CLEVELAND, Ohio — Judges, doctors and lawmakers on the front lines of the opioid addiction crisis have a problem: Three types of medications are available to help the estimated 200,000 Ohioans struggling to recover from addiction and yet there are no clear answers as to which, if any, drug works best.
The skyrocketing demand for treatment has spurred competition among drugmakers for a piece of the growing market, which in Ohio is worth well over $100 million a year in public money alone.
It has led to a vigorous, ongoing debate about how to spend limited tax money while also saving the most lives.
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The fastest-growing medication has the shortest track record and the highest price: Vivitrol, a monthly shot that blocks receptors in the brain so that a person can’t feel the euphoria or high from opioids.
In 2012, Ohio Medicaid paid for 100 doses of the injectable medication. Last year, it paid for over 30,000 doses — at a cost of more than $38 million.
Vivitrol is now a go-to option in many of Ohio’s 95 drug courts, which have become a de facto gateway to treatment for those arrested for possessing drugs or committing crimes to support an addiction.
It also has strong backing among state lawmakers, who decide how to spend the state’s considerable resources to combat addiction.
Research, however, is lacking on which medications are the most effective. But lawmakers say they can’t wait to act.
“It’s not as if we are sitting here with lots of time on our hands,” Rep. Robert Sprague, of Findlay, said of the ballooning epidemic, which now includes abuse of not only heroin but more deadly combinations of fentanyl and carfentanil.
“We’re going to fire all the bullets in the gun at the problem,” he said. “We don’t have time for a four-year double-blind study to see what works best.”
The beginning of Medication Assisted Treatments
It wasn’t long ago that the idea of using medicine to help treat addiction was frowned upon, especially in Ohio, the birthplace of Alcoholics Anonymous, which for more than 80 years has endorsed abstinence as the route to sobriety.
That has changed. And swiftly.
In 2011, in response to the mounting toll of addiction and death, Gov. John Kasich signed an emergency executive order that opened the door for wider use of what are referred to as Medication Assisted Treatments (MATs).
Since then, state spending on three types of medication — buprenorphine, naltrexone and methadone — has jumped, particularly after Medicaid coverage expanded in 2014 to cover an additional 700,000 uninsured, low-income Ohioans.
Since then, payments for MATs to treat opioid addiction have more than doubled, from $40 million to more than $110 million last year. Treatment and counseling services cost another $462 million in public money from 2014 to 2016.
Courts, jails and prisons received at least $16 million more in state grants to cover the cost of MATs, treatment and case management for the uninsured.
Opportunity to profit
Amid all the public spending, Alkermes, the Ireland-based company that manufactures Vivitrol in Wilmington, markedly stepped up its campaign to make the drug available.
“What is Vivitrol?” billboards dot the state, and since 2012 the company’s political action committee has donated more than $77,000 to nearly 40 candidates for state office, including $10,000 to a Kasich campaign fund. The company also hired a lobbying firm to push for provisions in roughly 30 proposed Ohio bills, including money in the state budget to pay for Vivitrol use in drug courts and to study its use.
In his 2017 State of the State address, Kasich gave a shout-out to Alkermes, which has increased production of Vivitrol as demand has increased, and hired an additional 51 employees at its Wilmington plant after getting a seven-year, 50 percent tax credit worth about $284,000.
The governor, however, has held firm to an “all strategies forward” approach that he cited in 2012 when vetoing a bill lawmakers passed that would have tested Vivitrol exclusively with inmates addicted to heroin or alcohol while they were incarcerated and after their release.
Federally, Alkermes has spent even more to promote the use of Vivitrol: more than $11 million on lobbying since 2014, and more than $300,000 to members of Congress, including nearly $30,000 to U.S. Sen. Rob Portman, Republican of Ohio.
The makers of other brand-name medications have donated to lawmakers in the past, often closer to when the drugs were first FDA approved but in Ohio not during the most recent MAT push, according to state campaign finance records. (See federal lobbying of another MAT maker, Reckitt Benckiser, which makes Suboxone.)
Shortly after Vivitrol was approved by the U.S. Food and Drug Administration in 2010, Alkermes started to leverage access to court systems in Ohio, and across the nation. Last year, the company gave $50,000 to the National Association of Drug Court Professionals as a “champion” level corporate member. (Alkermes has donated to the group since 2007.)
For that, the company received valuable face time with judges, some of whom used free samples of Vivitrol in their courts before it became more widely available. The company held dinners for judges and drug court staffs and assigned drug “reps” to courts, similar to the kind who visit doctors’ offices.
However, Chris Deutsch, spokesman for the National Association of Drug Court Professionals, said corporate partners like Alkermes and other drug makers do not influence the nonprofit’s recommended guidelines for judges, which don’t endorse a particular medication to treat addiction.
Vivitrol has become a “safety net,” now used in 400 drug court programs in 38 states, Alkermes spokesman Matthew Henson said.
Alkermes, he said, has consistently advocated for making all FDA-approved medications to treat addiction available, and that Vivitrol be included as an option.
Word-of-mouth interest in the medication is high among judges dealing with a growing number of opioid-addicted defendants in their courts and detoxing in jails with few treatment options, he said. “A lot of these judges have come to us,” he said.
Henson said the company decided it needed to do more to educate — not market to — judges, who were increasingly involved in decisions about what treatments would be offered.
A drug solution to a drug problem
The seeds of today’s opioid addiction and overdose epidemic in the United States were planted two decades ago, as pharmaceutical companies lobbied for fewer restrictions and wider use of pain medications.
Companies donated generously to political campaigns, telling lawmakers that pain was being massively undertreated, and that stronger medications, like OxyContin, posed no serious risk for addiction.
Soon enough, America consumed 80 percent of the world’s pain pills.
In 1997, Ohio passed the Intractable Pain Act, allowing doctors wide latitude to dole out painkillers — a move that’s now being dialed back with new state limitations on prescribing.
So the idea that a new set of pharmaceutical companies might jockey to profit from the epidemic? Not shocking, said Hocking County Municipal Judge Fred Moses.
“People made money getting [individuals] addicted to drugs and now people are making money getting them off,” said Moses, one of the first judges in the state to embrace medications for defendants with opioid dependence in his voluntary drug court.
Despite the optics, Alkermes’ push has had minimal impact on what treatment options get paid for, said Rep. Ryan Smith, a Republican whose district includes parts of four southern Ohio counties that have seen significant opioid-related deaths. When he first took office, there was a large push for the use of Suboxone or buprenorphine.
“I don’t want to minimize the lobbying aspect, but it is insignificant when compared to other things,” said Smith, whose campaign received $8,000 from Alkermes from 2013 to 2016. “They [Alkermes] have five lobbyists, and AT&T has like 40.”
He said he listens more to constituents who have recovered with the help of methadone, buprenorphine and Vivitrol over doctors.
“Doctors prescribed more than 800 million opioids on the front end of this problem,” he said. “That really aggravates me.”
Doctors want data
Dr. Jason Jerry understands why Vivitrol is an easy sell, especially to courts, but it’s not for doctors who treat addiction.
He’s one of many doctors who remain skeptical of claims about the medication.
“There’s not a lot of scientific literature to support its use,” said Jerry, a nationally recognized addiction psychiatrist. Jerry treated patients at the Cleveland Clinic and was a member of the Northeast Ohio Heroin and Opioid Task Force, before recently taking a job at a hospital in North Carolina.
Most studies supporting Vivitrol’s performance are paid for by the manufacturer and were done in Russia, where the alternative addiction medications available in America are illegal, he said.
It started with 250 patients, half of whom were to be given Vivitrol and the other half a placebo. Roughly 60 patients remained in the study and on Vivitrol for a full six months, and 36 stayed in treatment without a serious opioid relapse, compared to 23 percent in the placebo group.
Based on those small numbers, Jerry said, he can’t recommend the medication to most patients.
Jerry also worries there’s an increased risk of overdose when the shot is stopped and patients have a reduced tolerance for opioids. At least one Australian study showed a 40 percent increase after patients stopped using a naltrexone pill.
In general, the relapse rates after about a year for each medication appear similar if a patient also completes treatment, said Ted Parran. He’s an addiction specialist who teaches at Case Western Reserve University and is on staff at St. Vincent Charity Medical Center.
Most studies of Vivitrol in the United States involve people charged with crimes, where there’s another important and hard to measure factor at play — the threat of a jail or prison sentence.
One such study published last year in the New England Journal of Medicine — cited by Alkermes as proof the medication is helpful and by some doctors as proof it is not — found that Vivitrol, paired with treatment, doubled the time before opioid relapse from about five weeks to a little over 10 weeks.
However, by about a year, the chance of relapse for those using Vivitrol and other methods, such as buprenorphine or only counseling, were virtually the same. Vivitrol also didn’t affect cocaine or alcohol use or how likely a person was to be re-incarcerated. Alkermes says smaller, drug court-based statistics, are starting to show lower recidivism rates for those taking Vivitrol.
The lack of clear research is one reason Ohio hasn’t officially singled out any medication for treating opioid addiction, said Dr. Mark Hurst, medical director of the Ohio Department of Mental Health and Addiction Services.
Instead, the state promotes the use of all available medications to help prevent relapse and treat addiction, along with psychosocial therapy, Hurst said. Each has proved to reduce the chance of relapse that — without medication and treatment — happens 80 percent to 95 percent of the time.
The decision of which medication to use, if any, should be made between a patient and a doctor treating them, Hurst said.
Practically, that’s not always how it works.
Moses, of Hocking County, has stumped for Vivitrol, inviting dozens of judges, lawmakers and reporters to visit cozy courtroom in Logan.
But it’s because he’s seen the medicine work, not because he’s been influenced by Vivitrol marketing.
“I’ve never taken anything from anybody,” he said, after learning a reporter had requested his public financial disclosure forms and questioned the Ohio Supreme Court about his and other branded “Vivitrol Drug Courts.”
Moses said he approached an Alkermes presenter at a drug court conference in 2012. “I walked up and asked them, ‘You’ll give it to a rich county, but will you give it to a poor county?’ “
Alkermes agreed to provide doses of Vivitrol for free, he said. Moses later testified for lawmakers in Columbus about the positive results he saw from those taking the medication.
Now, a state grant is paying for 49 treatment slots for his court to use at a cost about $98,000 in 2016. It covers the shots and for chemical-dependency counseling, case management and treatment services, which he says are key to success of defendants in his program.
In April, participants in the program included a former steel plant foreman who, before becoming addicted, made up to $98,000 a year, and several mothers hoping to stay sober and raise their children. Most said they’d first used opioids after being prescribed or using pain pills.
Weekly in the court the defendants discuss together how they are managing sobriety and doing things like getting driver’s licenses reinstated or searching for jobs.
The last four graduating groups had 100 percent employment and only three have committed additional crimes, Moses said.
“It’s not just about a shot,” he said. “It’s about treatment. That’s what really works.”
Suboxone still most used
Many judges like Moses soured on the use of the other medications used to treat opioid addiction, especially Suboxone, which is a semi-synthetic opioid.
Suboxone, also sold generically as buprenorphine, partially activates the receptors in the brain that need opioids. Dosages are set to give an addicted person enough medication to not feel the symptoms of withdrawal but also not enough to feel a high. Methadone is used similarly, though it is more potent and tightly controlled.
Buprenorphine-based medicines are still largely preferred by doctors trained to treat addiction, and Ohio Medicaid spent a combined $72 million for brand name and generic formulations of these medications in 2016.
From the start, though, judges didn’t like the idea of giving a form of opioid to an addict, especially after some defendants covertly used the medicine to game their drug tests for heroin. It was also often “diverted,” meaning it had a street value and was sold or smuggled into prisons.
Too few doctors in Ohio were initially trained to prescribe and monitor patients on Suboxone, which was approved to treat opioid addiction in 2002. Cumbersome insurance preauthorization requirements also led to the opening of clinics that charged cash for monthly visits.
Parran called those who are taking cash “ethically challenged.”
“It’s an embarrassment to my profession,” he said.
Moses believes that medications like Suboxone keep the brain addicted, and doesn’t allow it to heal. Defendants on Suboxone appear more sluggish and tend to use other unprescribed medications, such as Xanax or Valium to get stoned, he said.
“You wouldn’t tell someone one with high blood pressure to go out and eat salt, would you?” he asks.
Despite his misgivings, he allows drug court defendants to use Suboxone but keeps that group separate from his Vivitrol court.
Jerry said complaints about buprenorphine sometimes reflect a misunderstanding of how the opioid-based medications work. It often was being sold, Jerry said, not for people to get high but to stave off withdrawal. “It means that a lot of people don’t have access to legitimate treatment. And so they are making halfhearted attempts on their own to stay away from the needle,” he said. Heroin is far cheaper on the streets if people wanted to score. “I’ve never had a patient that’s come in and said, ‘Doc, buprenorphine is my drug of choice.’”
Part of the problem, Jerry said, is that there’s a notion that people with addiction must be taken off medication to get “better.” That’s not the way we look at other diseases or conditions, such as diabetes or high blood pressure, where medicines are viewed as acceptable long-term treatment. “But here, with addiction, it’s looked at differently, and why?” he asked.
Common Pleas Judge David Matia, who started Cuyahoga County’s first drug court docket in 2008, said practical factors have “handcuffed” courts into using Vivitrol.
Defendants in drug court are required to get treatment, often followed up by a stay in a sober-living facility, like a halfway house, which increases the chance they’ll do better in recovery.
Few of those facilities allow the use of buprenorphine or methadone, Matia said. Some only recently allow Vivitrol use.
Matia admittedly also was skeptical at first about using any medication to prevent relapse. “I thought it was being treated like some magic bullet,” he said. Plus, he cringed at the steep cost, anywhere between $1,000 and $1,400 each month.
The court now has a $470,000 state grant to pay for Vivitrol and treatment for defendants not covered by Medicaid or other insurance. The program doesn’t cover Suboxone or other medications, though defendants can use them.
on the horizon
Along with the state drug court grants, lawmakers in 2015 devoted nearly $1 million pay The Treatment Research Institute to study the effectiveness of the different medications being used, in hopes it might provide insight for the future.
The study will look at results from more than 21 Ohio drug courts — including Cuyahoga and Hocking counties — and is due to be completed in June, although some have pointed out that at least one researcher associated with the study worked for Alkermes for nearly a decade, helping to develop and promote Vivitrol.
This past week, Republican lawmakers proposed pumping $170.6 million more into fighting the state’s opioid crisis over the next two years, including millions more for treatment and drug courts — and medications.
Smith, who heads the House Finance committee, said effectiveness ultimately will drive where the state spends its money. For now, lawmakers are still working to level the playing field.
“At the end of the day, I don’t care who it is or what it is. All I care about it is the results,” he said.