Opioid panel to hold hearings on funding ibogaine drug research including a promoter; member sees a conflict chair quashes talk-HEALTHYLIVE

By Melissa Patrick
Kentucky Health News

The commission that manages the state's opioid-settlement money voted June 13 to hold two public hearings to discuss the idea of funding development of an opioid-use disorder treatment using the psychedelic drug ibogaine.

Two members of the Opioid Abatement Advisory Commission questioned the idea, one saying it seems to benefit a company developing a treatment, but the head of the commission, who proposed the idea, said discussion about his proposal would have to happen at those hearings, not at that meeting.

Bryan Hubbard at the June 13 commission meeting
(Kentucky Health News photos by Melissa Patrick)

"The first order of business is to determine whether this is a pathway that should be pursued with an explanation of what ibogaine is, and make sure we educate ourselves on whether or not what we see here has legitimacy," said Bryan Hubbard, the panel's executive director and chairman.

Hubbard said the first hearing would be "focused on the science" and include "consensus experts on ibogaine." He added that "the very intent of those hearings is to have a full, vigorous examination of any and all aspects of ibogaine and whether or not we should get ourselves involved in it."

Ibogaine is a powerful psychedelic that comes from a plant mainly found in Africa. It is illegal in the U.S. but has been reported to stop withdrawal symptoms of opioid dependence but also cause heart problems.

Hubbard cut off discussion after Rep. Danny Bentley, who joined the meeting virtually, asked when the panel would be able to discuss the idea. State Health and Family Services Secretary Eric Friedlander also voiced concern that there was no discussion by the panel before Hubbard announced the plan May 31.

Bentley, a pharmacist and a Republican from Russell in Greenup County, said, "I think we should discuss it today." Hubbard replied, "The motion on the floor is to adopt the public hearing schedule and that is what the discussion will be centered around." 

Friedlander and another commission member appointed by Democratic Gov. Andy Beshear learned about the ibogaine idea only when Hubbard revealed it at an event hosted by his boss, Attorney General Daniel Cameron, the Republican nominee against Beshear in the fall election, Beshear said last month.

Hubbard said May 31 that the commission would "explore the possibility" of committing "no less than $42 million" to developing the treatment of ibogaine for opioid-use disorder, with a goal of getting it approved within six years from the U.S. Food and Drug Administration. 

Hubbard took a few minutes to address what he said were misunderstandings. He said no funds have been allocated and "At this stage in the game, the only thing that we aim to do is to explore the possibilities related to ibogaine, its applicability as a therapeutic to opioid-use disorder. And then the second question is whether and to what extent this commission would commit funds to help develop Ibogaine as a therapeutic go through the FDA approval process. We're a good bit away from answering that question."

Sharon Walsh questions the idea.

Sharon Walsh of the University of Kentucky, who oversses a multi-year, interventional research project to find tools for preventing and treating opioid addiction, with federal funding of $87 million, voiced several concerns. 

Walsh asked how the settlement money could be used to explore a drug that has not been approved by the FDA because the commission's guiding law clearly says that the money must be used on evidence-based pursuits.

Hubbard said the law includes language that would support this effort "insofar as it recognizes that the commission may allocate resources for any projects it deems appropriate." Further, he said, "We are well within our legal ability to explore. . . and that's the only thing we're seeking to do here." 

Walsh also pointed out that there are mixed opinions about the use of ibogaine for opioid-use disorder. She asked if there would be "point-counterpoint" participants at the public hearing, or if it would only be people who are trying to develop it.

Hubbard said at least two subject-matter experts will be invited to the first public hearing, including Deborah Mash, founder and CEO of DemeRx, a pharmaceutical company developing ibogaine for treating addiction. He told Walsh that if she had an expert she would like to invite, they would work to include them. 

Friedlander asked if the focus could be broadened to include other psychedelics, but Hubbard said that wasn't possible, because while other psychedelic drugs are closer to FDA approval, they don't appear to be effective against opioid withdrawal syndrome, as ibogaine may be. 

Walsh pushed back: "If the focus is on opioid withdrawal, we have medications that are already approved for opioid withdrawal. It's not something that is difficult to manage clinically. And there are protocols that have been in place for 30-some years. . . . Those are very effective drugs. I'm not sure why we need other drugs to target opiate withdrawal." 

Hubbard replied, "Well, there are others who would seem to believe that this is worth exploring"  and that it has " breakthrough therapy potential. I want to know if that's true, right? And that's why we're having this exploration."  

Walsh also noted that she has known the proposed witness, Mash, for 30-some years and that Mash has been working on ibogaine since the 1990s. 

"She's the CEO of a company that's trying to develop it. So she's going to come and talk to us about the development of this with it, you know, with the hope of getting money. There's a clear conflict of interest from a person who has ownership of a company whose sole purpose is to get the drug to market," Walsh said. "That's why I'm asking for balance."

Hubbard replied, "Insofar as there are individuals who you know, with expert credentials that offer alternative views, please share those with the commission staff and myself."  

Secretary Eric Friedlander also objected.

Friedlander said he wished commission members had been able to discuss the idea before the press conference, which he said presented it as a "a fait accompli," or accomplished fact, even if that was not Hubbard's intention. 

Friedlander said, "Part of what we've been able to do is have these discussions about proposals in subcommittees, among ourselves, and I feel like that didn't happen here -- which is to me a disappointment. I'm just being straight. And even today feels like it's not welcome. . . . If we can have a press conference, surely we can have a discussion." 

Hubbard said he hoped that there would be "uninhibited cross-examination questions and discussions" at the two public hearings and afterward. 

"If we get into this and we find that what I have had my eyes on for the past month is smoke without fire or lacks legitimacy, we will come to that conclusion and move on from this exploratory state without any aim at a predetermined conclusion," he said. 

Bentley and Friedlander were the only two commissioners to vote against the motion to hold two public hearings about ibogaine.  

Friedlander said, "It feels too narrow and it feels too specific. And I would have much rather have had the discussion here before a press conference and before we really were presented with a motion and couldn't have more discussion. So based on those two things, I vote no."

Bentley said he voted no because "Right now all the research on this drug is outside the United States because the FDA will not give an NDA, a new drug application, for it. So that's the reason I'm opposed."  

The hearings will be held July 17 and Aug. 16, from 9 a.m. to 3 p.m. in Room A125 of the Administrative Office of the Courts Building, 1001 Vandalay Dr,, Frankfort, at the northeast quadrant of the I-64/US127 interchange.

Hubbard announced reappointment of three members to two-year terms: Vic Brown, deputy director of the Appalachian High Intensity Drug Trafficking Area, representing law enforcement; and Karen Butcher of Georgetown and Simmons College of Kentucky Vice President Von Purdy of Louisville, representing citizens at large.

The commission's next business meeting will be held Aug. 8 at 1 p.m. in Suite 200 of 1024 Capital Center Dr. in Frankfort. 

Hubbard announced that the Opioid Conference will be held Oct. 8 to Oct.10 in Lexington and the sponsor will be the Kentucky Association of Health Plans.

from KENTUCKY HEALTH NEWS https://ift.tt/IMzoZJg

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