The ads have been popping up on billboards, buses, subways and in glossy magazines, with portraits of attractive men and women and a simple question in bold letters: What is Vivitrol?
Five years ago, Vivitrol was a treatment for opioid addiction that was struggling to find a market. Now, its sales and profile are rising fast, thanks to its manufacturers’ shrewd use of political connections, and despite scant science to prove the drug’s efficacy.
Last month, the health and human services secretary, Tom Price, praised it as the future of opioid addiction treatment after visiting the company’s plant in Ohio, setting off a furor among substance abuse specialists by criticizing its less expensive and more widely used and rigorously studied competitors, buprenorphine and methadone, as medications that “simply substitute” for illicit drugs.
It was the kind of plug that Vivitrol’s maker, Alkermes, has spent years coaxing, with a deft lobbying strategy that has targeted lawmakers and law enforcement officials. The company has spent millions of dollars on contributions to officials struggling to stem the epidemic of opioid abuse. It has also provided thousands of free doses to encourage the use of Vivitrol in jails and prisons, which have by default become major detox centers.
With the Trump administration sending $1 billion in new addiction prevention and treatment funds to states over the next two years through the 21st Century Cures Act, Alkermes’s marketing has shifted into even higher gear.
The company’s strategy highlights the profit opportunities that drug companies and investors see in an opioid epidemic that killed 91 Americans every day in 2015 and is growing worse. But some of its marketing tactics, and Mr. Price’s comments, ignore widely accepted science, as nearly 700 experts in the field wrote the health secretary in a letter.
Not a single study has been completed comparing Vivitrol to its less expensive competitors. Some studies have shown high dropout rates, or found that many participants return to opioid use while taking Vivitrol or after going off it. In one study that the company used to secure the Food and Drug Administration’s approval of Vivitrol for opioid addiction treatment, conducted with 250 patients in Russia, nearly half of those who got Vivitrol failed to stay abstinent over a six-month period, although they stayed abstinent and in treatment longer than those who got a placebo.
Alkermes executives say they welcome any addiction treatment. But in pitches to investors, doctors, law enforcement officials and legislators, they have presented Vivitrol as something of a miracle drug, a cleaner alternative to Suboxone, the most common formulation of buprenorphine. They described Suboxone as an addictive “black market” or “street” drug, emphasizing that it gets smuggled into prisons.
That view has resonated with drug court judges and sheriffs. But some addiction and public health specialists complain that the company unfairly denigrates its competition, without any data to suggest Vivitrol has better outcomes.
“If you care about actually solving the problem, you cannot stigmatize the most effective treatments,” said Dr. Joshua Sharfstein, a former Maryland health secretary who is now an associate dean at the Johns Hopkins Bloomberg School of Public Health. “This is a company that has put its own perverted idea of market success ahead of actually solving the problem.”
As health secretary, he said, he had to call a meeting to tell Alkermes to “back off talking down methadone and buprenorphine” to legislators as the company aggressively lobbied to get Maryland to use Vivitrol.
“They’re exploiting a stigma that exists out of a very narrow view of their own economic self-interest,” he said. “And the result is going to be more people dying if they cannot get access to effective treatment.”
In an interview, the chief executive of Alkermes, Richard Pops, noted a dearth of data on the long-term success of any medication for opioid addiction. “In this entire field, there’s just not a lot of research that’s been done looking at long-term outcomes,” Mr. Pops said. But he argued that the rush of states adopting Vivitrol programs indicates that those on the front lines of the opioid epidemic believe that the drug works. “The outcomes data that local ecosystems trust the most is their own,” he said.
Vivitrol, taken as a monthly shot, is an opioid antagonist, which means it blocks the brain’s opioid receptors so users cannot feel any high from heroin, pain pills or the synthetic fentanyl that has caused sharp increases in overdose deaths in some states.
Buprenorphine and methadone, on the other hand, are classified as “opioid agonists.” They bind to the brain’s opioid receptors just enough, with proper dosing, so that people taking them do not feel cravings or symptoms of withdrawal. There is a substantial body of research on both buprenorphine, a semisynthetic opioid, and methadone, a synthetic opioid, with studies generally finding that they reduce the risk of relapse and fatal overdose, especially when combined with counseling.
The Food and Drug Administration approved Vivitrol in 2006 for alcoholism and expanded its approved use to opioid addiction treatment in 2010, based on the Russian study.
Sales of the drug initially were so tepid that market analysts urged the company to drop it. Instead, Alkermes adopted what Mr. Pops described to potential investors last fall as a “new commercial model for pharma.”
Rather than appeal to doctors’ offices or medical associations, the company has primarily pitched Vivitrol to law enforcement officials and lawmakers, who have relied heavily on government grants and the Affordable Care Act’s expansion of Medicaid to pay for the drug. Medicaid pays about $500 per shot, while private insurers pay $1,000, according to Alkermes. Suboxone, produced by Indivior, tends to cost a third to half as much, and methadone much less.
Alkermes assigns sales representatives to judges who oversee drug courts, where addicts arrested on minor drug charges go through supervised treatment programs. It also provides free shots to inmates preparing to leave jails and prisons, where Medicaid usually does not pay for medical care. Once the inmates are released, Medicaid often picks up the cost for them to continue shots of Vivitrol in re-entry or treatment programs.
Alkermes also relies on a “speakers’ bureau” of doctors who are paid to promote Vivitrol to other doctors and nurses across the country, and sends “outreach kits” with information about the drug to leaders of local grass-roots organizations.
The company and its political action committee have spent heavily to get its product before policy makers: $19 million in federal lobbying since the drug was approved in 2010, according to the Center for Responsive Politics. It made $222,521 in political contributions to Congress last year and has purchased high-level sponsorships of associations of drug court professionals and addiction treatment professionals, as well as organizations researching addiction treatment.
Suboxone still has a far bigger share of the market, despite its critics in the criminal justice system. It has come under more scrutiny lately, from 42 state attorneys general who have sued its maker on charges that it blocked generic alternatives. And Alkermes’s strategy of appealing to law enforcement has paid off: Sales of Vivitrol reached $58.5 million in the first quarter of 2017, up 33 percent from the same period last year, with about half of that from Medicaid. In 2012, there were 15 programs using Vivitrol in nine states. By this April, there were 450 programs in 39 states.
In Massachusetts, where Vivitrol first took off, the company hired a lobbying firm led by Thomas P. O’Neill III, a former lieutenant governor. Company executives began attending fund-raisers and making contributions to lawmakers and political committees of both parties.
In 2012, one Republican, State Representative Randy Hunt, suggested a pilot program to the sheriff at the Barnstable County jail on Cape Cod, which has since become a showcase for Vivitrol. Other county jails then began offering the drug to inmates, and sheriffs from across the state have spoken on its behalf, including at a White House forum last year.
The drug courts often place offenders in treatment facilities or sober housing that allow only Vivitrol. “That’s where we’re handcuffed to Vivitrol,” said Judge David Matia, who leads the drug court in Cuyahoga County, Ohio.
Dr. Joshua Lee, the lead author of a 2016 study of Vivitrol, said he questioned whether the drug had given criminal justice authorities “too easy of an out” not to make buprenorphine or methadone more widely available in their settings.
The company lobbied hard to get more federal funding for Vivitrol through the bipartisan 21st Century Cures Act, which was passed last year. It directs states to prioritize medication-assisted treatment for opioid addiction.
Another federal law known as the Comprehensive Addiction and Recovery Act, also passed last year, is what Alkermes describes as “a game changer,” because it requires treatment providers to offer or provide referrals for all F.D.A.-approved medications. The law’s co-sponsors, Senators Rob Portman of Ohio and Sheldon Whitehouse of Rhode Island, were the company’s top two recipients of campaign contributions in the 2016 election cycle; Mr. Portman received $29,200.
“We hope to create a gentle federal breeze to kind of sweep behind us — behind our sales really, and help ignite what is going on individually,” the company’s chief commercial officer, Mark Stejbach, said at an investor presentation in September.
Mr. Price walked back his comments after they came under fire. In response to queries from news organizations, his spokeswoman, Alleigh Marré, said in a statement that he believed that “we should be open and supportive to the broadest range of options,” including all three medications. But the view he expressed is not uncommon.
Dr. Vivek H. Murthy, who was the surgeon general until Mr. Trump forced him out last month, said he had been disturbed, while traveling the country to discuss the opioid epidemic, to learn how many people had “profound misconceptions” about treatment, particularly about methadone and Suboxone.
“I’m talking about doctors, nurses, policy makers, lawyers and judges,” he said. “People would sometimes express the belief that buprenorphine and methadone are not good treatments because they are agonist medicines. But the people who voiced those views were often unaware of the depth of science we have behind these drugs.”
Alkermes, though, argues that opioid treatment has been “biased” in favor of Suboxone. It has unabashedly promoted the view Mr. Price did, that other treatments are just replacing one addiction for another. Mr. Pops, the chief executive, said in the interview that people who choose methadone or Suboxone over Vivitrol “aren’t strident about wanting to be drug-free.”
“People who want to be drug-free, those are the ones who should go on Vivitrol,” he said.
In then investor presentation in September, Sheriff Peter Koutoujian of Middlesex County in Massachusetts, who received $4,600 from Alkermes in an unsuccessful campaign for Congress, described the problems with Suboxone, which comes in thin strips that dissolve on the tongue. “This is a smuggled drug, a smuggled piece of contraband that has a black market value inside and uses for which it is not intended,” Mr. Koutoujian said.
But for all the company’s assertions that Vivitrol is superior to Suboxone or methadone, it offers no data. Dr. Nora Volkow, director of the National Institute on Drug Abuse, said she and other experts were eagerly awaiting results from the first study comparing outcomes of treatment with Vivitrol and Suboxone, expected this fall.
The clinical trial on Vivitrol that was conducted in Russia found that 36 percent of those who got the medication stayed off opioids for the full six months, compared with 23 percent of those who got a placebo. Those on Vivitrol also reported fewer cravings.
But a group of experts responding to the Russia study said it did not adequately assess the risk of overdosing after going off Vivitrol, given that earlier studies in Australia had found overdose risk to be particularly high in people going off the pill form of the medication. The experts also questioned why Alkermes chose to conduct the study in Russia, where regulations on clinical trials are looser, and why it had compared Vivitrol with a placebo instead of with buprenorphine or methadone.
“Due to their established efficacy, methadone and buprenorphine are on the World Health Organization’s list of essential medications,” said Dr. David Fiellin, an addiction specialist at Yale. “Naltrexone and Vivitrol are not.”
He added that he wanted more information about what happens to addicts after they stop taking Vivitrol. Dr. Mark Publicker, a longtime addiction specialist in Portland, Me. echoed that concern, questioning how many people are staying on Vivitrol for more than a few months.
“People advocating for it on a public policy level are essentially denying the chronic nature of this disease,” he said. “They’re operating under the premise that you can give this medicine for a few months, and that will be adequate to cure this disease. That’s untrue.”
A complicating factor with Vivitrol is that addicts have to go through a complete detoxification before getting their first shot; if opioids are not cleared from their body, they will experience a harsh and potentially dangerous withdrawal. This is why addicts doing time in jail or prison, who have no choice but to go through withdrawal once they are behind bars, are good candidates.
Raymond Tamasi, the president and founder of Gosnold on Cape Cod, a treatment center, said most of the center’s clients with opioid addiction now take Vivitrol instead of Suboxone and that it worked particularly well for those with less advanced addiction. Some have spent time at the Barnstable County jail, which gives a Vivitrol shot to addicted inmates just before releasing them.
But despite having a place to come for injections and counseling, most of Gosnold’s Vivitrol patients drop out after three or four months, Mr. Tamasi said.
Dr. Volkow said she was “very concerned” about Suboxone being used illicitly, but that she thought most people who did so were trying to avoid going through withdrawal, adding that the high it can provide is “far from ideal” for addicts used to heroin or oxycodone.
Too often, no medication works for long, especially if the person taking it is not getting behavioral therapy and other help. Patti Phelps, a retired bank administrator in Cincinnati, lost her son Andrew to a heroin overdose two years ago after neither Suboxone nor Vivitrol helped him overcome the urge to get high.
“Nothing helped him with the cravings,” Ms. Phelps said, adding that Mr. Phelps, who died at 20, had stuck with Suboxone for three months and Vivitrol for only one, during which he injected heroin despite the medication’s blocking effect.
“The Vivitrol people buy billboards here in Cincinnati, selling it, ‘This is going to solve all your problems,’” she said. “And maybe it does for some. But it didn’t for him.”