Austin Paolo had rebelled against previous efforts to overcome his opioid addiction, but his family remained hopeful when he turned to the Pinnacle clinic in Brainerd for medication to reduce his cravings.
Instead, the drug to treat the addiction killed him. The 26-year-old died in 2014 from an accidental overdose of prescription methadone.
Paolo's death underscores a stubborn dilemma as Minnesota confronts an epidemic of opioid addiction and overdose deaths. Methadone is one of the few proven treatments for opioid addiction, and physicians say it remains an essential tool. But it is addictive and dangerous in its own right, and in Minnesota it is provided largely at for-profit clinics with histories of lawsuits and licensing infractions.
Attorney Phil Sieff went so far as to ask, "Is the cure as bad as the disease?" in a presentation last month to 300 Minnesota lawyers.
"When it is done correctly, it can be a valid treatment," said Sieff, a medical malpractice attorney. "But when there is any mistake ... the problems and the risks are catastrophic."
As opioid overdose deaths have spiked in Minnesota — from 54 in 2000 to 355 last year — so has the number of methadone clinics and patients. Across the state, 16 clinics now treat some 6,700 addicts.
But methadone deaths have risen in tandem. Minnesota is on pace for more than 70 this year, up from just five in 2000, according to a Star Tribune review of death certificate data through September.
Methadone is a synthetic opioid that must be taken long-term to block the highs and cravings caused by other opioids. It can be difficult to manage, because its toxicity varies from patient to patient and it stays in the body long after its effects wear off. Patients with heart conditions face increased risks.
Methadone's hazards have long been known, which is why clinics using it to treat addiction operate under special regulations. For the first several months of treatment, patients must take their doses under observation at the clinic, and then can take their medication home only after demonstrating their reliability.
Even so, Dr. Charles Reznikoff of Hennepin County Medical Center said the state's opioid death toll would be far worse if methadone weren't available. The addiction specialist said HCMC's outpatient methadone clinic sees 300 patients a day — more than its emergency department.
"For every patient who dies [taking methadone], there are five who are saved," he said.
Fatal car crash
Treatment specialists say the problem may lie more with the clinics than with methadone itself. State inspection records show that all 16 active methadone clinics in Minnesota (other than a new Golden Valley facility that opened last week) have received correction orders from the state Department of Human Services since 2010. Such orders typically require clinics to improve prescribing practices or staff training, but 10 clinics received more severe "negative" disciplinary actions.
The Dakota Treatment Center in Burnsville, for example, had its license placed on conditional status in 2014 after inspectors found it was giving take-home doses to patients before they were ready under state and federal guidelines. The center also failed to provide the required amount of group counseling.
Valhalla Place in Woodbury was fined in 2015 for insufficient phone checks on patients with take-home doses.
The Lake Superior Treatment Center in Duluth closed in 2015 after numerous state violations, while Pinnacle Recovery Services in Brainerd was named in two wrongful-death lawsuits.
One of those lawsuits stems from the 2012 case of Vanessa Brigan, who injected her take-home methadone dose before leaving the clinic and caused a three-car crash that killed two people when she tried to drive home. An $8.5 million settlement is pending, according to an attorney in the case.
Paolo's family also sued Pinnacle, accusing the clinic of "failing to adequately assess, monitor, test or treat" a man with many risks, including a heart pacemaker. That suit is set for trial next year. Pinnacle's previous owner did not respond to a request for comment, and the clinic has since been acquired by Meridian Behavioral Health, a New Brighton-based clinic network. Chuck Hilger, Meridian's vice president for medication-assisted treatment, said the clinic is making changes to improve patient oversight.
"You won't see some of those things get out of hand,'' Hilger said.
Sieff, who represented a victim's family in the Brigan case, said he's troubled by the number of for-profit clinics in Minnesota. HCMC is the only nonprofit hospital system in the state that operates an outpatient methadone clinic.
"There is a huge, huge profit motive for these centers to, number one, get [patients] on methadone and, number two, keep them on the damn stuff," Sieff said.
Methadone has other uses, including treatment for pain, and Reznikoff said he suspects the rising number of fatal overdoses is linked to pain clinics. Some, he said, send patients home with methadone pills, unlike addiction clinics that dispense it in liquid form and provide thorough counseling.
"If you [give] methadone in that setting, watching them drink the dose and observing them for safety every day, that is totally different from giving patients 30 days of pills and saying, 'See you later,' " he said.
State death records don't clarify where overdose victims got their methadone, but they do show a strong link with prior drug addiction. A Star Tribune review of 58 methadone-related deaths through September of this year found at least 21 people with histories of drug abuse and at least 13 who overdosed on someone else's medication.
A safer alternative?
One solution could be greater use of Suboxone, a newer opioid treatment that isn't addictive and comes with fewer federal restrictions. The drug, known generically as buprenorphine, gained notoriety this spring when it was revealed that doctors tried to get it to the pop star Prince before his overdose death.
Access to Suboxone has increased in recent months, in part through a decision by the renowned Hazelden Betty Ford Foundation to include the drug as part of opioid treatment. In addition, Attorney General Lori Swanson announced last week that two of the state's largest health insurers had dropped prior-authorization restrictions that limited access to the drug.
On the other hand, doctors have been slow to seek federal certification to provide Suboxone, in part because they aren't eager to add opioid addicts to their patient base.
Dr. Mark Willenbring, a St. Paul addiction specialist and former research director for the National Institute on Alcohol Abuse and Alcoholism, called out the state's major health systems for failing to offer Suboxone. "The mainstream medical organizations have not stepped up to the plate in terms of meeting this public health crisis," he said.
Expanded Suboxone prescribing would also address care gaps in rural Minnesota, which leave patients driving long distances or receiving state-funded medical transportation to take methadone. But another barrier is Suboxone's high cost, a problem for opioid addicts who often live in poverty, Reznikoff said. "Methadone is dirt cheap, so the way these clinics are paid makes it financially feasible."
Some methadone clinics, such as the nonprofit ClearPath in Duluth, are trying to switch patients to Suboxone. But ClearPath chief executive Gary Olson said he's optimistic that improved methadone administration can reduce risks. The average methadone dose at his clinic has gotten smaller, and 30 patients are on track to withdraw from it altogether. The share of patients testing positive for other opioids has dropped from 15 percent last year to 3 percent now, he added.
The landscape of methadone providers also is changing. Instead of stand-alone methadone clinics, organizations such as ClearPath and Meridian Behavioral Health are operating them along with other mental health services that can support addicts.
Meridian has built a good reputation in northern Minnesota, where it operates three clinics, and has worked successfully with the White Earth reservation on addiction treatment, Hilger said.
Both Hilger and Willenbring said they worry that a focus on methadone deaths could discourage addicts from seeking proven medication therapy. Willenbring said patients die in abstinence-based programs too — which remain unproven for opioid addiction — but that number isn't tallied.
"Is methadone a perfect treatment that has no risks or social costs? Of course it has those," he said. "Is it worth it? There is no doubt about that."
Jeremy Olson • 612-673-7744
