West Virginia will receive close to $1.5 million from a nationwide settlement.
West Virginia will receive close to $1.5 million from a nationwide settlement with the maker of Suboxone, Indivio Inc.
Suboxone is a prescription medicine used to treat opioid addiction in adults.
West Virginia Attorney General Patrick Morrisey announced that 41 states and Washington, D.C. have settled with Indivior Inc. for a total of $102.5 million nationwide.
The lawsuit began in 2016 when a coalition of states filed a complaint against Indivior Inc., alleging the company used illegal tactics to preserve its drug monopoly.
The coalition argued the alleged unlawful conduct allowed Indivior time to switch the market to its brand name oral film (a film form that dissolves under the patient’s tongue) before generic manufacturers of the pill form were set to enter the market back in 2009.
“Companies should not resort to improper means to control the market, all the while hurting consumers,” Morrisey said. “Competition is the driving force in a free market economy, and those who resort to improper means will be held accountable to the full extent of the law.”
The agreement requires Indivior to pay a total of $102.5 million.
Indivior is also required to comply with negotiated injunctive terms that include disclosures to the states of all citizen petitions to the FDA, the introduction of new products, or if there is a change in corporate control, which will help the states ensure that Indivior refrains from engaging in the same kind of conduct alleged in the complaint.
For those working daily to treat addiction tied to the opioid epidemic in the Ohio Valley, resources have been limited. Beginning this week doctors will have a little more to work with.
The federal government will allow doctors to treat more patients with buprenorphine, a medication that can help ease people away from addiction.
While the science supports this treatment, some remain skeptical. Visits to three treatment centers in the region show the different approaches people in the recovery community are taking. In the fight against the addiction crisis, it appears there is no single silver bullet.
“Hi, James”
In a Louisville halfway house for inmates and parolees, a group of men gathered to offer support to one another as they work through addiction in a Narcotics Anonymous meeting.
James Sweasy stands up, offers an introduction and then begins his story.
Until three years ago, he lived a life of substance abuse that began with drinking and escalated to more dangerous substances.
“I would do just about anything,” he said. “I started off drinking alcohol, smoking marijuana. It progressed to cocaine, crack, painkillers, ecstasy. You name it. If you found a pill on the floor and didn’t know what it was, I’d take it, and let you know if it’s any good here in a minute. Anything to change the way I feel.”
Sweasy would eventually seek help in getting off the narcotics and went to a medication assisted treatment facility.
“They gave me a bottle of Suboxone,” he said. “Like most people who are on the drug now, I thought it was a miracle drug.”
Suboxone is a mixture of naloxone, the opioid-reversal medication, and a less potent opioid referred to as buprenorphine. Doctors typically prescribe buprenorphine to help individuals addicted to opioids detox and manage their cravings down the line.
Credit James Sweasy
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James Sweasy uses his social media site to encourage others in recovery from addiction.
Going to the MAT
The U.S. Department of Health and Human Services is expanding timely access to buprenorphine. A new federal rule allows certified physicians to treat up to 275 patients with the medication, up from 100.
This is important to those treating patients in rural areas who saw resources diminish while waiting lists got longer.
“For every client we saw with an opiate problem in the year 2000, we have 50 walk through the door today,” Dr. Joseph Gay, executive director of Health Recovery Services, said. While waiting lists are shorter than they used to be, Gay said, people still have to wait. “The service isn’t available as quickly as I would like it to be.”
Dr. Joseph Gay said there is strong science supporting medication assisted treatment for addiction. Credit Aaron Payne / Ohio Valley ReSource
Dr. Gay oversees the private, non-profit with eight outpatient behavioral health and addiction facilities to go along with two residential programs, all spread throughout southeast Ohio.
Two of the programs are listed as certified opioid addiction treatment programs, using the three major medication assisted treatment medications –including buprenorphine– combined with psychosocial treatments like therapy and job training.
Dr. Gay frequently gives educational talks to the community on medication assisted treatment, or MAT. He said the government has good science behind its decision to expand use of buprenorphine, with a body of studies showing the value of this approach to addiction treatment.
A recent study from 2015 published in the Journal of Substance Abuse Treatmentfound those treated with methadone or buprenorphine were less likely to relapse into addiction than those being treated without.
“The science is pretty clear,” Dr. Gay said. “But there’s still a lot of resistance to MAT.”
Credit Alexandra Kanik / Ohio Valley ReSource
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Ohio Valley ReSource
A Call for Vivitrol
That resistance is largely due to the abuse of buprenorphine.
Addicts have given the drug street value by using it to maintain their tolerance while getting stronger opioids –rather than completing treatment– and combining it with other substances to get a high.
Hopewell Health Centers is expanding its MAT program to facilities throughout southeast Ohio with a different drug, Vivitrol, as the lone medication.
Vivitrol –unlike buprenorphine and methadone– is not an opioid. It is injected into the body in 30-day doses and, once active, shuts off communication between opioids and natural receptors within the body, helping to manage cravings.
“It just seems to be a cleaner clean,” Kate Jiggins, Hopewell’s MAT director said. “That person is literally opiate-free and this medication blocks that mu-receptor. So, even if they were to use [opioids], there’s no high.”
In order to begin uses of Vivitrol, however, a client must be completely opioid free. By contrast, buprenorphine may be prescribed on the first day of treatment. The detox needed to begin Vivitrol can be a painful process without some assistance, and the resources are scarce in rural areas.
“We’ve had to consider using a facility up in Canton, Ohio, which is about two and a half hours [away], in order to get a cost-effective, appropriate non-opiate transition onto Vivitrol,” Jiggins said.
Jiggins said she thinks this may be why the government health experts favor buprenorphine treatment. Also, the body of scientific research supporting Vivitrol, while growing, is not as extensive as the research behind buprenorphine.
The Original Treatment Model
Credit Alexandra Kanik / Ohio Valley ReSource
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Ohio Valley ReSource
In Huntington, West Virginia, the opioid epidemic has hit particularly hard. Last year, the city had an overdose rate much higher than the national average, according to a report from the Robert Wood Johnson Foundation.
Recovery Point West Virginia was founded in the city to meet the demand for treatment, adopting an abstinence-based model. Its three residential treatment facilities – with a fourth on the way — encourage clients to recover without medication.
“We just believe at Recovery Point in total transformation without the presence of mood or mind-altering substances,” Recovery Point’s executive director Matt Boggs said.
However, Boggs acknowledged that there are many ways to reach recovery. That’s a more flexible position compared with some other leaders in the abstinence-only community.
With recovery resources scarce, Boggs said, he believes if one model of treatment doesn’t work, another should be sought.
Matt Boggs takes an abstinence-based approach to treatment at Huntington’s Recovery Point. Credit Aaron Payne / Ohio Valley ReSource
The buprenorphine treatment did not work for him. After abusing Suboxone, he eventually got clean without medication. Today he is a father, homeowner, and social media personality advocating for recovery purely through abstinence.
But Sweasy said he doesn’t think any treatment methods should be ruled out, and that medically-assisted treatments such as buprenorphine could work for others if administered properly.
“I think it is important to say that anything is better than being dead,” he said. “There are all types of treatment. I’m not locked into one thing.”
The Government Makes its Pick
Science, however, does not suggest all treatments are equal.
The new rule raising the cap on buprenorphine prescriptions and other provisions in the recently signed Comprehensive Addiction Recovery Act show that the Obama administration is acting on the evidence that medication assisted treatment is the strongest tool in the fight against addiction.
Programs that use medication to treat substance abuse are now more tightly regulated under West Virginia law.
The law endorsed by Democratic Gov. Earl Ray Tomblin and the GOP-led Legislature took effect Friday, June 10.
It provides requirements for licensure, registration, regulation and inspections of clinics treating people for substance abuse with medication, including Suboxone clinics.
Suboxone is a brand of buprenorphine, which lowers the effect of opioids. It can also be abused.
The law requires patient agreements and treatment plans describing the medication and expectations. It also warns patients about the ramifications of selling or abusing the medication.
The law ensures patients receive counseling and behavioral health therapies.
A database will monitor how effectively medication-assisted programs are treating substance abuse.
A rule determining many of the law’s specifics is being drafted.
Gov. Earl Ray Tomblin has approved two bills that address West Virginia’s substance abuse problem.
The Charleston Gazette-Mail reports that the Democrat signed bills Tuesday dealing with regulation of opioid treatment clinics and availability of life-saving opioid overdose medication.
One measure will regulate Suboxone and methadone clinics, which use medication-based treatment for opioids. It will require clinics to be licensed and to offer counseling.
The other law will make the overdose-reversing drug naloxone, known by the brand name Narcan, available without a prescription. Last year, Tomblin signed a bill letting first responders carry naloxone.
Tomblin introduced the bills, and the Republican-led Legislature passed them.
In the world of medication-assisted substance abuse treatment, there are three prescription drugs that are the most widely known: methadone, Suboxone and Vivitrol.
Traditional Opioid Agonists
Methadone and Suboxone have been the most widely used drugs in addiction therapy in West Virginia. Both are synthetic opioid-based medications that react with opioid receptors in the brain just as heroin or prescription narcotics would. These drugs are often used to wean people off of illicit drugs like heroin or prescription painkillers like oxycodone.
Dr. Erika Pallie works at Valley Alliance Treatment Services, a private medication-assisted treatment clinic in Morgantown, has just started using Suboxone for treatment, but she most often prescribes methadone.
“So how it works as a medication-assisted treatment is by replacing the drugs that they’re used to and you very gradually increase the dose until the patient is no longer in withdrawal and their cravings are blunted,” she said of methadone treatment.
The problem with methadone, Pallie said, is its bad reputation. Many people hear the name and think about its illegal use on the street, or the doctors who have been arrested for passing out prescriptions. Pallie agreed, it is sometimes sold illegally, but that doesn’t mean the treatment option should be discounted.
“The big complaint I hear is you’re just trading one drug for another,” she said, “which is a very judgmental approach to it and it’s coming from an abstinence-based philosophy, which doesn’t really work that well.
“I think that one thing that’s really important is that people need to realize that methadone clinics actually help people.”
Still, there are other barriers to drugs like methadone or Suboxone. For instance, addicts who choose those treatments must initially be supervised when they take the medication, meaning they have to go to a clinic every day to both receive and take the drugs.
A New Treatment Option
Vivitrol is an opioid antagonist. Taken just once a month through injection, the drug enters an addict’s system and coats the opioid receptors in the brain. That prevents an addict from feeling the high that comes with using heroin or prescription narcotics.
While Vivitrol has been used clinically by some health care providers in the state, during the 2015 session, members of the West Virginia Legislature approved a bill expanding access to the drug.
“It creates a unique pilot program within the criminal justice system in West Virginia,” Kanawha County Del. Chris Stansbury said of the bill. He was its lead sponsor.
The Pilot Program
Administered through the court system and paid for with Medicaid dollars from the state and federal government, the pilot program gives non-violent, low-level drug offenders participating in drug courts the option to use Vivitrol alongside counseling and rehabilitative services.
Drug courts are diversionary programs that allow addicts to work toward recovery with a team of medical and legal professionals instead of being incarcerated.
The pilot doesn’t just allow for Medicaid coverage, it also calls for two years of intense monitoring of Vivitrol’s use in five counties.
While those counties haven’t been determined by the West Virginia Supreme Court just yet, Justice Brent Benjamin — who helped create the drug court program — expects that decision to come soon. Then, he said, the data collection will be crucial.
“The one thing that we stress, we underscore in drug courts is that drug courts is an evidence-based program. We can tell what our re-occurrence rate is for people who graduate from the programs. They’re very good, in fact, they’re some of the best in the country, but we only know that because we keep the numbers,” he said.
The Counter
There are people who say Vivitrol won’t work, like Dr. Rolly Sullivan. He runs West Virginia University Hospitals’ addiction treatment clinic in Morgantown, where he specializes in using Suboxone coupled with individual and group therapy.
Sullivan said he doesn’t believe Vivitrol does much to help with an addict’s urge to get high.
“The cravings, which is that basic, biologic brain illness that is addiction, doesn’t go away when you’re on Vivitrol, and it doesn’t really get treated when you’re on Vivitrol,” he said. “That cravings still sits there and gnaws at people.
“Theoretically you should be able to put someone on Vivitrol and it would work fine. People wouldn’t use drugs because they couldn’t get high, but in reality, people will use Vivitrol once and the chances of them coming back for a second shot a month later are really low and the chances of coming back for a third shot is almost nonexistent.”
Sullivan was once a paid spokesman for Suboxone’s manufacturer, Reckitt Benckiser, but stopped accepting payment for speaking events in 2014.
Addicts Say It Works
Although the Federal Drug Administration hasn’t affirmed the claim, supporters of Vivitrol disagree with Sullivan. They say anecdotally, addicts have told them it does take away that itch to use.
“I’ve heard a lot of testimony on this, and the addicts, independent of one another and in testimony, have said it took my craving away and Vivitrol is the only thing I’ve heard people say that it took my craving away,” Ohio Representative Ryan Smith said. Smith wrote the pilot program for Ohio that West Virginia’s legislation was modeled after.
“That’s the thing we fight because we get people clean for 30 days or 60 days and then they fall off the wagon and end up using again,” he said.
Just like in West Virginia, Ohio administers the medication through state drug courts as an option for participants. Andrea Boxill, Deputy Director of the Ohio Governor’s Opiate Action Team, said while 82 percent of the drug court participants in that state’s six pilot counties chose Vivitrol, it’s not necessarily any more effective than another drug.
“You can use Vivitrol, which for some younger people who are just starting out in terms of heroin, it’s been effective, but it has not been any more effective than methadone, which is something that’s typically prescribed to people who are older who have been using heroin for years,” she said. “Nor is it any more impactful than Suboxone.
“The best way to say it is there is no one size that fits all disease, as with heart disease, high blood pressure or diabetes. You have to treat the individual and figure out which works best for that individual.”
But no matter which side of the fence you’re on, which medication you think is best, medical professionals, judges, politicians, they all say the same thing about the medications. They can’t be used alone. They must be used in conjunction with intense counseling and education.
Once counties are identified, both Justice Benjamin and Delegate Stansbury expect the Vivitrol pilot program in West Virginia to begin quickly. The bill went into effect June 16.
Those eligible for Medicaid or other government assistance within the pilot counties will have the option to use Vivitrol, but no medication or even participation in the drug court program is required.
Court officials expect to have preliminary results from the pilot program to report to the legislature during the 2016 session. A final report is due in 2017.
