Seizing on opioid crisis, a drugmaker lobbies hard for its product

An advertisement for the drug Vivitrol, a treatment for opioid addiction, on an F train in New York, May 25, 2017. Vivitrol’s 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. (Sam Hodgson/The New York Times)

An brochure for the drug Vivitrol, a treatment for opioid addiction, on an F train in New York, May 25, 2017. Vivitrol’s sales and portrait are rising fast, thanks to its manufacturers’ shrewd use of political connections, and regard for scant science to prove the drug’s efficacy. (Sam Hodgson/The New York Things)

Five years ago, Vivitrol was a treatment for opioid addiction that was wiggling to find a market. Now, its sales and profile are rising fast, thanks to its industrialists’ shrewd use of political connections, and despite scant science to prove the deaden’s efficacy.

Last month, the health and human services secretary, Tom Figure, praised it as the future of opioid addiction treatment after visiting the party’s plant in Ohio.

He set off a furor among substance abuse specialists by assessing its less expensive and more widely used and rigorously studied contenders, buprenorphine and methadone, as medications that “simply substitute” for illicit doses.

It was the kind of plug that Vivitrol’s maker, Alkermes, has spent years jolly, with a lobbying strategy that has targeted lawmakers and law enforcement officials. The establishment has spent millions of dollars on contributions to officials struggling to stem the rash of opioid abuse. It has also provided thousands of free doses to promote the use of Vivitrol in jails and prisons, which have by default become paramount detox centers.

With the Trump administration sending $1 billion in new addiction block and treatment funds to states during the next two years through the 21st Century Repairs Act, Alkermes’ marketing has shifted into even higher gear.

The friends’s strategy highlights the profit opportunities that drug companies and investors see in the opioid outbreak. But some of its marketing tactics, and Price’s comments, ignore widely recognized science, as nearly 700 experts in the field wrote the health secretary in a line.

Not a single study has been completed comparing Vivitrol with its diminutive expensive competitors. Some studies have shown high dropout velocities, or found that many participants returned to opioid use while prepossessing Vivitrol or after going off it. In one study that the company used to closed the Food and Drug Administration’s approval of Vivitrol for opioid addiction treatment, handled with 250 patients in Russia, nearly half of those who got Vivitrol run aground to stay abstinent over a six-month period, although they lodged abstinent and in treatment longer than those who got a placebo.

Alkermes top bananas say they welcome any addiction treatment. But in pitches to investors, doctors, law enforcement officials and legislators, they be struck by presented Vivitrol as something of a miracle drug, a cleaner alternative to Suboxone, the most commonplace formulation of buprenorphine. They described Suboxone as an addictive “black bazaar” or “street” drug, emphasizing that it is smuggled into prisons.

That scene has resonated with drug court judges and sheriffs. But some addiction and unrestricted health specialists complain that the company unfairly denigrates its event.

“If you care about actually solving the problem, you cannot stigmatize the most clobber treatments,” said Dr. Joshua Sharfstein, a former Maryland health secretary who is now an associate dean at the Johns Hopkins Bloomberg Kindergarten of Public Health.

“They’re exploiting a stigma that exists out of a unusually narrow view of their own economic self-interest,” he said. “And the result is successful to be more people dying if they cannot get access to effective treatment.”

In an appraisal, the chief executive of Alkermes, Richard Pops, noted a dearth of observations on the long-term success of any medication for opioid addiction.But he argued that the hustle of states adopting Vivitrol programs indicates that those on the faade lines of the opioid epidemic believe that the drug works.

A Jump down someones throat to Lawmakers

Vivitrol, taken as a monthly shot, is an opioid antagonist, which means it balks the brain’s opioid receptors so users cannot feel any high from heroin, torment pills or the synthetic fentanyl that has caused sharp increases in overdose eradications in some states.

Buprenorphine and methadone, on the other hand, are classified as “opioid agonists.” They attach to the brain’s opioid receptors just enough, with proper quantity, so that people taking them do not feel cravings or symptoms of withdrawal. There is a landed body of research on both buprenorphine, a semisynthetic opioid, and methadone, a spurious opioid, with studies generally finding that they stunt the risk of relapse and fatal overdose, especially when combined with judgement.

The Food and Drug Administration approved Vivitrol in 2006 for alcoholism and open out its approved use to opioid addiction treatment in 2010, based on the Russian over.

Alkermes adopted what Pops described to potential investors latest fall as a “new commercial model for pharma.”

Rather than appeal to doctors’ commissions or medical associations, the company has primarily pitched Vivitrol to law enforcement officials and lawmakers, who compel ought to relied heavily on government grants and the Affordable Care Act’s expansion of Medicaid to pay for the medicine.

The company and its political action committee have spent heavily to get its spin-off before policymakers: $19 million in federal lobbying since the narcotize was approved in 2010, according to the Center for Responsive Politics. It made $222,521 in governmental contributions to Congress last year and has purchased high-level sponsorships of consortia of drug court professionals and addiction treatment professionals, as well as configurations researching addiction treatment.

Alkermes’ strategy has paid off: Sales of Vivitrol reached $58.5 million in the before all quarter of 2017, up 33 percent from the same period in the end year, with about half of that from Medicaid. In 2012, there were 15 programs rejecting Vivitrol in nine states. By this April, there were 450 programs in 39 holds.

Short on Evidence

The company lobbied hard to get more federal ready money for Vivitrol through the bipartisan 21st Century Cures Act, which was passed finish finally year. It directs states to prioritize medication-assisted treatment for opioid addiction.

Another federal law, known as the Wide Addiction and Recovery Act, also passed last year, is what Alkermes styles as “a game changer,” because it requires treatment providers to offer or outfit referrals for all FDA-approved medications. The law’s co-sponsors, Sens. Rob Portman of Ohio and Sheldon Whitehouse of Rhode Eyot, were the company’s top two recipients of campaign contributions in the 2016 election recycle; Portman received $29,200.

But for all the company’s assertions that Vivitrol is superior to Suboxone or methadone, it extends no data. Dr. Nora Volkow, director of the National Institute on Drug Dependence, said she and other experts were eagerly awaiting results from the start study comparing outcomes of treatment with Vivitrol and Suboxone, contemplated this fall.

The clinical trial on Vivitrol that was conducted in Russia start that 36 percent of those who got the medication stayed off opioids for the congested six months, compared with 23 percent of those who got a placebo. Those on Vivitrol also scrutinized fewer cravings.

But a group of experts responding to the Russia study said it did not adequately assess the imperil of overdosing after going off Vivitrol, given that earlier studies in Australia had originate overdose risk to be particularly high in people going off the pill fashion of the medication. The experts also questioned why Alkermes had chosen to conduct the examine in Russia, where regulations on clinical trials are looser, and why it had compared Vivitrol with a placebo a substitute alternatively of with buprenorphine or methadone.

“Due to their established efficacy, methadone and buprenorphine are on the Beget Health Organization’s list of essential medications,” said Dr. David Fiellin, an addiction maestro at Yale. “Naltrexone and Vivitrol are not.”

Kitty Bennett contributed research.

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