NY TIMES
By DEBORAH SONTAG
November 16, 2013
For Shawn Schneider, a carpenter and rock musician, the descent into addiction began one Wisconsin winter with a fall from a rooftop construction site onto the frozen ground below. As the potent pain pills prescribed for his injuries became his obsessive focus, he lost everything: his band, his job, his wife, his will to live.
Mr. Schneider was staying in his parents’ basement when he washed down 40 sleeping pills with NyQuil and beer. His father heard him gasping and intervened, a reprieve that led Mr. Schneider into rehab, not his first program, but the one where he discovered buprenorphine, a substitute opioid used to treat opioid addiction.
In the two years since, by taking his “bupe” twice daily and meeting periodically with the prescribing psychiatrist, Mr. Schneider, 38, has rebounded. He is sober, remarried, employed building houses, half of a new acoustic duo and one of the many addicts who credit buprenorphine, sold mostly in a compound called Suboxone, with saving their lives.
Suboxone did not save Miles Malone, 20; it killed him. In 2010, a friend texted Mr. Malone an invitation to use the drug recreationally — “we can do the suboxins as soon as I give them to u, iight, dude?” — and he died that night in South Berwick, Me., of buprenorphine poisoning. The friend, Shawn Verrill, was sentenced this summer to 71 months in prison.
“I didn’t know you could overdose on Suboxone,” Mr. Verrill said in an interview at a federal prison in Otisville, N.Y. “We were just a bunch of friends getting high and hanging out, doing what 20-year-olds do. Then we went to sleep, and Miles never woke up.”
Suboxone is the blockbuster drug most people have never heard of. Surpassing well-known medications like Viagra and Adderall, it generated $1.55 billion in United States sales last year, its success fueled by an exploding opioid abuse epidemic and the embrace of federal officials who helped finance its development and promoted it as a safer, less stigmatized alternative to methadone.
But more than a decade after Suboxone went on the market, and with the Affordable Care Act poised to bring many more addicts into treatment, the high hopes have been tempered by a messy reality. Buprenorphine has become both medication and dope: a treatment with considerable successes and also failures, as well as a street and prison drug bedeviling local authorities. It has attracted unscrupulous doctors and caused more health complications and deaths than its advocates acknowledge.
It has also become a lucrative commodity, creating moneymaking opportunities — for manufacturers, doctors, drug dealers and even patients — that have undermined a public health innovation meant for social good. And the drug’s problems have emboldened some insurers to limit coverage of the medication, which cost state Medicaid agencies at least $857 million over a three-year period through 2012, a New York Times survey found.
Intended as a long-term treatment for people addicted to opioids — heroin as well as painkillers — buprenorphine, like methadone, is an opioid itself that can produce euphoria and cause dependency. Its effects are milder, however, and they plateau, making overdoses less likely and less deadly. And unlike methadone, buprenorphine (pronounced byoo-pruh-NOR-feen) is available to addicts by prescription, though only from federally authorized doctors with restricted patient loads.
Partly because of these restrictions, a volatile subculture has arisen, with cash-only buprenorphine clinics feeding a thriving underground market that caters to addicts who buy it to stave off withdrawal or treat themselves because they cannot find or afford a doctor; to recreational users who report a potent, durable buzz; and to inmates who see it as “prison heroin” and, especially in a new dissolvable filmstrip form, as ideal contraband.
“It’s such a thin strip they’ll put it in the Holy Bible, let it melt and eat a page right out of the good book,” said Ken Mobley, a jailer in Whitley County, Ky., who randomly screened 50 inmates recently and found 21 positive for Suboxone.
Many buprenorphine doctors are addiction experts capable, they say, of treating far more than the federal limit of 100 patients. But because of that limit, an unmet demand for treatment has created a commercial opportunity for prescribers, attracting some with histories of overprescribing the very pain pills that made their patients into addicts.
A relatively high proportion of buprenorphine doctors have troubled records, a Times examination of the federal “buprenorphine physician locator” found. In West Virginia, one hub of the opioid epidemic, the doctors listed are five times as likely to have been disciplined as doctors in general; in Maine, another center, they are 14 times as likely.
Nationally, at least 1,350 of 12,780 buprenorphine doctors have been sanctioned for offenses that include excessive narcotics prescribing, insurance fraud, sexual misconduct and practicing medicine while impaired. Some have been suspended or arrested, leaving patients in the lurch.
Statistics released in the last year show sharp increases in buprenorphine seizures by law enforcement, in reports to poison centers, in emergency room visits for the nonmedical use of the drug and in pediatric hospitalizations for accidental ingestions as small as a lick.
Buprenorphine’s staunchest proponents see these indicators as a byproduct of the drug’s rising circulation and emphasize its safety relative to other opioids.
“The benefits are high, the risk is low and it is worth it on a population-wide basis,” said Dr. Stuart Gitlow, the president of the American Society of Addiction Medicine.
But Dr. Robert Newman, a leading advocate of methadone treatment, said, “The safety factor should not be oversold.”
“It is diverted and sold on the black market,” he said. “It is misused, and it does lead to medically adverse consequences, including death. It is associated with a large number of deaths.”
The addiction drug was a “primary suspect” in 420 deaths in the United States reported to the Food and Drug Administration since it reached the market in 2003, according to a Times analysis of federal data.
But buprenorphine is not being monitored systematically enough to gauge the full scope of its misuse, some experts say. The Centers for Disease Control and Prevention does not track buprenorphine deaths, most medical examiners do not routinely test for it, and neither do most emergency rooms, prisons, jails and drug courts.
“I’ve been studying the emergence of potential drug problems in this country for over 30 years,” said Eric Wish, the director of the Center for Substance Abuse Research at the University of Maryland. “This is the first drug that nobody seems to want to know about as a potential problem.”
The government has a vested interest in its success.
The treatment is the fruit of an extraordinary public-private partnership between a British company and the American government, which financed clinical trials and awarded protection from competition after the drug’s patent expired.
The company, now a consumer goods giant called Reckitt Benckiser, hired several federal officials who had shepherded the drug, and it has financially supported many of the scientists and doctors who are studying it and advocating its use. But over the last few years, the company’s aggressive campaign to protect its lucrative franchise has alienated some of its customers and allies.
In an 11th-hour bid to thwart generic competition and dominate the market with its patent-protected Suboxone filmstrip, the company sought to convince regulators that the tablet form, which earned it billions of dollars, now presented a deadly risk to children as packaged in pill bottles.
The F.D.A. did not agree. Early this year, it approved generic tablets and asked the Federal Trade Commission to investigate potentially anticompetitive business practices by the company.
Reckitt Benckiser defended its advocacy for the Suboxone filmstrip — now its only pharmaceutical product — saying its research showed that the film was safer than the tablets, kept addicts in treatment longer and had less of a street presence. It added that it was overseeing an F.D.A.-required “risk evaluation and mitigation strategy to promote the appropriate use of buprenorphine with the goal to minimize the misuse, abuse and multidose unintentional exposure of these products.”
Dr. John Mendelson of San Francisco, a consultant for the company, said it could be proud of its management of a difficult product. “Their biggest success so far,” he said, “is that the whole system has not imploded, that enough doctors have prescribed the drug appropriately that there has been no move to withdraw it from the market.”
Ronni Katz, a health official in Portland, Me., is less impressed.
“I remember the early days when we met with the pharma rep in the area — I don’t think he was trying to mislead us — he truly believed it was a miracle drug,” she said. “But they way underestimated the potential for abuse, which means to me they really don’t understand addiction.”