Why millions are trying FDA-authorized alternatives to Big Pharma’s weight-loss drugs, exceedingly popular in Kentucky

Editor's note: Last year Kentucky led the nation in the percentage of population that had received these weight-loss druges by prescription.

By Arthur Allen

Britannica image

KFF Health News

Pharmacist Mark Mikhael has lost 50 pounds over the past 12 months. He no longer has diabetes and finds himself “at my ideal body weight,” with his cholesterol below 200 for the first time in 20 years. “I feel fantastic,” he said.

Like millions of others, Mikhael credits the new class of weight loss drugs. But he isn’t using brand-name Wegovy or Zepbound. Mikhael, CEO of Orlando, Florida-based Olympia Pharmaceuticals, has been getting by with his own supply: injecting himself with copies of the drugs formulated by his company.

He’s far from alone. Mikhael and other industry officials estimate that several large compounding pharmacies like his are provisioning up to 2 million American patients with regular doses of semaglutide, the scientific name for Novo Nordisk’s Wegovy, Ozempic, and Rybelsus formulations, or tirzepatide, the active ingredient in Eli Lilly’s Zepbound and Mounjaro.

The drug-making behemoths fiercely oppose that compounding business. Novo Nordisk and Lilly lump the compounders together with internet cowboys and unregulated medical spas peddling bogus semaglutide, and have high-powered legal teams trying to stop them. Novo Nordisk has filed at least 21 lawsuits nationwide against companies making purported copies of its drugs, said Brianna Kelley, a spokesperson for the company, and urges doctors to avoid them.

The U.S. Food and Drug Administration, too, has cautioned about the potential danger of the compounds, and leading obesity-medicine groups starkly warn patients against their use. But this isn’t an illegal black market, though it has shades of gray.

The FDA allows and even encourages compounding pharmacies to produce and sell copycats when a drug is in short supply, and the wildly popular GLP-1 drugs have enduring shortages — first reported in March 2022 for semaglutide and in December 2022 for tirzepatide. The drugs have registered unprecedented success in weight loss. They are also showing promise against heart, kidney, and liver diseases and are being tested against conditions as diverse as Alzheimer’s disease and drug addiction.

In recent years, the U.S. health-care system has come to depend on compounding pharmacies, many of which are run as nonprofits, to plug supply holes of crucial drugs like cancer medicines cisplatin, methotrexate, and 5-fluorouracil.

Most compounded drugs are old, cheap generics. Semaglutide and tirzepatide, on the other hand, are under patent, so they earn Novo Nordisk and Lilly billions of dollars a year. Sales of the diabetes and weight-loss drugs this year made Novo Nordisk Europe’s most valuable company and Lilly the world’s biggest pharmaceutical company.

While the companies can’t keep up with demand, they heatedly dispute the right of compounders to make and sell copies. Lilly spokesperson Kristiane Silva Bello said her company was “deeply concerned” about “serious health risks” from compounded drugs that “should not be on the market.”

Yet marketed they are. Even Hims & Hers Health — the telemedicine prescriber that got its start with erectile dysfunction drugs — is now peddling compounded semaglutide. It ran ads for the drugs during NBA playoff games. (According to a Hunterbrook Media report, Hims & Hers’ semaglutide supplier has faced legal scrutiny.)

The compounded forms are significantly cheaper than the branded drugs. Patients pay about $100 to $450 a month, compared with list prices of roughly $1,000 to $1,400 for Lilly and Novo Nordisk products.

Five compounders and distributors interviewed for this article said they conduct due diligence on every lot of semaglutide or tirzepatide they buy or produce, upholding standards of purity, sterility, and consistency similar to those practiced in the commercial drug industry. Compounders operate under strict federal and state standards, they noted.

However, the raw materials used in the compounded forms may differ from those produced for Novo Nordisk and Lilly, said GLP-1 co-inventor Jens Juul Holst, of the University of Copenhagen, adding that care must be taken in drug production lest it cause potentially harmful immune reactions.

To date, according to FDA spokespeople, reports of side effects from taking compounded versions haven’t raised major alarms. But everyone with knowledge of the industry, including the compounders themselves, worry that a single batch of a poorly made drug could kill or maim people and destroy confidence in their business.

“I liken the compounding industry to the airline industry,” Mikhael said. “When you have an airline crash, it hurts everybody.”

Warnings from the past

The industry endured just such a catastrophe in 2012, when the New England Compounding Center released a contaminated injectable steroid that killed at least 64 people and harmed hundreds more.

In response, Congress and the FDA had strengthened oversight. Mikhael’s company is an outsourcing facility, or 503B compounding pharmacy — so named for a section of the 2013 law that set new requirements for drug compounders. The companies are licensed to make slightly different versions of FDA-approved drugs in response to shortages or a patient’s special needs.

The law created two classes of compounding pharmacies: The FDA regulates the larger 503B compounders with standards like commercial drug companies, while 503A pharmacies make smaller lots of drugs and are largely overseen by state boards of pharmacy.

The 503A facilities also are producing compounded semaglutide and tirzepatide for hundreds of thousands of patients. Like the 503Bs, these operations take the active ingredient, produced as a powder in FDA-registered factories, mostly in China, then reconstitute it with sterile water and an antimicrobial in small glass vials.

Together, the compounding pharmacies may account for up to 30 percent of the semaglutide sold in the U.S., Mikhael said, although he cautions that is a “wild ballpark figure” since no one, including the FDA, is tracking sales in the industry.

The compounders say the companies should increase production if they’re worried about competition. Like the dozens of other drugs they produce for hospitals and medical practices, the compounders say, the two diet drugs are essential products.

“If you don’t want a 503B facility to make a copy, it’s pretty simple: Don’t go short,” said Lee Rosebush, chair of a trade association for 503B pharmacies. “FDA created this system because these are necessary drugs.”

Novo Nordisk hasn’t specified why it can’t keep up with demand, but the bottleneck apparently lies in the company’s inability to fill and sterilize enough of its special drug auto-injectors, said Evan Seigerman, a managing director at BMO Capital Markets.

The company announced June 24 that it was investing $4.1 billion in new production lines at its Clayton, N.C. site. The FDA last year issued a warning over procedural violations at the site and separate cautions at an Indiana facility that Novo Nordisk took over recently.

Compounding for dummies

At least 28 companies mostly in China, are registered with the FDA to produce or distribute semaglutide. At least half the companies have entered the market in the past 12 months, driving the raw material’s price down by 35%, according to Scott Welch, who runs a 503A pharmacy in Arlington, Va.

Compounders can buy powdered semaglutide from some U.S. distributors for less than $4,000 a gram, said Matthew Johnson, president and CEO of distributor Pharma Source Direct. That comes out to as little as $10 per weekly 2.5-microgram dose – not including overhead and other costs.

While Ozempic or Wegovy patients use a Novo Nordisk device to inject the drug, patients using compounded products draw them from a vial with a small needle, like the device diabetics use for insulin.

Some medical practices provide the compounded drug to patients as part of a weight loss package, with markups. Last July, Tabitha Ries, a single mother of six who works as a home health care aide in Garfield, Wash., found an online clinic that charged her $1,000 for three months of semaglutide along with counseling. She has lost 35 pounds.

She gets the drug from Mindful Weight Loss, a mostly telehealth-based operation led by physician Vivek Gupta of Manhattan Beach, Calif. Gupta said he’s prescribed the weight loss drugs to 1,500 patients, with about 60% using compounded versions from a 503A pharmacy.

He hasn’t seen any essential difference in patients using the branded and compounded forms, although “some people say the compounding is a little less effective,” Gupta said.

There’s some risk in using the non-FDA-approved product, he acknowledged, and he requires patients to sign an informed consent waiver.

“Nothing in life is without risk, but I would also argue that the status quo is not safe for people who need the medicine and can’t get it,” he said. “They’re constantly triggered by all this food that’s causing their weight to go up and their sugar to go high, increasing their insulin resistance and affecting their limbs and eyes.”

Compounding semaglutide is a helpful sideline for pharmacists like him, Welch said, especially given the pinch on drug sale revenue that has led many independents to close in recent years. He figures he earns 95% of his revenue from compounding drugs, rather than traditional prescriptions.

It’s important to distinguish compounded semaglutide from unregulated powders sold as “generic Ozempic” and the like, which may be contaminated or counterfeit, said FDA spokesperson Amanda Hils. But since compounded forms of the drug are not FDA-approved, those who make, prescribe, or use them also should have “an increased level of responsibility or awareness,” she said.

Corporate battles

Novo Nordisk and Lilly, in lawsuits each company has filed against competitors, say their own testing has found bacteria and other impurities in products made by compounding pharmacies. The companies also report patent infringement, but compounders, pointing to the FDA loophole for drugs in shortage, appear to have defeated that argument for now.

When the FDA removes the drugs from the shortage list, 503B compounders must immediately stop selling them. Smaller compounders may be able to produce their products for a reduced number of patients, said Scott Brunner, CEO of the Alliance for Pharmacy Compounding, which represents 503A compounders.

The evaporation of the compounded drug supply could come as a shock to patients.

“I dread it,” said David Wertheimer, an internist in Franklin Lakes, N.J., who prescribes compounded semaglutide to some patients. “People are not going to be able to plunk down a grand every month. A lot of people will go off the drug, and that’s a shame.”

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

New state health laws are in effect; one to regulate herbal drug kratom is in limbo due to lack of funding, Beshear says

Kentucky Capitol (Wikipedia photo)

By Melissa Patrick
Kentucky Health News

A number of new state health laws took effect July 15, ranging from measures on maternal health to improved access to a commonly used allergy medication.

The General Assembly passed more than 200 bills during its 60-day session. They become law 90 days after adjournment of the legislature unless they have a defined effective date, are general appropriation bills, or are passed with an emergency clause. This year, the effective date was July 15.

Some of the health measures that are now law are:

Health Care Liability: House Bill 159, sponsored by Rep. Patrick Flannery, R-Olive Hill, protects health-care providers from criminal liability when a medical error harms a patient. The bill does not apply to harm resulting from gross negligence or wanton, willful, malicious or intentional misconduct.

Kratom: HB 293, sponsored by Rep. Kim Moser, R-Taylor Mill, aims to regulate kratom, an herbal drug frequently sold online and in convenience stores. The bill prohibits sales to people under 21 and provides guidelines for manufacturing and labeling the product.

This bill was included in a list of 22 laws mentioned in an April letter from Gov. Andy Beshear to legislators saying there is a lack of funding to implement them, so that puts this new law in limbo, Liam Niemeyer reports for the Kentucky Lantern.

Maternal health: Senate Bill 74, sponsored by Sen. Shelley Funke Frommeyer, R-Alexandria, aims to support maternal and infant health and reduce the high mortality rate for mothers in Kentucky. Several sections of the bill took effect July 15, including one that will provide more information about breastfeeding and safe sleep to at-risk parents. Others establish a state maternal-fatality review team and require Medicaid to cover lactation consulting, breastfeeding equipment, and in-home and telehealth services. The bill also requires state health officials to compile an annual report about the number and types of delivery procedures performed at each hospital. Other sections of the bill will not take effect until 2025. This bill includes the “Momnibus” bill, which was originally filed as HB10 by Moser.

Medical cannabis: HB 829, sponsored by Rep. Jason Nemes, R-Middletown, updates some aspects of Kentucky’s upcoming medical cannabis program. It allows schools to ban medical cannabis from their campuses and allow local governments to apply a small fee to the program, among other changes. Three sections of the bill related to applications for business licenses, state enforcement and patient pamphlets will not take effect until 2025.

Pseudoephedrine: HB 386, sponsored by Rep. Robert Duvall, R-Bowling Green, eases purchase limits on pseudoephedrine to help people with chronic allergies legally obtain enough of the medication to meet their medical needs.

Vaping in schools: HB 142, sponsored by Rep. Mark Hart, R-Falmouth, bans all tobacco, alternative nicotine and vapor products in Kentucky public schools. It also requires school districts to adopt disciplinary procedures for students who violate the bans.

Veteran suicide prevention: Under HB 30, sponsored by Rep. Michael Meredith, R-Oakland, the Kentucky Department of Veterans Affairs will create a suicide prevention program for service members, veterans and their families.

Youth medical records: HB 174, sponsored by Rep. Rebecca Raymer, R-Morgantown, stipulates that parents have access to their child’s medical records. Prior to this law, children ages 13 and older had to sign a waiver for parents to have access.

Alzheimer's education: HB 459, sponsored by Moser, requires advanced practice registered nurses and physician assistants who primarily work with Kentuckians ages 50 years and older to undergo continuing education related to the detection and treatment of Alzheimer’s and other forms of dementia. This language was added from SB 211, sponsored by Sen. Stephen Meredith, R-Leitchfield, in the final days of the session. The bill also involves the APRN national certification exam and Kentucky Board of Nursing appointments.

News releases from the Legislative Research Commission contributed to this story.

Lee Co. harm-reduction chief says 80% of clients are homeless

Jo Ann Fraley runs the harm-reduction program for
the Kentucky River District Health Department.
(Photos by Stu Johnson, WEKU)

By Stu Johnson, WEKU

Homelessness is a reality in virtually every section of Kentucky. Although often thought of as an urban challenge, rural Kentucky also finds the plight of the unhoused a pressing issue. Here's a glimpse of how one Appalachian community is addressing homelessness needs.

There is a gathering spot inside The Hub in downtown Beattyville. It’s the Lee County Health Department's harm-reduction center, where staff work to connect clients with care providers.

The director is Jo Ann Fraley, a social worker who’s worked in addiction and recovery. Fraley said about 80 percent of The Hub's clients live on the streets or are couch surfing, and many don’t realize their health status.

“Lot of them have blood-pressure issues and they don’t even know. A lot of them have diabetes and they don’t even know,” Fraley said. “So, those issues we need to address as quick as we can.”

Fraley said the focus is getting people hooked up with doctors and health providers, because “We can’t expect change if we don’t help with the changing process.”

“They’ve lost hope. They give up. They’ve burnt every bridge that they have with family. And so, they let themselves go and they just think nobody cares about them. And whenever someone goes somewhere and they’re not treated very nice, they don’t go back,” said Fraley.

Another staff member at The Hub is Shawn Maynard, who was a user of oxycontin, pain pills, and then methamphetamine, along with alcohol. Maynard has been clean for six years and works with clients to address barriers. He said the homeless lifestyle itself creates health risks.

“When you’re homeless, your hygiene’s not gonna be good and that’s gonna create infection, staph infection,” said Maynard. “If you do get a cut and you’re not getting the proper wound care for it, it’s gonna get infected.”

Nathan Tipton

Nathan Tipton, a client of The Hub, said he’s been four months clean after struggling with drugs for years.

“I was on meth and drinking real bad and after my papa and mama died, it got worse and stayed out there in the woods for about four and half year; still homeless, but life makes a big difference when you got God on your side,” said Tipton.

Tipton said it’s different from before, he was stealing and robbing to get a fix.

The Lee County Health Department is part of the Kentucky River Health District. District Health Director Scott Lockard said he and Fraley brainstormed over The Hub concept, and said creating bonding relationships is important.

“We form that relationship. We show them that they can be treated with dignity. We establish trust and then when the timing is right and they’re ready for treatment, we can link them to treatment immediately,” said Lockard.

“Health is the foundation for everything. If you don’t have health, you can’t worry about education, you can’t worry about employment. You can’t worry about everything else.”

So, Lockard said that means linking up to a medical home and making sure the clients have a payer source, which for most is Medicaid. He said some don’t even realize they are eligible for the fedreal-state program that provides free medical care to lower-income people.

Lockard said the district is trying to to establish a similar program in Letcher County, and he envisions similar like services in all seven Kentucky River District counties, ideally in the next five years or so. Besides Lee and Letcher, the district also includes Knott, Perry, Leslie, Owsley and Wolfe counties.

Breathitt, Lee, Jessamine and Nelson counties are certified as Recovery Ready Communities, totaling 14 in effort's 14 months

Kentucky Health News map

Gov. Andy Beshear presents Recovery Ready Community
certificate for Lee County to Scott Lockard and Jo Ann Fraley
of the Kentucky River District Health Department. (Photo by Al Cross) 

By Al Cross
Kentucky Health News

Four more Kentucky counties have been certified as Recovery Ready Communities, signaling that they have the services needed to help their residents recover from addiction. That brings the total to 14 out of 120; the program began 14 monhs ago. "We've got 106 to go," Gov. Andy Beshear said.

Breathitt, Jessamine, Lee and Nelson counties earned cetification by showing they are able to provide addiction treatment to their 123,000 residents, according to Beshear, who presented Lee County's certificate at a wide-ranging press conference Thursday.

Scott Lockard, public-health director for the seven-county Kentucky River Disrrict Health Department, accepted Lee County's certificate with Jo Ann Fraley, who runs the department's harm-reduction program, which includes a syringe exchange to prevent disease among intravenous drug users and steer them into treatment.

"The substance-use-disorder problem is the largest public-health issue that we are facing today in Eastern Kentucky and many parts of our commonwealth," Lockard said.

Noting another major topic of Beshear's press briefing, Lockard said, "These great economic-development announcements are fabulous, but each one of those factories need people to work in them. Second-chance employment is huge, and we have so many people who are being impacted by substance-use disorder, especially in our part of the state, in Eastern Kentucky."

Lee County's recovery program is based in The Hub, in the health department's annex. "Our motto at the Hub is 'We meet people where they are, but we do not leave them there,' because it's key that everyone who comes through our door is treated with respect and dignity."

Lockard said the program has gotten more 230 people into treatment, including three that morning. They were immediately transported to a treatment facility, Lockard said: "When they're ready, we need to get them in there right then."

When people leave residential treatment, The Hub offers them 11 support groups, links to second-chance employment and "a ministry that fills the soul," Lockard said. "You know, this emptiness left by drugs, we need to fill it with somethng else, and if we can get individuals back and show them that they have worth, that they have dignity, then we have the possibility to really help them to be gainful members of our society and fill some of these many jobs and just have a higher quality of life."

 

Lockard said substance use must be approached as a disease. "We cannot incarcerate our way out of this problem." He said The Hub includes a court diversion program for low-level drug offenders.

Immediately before the recovery discussion, Beshear and State Police Commissioner P.J. Burnett announced a statewide drug roundup of 206 suspects, mostly on trafficking charges. Burnett said another 50 suspects are still being sought.

To be certified as recovery-ready, a county must have peer-support services, mental-health treatment, addiction treatment, employment services and a stigma-free environment to encourage recovery. The program "encourages communities to provide transportation to and from employment services and job interviews, allowing Kentuckians to make positive changes in their lives while filling much-needed jobs and contributing to the commonwealth’s record-breaking economic growth," a news release from Beshear's office said. 

The release included statements from representatives of the other counties.

“This is a huge step in continuing to move Breathitt County forward in applying for grants that will improve the lives of every person in our county,” said Breathitt County Circuit Court Clerk James Elliot Turner II. “We need to provide every opportunity for each person in Breathitt County to fulfill their potential. This is a win for our people.”

Shauna O’Nan, Jessamine County Health Department harm reduction director, said “There is no set path of recovery, but after going through this certification process, we are confident, as a community, that we will be able to meet people where they are on that path.”

In Nelson County, "Collaboration and community involvement underlie Nelson County’s efforts to provide recovery resources to its citizens," the release said. Jessica Bickett, safe-communities specialist with the Lincoln Trail District Health Department, said “Nelson County has a strong network of community partners who are committed to supporting the recovery community.”

"These communities are stepping up to help fellow Kentuckians who are struggling with addiction," Beshear said. "We are grateful for, and we applaud, their good work."

To learn more about the program and to apply for certification as a Recovery Ready Community, click here.

Paths to treatment

If you or a loved one are struggling with addiction, connect to treatment by calling 833-8KY-HELP (833-859-4357). Information about treatment programs all across the commonwealth is available at FindHelpNowKy.org.

Information on how to obtain the life-saving drug naloxone, which is used to reverse an opioid overdose, can be found at that website as well as at FindNaloxoneNowKy.org and FindMentalHealthNowKy.org.

Visit the State Police website to find a post where those suffering from addiction can be paired with a local officer who will assist with locating an appropriate treatment program through KSP’s Angel Initiative.

To find recovery housing, go to FindRecoveryHousingNowKY.org.

Coleman reappoints two members to state opioid commission

By Melissa Patrick

Kentucky Health News

Attorney General Russell Coleman has reappointed two members to the state opioid commission, thus not changing the balance of votes on the issue of syringe-exchange programs, which he says he opposes.

Those members are Jason Roop, an assistant professor of business and theology at Campbellsville University, who represents victims of the opioid crisis, and Van Ingram, who works for Gov. Andy Beshear as executive director of the Kentucky Office of Drug Control Policy and fills a slot representing the drug treatment and prevention community. Each of their terms expires in 2026. 

The Kentucky Opioid Abatement Advisory Commission has nine voting and two non-voting members. The legislature created the commission in 2021 to distribute the state's portion of the $900 million in settlements with opioid manufacturers and distributors, with half of the money going to the state and the other half going to local governments. 

The money is provided in installments and so far, the state has awarded 110 grants worth more than $55 million for treatment, prevention and recovery.

Attorney General Russell Coleman

Coleman's opposition to syringe exchanges was revealed when Chris Evans, the commission's executive director and a Coleman employee, passed on a vote approving a grant for the Boyle County Agency for Substance Abuse Prevention because it included help for a syringe exchange. 

In passing, Evans said Coleman doesn't support the exchanges. Coleman, a Republican who was elected in November, later said that was especially the case for programs that are not limited to one-for-one exchanges. His spokesman said Coleman would not base commission appointments on the issue.

As of February, 41 Kentucky counties had syringe-exchange programs that operate under a one-to-one rule and 24 counties have needs-based exchanges, according to the state Department for Public Health. It estimates that the overall return rate of syringes is 85% to 90%. 

Syringe exchanges are supported by research. The Centers for Disease Control and Prevention says injection drug users who have access to 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.

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. 

They also work to reduce overdose deaths by distributing naloxone; reduce medical harms such as skin, blood stream, and heart valve infections that severely injure substance users and incur large health care costs for society; and connect substance users to treatment and recovery supports in order to achieve sustained abstinence.

Patricia Freeman, a University of Kentucky pharmacy professor, has also been reappointed to the commission – by UK as a representative of the HEALing Communities study team, which is working on reducing drug-overdose deaths. Her term will expire in 2026. 

Two new non-voting members have also been appointed. State Rep. Chris Fugate, R-Chavies (Perry County), was appointed by House Speaker David Osborne to replace retiring Rep. Danny Bentley, R-Russell. Karen Kelly, chief of staff to U.S. Rep. Hal Rogers, R-5th District, was appointed by Senate President Robert Stivers to replace Carlos Cameron. 

Other members of the commission are Republican state Treasurer Mark Metcalf, who also passed on the Boyle County vote; Cabinet for Health and Family Services Secretary Eric Friedlander, who works for Beshear; Von Purdy, a vice president of Simmons College in Louisville, representing citizens at large; Darren "Foot" Allen, a retired state trooper, representing law enforcement; and Karen Butcher, representing citizens at large.

Recovering alcoholic built Kentucky's largest substance-use treatment provider, which has 1,800 beds and 1,350 employees

Map from Addiction Recovery Care website, via Kentucky Lantern, adapted by Ky. Health News

By Deborah Yetter
Kentucky Lantern

LOUISA, Ky. — Around the office at Addiction Recovery Care, Vanessa Keeton is still known as “Client One” — marking her status as the first client of the first recovery center ARC opened as a group home in Lawrence County.

But her official title is vice president of marketing, where she has worked since 2012, a little more than a year after she entered the program known as Karen’s House — choosing it over jail for a string of drug and alcohol-related offenses.

Vanessa Keeton
(Lantern photo by Matthew Mueller)

“Dec. 2, 2010, that was my first day,” she said. “That’s a day I’ll never forget as long as I live. That’s the day that everything changed.”

ARC, too, has changed dramatically since it started as a treatment home for women run by volunteers, based largely on Bible study and prayer.

It now operates as a for-profit company paid $130 million last year by Medicaid, the federal-state health plan which in 2014 expanded access to addiction treatment, or substance-use disorder, as it’s now known.

Gov. Andy Beshear has praised ARC for helping Kentucky — ravaged in recent years by addiction and overdose deaths — become the state with the most treatment beds per resident in the nation, according to an East Tennessee State University study.

“With the help of organizations like ARC, we are working to build a safer, healthier commonwealth for our people,” Beshear said, speaking at an ARC ribbon-cutting for a new facility in March.

Owned by founder and CEO Tim Robinson and his wife, Lelia, the company provides the couple an annual income of about $533,400, according to a 2022 tax-filing by Odyssey Inc., a non-profit affiliated with ARC.

Tim Robinson (Lantern photo by Matthew Mueller)

Robinson said he and his wife struggled financially for years while establishing the treatment business — facing potential foreclosure on their home and repossession of their car. He doesn’t think that income is unreasonable.

“We took a lot of risks,” said Robinson, 48, a lawyer and recovered alcoholic who says he has been sober since 2006 — two years before he started building the faith-based treatment business that would become ARC. “I’m living the American dream. I’m doing better than I ever thought I could be doing financially.”

Kentucky’s largest provider

The fast-growing company is by far the state’s largest substance-use treatment provider, with 1,800 residential beds in 24 Kentucky counties, and reaches hundreds more clients through outpatient services. ARC, which estimates it provides 75% of treatment beds in Kentucky, also is planning programs in Ohio and Virginia.

Earlier this year, ARC opened a 40-bed behavioral health unit with plans to expand to 300 at the former Our Lady of Bellefonte Hospital in Ashland, which closed in 2020. In 2020, ARC opened its largest center — with a capacity for 700 — on the campus of St. Catharine College in Springfield, which closed in 2016.

ARC is no longer simply a treatment organization, said Matt Brown, a former ARC client who overcame addiction and now serves as ARC’s chief administrative officer and president of ARC Healthcare. “We view ourselves as a behavioral health system,” Brown said.

While Christian faith remains at the heart of its mission, ARC relies on professional therapists, medical specialists including nurses and doctors, a structured treatment program and medication such as Suboxone to reduce the cravings of some patients for drugs and help them maintain sobriety, Robinson said.

Its religious component — which includes tracking how many clients decide “to follow Christ” (1,320 in 2023) — is strictly voluntary, according to Robinson, who said he was able to get sober in 2006 with the help of a local pastor and friend who “led me to the Lord.”

More importantly, he said, is that the number of clients who agree to stay in long-term treatment up to six months has increased steadily, which he thinks is the best indicator of effectiveness of the program.

Medicaid, which funds the majority of substance treatment, doesn’t require programs to measure outcomes.

But ARC measures its own outcomes, which it reports to Medicaid quarterly, Robinson said. That includes a retention rate of around 70% of its clients in treatment for up to six months and even longer through periodic contact with a case manager.

“I’ve been in this a long time,” Robinson said. “Long-term residential treatment is the reason people recover.”

As an indicator of success in addressing addiction, the Beshear administration points to the decline, for the second year in a row, of overdose deaths in Kentucky.

The state’s latest overdose report, released in June, shows a decrease in deaths to 1,984 from 2,200 the year before, a decline of 9.8%.

Last year, ARC received about $130 million in payments from Kentucky’s Medicaid program — more than double the amount of its closest competitor, Spero Health, a Nashville- based company that received $60 million in Kentucky Medicaid funds in 2023, according to the Cabinet for Health and Family Services, which licenses and oversees treatment facilities and Medicaid.

ARC accepts private insurance, but Robinson and Brown said almost all of the company’s revenue is from Medicaid, since their clients generally have lost jobs and any health insurance because of addiction.

The state spent $1.2 billion on substance-use-disorder services in the fiscal year that ended June 30, 2023, with most funds coming from the federal government, according to the cabinet.

Robinson, a former county prosecutor who started his business from a home office in Louisa, has emerged as a major political donor and well-connected business leader who recently joined the Kentucky Chamber of Commerce board.

Beshear singled out Robinson for recognition in his State of the Commonwealth speech in January, calling him “an essential partner in our fight against addiction.”

Robinson, a lifelong Republican, is effusive in praise for Beshear, a Democrat, in part because of the governor’s emphasis on addiction treatment and the governor’s frequent references to his own religious faith.

“I’ve never been for anybody like I’ve been for Andy Beshear,” Robinson said. “I hope he runs for president.”

‘Treatment on demand’

ARC employs 1,350 people, 500 at its headquarters in Louisa, population 2,600, perched above the forks of the Big Sandy River, across from West Virginia. The company is Lawrence County’s largest employer, even more than the school system.

About 40% of its workers are “graduates” of its treatment program, Robinson said, and most of its upper management — himself included — are in recovery from addiction.

ARC promises “treatment on demand,” and operates a 24-hour hotline people can call to identify help within 15 minutes, including transportation, if needed, to one of its centers. Last year it served more than 12,000 individuals from 119 of Kentucky’s 120 counties.

Tim Robinson in front of one of his buildings in 
downtown Louisa (Lantern photo by Deborah Yetter)

It has developed a network of job-training programs including welding, automotive repair, lawn service, culinary arts, chaplaincy and food service. As part of that, ARC has rebuilt more than a block of rundown buildings in downtown Louisa into a coffee shop, commercial kitchen, community theater and an event space.

It offers clients a chance to get certification toward a trade and get college credit for some training.

ARC owns a pharmacy used to provide medication to clients, a laboratory for medical testing and operates a health clinic in Louisa. Also, Tim and Lelia Robinson founded the private Millard School, a Christian academy in Louisa attended by some children of their employees.

Vanessa Keeton and her husband James live in Louisa and their son attends the Millard School. James, a 2011 ARC graduate, manages the Second Chance garage which repairs and restores vehicles for the public as well as maintaining an ARC fleet of about 200. “We restore cars and we restore lives,” he said.

ARC runs a sophisticated marketing program complete with a website, billboards, television and radio commercials, a social media presence, sponsorships and news releases, contracting with the Louisville-based public relations firm, RunSwitch. Scott Jennings, a CNN commentator and Republican political consultant, is one of RunSwitch’s founding partners. ARC spends about 4.5% of its revenue, or about $5.8 million a year on marketing.

Vanessa Keeton said the marketing is important to promote awareness of its services to those in need, “to meet people where you are.”

‘Dangerously brilliant’?

Some outsiders criticize ARC for its rapid growth, its size and Robinson’s political giving, including Mark La Palme, the founder and former CEO of Isaiah House, a treatment program based in Harrodsburg.

La Palme, now retired, said he worked with Robinson on a project in the mid-2000s but parted ways over disagreement with practices including designating clients as “interns” in ARC programs for low pay while in treatment, saving the company the cost of paying a regular employee.

He calls ARC “huge,” has called it a “bully” in a social media post and questions its rapid expansion. La Palme also questions the prolific giving of Robinson and ARC entities, which rank among the state’s major political contributors.

“It seems like you’re buying political influence,” he said.

But he acknowledges that Robinson has been highly effective in building ARC into the state’s largest treatment system: “He’s dangerously brilliant.”

Robinson said he considered La Palme a friend and colleague but they parted ways after a proposed collaboration fell through. Robinson said ARC’s programs meet all state standards, are accredited and the company works to provide high quality care.

He said internships are a way of introducing people to job skills they will need to succeed once they leave treatment and interns in various job training programs receive a paycheck either through ARC or an outside employer.

Robinson said he doesn’t apologize for political giving, seeing it as a way to support causes and politicians he believes in.

And he doesn’t think ARC is too big, saying that the company had to expand to remain viable within the constraints of Medicaid reimbursement, which pays for most of its clients. “We had to grow to survive,” he said.

The Robinson employees who spoke with Kentucky Lantern, including Brown, are highly enthusiastic about the boss.

Brown, trained as a physical therapist, battled addiction for 18 years before coming to ARC as a patient and remaining as an employee.

Robinson is “a visionary,” Brown said during a tour of ARC properties in Louisa, “He sees things in people before they see it in themselves.”

‘Papaw taught me’

Robinson said he grew up in adjoining Martin County, in “the poorest part” of a poor county. His introduction to business came from his grandfather who owned a country store. “He put me on a pop carton to run the cash register,” he said. “Papaw taught me about business.”

Another boyhood business venture of Robinson’s — selling baseball cards — would provide a life-changing entrée into college and law school, when he was befriended by Inez banker and businessman Mike Duncan, a former Republican national chairman and mentor to many young people in Martin County.

Robinson said he and Duncan crossed paths when he began selling baseball cards to Duncan's son, Robert M. “Rob” Duncan, who was appointed U.S. attorney for Eastern Kentucky under Donald Trump. Duncan is now the top deputy to state Attorney General Russell Coleman.

Robinson said he considers both Duncans friends but remains closest to Mike Duncan, a trusted friend and adviser. He said Mike Duncan, showed interest in his boyhood baseball-card venture and became a mentor, encouraging Robinson to go to college — a prospect he hadn’t considered.

“Nobody in my family ever went to college,” Robinson said.

But with Duncan’s encouragement, Robinson graduated from the University of the Cumberlands in Williamsburg, earned a law degree from the University of Kentucky and was elected student body president at both institutions.

Good times and bad times

“He helped me through the good times and the bad times,” Robinson said.

Among the worst times: Robinson’s 2003 indictment for felony vote fraud while he was student body president at UK, after some 750 voter registration cards collected during a student government drive were never turned in. Apparently forgotten, they were later found in a student-government office, according to a 2003 Lexington Herald-Leader story.

“It was devastating,” Robinson said. “I thought my whole life was over.”

Instead, with the help of his lawyers, Robinson pleaded guilty to a lesser misdemeanor charge of failing to turn in the registration cards and paid $90 restitution. Robinson said he dropped out of law school during the legal case, but was readmitted and graduated.

But that ordeal, plus the death of his mother while he was at UK, “finished my mental health off,” Robinson said. He returned home to Eastern Kentucky to work but alcohol by then had a powerful hold on his life.

Back in Lawrence County, Robinson joined in law practice with a friend and became an assistant county attorney but by then said he had become a “raging alcoholic” though still somehow able to perform his job.

He would drink on weekends, come to work on Mondays hung over and avoid alcohol on days he had to be in court. Toward the end of the week, Robinson said, he’d resume drinking and stay drunk till the following Monday. “I was leading kind of a double life,” he said.

That continued until a deputy sheriff at the courthouse where Robinson worked intervened. The deputy, also a pastor and a recovering alcoholic, helped Robinson stop drinking through prayer and support — taking him with him to nightly events where he would preach and play Bluegrass music.

Though Robinson said he knew nothing about treatment or programs such as Alcoholics Anonymous, he decided he needed to expand services in the region that in the mid-2000s offered little.

“I was convinced God was calling me to stop practicing law and start a recovery center,” Robinson said.

So he did, leaving his law job and starting out of a home office on Nov. 3, 2008.

Robinson got help from Rev. Ralph Beiting, a Catholic priest who founded the Christian Appalachian Project. Together they opened a recovery house for women in Lawrence County called Karen’s House.

It was a makeshift operation run by volunteers with donated goods, including some old Army cots. Meanwhile, Robinson was taking men to the closest treatment center, Chad’s Hope in Clay County, getting occasional funding from Operation UNITE, launched in 2003 by U.S. Rep. Hal Rogers to help Kentucky battle rising addiction — in particular the tide of opioid pain pills engulfing the state.

But broke and discouraged, Robinson was close to quitting when he contacted a consultant who suggested he expand by opening a second recovery center for men. He located a site in Fleming County and in 2013, Belle Grove Springs was opened by the company that would become ARC.

Brown, now ARC’s chief administrative officer, was among the first clients admitted to the men’s center.

The following year, under the expansion authorized by the Patient Protection and Affordable Care Act, Medicaid began funding substance use disorder services and a reliable funding stream opened. Kentucky was among the first states to include addiction as a service covered by Medicaid.

While the income was welcome, it wasn’t enough to finance ARC’s operation and Robinson said the company’s only choice was to expand and recoup more money through a higher volume of clients. “People thought we were growing because we were booming but we had to grow to survive,” he said. “You cannot make it on a couple of small facilities.”

ARC didn’t show a positive cash flow until 2019, he said.

‘Take our time’

While ARC expansion has slowed, Robinson said the company is still looking at other opportunities, including expansion into Virginia, which has far fewer treatment beds than Kentucky. “We’re going to take our time,” he said.

ARC also was flagged in a budget item this year by the state General Assembly with a $12 million allocation over two years directed to the Life Learning Center in Covington, an organization aimed at helping people develop skills to improve their lives “through gainful employment.”

The budget line says the funds are to be distributed to the center to support “treatment, rehabilitation, and community reintegration in partnership with Odyssey Inc.,” the non-profit arm affiliated with ARC.

Robinson said he expects Odyssey to submit a proposal as treatment provider for a program the center plans to establish in Somerset.

And while his work has expanded statewide and beyond, Robinson said he’s committed to staying in Louisa and keeping his company headquartered there.

“I’m where I’m going to be,” he said. “This is my adopted hometown.”

Some Ky. counties using settlement money to make new opioid-withdrawal treatment available to a small number of residents

The device uses low-intensity electrical pulses to reduce withdrawal symptoms. (WDRB photo, from NET Recovery Corp.)

The device uses low-intensity electrical pulses to reduce

withdrawal symptoms. (WDRB photo, from NET Recovery Corp.)

This story has been updated.

By Melissa Patrick

Kentucky Health News

four Kentucky counties are making a new treatment to reduce opioid-withdrawal symptoms available free to a few of their residents, using money from the state's settlements with drug manufacturers and distributors.

Three more counties are in the queue, and others are in discussion. Counties and most Kentucky cities get half the settlement money, more than $900 million over the next 15 years.

Meade, Scott, Bullitt and Franklin counties have committed settlement money for the treatment of limited numbers of residents with opioid-use disorder. Letcher and Shelby counties are in the process of final approval, and Bell County is in discussions with NET Recovery Corp.

The company is named for the "neuro-electric therapy" that its non-invasive "NET Device" delivers. Asked about the device's success rate, company spokesman Jeff Lott said, "A person treated with the NET Device for more than one day is significantly more likely to remain opioid-free without medication."

The amount of money committed to NET Recovery for treatment from each county varies. 

Company spokesman Jeff Lott said since the NET Device gained U.S. Food and Drug Administration approval, the cost for a treatment is $5,500. He said in an email that some counties received a discount if they started negotiations before FDA approval. 

"If we had already started negotiations with an amount for less than $5,500, we are still honoring that price for the first contract," Lott said. 

In Bullitt County, CFO and Community Development Director Keith Griffee said the county has signed a service contract for $50,000 to provide treatment services for 15 residents, or $3,333 per person.

The same per-person figure applies in Meade County, where Treasurer Tammy Graham said the county had allocated $60,000 of its opioid-abatement money for services to 18 residents.

Scott County Court Clerk Stacy Hamilton said Scott County had approved $110,000 for 34 residents. That amounts to $3,235 per person.

Franklin County's $75,000 contract is for 15 patients at $5,000 each, The State Journal reports.  

Lott said Shelby County plans to vote on its contract Tuesday, July 2. He said the county is looking to commit $100,000 to the program. He did not say how many residents this contract would serve. 

He said Franklin County had voted to approve a service agreement for $75,000 to cover 15 patients, but the contract has not been signed. That amounts to $5,000 per person.

Lott said NET Recovery is still in talks with Letcher County, which had backed out of its initial $125,000 contract with NET Recovery.  Lott said the two-year contracts allow either party to terminate the contract. 

"It is my understanding that they still want to participate for a lesser amount," Lott said.

He said the company is working to get other counties "to help their people get a brand new FDA-cleared treatment that can change the lives of their residents."

"We are counting on the counties to help fund this," Lott said. "If anyone has a question about how they can get their county to sponsor it, they can email me. I'd love to talk them through it." (His email address is jeff.lott@netrecovery.net.)

Isaiah House lauds NET Device

The neuro-electric therapy to reduce withdrawal symptoms will be offered exclusively through Isaiah House, a Christian-based rehabilitation center based in Harrodsburg.

The NET Device (Photo from company website)

Mike Cox, chief operating officer of Isaiah House, said the treatment involves taping tiny electrodes behind the participant's mastoid process, behind the ear, to deliver a carefully programmed series of tiny electrical pulses that stimulate the production of the body's natural neurotransmitters, such as endorphins.

"We know that those neurotransmitters become depleted and replaced by the drug" chosen by those with opioid-use disorder, Cox said. "When a person tries to stop taking the drug, then he or she begins to experience intense cravings and the body goes into withdrawal. It is that terrible experience of intense cravings, that horrible sickness that keeps people from stopping using the substance that keeps them using. Not for the euphoria of it, but just to survive." 

He said they will have 30 reusable units on hand for the treatment, which lasts five to seven days.

While the device will be helpful, Cox said, it is not the single solution. 

"We see it as a tool to help them on the front end of treatment," he said. "This device is a new tool in the toolbox to really help people overcome the fear and experience of being sick from withdrawal and the intense cravings, which are . . . really the reasons why many people are afraid to get treatment." 

According to state data, in 2023, nearly 80% of Kentucky's overdose deaths involved opioids.

Medications are available to treat opioid-use disorder, but Cox noted that many people use more than one substance. And while the clinical trial of the NET Device focused on opiates, he said it also helps with the withdrawal symptoms of other drugs, from nicotine to methamphetamine.

"We know the device to be effective for all drugs," Cox said. "They have specific programming for each type of drug, which makes this device unique. . . . The additional upside to this device over medications is that it addresses the concerns of abuse and diversion."

Later, he said, "We have witnessed, really the positive impact of this device on a lot of people without any negative side effects. And, FDA approval is further evidence of the efficacy of this device in reducing cravings and withdrawal symptoms."

Cox said Isaiah House will only be paid a "small amount" for the additional work required by his staff to offer the therapy.

Who qualifies for it? 

Cox said participants will be considered for the NET Device on a case-by-case basis. "We just want to help people," he said.

Because insurance does not pay for the treatment, Lott said, "At this time, we're only focusing on treating people from counties who have paid for it or anyone can choose to pay and be treated." 

Bullitt County's contract says the participant must be diagnosed with opioid-use disorder, be admitted on a separately paid basis into a participating service program with a residential drug-addiction treatment facility, be a resident of the contracted county, and meet the clinical eligibility for the treatment, including a desire to participate in the program. 

Lott added that a participant must also be 18, and cannot be pregnant or have a pacemaker.

Cox said Isaiah House is starting the program in one of its men's facilities in Washington County and one of its women's facilities in Mercer County. Eventually, he said the treatment would be offered at all of their residential facilities.

Health department director says she has work to do, to educate Attorney General Coleman about syringe exchanges

Dr. Crystal Miller with state
Health Commissioner Stack

Kentucky Health News

The director of a district health department with a syringe exchange has voiced disappointment to her local newspaper over Attorney General Russell Coleman's opposition to the exchanges.

Dr. Crystal Miller, director of the Wedco Health District, which serves Scott, Harrison and Nicholas counties, told the Georgetown News-Graphic that syringe-exchange programs are misunderstood.

“It is unfortunate that our attorney general doesn’t support syringe service programs,” Miller told the newspaper. “We have work to do to educate him on grasping a full understanding of what this program entails.”

Noting Coleman's statements to Kentucky Health News, Miller said, “This program is designed around the very things he’s supportive of, prevention and treatment. We work closely with community partners to create a system that no matter where someone enters, we know how to link them to an agency that can assist. Substance abuse is a problem in our society that we will never enforce our way out of, and successful mitigation requires all hands-on deck. Syringe service programs are a framework for that in our community.”

The News-Graphic notes, "Approval for such a program, here, was difficult and strongly opposed by the Scott County Fiscal Court several times until a magistrate who once opposed such a program became aware of a situation involving someone he knew and reversed his opposition."

Miller said, “At surface level, syringe service programs can be misconceived. This program provides an entry point to many resources for people who use drugs and allows us to promote recovery. Through this program alone, we have referred people to treatment for drug use, linked them to care and resources within the community to help them make better, healthier choices.

"We have success stories of people recovering in every SSP program across Kentucky. However, one of the biggest successes within this program is the amount of hepatitis C and HIV that we have been able to detect and treat within our communities. Without this program, we would not have identified communicable diseases that are killing people and costing taxpayers large amount of money. Just within the Wedco District, through our SSP program, we have saved taxpayers $1.3 million in early identification/treatment of Hepatitis C. We are effective at prevention and treatment and the data proves it."

As for Coleman's concern that syringe exchanges promote drug use, Miller said, “I can assure you that not one participant has ever reached our doors and decided to start using drugs because we are providing clean syringes. We prevent the spread of disease, focus on reducing as many barriers as possible and being a resource to helping people make better decisions and recover, all while saving taxpayers money. I hope that we can work more closely with our AG to help him understand and support the impact that this program has in communities.”

More than half of Kentucky's counties have syringe exchanges.

Community event at church addresses health needs in Frankfort

A variety of health-focused vendors set up tables in the parking lot of First Baptist Church Frankfort on June 14 to share information and host activities with attendees. (UK photos by Lindsay Travis)

By Lindsay Travis
University of Kentucky

Coretta Scott King said, “The greatness of a community is most accurately measured by the compassionate actions of its members.”

On a warm Saturday in June, First Baptist Church Frankfort opened its doors to more than 500 individuals in the community to put an emphasis on their well-being. It was part of the fourth annual Dr. Rosby L. Glover Unity in the Community event — a day of fun, food, music and raising awareness.

The fruits of this effort are an extension of collaborations with key community partners, including Capital City Activity Center, Meals on Wheels Greater Frankfort, Kentucky State University Cooperative Extension and the University of Kentucky.

“The day is an effort to bring the whole community together, to not only just have fellowship, but to bring awareness to physical health, diabetes and other health issues,” said Bishop Tiangello Hill, senior pastor of the church. “It means that we're doing our job. It means that we are reaching beyond the four walls and being a help to all mankind.”

The event is held in honor of the church’s late pastor, the Rev. Dr. Rosby L. Glover, who made it his mission to be an advocate for the Frankfort community for children and families. His widow, Lady Kimberly Glover, said “This was a vision of ours, and I’m elated to see Frankfort continue my husband’s mission to serve the community and its families.”

The compassion for Frankfort is evident in talking to those behind the June 14 event, like Glover.

“People care about this event because when people get together, we're all just people,” she said. “No matter what race, what nationality, it’s bringing love for one another, showing how much we care. And just to know that the church is here to help anyone in need.”

In an effort to share important health information with the community, inside the church, guests could complete free health screenings. The Lions Club partnered for diabetes screenings and the Franklin County Health Department donated screening materials and time for blood pressure screenings.

UK's Refocus Project, aimed at African Americans, answered
questions about opioid overdoses. (UK Photo by Lindsay Travis)

Tents and tables lined the church parking lot and nearby Clinton Street showcasing the services provided by a variety of health-focused agencies. Among those tables were UK’s Sanders-Brown Center on Aging and its Engaged Aging Lab, the College of Health Sciences’ Physical Therapy program, the Research Examining Factors Associated with the Opioid Crisis among Underserved African Americans (REFOCUS) research team, and the Cooperative Extension Service.

It’s an intentional approach from researchers and clinicians at UK to address the specific needs of the Frankfort community. The city, at one time, had the nation’s second-highest prevalence of Alzheimer’s disease in African American adults among other health challenges.

The partnership is an important one to Elizabeth Rhodus, assistant professor at Sanders-Brown and the Department of Behavioral Science in the UK College of Medicine.

“We connected with Dr. Glover a few years ago to think about how we can help provide health care, access and resources to individuals in the community,” said Rhodus. “We are excited to see that partnership grow.”

Saturday’s event is an extension of Sanders-Brown’s partnership with First Baptist Church Frankfort. Researchers meet monthly with church members to help address the commumity's needs. It’s part of Rhodus’ Engaged Aging Lab, which takes lessons learned from research and clinical spaces out into the communities to address health gaps.

Rhodus and her team provide support and resources for Alzheimer’s disease and dementia through research which focuses on everyday activities that support healthy brain aging, caring for individuals with dementia and community-engaged research for health equity. They use practical methods and everyday items in ways to help people live healthy and reduce their risks for diseases.

“We focus on telling people about five main areas to try to reduce your risk for dementia: sleep, nutrition, exercise, novelty — or doing something new — and socializing, are the great things for your brain,” said Celeste Roberts, research program manager at the Engaged Aging Lab.

Oil timers can relax the mind and body through visual cues.

Roberts kept a bottle of lavender-scented lotion and an oil timer on the table. The items may be simple, but as Roberts explains, they can relax the mind and body through aromatherapy and visual cues.

She and Sanders-Brown’s April Stauffer answered questions from people stopping at their tables for hours. They handed out helpful flyers on a range of topics related to brain health.

“Having a conversation with people about what they can do every day on their own and giving them the tools they need to ask the right questions about their health is key,” said Roberts. “Unity in the Community gives us an opportunity to start that conversation.”

On Clinton Street in downtown Frankfort, physical therapy students looked like they were playing games with attendees who stopped by their table. In actuality, they were conducting fall risk and balance assessments they’d use in clinic — a four-square step test and a timed up-and-go test out of a chair.

“Depending on how they score we can tell them if they’re at an increased risk for falls or not and provide them with helpful information,” said Sheila Clemens, an assistant professor in the Department of Physical Therapy. “This community is potentially at risk for being underserved and they may not get this information elsewhere. We’re happy to offer this easy access.”

In the next booth, the focus was on engaging members of the Black community in research. It’s part of the REFOCUS project, led by Danelle Stevens-Watkins, acting dean and professor in the Department of Educational, School and Counseling Psychology in the College of Education.

“We came to this event to help educate the community about opioid overdoses,” said Mona Goggins, a research assistant with REFOCUS. While the number of overdose deaths in Kentucky declined 9.8% frpom 2022 to 2023, there was an 8% rise in overdose deaths among Black Kentuckians. “Our hope is people want to participate in our study so we can increase awareness and gather information that will improve treatment in the Black community.”

The project is primarily focused on Lexington and Louisville, but the REFOCUS representatives shared that guests were “getting what they needed from the table” from education to sharing stories to seeing themselves represented in research efforts.

“I think that when you try to look at treatment from just one lens, you miss out on so many different groups in the population. I think it's important to recognize what different cultural backgrounds and factors that influence people's lives in the way that they experience opioid use,” said De’Asia Beard, a REFOCUS mresearch assistant.

UK’s Cooperative Extension Service has been a long-time partner in this community initiative. Sanders-Brown works closely with Carla Carter, an extension agent for family and consumer sciences at the Franklin County Extension Office.

Carter, a long-time member of First Baptist Church Frankfort, helps coordinate monthly workshops at the church and was the emcee for the Dr. Rosby L. Glover Unity in the Community. She thanked Debora Bobbitt and Reverend Anna Jones for organizing the day.

The event took a holistic approach to community health, with pieces focused on the spectrum of age ranges represented. In addition to health screenings for older age groups, the church donated 65 bicycles to kids in the community — doubling their previous giveaway goal — to foster health and exercise.

It took a team of people to put on the event and a strong spirit of collaboration from the team at the church to make such an impact in the capital city.

Rhodus and her team know there’s a health need in this area that can benefit from targeted resources and outreach paired with different research approaches. The team shares a similar goal with First Baptist Church Frankfort:

“Let’s literally build unity within all of these communities to support every individual, wherever they’re at in their aging journey — childhood all the way throughout their older age,” said Rhodus. “Let’s tailor the health pieces that they need to support a healthy, active lifestyle.”

Where to find more information:

• Sanders-Brown offers a variety of resources for people with questions about brain health. You can get started online here.
• The Engaged Aging Lab is ready to help caregivers and community members. You can find those resources online here.
• Anyone with questions about the study REFOCUS and opioid use in the Black community can email REFOCUS@uky.edu.
• UK’s physical therapy program also offers clinics for the public. More information is available online here.
• The Cooperative Extension Service provides practical education to help people, businesses and communities solve problems, develop skills and build a better future. Find more about their services online here.
• The Kentucky State University Cooperative Extension Program strengthens underserved communities, families, farmers, individuals and youth to improve their quality of life with state-of-the-art, research-based educational programs. You can learn more about their services online here.

Letcher County backs off its plan to spend $125,000 in opioid-settlement money on an experimental therapy by Isaiah House

The Bridge device, which requires a prescription,  "sends

gentle electrical impulses . . . to the brain to reduce

withdrawal symptoms," its website says. (Photo from site)

By Sam Adams

The Mountain Eagle

The Letcher County Fiscal Court has reversed itself — at least for now — on whether it will give $125,000 of its opioid settlement money to a Christian-based drug-rehab center for an experimental electrical-stimulation therapy.

The court voted 4 to 1 with one abstention to table the contract with Isaiah House, a Willisburg-based nonprofit, until County Attorney Jamie Hatton can negotiate it. Hatton said the contract, brought to the court by jail minister Ted Adams of Letcher, does not allow the county to back out in case the treatment doesn’t work. “There’s nothing in there about termination for cause,” Hatton said.

Three of the five magistrates who had voted to give the money for the treatment expressed reservations this week, echoing Hatton that the contract needs to be negotiated, and saying the treatment is unproven, and at $5,000 per patient would allow only 25 patients to participate.

Adams was livid that the court did not approve the contract, saying the court voted to give the money before the NSS-2 Bridge device was approved by the federal Food and Drug Administration, and now wants to back out after it has been approved. “ It doesn’t make any sense,” he said.

The device, marketed by Innovative Health Solutions Inc. of Versailles, Ind., was approved under an FDA program called “the de novo premarket review,” which the FDA describes as “a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence.”

Devices approved under that program are assessed to be low- to moderate-risk to patients, but it does not include an assessment of whether the devices have a therapeutic effect. A test included only 73 patients, 64 of whom self-reported decreased distress during opioid withdrawal after getting the device. Critics say the device has not undergone a randomized test to account for a placebo effect. While the company charges $600 per device, Isaiah House is asking the county for $5,000 per patient.

Adams said he could “bring in all the churches” where people have seen results of the device, but some magistrates said they would prefer that he brought in someone from Isaiah House and people who have used the device.

“The only thing is, I would like to talk to some people it helped,” District 5 Magistrate Benny McCall said. “I have talked to some people who said it didn’t do much for them, but I’d like to talk to some who say it has.”

District 1 Magistrate Jack Banks also questioned whether the device is worth the money the court would have to pay, saying it would only possibly help 25 people and that’s not guaranteed. Adams, however, criticized other programs the county has agreed to help fund, including the Harm Reduction Program run by the Kentucky River District Health Department. He said the court gave $50,000 to “buy needles for people to kill themselves.”

District 3 Magistrate Deb Collier responded, saying the needle exchange can’t be criticized because it prevents people who are addicted to drugs from passing deadly diseases such as AIDS and hepatitis to others by sharing needles.

Judge/Executive Terry Adams suggested the county wait to see how other patients in other counties that have agreed pay Isaiah House have progressed, but Ted Adams stopped him. “How many people are going to have die?” he said.

That also drew a response from Collier and from Banks, who said the court is watched about how it spends the opioid money and has a responsibility to spend it well. Banks said people are watching, and “if we spend $125,000 on this and it doesn’t work, how does that look on us?”

“How does it look to give $125,000 to CANE Kitchen?” Ted Adams asked.

Banks said CANE Kitchen is part of a rehab program that helps people get back to work, but Adams said that’s part of his ministry, too.

Collier, McCall, Banks, and Judge Adams voted to table the issue until Hatton can negotiate. Ted Adams left immediately when the vote was taken.