Showing posts with label attorney general. Show all posts
Showing posts with label attorney general. Show all posts

Friday, June 14, 2024

In third round of grants from opioid settlements, director passes on one, saying Coleman opposes syringe-exchange programs

Russell Coleman announced Chris Evans's
appointment on Dec. 19. (WKYT image)
By Melissa Patrick
Kentucky Health News
 
The leader of the agency that makes grants from the state's opioid settlements declined to vote for a grant with more money for a syringe-exchange program, saying Attorney General Russell Coleman does not support such programs -- which are considered a key tool for reducing harm to people who inject drugs.

Kentucky Opioid Abatement Advisory Commission Director Chris Evans, who works for Coleman, passed on a June 4 vote that approved a grant to the Boyle County Agency for Substance Abuse Prevention, one of 119 such county agencies.

"This application does increase outreach, which includes educational training, Narcan distribution and referrals to treatment," Evans said. "However, the request does increase the funding of the syringe-service position, which the Office of the Attorney General does not support syringe exchange programs. So I will be passing on the vote of this application."

Asked later why Coleman opposes syringe-exchange programs, Coleman spokesman Kevin Grout said in an email, "Attorney General Coleman is committed to supporting effective prevention, treatment and enforcement efforts. He strongly supports the distribution of Naloxone and other overdose reversal drugs. However, he cannot support syringe-exchange programs, which he believes enable drug use without effectively promoting recovery."

Syringe exchanges are supported by research. The Centers for Disease Control and Prevention says injection drug users who have access to syringe exchanges are five times more likely to get treatment than those who don’t. Another study says the exchanges do not encourage drug use or increase the frequency of drug use among current users.

The exchanges were authorized by the state's 2015 anti-heroin law, in an effort to thwart the spread of HIV and hepatitis C, which are commonly spread by the sharing of needles among intravenous drug users. As of March 14, the state had 80 operational syringe exchange programs in 65 counties.

Later voting against the grant request because of their opposition to syringe exchange programs were commission members State Treasurer Mark Metcalf and retired Master State Trooper Darren "Foot" Allen, whom Coleman appointed to fill a slot representing law enforcement.

Allen said, "There's some people that I trust that tell me this is okay. However, I'm just not in favor of needle exchange. I suspect that this time next year, I won't change my position but I am open to looking at that option," he said. 

Despite the opposition, Boyle County's ASAP grant request for $282,610 passed with a 6-2 majority vote. The commission is comprised of nine voting and two non-voting members from the legislature.

Third round of grants approved

The Boyle County grant was the only one put up for a vote that had any opposition at the commission's June 4 meeting. In all, the commission members approved 51 organizations to receive just over $12 million in grant money. 

The legislature created the commission to distribute the state's portion of the approximately $900 million in settlements with opioid manufacturers and distributors, half of which goes to the state and the other half goes to cities and counties. The commission is housed in the attorney general's office and is headed by Evans, a former chief operating officer for the U.S. Drug Enforcement Administration.

Of the $12 million in this round of grant money, 28 of the awards were given for treatment and recovery, and 23 were given for prevention. This is the third round of state grants, with $32 million awarded to 59 groups in the first round and $13.9 million awarded to 34 groups in the second round.

Asked for brief details of each grant, Grout said they would be announced next Thursday at a press conference at DV8 Kitchen-East End in Lexington, one of the grant recipients.

The 28 new treatment and recovery grants are:
Appalachian Regional Healthcare, $94,572.
Backroads of Appalachia, $167,025.
Boyle County ASAP Board, $282,610.
Celebrate Recovery Fairdale, $30,004.
Center for Employment Opportunities, $255,109.
Chrysalis House, $227,273.
Comprehend Inc., $426,087.
Eastern Kentucky Concentrated Employment Program, $450,000.
Family Nurturing Center of Kentucky, $221,937.
Family Scholar House, $245,110.
Grin Grant, Lexington, $361,251.
Hope Center, Lexington, $680,280.
Hope Springs Church, $50,462.
Horsesensing Inc., $115,219.
Isaiah House, $250,000.
Ky. Hospital Research and Ed. Foundation (Ky. Hospital Assn.), $250,000.
Lake Cumberland Area Development District, $277,552.
Life Learning Center, $498,500.
Mercy Health - Marcum and Wallace Hospital, Irvine, $179,834.
Natalie's Sisters, $88,356.
Northeast Kentucky Regional Health Information Organization, $331,997.
Ramey-Estep Homes, $222,801.
Recovery Café Lexington, $276,278.
Transitions Inc., $156,000.
Voices of Hope - Lexington, Inc., $538,021.
Volunteers of America Mid-States, $664,587.
Four Rivers Behavioral Health, $232,251.
Young People in Recovery, $301,440.

The 23 new prevention grants are:
Anderson County ASAP, $171,100.
Appalachian Research & Defense Fund (Legal Aid), $125,000.
Big Brothers Big Sisters of the Bluegrass, Inc., $185,301.
Boys and Girls Clubs of Kentuckiana, $200,000.
Carter County Public Library, $101,500.
Covington Partners, $225,450.
Cumberland Trace Legal Services (Legal Aid), $125,000.
DV8 Kitchen Vocational Training Foundation and DV8 Kitchens, $151,730.
Girl Scouts of Kentucky Wilderness Road Council, $59,052.
Jewish Family and Career Services, $77,207.
Legal Aid Society, $125,000.
Legal Aid of the Bluegrass, $125,000.
Mercy Health - Lourdes Hospital, $76,552.
Operation Parent, $87,011.
The Safety Blitz Foundation, $126,335.
Scott County Sheriff's Office, $91,847.
Taylor County Schools, $208,824.
Three Rivers District Health Department, Owenton, $320,803.
University of Kentucky Research Foundation, $380,572.
Operation UNITE, $751,850.
Wanda Joyce Robinson Foundation, $90,472.
WestCare Kentucky, $100,404.
Young Men’s Christian Association of Greater Louisville, $248,487.

The grant application portal is closed until the commission opens it for the next round of awards.

Friday, May 31, 2024

First naxolone shipment under settlement with drug maker arrives

Teva Pharmaceuticals' generic naloxone
Kentucky Health News

Nearly 8,000 doses of naloxone, which reverses the effects of drug overdose, were delivered to Kentucky this week as part of a settlement with Teva Pharmaceuticals, Attorney General Russell Coleman announced.

In October, Teva agreed to pay the state more than $71 million over 13 years, resolving allegations that the company’s marketing and promotional practices fueled the opioid-overdose crisis. In addition to the cash payments, Teva agreed to provide more than 23,000 units of naloxone.

The shipment, the first of four expected this year, went to facilities in Louisville, Florence, Ashland, Paducah and Frankfort. The Opioid Commission is partnering with the Cabinet for Health and Family Services as well as the Kentucky Pharmacists Association for distribution.

“Naloxone is a critical lifeline for Kentucky families struggling with addiction,” Coleman said in a news release. “Equipping first responders, health professionals and treatment providers with this all-important medication can help save lives for Kentuckians on the road to recovery.”

Half of all opoid-settlement funds go to local governments. The state's half is distribited by the Kentucky Opioid Abatement Advisory Commission is responsible for the distribution, part of the attorney general's office. On Tuesday, June 4,, the commission will award its next round of grants.

Kentuckians can find out how to get free naloxone near them at FindNaloxoneNowKY.org. Naloxone is also sold under the brand name Narcan by Emergent Solutions Inc.

Saturday, May 11, 2024

Online vision retailer Warby Parker will pay Ky. civil penalty for letting 69 Kentuckians to take its online vision test, illegal in Ky.

Image on Warby Parker's "Get a Prescription" page
Kentucky Health News

Warby Parker, an online retailer of prescription glasses, contact lenses and sunglasses, has agreed to pay at least $55,200 to the Commonwealth of Kentucky for allowing 69 Kentuckians to take its online vision test, contrary to state law, Attorney General Russell Coleman's office said in a news release Friday.

Coleman's office alleged that from July to October 2021, 69 Kentuckians were improperly given Warby Parker’s online test. "When the attorney general’s Office of Consumer Protection alerted Warby Parker of the problem, the company cooperated with the investigation and took the test offline," the release said. "Following a voluntary settlement process, Warby Parker will be penalized $138,000. If there are no further violations for five years, the amount will be reduced to $55,200."

The "Get a Prescription" page on Warby Parker's website says the online vision test is available to people who "reside in an eligible state, due to state-level regulations," and disqualifies residents of Alaska, Connecticut, the District of Columbia, Georgia, Idaho, Kentucky, New Mexico, South Carolina, South Dakota, Washington and West Virginia, using their two-letter postal abbreviations.

Kentucky consumers may complain about a business operating in the state to Coleman’s office at https://www.ag.ky.gov/Resources/Consumer-Resources/Consumers/Pages/Consumer-Complaints.aspx.

Tuesday, April 2, 2024

Database lists opioid-settlement payments to local governments

Screenshot of first page of KFF Health News database of settlement
payments
 in Kentucky through March 4 shows the top 15 recipients.
How much money are your local governments getting from the settlements of lawsuits filed against opioid manufacturers and distributors? You can track it with a new online database from KFF Health News.

Kentucky is getting $478 million from the settlements through 2038, and a like amount is being paid each year to local governments in the state. State government got $100.7 million in 2022 and $17.4 million in 2023. It will get $21.8 million this year and the same amount in 2025, and an average of $24 million a year after that.

The state's money is being allocated by the Kentucky Opioid Abatement Advisory Commission, operated out of the attorney general's office. Local governments' spending is up to their governing bodies.

"This database undercounts the amount of opioid settlement money most places have received and will receive," note Aneri Pattani and Lydia Zuraw and Holly K. Hacker of KFF Health News.

The database reflects only the largest settlement so far, $26 billion to be paid by pharmaceutical distributors AmerisourceBergen (now called Cencora), Cardinal Health, and McKesson, as well as opioid manufacturer Janssen (now known as Johnson & Johnson Innovative Medicine).

It does not include settlements with other drug manufacturers and retailers Walmart, Walgreens, and CVS. Data from these five companies will be added in July, according to BrownGreer, the settlement firm that gets the money and makes the payments. It is not handling some additional settlements such as the agreement between Kentucky and four Midwestern states with regional supermarket chain Meijer.

Other settlements, including with OxyContin manufacturer Purdue Pharma, are pending.

Tuesday, February 27, 2024

Bryan Hubbard, who wanted Ky. to help finance research into psychedelic for drug treatment, takes his cause to State of Ohio

Bryan Hubbard (Herald-Leader photo by Alex Acquisto)
Kentucky Health News

The man who wanted Kentucky to use some of its opioid-settlement money for research that could lead to legalizing a psychedelic drug to treat addiction, but lost his job when a new attorney general was elected last fall, is taking his cause to the State of Ohio.

"Bryan Hubbard, former executive director of the Kentucky Opioid Abatement Advisory Commission, has signed a contract with the State of Ohio," report Alex Acquisto and Austin Horn of the Lexington Herald-Leader. "His job: To help build public-private partnerships for potential projects 'related to the treatment of traumatic brain Injury, post-traumatic stress disorder and other related and unrelated mental-health and substance-use conditions,' according to a spokesperson in the office of Ohio Treasurer Robert Sprague. . . . Hubbard will be paid $45,000 for his independent contracting services, according to his contract, which was reviewed by the Herald-Leader."

Brittany Halpin, Prague’s press secretary, told the newspaper in an email, “In part, the work is set to assist the treasurer’s office with determining the feasibility of potential solutions with ResultsOhio and other pay-for-success models.” ResultsOhio uses public and private funding to address Ohio’s “most pressing social and public health challenges,” according to the treasurer’s website

Hubbard told the Herald-Leader that as he works with the state to “deliver novel treatment access and research opportunities for veterans and opioid dependent individuals,” he is partnering with an Ohio-based foundation to “create the framework for ibogaine clinical trials in Ohio.”

Ibogaine is a psychedelic derived from the African iboga plant. It is illegal everywhere except Mexico and New Zealand and has been reported to reduce or eliminate drug-withdawal symptoms while posink risks to the heart. Hubbard wanted the Kentucky commission to spend $42 million, 5 percent of what the state had received in lawsuit settlements from drug makers and distributors, to help fund research that could lead to legalization of the drug as a treatment for addiction.

Hubbard's boss was then-Attorney General Daniel Cameron, who countenanced Hubbard's advocacy but did not endorse it outright as he ran for governor. He was succeeded by Russell Coleman, a former U.S. attorney who was not keen on ibogaine or Hubbard, and asked him to resign.

Hubbard told the Herald-Leader that he was “saddened that a lack of courage and vision from [Coleman] has deprived Kentucky of its opportunity to lead the nation in the development of ibogaine’s revolutionary therapeutic potentials. However, I am strongly encouraged that genuine leaders exist across the river to ensure that ibogaine’s promise has an opportunity to be fulfilled for all who may choose to seek it.” Coleman’s office did not respond to emailed questions from the Herald-Leader.

Hubbard is part of a broader ibogaine effort. Last week, the REID (Reaching Everyone in Distress) Foundation announced that he would “research and raise awareness for emerging therapies such as ibogaine as potential breakthrough treatments for PTSD and opioid addiction in Ohio.”

"The REID Foundation was created by Rex Elsass, who lost his son to addiction in 2019," the Herald-Leader reports. "Elsass is also one of the nation’s premier Republican operatives. In 2016, GQ magazine dubbed him “The Most Powerful Man in the GOP (And You’ve Never Heard Of Him).” His political media and consulting firm is called The Strategy Group. Elsass has been close to Kentucky Sen. Rand Paul, serving as a key adviser in Paul’s 2016 bid for president. As senator, Paul has spearheaded efforts into seeking alternative therapies to treat addiction. A donor with close connections to Paul, Jeff Yass, was the primary funder of outside groups" that helped Cameron's challenge to Democratic Gov. Andy Beshear. "Elsass’ political firm has performed work for those groups."

Yass’ investment firm "has some interest in biopharmaceutical companies with a focus on psychedelic addiction treatments like ibogaine," the Herald-Leader notes. "Elsass’ advocacy for ibogaine can be traced back to Hubbard’s time in Kentucky." He did that at an opioid-commission meeting, and "a former executive assistant at his political operation started a group called the Kentucky Ibogaine Initiative. Elsass and the current president of The Strategy Group, Ryan Rodgers, are still listed as directors" with the Kentucky secretary of state.

Tuesday, February 13, 2024

Attorney General Coleman sues Kroger over opioid dispensing

Attorney General Russell Coleman has sued the Kroger Co. for its role in the opioid epidemic in Kentucky. 

The lawsuit, filed in state court in Bullitt County, alleges that the Cincinnati-based grocery chain, the nation's largest, bought more than 4 billion morphine-milligram equivalents of opioids for Kentucky from 2006 to 2019, and during that time distributed almost 194 million hydrocodone pills to its Kentucky pharmacies while failing to effectively monitor for suspicious opioid orders.

"Kroger's 100-plus pharmacies in the state were responsible for over 11% of all opioid pills dispensed in Kentucky, totaling hundreds of millions of doses flooding into communities without any reasonable safeguards," a news release from Coleman's office said.

Russell Coleman
“For more than a decade, Kroger flooded Kentucky with an almost unthinkable number of opioid pills that directly led to addiction, pain and death,” Coleman said in the release. “Kroger, which families have trusted for so long, knowingly made these dangerous and highly addictive substances all too accessible. Worst of all, Kroger never created a formal system, a training or even a set of guidelines to report suspicious activity or abuse. The scourge of addiction that has plowed through graduating classes, work forces and entire families is the devastating result.”

"Despite clear red flags, Kroger did not report a single suspicious prescription in the Commonwealth between 2007-2014," the release says. "No state was harder hit by the opioid epidemic than Kentucky, and the consequences have caused suffering and grief for many families across the commonwealth."

Previous attorneys general have sued other opioid retailers and won multi-million-dollar settlements, which the legislature is funneling through local governments and a commission overseen by the attorney general to mitigate the opioid epidemic.

Tuesday, December 19, 2023

Incoming attorney general replaces leading advocate of funding research aimed at legalizing psychedelic for addiction treatment

By Al Cross
Kentucky Health News

The main proponent of using state opioid-settlement money to fund research into a psychdelic drug as a treatment for addiction will soon be out of a job.

Bryan Hubbard, the chair and executive director of the state Opioid Abatement Advisory Commission under outgoing Attorney General Daniel Cameron, will be replaced when Russsell Coleman becomes attorney general Jan. 1. Coleman was elected in November, as his fellow Republican was losing the race for governor.

D. Christopher Evans
The commission's new chair and executive director will be Christoper Evans, a former Drug Enforcement Administration agent and leader who was acting administrator of the agency for more than five months in 2021, while President Biden's nominee, Anne Milgram, was being chosen and confirmed.

When Coleman announced his executive team in the state Senate chamber Tuesday, Kentucky Health News asked for his opinion and Evans's opinion of funding research on ibogaine, the African psychedelic that can suppress opioid-withdrawal symptoms but poses risks to the heart and is illegal everywhere but Mexico and New Zealand.

Coleman didn't give Evans an opportunity to respond, but said "We're gonna take a look at ibogaine," and would "make sure we look at that objectively." He said earlier that "Personnel is policy" and the change signals his belief that the "three-legged stool" of prevention, enforcement and treatment needs to focus more on prevention of drug use.

"We do not have a statewide prevention effort in the commonwealth," he said, adding later, "There's some great ideas out there on the prevention side. I want to see if we can scale those up. . .  I understand there's been a lot of ink spilled on ibogaine. My concern is we are not as focused as intently as we should be on the prevention piece of this."

The commission handles the state's half of the $900 million or so that the state will get in lawsuit settlements from opioid manufacturers and distributors. As chair and executive director, Hubbard promoted the idea of spending $42 million, about 5 percent of the money, on research aimed at getting Food and Drug Administration approval for use of ibogaine in addiction treatment.

At the commission's Nov. 14 meeting, Hubbard read several endorsements of ibogaine by experts, foundations and the American Legion. One foundation is supporting ibogaine research at Stanford University, which is awaiting publication, presumably in a peer-reviewed journal. Hubbard said the researcher had agreed to discuss his findings with the commission after they are published.

Bryan Hubbard
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. The notice says "There is an urgent need to develop novel treatments for SUD in light of the escalating rates of substance use, addiction, and overdose."

Several commission members spoke favorably of funding ibogaine research, but a non-voting member, state Rep. Danny Bentley, R-Russell (Greenup County), a pharmacist, called it "false hope," 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. Other critics have said the heart effects would mean that treatment would be limited to hospitals, and thus expensive.

Bentley cautioned the commission to be aware of who is funding ibogaine research. Citing his education as a pharmacist and one of the earlier witnesses at the commission, 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."

Gov. Andy Beshear was also critical of the idea and the way it was promoted by Hubbard. His initial promotion of it was countenanced by Cameron, whom Beshear defeated for re-election.

Around the time Cameron implicitly endorsed the idea, a firm owned by a major national political contributor increased its investment in such research and gave Cameron a political boost, the Daily Beast reported.

Unlike Hubbard, Evans will have a deputy: Jessie Halladay, now a senior policy specialist with the Criminal Justice Institute. She has been special adviser to the Louisville Metro Police Department, senior policy adviser to the Kentucky Justice and Public Safety Cabinet, communications director for Jefferson County attorney and a public-safety and social-services reporter for the Louisville Courier Journal.

Evans, who will head the commission starting next month, was the first special agent in charge of the DEA's Louisville Field Division. In that job, he partnered with Coleman, then U.S. attorney for Western Kentucky, to create a DEA office in Paducah, a Coleman news release said.

Coleman said Evans rose to become chief of operations for DEA, which led to his stint as acting administrator. The release said he is a director of Christopher 2X Game Changers in Louisville and the Kentucky State Police Foundation.

Friday, November 17, 2023

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.

Wednesday, November 15, 2023

Walgreens to pay state $102 million to settle opioid claims

Attorney General Daniel Cameron said Wednesday that Walgreens and its subsidiaries have agreed to pay a $102 million settlement to the state for business practices that worsened the opioid epidemic.

Walgreens will pay the money over 15 years, and has agreed to monitor, report, and share data about suspicious activity related to opioid prescriptions, under the settlement in Boone Circuit Court.

“This settlement has been a long time coming,” Cameron said in a press release. “And while nothing can truly fix what the opioid epidemic has stolen from us, this money is a glimmer of hope for Kentucky—real dollars for real recovery.”

Under state law, half of opioid settlements with drug manufacturers, distributors and retailers go to cities and counties, and half go to the state, where the money is spent by a commission staffed by the Office of the Attorney General. Cameron, who lost the governor's race to Gov. Andy Beshear, will be succeded as attorney general Jan. 1 by another Republican, former U.S. Attorney Russell Coleman.

Beshear filed the lawsuit against Walgreens when he was attorney general.

Friday, November 3, 2023

Poll shows Beshear, Cameron in dead heat; most voters say they oppose current abortion law that lacks rape and incest exceptions

Emerson College graph adapted by Kentucky Health News; click to enlarge
By Al Cross
Kentucky
Health News 

From the start, the X factor in the Kentucky governor’s race has been former president Donald Trump: Would his endorsement propel Republican Attorney General Daniel Cameron past Democratic Gov. Andy Beshear, who has had high approval ratings and led in every public poll? Now a poll taken in the last four days indicates strongly that it could.

The survey, taken by Emerson College of Massachusetts, shows Beshear and Cameron in a dead heat, with 46.9 percent for each candidate and 3.9 percent undecided. Another 2.3 percent said they would vote for someone else, which would require write-in voting, because no other gubernatorial slate is on the ballot. Adding undecided voters who said they were leaning one way or another, Cameron leads, 49.3% to 48.4%. The poll has an error margin of plus or minus 3 percentage points.

The result differs strikingly from an Emerson poll taken at the start of October, which showed Beshear with 49% and Cameron with 33%. But that poll was of registered voters, while this one was of 1,000 Kentuckians who said they were very likely to vote or had already voted. Early voting began Thursday, the last day of the poll, and about 2% of votes in statewide races are typically cast by absentee ballots.

Even with this poll, the big question about the election remains which voters will actually turn out to vote. In response to a question from Kentucky Health News, Emerson said it called about 250,000 people, texted about 15,000, emailed about 15,000 and had an online panel of voters aged 18 to 29. 

The poll started Monday, Oct. 30, and ended Thursday, Nov. 2. At midday Tuesday, the Cameron campaign sent Trump supporters a video endorsement of Cameron by the former president. Before that, TV advertising by Cameron and groups supporting him increasingly featured the endorsement, which Cameron obtained months before the Republican primary election.

Spencer Kimball, director of the poll, said in a press release that Cameron appears to have gained ground by consolidating support from Republicans who supported Trump in 2020. In the October poll, 54% of Trump supporters supported Cameron; in the latest survey, it was 79%.

The poll also found a similar increase for Cameron among voters aged 50 to 69; 58% of them said they support Cameron; in the October poll, he was getting only 36% of their votes. Beshear’s share dropped to 40% from 49%.

The poll also asked voters if they “support or oppose Kentucky’s current laws that ban abortion in nearly all cases, with no exception for rape or incest.” Beshear has criticized Cameron for opposing such exceptions and said the overturned Roe v. Wade Supreme Court decision was generally correct.
The poll found that 55% of likely voters oppose Kentucky's law and only 28% support it, with 17% unsure.

“Majorities of both men and women voters oppose the abortion law,” Kimball said. “Fifty-two percent of men and 58% of women voters oppose the laws, while support is relatively similar: 30% of male voters and 28% of women voters support the abortion laws.”

Three-quarters of Democrats said they oppose the law, and 47% of independents said likewise. Among, Republicans, 42% said they support it, while 37% said they opposed, and 21% were unsure. Generally, the younger the voter, the more likely they were to oppose the law.

The poll was sponsored by WDKY-TV, Fox 56, in Lexington. It was conducted mainly by automated, recorded calls to landlines. About 10% of responses came via texts to and from cell phones. About 34% came from an online panel of voters provided by Centiment Data and 1.6% came from emails provided by Aristotle, the Emerson press release said.

Wednesday, November 1, 2023

Candidates for governor fuss over credit for opioid settlements

Gov. Andy Beshear and Attorney General Daniel Cameron in
December 2019, after Beshear appointed Cameron to fill his
unexpired term as AG (Associated Press photo by Bruce Schreiner)
By Aneri Pattani
KFF Health News

Opioid settlement cash is not inherently political. It’s not the result of a law passed by Congress nor an edit to the state budget. It’s not taxpayer money. Rather, it’s coming from health-care companies that were sued for fueling the opioid crisis with prescription painkillers.

But like most dollars meant to address public health crises, settlement cash has nonetheless turned into a political issue.

Gubernatorial candidates in Kentucky and other states are clashing over bragging rights for the funds — which total more than $50 billion and are being distributed to state and local governments over nearly two decades. Kentucky's share of the pie is $842 million.

Among the candidates are curremt or former attorneys general who pursued the lawsuits that produced the payouts. And they’re eager to remind the public who brought home the bacon.

“Scoring money for your constituency almost always plays well,” said Stephen Voss, an associate professor of political science at the University of Kentucky. It “is a lot more compelling and unifying a political argument than taking a position on something like abortion,” for which you risk alienating someone no matter what you say.”

Attorney General Daniel Cameron, the Republican candidate for governor, wants sole credit for the hundreds of millions of dollars his state is receiving to fight the opioid epidemic. In a post on X, formerly known as Twitter, he wrote that his opponent, former attorney general and Democratic Gov. Andy Beshear, “filed a lot of lawsuits during his time [in] office, but in this race, there is only one person who has actually delivered dollars to fight the opioid epidemic, and it’s not him.”

Beshear filed nine opioid lawsuits during his tenure as attorney general, several of which led to the current payouts. At a January news conference, Beshear defended his role: “That’s where these dollars are coming from — cases that I filed, and I personally argued many of them in court.”

Christine Minhee, founder of OpioidSettlementTracker.com, who is closely following how attorneys general handle opioid-settlement money, said voters likely don’t know that the settlements are national deals crafted by a coalition of attorneys general and private lawyers. So when one candidate claims credit for the money, his constituents may believe “he’s the sole hero in all of this.”

Candidates in other states are touting their settlement credentials, too. North Carolina Attorney General Josh Stein, a Democrat, lists securing opioid settlement funds at the top of the “accomplishments” section of his 2024 gubernatorial campaign website. West Virginia Attorney General Patrick Morrisey, a Republican gubernatorial candidate for 2024, has repeatedly boasted of securing the “highest per capita settlements in the nation” in news conferences and on social media and his campaign website.

Louisiana Attorney General Jeff Landry, a Republican who was recently elected governor, ran on a tough-on-crime platform, with endorsements from sheriffs and prosecutors. As attorney general, he led negotiations on dividing opioid settlement funds within the state, resulting in an agreement to send 80% to parish governments and 20% to sheriffs’ departments — the largest direct allocation to law enforcement in the nation.

In Kentucky, half the settlement money is being distributed among cities and counties, and the other half is controlled by the Opioid Abatement Advisory Commission, staffed by Cameron's office.

It’s a common joke that AG stands for “aspiring governor,” and officials in that role often use big legal cases to advance their political careers. Research shows that attorneys general who participate in multistate litigation — like that which led to the opioid settlements and the tobacco settlement before it — are more likely to run for governor or senator.

But for some advocates and people personally affected by the opioid epidemic, this injection of politics raises concerns about how settlement dollars are being spent, who is making the decisions, and whether the money will truly address the public health crisis. Last year, more than 100,000 Americans died of drug overdoses.

Average people “don’t really care about the bragging rights as much as they care about the ability to use that funding to improve and save lives,” said Shameka Parrish-Wright, director of Vocies of Community Activists and Leaders (VOCAL-KY), a Louisville-based advocacy group that champions investments in housing and health care.

“What I see in my state is a lot of press conferences and news pieces,” said Parrish-Wright, a Democrat who is active in local politics. “But what plays out doesn’t get to the people” — especially those deeply affected by addiction.

For example, when Beshear celebrated a decrease in the state’s overdose deaths, his announcement overlooked the increasing deaths among Black Kentuckians, Parrish-Wright said.

And when the Cameron aide who chairs the opioid commission proposed that 5% of settlement funds be used to research ibogaine — an illegal psychedelic drug that has shown potential to treat addiction — to help get it approved by the Food and Drug Administration, Parrish-Wright said her first thought was “most poor people can’t afford that.” A recent witness before the commission said the FDA is unlikely to approve it, and even iof it did, treatment should occur only in hospitals because of the risk of heart damage.

The ibogaine announcement caused additional controversy. It’s an experimental drug, and, if approved, the $42 million allocation would be the single-largest investment from the commission. The Daily Beast reported that a billionaire Republican donor backing Cameron’s gubernatorial campaign stands to reap massive profits from the drug’s development.

Neither Cameron’s office nor his campaign responded to requests for comment for this story.

Beshear’s office declined an interview request but referred KFF Health News to his previous public statements, in which he criticized the potential investment in ibogaine. He has suggested that Cameron, whose campaign has emphasized support for police, is not putting his money where his mouth is.

“If you only provide $1 million to law enforcement and 42 [million] to pharma, it doesn’t seem like you’re backing the blue. It seems like you’re backing Big Pharma,” Beshear said at a May news conference.

Minhee, founder of OpioidSettlementTracker.com, said she’s concerned that mixing politics with settlement funds could result in ineffective investments nationwide.

“If some of this money is going to be politicized to advance careers of attorneys general who support the war on drugs, then that is literally using monies won by death to feed into more death,” she said.

Parrish-Wright said she worries that candidates — and some voters — will forget about the significance of the money once ballots are cast. “We cannot let it fade after the election cycle,” she said.

Her solution depends in part on politics. She’s on the ballot herself Nov. 7, for a seat on Louisville’s Metro Council. If she wins, she said, she intends to keep the settlement in the public conversation.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs of the Kaiser Family Foundation, an independent source of health policy research, polling and journalism.

Tuesday, October 24, 2023

Cameron, other attorneys general sue Meta, accusing Facebook and Instagram of purposely harming mental health of youth

Illustration from DB Investing
Kentucky Health News

Attorney General Daniel Cameron is among a large, bipartisan group of attorneys general suing Meta, the parent firm of social-media platforms Facebook and Instagram, accusing them of purposefully harming the mental health of youth in those states.

The suit alleges that Meta knowingly designed and deployed addictive features that put Kentucky’s youngest residents at risk despite claiming the features were safe. It was filed in federal court for the Northern District of California. 

“Protecting the safety and well-being of our most vulnerable remains my utmost priority,” Cameron said in a news release. “Meta has disingenuously downplayed the devastating effects of its platforms to exploit every scroll, click, and tap of our youth. This social media giant must stop these reckless actions and must be held accountable.”

The release said, "Meta maximized profits by monetizing children’s addiction. Features like infinite scroll and near-constant alerts were created with the express goal of hooking young people, according to former employees, and its algorithms push users into descending 'rabbit holes' in an effort to maximize engagement. The social media company also targeted young users to maximize their profits, calling them a 'valuable, but untapped market'."

Citing reports, the suit alleges that the social media giant knew the techniques negatively impacted young people’s physical and mental health, such as undermining their ability to get adequate sleep. However, Meta failed to make meaningful changes to minimize the harmful effects. The suit also cites the finding of a “youth mental health crisis” by the U.S. surgeon general.

The news release said the suit was "brought by General Cameron and 41 attorneys general on behalf of their states," but also said it was filed by "Kentucky and 32 states" and the complaint listed only 33 states. Cameron's spokeswoman, asked for a clarification, did not reply Tuesday.

Scientists have been reluctant to say outright that social media are addictive, but David Greenfield, a psychologist and founder of the Center for Internet and Technology Addiction in West Hartford, Conn., told The New York Times that the platforms use powerful tactics to keep users using.

One is “intermittent reinforcement,” which creates the notion in a user could that a reward is in the offing, but its timing is unpredictable. “Just like a slot machine,” he said, noting the platforms' use of lights and sound. Even more powerful, he said, are information and rewards that are tailored to users.

"Young people are particularly at risk, because the brain regions that are involved in resisting temptation and reward are not nearly as developed in children and teenagers as in adults, the Times reports, quoting Greenfield: “They’re all about impulse and not a lot about the control of that impulse.” Also, "the adolescent brain is especially attuned to social connections," the Times notes. Social media are “a perfect opportunity to connect with other people,” Greenfield said.

"Meta responded to the lawsuit by saying that it had taken many steps to support families and teenagers," the Times reports, quoting the company: “We’re disappointed that instead of working productively with companies across the industry to create clear, age-appropriate standards for the many apps teens use, the attorneys general have chosen this path.”

Sunday, October 22, 2023

In debate, Cameron slams Beshear's handling of pandemic; governor says 'I'd rather save lives than win re-election'

Atty. Gen. Daniel Cameron and Gov. Andy Beshear debated Saturday night. (WLKY image via Ky. Lantern)
By McKenna Horsley
Kentucky Lantern

During a debate Saturday night, the candidates for governor were asked if the state should have an ongoing plan for a future pandemic, like the Covid-19 pandemic that began in 2020, as well as what they thought were successes and failures in the response to the coronavirus.

Republican Attorney General Daniel Cameron, who answered the question first, criticized Democratic Gov. Andy Beshear for closing schools, businesses and churches during the pandemic. Cameron has made similar comments on the campaign trail and in press conferences.

“What Andy Beshear did was wrong. I will respect your constitutional rights. I will look out for our most vulnerable populations,” Cameron said. “But at the end of the day, I will make sure that we respect you as a citizen and your constitutional rights.”

Beshear called the pandemic “the challenge of our lifetime” and noted that it killed 18,000 Kentuckians. He also praised health-care workers who worked during the pandemic and added that it was “a slap in the face of the heroism that they showed” for Cameron to refuse “to act like this pandemic was as deadly as it was.”

“I made decisions to save lives,” Beshear said. “It’s clear this attorney general would have played politics. That would have caused more death, more destruction. I’d rather save lives than win re-election.”

Saturday’s debate was hosted by the League of Women Voters of Louisville and TV station WLKY. During a couple of tense moments, Beshear directly asked Cameron to answer questions about abortion.

Cameron said last month that he would sign legislation adding exceptions in cases of rape and incest to Kentucky’s near-total abortion ban if the General Assembly passed it. However, he has not directly said if he personally supports those exceptions and continues to call himself the “pro-life candidate.”

I a rebuttal, Beshear said, “I got a few seconds left. So, General Cameron, will you look at the camera and say, ‘I support exceptions for rape and incest?’”

Cameron replied, “I’ve already said that I will sign the exceptions if they are brought to my desk. At the end of the day, this governor wants more abortions. There is no difference between him and Joe Biden on this issue.”

The next gubernatorial debate, hosted by KET, is set for 8 p.m. ET Monday. followed by the candidates' last debate at 7 p.m. ET Tuesday, hosted by Lexington's WKYT-TV.

Beshear’s running mate, Lt. Gov. ​Jacqueline Coleman, and Cameron’s running mate, state Sen. Robby Mills of Henderson, will face each other in a KET debate on Oct. 30. Voting concludes Nov. 7.

This story was excerpted from a longer one. For the original, go here.

Friday, October 20, 2023

Heart expert: Ibogaine to treat opioid addiction is safe only in hospitals; others say risk can be mitigated; 'rough' plan outlined

By Melissa Patrick
Kentucky Health News

In a session focused on challenges of getting the psychedelic drug ibogaine approved by the Food and Drug Administration for treating addiction with help of the state's opioid settlement funds, a cardiologist said it couldn't be done in a reasonable time and the drug is unsafe.

"My opinion is that ibogaine is not safe, the efficacy is unproven, it's unlikely to be approved by the FDA in a reasonable time period, and the cost to Kentucky would be unsupportable," said Dr. Mark Haigney, a board-certified cardiologist and electrophysiologist, and an attending physician at the Walter Reed National Military Medical Center.

Haigney was invited to a special Kentucky Opioid Abatement Advisory Commission meeting on Oct. 17 by commission member Patricia Freeman, a pharmacy professor at the University of Kentucky. The meeting also saw the head of the commission discuss a "rough" plan for funding ibogaine research.

Patricia Freeman
(Photos by Melissa Patrick)
After two hearings that focused on ibogaine development and personal testimonies favoring the drug, she asked to invite experts in regulatory drug development to testify about the challenges of navigating ibogaine through the FDA process, given its potential for damage to the heart and its current classification as a Schedule I drug with no medical use.

Freeman said she had concerns that people at one hearing thought there would be quick access to ibogaine with the $42 million investment and felt compelled to ensure they understand that this would be a multi-year endeavor with no guarantee of success. 

"I felt this was important as it would help make sure that at large, our commission would be as fully informed as possible prior to making a decision on proposed ibogaine funding," Freeman said. 

The proposal comes from Bryan Hubbard, chair and executive director of the commission, which operates in the office of Attorney General Daniel Cameron, the Republican nominee for governor. Ibogaine is illegal everywhere but Mexico and New Zealand, but has been anecdotally reported to stop drug-withdrawal symptoms. 

Haigney, who described himself as an "expert in drug-induced sudden death and drug-induced loss of consciousness," said that while he recognized the attractiveness of a single-dose drug like ibogaine to treat opioid-use disorder, such a drug must be "safe in the immediate term, effective in the long term, FDA-approved, and affordable for the huge number of Kentuckians with opioid-use disorder." 

He said ibogaine isn't safe because it is known to cause cardiac arrhythmias and sudden death. In detail, he explained that this happens because ibogaine causes a "prolonged QT interval," which is one of the measurements taken by a standard electrocardiogram. 

A prolonged QT interval occurs when the heart muscle takes longer to contract and relax than usual, which can affect heart rhythms and lead to sudden cardiac arrest. 

Haigney said the FDA requires all drugs to undergo cardiac testing and that "the finding of QT interval prolongation is the most common reason for removal of a drug from further development." 

He added that a prolonged QT interval can happen when a drug blocks the cardiac potassium channels to the heart and that ibogaine is a "potent blocker" of this channel, even with normal therapeutic doses. 

"So this means that most if not all subjects would experience some significant degree of blocking the channel," he said. "And this is a very poor prognostic finding for a drug."

Haigney pointed to a study of 14 hospitalized patients who received a "relatively low dose" of ibogaine. The average increase in QT interval was 95 milliseconds. He said the FDA's published guidelines say it is concerned when a drug prolongs the QT interval by 5 milliseconds or more. 

"I've never seen a drug prolong the QT interval so profoundly," he said, adding later, "This degree of QT prolongation would be expected, associated with increased risk of fatal events."

He then asked rhetorically, "Can this drug be given safely?" His answer, "Yes, in the hospital. We do a lot of dangerous things in the hospital with a lot of technology," adding that this would be "an incredibly resource-demanding" drug to administer. 

"The likelihood that this drug with this safety profile will be approved by the FDA in less than 10 years, in my opinion, is remote and the effort will require at least a billion dollars," Haigney said. "The administration of ibogaine would strain hospital resources at a time when bed shortages are severe. This is a treatment for wealthy individuals who can pay for hospitalization with intensive monitoring," so it would not help most Kentuckians "who struggle with opioid dependence." 

Freeman also invited Robert Walsh, recently retired from working in the National Institute on Drug Abuse for 36 years, where he headed NIDA's Regulatory Affairs Branch. 

Walsh spoke to the regulatory challenges of ibogaine development, including cardiac safety, ensuring enough supply of a plant-based drug from another country, creating a plant-based drug with the same dose in each pill, and the challenges of working with a Schedule I drug in laboratories and clinical settings.

Dr. Sidney Peykar, a cardiac electrophysiologist and medical director at the Cardiac Arrhythmia Institute, said the drug could be given safely in a hospital setting and said he has expanded the protocol for how to administer ibogaine safely at the Beyond Ibogaine Treatment Center in Cancun, Mexico.

"Most if not all of these deaths could be mitigated or completely prevented through safety protocols," he said.

Dr. Javier Muniz, the FDA's supervisory general-health scientist for controlled-substances initiatives, was asked if FDA would definitely not approve ibogaine. He said that without all of the information in front of him, "I have no idea." 

Asked by Freeman if a 95-millisecond QT prolongation would disqualify ibogaine from being approved, he said it's important to remember that when the FDA is considering the approval of a drug, the agency looks at a drug holistically and considers both risks and benefits. 

Bryan Hubbard, right, and
Carlos Cameron, commission
member. 
Hubbard was asked after the meeting if any speaker had caused him to change his mind about his ibogaine plan. He said, "Dr. Haigney was brought in here to oppose this initiative and he articulated all of the talking points that the opponents of this initiative have already parlayed at public remarks. So there was nothing that was either surprising, nor persuasive about his remarks, and insofar as what he has articulated, are already widely publicly disseminated talking points of opposition."

He said Haigney was "thoroughly debunked [by] individuals who serve, respectively, on an FDA advisory board for psychopharmacology, as well as the science journal for the FDA's research arm related to controlled substances."

At the end of the meeting, Hubbard gave the commission a "very rough draft" of a plan with a list of requirements that would have to be met before the commission would commit $42 million to the project. He did not release the plan, but told Kentucky Health News after the meeting that it contains these points:
  • "Viable research proposals from qualified research entities" that will match the state's $42 million
  • The state would have ownership of any patentable intellectual property that is generated
  • Clinical trials would be held in the West End of Louisville and in Wast Kentucky, "in a way that ensures social, racial, and economic equity of access to the treatment,"
  • An approved drug-investigation application from the FDA "with secured clinical-trial sites and a diverse group of qualified clinical-trial participants before the first dollar is ever matched by the commission," 
"This will have to be a viable, go project before any commission resources are put on the table," Hubbard said,. Nothing like this has ever been done. So all of this is breaking ground." He cited "the competing interests, the areas of concern, the nature of this money, the necessity of protecting it, the necessity of making sure that the Commonwealth of Kentucky has a leadership position that is protected and recognized, and consideration of risk that we are taking by making this bet."

When it comes time for the commission to vote, he said, "Theoretically, the vote will be to legally authorize a $42 million match from the commission for our clinical research team that is ready to conduct clinical trials with ibogaine in Kentucky."

Hubbard said it is imperative that no vote be taken until Dr. Nolan Williams' peer-reviewed research of veterans who have suffered from traumatic brain injury and received ibogaine is published and they hear from him about his findings. Williams is an associate professor at Stanford University.

At the commission's first public hearing, Williams said he had let other professionals look at the data from his study and they said "the findings are shocking and that they've never seen a drug do this before." 

Before the eight guests spoke, Hubbard took about five minutes to address how he and the commission came to explore ibogaine and its potential therapeutic uses. He said as far back as 2018, he became aware of emerging science on therapeutic psychedelics and an author who at the time wrote about the topic and led him to other sources of information. Her newsletter The Journey is published on Substack. She wrote under the pen name of Julia Blum now uses the name Julia Christina.

Hubbard was responding to an Oct. 9 Daily Beast story, excerpted in Kentucky Health News, which reported that about the time Cameron implicitly endorsed his plan at a public event, a major national political contributor increased its investment in ibogaine research and later gave Cameron's campaign a political boost. He is running against Democratic Gov. Andy Beshear, who has objected to Hubbard's ibogaine plan.

Hubbard said, "It's important to set the record straight in full public view, lest the fictitious narrative of a smoke-and-mirror smear job generated by a third-rate, agenda-driven political tabloid prevail in the public arena against the integrity and sincerity of all who have offered their time, expertise and visceral lived experiences for all the world to see on behalf of all Kentuckians."

The commission's next regular business meeting is scheduled for 1 p.m. Nov. 14 at 1024 Capital Center Dr., Suite 200, Frankfort.

Sunday, October 15, 2023

Report: Big political giver boosted stake in psychedelic research implicitly endorsed by Cameron, then funded anti-Beshear ads

Jeff Yass (Photo from MIT Sloan Sports Analytics)
Kentucky Health News

Around the time Attorney General Daniel Cameron implicitly endorsed using 5 percent of the state's opioid settlements to fund research to win federal approval of a psychedelic drug for addiction treatment, a firm owned by a major national political contributor increased its investment in such research and gave Cameron a political boost, Roger Sollenberger of the Daily Beast reports.

Jeff Yass of Philadelphia increased his investment in the second quarter of the year, and on June 8, he "gave $3 million to a super PAC that has recently pumped out at least $1.2 million worth of ads backing Cameron’s candidacy, according to Federal Election Commission filings," Sollenberger reports. "That donation has accounted for roughly 98 percent of the group’s total reported fundraising this year." Cameron is the Republican nominee for governor; the ads attacked Democratic Gov. Andy Beshear, who has criticized the plan to fund research into ibogaine, a psychedelic.

The contribution came nine days after Bryan Hubbard, a Cameron aide who heads the state Opioid Abatement Advisory Commission, proposed that the commssion put $42 million into research that would show the usefulness of ibogaine and help it win approval from the Food and Drug Administration.

Cameron appeared at the May 31 event where Hubbard issued his call, saying, "Something has to change. Obviously, we need to continue to fund the work that has been ongoing in Kentucky. We also need to explore a new approach. We have to imagine new possibilities. We have to invest in programs and potential solutions for tomorrow."

Also at the event was Ben Chandler, president and CEO of the Foundation for a Healthy Kentucky and a former Democratic attorney general and congressman. He applauded the proposal, and later endorsed it, citing the low success rate of drug treatment and recovery. Ibogaine has been reported to relieve withdrawal symptoms, but poses risks to the heart and is legal only in Mexico and New Zealand.

At a public hearing held by the commission in July, all the witnesses testified for the idea, including executives at two firms getting the investment from Yass. Sollenberger's story did not mention any attempt to reach Yass for comment.

Hubbard "declined to answer questions on the record," Sollenberger reports. "After an off-the-record phone call, Hubbard texted The Daily Beast the email address of Brett Waters, the head of a nonprofit that has been closely involved in the ibogaine project from the beginning. Waters is co-founder and executive director of Reason for Hope, a group whose CEO—a former Sen. Mitch McConnell appointee—joined Hubbard and Cameron at the May 31 press conference.

"The group has no corporate backers, Waters said. He also called Hubbard an 'incredibly positive figure' in this process, one who ensured that 'diverse voices' contributed to the discussion, including indigenous voices." He said of Hubbard, “He is genuine in his desire to help people break free of substance use disorder, and this is a brave proposal.”

Cameron's office "provided a 264-word statement expressing confidence in the commission and promoting the Kentucky Opioid Symposium," Sollenberger reports. "It did not address almost any of the detailed information and questions we provided as the focus of this article. The office did not respond when offered the chance to follow up."

However, the statement said the work on the synposium “required that certain agenda items be pushed until the commission’s November meeting.” Sollenberger writes that he asked "why the vote on the grant was pushed back to Nov. 15—a week after the election, and more than a month after the symposium."

Yass, the nation's fourth-largest political megadonor, "stands to profit massively from ibogaine, especially in the long run," Sollenberger writes. "Yass’s investment firm, Susquehanna International Group, currently holds around $5 million in ground-floor stakes with four biopharmaceutical firms focused on developing psychedelic addiction treatments. More than $4 million of it lies with two entities leading the charge on ibogaine, according to SIG’s August filing with the Securities and Exchange Commission.

SIG's total investment portfolio is $491 billion, Sollenberger reports: "If treatments like ibogaine gain traction with the public—and more importantly, with regulators—that niche market, and those holdings, will explode. As The Daily Beast previously reported, the entire purpose of the Kentucky program is to help ibogaine receive federal approval as a 'breakthrough therapy,' which would 'accelerate the regulatory pathway for legal status nationwide.'"

Witnesses from the two firms testified at the opioid commission's public hearing in July, Sollenbergher notes: "The meeting agenda published by the OAAC only discloses the corporate background of one of them—Dr. Srinivas Rao, co-founder of German biopharmaceutical firm ATAI Life Sciences. The other person in the joint venture, Dr. Deborah Mash, was only identified as professor emerita at the University of Miami School of Medicine, not in her capacity as founder and CEO of DemeRx—where ATAI holds majority control, according to SEC filings. Kentucky Health News reported that affiliation, which was included in a press release about the hearing.

Mash's ties were noted by commission member Sharon Walsh at the last meeting before she resigned from the commission. She told Hubbard, “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. That’s why I’m asking for balance,” with contrary testimony.

"Two people familiar with the events told The Daily Beast that she stepped down in protest of funding ibogaine," Sollenberger reports. Walsh told Kentucky Health News in July that she resigned because UK's largest-ever grant, which she supervises, was extended for two years.

Sollenberger reports, "Yass has stakes in ATAI, which is heavily backed by another billionaire Republican megadonor, Peter Thiel. . . . ATAI also owns a considerable share of another one of Yass’ psychedelic investments, Compass Pathways. According to an SEC quarterly filing submitted in August, after ditching the stock entirely months earlier, Yass’ firm upped its ATAI investment significantly between April 1 and June 30. That filing also shows about $3.6 million in a company called Mind Medicine, which has been conducting ibogaine opioid abatement trials. All of these investments would stand to give SIG exponential returns if regulatory gatekeepers begin to clear the way for ibogaine development—and a partnership with a state government is a major step along that path."

Sollenberger also reports on "Rex Elsass, an influential longtime GOP strategist and media buyer who has performed millions of dollars of work for Yass-aligned groups. Elsass’ son, Reid, died tragically of an overdose, and his family created a nonprofit called the REID Foundation dedicated to recovery efforts, including emergent therapies." At the commission's Sept. 15 hearing, "Elsass, an Ohio resident, spoke movingly at a public hearing in support of ibogaine, reportedly describing himself to the commissioners as 'your neighbor next door' without apparently disclosing his long and unavoidably political background."

Sollenberger adds, "A former adviser at Elsass’ company, The Strategy Group, named Sally Hauser, now heads a group called the Kentucky Ibogaine Initiative, according to her LinkedIn. The nonprofit just registered with Kentucky this year. (Hauser’s position with the group disappeared from her LinkedIn page at some point after The Daily Beast sent out comment requests.)

"Elsass told The Daily Beast in a phone call that, to the best of his knowledge, he had never met Jeff [Yass] in person, and that he had been first tipped to Kentucky’s potential by the Etheridge Foundation, started by folk-rock LGBTQ icon Melissa Etheridge. He explained that his ibogaine advocacy—a 'miracle medicine that needs to be researched'—is rooted in deep, personal loss and a desire to help mitigate tremendous future tragedy."

Elsass told Sollenberger, “The solutions just weren’t there, and I was desperate for new methods to help my son. So we looked for other means, and as a result, he ended up in Peru” for an ibogaine treatment. “Plant medicines helped him and extended his life for several years, and left me with a mission.”

Sollenberger adds one more politician to the mix, U.S. Sen. Rand Paul. He notes that Paul and Sen. Cory Booker (D-N.J.) introduced a bill to "make it easier for patients to access controlled substances for medical treatment, starting with psilocybin and MDMA. . . . Last October, the Louisville Courier Journal said Paul was Yass’s 'favorite politician on the national scene.' The relationship also runs deep, with Yass pouring more than $15 million into the Paul-aligned Protecting Freedom super PAC since 2017, according to Federal Election Commission data. Protecting Freedom also contracts with Elsass, with one of his entities as its top vendor in the 2022 cycle, according to data compiled by the Center for Responsive Politics."