Credit: Chris Reisenbichler

A multinational drug company has quietly carved out a lucrative, publicly subsidized market for an expensive—and risky—medicine that the company promises can help rescue Illinois from its opioid crisis.

Alkermes, a $6.7 billion biotech company founded in Massachusetts but now headquartered in Ireland, has been hawking its drug, Vivitrol, as an answer to the prayers of those fighting the epidemic for nearly a decade. An army of sales reps and lobbyists has convinced federal, state, and local officials across the country to buy Vivitrol to treat addicts nearly everywhere, from public health clinics to prisons.

As the opioid crisis worsens in Illinois, Alkermes has arrived, promising a clean break from opioids for the legion of addicts the state is struggling to treat. Ads for the drug, which have come under fire elsewhere, can be seen all over the city.

As part of a two-year, $32.6 million grant from the Trump administration awarded last year, Illinois officials are testing or planning to test Vivitrol on inmates in 13 counties across the state, including in McHenry, DuPage, Lake, Kane, Will, and Cook County Jails, state records show.

Vivitrol is also being dispensed by other public health officials and in private treatment clinics all across Illinois. Alkermes’s website lists at least 60 different Vivitrol providers in Chicago and the suburbs. Last year, Vivitrol was written into Governor Bruce Rauner’s “Opioid Action Plan” along with two more established drug treatments. State officials have also been testing it on prisoners in the Sheridan Correctional Center in LaSalle County since October and have indicated they hope to expand its use throughout Illinois’s prisons, public records and interviews with therapists and state officials reveal.

“The early results are promising,” Illinois Department of Corrections spokeswoman Lindsey Hess said. Hess said 19 men are enrolled in the program, which is voluntary.

While the pilot just started in Illinois, the company has locked in exclusive public contracts and grants that make Vivitrol the favored medicine in other states. In 2011, state Medicaid agencies around the country spent $13 million on Vivitrol; by 2016, that figure had risen to more than $156 million, an analysis by the Urban Institute found. Alkermes has told investors it expects Vivitrol sales will reach $1 billion by 2021. That’s not bad growth, considering Alkermes only began marketing the drug for opioid therapy in 2010.

But how well Vivitrol works—and whether it’s as safe and effective as Alkermes claims—is an open question.

“Their marketing has gotten beyond the evidence,” says Kevin Fiscella, a professor of family medicine and public health at the University of Rochester who specializes in addiction treatment and research. “We don’t know, exactly, what the long-term risks are.”

Vivitrol is one of only three drugs to have won federal approval for the treatment of opioid addiction.

On the surface, there are a lot of reasons to recommend it. Its two competitors, methadone and buprenorphine-naloxone (commonly known by its brand name, Suboxone), are both opioid based and addictive themselves, which makes Vivitrol attractive to legislators and policy makers who worry that those treatments replace one addiction with another. What’s more, there can be a black market for those drugs in prison and on the street, law enforcement officials say. (From 2010 to 2012, Illinois officials studied the effects of Suboxone on parolees from Sheridan and downstate Southwest Illinois Correctional Centers, , IDOC spokeswoman Hess said. Results of the pilot were not released.)

Another advantage is that Vivitrol is delivered in a once-a-month injection, which means it’s easier for patients and caregivers to manage. Methadone and Suboxone, by contrast, require daily doses—often at state-licensed clinics where they have to be carefully monitored.

No one disputes that Vivitrol can help. A study by the Canadian Agency for Drugs and Technology in Health that was published in February found that at least half of the patients who used Vivitrol remained drug free a year after starting treatment.

There are drawbacks to Vivitrol, though. For one, it’s not cheap—$1,000 or more per injection, which is much more expensive than either of the other two drugs. A 2013 study by Illinois Medicaid officials found that Vivitrol was nearly twice as expensive as Suboxone and nearly three times pricier than methadone. Nonetheless, Medicaid pays for prescriptions of Vivitrol and Suboxone, but not methadone, public records show.

There is also far more research on the safety and efficacy of the alternative drugs since they’ve been in use for much longer.

“Right now, we have evidence for two other drugs. We don’t have that for Vivitrol,” Fiscella says.

Credit: AP

What research there is on Vivitrol has not yet established whether it’s worth its risks or costs as compared to the other drugs, experts say. In a 2017 study published in the British medical journal the Lancet, researchers compared six-month recovery rates for addicts taking Vivitrol with those taking Suboxone and found them to be very similar.

Vivitrol, meanwhile, can be dangerous. Addicts have to be clean for at least seven days before their first injection. If they’re not, Vivitrol can cause them to go into immediate, precipitous withdrawal, a study published last month in the American Journal of Medicine found. A 2015 Australian study found that patients taking an oral version of generic Vivitrol were three and a half times more likely to die than patients taking methadone. There’s also risk of accidental overdose, especially within the first month of usage. (The FDA has put a “black box” label on Vivitrol—its strongest possible warning —telling users that, because Vivitrol lowers the body’s tolerance of opioids, those who relapse face a higher risk of overdose, especially in the first month of drug treatment.)

And some experts like Fiscella are also worried about the long-term risk of overdose if someone gets clean and then starts using again.

It’s easy to see the appeal of anything that might offer relief from the opioid crisis. Illinois isn’t the worst of the 50 states for opioid abuse, but it’s heading in the wrong direction.

Between 2013 and 2016, deaths from heroin overdose nearly doubled, and deaths from prescription-opioid overdoses nearly quadrupled, state public health data show. The rate of drug overdoses in Illinois grew by more than 34 percent between 2015 and 2016, the ninth-highest increase in the country, according to federal data. Trips to Illinois emergency rooms jumped by nearly 66 percent between 2016 and 2017, also among the highest increases in the country, federal data show.

Chicago is home to much of the devastation. In 2015, 426 people died from opioid-related overdoses in Chicago. By 2016, the number had risen to 741, according to the city’s Department of Public Health. Roosevelt University found that 35 percent of the city’s hospitalizations for opioids in 2013 took place along the “heroin highway” on the west side; another 20 percent were on the south side. From 2013 to 2015, opioid-related deaths jumped by 16 percent in Chicago’s suburbs, Cook County Public Health data show.

Rural Illinois is also faring poorly. In Whiteside County, about 120 miles west of Chicago, the situation got so bad a few years ago that Natalie Andrews reached out to Alkermes for help.

A licensed clinical social worker and the director of the Sinnissippi Centers, one of the few mental health clinics in that part of northwestern Illinois, Andrews and her colleagues found themselves at the forefront of the growing crisis. Visits to the Emergency Room related to opioid or heroin overdoses leapt by 90 percent in Whiteside County between 2010 and 2015, Illinois Department of Public Health records show. She was ready to listen to anyone with ideas. Drug reps from Alkermes were happy to oblige, Andrews recalls.
 “All of the sudden they came out and they were going everywhere, it seems like,” Andrews said in an interview. “You know, they went to the jail, they went to every treatment provider and that.”

Alkermes’s sales rep, Julie Naples, is a “very professional, friendly marketing person. I mean, she bends over backward to come over,” Andrews says.

When Andrews worried about the cost, Naples offered to help her write grant requests to Alkermes’s nonprofit foundation, Andrews says. Free samples from the company are often available.

Naples couldn’t be reached for comment.

Last year, Alkermes spent more than $34 million on advertising nationwide, according to its latest SEC filing. That includes large ad buys with the CTA and Metra for campaigns running through late June, spokespeople from both transit agencies confirm. There are ads on digital screens in 75 locations throughout the Metra and CTA systems as well as on el cars and buses, and at Union Station and Ogilvie, the agencies said.

The company has hired at least 100 sales reps to push Vivitrol across the country, company documents show.

In states around the country, Alkermes has followed a similar pattern to the one that Andrews observed here in Illinois: sales reps fan out through stricken areas, targeting drug-court judges, treatment-center therapists, doctors, cops, legislators—anyone looking for a way out of the opioid nightmare.

But that has led to concerns that Alkermes—rather than taking a cautious approach after opioid manufacturers pushed pain pills and drove the country into the current crisis—has instead copied their sales model: hiring and rewarding reps who move its product in high volumes, using “speakers’ bureaus” that pay doctors fees to hype the drug, and even employing reps who got their start with opioid manufacturers.

The concern over Alkermes’s hyperaggressive sales pitch has won the company some unwelcome attention. In November, California senator Kamala Harris, a Democrat, sent a letter to the company demanding an explanation of its sales practices. A shareholders’ class-action lawsuit is currently pending in New York, alleging that Alkermes “systemically engaged in deceptive marketing campaigns to influence policymakers to use Vivitrol in addiction treatment programs over more scientifically proven and efficacious alternatives.” (Alkermes’s stock price plunged after Harris’s letter went public. In legal documents, the company has argued the complaint should be dismissed.)

In addition, in its 2017 filing with the Securities and Exchange Commission, Alkermes acknowledged that it had “received a subpoena from an Office of the U.S. Attorney for documents related to VIVITROL. The Company is cooperating with the government.” The company did not release any more details of the investigation or where it originated.

Credit: Chris Reisenbichler

Part of the concern about Alkermes’s marketing techniques stems from its tactics. In 2014, Vice News reported that Alkermes was one of several drug companies bankrolling doctors to bad-mouth medical marijuana. In 2016, Alkermes’s Arizona lobbying firm poured money into the fight against a referendum that would have decriminalized pot. (Studies, including research published in March in the Journal of Health Economics, have consistently found that states with more liberal marijuana laws have lower rates of opioid overdoses; the Arizona ballot measure narrowly failed.)

Through a spokesman, Alkermes declined to comment for this story. But in previous statements and SEC filings, the company has said it uses “customary pharmaceutical company practices to market our product and to educate physicians.”

In a statement issued last year, the company said it was “disappointed with some of the recent media coverage about our company and Vivitrol. . . . The opioid epidemic is the public health crisis of our time. . . . Alkermes is committed to helping address this serious disease with Vivitrol.”

It said it had demonstrated the safety and efficacy of the drug and noted that more than “180 scientific articles have been published about Vivitrol. And since its approval, tens of thousands of patients have been treated with Vivitrol.”

Richard Pops, Alkermes’s chief executive, testifying in September at the President’s Commission on Combating Drug Addiction, said that Vivitrol offers “a treatment option that has no risk of abuse and that is not diverted, traded or sold illicitly on the street.”

In addition to its robust sales operation, the company has been a lobbying force. Alkermes reps have targeted a range of politicians at all levels, the New York Times has reported. That includes a $4,600 donation to the congressional campaign of a Massachusetts sheriff who criticized Suboxone, but also efforts to win over then-U.S.Health and Human Services secretary Tom Price, who toured the company’s Ohio plant last year and who touted the drug and criticized other treatments (although he later said all three opioid-abuse treatments are useful).

Going after Price represents a relatively new strategy for the company, which spent most of its earliest lobbying efforts building its clout at the state level. After a decade and a half keeping a relatively low Washington profile, the company has spent about $4 million per year in each of the last three years to lobby federal officials, according to an analysis by the Center for Responsive Politics, a campaign finance reform group based in Washington, D.C.

The lobbying seems to have been effective. In Ohio, for instance, one of the states hardest hit by opioids, officials bought 100 doses of Vivitrol in 2012; by the end of 2016, the state had paid for more than 30,000 doses—at a cost of more than $38 million. In Arizona, Republican governor Doug Ducey praised Vivitrol in back-to-back state-of-the-state addresses. And earlier this year, President Donald Trump  made it the exclusive antiopioid drug of the federal prison system.

The efforts have helped the drug—which has been on the market since 2006 but only won FDA approval for opioid treatment in 2010—become a blockbuster. Between 2015 and 2017, sales of Vivitrol rose 86 percent, company records show, to $269 million in 2017, the company says in its SEC filings.

Here in Illinois, the company has employed the Nolan Group to do its lobbying, state records show. Based in Hinsdale, Nolan has given thousands of dollars in campaign contributions to Illinois politicians, although the group has a variety of other clients, including the Home Care Association of America. Nolan Group principal Thomas M. Nolan didn’t respond to requests seeking comment.

While Illinois-specific sales figures weren’t available, Alkermes reps have certainly been busy in the state beyond Whiteside County.

Last year, for instance, when the Illinois Association of Problem-Solving Courts held its annual meeting in downstate Bloomington, the group’s networking reception was sponsored by Alkermes (and hosted by its sales rep, Julie Naples), records show. Both the city of Chicago and Sangamon County have been awarded $3 million in state funds over the next three years to administer Vivitrol (as well as methadone) to ex-Sheridan inmates, records show. When Rauner convened an opioid advisory council, Alkermes’s top lobbyist for the midwest, Adam Rondeau, took a seat at the table, public records show.

Rondeau’s career illustrates the way in which drug companies’ sales models can work on both sides of the opioid crisis. Trained as a nurse, Rondeau spent most of his career selling drugs, including five years with pharmaceutical giant Cephalon, his LinkedIn profile states. From February 2003 until January 2006, Rondeau’s bio states, he was “responsible for sale of products in therapeutic areas including: Neurology, Psychiatry, Neurology/Pulmonary (Sleep Disorders), and Pain.”

In 2008, Cephalon agreed to pay the federal government $425 million to settle claims that, from 2003 until 2005, it illegally marketed three drugs—Gabitril, for the treatment of epilepsy, Provigil, for the treatment of daytime sleepiness related to narcolepsy, and Actiq, a particularly potent opioid designed for late-stage cancer patients. Federal authorities alleged that Cephalon sales reps had illegally oversold general practitioners on the benefits of the drugs and failed to warn them of the drugs’s risks. Their efforts were so fruitful that people with ordinary back pain, for example, began getting prescriptions for Actiq, federal prosecutors said.

In a brief phone interview from his home in Michigan, Rondeau denied that he had ever sold Actiq for Cephalon but said he had sold Provigil. He also defended Alkermes’s sales and lobbying approach.

“The reality is you’re dealing with a public health crisis,” he said. “There’s not a lot to choose from. You try to make the choice that fits best for the patient. It’s a huge issue that we’re dealing with, and you have limited options.”

Other Cephalon alumni who have worked at Alkermes include Daniel Still, a regional medical science director at Alkermes; Katie Driscoll Alberta, Alkermes’s global head of quality; Kerri (Knauer) Daman, a territory sales manager; and Greg Keck, a vice president of Alkermes’s addiction division (whose LinkedIn profile identifies him as a “President’s Club winner representing Provigil, Actiq and Gabitril” from 2003 until 2005).

Although its use has skyrocketed recently, Vivitrol is not new. It’s the brand name of a drug called naltrexone, which has been on the market since the 1980s, the University of Rochester’s Fiscella says. Naltrexone was initially sold as a daily tablet and marketed as a treatment for heroin addiction and then, later, for alcoholism. It didn’t show much promise—in fact, it seemed to show a lot of risk—and fell out of favor 1990s, Fiscella says. (Early studies showed that the tablet naltrexone increased the risk of heroin overdose deaths in the first 30 days of treatment.)

Alkermes discovered a way to deliver naltrexone as a once-a-month injectable and beginning in 2006 sold it as a treatment for alcoholism. But as the opioid crisis intensified, the company shifted its focus.

Vivitrol works by blocking the brain’s opioid receptors, including ones that the body produces naturally. Which is why sustained use of Vivitrol lowers patients’ tolerance for opioids and puts users at higher risk for overdose if they relapse, Fiscella says.

It’s also not clear that Vivitrol offers its patients any “pharmacological incentives” to keep taking the stuff, Fiscella says. For example, if you stop taking Suboxone or methadone, you can go into withdrawal, which is extremely painful. The risk ensures you keep showing up for treatment, Fiscella says.

“They’re less likely to use and [therefore] less likely to overdose while they’re being treated” with Vivitrol, Fiscella acknowledges. “But that’s not the issue. The issue is, are they going to continue to show up [for treatment]?”

This question is more—not less—critical when you’re talking about prisoners like those in Sheridan, Fiscella says. Vivitrol may help them stay clean while in prison, but what happens when they’re released?

Cook County JailCredit: Santiago Covarrubias/Sun-Times

Hess, the Department of Corrections spokeswoman, says that inmates released from Sheridan will be “monitored by a licensed Division of Alcoholism and Substance Abuse provider” and will be offered case management.

Fiscella says the drug seems best suited for addicts who are committed—or even well into—a long-term recovery.

“I think it has roles,” Fiscella says. “The problem is, it has some very small niche roles. But that’s not what the company wants to hear.”

Cook County Jail is prescribing some inmates methadone, Suboxone, or Vivitrol to treat opioid addictions, and staff is helping inmates make arrangements for treatment once they are freed.

“More than 250 individuals have benefited from our Medication Assisted Treatment programs at the jail since we started in 2017,” Cook County Health and Hospital System spokeswoman Caitlin Polochak said in an e-mail. “The regimen varies from patient to patient. More than 50 individuals have been treated with Vivitrol to date. CCHHS staff also work to link these individuals to community-based outpatient services upon discharge.”

For those on the front lines like Andrews, the questions about Alkermes’s aggressive marketing and lobbying are less significant than its effectiveness—and certainly not enough to make them refuse Vivitrol altogether. People are dying and families are being destroyed, leaving little room to say no to any kind of help, she says.

“You have to get what works with that person, not just dosage, but with lifestyle and everything,” Andrews says. “It takes some time to find out what works best for which person.

“We used it at Sinnissippi,” Andrews says of Vivitrol. “And it helps people.”

Which is why Illinois might not be in a position to slow things down.

“The opioid epidemic is the most significant public health and public safety crisis facing Illinois,” the state’s Opioid Action Plan, released last September, stated. “It is also a human crisis—even a single death is one death too many, and we must take action to turn the tide.”

The main goal of the plan is to cut overdose deaths from more than 2,700—the projection for 2020 if trends continue—to 1,800, just under the actual number who died in 2016.   v