Tag: pharmakeia

The conference, on medical care inside America’s jails and prisons, had been put on by an organization that sets standards for treatment in correctional facilities. Potenza paced the stage, talking animatedly about a national mental-health epidemic that had burdened jails and prisons. He flipped to a presentation slide showing that nearly half of all inmates diagnosed with schizophrenia were “non-adherent,” meaning that they weren’t taking their daily medications as prescribed.

Then, Potenza suggested a solution: a single shot of long-acting antipsychotic medicine, whose effects last for as long as three months, administered to patients while they’re still incarcerated. To show how this might help, Potenza presented a hypothetical scenario in which an inmate with schizophrenia becomes eligible for release but is denied parole because a medical provider describes the person as non-adherent. Parole-board members might be willing to reconsider if they could ensure that the person would receive his or her medications as prescribed ahead of release. In some cases, a “treatment resistant” patient who is simply forgetful might agree to the shot. However, in some cases, a judge might order a shot to be administered without the patient’s permission.

Potenza didn’t recommend a specific drug, and he was presenting at the conference at his employer’s expense, having been invited by its organizers.  But if you looked inside the conference program, you would learn that the keynote address on schizophrenia had been underwritten by Alkermes, an Irish company that manufactures one of the long-acting medicines, Aristada. If you walked through the exhibit hall, you would see Alkermes banners hanging from the rafters, along with a booth of salespeople expounding on the benefits of the antipsychotic drug. An Aristada flyer they passed out featured two buildings—a guard tower surrounded by a razor-wire fence, and a community health center—with the slogan “Transition of care takes time.”

For most of the twentieth century, pharmaceutical companies expressed little interest in inmates. People in need of mental-health treatment often received it at state-run psychiatric hospitals. But in the 1950s and ’60s, states began shuttering many of America’s psychiatric hospitals, pushing patients toward treatment in their communities. Then, in the 1980s and ’90s, lawmakers passed “tough on crime” policies that dramatically expanded the nation’s corrections population. Taken together, those developments had the unintended consequence of turning jails and prisons into warehouses for the mentally ill. By 2005, more than a million adults behind bars had some form of mental illness, according to the Bureau of Justice Statistics.

The dramatic shift in American mental-health care presented new opportunities for pharmaceutical companies. Correctional officials are required by law to provide adequate health care, including prescription drugs, to inmates. They also have an imperative to try to make sure people have enough medication when they are released to tide them over until they can seek care on their own. Federal researchers have found that releasing inmates with a supply of medication, and connecting them to community-based treatment, has lowered the odds of recidivism. But by the turn of the millennium, psychiatric-drug prices were rising. As early as the 2000s, to help mitigate costs, local officials in some states, including Washington and Ohio, sought free samples of antipsychotic medications from pharmaceutical companies.

Since then, the relationship between drug companies and the criminal-justice system seems to have intensified: free samples to detention facilities; comped lunches during which jail and prison doctors learn about medications; and payments to physicians to tout certain medications at conferences for criminal-justice professionals, including those without health-care licenses such as sheriffs and drug-court judges. At recent conferences about correctional health care, Merck, Gilead, AbbVie, and other big pharmaceutical companies have staged “product theaters” or “education luncheons” that show how their products could help treat inmates. The criminal-justice system isn’t just a lucrative market because of current inmates; it also introduces incarcerated people to medication that they might continue using after they’re released. (The full cash price of Aristada is about $1,300 for a four-week shot. The drug is covered by Medicaid and Medicare but can still require hefty copays.)

Dr. Joseph Penn, the director of mental-health services for the Correctional Managed Care division of the University of Texas Medical Branch, which oversees treatment in many of the state’s jails and prisons, says drug companies have awakened to the potential market behind bars. “No other country incarcerates as many people as we do, and they realized, ‘Hey, that’s a whole market we haven’t tapped,’” Penn said.

Long-acting schizophrenia drugs, in particular, can be an effective medication for inmates who might otherwise resist treatment, potentially leading to a safer and more predictable environment for them and for the correctional officers on shift. Potenza, the doctor who presented at the Tennessee conference, told me that meetings with drug companies allow doctors like him “to understand the benefits, despite the amplification”—of a particular drug’s merits—“from the company reps.” And free samples of these drugs can make them more accessible.

But despite having benefits for detention facilities and prisoners—free drugs, more information about new treatments—these marketing efforts have raised worries among criminal-justice advocates that drug companies could influence both the prescribing habits of correctional doctors and the choices of non-health-care professionals such as sheriffs and drug-court judges. A recent ProPublica analysis found that doctors who accepted money from pharmaceutical companies for top brand-name drugs were more likely to prescribe those companies’ medicines than doctors who did not. And Dominic Sisti, a medical-ethics professor at the University of Pennsylvania, worries that nonmedical professionals might not be able to analyze drug companies’ marketing messages the way doctors can. “It’s a sales pitch,” Sisti said.

Potenza said that audiences should “apply a keen eye as to anything that is biased.” Dr. Brent Gibson, the chief health officer for the National Commission on Correctional Health Care, which organized the conference at which Potenza presented, said in an email that Alkermes and other sponsoring companies do not have input into presentations like Potenza’s. “We do reserve the right to not accept financial support from a corporate entity that is in conflict with our mission, but we do not feel that is the case with pharmaceutical companies that offer medications that can be useful in the correctional setting,” he wrote.

While drug companies have long marketed to people in a position to help patients make decisions, critics say their efforts in the criminal-justice sphere are particularly troubling because the patients involved, being incarcerated, may not feel that they have as much of a say in their own health-care decisions.

John Snook, the executive director of the Treatment Advocacy Center, a group that calls for better mental-health treatment, said, “If you’re a jailer, and someone says, ‘We’re going to provide you with a solution that gets regular levels of therapeutic medicine to a population that’s difficult for you to control’”—in the form of samples of psychiatric drugs—“that’s going to be extremely attractive.”

But David Fathi, director of the ACLU’s National Prison Project, expressed concern about whether this kind of marketing, aimed at jailers and judges rather than incarcerated people themselves, further diminishes the agency of prisoners, who are disempowered in nearly every facet of life behind bars. Even in cases where incarcerated patients elect to take a psychiatric drug, he said, it may be a choice made under duress, knowing that they may be medicated against their will if they refuse. “If you know you can be forcibly medicated, can you really make a free and noncoercive choice about medication?” he said.

Geoff Mogilner, a spokesman for Alkermes, said, “We expect healthcare professionals to utilize their independent clinical judgment to continually assess, with their patient’s input, how a medication is working and to recommend the medication that works best.”

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.

Janssen, whose schizophrenia drug leads the market, offers free samples and financially supports advocacy groups aimed at keeping individuals with mental illnesses out of jails. Last year, the company won approval from the FDA to market Invega Sustenna as a treatment that can keep schizophrenic patients out of jail. Before then, Janssen could market the drug’s ability to treat schizophrenia but not make further claims about how it might help incarcerated populations.

Once it got the additional approval, Janssen rolled out video testimonials of formerly incarcerated individuals receiving injections, including a 31-year-old woman identified only as “Tanara” who was incarcerated after a fight with a neighbor. Tanara explained that the injection allowed her to not worry about missing daily pills for schizophrenia and helped her get a steady job as a peer-support specialist after she was released.

Kaitlin Meiser, a Janssen spokeswoman, said free samples allow doctors to “familiarize themselves with the medicine and for patients to try the medicine and determine if it is the right fit for them.” But she noted that the company does not have any “concerted” efforts to specifically educate correctional doctors through the use of paid speakers or free meals.

Otsuka’s criminal-justice efforts appear more limited. Public records show that psychiatrists who have worked in corrections have received payments or perks from Otsuka, but Robert Murphy, a spokesman, said the company’s marketing does not specifically target the criminal-justice system. It has offered free samples of Abilify Maintena to just one correctional system, in Maricopa County, Arizona—and that was on request. He also said that Otsuka has not made “any payments for meals or speaking fees at any meetings or conferences where the audience was doctors or individuals who work with jails, prisons, or courts.”

Aristada, a relative newcomer in the antipsychotic-injection sector, trails behind Invega Sustenna and Abilify Maintena. As Alkermes seeks to catch up, it has provided the treatment in 40 correctional facilities in 18 states, offering free samples to many of them. And it has paid doctors to speak at criminal-justice conferences about its potential, as well as designing advertisements that depict people reentering society thanks to the shot. Two doctors told me Alkermes paid them to participate in focus-group panels where they were asked by company representatives about how to market the shot to criminal-justice officials.

Mogilner, the Alkermes spokesman, did not answer specific questions about the company’s marketing and sales tactics but noted that they are, to a large degree, no different from other companies’ efforts. He wrote in an email that Aristada can offer people leaving prison or jail “consistent and sustained” treatment during “the often-challenging transition back to the community.”

Corrections officials don’t have to exclusively prescribe Aristada in exchange for free samples, Mogilner added, or continue prescribing the shot after the samples run out. “We work to educate healthcare professionals and other stakeholders with whom they work about the treatment of schizophrenia in diverse settings of care, including criminal justice healthcare settings, community mental health centers, and hospitals,” he wrote. “No one medicine is right for every patient.”

Several health-care officials and practitioners told me that free samples of long-acting antipsychotic shots have helped their patients in the criminal-justice system access helpful drugs that would otherwise be too expensive for them to offer. “Funding is always an issue,” Rachel Waddell, a nurse practitioner who treats inmates in a 662-bed jail in Rapid City, South Dakota, told me. The jail has provided samples of Aristada to 10 inmates but hasn’t accepted payments from drug companies, or perks such as free lunches. “With Alkermes, we don’t have to jump through hoops.”

Officials in Maricopa County, Arizona, have not taken perks or payments from drug companies, but they have accepted free samples of long-acting shots from Janssen, Otsuka, and Alkermes. Grant Phillips, the medical director of Maricopa County’s correctional-health services, said that nearly 120 inmates are on long-acting shots and that they work well. More than half of those are ordered by judges, he said, but judges leave it up to doctors to decide which product is best for their patients. The medication consumes a fifth of the total pharmacy budget for a jail population of about 7,500.

While some jail officials see mostly an upside in drug companies’ marketing efforts, others say it’s more complicated. Jeff Gromer, the former warden of the Minnehaha County Jail in Sioux Falls, South Dakota, said he hasn’t accepted perks or consulting payments, but he has given samples of Aristada to 16 patients since 2018; their symptoms stabilized while on the drug. “When you put someone with anxiety and paranoia in [a jail] environment, it gets hard for them to cope,” Gromer said. “When they can’t cope, there’s behavioral problems such as self-harm or aggression toward inmates or staff, or hiding in their cell.” Still, he’s wary of Alkermes’s efforts to reach patients by marketing to criminal-justice officials overseeing them. “Alkermes’s hope is that the prescription is continued once they’re out of custody, and they’re going to get paid for that,” he said. (Alkermes didn’t comment on Gromer’s characterization.)

Penn, the doctor working with Texas prisons, said his system does not accept samples from drug companies at all and restricts the perks or payments doctors receive. While patients in Texas prisons are sometimes prescribed long-acting antipsychotic drugs—typically as a last resort—Penn expressed concern, noting that “there’s not much literature” on them yet. Though more company-funded studies are emerging, he hasn’t seen enough “good head-to-head studies of the medications,” he said.

Alkermes and other drug companies have marketed not only to jailers but to judges as well. Earlier this year, at a conference for drug- and mental-health-court professionals in Maryland, Alkermes sponsored a closed-door promotional session about using long-acting shots in a court setting. Featured at the session was Richard Jackson, a former psychiatrist at the Women’s Huron Valley Correctional Facility in Ypsilanti, Michigan, and Ernie Glenn, a magistrate in Bexar County, Texas, who had helped defendants in his court get access to long-acting antipsychotic shots. While Glenn had received no payments from Alkermes, the company had paid Jackson more than $250,000 between 2015 and 2018 for speeches, travel and lodging, and meals, according to the Centers for Medicare and Medicaid Services’s open payments database. (Jackson also received $252,608 in payments from Otsuka from 2015 to 2018, and said he has continued receiving payments from drug companies in 2019; it wasn’t immediately clear whether Alkermes was one of them.) The conference program, as in the conference in Nashville, directed people to learn about Aristada at Alkermes’s exhibit booth. “It wouldn’t matter to me if the info was sponsored by one company or all the companies, so long as the info about the medication gets out to the public,” Glenn later told me.

“A lot of people in corrections … they’re not even aware,” Jackson said of long-acting injections. “If you’re not getting educated, you’re not using them, there’s no way it’ll ever be afforded to those prisoners.”

Judge Robin Faber, who presides over a Miami-Dade County court division that aims to divert inmates into mental-health treatment, has not been the target of marketing by Alkermes or any other pharmaceutical firm but said he sees the potential of long-acting drugs in his sixth-floor courtroom. One sweltering afternoon in early September, a young man named Chris Sellers took off his orange cap and slouched into the back of Faber’s courtroom. (Sellers’s name has been changed; Faber, Sellers’s lawyer, and Sellers allowed The Atlantic to sit in the courtroom, which isn’t open to the public, on the condition that his real name not be used.) Faber was reviewing Sellers’s medical records.

“You look good,” Faber said. The first time Faber had met Sellers, several months earlier, Sellers had recently been arrested for stealing a $20 T-shirt. Having looked at his records, along with his initial health assessment from a doctor, Faber felt Sellers’s nonviolent offenses were linked to untreated mental illness, and decided to require treatment instead of incarceration. At the time, to ensure that Sellers received his medication, Faber ordered an involuntary shot for his schizophrenia. Faber believed that Sellers would reoffend without it—and hoped that it would break his cycle of incarceration. As Faber continued reviewing the records, he noticed that Sellers had since received another long-acting shot. “That’s probably helping a lot,” Faber said, agreeing to keep Sellers on the treatment regimen instead of sending him to the Dade County Jail.

After Sellers’s hearing, Faber told me he defers to doctors regarding which medications patients should get. Ernesto Grenier, a psychiatrist at Jackson Health, the medical provider for three of Miami-Dade County’s jails, is often the one choosing those drugs.

When I spoke with Grenier, he told me that Jackson Health prohibits free samples from pharmaceutical companies. But, on occasion, Grenier has listened to pitches from Otsuka, Janssen, and Alkermes. From 2016 to 2018, he accepted food or drinks from the three companies 22 times, for a total of $949.92. He said he does not typically prescribe Aristada—which he considers less proven than some other drugs because it is newer—and dismissed the notion that free lunches or drinks from any drugmaker might have influenced his care. “They all say theirs is the best,” Grenier said. “We choose medication based on the patient.” (Click to Source)