Addiction to heroin and prescription painkillers bedeviled Marc Goldfinger for three decades. At times, it conspired to make him homeless; at others, it put him in prison.
Then, in 2004 he was introduced to Suboxone, one brand of the drug buprenorphine, a less-potent opioid used to treat opioid addiction. He has taken it every day since. Not once has he slipped back to the old addiction.
“It’s changed my whole life,” says Mr. Goldfinger, 68, a poet in Boston.
The US Food and Drug Administration (FDA) had hoped to create thousands of stories like Goldfinger’s when, more than a decade ago, it partnered with a British company to develop Suboxone, a new treatment for addiction to opioids. But that effort has had highs and lows, experts say. Lifesaving to some opioid abusers, Suboxone and generic drugs like it have not helped others to whom they have been prescribed – in part, these experts say, because of poor oversight of how the opioids are dispensed and used.
Those drugs have also ended up where the US government hoped they wouldn’t: on the street, where they are sold in the same illicit subculture in which heroin and prescription painkillers are peddled. There, "bupe," as these drugs are called, has been for some a seductive introduction to an opioid’s high, experts say. Indeed, some are now asking if a drug proffered as an answer to the US opioid problem might be perpetuating it.
“The benefits of the appropriate medical use of Suboxone probably far outweigh the potential for abuse,” says Eric Wish, director of the Center for Substance Abuse Research at the University of Maryland. “But those benefits will be jeopardized if we don’t take care of this abuse issue.” [Editor's note: The original version has been changed to correct the name of Dr. Wish's center.]
The new treatment method
In 2002, the FDA collaborated with Reckitt Benckiser, a British manufacturer that also produces big consumer goods such as Lysol and French’s Mustard, to bring Suboxone to the US market. Suboxone is intended to be an alternative to methadone, the chief treatment for opioid addiction since the 1970s. Methadone, a potent opioid that had acquired a reputation for abuse, is dispensed only at methadone clinics, and, often, those are hard to come by in the rural and suburban communities where opioid addiction has spread.
Suboxone, by contrast, is available by prescription for take-home use, and it’s not as strong as methadone. The drug is a mixture of buprenorphine, also called “bupe,” and naloxone, an overdose-reversal drug. The FDA has since approved a generic version of Suboxone, as well as generic bupe, without the naloxone.
About 2 million people abuse or are dependent on heroin and prescription painkillers in the US, according to 2011 federal government data. Meanwhile, Suboxone sales topped $1.4 billion in 2012, a colossal increase from $137 million in 2006.
Some patients use it as a bridge toward a drug-free life, though few appear to succeed: A Harvard-led study in 2011 found that 91 percent of Suboxone users had returned to opioid use within eight weeks of weaning off it.
“We do have a treatment for opiate addiction, but we don’t have a cure,” says Sharon Stancliff, medical director of the Harm Reduction Coalition, in New York City, a group that advocates deploying all options that minimize the harmful effects of drug use.
So, some people hoping to overcome opioid addictions, like Goldfinger, take bupe for the long term, much as a heart disease patient takes medication on a regular basis, says Dr. Stancliff. Often, users describe the drug as making them feel “normal,” she says, in that it restores to them the ability to want something other than the feeling of being high – and to develop relationships, hold jobs, and pursue goals. In keeping them off heroin and pills, it also saves them from the opioid overdoses that killed 19,687 Americans last year, she says.
Statistics bear out that lifesaving aspect. In Baltimore, for instance, heroin overdose deaths dropped from 312 in 1999 to 118 in 2009, after Maryland expanded access to bupe, according to a recent study.
“When it’s unavailable, it’s a lost opportunity to save lives,” says Stancliff.
Goldfinger says it did save his life. His tale of addiction began with the bottle of codeine-based cough syrup he downed with his high school girlfriend. It was 1960, and he and his friends began hitting New York City drugstores every Friday night, drinking three, maybe four bottles of the prescription-strength syrup each. It went from there to shooting heroin.
“I sat back and I said, 'Wow, I want to do this for rest of my life,' “ says Goldfinger, of his first exposure to heroin, at 16. “That almost came true.”
The heroin addiction was ruinous, but he is no longer a user. Each afternoon, Goldfinger – who’d previously tried both methadone treatment and in-patient rehab, without success – puts three orange Suboxone films under his tongue. He also attends a support group three to five days a week and sees a therapist. He now has a home, a wife, and a writing career.
The regulatory regimen
The federal government regulates bupe under the Drug Addiction Treatment Act of 2000. The law requires a physician who wishes to prescribe bupe to get a waiver from the US Drug Enforcement Administration (DEA), take an eight-hour training course, and have no more than 100 patients at a time.
Those regulations, which Reckitt Benckiser says it supports, are meant to ensure that physicians prescribing bupe follow the US government’s strict guidelines. The guidelines include giving patients regular urine tests and keeping detailed records to show that the bupe is being taken as directed – that it isn’t being given away, overused, or mixed with other controlled substances, including opioids, marijuana, or alcohol. Patients are also supposed to attend counseling, according to the guidelines.
But not all prescribers run reputable practices that follow such protocols. And that means not all who take Suboxone or the generic drugs use them as intended.
“If a physician isn’t knowledgeable about addiction, I don’t think you can help your patient in a meaningful way,” says Dr. Charles Kutler at Medical Associates of The Hudson Valley, in Kingston, N.Y, who is licensed to prescribe bupe. “I see some doctors just prescribing this over and over again, and that scares me," he says.
Some patients opt to sell some or all of their prescription on the streets – and then, sometimes, use the earnings to feed heroin habits. Some who buy bupe in illicit exchanges use it to temporarily medicate withdrawal symptoms when they can’t afford heroin. (Street bupe costs about half what heroin does.) Then, they go back to heroin.
It's also possible for a recreational opioid user to become addicted to bupe and graduate to stronger opioids. A new abuser can overdose on it, and it can be lethal even to someone who has a high opioid tolerance if it is injected, not ingested, or if it is mixed with benzodiazepines, according to the federal government. Suboxone's manufacturer notes that it has taken steps to try to prevent abuse of its product, by including naxolone (which has unpleasant physical effects) in its formulation.
The scale of the abuse problem
Police reports of bupe-related seizures increased nationwide from 90 reports in 2003 to more than 10,500 by 2010, according to the DEA. Meanwhile, the number of emergency room visits involving bupe increased tenfold over a five-year period, reaching more than 30,000 incidents in 2010, with over half of them involving nonmedical use of bupe, according to the Drug Abuse Warning Network.
“It just kept ballooning and snowballing,” says Linda Ryan, executive director of the Samaritan House, a homeless shelter in St. Albans, Vt., who became an advocate of stricter regulation of the drug after abuse rose at her shelter over the past three years. “Actually, it’s kind of a nightmare.”
Reckitt Benckiser says it is “greatly aware” of such issues and is “concerned about misuse and/or diversion of our products" that deviate from the drug's intended use solely as part of a regulated, broader treatment program. The company says it funds an “extensive risk management program” to monitor and intervene in instances of abuse and that it maintains "open communication" with doctors to educate them how to avoid abuse.
To be sure, rates of bupe abuse pale in comparison to abuse rates for prescription painkillers, heroin, and methadone. In 2009, emergency-room visits for methadone-related incidents hit more than 63,000, almost double the number five years earlier, and more than 60 percent were for nonmedical use, according to federal data.
But experts also say they don’t know the full scale of the bupe problem, because bupe has yet to become a drug for which medical examiners regularly test. A pilot program to better gauge the rate of bupe abuse found that 98 of 1,061 urine samples collected by Maryland parole and probation agents tested positive for bupe. Almost half of those samples tested positive for at least two other drugs, suggesting abuse.
“This is the first time we have found a new potential drug problem and our efforts to address it have been met with resistance,” says Dr. Wish.
The question: to limit bupe, or to make it more available?
One reason for resistance is that physicians remember how hard some communities fought against methadone clinics, after the drug became stigmatized for its potential for abuse, says Wish. Physicians who see bupe helping their patients don’t want to see a drug pick up that same stigma, he says.
“There are a lot of people who worked very hard to make Suboxone available," he says, "and they are very threatened by any arguments against it.”
Federal restrictions limit the availability of Suboxone prescriptions to doctors' offices. Some 15,568 physicians in the US are licensed to prescribe bupe, according to the government, but only about one-third of them actually do, often due to skittishness about working with a highly regulated drug, according to The National Alliance of Advocates for Buprenorphine Treatment.
Some insurance companies also impose high barriers to getting bupe prescriptions, though the Affordable Care Act appears likely to ameliorate those issues, experts say. Coverage through Medicaid can be uneven across the US, with some states putting 12- or 24-month lifetime limits on a patient's access, though bupe users can apply to continue treatment. Such hurdles to long-term bupe treatment point to an enduring societal wariness of treating drug addiction with drugs, advocates say.
Indeed, some experts say that many people who buy bupe on the street do so because they can’t get it from a doctor.
“Sadly, whenever you create an artificial decrease in supply, you are going to cause a black market on the streets,” says Whitney Englander, government relations manager at the Harm Reduction Coalition.
In the Albany area, the waiting time to see a physician who can prescribe bupe averages 150 days, says Heather Long, an emergency room toxicologist at Albany Medical Center.
“It’s such a hard step to even decide to quit and to want to quit,” she continues, “but then to have to wait months is a huge deterrent. I have to think that many of them resort back to heroin, or to some other opioid."
Some doctors urge easing the restrictions, including allowing prescribers to bring more patients into their programs.
“We get four or five calls a day from people that I can’t take, and I have to turn them away,” says Gary Horwitz, a psychiatrist and addiction specialist at Westfall Associates, a filled-to-capacity outpatient rehabilitation center in Rochester, N.Y. “We’re in the midst of an epidemic, and our hands are tied."
Dr. Horwitz, who is a paid speaker for Reckitt Benckiser, says he is confident his program could double the number of enrollees without compromising vigilance. Although he acknowledges bupe’s abuse potential, he says “the bigger problem is the amount of heroin out there.”
Still, others worry that looser regulations on bupe might not help the heroin problem. Laxer standards could mean that more people will be on bupe, but that fewer will be under the care of physicians who ensure that it is helping them beat, not sustain, their addictions, and that it is not ending up in the wrong hands, they say.
Such concerns reflect in part the broader problem that the addiction treatment landscape in the US is patchy and uneven, and that help is not available to everyone who wants it.
“The expected outcome of all opioid addiction treatments today is relapse,” says Robert DuPont, the first director of the National Institute on Drug Abuse.
“There are some Suboxone patients who are benefiting substantially,” he says. “But Suboxone is part of the story – not the solution. This is not the silver bullet for opioid addiction.”