August 7, 2017

Should A Judge Tell You What Medication to Take with The Power to Make You?





Philip Kirby says he felt pressured into taking Vivitrol for his heroin addiction by his drug court treatment program. "Like I couldn't come into the program until I got it," he says.
Jake Harper/Side Effects Public Media
Philip Kirby says he first used heroin during a stint in a halfway house a few years ago, when he was 21 years old. He quickly formed a habit.
"You can't really dabble in it," he says.
Late last year, Kirby was driving with drugs and a syringe in his car when he got pulled over. He went to jail for a few months on a separate charge before entering a drug court program in Hamilton County, Ind., north of Indianapolis. But before Kirby started, he says the court pressured him to get a shot of a drug called Vivitrol.
Vivitrol is a monthly injection of naltrexone, which blocks opioid receptors in the brain. It's one of three medications approved by the Food and Drug Administration for treating opioid addiction. While it's effective in some people, it's not for everyone. Patients have to be ready to be opioid-free, and some patients won't do well on it. It can also have side effects, which Kirby says he experienced.
"I had sinus problems, chest problems for the whole month I was on it," Kirby says. "I couldn't shake it."


He says he also got a rash — another possible reaction to Vivitrol, according to the product's warnings. Months after he had the shot, he still had white splotches on his arms, which he attributed to the drug. But even with those symptoms, Kirby says the court urged him to stick with the medication for a couple of more months. "They were way too pushy about it," he says.
More than 130,000 Americans will go through drug courts this year, according to the National Association of Drug Court Professionals. Drug courts are designed to allow some people whose crimes stem from addiction to get treatment instead of jail time. But the treatment that is offered varies from court to court and is entirely at the judge's discretion.
Some courts offer participants a full range of evidence-based treatment, including medication-assisted treatment. Others don't allow addiction medications at all. And some permit just one: Vivitrol.
Prime targets for marketing
One reason for this preference is that Alkermes, the drug's manufacturer, is doing something nearly unheard of for a pharmaceutical company: It is marketing directly to drug court judges and other officials.
The strategy capitalizes on a market primed to prefer their product. Judges, prosecutors and other criminal justice officials can be suspicious of the other FDA-approved addiction medications, buprenorphine and methadone, because they are themselves opioids. Alkermes promotes its product as "nonaddictive."
The argument worked for Judge Lewis Gregory, who heads the city court in Greenwood, Ind. About a year and a half ago, Gregory didn't allow participants to start on addiction medications while in the program. "We were failing miserably with the heroin population," he says.

Judge Lewis Gregory, head of the city court in Greenwood, Ind., began allowing drug court participants to begin taking Vivitrol after meeting with an Alkermes sales representative.
Jake Harper/Side Effects Public Media
At the time, Gregory was only familiar with buprenorphine and methadone. Both are opioid medications that can prevent withdrawals, reduce cravings and ultimately help people maintain a stable recovery. When they are properly prescribed and administered, patients don't get a euphoric feeling or a "high."
Buprenorphine and methadone have been the standard of care for opioid addiction for years, but because they're opioids, it is possible to misuse them. They're also sold illegally on the street.
"I was certainly not going to do a medication-assisted treatment program with drugs which people use to get high," Gregory says, adding that he would not order someone to stop buprenorphine treatment if it were legally prescribed by a physician, a situation he rarely sees.
Then he received some Vivitrol literature in the mail and a phone call from an Alkermes sales representative. "So we ended up meeting in the early part of 2016, and she began educating me a bit," he says.
Six months later, his court began a Vivitrol program, permitting some participants to use the drug. A sales representative sometimes sits in on the court's treatment team meetings, Gregory says.
Many treatment specialists say allowing judges and other criminal justice officials with no medical training to exert influence over medical decisions is problematic. The power makes them prime targets for Vivitrol marketing, they say.
"You would think it would be more appropriate to go after physicians," says Basia Andraka-Christou, who researches drug courts at the Fairbanks School of Public Health at Indiana University.
"What this is implying is that the judges in these cases are actually making a lot of the medical decisions, and that should be very concerning to everyone," she says.
Adriane Fugh-Berman, who researches pharmaceutical marketing at Georgetown University, says she has not heard of another drug company going after judges. She says it's not just unique — it's inappropriate and could ultimately be damaging to patients. "They're not health care providers. They don't know data. They don't know research," she says. 
A company strategy
The drug court Kirby went through doesn't allow medications other than Vivitrol for treating addiction. In fact, NPR and Side Effects Public Media have identified at least eight courts out of the several dozen in Indiana that say they only allow Vivitrol treatment.
NPR and Side Effects Public Media have learned that Alkermes sales reps have also marketed the drug to court officials in Missouri and Ohio. A report from ProPublica found that extensive marketing is leading judges to favor Vivitrol around the country.
The company is open about this part of its sales strategy. At an investor event last year, policy director Jeff Harris said drug courts are a huge market for Vivitrol.
"We're making progress but still just barely scratching the surface on the need that exists across the country," Harris said in a presentation. "There are over 3,000 counties in the United States, and there are over 3,000 drug courts." A shot of Vivitrol costs about $1,000, making it pricier than the other addiction treatments. In many cases, the drug is paid for through Medicaid or other public funds. And marketing to criminal justice settings seems to have paid off for the company, whose earnings have grown significantly since its introduction. Vivitrol sales reached $209 million in 2016 — up from just $30 million in 2011. Sales have continued to climb this year.
Alkermes goes beyond marketing to judges. It also lobbies state and national policymakers to write laws that favor Vivitrol — and in some cases, hamper access to other addiction medications. The company has said it supports the use of all medications for addiction, but in practice, it doesn't.
The company supported one law in Indiana that encourages the use of Vivitrol in drug courts. Signed in 2015, the bill allows judges to require medication as a condition of participating in a drug court, and the language specifically highlights Vivitrol treatment.
Alkermes declined repeated interview requests. In a written statement, the company defended the practice of marketing in criminal justice settings by noting that judges don't actually prescribe their product.
No one-size-fits-all solution
Drug court judges interviewed for this story say they don't mandate Vivitrol treatment, and that people can say no.
"We encourage it, but we never force anybody," says Judge Gail Bardach of the Hamilton County, Ind., drug court, where Philip Kirby was a participant.
But facing potential jail time and court officials who really believe in Vivitrol, participants say getting the shot doesn't always feel like a choice.
"They made it seem like they were forcing it upon me, like I couldn't come into the program until I got it," Kirby says.
For some patients, Vivitrol does help. Jeremy Templin went through the Hamilton County drug court program a few years ago after he was arrested for theft. He said the decision to go on Vivitrol seemed like it was made without him, but he credits his recovery, in large part, to the drug.
"I don't know what it would have been like without it, but I know that I did have it, and here I am today," he says. "I'm still alive."
But Vivitrol is far from a one-size-fits-all solution. It's not ideal for patients who are dealing with chronic pain on top of their addiction, or for pregnant women. It's expensive. Furthermore, relapse rates for all kinds of opioid addiction treatment are high, and after a period of not using, tolerance for opioids is low. Treatment with Vivitrol, which contains no opioid ingredients, could make someone more likely to overdose if they relapse, addiction specialists warn.
Dan Mistak, an attorney with Community Oriented Correctional Health Services, says courts should allow all medication options and let doctors make treatment decisions — including whether someone should use medication in their recovery.
"We rely on outside experts all the time in the judicial system. We don't ask a judge to come in and be an expert in arson," for example, he says. "This is a responsibility that a judge doesn't want."
The federal government and the National Association of Drug Court Professionalsagree that courts should allow all three FDA-approved opioid addiction medication options.
"Especially with this exploding opioid use epidemic, we have to make available, as much as we can, whatever interventions are out there that are likely to be effective," says Terrence Walton, chief operating officer for the NADCP, which lists Alkermes as one of its biggest donors.
For some judges, limited access to buprenorphine and methadone shapes their decisions about what to allow in drug court programs. The medications are heavily regulated, and many communities lack providers who can prescribe and dispense the drugs. Judge Bardach says she would consider allowing participants to use methadone if there were a provider closer to the court.
A need for regulation?
Currently, there is no regulatory agency that can ensure that judges follow best practices.
"There are not that many ways to leverage accountability over these courts," says Christine Mehta, a researcher at Physicians for Human Rights. Mehta recently authored a report on drug courts, focusing on three states. "Really the key is attaching restrictions and requirements to funding," she says.
The federal government has put some requirements in place for courts receiving grants from the Bureau of Justice Assistance. They have to show that they "will not deny any eligible client access to the program because of their use of FDA-approved medications for the treatment of substance use disorders." But only about 200 of the more than 3,000 drug courts nationwide operate with help from a BJA grant.
The Substance Abuse and Mental Health Services Administration has similar grant-making guidelines in place, but it currently funds only 172 courts.
Mehta says states and counties need to implement similar requirements and work to educate drug court officials about all addiction medication options. She argues that until drug courts allow all of the medications, they're not fulfilling their promise.
"If drug courts say that they provide access to treatment instead of prison, they are inherently violating that by saying, 'Well, we only provide Vivitrol,' " she says.
Mehta says Alkermes' marketing would be less effective if judges were compelled to follow best practices.
Georgetown researcher Fugh-Berman thinks that pharmaceutical companies like Alkermes should be barred from marketing to court officials and lawmakers.
"It would be great if the [FDA] went after this," she says. "I think it does fall under their jurisdiction, but I wouldn't rely on that being enough." She says Congress could pass a law preventing such marketing, as well.
Philip Kirby says his probation officer finally relented when he lifted his shirt and showed that his rash was covering his whole body.
That rash has since cleared up, but it has left a pattern of white spots on his arms.
"I don't know if they'll go away," he says. "I hope they go away eventually."
He says he wishes he'd never taken Vivitrol in the first place.

This story is part of a reporting collaboration with NPR, Side Effects Public MediaKaiser Health News and WFYI. Esther Honig of WOSU in Columbus, Ohio; Bram Sable-Smith of KBIA in Columbia, Mo.; and NPR's Shaheen Ainpour contributed reporting.

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