Drug cuts heroin cravings, but is expanding use worth the risk?

Erin Roalson spent her late teens raging against family and shunning old friends for drug buddies. Three and a half years later, a $100-a-day heroin habit was all she had left.

Thoughts of suicide led to a 72 hour hospital stay and methadone, a common therapy for heroin addiction. But her cravings wouldn't leave. That's when a drug counselor suggested buprenorphine, a treatment designed to offset cravings and withdrawal associated with opiate addiction. A daily dose made Roalson feel like herself again.

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"When I first was able to cry, I cried forever, and then I started laughing because I could laugh, and I did it because I wanted to," Roalson said. "I needed to get all of those feelings out of me so I could move on and start over."

Buprenorphine is fairly new and has shown promise helping Roalson and other addicts. But there's a catch: Congress capped the number of patients each doctor can treat with the drug and a doctor must request a waiver to prescribe it.

Now, more than a decade after federal regulators first approved buprenorphine treatments, opiate abuse is skyrocketing. Some doctors and public health officials say it's time to remove the caps limiting patient access to the potentially life-saving medication.

Change may be coming. In Washington, several senators recently questioned the restrictions during a hearing on buprenorphine, known by the brand name Suboxone.

Treatment centers add another tool

In 2012, about 14.6 million Americans reported illicitly using an opiate, either illegal drugs like heroin or prescribed painkillers, according to the most recent annual survey of drug use by the federal Substance Abuse and Mental Health Services Administration.

The number of overdose deaths this year surpassed car accidents as the number one cause of death in the U.S. The Centers for Disease Control and Prevention has called opiate overdose deaths an epidemic.

Buprenorphine isn't a magic pill. It's one of many tools, including counseling and methadone, available depending on patient circumstances, said Chuck Hilger, executive director of Twin Cities-based Valhalla Place, which provides medication-assisted treatment.

Buprenorphine is a partial opiate, which means it bonds with people's opioid receptors for between 24 and 36 hours, during which time other opiates, like heroin, are unable to access them. Essentially, buprenorphine blocks the heroin high.

"The advantages of methadone and [buprenorphine] for treating opiate addiction is it takes care of the cravings, eliminates the physical illness, the withdrawal, normalizes your brain functioning," said Hilger, who's witnessed the surge in opiate abuse.

Those changes can help opiate addicts, like Roalson, who is a patient at Valhalla Place, access other treatment services and stabilize their lives, after which the treatment center can help them start to taper their dosage.

But even at that point, Hilger said, treatment counselors are cautious about slowing any anti-opiate medication too drastically. Some clients may stay on them for life -- not so much because of the physical withdrawal symptoms caused by opiate dependency but because drug use may have interfered with the patient's ability to naturally produce endorphins, he added.

"Every day looks like the second Tuesday in February, and it doesn't get any better than that, and they know that at any given time that they can take a pill or use heroin," Hilger said. "That's often what gets people to relapse."

Because buprenorphine is a partial opiate, it also has potential for abuse.

The American Association of Poison Control Centers annual report showed that U.S. poison centers encountered 3,625 reports and three deaths involving buprenorphine in 2011, although doctors say the medicine is relatively safe.

A spokesperson for the Hennepin County Sheriff's Office said buprenorphine is on their radar, but that they haven't run into any major problems with it being abused or trafficked.

The CDC and SAMHSA acknowledged in an April article in the New England Journal of Medicine that medication-assisted therapies have effectively helped patients recover from opiate addiction. In a Baltimore study, the medications saved lives by decreasing the fatal overdoses by about 50 percent.

Medication-assisted therapies are still only offered in less than half of all private-sector treatment programs. The report also cited skepticism by officials at treatment centers that focus on abstinence-only models as a reason why drugs like buprenorphine aren't more widely available to those in treatment.

That may be changing.

Minnesota-based Hazelden, part of the largest private, non-profit treatment system in the country, has been a longtime stalwart of abstinence-only treatment. But in January of last year, the clinic expanded its use of buprenorphine.

The decision is based on data showing it could help patient outcomes, said Scott Hesseltine, director of clinical support and operations for Hazelden. The clinics still do not offer methadone, which has a greater stigma associated with it.

"Certainly, this initiative was not without controversy," he said. "But I think people are starting to realize that we're in the midst of a public health crisis that demands us really working together and using every means that's at our disposal to help more people recover and not die from this disease."

Hazelden's initial findings show the number of people who left treatment despite the advice of their doctors fell from 20 percent to about 11 percent.

Other abstinence-only treatment centers may be changing their attitudes toward medication-assisted treatment as more data is gathered about patient experiences. Hesseltine said.

"For some people they've reported that overnight they feel normal again, they went from feeling miserable to feeling normal and being able to engage with other people and family and relationships," Hesseltine added. "It's pretty remarkable."

Access limited through physicians

In 2000, Congress passed a bill called the Drug Addiction Treatment Act, which for the first time allowed doctors to prescribe medication-based treatment of opiate addictions out of their offices.

Each physician has to take eight hours training and apply for a waiver. After one year of treating up to 30 patients, they can apply to treat up to 100 patients.

Congress originally imposed the caps because lawmakers were concerned about kindling a new black market for prescription opiates, said Robert Lubran, director of the division of pharmacologic therapies in the Substance Abuse and Mental Health Services Administration.

The cap, however, has sometimes made it hard for patients to get access to buprenorphine because so few doctors have applied to distribute the drug, he added.

About 1 million people received buprenorphine prescriptions at some point last year but only about 3 percent of eligible physicians -- about 26,000 doctors -- can prescribe the drug, Lubran said. Many of those doctors don't treat as many patients as they're allowed to under the law.

"Many physicians are not taking on new patients, there's a waiting list," Lubran said. That's something we'd like to see changed."

The huge rise in prescription opiate use in recent years leaves the few doctors willing to treat addiction in huge demand, said Dr. Anne Pylkas, who works at a St. Paul HealthPartners pain clinic and practices addiction medicine services privately.

"Nobody in primary care wants to do this, and the reason they don't want to do this is they don't want to attract this group of patients to their office, they don't want the trouble," Pylkas said. "What I'm saying is that people who do want the trouble, like me, let me do it."

She's certified to prescribe buprenorphine-based drugs to up to 100 patients, but because the demand is so high and so few doctors prescribe the drugs, she bumps up against the patient cap all the time.

"I find people weekly who I want to start on Suboxone. There are people I'd like to have on Suboxone that I don't start on it because I think I can probably get away with trying something else first," Pylkas said. "To me, that's ridiculous that I have to do that, that I have to give somebody treatment that I don't think is the best treatment because of some arbitrary limit."

A recent statement by the American Society of Addiction Medicine supports her view.

Saying it was concerned "prescribing limits restrict patient access to treatment," the society recommended lifting limits using a "graduated, thoughtful approach that focuses on higher levels of training for non-addiction certified physicians who are interested in prescribing beyond the 100-patient limit."

Not every doctor believes lifting the cap is the best approach.

"We don't need the few docs we have to see more patients, we need many more docs to see fewer patients," said Dr. Charles Reznikoff, an addiction medicine specialist at Hennepin County Medical Center. "We need to mainstream it."

Doctors' understanding of addiction has lagged, even as prescriptions of opiates for painkillers have skyrocketed, he said. Physicians need to understand that opiate addiction isn't a moral failing, but a side effect of prescribing opiates, just like prescribing a blood thinner can cause adverse reactions in a patient, he added.

"The risk of bleeding with blood thinners is the same as the risk of opioid addiction, it's a couple percent. You say that to a doc, they'll say, 'That's absurd, I would never give them a blood thinner and then turn them away if they start bleeding,'" Reznikoff said. "But you're giving them opioids, and then you're turning them away if they get addicted."

There may be signs of a shift in Congress.

Sens. Carl Levin, D-Mich., and Orrin Hatch, R-Utah, the original sponsors of the 2000 bill that let doctors apply for the waiver, held a forum last week on buprenorphine where they questioned the need for the patient cap.

"Doctors take an oath to do no harm as they treat their patients, but harm is done when an opioid addiction is ignored," Levin said. "As long as we have too few doctors certified to prescribe [buprenorphine], we will be missing a major weapon in the fight against the ravages of addiction."

The Substance Abuse and Mental Health Services Administration doesn't currently have a position on lifting the cap, but that agency officials are preparing recommendations for the U.S. health and human services secretary, Lubran said.

"This is a very important part of the solution to the prescription and heroin problem, as well as the overdose deaths," Lubran said. "We just think that if we can get more physicians treating more people, it will be beneficial to society and to the individuals who are suffering from addiction."

Roalson of St. Paul is more than five years sober.

Now 24, though, she feels like she lost her youth after years drifting around the Twin Cities under the sway of heroin.

"There's a lot of my life that when I was using that I don't remember," she said. "I don't know if it's a personal choice where I choose not to remember or if it's just my brain saying, 'You don't need to remember this.'"

She's currently visiting her older sister and new nephew in Alaska for the summer. If she decides to stay there, she may face the same quandary many others struggling with opiate dependency in the United States do: how to find a doctor to prescribe medication that she credits with keeping her clean and helping her rebuild her life.

"Me and my older sister, we fought all the time, she didn't want to be a part of my life, she told me never to talk to her again," Roalson recalled. "It makes me really happy that I've proven to my family again that I'm able to be respected and that she trusts me with her child."