S

tinging investigations by the New York Times, National Public Radio, ProPublica, and others have recently exposed how the drug maker Alkermes is promoting Vivitrol — a long-acting injection that blocks the effects of opioids — at the expense of other, better-studied treatments for opioid dependence. We can and should blame prescription drug companies for the misleading marketing they use to boost sales. But we should also look in the mirror and recognize that, in the case of opioid dependence, these schemes work so well because they reflect the bias — often unconscious and well-meaning — that prioritizes the fantasy of being drug-free over the real interests of people in need of help.

The investigations revealed how Alkermes marketers and lobbyists deride the daily administration of methadone and buprenorphine, two medicines that are the gold standard for treating opioid dependence. The sales pitch is that Vivitrol is an opioid blocker and “non-addictive.” The company has blanketed New York and other cities with promotional materials, and has dispatched lobbyists to prey on well-placed community worries about the spiking number of fatal overdoses.

The pitch is working. Sales of Vivitrol have skyrocketed more than 600 percent since 2011, and legislators in 15 states have written Vivitrol — by brand name — into their laws. Multiple jurisdictions have now created “Vivitrol courts.” These require drug offenders appearing before them to use that medication if they wish to avoid imprisonment.

advertisement

A recent survey of criminal justice representatives found that most favored Vivitrol over methadone and buprenorphine because, they said, the evidence showed it was better — an astonishing claim given that there is actually no evidence. Not a single published trial (one is now underway in New York, for which Alkermes declined to donate its product) has compared Vivitrol to methadone or buprenorphine.

What criminal justice officials and legislators mean but don’t say is that Vivitrol fits the bias against prescribing psychoactive medicines like methadone or buprenorphine to someone who has used an illegal drug — even if these medicines reduce HIV risk, improve family function, increase employment, and reduce the risk of heroin overdose. Vivitrol’s appeal is largely because its physical blockade of opioids echoes the urge to control and contain, with the medicine locking up receptors in the brain the same way we might lock up a drug offender.

For some people, this blockade is an extremely useful crutch, with the medicine helping them help themselves abstain from drugs. But for many others, the long-acting shot prevents them from getting high but doesn’t relieve their psychological suffering.

Vivitrol’s appeal is largely because its physical blockade of opioids echoes the urge to control and contain, with the medicine locking up receptors in the brain the same way we might lock up a drug offender.

Alkermes did conduct a single clinical trial to demonstrate the efficacy of Vivitrol for heroin addiction and secure its approval from the Food and Drug Administration. But the company did it in Russia, which bans both methadone and buprenorphine. Even there, where treatment options are severely limited, expensive, and abusive, nearly half the people in the trial who were getting free Vivitrol dropped out.

Worse still is the possibility that Vivitrol treatment may actually increase the risk for overdose. Using the drug requires patients to go through a painful detoxification. Evidence shows that those who return to using heroin or another opioid after a period of abstinence are at greatest risk of fatal overdose. We cannot know for sure if there’s a link between stopping Vivitrol and fatal overdose since Alkermes declined to track overdoses among the individuals in the Russian trial who stopped the medication. This omission raises the terrible possibility that the aggressive marketing of Vivitrol might actually accelerate the overdose crisis.

Would we really rather risk that our family members perish than include controlled substances like methadone or and buprenorphine among their treatment options? That has certainly been the Russian way — the country’s ban on methadone and buprenorphine has coincided with skyrocketing deaths from overdose as well as a huge and growing HIV epidemic fueled by contaminated injecting equipment.

Here, as in other matters, the Trump administration seems to have a disquieting alignment with the Putin government. Tom Price, the secretary of Health and Human Services, recently made headlines by disregarding years of studies and millions of stories of patient benefit when he dismissed methadone and buprenorphine as simply “substituting one opioid for another.”

For anyone who has seen the suffering caused by opioids, blocking them out — in the body, or in our society — is a powerful impulse. But when we allow it to deprive patients of options or to blind us to the realities of drugs and effective treatment, it begs the question of how high a price we are willing to pay for a drug-free fantasy.

And a fantasy it is. Vivitrol patients, who require a monthly injection, are not drug-free, and the medication’s price tag is many times that of methadone and buprenorphine.

Far more important, patients pay a terrible cost including, in some instances, their lives, when we allow criminal justice officials or health providers who have internalized the thinking of drug control to predetermine what treatments work. Anyone who insists that there is only one acceptable approach to treating drug dependence is motivated more by ideology than evidence.

The siren song of enforced abstinence — no matter the human or financial cost — is distracting, deadly, and as old as the drug wars.

Daniel Wolfe is the director of international harm reduction development at the Open Society Foundations.

Leave a Comment

Please enter your name.
Please enter a comment.

  • How exactly is Daniel Wolfe an expert in addiction? He’s not a doctor. He’s never treated addicts. He doesn’t do clinical research in this area. I see he tweets a lot about the subject, and has some long-standing opinions on the ethics of treatment, but Mr. Wolfe is a pretender when it comes to the evaluation of MAT. Statnews needs to have higher standards.

    Fyi, Mr. Wolfe and his employer the Open Society Foundation advocate for legalization of all drugs, including heroin. His slant should be understood in that context.

  • The criticism that Vivitrol was tested in a pivotal placebo controlled trial instead of versus an active control is invalid; the same argument can equally be applied equally to the buprenorphine studies what were also placebo controlled (e.g., RBP-600, etc.). Equally, a substantial proportion of patients recruited in various buprenorphine trials were from outside the USA, including Russia, E. Europe, etc., so unless those data are de facto invalid, neither should Vivitrol’s.

    That said, there was a recently published trial in Jama Psychiatry of an independently sponsored head to head trial comparing Vivitrol to Buprenorphine that demonstrated the two were about equal, with Vivitrol trending better on virtually all secondary endpoints.

    I also noticed, the author is not involved in research of treatment (his bio suggest he studied music, not medicine) in this space, so perhaps with additional study these obvious defects in his argument can be avoided.

Recommended Stories

Overdose ambulance
First Opinion
High School Football
First Opinion

Sign up for our Morning Rounds newsletter

Your daily dose of news in health and medicine.