Addiction Professional Magazine

Issue Date: May-June 2011, Posted On: 5/15/2011
Cover Stories

The medication holdouts
Some experts charge centers that avoid drug treatments with shunning science and ethics

by Alison Knopf

Disulfiram, naltrexone, acamprosate, methadone, buprenorphine-the medications approved to treat addiction literally can be counted on the fingers of one hand. Although they have been available for at least 10 years (buprenorphine) and in some cases more than 50 (methadone), these medications have been shunned by many addiction treatment clinicians, despite evidence that these treatments could help their patients.

Nowhere else in medicine are the people who treat a condition so suspicious of the very medications designed to help the condition in which they specialize. The situation is improving, but not fast enough for many, and advocates of medication-assisted treatment are speaking out.

“It's unethical not to use medications,” says Charles O'Brien, MD, PhD, Kenneth Appel Professor in the Department of Psychiatry at the University of Pennsylvania and one of the country's top clinical researchers in addiction treatment. “If you're discouraging people from taking medications, you are behaving in an unethical way; you are depriving your patients of a way to turn themselves around. Just because you don't like it doesn't mean you have to keep your patients away from it.”

O'Brien adds, “This is a subject that I feel very strongly about,” saying he has “stopped pussyfooting around” and doesn't care who he offends in his speeches. “There is a long history of rigidity about refusing to use medications.”

O'Brien lays much of the blame for this at the foot of organized medicine, saying 12-Step programs and Alcoholics Anonymous (AA) were founded because the medical profession traditionally ignored alcoholism. But by the late 1960s and 1970s “we got science involved,” he said. Many in the treatment field, however, haven't caught up.

And to the extent that the treatment community is catching up, it is still largely leaving buprenorphine out of the picture, and not even considering methadone, the province of specialty opioid treatment programs. These two medications are proven to help keep opioid-addicted patients in recovery, but many highly respected treatment programs refuse to consider them, even though the prevalence of prescription opioid addiction is dramatically increasing.

Outlook at Betty Ford

The only addiction treatment medication used at the Betty Ford Center, the nationally renowned licensed addiction treatment hospital in Rancho Mirage, Calif., is buprenorphine, and it is used only for detoxifying opioid-dependent patients, says James Golden, MD, director of inpatient services. “We like them to leave the center taking no medications,” says Golden.

He concedes that the non-abuseable addiction treatment medications-acamprosate, oral naltrexone and the injectable naltrexone formulation Vivitrol-“can be used with some success in clinical subsets.” But not at the Betty Ford Center-at least not “at this time,” says Golden.

There are several reasons for this, he explains. The first is that these are agents that need to be monitored on an ongoing basis by qualified addiction physicians, he says, noting that many patients come to the Betty Ford Center from long distances. “If I were to start an opioid-dependent patient on a drug such as naltrexone as a blocking agent, I would want the person following that patient to be reliable, to be maintaining the same kind of quality we have here,” Golden says. “We're not always certain that will happen.”

Patients are, of course, free to obtain medication from a physician after completing treatment at the Betty Ford Center, but this would occur on the patient's own initiative.

Golden admits that he is “not in a good position to give good information on Vivitrol” because he doesn't use it on patients. “But I see what the evidence is, so I have to say that when these patients transition out, if they're eligible for this treatment, I don't have a problem with it,” he says.

Golden adds that many patients simply choose not to be on any medications. “When they come here they may be on benzodiazepines, mood stabilizers and opioids,” he says. “Getting them off these medications is a challenge, and when they're done they really don't want to be on any drugs anymore,” even an antidepressant. “The patient is the one who says, ‘I want to get off these things,’” he says.

Finally, many patients who come to the Betty Ford Center have had multiple relapses, says Golden. “I see some patients who tried naltrexone and drank through it,” he says. “I know the studies showed that it decreased heavy drinking days, and it has helped some people. But the ones we see here are the ones who were not successful.”

Golden says that mood disorders and comorbid medical conditions are treated with medications at the Betty Ford Center. But he tries to discourage patients from medications that are not necessary. For example, insomnia is a problem for many patients, and they might request sleeping medication. “I ask them, ‘Do you really want to be looking for a pill every night to go to sleep?’” he says.

Change at Hazelden

Another treatment program that has a history of not using medications, the Center City, Minn.-based Hazelden, now uses naltrexone, acamprosate and disulfiram (Antabuse), says medical director Omar Manejwala, MD.

“We've changed our practices,” says Manejwala, who joined Hazelden last year. “Every single alcoholic is offered either naltrexone or acamprosate at the admitting physical.” Those who decline are given another opportunity at their next physical. In addition, counselors may recommend that patients talk to the physician about medications.

“Acamprosate and naltrexone improve outcomes, and we use them because we know they work,” says Manejwala. There are no philosophical objections to those medications, even among counseling staff, he says. Typically, naltrexone is used over acamprosate at Hazelden.

But there are objections to buprenorphine, the main one being that it itself can be abused. Hazelden, like the Betty Ford Center, uses buprenorphine for detoxification, but not for maintenance.

“It's a complicated issue,” says Manejwala. “We have a lot of questions about buprenorphine. What characterizes buprenorphine abuse? What are the cognitive impairments? What are the long-term outcomes? What about relapse to other intoxicants-benzodiazepines and alcohol?”

Citing a 2003 article on buprenorphine in the New England Journal of Medicine (Fudala et al.; www.nejm.org/doi/full/10.1056/NEJMoa022164), Manejwala notes that abstinence rates were 20 percent, compared with 6 percent for placebo. “20 percent isn't stellar,” he says. “I'm not saying I'm for or against buprenorphine maintenance, but I'm saying there are a lot of questions.”

A 20 percent medication response rate compared with 6 percent for placebo is a “very positive finding,” counters Shaun Thaxter, president and global CEO of Reckitt Benckiser, which makes Suboxone (buprenorphine plus naloxone) and Subutex (buprenorphine alone).

Furthermore, Thaxter notes that the Fudala study terminated the four-week blinded arm early “since buprenorphine therapy so clearly benefited patients that they did not want to continue withholding it from the placebo group.” The 48-week open-label arm of the trial, which yielded abstinence rates of 50 to 60 percent, “much more closely approximates the real-life clinical experience using buprenorphine to treat this disease over the past eight years,” says Thaxter.

Evidence vs. belief

 

Source: butler center for research at hazelden
Source: Butler Center for Research at Hazelden

“We present people with the scientific and medical evidence,” says Thaxter, explaining how the pharmaceutical company tries to encourage treatment providers to prescribe its medication for opioid addiction. “And we encourage people to talk to their peers, and to try and identify one or two patients.” By trying the medication on these patients, the provider may find out how successful it really is, he says.

 

“We can all think of examples in our lives when we've held a view, and can change our minds based on experience and education,” Thaxter says.

But if a provider doesn't want to use buprenorphine for patients, there's nothing Reckitt Benckiser can do about it. “I don't think there's any sort of clever marketing trick,” says Thaxter.

“We're doing everything we can to ensure that it is an option, but ultimately, having educated them, they will still reach their own decision,” he says. The case for the medications has been made in the scientific community, so in essence it is now up to clinical professionals to respond to that information.

Thaxter recognizes that “some patients would prefer treatment without any medicine, and we respect their decision.” On the other hand, many patients find that buprenorphine “removes the cravings, enabling them to focus on the behavioral aspects of treatment, with counseling and psychosocial support.”

Federal role

The federal government, which helped support the development of buprenorphine-it was designated an orphan drug-urges treatment providers to look at the evidence. “There are scores of peer-reviewed journal articles that evaluate the success of buprenorphine,” says Nicholas Reuter, MPH, senior public health adviser in the Division of Pharmacologic Therapies at the federal Center for Substance Abuse Treatment (CSAT). “It's well-established that the data and the evidence are there.”

Not treating patients with a medication consigns most of them to relapse, adds Reuter. While some opioid-addicted patients, as many as 20 percent, do respond to abstinence-based therapy, “That still leaves us with the 80 percent who don't,” he says.

The medication-assisted treatment model-which Reuter says was based on methadone in addition to counseling but applies equally to buprenorphine in addition to counseling-was assessed by the National Institutes of Health (NIH) as being effective.

One concern, however, involves whether the office-based physicians who prescribe buprenorphine are providing adequate counseling in conjunction with the medication, says Reuter. “We asked physicians how much counseling their patients are getting on a monthly basis, and it ranged from one day a month to up to 20 days or more,” he says. “There are some physicians who aren't ensuring that patients receive counseling.”

That just helps to make the point, however, that addiction treatment providers who do offer counseling are ideal prescribers of buprenorphine, and are missing out on something that would help their patients by avoiding it.

Another concern is buprenorphine abuse and diversion, both of which are “significant,” says Reuter. “I talk to counselors who tell me that most patients who report to their treatment programs have already used buprenorphine in non-medical settings because it is available on the streets,” he says. “They obtain the illicit Suboxone and Subutex when they can't obtain other opioids.”

In early 2009, an ethnographic study conducted in Vermont and Massachusetts interviewed illicit Suboxone users, and found that “a surprising number were using it to self-medicate their addiction and withdrawal,” says Reuter. They obtained the buprenorphine from their heroin dealer, but technically they were using it for the purpose for which it was intended.

More recently, Reuter says, there were 14,000 reports in Drug Abuse Warning Network (DAWN) data of patients going to the ER for non-medical use of buprenorphine, including a surprising number of cases of toddler and pediatric exposure.

Reuter says the “old notion that you're substituting one addiction for another” still persists, for both methadone and buprenorphine. “We dispel it by saying these are medications-medically monitored, supervised medications,” he says, adding that they “enhance and improve counseling.”

The medication naltrexone also has received a great deal of attention as of late, with both the daily pill form and now the monthly injection Vivitrol available to treat both alcohol dependence and opioid addiction. Naltrexone completely blocks the effects of opioids, and reduces craving for alcohol in some alcoholics. One criticism of the anti-craving effects of the medication is that it doesn't work for everyone, but O'Brien says the University of Pennsylvania has found that genetic factors might influence naltrexone's effectiveness in treating alcoholism.

“One of the things that we discovered at Penn is that alcohol activates the endorphin system in the brain,” says O'Brien. In people with a certain gene, alcohol “turns on the opioid system,” he says. “But if you put them on naltrexone, they don't feel it, so the craving is reduced, and very often they learn to avoid alcohol.”

Counselors' view

At NAADAC, The Association for Addiction Professionals, the prevailing philosophy is pro-medication. “We are for medications,” says Misti Storie, education and training consultant. She says the “disconnect” at some treatment centers is “related to a lack of education about the connection between biology and addiction.”

At NAADAC trainings, members demonstrate “a lot of resistance” to medication at first, Storie says. “They say, ‘I don't believe in it; I've had experience with it and it doesn't work.’ But after a daylong training, once they understand how addiction modifies the brain, they do understand.”

It's true that counselors working in programs that don't allow medications might be put in a difficult position, but they have to follow the policies at their employer, says Storie. “They have no options except to be educated themselves, and explain to the patient that the program doesn't utilize medications,” she says.

Incorporating medications into addiction treatment is still “a movement in process,” says Storie, adding, “We have not arrived at where we need to be.” The addiction treatment community has “compartmentalized” into abstinence-only and medication-friendly groups, she says. But the science indicates that medications such as buprenorphine are meant not only for detoxification, but also for ongoing treatment, she says.

Medications can do what treatment has not been able to do so far: prevent relapse, Storie indicates. “The numbers speak for themselves,” she says. “We have been providing treatment the same way for decades, and have plateaued at a relapse rate of two-thirds. Something is missing.”

Alison Knopf is a freelance writer based in New York. She wrote on concerns over the DSM-5's proposed new category for substance use disorders in the September/October 2010 issue.
Addiction Professional 2011 May-June;9(3):14-18