Hal Pyzyna of Lexington was 35 when he died of an opioid overdose a little more than a month after leaving an Addiction Recovery Care facility. (Photo provided)

Striving to stay sober, Hal Pyzyna succeeded for nearly a decade until the COVID-19 pandemic struck in 2020 — the stress causing him to relapse into drug use, said his mother, Kristine Pyzyna.

She hoped he would get help through a court diversion program that in 2022 referred him to Crown Recovery Center in Springfield.

Instead — just days after he became violently ill from an injection of Vivitrol, a powerful anti-abuse drug his mother says her son was pressured to accept — he left Crown Center, operated by Addiction Recovery Care, or ARC, the state’s largest provider of drug and alcohol treatment.

And little more than a month later, Hal died at 35 from a drug overdose.

Kristine Pyzyna believes Vivitrol, a name-brand drug that blocks effects of opioids, was a factor, along with improper administration of the medication at ARC and lack of adequate education for her son. The drug, while considered effective, comes with serious risks including potential for a fatal overdose if a patient uses drugs before the injection wears off because of reduced tolerance to opioids, according to the U.S. Food and Drug Administration.

Now, Pyzyna, a nurse and health lawyer who lives in New Jersey, is relaying those concerns to Kentucky and federal regulatory authorities and some state legislators who oversee health policy, seeking stricter oversight of ARC and its use of Vivitrol.

“There is no doubt in my mind or in the minds of all who knew Hal and loved him that Hal would be alive today, had he not received the Vivitrol injection administered by ARC,” Pyzyna said in an Oct. 26 letter to Sen. Stephen Meredith, R-Leitchfield, chairman of the Senate Health Services Committee, that she provided to the Lantern.?

Meredith’s office didn’t comment.

Pyzyna’s letter was copied to the Inspector General of the U.S. Department of Health and Human Services, which administers Medicaid, a major funder of treatment services in Kentucky, and to the state nursing and medical licensure boards. Copies also went to the private health insurers, or managed care organizations, that handle most of Kentucky’s Medicaid claims, including those of her son.?

‘Heartbroken for this mother’

ARC, in a statement, said it could not comment on individual cases because of medical privacy laws or confirm whether Hal was a patient.

But Vanessa Keeton, vice-president of marketing for the for-profit, Louisa-based company, said ARC remains committed to providing quality care for those affected by drug and alcohol addiction.

“We are heartbroken for this mother who, like too many parents across our nation, has endured the loss of a loved one to the addiction crisis,” Keeton said in an email. “Our mission at ARC is rooted in the belief that everyone deserves a chance to recover and to find their God-given destiny.”

A spokeswoman for Alkermes, a global pharmaceutical company that holds the patent for Vivitrol, said in a statement that the drug is approved for use to aid in treatment of alcohol or opioid dependence and its safety is “well-established” when used under FDA guidelines.

“The medication plays an important role in the addiction landscape,” the statement said.

However, Vivitrol “may not work for everyone” and patient education about the drug is a critical part of its use, the statement from Alkermes said, adding that FDA prescribing guidelines contain several important warnings including “the vulnerability to opioid overdose.”

ARC employs an array of treatment services including medication for drug and alcohol avoidance for patients who are informed of the options and “are given the choice of which treatment pathway is best for their goals,” Keeton said.

And she said ARC’s programs are accredited and employ a “large, comprehensive medical team” to oversee care.

But Pyzyna, who as administrator of her son’s estate has assembled his medical and other records, believes the records show missteps in her son’s care, especially with the use of Vivitrol, which comes with strict FDA protocols.?

She said recent news reports of possible problems at ARC prompted her to pursue complaints she had been considering after she began collecting Hal’s records, some of which she provided to the Kentucky Lantern.

“Hal was a wonderful young man,” she said in her letter to lawmakers and regulatory agencies. “Hal struggled with opioid use disorder, a terrible chronic disease that must be managed throughout one’s lifetime.”

Cuts amid FBI probe

Pyzyna’s complaint comes as ARC is facing other problems, including an FBI investigation into possible health care fraud and major staff cuts. ARC receives almost all of its revenue from Medicaid, the federal-state health plan that covers substance use disorder treatment.

Last year, ARC received $130 million in Medicaid funds, making it by far the largest recipient among treatment programs in Kentucky. The investigation became public in July when the FBI asked for the public’s help in gathering information through a link on its website.

ARC has said it is cooperating with the FBI and stands by its treatment services.

Also, ARC has announced a series of program cutbacks and employee layoffs after reimbursement cuts enacted by some of the private insurers that handle Medicaid claims for the state. It has cut nearly a quarter of its 1,350 employees since September.

But ARC says it remains committed to its work, which has been praised by Gov. Andy Beshear for its role in fighting addiction and helping reduce overdose deaths in Kentucky.

“We are still very committed to our nearly 1,900 patients and our remaining employees,” Matt Brown, chief administration officer told the Lantern last month.

ARC and its founder and CEO Tim Robinson have emerged as prolific political donors in recent years to Republicans but also to Beshear, a Democrat.

A Lantern analysis showed that Robinson, his corporations and employees have made at least $570,000 in political contributions over the past decade as his for-profit company grew rapidly from a single halfway house in 2010 to about 1,800 residential beds and outpatient care for hundreds more clients.

In addition, ARC chief operating officer Pat Fogarty, a former executive with Alkermes, the global pharmaceutical company that holds the patent for Vivitrol, gave $2,600 in political donations in Kentucky between 2018 and 2020, the Lantern analysis found. Fogarty joined ARC in 2020 and made the donations while working for Alkermes to Republican candidates.?

Pyzyna said she believes further investigation of ARC is warranted.

Meanwhile, she is asking for tighter controls over addiction treatment programs, an end to Medicaid funding of Vivitrol without more rigorous oversight and an investigation by state authorities into whether any regulations were broken through events she believes contributed to her son’s death.?

She also urges anyone with knowledge of potential problems to contact the FBI.

“That’s a mother’s plea,” Pyzyna said. “I would encourage them to talk to the FBI.”

The $1,700 drug

Medications for opioid use disorder have emerged as a major component of treatment? in recent years and ARC said it offers patients a choice of drugs approved by the FDA, including generic drugs such as? buprenorphine (known by the brand name of Suboxone) and Vivitrol.

“We do not prioritize one treatment option over another,” Keeton, ARC’s s marketing VP, said in an email.

But last year, nearly all of ARC’s billing for drugs used for alcohol and drug treatment was for Vivitrol, an expensive, name-brand drug administered as a single dose through a long-acting injection given once a month.?

It costs around $1,700 a dose for patients who pay cash, though insurers and programs such as Medicaid would pay less through negotiated discounts, according to the website drugs.com.

Kentucky’s Medicaid Department did not respond to requests for what it pays for an individual dose of Vivitrol.

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ARC uses South Creek Drug — a pharmacy owned by CEO Robinson and his wife, Leila, according to records from the Kentucky Board of Pharmacy — to fill prescriptions for its residents in treatment.

Kentucky Medicaid last year paid ARC $8.8 million a year for Vivitrol, 89% of the total cost of all substance use disorder medication ARC billed for that year through South Creek Drug, according to records from the Kentucky Department of Medicaid Services.

By contrast, ARC billed Medicaid just $78,746 for all other drugs it dispensed — mostly forms of buprenorphine.

Buprenorphine, a generic version of Suboxone, costs about $62 for 30 pills, according to drugs.com.??

Overall, last year? Kentucky Medicaid spent $110 million on substance use medication, with $31 million — or 28% — on Vivitrol. The rest of the spending was largely for two other standard, much cheaper drugs, buprenorphine and methadone.

ARC’s Keeton said the company records show that it has served 12,185 individuals with substance use disorder in the past 12 months and that about 22% were prescribed Vivitrol.

Also, the state Medicaid records show only what ARC billed through its pharmacy and may not include prescriptions obtained elsewhere by those in outpatient treatment, she said.

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And she said ARC utilizes “external providers who provide Vivitrol management.”

She said ARC does not receive any direct compensation for the medication but the Robinsons’ South Creek Drug pharmacy is one of the providers used by the external providers to buy Vivitrol. A cheaper, generic version of Vivitrol is not yet available.

Alkermes, its manufacturer, holds the patent until early 2027, according to an article last year in Pharmacy Technology. Vivitrol won FDA approval for alcohol treatment in 2006 and in 2010, for opioid treatment.

Vivitrol has emerged as a blockbuster drug for Alkermes, which listed $1.6 billion in revenues last year, according to a company press release. Vivitrol was its top selling drug last year, with $400 million in sales.

Vivitrol advantage

Suboxone and methadone, which are considered opioids and ease cravings for drugs, are typically taken daily. They are controlled substances and therefore, more tightly regulated than Vivitrol, which comes as a monthly injection which serves to block the effect of opioids.

Because of the tighter regulations surrounding methadone and buprenorphine and because Vivitrol is not a narcotic — reducing risk of diversion — it has become more prevalent in institutional settings, such as jails or prisons, said Dr. Michelle Lofwall, a psychiatrist and addiction medicine physician and professor at the University of Kentucky College of Medicine.?

The Kentucky Department of Corrections, as part of its drug treatment programs, provides Vivitrol as well as all forms of FDA approved medications, a spokeswoman said.

Corrections offers treatment options “that are consistent with the best practices in the field of addiction and allow for different pathways of recovery,” said the statement from Morgan Hall.

Lofwall said evidence shows methadone and buprenorphine significantly reduce the risk of overdose deaths.

“That data is not there for Vivitrol,” she said.

Still, Lofwall said that doesn’t mean it’s not an effective tool for treating addiction.

“What’s right for the patient?” she asked. “The one the patient is willing to take.”

‘Be a man’

Pyzyna said her son’s struggles with addiction began in his late teens, first with alcohol, later with opioid drugs.

He was born in Chicago and later lived in Philadelphia and Indianapolis before settling in Lexington where he had received treatment through the Hope Center that helped him achieve sobriety, find work and buy a home, Pyzyna said in an email.

But after about eight years, her son relapsed and in 2021 was charged with drug possession and driving under the influence in Lexington. He was referred to ARC through a court diversion program, she said.

Soon after he entered ARC’s Crown Center in early September 2022, Pyzyna’s letter said her son told her he was directed to attend a “mandatory Vivitrol meeting,” where he was pressured to take the drug.

When he initially refused, staff increased pressure, she said, telling him he would be fine, the drug was “no big deal,” and to “be a man.” When he still resisted, staff said they would tell his court worker he was uncooperative and “drug seeking,” her letter said.

Finally, she said, Hal agreed to sign a consent form to accept an injection of Vivitrol.

Pyzyna, in her letter, alleges ARC failed to follow proper protocol specified by the FDA , including assessing Hal’s medical history and fully informing him of risks.

Within several hours of receiving the shot, he became violently ill, with severe vomiting, diarrhea, chest pains, shortness of breath and high blood pressure, her letter said. He passed out and was taken by ARC to a local hospital emergency room where it was determined he had experienced a reaction to Vivitrol, her letter said.

The hospital staff recommended ARC “support him through the symptoms” until the drug wore off, she said. When Hal’s symptoms continued, ARC staff took him back to the emergency room a second time where he was again sent back to the Crown Center to try to recover, her letter said.

On Sept. 17, 2022, still suffering effects from the drug a week after the injection, Hal decided to leave the facility and asked his mother to drive to Kentucky to get him, her letter said.

Pyzyna found her son sitting in the parking lot at Crown Center with his possessions, her letter said. She said staff directed him to wait there since he was leaving “against medical advice.”

Her account of his experience is based on what he told her, medical records she obtained and a journal he began keeping while at ARC, which he told her he started because “he was afraid he was going to die and wanted me to know what had happened to him if he didn’t make it out,” the letter said.?

A fatal overdose

Pyzyna was able to line up treatment for Hal in the Lexington area and he did well, she said. But facing a return to court on his pending charges and possible jail time,? he found and used a hidden “stash” of drugs, which caused his overdose death.

A pathologist report found he died from “drug toxicity” with a “potentially fatal” level of fentanyl in his system. A friend found him on the bathroom floor of his home on Oct. 21, 2022, it said.

Pyzyna said both she and her son were aware the risk of overdose was greater if someone had ceased using drugs, therefore lowering tolerance.

What they did not know, she said, is that Vivitrol increased that risk.

That was the subject of a 2019 FDA warning letter to Alkermes, the manufacturer, for not fully describing the potential for the most serious risk — a fatal overdose — in advertisements for the drug.

“While the print advertisement contains claims and representations about the drug’s benefits, it fails to adequately communicate important warnings and precautions listed in the product labeling, including vulnerability to opioid overdose, a potentially fatal risk,” an FDA news release said.

“This is concerning from a public health perspective because of the potential for fatal opioid overdose on this vulnerable patient population,” it said.

The following year, the FDA found the company had corrected the problem.

Pyzyna said she wants authorities and the public to know about her son’s situation in hopes of preventing someone else from going through it.

She misses her son, whom she describes as bright and funny. He loved hunting, fishing and working as a mechanic on cars and his beloved Ford truck.

“He was the most wonderful young man ever,” said Pyzyna, who arranged a memorial service after her son’s death. “Someday I’m going to scatter his ashes after this is all over.”

Tom Loftus contributed to this story.