By Doug Donovan and Fred Schulte
December 18, 2007
They're among tens of thousands of addicts nationwide being treated with the buprenorphine drug Suboxone. Federal officials promote it as the best hope for overcoming opiate addiction and are encouraging thousands of doctors to prescribe the drug.
It is the best medication for relieving the cravings and sickness of heroin use that Wendy Merrick has seen. But Merrick, who directs addiction care at the Total Health Care center in West Baltimore, says it's no cure-all. Addicts need counseling and other services to get well.
"I never understood this whole idea that you could just give people a pill and that that is the answer to drug addiction," she said.
The federal government equipped doctors and patients with little more than a pill when it approved prescribing buprenorphine to opiate addicts. The law doesn't require that doctors provide additional treatment - or receive much training to deal with the complexities of addiction. Nor did lawmakers authorize funds to help patients pay for the drug or additional care, costs that can quickly reach thousands of dollars.
Even with the extra services that a substance abuse clinic offers, Suboxone patients are having a hard time shaking old habits they learned on the streets. Up to a third of Merrick's patients have been caught at one time or another using illegal drugs such as heroin and cocaine. Other city clinics and doctors elsewhere note similar patterns.
Many patients also experience difficulty quitting the medicine, which is a narcotic. They become dependent on its effects or fear succumbing to heroin again. Lengthy use is often the norm with Suboxone, but its price becomes prohibitive the longer the treatment - especially for impoverished heroin addicts.
"It's really tough for those people, no matter what medication you give them," said Dr. Charles P. O'Brien, a University of Pennsylvania psychiatry professor who advises Suboxone's manufacturer on tracking abuse. Habitual drug users need job skills, among other things. "If they've been using heroin for 15 years, how's a treatment program going to turn them into a taxpaying citizen?"
The federal government had that sort of transformation in view when it approved buprenorphine in 2002 amid expectations that the drug would revolutionize addiction treatment with minimal abuse. But its wide availability is starting to create some of the problems it was meant to solve. An investigation by The Sun has found that patients are selling their prescriptions illegally, creating a new drug of abuse that some people are injecting to get high.
Hard-core heroin addicts, like the thousands living in Baltimore, are a difficult population to wean off illegal drugs, as they typically have criminal histories, unstable families and few job skills.
"It was never meant to treat people who live in chaos," said Dr. Erik Garcia, who treats addicts in Worcester, Mass. "It was meant to treat people who have gotten hooked on painkillers who have relatively stable lives. But the need is so huge, it ... outstrips the capabilities of the methadone clinics."
Methadone continues to be seen by many experts as the best replacement medication for heavy-use heroin addicts. Most of the 170,000 people being treated with Suboxone in the United States are pain-pill addicts who often have more resources to help them recover.
But Baltimore Health Commissioner Dr. Joshua M. Sharfstein says he believes heroin addicts also can benefit from Suboxone, especially if they get extra support. He enlisted six addiction treatment clinics to become the first stops for hundreds - and eventually perhaps thousands - of addicts. After being stabilized at the clinics, they can transfer to private physicians.
Vermont and some counties in Pennsylvania are also using a clinic model. But the vast majority of addicts in Maryland and other states aren't taking this more comprehensive route to Suboxone treatment.
Whether they get Suboxone directly from a doctor or at a clinic, addicts face similar challenges.
The clinics in Sharfstein's program have been able to transfer to private doctors only 122 of 653 addicts receiving Suboxone. One reason is that so many keep using drugs. Another is lack of health insurance.
A third to a half of the buprenorphine patients in the clinics have been flunking urine tests, indicating that they have been taking illegal or unauthorized drugs. People treated with Suboxone do no better or worse than addicts on any other type of treatment, clinic directors say.
Merrick said abstaining from illegal drugs is a significant sign that patients are committed to treatment. "If the goal is recovery," she said, "you can't fill the program up with people who don't want that."
It's not just heroin addicts who have trouble staying clean. Dr. Mark Logan of Rutland, Vt. prescribes Suboxone mostly to people addicted to the pain pill OxyContin. He said he had to kick out 45 percent of 139 patients for abusing other substances or selling their Suboxone on the street.
Addicts often seek Suboxone for its ability to eliminate withdrawal sickness that accompanies opiate use, Logan and others said. But without those painful physical consequences, addicts are less motivated to stop using those drugs while on Suboxone.
The goal is to minimize relapses, building addicts' confidence in their potential to quit illegal drugs. If it takes months or even years of Suboxone treatment, that's acceptable, some advocates say.
"The longer they're on it," Sharfstein said, "the better."
But critics say such treatment merely substitutes one narcotic for another. In Baltimore, recovery centers that emphasize a drug-free approach are balking at a state proposal to require them to accept patients using Suboxone or methadone - or risk losing state funding.
"Individuals can lead useful lives without the need of a mood-altering drug," an official of Gaudenzia Inc., one of Maryland's largest residential treatment programs, told state lawmakers this year.
Some recovering addicts also worry about becoming hooked on buprenorphine.
Valarie Clark has been taking Suboxone for a year under the supervision of Merrick's Total Health Care center. She calls it a "wonder drug" for having helped her kick a heroin-snorting habit of two decades.
Clark, 52, began using heroin in her 30s. Her drug use spiraled after her daughter died while having a baby in 1994. She unsuccessfully tried methadone treatment, saying it didn't stop her heroin cravings the way Suboxone does. She learned about Suboxone's effects after buying it on the street.
Now her goal is to stop taking Suboxone by February. The doctor she sees at the clinic has tapered her dose from 8 milligrams a day to 4 milligrams. Having twice used heroin while in treatment, Clark is wary of relapsing, especially since she has landed a job.
"I'm an addict, I have to be careful of all drugs, even Suboxone," she said. "At this point, I feel that it's becoming an abuse for me."
Many doctors said patients can quickly relapse when they stop Suboxone. That in turn brings on mild withdrawal and cravings for opiates. That's why doctors try to lower the daily dose over several months.
But getting patients off Suboxone's lowest dose of 2 milligrams is challenging. Some experts say it's a psychological barrier, others say it's physical.
"The biggest problem is how do we get you off [the drug] - I think it's a very real problem," said Dr. Sharon Levy, medical director of the Adolescent Substance Abuse Program at Children's Hospital in Boston and a Harvard University pediatrics professor. The program prescribes Suboxone to teenage addicts.
Yet Levy said any worries about dependence are offset by the progress that patients experience by not using heroin. "I'm struggling to get them off," she said, "but they've had two years of being off of drugs and graduating high school."
The same clinic trying to help Clark stop taking Suboxone also has patients like Lorraine Keating, who wants to remain on the drug for the foreseeable future, because she's "nervous" about falling back into heroin use.
"My life has really changed dramatically," said Keating, 55, of West Baltimore. She had been arrested numerous times for drug-related charges before starting the 24-milligram dose of Suboxone that she has been on since Jan. 23. She hasn't been arrested since beginning treatment at Total Health Care.
Helping patients with varying drug habits, such as Clark and Keating, can challenge even experienced doctors. But Congress required only an eight-hour training course covering how the drug works, addiction issues and counseling methods. Lawmakers did not want to meddle in the practice of medicine, and heeded the advice of federal health officials eager to make it easy for physicians to qualify to prescribe Suboxone.
Dr. Daniel R. Howard, who runs a private family practice in Baltimore, said he found the eight hours of training "helpful," but he wanted additional assistance and sought a mentor.
"I felt like I needed a little more guidance in dosing," said Howard, who has treated about 120 patients with Suboxone.
Dr. Karl Spector of Bel Air, an internist, has treated nearly 400 patients with Suboxone since February 2003. He said the training is "not enough" and determined that the manufacturer's guidelines for doses and duration don't meet everyone's needs. "I find that patients can determine what is the right dose for themselves," he said.
Woody Curry scoffs at the eight-hour requirement.
Curry's a certified addiction counselor who runs Baltimore Station, a 200-bed, two-year residential treatment program that relies on 12-step philosophies, counseling and employment development. He said doctors should have as much experience as counselors, whose certification can require up to eight years of training.
MedChi, the Maryland State Medical Society, provides the training course. While it's available online, many doctors prefer to take it in person. "They have a lot of questions," said Elaine Gisriel, buprenorphine project coordinator for the group's Center for a Healthy Maryland.
Federal law also requires doctors to recommend additional treatment to their patients, such as counseling.
But the law doesn't require doctors to provide it.
The drug's manufacturer, Reckitt Benckiser Pharmaceuticals Inc. of Richmond, Va., says Suboxone works best when paired with individual or group therapy.
"If we promote treatment, Suboxone will be a success," said Vice President Rolley E. Johnson, a former Johns Hopkins researcher who helped make the scientific case for buprenorphine's benefits in treating addiction. "If we promote Suboxone, treatment can be a failure. We believe that strongly."
Baltimore's system is intended to provide addicts with comprehensive care as they begin Suboxone treatment. That model might also work in other areas of the state, said Dr. Peter Cohen, who is directing Maryland's rollout of buprenorphine.
He's asking county drug councils to devise plans for tailoring treatment to their specific populations. As in Baltimore, patients could transfer to the care of doctors after being stabilized in clinics.
"Buprenorphine is not the miracle drug," Cohen said. "But with really good treatment, you can save a lot of people's lives."
Meanwhile, many addicts are entering treatment directly with private doctors, as federal officials envisioned. Howard said he refers his patients to support groups and other programs but is not sure that's absolutely necessary.
"I try to pick patients who are committed to recovery and that are compliant," he said.
He prescribes Suboxone to patients he has treated for other conditions and makes them sign contracts promising not to abuse other drugs.
At the same time, Howard conducts urine tests to determine compliance. He immediately begins to wean patients off Suboxone if he catches them taking tranquilizers with it. Patients who are caught abusing other substances, such as cocaine, get three chances.
He has 13 patients on Suboxone now, but over the past year he has treated about 35. And nearly 15 have failed urine screens.
Howard's Suboxone mentor is Dr. Michael Hayes, a Baltimore addiction specialist and buprenorphine proponent. In addition to sharing his knowledge of appropriate treatment, he warns of deceit by addicts.
"Let nobody think that all of a sudden heroin addicts become choirboys," said Hayes. He booted two Suboxone patients from his practice after learning they got narcotic pain pills from another doctor - a practice called "doctor shopping."
"It looked like they were selling them," he said. "That was a scam."
Logan of Vermont has limited his patients to people who, among other things, have completed a 28-day detox program and are over 30 years old. "I think it's a much smaller population that we can be successful with," Logan said.
Doctors acknowledge that inexperience can lead to "lax or inappropriate prescribing," according to a survey of physicians done for Reckitt Benckiser. The company's advisory panel has discussed whether doctors should be urged to refrain from prescribing until they know their patients well.
Howard said in his practice the expense "ends up being a pretty big issue. I've had patients who have asked to come off the medication because of costs."
Many of his poor, mostly working-class patients must pay with cash because they don't have insurance.
Spector, the Bel Air internist, said he gives his patients up to two months' worth of refills to help them avoid paying for frequent office visits. Otherwise, he said, "They try to get off of it too soon because they feel pressure financially."
A month's worth of Suboxone can cost $300 or more, depending on dose and the price charged by the pharmacy. That doesn't include doctors' fees and charges for any other treatment. In all, Sharfstein said, a patient under the care of a private physician might pay an average of $500 a month, or $6,000 a year.
But those costs are less than what an addict might have to pay for heroin, Howard and Spector say.
Addiction experts worry that without subsidies, Suboxone could be unaffordable. Chris Kelly, president of the Washington chapter of Advocates for Recovery Through Medicine, termed buprenorphine "methadone for rich people."
Johnson of Reckitt Benckiser said the company has pushed for state Medicaid coverage and broader insurance coverage to widen access. "We don't want to see a two-tiered system," he said.
The company provides the medicine for free to a limited number of patients whose doctors recommend them, according to a spokeswoman.
Baltimore has spent close to $1 million to ensure that patients receive buprenorphine. Another $725,000 has come from a state medical coverage plan for low-income adults across Maryland. Last week, a legislative committee authorized $3 million sought by Gov. Martin O'Malley to help local officials develop their own programs, recruit doctors and cover medication costs.
Sharfstein said that in addition to finding funds, his priority has been recruiting addiction professionals and physicians.
As he put it, he has been the "Johnny Appleseed of getting doctors to prescribe or be interested in buprenorphine."
Now he's lobbying Rep. Elijah E. Cummings of Baltimore to introduce legislation to allow physician assistants, nurse practitioners and doctors in residency to prescribe it for addiction treatment.
"It really is the beginning. We're rushing out," Sharfstein said. "I think it's way too early to declare what we're doing a success, and it's way too early to declare it a failure."
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