In an article reprinted by the Bangor Daily News on April 3, ProPublica writer Alec MacGillas cites a study published in the journal Drug Safety that incorrectly associates use of extended release naltrexone, marketed under the brand name Vivitrol, with an increased risk of overdose. Vivitrol is an important pharmacotherapy in the treatment of opioid use disorders, and current scientific evidence does not support the conclusion that its use increases the risk of overdose.
This article harms public perception and could reduce the utilization of an important medication. As a society, we should be increasing access to medication-assisted treatment, not disparaging agents that have proven to be effective.
In opioid use disorder, there is not a “one size fits all” approach to treatment. Currently, there are two different types of medications in use: antagonists, such as Vivitrol, that block the effect of opioids and reduce cravings, and agonists, such as methadone and buprenorphine, that act as a substitute for opioids like heroin to reduce cravings and withdrawal.
For individuals whose primary goal is to reach abstinence, Vivitrol is a good treatment option, but it requires them to avoid opioids for seven to 14 days. Sometimes patients are unable to tolerate full withdrawal, which is required to start Vivitrol, and may have a high risk of resuming addictive behaviors. In these cases, Suboxone, a combination of buprenorphine and naloxone, or methadone may be preferred.
Within this regard, MacGillas’ article correctly points to limitations in the criminal justice system, which often limits treatment to just Vivitrol. This is not the best approach because it is not the best option for all patients. With this considered, criminal justice offenders are at a high risk of overdose mortality and current evidence supports that Vivitrol use does not increase this risk.
Peter D. Friedmann, a researcher from the University of Massachusetts Medical School-Baystate, and his colleagues assessed opioid use disorder relapse in criminal justice offenders who were treated with Vivitrol and counseling versus “standard therapy” — just counseling, no Vivitrol — for 24 weeks followed by 54 weeks of monitoring. There were no overdoses in the Vivitrol group at 78 weeks following the start of treatment and seven overdoses in the group that did not receive Vivitrol.
The MacGillas article also examined a 2017 study published in The Lancet that compared effectiveness of Vivitrol and Suboxone. This study demonstrated that overdoses occurred at a similar rate among participants who received Vivitrol and Suboxone, meaning the use of Vivitrol did not produce higher rates of overdose compared to agonist treatment.
But the article failed to outline the implications of this, highlighting the high rate of patients who dropped out before treatment began in the Vivitrol group (28 percent) versus the Suboxone group (6 percent). While this demonstrates that starting treatment with Vivitrol is not easy as patients are required to go through withdrawal, the failure to begin treatment indicates that Vivitrol is not the best treatment for all patients and that some patients require an opioid agonist, such as Suboxone or methadone.
The primary study MacGillas cites attempts to correlate Vivitrol use with an increased risk of overdose, particularly following premature discontinuation. This study is flawed in that investigators searched through reports filed with the U.S. Food and Drug Administration to find cases where an overdose occurred after the effect of Vivitrol wore off. Studies structured in this way are open to bias because there is no group to compare Vivitrol against and participation in the study is based on the outcome (overdose) and exposure (Vivitrol use) already occurring. Therefore, conclusions can be drawn to support a particular narrative rather than outline a potential area of study.
With this considered, the conclusion made by the primary investigators cannot be made with the evidence provided.
While Vivitrol alone is not a cure-all for opioid use disorder, current scientific evidence demonstrates that it is a safe and effective treatment. The answer is not “either/or.” It is to apply our best knowledge in a safe manner and to customize treatment to best meet the needs of each individual we are treating. Creating public skepticism, outside of the scientific evidence, does little more than decrease utilization of an effective medication that can potentially save lives.
Dr. Kristopher Ravin is a registered pharmacist and holds a doctor of pharmacy degree from Husson University’s School of Pharmacy.
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