On buses and billboards across the country, preened models with crossed arms stand next to the question: What is Vivitrol? Though a provocative question, policy makers and community members ought to be asking a more important one: why Vivitrol?
In the mid-2000s, Vivitrol (generic name naltrexone) was an alcohol and opioid addiction treatment with a fledgling market that few people had heard of. By 2016, its net sales were $209 million. Today, it is mentioned by name in multiple state legislations, from Arizona, to West Virginia, to Indiana. How did Vivitrol become so popular so quickly, especially when other effective medications for opioid dependence, such as Suboxone (generic name buprenorphine), are still struggling to find widespread adoption? Like so much of drug policy, it appears that the rush to make Vivitrol widely available is not based on research about it's effectiveness or patient preference as much as a $4 million dollar-a-year political lobby.
With 78 people dying every day in 2016 from opioid overdoses, policy makers are anxious for life-saving solutions. They are increasingly advocating for Vivitrol, a monthly injectable form of naltrexone, as a “magic bullet.” The medication, a type of opioid antagonist, works by blocking receptors in the brain, blocking opioids’ effects. It requires that those receiving shots have not taken opioids for 7-14 days prior.
Vivitrol clearly works for some people, but the evidence base for its efficacy is relatively weak compared to other medications. As recently reported by The New York Times and National Public Radio, the market strategy of the company that produces Vivitrol, Alkermes, has raised eyebrows – it is based on intense political lobbying and minimal research.
Vivitrol has been marketed in competition with methadone and buprenorphine, opioid agonists and partial-agonists. These medications use controlled activation of opioid receptors in the brain to partially replace the effects of illicit opioids. They provide a safe dosage that reduces the risk of overdosing during relapse and minimizes harmful behaviors linked to addiction. In addition, they’re between 10% and 50% of the price of a Vivitrol shot. Methadone and buprenorphine’s efficacy has a strong base of evidence, with positive results in retaining people in drug treatment and reducing illicit opioid use. When Secretary Tom Price maligned opioid agonists, nearly 700 experts signed a letter in support of these treatments.
In comparison, Vivitrol’s research base is weaker and more flawed. There have not been studies on its long-term effects, nor any published comparing it to buprenorphine or methadone, the standard of care for opioid dependence treatment. Instead, the few Vivitrol studies out there generally use control groups receiving placebos (see also here) or therapy and community program referrals. This means we don't actually know if Vivitrol works as well as, better, or worse than methadone or buprenorphine. In contrast, methadone and buprenorphine have been repeatedly compared in dozens of randomized controlled trials.
Much of the research on Vivitrol, partially funded by Alkermes though conducted by unaffiliated researchers, has recruited from incarcerated, pre-release populations (see also here). The vulnerability of such groups raises questions of coercion and comes with unique barriers, particularly when correctional facilities offer only Vivitrol treatment, rather than multiple individualized options.
Despite the discrepancy in evidence, Vivitrol has been written into 70 bills spread across 15 states. Arizona and West Virginia, for example, created Vivitrol programs in state correctional facilities through Medicaid. In Indiana, a house bill allows Vivitrol’s integration into parole and probation. Troublingly, the rhetoric of this legislation has painted Vivitrol – or medications with a description only Vivitrol fills – as an alternative, not a complement, to buprenorphine and methadone.
Meanwhile, access to and widespread use of methadone and buprenorphine continues to be restricted by burdensome regulations, from requiring daily attendance at methadone clinics to requiring doctors to take eight hours of education to prescribe buprenorphine. Policy makers, no doubt swayed by the strength of Alkermes’ lobby and their own desire to address addiction, are paving the way for Vivitrol’s widespread implementation when they should be focused on making all medication treatments more widely available.
It is not that Vivitrol shouldn’t be increasingly available for those seeking treatment. Many advocates, academics, and community members, however, are frustrated by Vivitrol’s adoption in lieu of a diverse set of evidence-based treatments. Its rise has depended on political advocacy, monopolized by a pharmaceutical corporation, not on the voices of other stakeholders nor the strength of research.
We know that opioid misuse is an urgent problem, and we know that there are good treatment options for it – researchers have the evidence to prove it. While Vivitrol may not a good example of evidence-based policy, it is a good example of how effective advocacy can reshape drug policy. Rather than let industry drive policy, we need those directly involved in drug-related research to flex their advocacy muscles more often.
If we do not actively work to bridge the gap between rigorous research and policy, companies like Alkermes will step in and do it. Vivitrol exemplifies the current divide between these worlds, and in doing so, should inspire more researchers to become better advocates.
Iolanthe Brooks is an intern at the Drug Policy Alliance.
Image via Wikipedia.