug makers, distributors and retailers agreed Tuesday to simplify its grant application process, then had a robust discussion about its chair's proposal to spend up to $42 million on clinical trials that could lead to legalization of the psychedelic drug ibogaine for treatment of opioid-use disorder.

Commission Chair Bryan Hubbard

Bryan Hubbard, the commission's chair and executive director, said the application process should be simplified to help organizations that don't have the money to hire grant writers or legal counsel, and to ensure that grant applications directly target opioid-use disorder or any co-occurring substance-use disorder or mental-health issue, as required by state regulation.

The portal to submit an application to the Opioid Abatement Advisory Commission will reopen Jan. 1 and stay open through March, a much shorter period than before. The application review process will not be shortened. 

"By us shortening the application window from what was essentially 10 months to three," Hubbard said, "we give ourselves the opportunity to not be shooting at a moving target and to have the full universe of grant proposals so that we can strategically evaluate, review and put together the sort of infrastructure that the commission is charged with delivering regionally and based on areas of need." The other half of the state's settlement money is spent by cities and counties.

Pros and cons of ibogaine

The commission's discussion about ibogaine came after Hubbard shared materials from organizations lauding the plan to help fund research into the drug, which comes from the African iboga plant.

The first was a resolution from the National Executive Committee of the American Legion urging Congress to fund research of psychedelics, including ibogaione, as therapies for veterans' health.

Hubbard also read a letter from Robert Malenka, Pritzker Professor of Psychiatry and Behavioral Sciences at Stanford University. He praised Kentucky's plan for "innovative approaches to the treatment of opioid use disorder" and offered his assistance to help with the clinical trials. 

"While current treatments for opioid-use disorder need to be made more available, there is a need for more efficacious treatments and the study of psychedelics such as ibogaine, its therapeutic treatments is an exciting area that deserves rigorous, thoughtful and ethical research," Hubbard read from Malenka's letter, saying his lab is studying the efficacy of psychedelics and treatment models for opioid addiction and consults with companies that are pursuing psychedelics as potential therapies.

Hubbard read an email from Bennett Nemser, chief program officer for the Steven & Alexandra Cohen Foundation, who said it is "one of the largest nonprofit partners in the psychedelic research space." According to Hubbard, Nemser lauded Kentucky's "courageous spirit towards driving innovation in this arena" with public-private partnerships, and offerred to help start one.

Hubbard also read from a letter submitted by Genevive Jurvetson, co-founder of The Jurvetson Foundation, which says it is "Exploring moonshots in mental health, ending Veteran suicide." According to Hubbard, she said "Our steadfast belief is that psychedelic therapies present some of the most potent tools for addressing our mental-health crisis.

According to Hubbard, Jurvetson said the foundation supported Dr. Nolan Williams' ibogaine research at Stanford University, which is awaiting publication, presumably in a peer-reviewed journal. Hubbard told the panel that Williams had agreed to discuss his findings with the group after they are published. 

Hubbard noted that on Oct. 31 the National Institutes of Health and the Department of Health and Human Services issued a notice of funding opportunity for research on psychedelics including ibogaine as treatment for substance-use disorder, which says "There is an urgent need to develop novel treatments for SUD in light of the escalating rates of substance use, addiction, and overdose."

State Health Secretary Eric Friedlander said he was thrilled to see a discussion about outside entities supporting funding of such research, and that they also want to explore the use of other psychedelics.

Friedlander works for Gov. Andy Beshear, who has criticized Hubbard's plan, saying it would shortchange Kentucky anti-drug organziations. Hubbard works for Attorney General Daniel Cameron, who lost the governor's race to Beshear and will be succeeded by fellow Republican Russell Coleman.

Alluding to Beshear's criticism, commission member Jason Roop said the commission could fund along with "the great organizations in Kentucky that are already doing great work on this front. . . . We'll continue to support efforts. But we also want to explore this medication, this plant, because what it does, the mechanism, it says it right here, it does something different than other medications do. It encourages, it fosters, and apparently initiates a path of self-discovery, which can bring about healing, optimism, dignity, self-respect, and hope for the recovery journey." 

Roop, a pastor who describes himself as "a person in recovery," was referring to the spiritual awareness that some ibogaine users have reported.

Other commission members supported the idea. Vic Brown, who represents law enforcement, said that at a time when we continue to lose 100,000 people a year nationwide from drug overdoses, it's time to try something different. "We haven't found a solution to curtail that number in any way," he said. "We as a commission have a unique opportunity in history to try something new . . . "

Commission member Von Purdy said she wanted to ensure that if they fund the proposal, the drug would be available to everyone. Hubbard assured her that his draft proposal presented at the last meeting would make this a requirement. The principal objection to ibogaine is the risk it poses to the heart, which critics say would require hospital-based treatment that few people could afford.

Commission member Karen Butcher, whose son died of an opioid overdose, said, "If all fears were addressed, why wouldn't we, as I've said before,  want to do something groundbreaking and promising because of the escalation of this disease. . . . What is the opposition to doing something that's going to save lives, as opposed to the same-old, same-old that we've been doing, and we keep losing lives." 

Rep. Danny Bentley

The chief dissenter at the meeting was state Rep. Danny Bentley, R-Russell, a pharmacist and a non-voting member of the commission. He called ibogaine "false hope for the people of Kentucky," saying "It will take $2 billion and 10 years to get that product on the market."

Bentley said the drug's effect on the heart will put it in a "black box," meaning it will have one of the highest safety-related warnings assigned by the U.S. Food and Drug Administration. 

Bentley also noted that Williams' research at Stanford was not a "double-blind" study, which is the gold standard for clinical trials, but a pre-and post-observational study. Hubbard encouraged Bentley to take that up with Williams when he comes to present his findings.

Bentley cautioned the commission to be aware of who is funding ibogaine research. Citing his education as a pharmacist, he said he was taught that "If the people paying for the research own the company and the drug, it was invalid from the get-go."

"There is some evidence that one dose of ibogaine is an effective treatment for patients with opioid-use disorder," Bentley said, creating the notion that "As a one-and-done drug, this will eliminate the need for chronic treatment for opioid-use disorder. Unfortunately, unfortunately, the evidence is to support these claims are not only weak, but also heavily biased." 

As an example, he pointed to Dr. Deborah Mash, founder and CEO of DemeRx, a company focused on developing ibogaine for addiction treatment, who spoke at the commission's public hearing in July.

"All her research and all her statements should be invalid," Bentley said.  "Very few research studies have been done to evaluate the effectiveness of ibogaine as a treatment for opioid use disorder. Ibogaine may have some promise, and it could be further studied through smaller, single-site trials and collaboration with medical schools or product-research organizations, in partnership with drug-development companies that make ibogaine."

Using a common term for the pharmaceutical industry, which is paying most of the settlement funds that the commission will spend, Bentley said, "We have taken money from Pharma to help the people of the state of Kentucky, and now we're getting ready to give it right back to Pharma."

 

Patricia Freeman of the University of Kentucky asked Hubbard to see that future guests of the commission provide information about who paid for their travel expenses. Hubbard said the state could ask for this information, but not require it. He said the state had not paid any such expenses. 

The commission's next business meeting was rescheduled for Dec. 13.