Senators question drug-marketing tactics

Nov 20 2017

Senators question drug-marketing tactics

Two members of the U.S. Senate’s primary investigative body have raised questions about the marketing tactics used by companies to promote their opiate addiction treatment drugs.

 Sen. Kamala Harris (D-California), a former California attorney general, recently wrote a letter to Alkermes CEO Richard Pops demanding documents about its efforts to market Vivitrol, its drug used to treat opiate addiction and alcoholism.

In September, Sen. Claire McCaskill (D-Missouri), the top Democrat on the Homeland Security and Governmental Affairs Committee, presented findings that drugmaker Insys Therapeutics tried to sought to avoid the normal prescription approval process to have its fentanyl opioid Subsys given to patients who didn’t need it, according to a Senate Democratic report.

Last summer, the New York Times and NPR reported that Alkermes has taken the unusual approach of marketing Vivitrol directly to law enforcement personnel and legislators, while inaccurately portraying its drug as a safer choice than competing medications buprenorphine and methadone.

In the process, “cheaper and more thoroughly studied treatments appear to have been stigmatized and marginalized,” Harris wrote in a recent letter to CEO Richard Pops.

Alkermes’ current advertising campaign claims that Vivitrol is the only ‘non-addictive’ treatment for opioid addiction. This is a deliberate attempt to discourage use of opioid agonist therapy in favor of Vivitrol, despite the fact that the evidence for effectiveness of buprenorphine and methadone maintenance is robust,” Dr. Anna Lembke, chief of the Stanford Addiction Medicine Dual Diagnosis Clinic, said in an email quoted by McClatchy. “Alkermes is playing on fears and biases against opioid agonist treatment, which are longstanding, despite the overwhelming evidence for their effectiveness.”

In her letter to Pops, Harris asks the company to provide a list of documents, including: a list of judicial officials and drug courts to which Alkermes has assigned sales representatives; a list all jails or prisons where Alkermes has provided free Vivitrol shots; copies of educational materials provided to law enforcement personnel or judges; and research or data “concerning the superiority of Vivitrol as an opioid addiction treatment.”

Alkermes has responded with a statement that it “strongly disagrees with Senator Harris’ comments.” Vivitrol, the statement says, “is the only FDA-approved medication that completely blocks the effects of opioids. It does not produce physical dependence and thus is non-addictive.” And it says the company “believes that patients should have access to all medications.”

Harris is a junior member of the Homeland and Governmental Affairs Committee. As California attorney general, Harris headed the reorganization of the state’s prescription drug monitoring system and joined a 2016 lawsuit with 34 other states against two pharmaceutical companies alleged to have tried to block competition to the drug Suboxone.

McCaskill’s focus on Subsys is part of a wider investigation she is conducting of opioid painkiller manufacturers and how their marketing practices have contributed to the addiction epidemic.

Meanwhile, a new federally-funded study comparing Vivitrol and Suboxone, has found that their effectiveness is about equal. Suboxone is taken daily in strips that dissolve on the tongue and contains a relatively mild opioid that helps minimize withdrawal symptoms and cravings. Researchers found that 52 percent of those who started on Vivitrol relapsed during the 24-week study, compared with 56 percent of those who started on Suboxone.

But the study, conducted with 570 adults addicted mostly to heroin, also found a major difference between the two drugs in the rate of patient “dropout.” Because the medication can be started only after complete detox from opioids, more than a quarter of the study participants assigned to Vivitrol dropped out before being able to take their first dose. Because Suboxone can be started soon after withdrawal symptoms start,  only 6 percent of assigned recipients dropped out before receiving their first dose.