December 23, 2019
Vivitrol And The FDA
By Michael D. Shaw
Vivitrol® (naltrexone for extended-release injectable suspension) is used to treat alcohol dependence; and to prevent relapse to opioid dependence after opioid detox. Naltrexone is an opioid antagonist, which binds to opioid receptors with higher affinity than agonists but does not activate the receptors. (An agonist would activate the receptors.) This effectively blocks the receptors, preventing the body from responding to opioids and endorphins. Thus, by definition, Naltrexone is “non-addictive.”
As such, Vivitrol can be contrasted with the other opioid addiction treatment drugs methadone (full opioid agonist) and buprenorphine (partial opioid agonist). An article from 2017 indicated that the criminal justice community favored Vivitrol, presumably because of research evidence, even though there was none at the time. Perhaps there was another reason.
As harm reduction expert Daniel Wolfe noted:
“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.”
Bear in mind that with the effect of opioids being blocked, there is a very real danger of overdose, should a patient backslide and consume their opioid of choice. Per the patient brochure: “One serious side effect of Vivitrol is the risk of opioid overdose. Using opioids, even in amounts that you used before Vivitrol treatment, can lead to accidental overdose, serious injury, coma, or death.”
Moreover, the attitude of some—including former HHS secretary Tom Price—that methadone and buprenorphine merely substitute one opioid for another was roundly condemned by a legion of addiction treatment professionals.
Then, there is the matter of a patient needing to be completely detoxed before being put on Vivitrol. A study published in The Lancet concluded that treatment with either Vivitrol or buprenorphine was safe and effective, but it is more difficult to initiate patients to Vivitrol, negatively affecting overall relapse.
Addiction expert Anna Lembke, MD commented on the study: “[Naltrexone is] a useful medication when people get on it, stay on it, and are motivated to abstain. The problem is that in the real world, which seldom resembles the clinical study world, patients are much less interested in this option.” She added that the study used inpatients, and this also could have distorted the results. In an outpatient population, naltrexone may fail to retain even more patients—and have even worse outcomes compared to buprenorphine.
And now, Alkermes, Inc., the maker of Vivitrol, is in trouble with the FDA. On December 2, the agency issued a Warning Letter to the company stating that a print ad for Vivitrol was false or misleading because it omitted important risk information. Alkermes failed to sufficiently communicate the risk of overdose, owing to the reduction of opioid tolerance, and leaves its users more vulnerable to opioid overdose for patients who relapse, even at comparatively low doses.
According to an FDA news release quoting Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion, “Vivitrol is being promoted in a way that does not adequately present important risk information in a truthful and non-misleading manner. This is concerning from a public health perspective because of the potential for fatal opioid overdose in this vulnerable patient population.”
It should be added that Vivitrol is by far the most expensive of the three drugs. But perhaps it has to be, since Alkermes is spending a fortune marketing it, largely by focusing on the criminal justice system. After all, who better than a judge to mandate which drug you should be taking, right?
A ProPublica article includes these mordant quotes:
“In what other medical situation do judges prescribe specific treatments from the bench?” asked Mark Willenbring, an addiction psychiatrist in St. Paul, Minnesota. “If you get in a car crash because you’re diabetic, do they prescribe a specific medication from the bench? This is the only area in medicine or health care where judges think they know more than doctors.”
Jeffrey Junig, a Wisconsin psychiatrist specializing in substance abuse who himself overcame an opiate addiction, puts it more bluntly. “They make you an offer you can’t refuse,” he said. “People are being forced to take medication with jail over their heads.”
With ethics like this, what could possibly go wrong?