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Thursday, July 20, 2023

State, far behind on nursing-home inspections, focuses on responding to complaints, but that often takes too long

Lexington Herald-Leader graph by John Cheves; click to enlarge
"As of June, 73 percent of Kentucky’s 277 nursing homes were listed as going more than two years without a so-called 'annual' inspection. It’s putting patients at risk," the Lexington Herald-Leader reports. The national average is 11%.

The federal government, which "essentially funds the American nursing home industry," requires annual, multi-day inspections "to catch problems early, before they get serious enough for residents to be hurt, sickened or killed," John Cheves reports. "But because of a dangerous shortage of inspectors — the worst in the United States, according to one report — Kentucky hasn’t reliably performed standard surveys since the Covid-19 pandemic shut down the state in spring 2020."

All this means "scant oversight at long-term care facilities, typically owned by for-profit corporate chains and where many thousands of vulnerable Kentuckians live every day," Cheves writes. "The delays also erode the accuracy of Nursing Home Compare, the quality rating website" of the federal Centers for Medicare and Medicaid Services. "It’s based largely on state inspections. Families consult this website before picking a nursing home for their loved ones. They are referred to it by the state health cabinet and respected experts at AARP and the National Institute on Aging. Even before the current inspection backlog, Kentucky nursing homes had among the worst collective ratings in the country. In 2018, 43 percent were rated 'below average' or 'much below average' by CMS."

Officials of the state Cabinet for Health and Family Services declined to be interviewed, and "also declined to answer most written questions the newspaper submitted over the next two months about Kentucky’s nursing home inspection backlog and the reasons for it," the Herald-Leader reports. "In a brief statement, health cabinet spokeswoman Susan Dunlap said the cabinet acknowledges an inspection backlog has been created in Kentucky since the pandemic.

Dunlap said the state is working to address the backlog "by raising salaries for inspectors in an effort to boost hiring and retention," Cheves writes, and is concentrating on “complaint surveys,” which are more focused visits "to look at a specific grievance about care that can be filed by residents, their families or others. . . . However, it can take two to three years for complaint surveys to work their way through their own separate backlog, said nurse Barbara Lear, a Kentucky nursing-home inspector who quit last summer. By the time inspectors finally arrive at a facility to investigate an old complaint, Lear said, residents involved in the case likely have died, and the employees no longer work there and might not want to speak to state officials about the allegations."

Cheves reports, "State records show that last year, Kentucky inspectors received more than 1,700 of the most serious kinds of complaints, classified as 'immediate jeopardy,' up from about 1,000 in 2018. The percentage of complaint surveys started in the 'federally required time frame' — within a matter of days — fell from 85 percent to less than 4 percent during this period."

Wednesday, July 19, 2023

Mosquito repellents tested: DEET is best; plant-based alternatives to it work fine in lower-risk areas if they are reapplied as needed

For a larger version of this graph, click on it. To download and save, right-click.
By Immo A. Hansen and Hailey A. Luker
For The Conversation 

Now that summer is in full swing, mosquitoes have come out across the United States. The use of mosquito repellents can protect both your health and sanity this summer.

While mosquitoes leave bothersome, itchy bites on your skin, they can also pose a serious and sometimes deadly risk to your health. When a mosquito bites you, it may transmit harmful pathogens that cause dangerous diseases like malaria, Dengue fever, Zika and West Nile.

Avoiding mosquito bites

Mosquito females bite people to get vital nutrients from our blood. They then use these nutrients to make their eggs. One single blood meal can give rise to about 100 mosquito eggs that hatch into wiggling larvae.

There are several ways to avoid getting bitten by mosquitoes, from wearing long, loose clothing and limiting time outside to placing screens over your windows and getting rid of standing water that mosquitoes might use to breed.

However, one of the best ways to protect yourself when you’re going to a place where hungry mosquitoes will be buzzing around is by using mosquito repellents.

Our team at the New Mexico State University Molecular Vector Physiology Laboratory has studied different types of mosquito repellents and their efficacy for over a decade. Here’s what you need to know to protect yourself this summer:

All about repellents

The use of mosquito repellents goes far back in history, certainly predating written historical accounts. Some of the oldest records of the use of mosquito repellents date back to early Egyptian and Roman history. During this period, smoke from smudge fires was often used to repel mosquitoes.

Today, we have more options than our ancestors when it comes to choosing what type of mosquito repellent to use – sprays and lotions, candles, coils and vaporizers, to name some.

These repellents interfere with a mosquito’s sense of smell, taste or both. The repellent either blocks or overstimulates these senses. Scientists understand how certain repellents like DEET work at the molecular level, but for many of them, it is still unknown why exactly they repel mosquitoes.

Testing repellents

We used a variety of scientific laboratory experiments and field tests to find out what works. For some products, testing was as simple as putting a volunteer’s treated arm into a cage with 25 mosquitoes and waiting for the first mosquito bite.

For others, like citronella candles, we used a slow-speed wind tunnel and put a candle or device between a person and a cage of mosquitoes. Depending on the repellent efficacy of the device, mosquitoes either flew toward the person or away. Another experiment we conducted was the Y-tube choice assay where mosquitoes chose to fly toward someone’s hand or, if repelled, fly toward the blank or empty option.

Mosquito repellents that don’t work

Bracelets don’t work. Department stores and pharmacy chains sell hundreds of different varieties of bracelets. They are marketed as “mosquito repellent” bands, wristbands and watches, and their materials can vary from plastic to leather. Even if they are loaded with repellents, they can’t protect your whole body from mosquito bites.

Ultrasonic repellent devices don’t work. These come as electrical plug-ins, free-standing varieties or watchlike accessories that claim to emit a high-frequency sound that deters mosquitoes by mimicking bats. However, in scientific studies, ultrasonic repellent devices fail to repel mosquitoes. In fact, when our lab tested one of these devices, we found a slight increase in mosquito attraction to the wearer.

Dietary supplements – vitamin B, garlic and so on – don’t work. No scientific evidence shows these supplements protect people from mosquito bites.

Light-based repellents don’t work. These devices come as colored light bulbs, and they don’t attract insects that fly toward white light. This approach works well on moths, beetles and stinkbugs, but not on mosquitoes.

Mosquito repellents that work

And here is our ranking of what does work, starting with the best repellent/active ingredient:
  • DEET works. DEET, chemical name, N,N-diethyl-meta-toluamide, was developed in the 1950s by the U.S. Army and is a well-established mosquito repellent with a long history of use. The higher the percentage, the longer the protection time is – up to six hours.
  • Picaridin works. This synthetic repellent can protect for up to six hours at a 20% concentration. This repellent is a promising alternative for DEET.
  • Oil of lemon eucalyptus, or OLE, works. OLE, with the active ingredient PMD, is a plant-based alternative to DEET and picaridin. Its repellent properties can last for up to six hours.
  • Other essential oils – some work, some not so much. We applied 20 different essential oils in a 10% essential oil lotion mixture to volunteers’ skin. Here’s what we found: Clove oil works. This oil, with the active ingredient eugenol, can protect from mosquito bites for over 90 minutes at a 10% concentration in lotion. Cinnamon oil works. This oil, with the active ingredients cinnamaldehyde and eugenol, can protect from mosquitoes for over 60 minutes at a 10% concentration in lotion. Geraniol and 2-PEP, or 2-phenylethyl propionate, work for about 60 minutes at a 10% concentration in lotion. Citronella oil works, just not so great. We found citronella oil at a 10% concentration only protected from mosquito bites for about 30 minutes.
If you are planning to mix your own plant-based mosquito repellent this summer, remember that essential oils are complex mixtures of plant-made chemicals that can cause skin irritations at high concentrations.

Based on our study, we recommend using repellents with the active ingredient DEET if you live in or are traveling to regions with a high risk of vector-borne disease transmission. However, plant-based repellents will work just fine to prevent nuisance mosquito bites in low-risk areas, as long as you reapply them as needed.

Immo Hansen is a professor of biology at New Mexico State University, where he studies new ways to control vector-borne diseases. Hailey Luker is a Ph.D. biology student at New Mexico State. Her research ranges from repellent testing using ticks and mosquitoes to molecular research studying amino-acid transport proteins in mosquitoes.

Tuesday, July 18, 2023

Advocates of using psychedelic drug ibogaine to treat addiction say its risks to the heart can be mitigated in a controlled study

The Opioid Abatement Advisory Commission held its first public hearing July 17, in Frankfort, to hear about use of the psychedelic drug ibogaine for treatment of opioid-use disorder. (Photo by Melissa Patrick)
By Melissa Patrick
Kentucky Health News

The Kentucky Opioid Abatement Advisory Commission held its first public hearing Monday, July 17, to discuss funding development of an opioid-use disorder treatment using the psychedelic drug ibogaine with some of the money the state is getting from settlements with drug makers and distributors.

The commission heard from five experts, all in favor of the idea, and two people who have successfully used ibogaine in other countries to recover from their opioid addictions. The drug is illegal in the U.S. but has been anecdotally reported to stop the withdrawal symptoms of opioid dependence.

Juliana Mulligan, a psychotherapist and ibogaine treatment specialist in New York, told the story of her opioid addiction and the seven years she spent in and out of treatment and jail. With the support of her parents, she traveled to an ibogaine clinic in Mexico, and that experience involved a "plethora of mistakes" that landed her in the hospital with cardiac issues that resulted in a heart attack.

Ibogaine's effects on the heart are a major obstacle to its use, and the commission discussed that with another expert. But Mulligan called her experience with the drug "nothing short of miraculous" and said she has not used an opioid or had a craving since November 2011.

"Despite the dramatic hospital story, the medicine did its job for me," she said. "I remember suddenly feeling with total certainty that ibogaine is the future of opioid-disorder treatment. . . . Of course, ibogaine isn't magic and it isn't a cure, but it is hands-down the best door open to the path of healing that myself and many other could find."

Jessica Blackburn of Floyd County talked about her success with ibogaine in 2008 for opioid-use disorder after many attempts at recovery. Blackburn said she relapsed, but in August will have gone eight years without using any drugs.

Blackburn said she would not be alive today "without the use of iboga," the African shrub from which the drug is produced. "No Kentuckian should have to leave the country to receive this life-saving treatment."

Drug developer calls for 'Manhattan Project'

Dr. Deborah Mash, founder and CEO of DemeRx, which wants to develop ibogaine as an addiction treatment, told the commissioners that if clinical trials are approved for it, her company would look to demonstrate that ibogaine could be used for relapse prevention. 

"This class of molecules, ibogaine in particular, opens plasticity in the brain, and this is, we believe, why we will be able to prove — in effective and well-designed clinical trials — that this drug is transformative," said Mash, an emeritus professor of neurology at the University of Miami.

Plasticity is the brain's ability to alter its connections and rewire itself to function in a way that differs from how it previously functioned.

"What we want to be able to demonstrate, working in a public-private partnership, is that this drug [will] help break the cycle of addiction and promote that transition to abstinence-based treatments," Mash said, adding later that it needs to be "a Manhattan Project," like the one that developed nuclear weapons.
 
"I think we need the best scientists, the best people who know how to do clinical trials, our academic colleagues together (with) public-private partnership, to accelerate the pace of this," she said. 

Mash said she has studied ibogaine for 30 years and her initial published research was done on the West Indies island of St. Kitts, with permission from its government, and published in 2018 in Frontiers in Pharmacology. 

She said that research of treating hard-core drug users with ibogaine "demonstrated . . . not only that it benefited people, but we also demonstrated that it could be administered safely under full medical monitor." 

Dr. Kenneth Alper, a neuropsychiatrist and visiting scientist at the Nathan Kline Institute for Psychiatric Research in Orangebrg, N.Y., said his research has found that the drug's "action is novel, which suggests that ibogaine could provide a basis for the development of fundamentally innovative pharmacotherapy."

This is important, Alper said, because while effective medications are available for addiction, "The need for innovation in the treatment of opioid-use disorder is clear" because "only a fraction of those with OUD access medication-assisted therapy, and when they do, a third or more will drop out within eight months." 

He said 20% to 60% of people in medication-assisted treatment use illicit opioids, "completion of detoxification fails one-third to one-half of the time," and even if treatment is successful, it "is followed by relapse within four to six weeks 75% to 80% of the time." 

Dr. Nolan Williams, an associate professor at Stanford University, told the commissioners that his study of veterans who have suffered from traumatic brain injury, which is under peer review for publication, is "the most comprehensive evaluation ever done" on people who have received ibogaine treatment. 

He said that while the results won't be available for about six weeks, he's let other professionals look at the data and they have said "the findings are shocking and that they've never seen a drug do this before."  

Cardiac concerns

State Rep. Danny Bentley, R-Russell, a pharmacist, asked about ibogaine's effect on the heart. Williams said that risk could be mitigated by an additional layer of controls to protect patients, such as careful screening. 

Williams said some people who take ibogaine display an electrocardiogram change called "QT prolongation" associated with a particular type of dysrhythmia that can progress into ventricular fibrillation and death. But "If you're in a supervised medical setting, there's a lot you can do about it." 

He said the deaths associated with ibogaine treatment have largely occurred in hotel rooms in other countries, and in an appropriately monitored setting, the threat would be dealt with in the same way "a lot of drugs that have QT prolongation," he said.

Mash said there have been 33 deaths from ibogaine in the published peer review literature over 20 years.  

Alper said his work in forensic toxicology, aimed at informing efforts to make ibogaine safer, found that ibogaine-related deaths often involved pre-existing medical conditions, particularly cardiac conditions. Other factors include the use of ibogaine of uncertain or impure composition or co-ingestion of substances of abuse. 

"I believe that many of these deaths were likely preventable," he said. "This highlights the need for adequate medical supervision during ibogaine treatment, minimally including cardiac monitoring." 

Federal approval process

Bryan Hubbard, chair and executive director of the commission, has asked it to consider committing $42 million of the settlement money from drug companies to help get ibogaine through the FDA approval process in the next six years.

Hubbard works for Attorney General Daniel Cameron, the Republican nominee for governor. Democratic Gov. Andy Beshear's appointees on the commission, Health Secretary Eric Friedlander and Office of Drug Control Policy Director Van Ingram, asked how long it takes to get a drug through the FDA process.

Dr. Srinivas Rao, co-founder and chief scientific officer of Atai Life Sciences, a German company. said the estimates are around 10 years at a cost of between $600 million and $800 million. Mash said it can go faster. 

"I believe the open-label data, the observational data, supports this. I believe that the regulators are going to be supportive of this," Mash said. "And certainly when you see these initiatives, these types of public-private initiatives, this will not be lost on other partners that will come. So the leadership today, even having this meeting, is really groundbreaking." 

Mash said it is time for a "pivotal, Phase II study" to demonstrate safety and efficacy of the drug. She said there have been no controlled trials but there is an abundance of observational data that show ibogaine treatments have resulted in patients having remission from addiction.

Mash said the trials would be done in a monitored, in-patient setting after the person had been screened to make sure they would be a good candidate. She said the drug would be given by tablet, and in about 45 minutes the patient would enter a deep phase of cognitive introspection for four to eight hours. She said the patient would be required to stay overnight and be released the next day. 

Why $42 million? 

Friedlander asked Hubbard why he is asking the commission for $42 million and exactly what the state would get from it.

Hubbard said the legislature gave the same amount to Senate Bill 90, a criminal-justice reform initiative related to addiction and recovery, and noted that it is 5% of the more than $900 million in settlement money that will come to the state. The commission handles half and local governments the other half. 

"If this commission can pay for a highly consequential criminal-justice reform initiative in 11 counties to the tune of $42 million over four years," he said, "then perhaps we can explore devoting $42 million, which would be matched by the participating clinical research entity for a total of $84 million over the next six years, to potentially revolutionize how we treat opioid use disorder for the people of this state, for the people of this country, and for the people of this world." 

Williams said, "It's an important point that maybe something like this wouldn't fund all of it, but if you could get some momentum going, then that's very helpful to getting other parties involved." 

The second public hearing about ibogaine will be held from  9 a.m. to 3:30 p.m. Sept. 15 in Conference Room A-125 at the Administrative Office of the Courts building, 1001 Vandalay Drive, Frankfort.

Sunday, July 16, 2023

In the first two months of resumed checks for Medicaid eligibility, almost half of Ky. members up for renewal lost their coverage

By Melissa Patrick
Kentucky Health News

The end of the pandemic meant resumption of eligibility verification for Medicaid, and almost half of the Kentuckians who have been asked to renew their Medicaid coverage in the first two months of verification have lost it, mainly because they did not respond.
 
Of the 153,386 people asked to renew so far, nearly 34 percent didn't respond, and 46 percent of the total were terminated for that or other reasons, according to state data.

Priscilla Easterling, outreach coordinator for Kentucky Voices for Health, called the number of terminations and the number of people who have not responded to a renewal request "worrisome." 

More than 52,000 "of these terminations were for procedural reasons; people simply did not reply to those notices requesting information, and that's scary," she said. "These aren't folks who were determined ineligible. We don't know if they're ineligible. They didn't reply to a notice, and so they lost their coverage." But Easterling cautioned that it's too early to call it a trend. 

The state Department for Medicaid Services resumed its annual renewal process for Medicaid members in April because the pandemic rules that allowed for continuous enrollment ended. In April, Kentucky had 1.7 million people on its Medicaid rolls. 

The process that allows state Medicaid agencies to restart the annual renewals or kick off those who no longer qualify has been dubbed the "Medicaid unwinding," a process that will take 12 months to complete in Kentucky; each Medicaid beneficiary has a renewal month.

During the renewal process, Medicaid members are getting a notice of eligibility, a renewal packet or a request for more information. 

May was the first renewal month. Of the 74,004 individual renewals that were due May 31, state data shows 37,779, or 51% of them, were approved and 33,794, or nearly 46%, were terminated. And despite multiple notices, calls, texts and emails from the state, 23,756, or 32%, did not respond.

The non-response rate rose in June, when 79,382 individual renewals were due. The state says 40,333, or nearly 51%, were approved; 37,140, or nearly 47%, were terminated; and 28,281, or nearly 36%, did not respond. 

The report also notes that of the 33,794 Kentuckians who were terminated in May, 5,808 of them were eligible for a federally subsidized or "qualified" health plan through Kynect, the state-based marketplace for health insurance. Of those, only 465, or 8%, enrolled in a qualified plan. 

That rate increased in June to 10.9%. Of the 37,140 Kentuckians who were terminated that month, the report says 5,142 would qualify for a qualified plan, and 559 of them enrolled in one.

Easterling said there is a concern that people who have not responded won't realize they don't have coverage until they seek treatment and learn they are no longer on Medicaid. If that happens, she said a person has 90 days after their loss of coverage to be reconsidered. 

She also encouraged people to not assume they don't qualify, especially if they have children, because it's easier for children to qualify.  

Easterling said it's not clear why so many Kentuckians have not responded to renewal requests, so it's important for people on Medicaid to visit their account at kynect.ky.gov and make sure their address and income information are up to date. She encouraged Kentuckians who need help to reach out to a "Kynector," who can answer questions and help you understand your coverage options. 

Managed-care organizations, mostly health-insurance company subsidiaries, which manage the care of Medicaid beneficaries, are also working to help Kentuckians with the renewal process. 

"MCOs are engaged in extensive outreach to capture the most up-to-date contact info for the state and providing referrals for other sources of coverage when necessary," Tyler Glick, Kentucky Association of Health Plans spokesman, said in an email. "In addition, MCOs are partnering with hyperlocal organizations to distribute renewal kits and host workshops to assist plan members with the redetermination process. The goal is continuous coverage, whether in Medicaid, via employer-provided coverage, or through Kynect with a qualified health plan or other options." 

As an example, the Northern Kentucky Tribune reports that one of the ways Anthem Kentucky Medicaid is joining with local agencies across the state to help its members redetermine their Medicaid eligibility by asking them to remember a simple acronym, ACT, which stands for: 
  • Address — make sure kynect.ky.gov has your correct mailing and email address, along with your phone number.
  • Check mail — you may receive a letter about your Medicaid or Kentucky Children's Health Insurance Plan renewal letting you know that you need to complete a redetermination form to maintain your coverage.
  • Turn the form in — if you get the form, fill it out and return it right away. This may help you avoid losing Medicaid or KCHIP.

Judge reverses his ruling that blocked law on gender-affirming care, citing 2-1 ruling of appeals court handling similar cases

By Sarah Ladd
Kentucky Lantern

A federal judge on Friday stayed a temporary block on part of a new Kentucky law that banned gender-affirming medical care for transgender minors.

That means Kentucky’s transgender children are now banned from receiving hormone treatments, a move celebrated by Attorney General Daniel Cameron, who requested the reversal.

Corey Shapiro, legal director for the American Civil Liberties Union of Kentucky, gave the other side: “While we strongly disagree with this opinion, it is only in effect while our appeal is pending in front of the Sixth Circuit. It is not the final word, and we remain optimistic that with a full briefing we will achieve a positive result.”

District Judge David Hale
In late June, U.S. District Judge David Hale sided with the ACLU of Kentucky in temporarily blocking the part of Senate Bill 150 that banned certain health-care options, such as puberty blockers, for transgender minors.

Last week a panel of the 6th Circuit Court of Appeals, in a 2-1 decision, overturned a similar district court ruling in Tennessee, allowing that state’s ban on gender-affirming medical care for minors to take effect.

Hale, an appointee of Barack Obama, based his latest decision on the appeals court ruling in the Tennessee case.

Cameron, who is running for governor, said in a statement that the ruling was a “win for parents and children.” He also criticized the “influences of leftist activists.” 

“Moving forward, my office will continue to defend Senate Bill 150 and stand up for the right of children to be children,” Cameron said.

State Sen. Max Wise, who sponsored SB 150, also celebrated the court’s decision.

“I’m pleased to know the holistic well-being of Kentucky’s transgender children, at least for now, will be fully considered,” said Wise, a Republican from Campbellsville.

Rebecca Blankenship, executive director of Ban Conversion Therapy Kentucky, and Michael Frazier, its government-affairs director, said in a joint statement that the decision marks “an extremely difficult moment” for the state’s trans children.

The decision, they said, “was a lost battle, but not the end of the war in this case or the broader fight to protect Kentucky’s kids.”

10th annual hepatitis conference to be held July 27 in Lexington

By Melissa Patrick
Kentucky Health News

Kentucky, which has one of the nation's highest rates of hepatitis C infection, will hold its 10th annual Viral Hepatitis Conference next week, on the day before World Hepatitis Day.

The conference, hosted by the Kentucky Rural Health Association, will look back at hepatitis over the last 10 years, and make some predictions for what the next decade may hold. It will run from 7:30 a.m. to 5:30 p.m. July 27 at the Embassy Suites on Newtown Pike in Lexington. 

After the conference, from 6 to 8 p.m., there will be 10-year celebration dinner and awards ceremony and dinner. All who attend the conference are invited. 

Each conference session will evaluate the key question asked in the conference title, "How Far Have We Come, and Where Do We Go From Here?"  

The morning sessions will include discussions of HIV (human immunodeficiency virus) in Kentucky, including screening, referral and resources; and an introduction to PrEP (pre-exposure prophylaxis), medicine that can reduce a person's chance of getting HIV from sex or injection-drug use.  

Afternoon sessions will offer a national and a statewide view. The conference will also include sessions that take a look at hepatitis D, perinatal hepatitis B, hepatitis C projects in Kentucky, and pregnant women and children with hepatitis C, and explore drugs and interventions available to treat the disease. 

Click here to register for the conference. The cost to register is $50 before July 20. After that date, the cost increases to $75.  Click here for more information and the agenda. 

In 2020, the latest data available on the Centers for Disease Control and Prevention website, the rate of reported cases of acute hepatitis C in Kentucky was 3.2 cases per 100,000 people, more than double the national rate of 1.5 per 100,000. Kentucky ties with Utah for the sixth highest rate in the nation.

Thursday, July 13, 2023

Opioid commission, with new member, will hold hearing Monday, July 17 on ibogaine, exotic drug proposed for drug treatment

By Melissa Patrick
Kentucky Health News

The Kentucky Opioid Abatement Advisory Commission will hold its first public hearing Monday, July 17, about the use of an exotic psychedelic drug, ibogaine, as a treatment for opioid-use disorder.  

The hearing follows the May 31 announcement at which Bryan Hubbard, the commission's chair and executive director, asked the commission to consider using $42 million of the more than $900 million in settlement funds being paid by drug companies to invest in clinical trials of the drug to win approval for its use. 

The public hearing will be held in the Administrative Office of the Courts building, 1001 Vandalay Drive, Conference Room A-125, Frankfort from 9 a.m. to 3:30 p.m. It will be live-streamed for those unable to attend. 

Hubbard told the commission at its July 11 meeting that the hearing will include an expert panel of researchers and clinicians who will provide insight into ibogaine therapy as a treatment for addiction. Hubbard told Kentucky Health News that all of panelists will speak in support of the treatment. 

The panelists listed in a press release are Dr. Kenneth Alper, associate professor of psychiatry and neurology at the New York University medical school; Dr. Deborah Mash, professor of neurology and molecular and cellular pharmacology and director of the Brain Endowment Bank at the University of Miami, and founder and CEO of DemeRx; Dr. Srinivas Rao, chief scientific officer at ATAI Life Sciences in Berlin; Dr. Douglas Kramer, senior vice president, pharmacovigilance and regulatory affairs, Athenex Inc.; and Dr. Nolan Williams, associate professor at Stanford University and director of the Stanford Brain Stimulation Lab.

The press release was issued by a public-relations firm that is being "retained by a private benefactor who is supportive of " the commission's efforts "who wishes to remain anonymous," said an email from Brad Burge, founder of the firm.

After opening remarks from each panelist, there will be a "round robin" question-and-answer session with the commissioners that will last four hours, Hubbard said. He said this process will allow for "a very open and vigorous and enlightening conversation about whether ibogaine is something that is worth considering or pursuing or not." 

He said at least two people will talk about their recovery experience with ibogaine treatment outside the U.S., which has not approved the drug for any use. He told Kentucky Health News that the public would be allowed to ask questions for about 30 minutes at the end of the meeting. 

The second public hearing on ibogaine has been rescheduled to Sept. 15 from 9 a.m. to 3:30 p.m. at the Administrative Office of the Courts, 1001 Vandalay Drive, Conference Room A 125, Frankfort.  

New commissioner appointed

Patricia Freeman
Since the June meeting, University of Kentucky President Eli Capilouto named Patricia Freeman, a pharmacy professor whose research focuses on substance-use policy and the prevention and treatment of substance-use disorders, as the university's new HEALing Communities Study representative on the commission.

Freeman replaces Sharon Walsh, principal investigator of the $87 million National Institutes of Health-funded study, which is aimed at finding tools for preventing and treating opioid addiction.

Walsh told Kentucky Health News that she was leaving the appointment due to additional and ongoing work responsibilities. She wrote in an email:

"We were informed a few weeks ago by the federal government that the HEALing Communities Study (which I lead) is being extended once again by the NIH (it was originally a 4-year project and is now going to be a 6-year project). Between that, other new NIH projects, and my leadership responsibilities at the university, I needed to reduce some of my extra external activities. Of Freeman's appointment, she said, "She is very knowledgeable and I know she will do a great job."

At the June meeting, Walsh questioned the idea of using opioid-settlement money to do clinical trials of ibogaine and pointed out that Mash, whom she knows, is the founder and CEO of a pharmaceutical company developing ibogaine for treating addiction, which presents a "clear conflict of interest."  She also pointed out that there are already drugs available for opioid withdrawal if that is the main goal of these trials. 

Hubbard told Walsh at the meeting that she could invite an expert of her choosing, but as of July 11, he told Kentucky Health News that he had not received any suggestions. 

Asked if her opposition to ibogaine had anything to do with her leaving the commission, Hubbard said as far as he was concerned, it didn't. "I don't have any issue with any commission member who takes a principal position of disagreement," he said.  

Application portal to close and reopen

The application portal to apply for an opioid settlement grant will close Aug. 30, 2023 for maintenance and will re-open on Jan. 1, 2024. Hubbard said because of this, any grants that are in process and those who want to complete their application need to have that done by Aug. 30. He added that more information will be forthcoming on the website.