Is Vivitrol More Effective Than Suboxone And Methadone?

By Paul Gaita 07/21/17

The makers of Vivitrol have mounted an aggressive campaign to push this narrative to the government and law enforcement.

Image: 
a doctor preparing an injection

Alkermes, the drug company that manufactures the opioid antagonist Vivitrol, has mounted an aggressive campaign to market its drug as a more effective treatment for opioid dependence than methadone or buprenorphine (also known as Suboxone).

The company has spent millions lobbying its product before federal review panels, dispatched sales agents to drug court judges and medical professionals, and provided free shots to jails and prisons across the country. Its efforts appear to be working: sales topped $58.5 million for the first quarter of 2017, and 39 states now have 450 drug treatment programs that employ Vivitrol. 

The company also received a major push in April when Health and Human Services Secretary Tom Price derided methadone and Suboxone-based treatment as "trading one opioid for another."

Comments like these have been echoed by law enforcement and political figures, who have used terms like "smuggled contraband" to describe Suboxone. The problem with the wave of support for Vivitrol? There is no evidence, beyond what its manufacturers have put forward, that the drug is any more effective in treating opioid dependence than methadone and Suboxone.

As an opioid antagonist, Vivitrol provides a different form of treatment for opioid dependency than methadone and Suboxone. The latter drugs are opioid agonists, which bind to the brain's opioid receptors and with the proper dosage, relieve symptoms of craving and withdrawal. Vivitrol blocks the brain's opioid receptors, which prevents the user from experiencing any sort of euphoric effect from opioids, including heroin and fentanyl.

Initially approved as a treatment for alcohol dependency, the Food and Drug Administration (FDA) expanded its approval for use with drug dependency in 2010, though sales were initially weak. Alkermes responded with a marketing strategy that its chief executive officer, Richard Pops, described as "a new commercial model for pharma."

This included $19 million in direct appeals to government officials since 2010—as well as law enforcement and medical professionals—through sales agents and "speakers' bureaus" of doctors paid to promote Vivitrol to their peers. It also contributed to numerous Congressional campaigns—more than $222,000 in 2016 alone—including those of Senators Rob Portman (R-Ohio) and Sheldon Whitehouse (D-Rhode Island), who co-sponsored the Comprehensive Addiction and Recovery Act, which required treatment providers to offer or refer all FDA-approved medication for treatment.

The widespread exposure and support for Vivitrol led to pilot programs in county jails across the country, and drug courts directing applicants to treatment facilities that employ Vivitrol-based plans.

Throughout these promotional activities, Alkermes representatives have frequently presented their product as a better alternative to the traditional method of drug-based treatment. Suboxone, in particular, has been labeled as a "black market" drug, marked by reports about the drug being smuggled into prisons. That message has resonated with law enforcement—Sheriff Peter Koutoujian of Middlesex County, Massachusetts, who received $4,600 for his Congressional campaign from Alkermes, described Suboxone as "contraband" in a presentation to investors—and received its most far-reaching endorsement from Secretary Price, whose comments were in turn decried by nearly 700 science and medical professionals.

While a 2016 study—supported by grants from Alkermes—found that the drug can prove effective during the early stages of treatment (a 24-week period)—no significant studies confirm that Vivitrol is more effective than either methadone or Suboxone.

The study that Alkermes used to win the FDA's approval was conducted with 250 patients in Russia, 36% of which stayed off opioids for six months and reported fewer cravings. But the study compared Vivitrol to a placebo, not methadone or Suboxone, and the decision to conduct the study in Russia, which places less strict regulations on clinical trials, has called its efficacy into question. Medical professionals are currently awaiting the results of a test that compares Vivitrol with methadone and Suboxone, which is slated for release in the fall of 2017.

In the meantime, Alkermes' CEO continues to assert that his product is superior to the more traditional and established methods of treatment. Individuals that choose methadone or Suboxone "aren't strident about wanting to be drug-free," he said in an interview. According to Pops, "people who want to be drug-free, those are the ones who should go on Vivitrol."

Please read our comment policy. - The Fix
Disqus comments
PaulG.jpg

Paul Gaita lives in Los Angeles. He has contributed to the Los Angeles Times, Variety, LA Weekly, Amazon.com and The Los Angeles Beat, among many other publications and websites. 

Disqus comments