W

ASHINGTON — The White House’s national strategy to combat the opioid crisis, unveiled last week, would expand a particular kind of addiction treatment in federal criminal justice settings: a single drug, manufactured by a single company, with mixed views on the evidence regarding its use.

Federal prisons should “facilitate naltrexone treatment and access to treatment” to inmates as they transition out of incarceration, according to a fact sheet circulated by the administration. A White House spokesman later confirmed to STAT that the document referred specifically to naltrexone in its injectable form.

Only one manufacturer makes a drug fitting that description: Alkermes, a Massachusetts pharmaceutical company that makes Vivitrol, a monthly injectable drug that blocks the effects of opioids and reduces cravings. The company has been criticized for aggressive tactics in pitching its product — which can cost over $1,000 per dose — to criminal justice systems. In November, Sen. Kamala Harris (D-Calif.) opened an investigation into the company’s marketing practices.

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The federal prison system oversees roughly 185,000 inmates, and some estimates indicate that nearly half meet criteria for a substance use disorder. The plan, according to the White House spokesman, was to use Vivitrol to provide a month of reduced risk for relapse before transitioning individuals into longer-term recovery. The spokesman later added that the policy objective was to save lives and not to punish the pharmaceutical industry.

But addiction experts say that, though ensuring access to medication-assisted treatment (MAT) is an improvement on status quo, multiple MAT drugs should be made available and chosen according to physician judgment and patient need.

Criminal justice systems have often favored naltrexone since it is not opioid-based and not a potential drug of abuse, as are true of methadone and buprenorphine. Alkermes CEO Richard Pops, when testifying before a White House commission on the opioid crisis in September, stressed the importance of increasing insurance coverage for Vivitrol, but added that patients should be made aware of all available treatment options.

When asked about the plan, administration health officials themselves expressed doubts about the approach.

“We don’t per se favor one drug over the other, because some patients respond better to one or the other,” said Nora Volkow, the director of the National Institute on Drug Abuse, at a press event on Tuesday. “It is clear that treatment in the prison system significantly improves outcomes, whether it’s [with naltrexone or buprenorphine].”

Health secretary Alex Azar was unfamiliar with the proposal to provide Vivitrol exclusively, saying in response to a STAT question: “I have a feeling that was an inadvertent reference. I think the key thing was the prison population, as opposed to any one product.”

Azar, who was sworn in as health secretary in late January, walked back his remark 15 minutes later, citing “staff-level discussions” and a directive from the Substance Abuse and Mental Health Services Administration that anyone “coming out of prison or a detox program should in fact be put on naltrexone, but that doesn’t mean it’s the best form [of MAT] for all populations.”

Limited options

Vivitrol’s favored position may be thanks to a distinction in its chemistry — the drug isn’t itself an opioid. The predominant other forms of medication-assisted treatment on the market, methadone and buprenorphine, are opioids. Many in public health and policy spheres have expressed doubts regarding those drugs’ use, including former health secretary Tom Price, who said in May that they may amount to “substituting one opioid for another.”

Vivitrol, by contrast, blocks drug users’ high from opioids.

“Methadone and buprenorphine have been shown on a variety of metrics to be far superior to Vivitrol — that includes safety, effectiveness, and cost,” said Leo Beletsky, a professor of law and public health at Northeastern University who focuses on drug policy. “The reason Vivitrol is preferred is that it’s a medical version of forced abstinence. That is why it’s been the darling of those who rhetorically support medication assisted treatment.”

A Vivitrol-only policy is unlikely to yield the best possible outcomes, Beletsky and other experts said, because it limits patient options in a situation where multiple medications are available. A better system, they said, would involve offering Vivitrol alongside either buprenorphine or methadone, and preferably both.

It’s a model being pioneered by the corrections system in Rhode Island, the results of which were recently praised by Chris Jones, who directs the National Mental Health and Substance Use Policy Laboratory, in an interview with STAT.

Rhode Island offers methadone, buprenorphine, and naltrexone to inmates with opioid use disorder based on which medication is deemed to be most appropriate. The state’s approach is increasingly seen as a nationwide model for administering MAT within prisons.

Connecticut similarly strives to ensure multiple options for patients seeking treatment.

“We favor an approach to patients with [substance use disorders] that offers the full range of medicines, including no medicine, as well as behavioral treatment like psychosocial counseling, and to provide patients with a full accounting of the risks and benefits of the treatment option,” Kathleen Maurer, who oversees health services for Connecticut’s corrections department, told STAT. “If we start someone on a medicine in our system, we have to make sure they have access to that medicine when they go home.”

Evidence and marketing

The White House’s plan is consistent with a number of efforts Alkermes has made around the country to market its drug at the state level. In California, for instance, Alkermes employs Kathryn Jett as a consultant in criminal justice and substance use disorders. Previously, she spent four years overseeing drug and alcohol treatment programs in California’s department of corrections.

Alkermes hired Jett, a company spokeswoman said in a statement to STAT, because “it is important for us to understand how we can best support access to our medicine for all patient populations, including those involved in the criminal justice system.”

Vivitrol has also marketed its product directly to judges in drug court systems. Many judges, NPR reported last year, were willing to order a Vivitrol prescription because it had no potential for abuse.

“Alkermes believes that all FDA-approved medicines have an important role to play in our national response to this epidemic,” the spokeswoman said. “This is something that we have communicated consistently in testimony, press releases, earnings updates and interactions with addiction-related stakeholders.”

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Evidence of Vivitrol’s efficacy became much stronger in November, when a study funded by NIDA found the drug to be as effective as buprenorphine, another common form of MAT, in patients who adhered to treatment for an extended period. However, Vivitrol was found to be at a disadvantage for immediate treatment, given that patients need to detox for seven to 10 days prior to the drug’s use. A White House spokesman said Vivitrol was most appropriate for addiction treatment in federal prisons in part because inmates who had been incarcerated for long periods would already have detoxed.

Another recent paper — co-authored by Andrew Saxon, a researcher at the University of Washington, and a number of other researchers who had been employed or otherwise compensated by Alkermes — used data from 2011 to 2013 to show some positive results for Vivitrol users. Their data, however, also showed that 49 percent of participants, for a variety of reasons, never received more than two injections.

Low adherence rates are an obstacle in delivering addiction treatment regardless of the drug in question. For that reason and others, multiple experts in addiction treatment including Saxon said doctors and patients should have options in choosing a medication.

“I would not want to treat people in the criminal justice system any differently than I would want to treat any other patient,” Saxon said.

Correction: An earlier version of this story misstated the number of participants who discontinued treatment in a recent study about adherence to Vivitrol.

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  • Vivitrol and Oral Naltrexone should not be in the same category as buprenorphine-based drugs like Suboxone. I understand that some of the buprenorphine drugs (agonist) contain a small amount of Naltrexone, but they are still opioids. In other words, they have the same characteristics of causing dependence addiction and withdrawal. They are replacement opioids. Unlike Vivitrol and Naltrexone, which are given after a “complete detox from the opioids.” Which mean, the patient is opioid-free, and this drug blocks the effects of opioids while also eliminating physical cravings. So, if Trump is pushing for Vivitrol, is because he probably understands that while one can be a treatment for the initial cravings, it means the patients in no longer opioid dependent, while Suboxone (an opioid) often keeps people in the eternal revolving doors of addiction.

  • I wanted to quickly reply to 2 responses I got below to an earlier comment.
    1.)Notso: Buprenorphine is now available in several generic brands, but Suboxone in particular is the brand name, yes.
    2.) Allan L.: I’m not sure where your hostility is coming from, but I happen to speak from experience and I have the utmost compassion for anyone suffering from opiate addiction. I’ve been there, and I hope that all addicts can get the help and support they need, no matter what form of help or medication works best for them. Also, I’m sorry for my use of “big words;” I wasn’t aware that I was using any. That’s what I get for posting in the comment section I suppose.
    If you’re currently struggling with an opiate addiction I hope you get better and you have my sincere compassion and good wishes.

    • @Allan, continued: if naltrexone works best for you, have at it, but the idea that Buprenorphine is “lethal” and just as dangerous as heroin is nonsense.
      Misinformation like that has taken enough lives already and it must stop.

    • Mike,

      Apparently, everyone participating in this comment section at one point or another has had their share of struggles with opiates. Clare made an excellent comment today… Please take a look at your convenience. This has nothing to do with economics and kickbacks, this is common sense. Stop giving addicts opiates! This is ridiculous. Methadone and Suboxone are worst than heroin because they are LEGAL alternatives. Misinformation???? You are misinformed!

  • We human beings love quick,easy, preferably inexpensive, solutions. But it’s fatuous to think there’s one, simple answer to the very complicated problem of addiction. There are well-studied medicines that can enable patients to access the other evidence based modes of treatment. But without easy access to those tools that can address the various psychosocial components in a long range, flexible, compassionate manner the self destructive behaviors will tend to continue.

  • Vivitrol is an excellent choice barring the unaffordable cost.Oral Naltrexone is a considerably cheaper option and equally effective if compliance is achieved e.g. by direct observed therapy. Hence it should be offered to well motivated patients.Patients should be given the choice

  • If this is the outcome Alkermes lobbying effort, then we need more of it. Not less. Indivior should be learning and doing the same. Addiction treatment is underfunded and underutilized. All effort are welcome. We need funding, not criticism of it.

    Amidst this crisis, what is very unwelcome to doctors in the field are self-proclaimed policy “experts” like Leo Beletsky who incite false choices between agonists v. antagonists.

    While your house burns, would you fuss over which wallpaper to choose?

  • It seems obvious that Vivitrol is preferred by the courts and politicians primarily because it is still patent protected, unlike buprenorphine and methadone, allowing for a potential kickback scheme as described above. Buprenorphine in particular has been proven to dramatically reduce mortality in opioid dependent people, and it cannot be stated enough that it is not a drug of abuse – at least not in the way that it is almost always described by law enforcement officials and politicians. Bup. has a “ceiling effect” which discourages abuse – taking ten times the dose does not produce a “high” which is ten times stronger, unlike classic opioids. It also does not cause respiratory depression which is the ultimate cause of the ten of thousands of annual opioid-related deaths in the US alone. Vivitrol by comparison is a new, relatively untested preparation of an old drug. Studies have shown that Vivitrol not only blocks the “high” of opiates, but also seems to make some people incapable of taking pleasure in anything, including sex, eating, and exercise. Obviously, this creates a huge disadvantage for people that must learn how to find pleasure again without the immensely powerful opiates that have hijacked their brain chemistry. If courts and the police insist on using a long-acting medication to improve compliance, buprenorphine is now available in a subcutaneous implant which lasts for six months. It’s not cheap, but neither is Vivitrol – and the buprenorphine just might work.

    • Dear Mike,

      People like you who love using big words like kickback and conspiracy in order to create news.
      Buprenorphine and methadone are MORE addictive than heroin. These two drugs are lethal and in fact are used by the US government to replace the opioid (oxy) dependence. Naltrexone is the ONLY hope. It works! Do your research! Speak to actual addicts who want to live without a dependency on another drug.

  • Providing injectable naltrexone to persons released from prison reduces cravings for opioids for 28 days, providing a bridge for them to secure the treatment and support they need in the community to remain in recovery. It does not preclude persons from switching after 28 days to methadone or buprenorphine if these medications are preferred. We know from (non-federal) prison MAT reentry programs providing injectable naltrexone, that many persons do make the switch without problems. We also know that many persons induced on methadone or buprenorphine in prison or jail, like those that are provided naltrexone, do not continue to take these medications upon release. Studies have found the retention rates for buprenorphine and naltrexone do not differ after induction.

  • Mark is correct, naltrexone is in fact an opioid. It is an opioid antagonist rather than an opioid agonist, and is not only not a drug of potential abuse, if administered to someone physically dependent on opioids it will cause withdrawal. That’s why patients need to be opioid-free for awhile before starting Vivitrol.
    This administration is consistently hostile to science and evidence when it doesn’t match their ideology.
    As Neil deGrasse Tyson has said, nothing is more dangerous than a scientifically-illiterate adult in power. I couldn’t agree more. That said, acknowledging the role of MAT at all is a step in the right direction.

  • An opioid is a drug which binds to opioid receptors, which naltrexone does. It is by any definition and opioid, unlike burprenorphine or methadone, it is not an opioid agonist.

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