Alkermes, which manufactures drugs for conditions that are disproportionately found behind bars—such as schizophrenia and alcohol and opioid addiction—is among several companies that have embraced the criminal-justice system as a source of customers. Starting in the early 2010s, Alkermes promoted Vivitrol, a treatment for opioid-use disorder, to correctional facilities. The treatment, generically known as naltrexone, had previously been used for alcohol-use disorder, but the drug floundered. When Alkermes recast it as a solution to the opioid epidemic, the company directly lobbied jailers and judges on the shot’s merits, selling the promise of the drug despite scant evidence of its effectiveness compared to competing treatments like buprenorphine, one of the active ingredients in the brand-name drug Suboxone. In closed-door meetings, Alkermes disparaged Suboxone as a “black market” drug that was illegally abused inside correctional facilities, according to a report from The New York Times. The company’s marketing practices received blowback. (Alkermes has pointed to studies it says offer further evidence for Vivitrol’s effectiveness. In some cases, the company has pushed back against criticisms. Earlier this month, in response to a warning letter from the Food and Drug Administration, the company responded that it was taking steps to be “fully compliant” with federal regulations.) Alkermes accomplished its goal: People received Vivitrol while behind bars, and kept using it once they were released. Today Vivitrol is widely available in treatment facilities across the country, in part thanks to this early push.
Drugmakers introduced long-acting schizophrenia shots more than 50 years ago as a way to infuse consistency into psychosis treatment. But some psychiatrists and mental-health advocates were skeptical because of concerns about extended exposure to side effects such as sleepiness and low blood pressure, and because the shots seemed like “an attempt by psychiatrists to impose their will on patients,” according to a paper by Ahsan Khan, a psychiatrist at Saint Louis University, and colleagues.
As long-acting antipsychotic drugs improved, along with their public image, drug companies thought they could reinvigorate the market. In July 2009, the Food and Drug Administration approved Invega Sustenna, a long-acting, injectable form of an earlier antipsychotic pill made by Johnson & Johnson’s Janssen brand. Abilify Maintena, from a Japanese company called Otsuka Pharmaceutical, followed four years later. Then came Aristada, green-lit in 2015.
Within the multibillion-dollar schizophrenia-drug market, the makers of all three drugs are seeking to cast long-acting injections as the future of schizophrenia treatment. A 2015 study by the University of California, Los Angeles, found that patients who were given such injections were more likely to adhere to treatment and see reduced symptoms over a 12-month period, compared to those taking the same medication orally. But there’s also a chance that side effects will last longer than with the pill form, and that’s one of the key reasons some psychiatrists still start with the pill.
Recognizing the importance of detention facilities in the mental-health market—approximately 15 percent of state prisoners experience serious mental illness, more than three times the rate found in the total U.S. adult population—drugmakers are, to varying degrees, marketing the long-acting drugs to criminal-justice audiences. [Continue reading…]