A decade ago, a small biotech company based outside of Boston faced a quandary. Its scientists had cracked a puzzle that long eluded the industry. But that soon led to another problem: There was no obvious way to market its promising new product.
The company, named Alkermes, had been tinkering with a medication called naltrexone, which had for years been prescribed with middling success to people with alcoholism. The drug reduced the pleasurable effects of drinking, and patients could take the pills until their cravings were under control. While the medicine also showed promise in suppressing opiate addiction, it was unlikely to be widely used for that purpose. Opiate addicts would have to first go through excruciating withdrawal and then have the commitment to pop a pill every day that didn’t make them feel any better. The trick was coming up with a version that didn’t need to be taken daily.
Now Alkermes had beaten its competitors to an extended-release form of naltrexone. Administered by a shot in the buttocks, it blocked the patient from getting high for 28 days.
Just as a scourge of opiate addiction was building in the U.S. heartland, Alkermes suddenly had a product it could pitch as a once-a-month solution. It won approval from the Food and Drug Administration, named the drug Vivitrol, priced it at $1,000 per shot and prepared to rake in the profits.
Instead of being hailed as a breakthrough, though, Vivitrol quickly ran into resistance. While some experts in the field of addiction science welcomed it as a new treatment option, many others expressed skepticism about Vivitrol’s effectiveness, questioning the company’s decision to go to Russia to conduct the clinical trials required by the FDA. The vast majority of addicts and their physicians continued to favor methadone and buprenorphine, proven medications that allowed for a more gradual exit ramp from addiction. And then there was the steep price.
If the usual route of selling medications — pitching them to physicians and directly to patients — wasn’t going to work, the company had to find another way. And so it did. It began focusing on a market where consumer choice was less relevant: drug courts.
Initiated in the 1980s and until recently a small slice of the criminal justice system, drug courts now number more than 3,000, a sprawling network that touches half the counties in the country. Tens of thousands of drug offenders are diverted to them each year, giving local judges wide discretion to impose alternatives to jail and prison time. Over the past five years, Alkermes has persuaded hundreds of them to favor Vivitrol injections. The judges say they don’t force anyone to take a particular medicine. But in effect, they give addicts a choice: the shot, or jail.
Thanks in great part to these judges, and to an explosive epidemic that only seems to be accelerating, some 30,000 people are now receiving Vivitrol shots. In the first quarter of 2017, sales totaled $58 million, a 33 percent increase over the year before. The company is ramping up manufacturing capacity, enough so that it could soon handle $800 million in annual sales, which it projects it will reach by 2020.
Leading the way in sales is Ohio, which has been especially devastated by the epidemic — more than 2,500 deaths in 2015, nearly 10 percent of all fatal opioid overdoses nationwide — and also happens be the site of the Alkermes factory that produces Vivitrol. Last year the state’s Medicaid program alone paid for more than 30,000 doses of Vivitrol at a cost of more than $38 million, a nine-fold growth over just two years, according to The Cleveland Plain-Dealer. And now every day, it seems, brings news of another hard-hit county in another state embracing the medication. It is the centerpiece of the drug court in Anchorage, Alaska. West Virginia is setting up a pilot program for using Vivitrol in five county drug courts, modeled on Ohio. Michigan is giving the shot to parolees who are picked up again on drug-related crimes. Illinois, Wisconsin, Vermont, New Hampshire, Pennsylvania and other states are giving inmates shots just prior to release, to serve as protection for their first few weeks on the street. All told, more than 450 public initiatives in 39 states are making use of Vivitrol.
The chief executive behind the success of Vivitrol is Richard Pops, who arrived at Alkermes as a 28-year-old banker in 1991, when it was an MIT-linked research lab with just two dozen employees, and has presided over its growth into a 1,900-person company. The anti-addiction shot became one of its most important products as the firm’s stock market value soared from about $2.5 billion in 2012 to more than $9 billion today. At an industry conference last year, Pops explained the strategy for the drug. At first, he said, “There was no treatment system that could accommodate the use of Vivitrol. So the last several years has been a story not about reps calling on doctors, not about generation of more clinical data.” He added, “It’s been about creating the milieu, creating the infrastructure, the ecosystems to be able to use Vivitrol.”
And it was plain where to build that ecosystem, he said. “Criminal justice has been a really important catalyst, because it’s the drug court judges and the police chiefs and the sheriffs in their communities who just got tired of seeing the same people relapsing and ultimately dying.”
The rise of Vivitrol, aided by the company’s political contributions and its advertising campaigns that have erected billboards from Ohio to New Jersey, concerns addiction specialists who say the drug’s popularity is outpacing the science behind it and the results it produces. Many question whether the criminal justice system is rushing headlong into a solution that’s too good to be true, not recognizing that Vivitrol should be only one option, one that’s carefully weighed against other means of treating the country’s worst public health catastrophe in years.
“In what other medical situation do judges prescribe specific treatments from the bench?” asked Mark Willenbring, an addiction psychiatrist in St. Paul, Minnesota. “If you get in a car crash because you’re diabetic, do they prescribe a specific medication from the bench? This is the only area in medicine or health care where judges think they know more than doctors.”
Jeffrey Junig, a Wisconsin psychiatrist specializing in substance abuse who himself overcame an opiate addiction, puts it more bluntly. “They make you an offer you can’t refuse,” he said. “People are being forced to take medication with jail over their heads.”
Drug court judges represented a ripe market for Vivitrol. They were at the front lines of the epidemic, with a growing stream of addicts coming through their courtrooms. They lacked medical training — a survey of drug court judges published in 2014 revealed widespread ignorance about treatment options. And while the whole purpose of their courts was to offer treatment as an alternative to incarceration, the judges (who were often elected) tended to reflect local cultural biases about addiction, viewing it as moral weakness that called for tough paternalism.
Few were as receptive as an Ohio judge named Fred Moses. A genial, plainspoken man in his late 40s, he had grown up in Columbus, the state capital, and spent a dozen years as a supervisor at the local Anheuser-Bush plant before deciding to go to law school. He was elected to the bench in 2011 in Hocking County, a hilly, wooded region that is Ohio’s gateway to the Appalachians. Its struggling towns and back-road settlements were becoming riddled with opiate addicts, most of whom had gotten hooked on prescription painkillers and many of whom were turning to heroin as authorities belatedly clamped down on the flow of pills. Not only was Moses working in a state where Alkermes was paying special attention — the company produces Vivitrol at a plant in Wilmington, employing more than 400 people — but he had become quickly disillusioned with the existing approach to treatment.
For years, the only real medication available for people seeking to break their addiction had been methadone and buprenorphine, which is commonly known by its brand name Suboxone. Both were opioid substitutes that quieted the brain’s cravings with less risk of overdose than heroin or opioid painkillers while allowing people to rebuild their lives and, hopefully, ease themselves off the drugs. Both were embraced by specialists who argue that opiate addiction is a chronic condition — that the damage done to the brain may require at least several years of maintenance on methadone or buprenorphine, just as people with diabetes or high blood pressure may go years on insulin or other medications. The emphasis, they say, should be less on strict abstinence than on a broader concept of sobriety — carrying on a normal life even if it involves taking a prescribed substitute.
But these medications faced resistance in some quarters. Many 12-step-based treatment programs viewed them as a crutch and disdained those who depended on them for falling short of true abstinence.
Ohio had never been particularly welcoming to methadone — there are only 23 methadone clinics in the entire state, far fewer than in, say, Massachusetts, a state barely more than half the size — and they are concentrated almost entirely in the state’s largest cities. While there was more institutional support in the state for Suboxone — which unlike methadone could be prescribed for home use, since it is harder to abuse — only so many physicians were willing to prescribe it, and they were concentrated in the state’s urban areas. Many small-town general practitioners were wary of having their waiting rooms fill with opiate addicts seeking the medication, were unsure of their ability to carry out the monitoring necessary to make sure people were using the medication as directed, or themselves viewed Suboxone as just another addictive drug.
As a result, even as the opiate epidemic soared in Ohio, there were entire swaths of the state without physicians prescribing Suboxone. Soon enough, the market responded to the unmet demand: Opportunists started opening up clinics where addicts had to pay $200 or more — cash-only — for the monthly appointments to pick up their prescriptions (the medication itself, which comes in the form of sublingual tabs, now typically costs less than $200 per month). To cover this cost, many took to selling some of their Suboxone on the side to people who lacked legal access to it. Some of these black-market buyers were using the pills more or less as intended: to get themselves off heroin or painkillers.
But others were trying to get high off of it — difficult but not impossible, especially if injected or combined with benzodiazepines like Xanax — or using it simply to stave off withdrawal between stints of heroin or painkillers. To clamp down, state medical and pharmacy boards imposed new requirements that, in some cases, simply had the effect of making responsible physicians even more reluctant to prescribe.
In well-managed treatment centers, buprenorphine was working as intended for addicts in the care of physicians. But in many small towns and cities, Suboxone took on a stigma — just another pill being sold on the street, one that, instead of allowing recovering addicts to function normally, often left them looking groggy, either because a cash-clinic doc had prescribed too strong a dose or because it was being misused.
This latter reality was very much in force in Hocking County, which holds just under 30,000 people and sits 50 miles southeast of Columbus, 25 miles away from the closest treatment center with methadone and buprenorphine, in Athens. Fred Moses knew that, in theory, buprenorphine was a help for many addicts, but all he saw before him were befogged defendants who were overmedicated or not using the drug as prescribed. “Doctors don’t want it because it’s a plague and no one does it responsibly,” he said.
In 2012, six months after he was elected to the bench, he traveled to the annual convention of the National Association of Drug Court Professionals, which was held in Nashville. There, he attended a presentation by Alkermes. He approvingly noted that the new drug worked very differently from methadone and buprenorphine. Whereas those “agonists” act by gripping the opioid receptors in the brain, thus delivering their own mild effect while preventing heroin or painkillers from latching on, the “antagonist” naltrexone acts like a glove over the synapses, preventing any opioid from reaching them. And it seemed more punitive in nature: Instead of providing a substitute high, it functioned as a roadblock, denying any high at all.
The salespeople said the company was willing to give some free starter doses to counties that were interested in incorporating it into their regimen. “You’ll give this to a rich county, but will you give it to a poor county?” Moses asked them. He gave them his card. “And to their credit, a month later, they called us up.”
Within just a few months, Moses had set up a special program within his jurisdiction. He called it “Vivitrol Court.” He never took a dime from the company, he said. But he was such a believer that he soon became a nationwide proselytizer for the medication.
As it made inroads into the criminal justice system, Alkermes moved to expand its gains. The company got heavily involved in politics. It has spent $19 million on lobbying in Washington in the past seven years, as The New York Times recently reported. But Alkermes has been especially active at the state level, where decisions about drug treatment and law enforcement tend to be made. It became a member, at the second-highest tier of corporate donor, of the American Legislative Exchange Council, or ALEC, the corporate-backed group that promotes conservative ideas for state and local policy. Nationwide, the company’s PAC has given more than $430,000 in campaign contributions to state legislators, governors and candidates for other state-level offices in recent years, a striking sum for a small biotech company.
The company has made more campaign contributions in Ohio than in any other state, with top beneficiaries including Gov. John Kasich, as well as the chairman of the Senate committee that oversees Medicaid, the speaker of the house and the former No. 2 person in the House, all Republicans. The company also hired a handful of lobbyists in Columbus. One of them, Zach Holzapfel, reached out in 2013 to Ryan Smith, a newly elected Republican from his own district in southern Ohio. Holzapfel put Smith in touch with Moses, who highly praised Vivitrol.
Soon, Smith, who would become another top recipient of Alkermes support, joined an ad hoc group of legislators to travel the state and study the opiate epidemic. The group was chaired by Robert Sprague, a Republican representative from northwestern Ohio, who’d learned of Vivitrol from a constituent who’d seen both of her daughters succumb to opiate addiction — one had landed in prison, but the other, after countless failed rehab attempts, had had success with Vivitrol. (The mother, Tracy Morrison, was such a convert that she became Alkermes’ sales rep for northern Ohio.)
The group grew very enthusiastic about Vivitrol. “Most people want to see us use a non-opioid type of treatment,” Smith told me. “Why treat people who have a drug problem with another drug?” The group proposed several bills to address the epidemic, Moses came to Columbus to testify on his success with Vivitrol Court, and in July 2013 Kasich signed a bill that gave a big boost to Alkermes: $5 million to expand medication-assisted treatment in drug courts in seven counties. A year later, the state approved another $11 million to expand to 14 additional counties. “Courts are a good place to do” drug treatment, state Sen. Dave Burke, a Republican, told me. “You have a black robe and the threat of jail time.”
Since most of the drug courts were opposed to buprenorphine and methadone, or located in places that lacked access to them, the vast majority of the counties put their funding toward Vivitrol-based programs. As it had initially offered to Moses, Alkermes spurred the move toward Vivitrol by giving away rounds of the costly shots in some counties. In at least one county, Athens, adjacent to Hocking, the embrace of Vivitrol by the criminal justice system went even further: County prosecutor Keller Blackburn started a program that is providing Vivitrol shots not only to people facing charges, but to addicts coming in off the street seeking help, for a total of more than 150 people now getting shots. “We’re not forcing anyone into Vivitrol that doesn’t want it — it’s just one of our options,” Blackburn said. But, he added, “I’m a little more comfortable probably not sentencing someone to prison that wants to go on Vivitrol.”
The company reinforced its relationship with drug court judges in 2014, when it paid $50,000 to become a “champion” sponsor of the National Association of Drug Court Professionals. The group has sometimes aligned with the company’s best interests, as when it lobbied the Obama administration in 2014 against increasing a limit on how many patients an individual doctor could have at one time taking Vivitrol’s rival treatment, Suboxone.
In a telephone interview, Pops, the Alkermes CEO, said that Vivitrol’s rapid spread in the criminal justice system was the result more of local demand than of the company’s push into that market. “It was sheriffs, police chiefs and charismatic judges who took it upon themselves to see if they could drive better outcomes,” he said. “It was people saying the status quo isn’t working.” And he said the company did not believe in requiring drug court participants to get Vivitrol shots. “We’ve always said we don’t believe it’s the right drug for every patient,” he said.
As Moses touted his success with Vivitrol, the county sheriff and town police departments saw a way to lighten their growing drug caseloads. They would, he said, call him at night and say, “Hey, we busted somebody, we could probably hit ‘em with felonies but they’re not going to get the help up there [in state prison], would you take them down here?” According to Moses, they would tell the suspects: “Do you want to do this program? We won’t charge you with felonies, we’ll let you work it out down here.”
When I visited Moses earlier this year at his Vivitrol Court, he sat up at the bench, but everything else exuded informality — he was in shirtsleeves, and spoke to the 16 participants coming in for their weekly check-in, plus a half-dozen counselors, social workers and support staff, with a familiarity that seemed, at first, more teacher than judge. He asked a woman with dyed-orange hair about her dog and another about her mom’s cancer. He urged those progressing to the next phase of treatment to get a free T-shirt out of a box. There were the makings of solidarity — participants applauded for those advancing to the next level. The woman whose mom was fighting cancer said, “My mom wanted to thank everyone for all the help I got. She’s not worried about me now.”
But Moses grew stern with those who had missed counseling appointments or failed urine tests for drugs other than opiates, which some used to circumvent the Vivitrol block. “So what’s going on? Are you getting back on track?” he asked a young man who’d missed a couple appointments. “There’s, like, something missing you used to have, and you’re the only one who can figure it out.”
He sharply reminded another man with an Amish-style beard and yellow hoodie that he faced a four-year sentence in a nearby county if he didn’t succeed in Vivitrol Court. “You need to understand where you’re at,” Moses told him. “You’re being given an opportunity to be in a program where you can really succeed and get your life back on track. If I had four years sitting on a shelf I’d be here early every day.” The man said, with backup from the counselors, that he was just struggling to balance appointments with his excavation job and probation requirements. Moses was unswayed: “If you don’t respect this program, we’re wasting our time.”
And he admonished a man with a scruffy beard and long hair who recently failed a urine test. “What bothers me is that once the pressure got to you, you went back to your old behaviors. That’s the part that scares me,” he said. “The truth is, people won’t say it, but life sucks sometimes, the pressure gets on you and there’s nothing you can do about it and it’s always about how you react to it, whether you fold or are going to stand up and do what you’ve got to do. … Running’s easy. Running’s the coward act, running away from all your problems. You’ll be running all your life, you’ll be using the next 30 years and never get better. At some point, you need to man up.”
Moses still runs a regular drug court as well, where Suboxone treatment is allowed, but throughout this session, he made his preference for Vivitrol plain, urging those who were doing well in the program to talk about how much they preferred it to Suboxone. “My cravings have been really light. I’m a lot happier sober. It’s amazing. You can be sober and happy and not have to be high,” said one woman in a camo jacket. “I spent 10 years trying to get clean. With Suboxone, I was just trading one drug for another and it didn’t help,” said a man gripping a Monster energy drink. “This right here, it blocks everything. I have no worries now, I wake up every morning not sick. I’m a lot happier.”
Another man, a 31-year-old also in camo, said, “I’m pretty surprised with how it’s going, how easy it is. I tried to quit before. I did the Suboxones and stuff.”
Moses interjected, “That’s not really quitting, is it?”
“It’s not,” the man said.
“Big difference, huh?” Moses said.
“Big-time,” the man said. “I was on [Suboxone] for six months. Just substitute one drug for another.”
To see if the Moses court was just an outlier, I drove north for a couple hours to sit in on the proceedings of another Ohio judge, Robert Batchelor, in the stately 142-year-old Coshochton County Courthouse. Batchelor, a forceful presence with a shaved head and a pistol tucked in his belt in the small of his back, learned about Vivitrol at a state summit on opiate addiction several years ago. He told me that he had initially been leery — “Nobody was really interested in getting involved in some weird ‘Clockwork Orange’ thing where the government is making you take medication when you’re a criminal. That’s really how it came off to me originally.”
But it appealed to him for what it was not: Suboxone. There were no physicians prescribing Suboxone in his county, and Batchelor didn’t want his drug court to have anything to do with it. So he welcomed Vivitrol instead. “If you want to get treatment, you’re scared enough to not want Suboxone because you know the Suboxone zombies aren’t getting a better — a lot of them are using heroin, etcetera, etcetera. It’s really bad. The people who want the Vivitrol are the ones who want to get healthy and get better.”
About two dozen people in Coshocton were getting Vivitrol through the court, including some who’d been released early from jail or prison on the condition that they take the medication. Every two weeks, a nurse practitioner administered shots at the local drug treatment provider. And every month, the Alkermes rep for eastern Ohio — whose LinkedIn profile notes that she was ranked No. 2 in the country for “consistently high levels of sales performance” at Alkermes — would swing by with free accessories, plus pizza for the treatment center staff. “She holds our hands,” said David Dosser, a counselor at the center.
Batchelor had the bailiff bring in that day’s five drug court participants, two of whom were on Vivitrol (the others had non-opiate substance issues). Batchelor stayed seated at the counsel’s table, rather than going up to his high bench, as he called up one participant at a time. He chided a man for not having done his reading in The Big Book, the Alcoholics Anonymous tract, and scolded a woman for not having gone to any 12-step meetings. He praised the two who had completed their regimen — one had delivered his final urine sample just moments earlier in the courthouse bathroom — and even gave them hugs that were made slightly stilted by the presence of the pistol.
What happens to addicts after they leave drug court — after they stop getting the shots that block the opiate effect — is key to the question of whether Vivitrol is as effective as its proponents say.
As of this this spring, 60 people had graduated from Moses’ Vivitrol Court — that is, completed a year’s worth of shots and the frequent counseling sessions that the court required and paid for with the help of nearly $100,000 in annual grants from the state. The judge and his colleagues told me that only three of his graduates had caught new drug-related charges. That’s a very impressive rate, suggesting that they fare well even after the coercion of the program is lifted.
But the numbers could be misleading, because they don’t take into account the many other people who did not make it through the yearlong regimen. More than 185 people were initially assessed for the program, and of those several dozen were not accepted. More than 50 others dropped out after starting, mostly for absconding or failing drug tests. (Vivitrol blocks highs from opiates, but not from other drugs, like methamphetamine and cocaine.)
Supporters of the drug cite a study published in The New England Journal of Medicine last year that showed, similar to the Russian study the company used to get FDA approval, that addicts fared better on Vivitrol than on treatment without medication — hardly surprising, given the drug’s blocking effect. But critics point out the study also showed that, a year after they stopped the shots, the rate of relapse for those on Vivitrol was the same as for those on the placebo.
More disconcerting were the results of an in-house study by Alkermes, which it has not yet published. I viewed a PowerPoint presentation from the company, based on that study, which indicated that nearly 30 percent of the people being tracked dropped out before the second shot, another third dropped out by the third month, and fewer than 20 percent made it a full year. In another study just published in The American Journal of Psychiatry, only half of those participating came back for their second shot.
Skeptics of Vivitrol note that people who get a few shots or more and then relapse are at particularly high risk of overdose, given that their tolerance has plummeted while on the shot. In December, a 30-year-old in Germantown, Ohio, died after eight months on Vivitrol when he relapsed after being unable to get his next shot. One person in the state-funded trial died of an overdose shortly after having to go off Vivitrol to be able to take painkillers for surgery. And Dosser, the treatment worker in Coshocton County, told me that the Alkermes rep had notified him of a recent fatal overdose that occurred in her region when a woman tried to override the Vivitrol block with a large dose of opiates. The company declined to respond to a question on that incident.
Moses and his colleagues told me earlier this year they were aware of only one person who suffered an opiate overdose, a nonfatal one, after months in their program; they knew of another person who left the program and suffered a fatal overdose that they said was non-opiate-related. But because those who dropped out weren’t tracked, those who vanished after a shot or two wouldn’t come back into contact with the system again unless picked up on their outstanding warrant. If someone suffered an OD in that period, it wouldn’t necessarily show up on the drug court’s record — even if it was the drug court that had urged a course of treatment that turned out not to be the right one.
It makes for a striking lack of transparency. Drug courts are clearly an improvement on the old approach of just throwing addicts in jail. But they exist in a legal gray zone — hailed for successes, unaccountable for failures.
With this in mind, I spoke with one of Moses’ graduates — a former high school football star who’d gotten himself jammed up. His troubles began years earlier when he broke his ankle early in senior year and saw potential college scholarships melt away. He joined the Army instead and served in Paktita Province in Afghanistan. His company lost 12 men. In late 2012, this young man returned to southeast Ohio, where the opiate epidemic was raging. He was contending with night terrors and flashbacks. Escape was close by. “I kind of fell into an alcohol and pill routine to kind of deal with my own issues,” he told me.
Eventually he was arrested for attempting to pawn his grandfather’s heirloom rifle to pay for illicit painkillers. He faced three years in prison. But instead of pressing charges, the police asked Moses if he’d be willing to take the young man into Vivitrol Court. When he was offered the shot, “I was at rock bottom and knew that if I didn’t take it I was probably going to end up in prison or end up dead,” he told me.
He had already detoxed during his brief stay in jail, so that wasn’t an issue for him. For him, the shot helped eliminate cravings, simply by knowing that he couldn’t get high even if he tried. He attended the weekly check-ins in court with Moses and the required counseling sessions. He learned to avoid triggers, notably the friends who were still using pills. He learned to reckon with the hurt he’d caused others with his addiction, especially the mother of his young daughter.
And he had no regrets about relying on Vivitrol rather than buprenorphine, which he was hearing Moses denigrate on a regular basis. “The judge always said, ‘Suboxone is not a treatment.’ It really isn’t. It’s a temporary fix — it’s part of the problem, honestly,” the young man told me. “I’ve never specifically tried Suboxone, but I know friends who’ve tried it and I know there’s a black market for it and if there’s a black market for it then it can’t be effective. … It’s mask. It’s a mask to addiction, is all it is.”
His graduation from Vivitrol Court in April 2016 took place at the woodsy Hocking Hills Dining Lodge. Each graduate received a T-shirt, a proclamation from a local state senator and a graduation certificate. Moses presided over the ceremony. “Everyone graduating today are volunteers — they volunteered to go through the program. Was there some controlling, some convincing? Yeah, maybe,” he said, according to a story in The Logan Daily News. “But no one was ever ordered into this program.”
At a similar graduation ceremony I attended at the lodge in late 2016, Moses also emphasized this voluntary nature. “I heard a rumor last week that people were forced into this program. Were any of you forced into this program?” There was no response from the dozens in the room, just shuffling.
I originally interviewed the Afghanistan veteran in January, and I wondered if he’d managed to stay on the path to recovery. Earlier this month, I returned to southeastern Ohio. The phone number where I’d reached him before was no longer functioning. One evening, as storm clouds were gathering above, I went to the home of his grandfather. He came out on his back deck to talk. I asked him how his grandson was doing. “Not well, right now,” he said.
Vivitrol had seemed to help him, his grandfather said, but roughly one year out of the program, he had relapsed. “He was doing really well,” he said, “but when there’s no one controlling him with authority…” His grandson had checked in to a rehab center in Chillicothe, an hour west, but it had closed only a few days after he got there. Then he flew to Houston, where a friend runs an organization that takes care of veterans in need, but he returned very soon afterward. “And that’s the last we heard anything from him,” his grandfather said.
I checked back with Moses to ask about this graduate, whom he had previously raved about to me as a sterling participant. Moses had heard about the relapse, and said that the latest word was that he was now in treatment in Cleveland.
And Moses told me some other unwelcome news: In early June, he said, the program had suffered its first known fatal opiate overdose by a recent graduate, a woman who had graduated in late April. Moses said he knew that this would happen eventually, but that it was still “hard and terrible” to hear. “We gave every level of care we could,” he said.
Even addiction specialists long engaged in the Vivitrol vs. Suboxone debate were startled when I described what was happening in the drug courts of Ohio. One expert after another told me that they welcomed Vivitrol as another option, but were troubled by the prospect of judges with no medical training requiring or strongly favoring one treatment over another, because what works for one person may not be best for another.
Daniel Wolfe, an opiate addiction expert with the Open Society Institute, said that Vivitrol should be part of the continuum of options. But he added, “You don’t want prescriptions for treatment, especially from the criminal justice system, to run ahead of the evidence. When people make all kinds of claims for why Vivitrol is better and tell people they have to get off methadone or buprenorphine and have to go on Vivitrol, these are ideological decisions, not medical decisions. Anyone who says there is one answer to addiction treatment and one medicine is probably not motivated by the evidence.”
Wolfe said he understood the appeal of the medication for drug courts. “Judges feel like Vivitrol splits the difference — it allows them to be dispensing a medical solution as well as a punishment while still adhering to the drug-free message that has dominated so much of the addiction world.” But, he said, “The idea of a ‘Vivitrol Court’ raises the question of the court stepping into the medical zone in ways that are not medically or ethically appropriate.”
Others pointed to how relatively thin the research base remains for Vivitrol, compared with reams of studies showing the effectiveness of methadone and buprenorphine. “There are effective treatments for this condition, treatments that have gone through the gold standard for clinical trials, years of clinical experience,” said Andrew Kolodny, a Brandeis University professor who spent years as medical director at Phoenix House, a large New York treatment center. “We know that buprenorphine and methadone work. Vivitrol does not have the same evidence supporting its use.” Orman Hall, a former state addiction and mental health director in Ohio, told me, “The limited evidence we have is that methadone is the most effective, followed closely by buprenorphine followed distantly by Vivitrol.”
Even an executive of the National Association of Drug Court Professionals expressed misgivings about what I described having witnessed in the Ohio drug courts. The association’s chief operating officer, Terrence Walton, said the group is no longer actively lobbying against Suboxone, as it did in 2014. “We believe that for many participants [Vivitrol] has been a lifesaver, but that many others are unable to achieve the abstinence required to use that, and for them the only thing that would work is access to methadone and Suboxone and if that’s being denied across the board without medical guidance that’s a real concern.”
Supporters of methadone and buprenorphine say the evidence of efficacy shouldn’t be undermined by a moral or social stigma against long-term medication for a chronic condition like addiction. “There are so many other problems with lesser consequences that we’re comfortable treating for life — diabetes, high blood pressure, cholesterol,” said Kevin Fiscella, an addiction specialist at the University of Rochester. “With opioids, we’re uncomfortable with staying on it for life.”
Vivitrol advocates counter that with other chronic conditions, there is an effort to get people off medications, with changes in their diet and lifestyle. Vivitrol, they say, allows the equivalent of that effort, by getting addicts’ heads clear enough for six months or a year so they can fundamentally change their thinking and behaviors in a way that simply being maintained on buprenorphine or methadone would not. “To say you should always have someone addicted to something simply because they’re addicted is illogical to me,” said Dave Burke, the Republican state senator from western Ohio, who is a pharmacist by trade. “You’ve never really cured someone. That’s a replacement therapy — not a curative therapy.”
That argument doesn’t persuade Melinda Campopiano, the medical officer at the federal government’s Center for Substance Abuse Treatment. “If you had high blood pressure and I said, ‘Start exercising and cut salt out of your diet,’ and if you did that and it didn’t work, would I take your medicines away and say, ‘Too bad for you if you have a stroke?’” she asked. “With other people, we don’t punish people who don’t get better. If your diet didn’t work, we don’t take your medication away and say, ‘You’re a bad patient, too bad and go die.’”
Westley Clark, who served 16 years as the director of the Center for Substance Abuse Treatment, grew indignant when I offered Burke’s retort. “My mother’s 98 and has been on insulin for 20 years. What’s with this ‘We don’t want people on medication’ rhetoric?” Clark said. “What we continue to have is a political philosophy colliding with therapeutic strategies, and that political philosophy has less to do with the individual and more to do with moral views about drug abuse. In these states, the issue isn’t what’s best for the client. It’s what’s best for the political appointees and the criminal justice system.”
More research is now underway that seeks to compare Vivitrol more directly with buprenorphine and methadone. One study in the works is an evaluation of Ohio’s state-funded drug court program. It is being conducted by the Treatment Research Institute in Philadelphia — where David Gastfriend, Alkermes’ former director for scientific communications, is now the scientific adviser. Gastfriend, who is a shareholder of Alkermes and still consults for it, told me he would be playing only a supporting role in the Ohio evaluation.
Pops, the Alkermes CEO, told me that the company has from the start discounted the value of comparing Vivitrol to other medications because they are such different treatments and are, he said, intended for different sorts of addicts. That’s why, he said, the company had tested the drug in Russia, which doesn’t even allow methadone or buprenorphine. “We don’t make any comparative claims. We really don’t need to. It’s a fundamentally different approach,” he said.
The Vivitrol expansion is likely to accelerate, considering that the federal government just committed $1 billion more to fighting the opioid epidemic. The Comprehensive Addiction and Recovery Act passed last year was one of very few bipartisan accomplishments in recent years, and Alkermes invested heavily in making sure its interests were represented in the negotiations. The company spent $4.7 million on its in-house lobbying efforts in Washington last year, five times what it spent three years earlier, and also contracted with seven other lobbying firms at a cost of $1.8 million. Among the lobbyists it hired was Jessica Nickel, a former aide to Sen. Rob Portman, the Ohio Republican who was a leading proponent of the legislation. Portman is also the top recipient of the dozens of candidates for Senate and the House of Representatives, mostly Republicans, who have received a total of more than $170,000 in contributions from the Alkermes PAC in recent years, according to the Center for Responsive Politics. Alkermes’ chief lobbyist was at a Senate celebration of CARA’s passage.
Pops, who received more than $12 million in compensation as CEO in 2015, told me that the company invested so heavily in Washington not just to build the case for more resources to fight the epidemic, but also to build awareness of Vivitrol. The company still sees itself as an underdog, he said, and simply wanted to make sure its voice was heard. “We’ve been living this, fighting it hand-to-hand and the vast majority of Americans don’t know Vivitrol exists,” Pops said. He said the company was not lobbying to gain advantage against rival medications, he said. “When we advocate on behalf of better treatment, we don’t advocate for Vivitrol alone, we advocate for all medication-assisted treatment,” he said.
But a recent report by NPR and Side Effects noted that Alkermes’ lobbying in Washington also included the circulation of a document in the House that denigrated Suboxone for its potential for diversion and abuse, an echo of efforts by Alkermes’ lobbyists in Ohio to push tighter restrictions on doctors prescribing Suboxone.
For Ohio, the legislation will bring $26 million in additional funds in the first year. Alkermes wasted no time in trying to capitalize on that. In December, Holzapfel, one of the company’s lobbyists in Columbus, sent an email to the chief of the bureau of criminal justice services in the state’s addiction treatment and mental health department offering help in crafting proposals for spending the money. “I passed on to senior leadership your willingness to assist,” the bureau chief responded. Hall, the department’s former director, says Vivitrol’s momentum in Ohio is only growing stronger. “The overdose situation in our state is acute and every year is getting worse, and I think we need to take a more balanced approach with all three medications, but there is a growing bias against Suboxone and methadone,” he said.
Two additional factors could yet complicate Vivitrol’s fast rise. Full repeal of the Affordable Care Act would be a major setback, since many of those getting the shots, including in Ohio, are paying for them thanks to the law’s Medicaid expansion. Also, last May, the FDA approved an implantable form of buprenorphine that releases the medication gradually over six months. It will be expensive, about $825 per month, and some addicts may be wary of having an implant, but it would address the concerns around the diversion and misuse of Suboxone. Judges might even be willing to encourage buprenorphine’s use in their courts as they now do Vivitrol’s — if they’re able to put aside their basic ideological opposition to agonist treatment.
And as the treatment battle wears on, Alkermes has recruited an influential figure to its side. In late April, Pops gave President Trump’s health secretary, Tom Price, a tour of the Alkermes plant in Ohio. Two weeks later, on a visit to West Virginia, Price weighed in against Alkermes’ competition. “If we just simply substitute buprenorphine or methadone or some other opioid-type medication for the opioid addiction, then we haven’t moved the dial much,” he told the Charleston Gazette-Mail. This represented a sharp reversal from the Obama administration, which pushed to expand access to buprenorphine.
What was far more promising, Price said, was Vivitrol, which “actually blocks the addictive behavior as well as the seeking behavior.” “That’s exciting stuff,” he said. “So we ought to be looking at those types of things to actually get folks cured so that they can come back and become productive members of society and realize their dreams.”
One evening, I met at a diner in Lancaster, between Hocking County and Columbus, with another recent graduate of Judge Moses’ Vivitrol Court. The man, who is in his mid-20s and asked that his name not be used, had gotten hooked on painkillers in the years after graduating from high school. His tolerance built up to where he had trouble getting high off the pills, but his fear of needles kept him from the next step of injecting painkillers or heroin, so he started abusing black-market Suboxone instead. He managed to hold his jobs in carpentry and restaurant delivery, but the hard living caught up with him — he got in a fight with his brother, was charged with assault and landed in Moses’ court. The thought of the Vivitrol shot scared him at first, but with the charge hanging over his head, he agreed to it. Withdrawal was very tough, and for the first several weeks, he was fighting the temptation to use, but over time things got better. He attributes this not just to the shot, but to the program’s structure — frequent counseling, the visits to Moses’ court, the frequent urine checks. “Just being in it helped at first, having to go every week,” he said. “Being accountable, being held accountable.”
He graduated last year, was now back working for a home-renovation contractor and, he said, he had not relapsed since he stopped getting Vivitrol. “I like to drink, that’s it,” he said. He had money to spend, now that he wasn’t blowing it on pills. “Back then I was never able to go out and buy myself a candy bar because I never had the money,” he said.
After he got up to leave, our waitress came over and asked, tactfully, what we had been discussing. Wanting to maintain discretion, I mumbled something about a medication. “What medication?” she asked. “Something called Vivitrol,” I said, assuming that obscure mention would curtail her curiosity.
Her face lit up. She knew all about Vivitrol, she said. Her name was Chelsea Vancuren, she was 30, and she, too, was a recovering opiate addict. Her sister was also an addict, and her niece and nephew were born with an opiate dependency. Her own husband had introduced her to drugs back when they were dating more than a decade ago, when she was in nursing school. They eventually got hooked on heroin. He died of an overdose three years ago.
This prompted her to seek treatment, after eight years of drug use. She had first tried Vivitrol, but had a very bad reaction to it, as happened with some people — terrible hallucinations, mainly. So she went on Suboxone instead. She was still on it, was doing well with it and was hoping to taper off of it over the next year or so. “I use it the way you’re supposed to,” she said. “We all have days when we want to get high, but I have a support system.”
Having been through the criminal justice system — she served three stints in jail — she was well aware of the bias against Suboxone. This was unfortunate, she said, since, as her own situation showed, Vivitrol wasn’t the right thing for everyone. Nothing was. “They should look at each case individually, but it’s black and white,” she said. “It’s Vivitrol or jail. That’s the hard part.”
The exchange left me slightly shaken — the fact that the epidemic had advanced so far that I should encounter two addicts in a single location, and end up discussing treatment approaches as casually as the weather. Soon afterward, The Columbus Dispatch reported that the number of fatal drug overdoses in Ohio had surpassed 4,100 in 2016, the vast majority of them from opioids and an increase of more than a third over the year prior. The Montgomery County coroner’s office in Dayton earlier this year became so crammed with corpses that it asked a funeral parlor to take in four bodies and looked into using refrigerated trailers for others. In May, the state’s lieutenant governor disclosed that both her sons had struggled with opiate addiction. And in the span of a single week earlier this month, three infants in the state suffered opiate overdoses, one fatal.
But it’s precisely this reality that gives Alkermes such corporate confidence. At the JPMorgan Healthcare Conference in San Francisco in January, Pops declared that when it came to Vivitrol, the sky was the limit, considering that the drug still held only a fraction of the market for medication-assisted treatment and that there was no sign of the biggest driver of demand abating anytime soon.
“There’s more and more opioid deaths,” he told his audience. “The country is ablaze with opioid deaths and it’s defying socioeconomic or geographic categorization. It’s just happening all over the place. So, that’s why we think at 2 percent market share, there’s only one way to go.”
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