- "MYCHART" the new patient portal
- BELMONT MEDICAL ASSOCIATES
- MOUNT AUBURN HOSPITAL
- PRACTICE PHILOSOPHY
- My education and training
- PCP : PRIORITY CARE PRACTICE
- CONTACT ME
- APPOINTMENT REQUEST
- LAB RESULTS
- RECORD RELEASE
- Email : Visit Preparation
- Email : Update my file
- Forms and Letters
- My Medical Scribe
- Medicare Annual Wellness Visit
- Case management/Social work
- Quality Care Measures
- My Personal MEDICAL MANAGER
- Emergency closing notice
- Talking to your doctor
- Choosing..... and losing a doctor
- INDEX A - Z
- ANNOUNCEMENTS : There's a lot of that "going around" now!
- ALLERGIC REACTIONS
- Alternative Medicine
- Alzheimer's Disease
- Bladder Problems
- Blood disorders
- Cancer Concerns
- GENETIC TESTING FOR HEREDITARY CANCER
- Chronic Obstructive Pulmonary Disease
- Controversial Concerns
- CPR : Learn and save a life
- CRP : Inflammatory marker
- Diabetes Management
- Dizziness, Vertigo,Tinnitus and Hearing Loss
- FEMALE HEALTH
- GASTROINTESTINAL topics
- Foot Problems
- HEART RELATED topics
- Antibiotic Resistance
- Cat bites >
- Clostridia difficile infection - the "antibiotic associated germ"
- Dengue Fever and Chikungunya Fever
- Food borne illnesses
- Shingles Vaccine
- Hepatitis B
- Hepatitis C
- Helicobacter pylori - the "ulcer germ"
- HIV Screening
- Lyme and other tick borne diseases
- MRSA (Staph infection)
- Sexually Transmitted Diseases
- Shingles (Herpes Zoster)
- West Nile Virus
- Whooping Cough (Pertussis)
- Zika virus and pregnancy
- INSURANCE related topics
- Kidney Stones
- Leg Cramps
- LIBRARY for patients
- LIFE DECISIONS
- MALE HEALTH
- Medication/Drug side effects
- MEDICAL MARIJUANA
- MENTAL HEALTH
- Miscellaneous Articles
NUTRITION - EXERCISE - WEIGHT
- Cholesterol : New guidelines for treatment
- Advice to lower your cholesterol
- Cholesterol : Control
- Cholesterol : Raising your HDL Level
- Food : Making Smart Choices
- Food : Making Poor Choices
- Food : Grape Fruit and Drug Interaction
- Food : Vitamins, Minerals and Supplements
- Omega 3 fatty acids
- Vitamin B12 deficiency
- Vitamin D
- Weight Loss
- PATIENTS' RIGHTS
- SUBSTANCE ABUSE
- Travel and Vaccination
- Warfarin Anticoagulation
- OTHER STUFF FOLLOWS
- Fact or Opinion?
- Hippocratic Oath
- FREE ADVICE.......for what its worth!
- LAUGHTER.....is the best medicine
- Physicians Pet Peeves
- PHOTO ALBUM - its not all work!
- Cape Town, South Africa
- Tribute page
- Free Wi-Fi
- Cape Town, South Africa
SUBOXONE : Addiction Treatment With a Dark Side
By Deborah Sontag : NY Times : 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.”
Skeptics and Believers
Nearly a half-century ago, buprenorphine was born in the laboratory of an English company specializing in mustard and shoe polish, where chemists were competing to invent a less addictive painkiller.
“We were trying to beat morphine, not methadone,” said John W. Lewis, 81, who oversaw the drug’s development.
Though far more potent than morphine, buprenorphine appeared in animal tests to be unusually safe even in very high doses. In 1971, Dr. Lewis and colleagues traveled to an infirmary in Glasgow to conduct the first human tests — on themselves.
Buprenorphine made Dr. Lewis violently ill. “It quite took the edge off our stay in a splendid hotel on the banks of Loch Lomond,” he said in a speech, and it exposed the painkiller’s “Achilles’ heel” — “the rather high incidence of nausea and vomiting.”
In the mid-1970s, Dr. Lewis began shipping the drug to the United States Narcotic Farm in Lexington, Ky., to test its abuse potential on detoxified addicts. A prison that doubled as a treatment hospital, the farm was home to the government’s Addiction Research Center (and at times to jazz greats like Chet Baker, Elvin Jones and Sonny Rollins).
With opposition to human research mounting, buprenorphine would be the last drug tested there; government scientists justified the research by arguing that the painkiller also had the potential to treat addiction.
“Here’s the thing: The Lexingtonians were against methadone,” said Nancy Campbell, a historian of drug policy. “They felt like addicts liked it too much, and it had overdose potential. They never thought abstinence and ‘Just Say No’ would work with this population. So they were eager to find an alternative.”
The idea of using opioid substitutes to treat opioid dependence is based on the premise that long-term drug use profoundly alters the brain, that the craving, seeking and taking of opioids is a “bio-behavioral” compulsion. While addiction is considered a chronic, relapsing disease, experts believe that replacing illegal drugs with legal ones, needles with pills or liquids and more dangerous opioids with safer ones reduces the harm to addicts and to society.
Like heroin, buprenorphine attaches to the brain’s opioid receptors, but it does not plug in as completely. It is slower acting and longer lasting, attenuating the rush of sensation and eliminating the plummets afterward. Addicts develop a tolerance to its euphoric effects and describe themselves as normalized by it, their cravings satisfied. It also diminishes the effects of other opioids but, studies have shown, does not entirely block them, even at the highest recommended doses.
A devoted cadre of government scientists saw buprenorphine as a “holy grail” and over the next few decades “floated in between the public and private sector for most of their careers,” Dr. Campbell said. The farm’s pharmacist would become an executive vice president of Reckitt Benckiser Pharmaceuticals, for example, and the company would contract with the former National Institute on Drug Abuse director who originally promoted the public-private partnership.
It was a collaboration that the company, whose brand names include Lysol, resisted for a long time, said Charles O’Keeffe, a former White House drug policy official who incorporated Reckitt in the United States.
“They were grocers,” he said. “Finally, I went to the board and said, ‘It’s for the social good.’ Ultimately, they relented but said, ‘Just don’t spend a lot of money.’ ”
He did not have to. The federal drug abuse institute financed the two big clinical trials necessary to win F.D.A. approval for $28 million and later spent an additional $52.4 million for studies at its clinical research sites. At least $19 million more in studies are underway.
Further, the F.D.A. granted the company a seven-year monopoly based on its claim that it would never recoup its development costs. (Reckitt now has a market value of $56.7 billion; 21 percent of its operating profits last year came from Suboxone.)
Still, hurdles had to be cleared.
First, Mr. O’Keeffe said, “We had to change the law because it would have been illegal.”
The Harrison Narcotics Act of 1914, as interpreted, prohibited doctors from prescribing narcotics to narcotics addicts “to maintain their addictions.” In the 1970s, methadone treatment was authorized but limited to clinics where the drug was dispensed, usually daily.
The original advocates of buprenorphine, though, wanted to make addiction treatment mainstream rather than segregate addicts in clinics that became lightning rods for community opposition. They wanted doctors in offices to prescribe it, just like any other take-home medication.
So Mr. O’Keeffe found “influential members of Congress interested in doing this”: Senators Carl Levin, Democrat of Michigan, and Orrin G. Hatch, Republican of Utah, with support from Senator Joseph R. Biden Jr., Democrat of Delaware. In the end, because of law enforcement concerns, the Drug Addiction Treatment Act of 2000 included unique prescribing restrictions: that doctors seek federal permission, get eight hours of training, accept a 30-patient limit and attest to their ability to make counseling referrals.
The concerns grew from other countries’ experiences with buprenorphine treatment over the previous decade; successes had been accompanied by abuses. So F.D.A. officials insisted on the addition of an “abuse deterrent” — naloxone. If addicts crushed and injected the tablets, the naloxone would precipitate excruciating withdrawal symptoms.
The Drug Enforcement Administration was skeptical, saying studies showed that naloxone did not provoke “any evidence of withdrawal” in “a substantial percentage” of opiate abusers, and that the amount in the proposed compound would produce only a half-hour of “unpleasantness” in those susceptible.
Skeptical, too, were buprenorphine’s original champions at Reckitt, who would have preferred a different additive or more naloxone. “It was not a perfect solution,” Dr. Lewis said.
Even so, Suboxone — four parts buprenorphine, one part naloxone — was created. And in late 2002, along with Subutex (plain buprenorphine), it was approved by the F.D.A. just as its target audience was about to expand unexpectedly.
An estimated 2.5 million Americans were dependent on or abused opioids last year, mostly painkillers, although heroin dependence has skyrocketed, with the number of addicts doubling over a decade to 467,000, government data indicate. In 2010, the last year studied, 19,154 people died of opioid overdoses.
“Had buprenorphine never been released and all we had was methadone, that number would be much higher,” said Dr. Andrew Kolodny, the president of Physicians for Responsible Opioid Prescribing.
In the early days of Suboxone, with Reckitt Benckiser barely marketing its own drug, Dr. Kolodny, then a New York City health official, crisscrossed the city with colleagues to spread the word about the new medication, entice public hospitals to try it with $10,000 rewards and urge doctors to get certified.
“We had New York City staff out there acting like drug reps,” Dr. Kolodny said.
He himself became a prescriber. “All of a sudden, I started getting calls from white kids on Long Island who were all addicted to pain pills,” he said. “It was 2003 or 2004, and my first experience of the painkiller epidemic.”
A psychiatrist accustomed to the slow, subtle effects of antidepressants and mood stabilizers, Dr. Kolodny was stunned by patients who arrived “a total mess” and in days seemed “back to normal.”
“I’m thinking, this cures all addictions,” he said.
Dr. Jeffrey T. Junig of Wisconsin experienced a similar revelation. He was concerned that buprenorphine would create “all these dry drunks, people who were no longer using but who hadn’t addressed their defects.” Instead, he witnessed something different: “The process of craving opioids itself causes people to be so one-dimensional that it is a defect itself. Freed from the obsession to use, people change.”
Buprenorphine worked so well on his first patients, middle-aged painkiller addicts, that “they would have tears rolling down their faces talking about how grateful they were,” he said.
Among them was Shawn Schneider, who had found his way to Dr. Junig after swallowing 400 milligrams of Ambien, thinking, “If I wake up, I wake up; if I die, I die.”
Like Mr. Schneider, dozens of addicts interviewed portrayed themselves as exhausted and frightened before they started on Suboxone. They acknowledged having “loved” their chosen opiate but not what turned into a miserable existence dominated by drug-seeking to avoid “dope sickness.”
Travis Norton, 33, gravitated to heroin in adolescence as a result of a misguided infatuation with artist addicts like William S. Burroughs and Kurt Cobain, he said. For years, he cycled through costly abstinence-based programs, always returning to the needle.
“I was a chronic relapse,” said Mr. Norton, who is now an addiction counselor in a Minneapolis suburb. “I was a wreck until I started maintenance therapy in 2003. And I’ve been great since.”
Mr. Norton switched for a time to methadone when his Suboxone doctor retired. At that point, Suboxone, around $16 for an average daily dose, was considered “the rich man’s methadone.” Mr. Norton, not rich but a college-educated professional, found the methadone clinic “a ball and a chain.”
“I had to travel for my job, and there was zero flexibility,” he said. “They had thousands of clients, and I was a number.”
Dr. Edwin A. Salsitz of Beth Israel Medical Center in New York, who has been treating addiction for decades, said that in the pre-Suboxone universe, he encountered all too many middle-class addicts who refused to set foot in a clinic.
“And then sometimes, a couple of years later, they’d be H.I.V. positive, or something more catastrophic would have occurred,” he said. “There’s no way to explain what this meant to the addiction field to have another option besides the clinics.”
Reckitt Benckiser gradually built a stable of doctors paid to advocate use of the treatment, Dr. Salsitz among them.
The recruiting was tough. Those outside the addiction field were reluctant to deal with the hassles of certification, potential visits by the D.E.A. and the addicts themselves. Within the field, buprenorphine faced stiff opposition from the methadone industry as well as traditional rehabilitation programs and the Alcoholics Anonymous movement, which promotes abstinence.
“With Suboxone, there is a lot of misinformation out there, and the most common is you’ve replaced one drug with another,” said Melissa Iverson, a 48-year-old social worker who lives in Florida and is now on disability because of fibromyalgia.
Ms. Iverson first requested anonymity, like most other professionals interviewed, some of whom have never acknowledged their problem to their families, primary care physicians or even insurers. Eventually she decided to “come out of the closet,” saying, “The stigma needs to be tackled by real people with real names, or else it will haunt us forever.”
Relying on ever-escalating doses of painkillers to cope with her chronic pain, she had gone “crazy out of control.” Her life revolved around pills; she would pass out smoking in bed and wake up with burns on her hands or get into car accidents and nod out in the tow truck. Four years ago, she had “a psychotic break,” ended up hospitalized and “came out on Suboxone.”
In contrast to her painkiller use, she has taken Suboxone at increasingly lower doses, finding that it alleviates her pain without “those self-destructive behaviors.”
“As an addict, I was high all the time,” she said. “With Suboxone, I developed a tolerance within a week. There’s zero euphoria.”
Successes like hers multiplied until demand outstripped supply because of the limited number of doctors and the patient cap. This brought some unintended consequences.
First, some prescribers pushed patients off the medication prematurely to replace them with new patients because the early treatment phase was more lucrative. Second, patients began sharing the drug, trading it and selling it. Buprenorphine trickled out onto the street.
Health officials, concerned about restricted access, lobbied alongside Reckitt Benckiser for the patient cap to be raised. “Why should we bind a healer’s hands from helping as many as he or she could?” Senator Hatch said, getting an amendment passed in 2006 that allowed doctors, on request, to go from 30 to 100 patients after a year.
The stage was set for more patients, prescriptions and problems. “It’s when the limit was raised from 30 that doctors started to get commercial about it,” said Dr. Art Van Zee, whose buprenorphine program at a federally funded community health center in rural Virginia is surrounded by for-profit clinics where doctors charge $100 for weekly visits, pulling in, he estimated, about $500,000 a year.
“They are not savvy about addiction medicine, don’t follow patients very closely, don’t do urine testing and overprescribe,” he said. “That’s how buprenorphine became a street drug in our area.”
In Fond du Lac, Wis., on the shores of Lake Winnebago, addicts come and go from a bland building housing a medical office, a cheese business and a title company. They bring their tumultuous lives into a tranquil space with hunter green walls, heathered carpet and easy-listening music, presided over by Dr. Junig’s wife, Nancy, candy jar by her side.
Fond du Lac Psychiatry is the kind of setting the original idealists envisioned. They did not foresee the buprenorphine mega-clinics that resemble and frequently double as painkiller pill mills, sometimes with armed guards to protect their cash.
They did not foresee a buprenorphine empire like the one Dr. Thomas E. Radecki, 67, built in northwestern Pennsylvania.
According to the evidence presented to a grand jury this summer, Dr. Radecki operated four clinics under the business name Doctors and Lawyers for a Drug-Free Youth, serving 1,000 people, many of whom did not need or use buprenorphine and resold it in their neighborhoods. To override the patient limit, he employed other doctors part time. He sold the drug directly to patients, which is legal, and was the country’s largest individual buyer of buprenorphine in the first half of last year, according to investigators. The previous year, he netted $280,000 in profits from the tablets alone, they said.
In August, the Pennsylvania attorney general announced Dr. Radecki’s arrest on charges of improper prescribing and trading addiction drugs for sex. His lawyer, John Froese, said Dr. Radecki “denies that he ever prescribed any medicine that was not helpful to his patients” or had sexual relationships with his buprenorphine patients.
Dr. Radecki lost his Illinois license for just such a relationship, and his Pennsylvania license was made probationary in 2007. Nonetheless, the federal government subsequently authorized him to prescribe buprenorphine and then expand his patient load.
“Very few if any” doctors are denied permission unless they are “under investigation or something pops up,” said Rusty Payne, a D.E.A. spokesman.
The Times analyzed the disciplinary records of the doctors on the federal government’s online listing of buprenorphine providers, which is not comprehensive because doctors can opt out, and calculated state-by-state disciplinary rates.
In 30 of the 31 states that provided their overall disciplinary rates for comparison, buprenorphine doctors are far more likely to have been sanctioned than doctors over all. In Florida and Kentucky, they are four times as likely to have been sanctioned. In New York, they are six times as likely; in Arizona, seven times; in Minnesota, nine times; and in Louisiana, 10 times.
Rates are even higher for the subset certified to treat the maximum patient load, The Times found in analyzing records from a sampling of states.
In Ohio, nearly 17 percent have disciplinary records, compared with 1.6 percent of all doctors. They include individuals sanctioned for: amphetamine addiction coupled with a Medicaid-fraud conviction; conducting an “excessive number of invasive procedures”; smuggling steroids from Mexico; engaging in conversations regarding a “murder for hire” and neglecting to report the rape of a pediatric patient; “digitally penetrating” patients and having sexual intercourse with them in the office.
Some were reprimanded or placed on probation before becoming Suboxone doctors; others, stripped of their licenses recently, had their offices shuttered.
This adds to the volatility of the treatment culture.
A 30-year-old Michigan woman said she was invited into treatment by a doctor who frequented the strip club where she was a bartender and who paid for her medication for several months. When he was placed on probation for “violation of duty/negligence” unrelated to her, she switched to a second doctor, who also got in trouble. After that, the woman bought her buprenorphine on the street for a year — saving $5,500 in medical and counseling fees, she noted — until she found an addiction specialist with an opening.
In some areas, like New York City, there is almost a glut of buprenorphine prescribers. In others, specialists routinely turn away addicts begging for help.
Non-specialists pick up the slack.
Reckitt Benckiser recruited “any doctor willing,” said one former company drug representative who asked not to be identified to protect her career. Those in her territory ranged from “extremely passionate” to intensely commercial, she said: “One charged a $50 co-pay, and another $500 for an initial visit. I had a few physicians using the medication themselves. One guy was so enthusiastic I signed him up as a treatment advocate, but then it turned out he relapsed and lost his license.”
Just because doctors have disciplinary histories does not mean that they are unscrupulous. Some of the most knowledgeable, compassionate addiction doctors are former addicts themselves, with medical board actions on their records that sometimes limit their career options.
Dr. Junig, 53, is an anesthesiologist with a doctorate in neurochemistry who retrained as a psychiatrist after his own recovery from addiction. He did not intend to become a buprenorphine doctor.
“To be honest, I was just trying to build a practice,” he said.
Nor did he intend to become a buprenorphine blogger or the host of an online conversation about the drug through his website Suboxone Forum, which gets 30,000 visits weekly, and a LinkedIn group with nearly 800 professional members. It grew from his initial passion for the treatment — a passion that got him hired briefly as a “treatment facilitator” for Reckitt Benckiser and also got him in trouble.
In 2011, the Wisconsin medical board reprimanded him for using “tele-psychiatry” to treat five out-of-state addicts he had seen only over Skype.
Over time, Dr. Junig said, he moved “from skeptic to true believer to skeptic.” Others similarly modulated their enthusiasm as they gained a nuanced appreciation of the difficulties of managing a complex patient population and a medication that had become a rampant street drug.
Some patients stopped and started their medication so they could still use other opiates or mixed it dangerously with drugs like Xanax. Appointments were missed, prescriptions “lost.” Patients cheated, dropped out and relapsed, sometimes fatally.
Joseph McMahon IV, a gregarious, troubled New Yorker, was prescribed a couple of thousand Suboxone pills over nearly three years. Still, he overdosed on other drugs at least five times and at 25 died of one final overdose in December 2011, turning his father, a retired New York City fire lieutenant, into a bereft chronicler of Suboxone abuse.
“My son swore Suboxone was working for him,” Joseph McMahon III said. “But if I’m an alcoholic and you switch my Budweiser for a Bud Lite, sure, I’m doing great. They call Suboxone ‘heroin in a pill.’ It makes tons of money for the pharmaceutical industry, which has us totally bamboozled, and for these doctors.”
For Dr. Junig, early positive experiences with older patients have been offset by rocky ones with a new generation of heroin and “poly-drug” abusers.
Last spring, he prepared to confront a 26-year-old patient who had landed in an emergency room with an arm infected from injecting cocaine. The man had tried to hide his cocaine use by presenting a specimen of “old urine” to Dr. Junig, who said, “I’m an inch from kicking him out, but I think he’ll die if I do.”
The patient, a mechanic with a young daughter, said he had “slipped up” during a period of homelessness. “It was just cocaine,” he said. “I don’t even really like cocaine. I wanted to tell you so bad, man. But if I lose the Suboxone, I’ll go back to the heroin and the pills, and then I’ll be in real trouble.”
Dr. Junig told the mechanic he would be summoned for surprise testing.
“What worries me most are the needles,” the doctor said. “But people die from cocaine, you know. What you were doing — there’s a genuine risk. If you get busted for cocaine, you could end up in a situation where social services are involved. People lose their kids.”
An Escalating Problem
In late 2009, a discovery made in a Walgreens in Michigan lit up the forums where recovering addicts chat: “Generic bupe!”
The F.D.A. had just approved generic Subutex, buprenorphine without the abuse deterrent, despite Reckitt Benckiser’s effort to prevent it. It was, according to that post, about one-third the cost of brand-name Suboxone.
For the previous six years, Reckitt Benckiser, with the government’s support, had successfully discouraged Subutex except in special circumstances. Doctors and insurers, told that Suboxone was safer, had favored it.
But then Suboxone itself ended up being diverted, misused and abused by injection, indicating that the safeguard was not foolproof, although Reckitt says it stands by it. So when uninsured patients clamored for the cheaper generic, some doctors, including Dr. Kolodny, started accommodating them.
“At first, I did believe the marketing that there was a booby trap in there,” he said. “But my impression is that it doesn’t work as well as promised as an abuse deterrent.”
The most recent data signal an escalating problem with buprenorphine.
Last year, forensic laboratories identified 10,804 drug seizures as buprenorphine, up eightfold from 2006.
In 2011, emergency room visits for the nonmedical use of buprenorphine were estimated at 21,483, nearly five times what they were in 2006. Also in 2011, poison centers recorded 3,625 cases of toxic buprenorphine exposure, nearly five times as high as the previous year.
More young children were hospitalized because of accidental ingestion of buprenorphine than for any other medication in 2010 and 2011, a federal study found. Another study, financed by Reckitt, of 2,380 buprenorphine overdoses in young children found that 587 had to be hospitalized in intensive care units and that four died.
John Burke, the president of the National Association of Drug Diversion Investigators, said buprenorphine remains “down on the totem pole” of worrisome prescription drugs.
“I wouldn’t say buprenorphine is not a serious problem; it’s a product for addicts, so the propensity for diversion is probably much higher than with the other prescription drugs,” he said. “But oxycodone, hydrocodone, Xanax — those make up the bulk of the problem.”
Even so, many local authorities say buprenorphine is their nemesis.
“What we’re seeing here in Delta County is really troubling,” said Steven C. Parks, a prosecuting attorney in Michigan. “Arrest after arrest of people who are possessing or abusing Suboxone, who don’t have a prescription for it, who are shooting it up and who are snorting it.”
“It’s what has followed the oxycodone and the hydrocodone trends here,” he added. “We don’t have heroin yet.”
Mr. Parks said a big local pharmacy had stopped stocking the medication because its employees felt “very threatened.”
Pharmacy robberies for Suboxone alone are rare, but they do happen.
In June, Michelle Wilcox, 27, wearing a hooded sweatshirt and surgical gloves, handed a Maine pharmacy technician a note: “Give me all the 8 mg Subs you have. I have a weapon and I will use it.” She walked out with 84 doses of Suboxone — worth about $640 — and drove off in a pickup truck, only to be arrested within hours, according to documents and interviews.
“She was just desperate,” said Sheriff Scott Nichols of Franklin County, Me. “She said her own medication had been stolen.”
Ms. Wilcox awaits sentencing after pleading guilty to felony robbery charges in federal court.
In Maine, Ms. Katz, the Portland health official, described a seemingly unstoppable flow of Suboxone onto the streets in recent years, with addicts injecting it. Shawn Verrill, serving time for Miles Malone’s death from buprenorphine, said he used to sell the drug in York Beach to supplement his income as a lobster deliveryman.
“Every kid on the beach was looking for it,” he said. “The high lasts all day.”
Mr. Verrill said he bought cases of “stop signs” from a pharmacist and charged $10 to $12 for each orange hexagonal Suboxone tablet, earning $4,500 in a good month.
Most buprenorphine advocates interviewed said they believed that deaths were extremely rare. But Suboxone and Subutex were considered the “primary suspect” in 690 deaths — 420 in the United States — reported to the F.D.A. from spring 2003 through September.
This pales in comparison with the 2,826 deaths from methadone reported to the F.D.A. over roughly the same period, as calculated by AdverseEvents, a company that analyzes data on drug side effects. C.D.C. data, drawn from death certificates, makes it clear that number is a serious undercount. The C.D.C. does not track buprenorphine deaths, which may also be undercounted.
The F.D.A. information, which is spare, does show that more than half the American buprenorphine deaths involved other substances and that only two of 224 cases specifying “route of administration” indicated injection — the primary concern of regulators.
Fifty deaths are listed as suicides, and 69 involve unintentional overdoses, drug abuse or drug misuse. Thirty were fetal or infant deaths after exposure in the womb.
Outside the United States, 118 of the 270 deaths reported were in Sweden. Last year, Sweden’s National Board of Forensic Medicine published an analysis of 100 autopsies where buprenorphine had been detected. In two-thirds, it was the direct cause of death, mostly in combination with other drugs. Swedish researchers attributed the “fatal intoxication” to low tolerance because of first-time use or a period of abstinence.
The F.D.A. cautions against assuming that a “primary suspect” drug was indeed a cause of death.
But Brian M. Overstreet, the president of AdverseEvents, said, “The reality is that hundreds of thousands of cases are reported every year by front-line health care providers who purposefully identify a drug as being the primary suspect cause of a specific adverse event.
“We believe that the link between drug and event,” he continued, “is quite real.”
A Death Lingers
Mr. Malone’s death remains hauntingly real for his family.
In July, his mother told a federal judge: “I try very hard to forget the last time that I saw him at his wake. He wasn’t smiling at me. He didn’t hug me. I touched his hand, and he didn’t touch me back.”
Mr. Verrill pleaded guilty to the distribution of buprenorphine resulting in death. “I feel guilty,” he said in the recent interview, wearing prison khaki, his arms inked with the saying, “What goes around comes around.”
They were friends who had met on the beach.
On the evening of Oct. 12, 2010, Mr. Malone dropped by Mr. Verrill’s garage apartment with a mutual friend. He appeared “high but not wasted,” Mr. Verrill said, although a convenience store clerk had called the police saying Mr. Malone had seemed worryingly intoxicated.
All three young men did drugs. Mr. Verrill and the friend snorted Suboxone and swallowed some tranquilizers. Mr. Malone took only Suboxone, two tablets under his tongue, Mr. Verrill said. Then they smoked marijuana, listened to country music and played video games.
Mr. Verrill said he covered Mr. Malone with a blanket when he himself went to bed, thinking he was just sleeping.
Maine’s medical examiner said Mr. Malone died of buprenorphine toxicity. Traces of marijuana, but no alcohol or other drugs, were found in his system; the level of buprenorphine, though, was high for just two pills.
Before being taken into federal custody, Mr. Verrill served time at a county jail on other charges. Suboxone was everywhere, he said, with detainees paying $20 for a quarter-strip that, transformed with water into a crushable pill for snorting, was enough to “rock” two people whose systems were clean of drugs.
“People were beating each other up and taking their commissary food to sell it and buy Suboxone,” he said.
Referring to the federal prison, he added: “That doesn’t happen here. I’m clean now. If I hadn’t been arrested for Miles’s death, I’d probably be dead myself.”
Competition on the Shelves
Over the years, Reckitt Benckiser started acting more like a pharmaceutical company. It built its Suboxone sales force to about 200; flew members to Italy, Mexico and Spain for motivational meetings; and paid 400 to 500 doctors as advocates, former employees said. It lobbied for influence, the only “corporate round table” member to pay at least $100,000 in dues to the American Society of Addiction Medicine.
After losing its exclusive right to sell buprenorphine in 2009, the company used the drug’s problems to its advantage. Moving aggressively to protect its franchise, it fought the increased prescribing of generic buprenorphine, or Subutex, by telling doctors they would be responsible for worsening diversion and abuse.
“We had lists of the Subutex writers, and we were actively targeting them,” a former employee said.
Even so, over all, Subutex prescribing increased more than tenfold the first year the generic version was sold. Since it was only a matter of time before generic Suboxone would be developed, too, the company began to argue that the black market and the pediatric poisonings demanded a new formulation.
That formulation was the filmstrip, individually wrapped with a traceable bar code, which the company believed would be patent protected until 2023.
Its release was delayed by F.D.A. concerns that challenged the company’s rationale for creating it. First, officials predicted “significant abuse and diversion,” noting that 6,000 Suboxone filmstrips went missing during clinical trials.
Second, they worried that the film might be more dangerous to children because it could not be easily spit out. The individual wrappers would not help if, once opened, each dose was divided, as is common, the F.D.A. said. It demanded better labeling and a patient-counseling plan.
Once the film was approved in 2010, Reckitt Benckiser directed its sales force to discourage the use of the tablet by arguing that its packaging made it hazardous to children — “fear-based messaging,” one former employee called it; “selling against our own medication,” another said.
From that point, the company’s representatives earned bonuses only for Suboxone film. If they did not reach a target “film market-share penetration” in their territory, they risked being dismissed, as personnel records in an employment-related lawsuit show.
The company lured patients directly by offering discounts for the film while raising the price of its tablets. It used rebates to persuade public insurers to give preference to the film. At least 15 state Medicaid agencies do; West Virginia even passed a law banning the pills and requiring the film.
In September 2012, Reckitt Benckiser, calling it “a moral obligation,” announced that it would withdraw its Suboxone tablets from the market — in six months — because of “increasing concerns with pediatric exposure.” It effectively asked the F.D.A. to block generic tablets for the same reason, citing a company-financed study that indicated the film was far safer.
The F.D.A. disagreed and approved generic Suboxone tablets early this year.
Since then, Reckitt’s Suboxone journey has become bumpier. It is battling antitrust lawsuits by a dozen drug wholesalers and insurers who say the company “schemed” to extend its monopoly, overcharging them and, more broadly, the health care system.
In July, Reckitt Benckiser’s stock suffered its biggest one-day loss in two years after CVS Caremark announced that it would drop the film from its preferred drug list in favor of tablets. And there is a new brand on the shelves, too: Zubsolv, which its manufacturer, Orexo, says has “higher bioavailability, faster dissolve time and smaller tablet size with a new menthol taste.” Orexo’s United States medical director is Dr. Gitlow, the addiction medical society president.
In the third quarter of this year, Reckitt Benckiser’s net revenues from Suboxone declined 14 percent from the same period last year, which the company attributes to its discontinuation of the tablets. The company recently announced that it was “reviewing all options” for its pharmaceutical unit, which includes the possibility that it will sell, bringing its profitable foray into the drug business to a close.
Dr. Robert L. DuPont, the first director of the national drug abuse institute, said he marveled at the cutthroat business competition when “you couldn’t get pharma companies to even think about addiction treatment before this $1.5 billion drug got their attention.”
At a recent meeting of the addiction medicine society, “the buprenorphine sessions were all packed with doctors who wanted to get in on the gold rush,” he said. “It seems to me like they are repeating the experience of pain doctors in terms of reckless disregard of the nonmedical use of the drug.”
The system could well be at a turning point, with more drug options, lower prices and expanded insurance coverage under the new health care law and an “addiction equity” mandate. In addition, with a recent regulation change, for-profit addiction companies that run methadone clinics are expanding their buprenorphine programs, which have no patient limits, and some state governments are pressing federally funded health centers to increase nonprofit buprenorphine treatment.
For now, though, patients whose lives have been transformed by the medication say they feel stressed by the struggle to get and pay for treatment, the long waiting lists, the doctors who overcharge and the ones whose offices are shut down. The misuse and abuse of the drug make even their own relatives suspicious of them — not to mention the public and private insurers that restrict the dosage and length of treatment, despite studies showing that higher doses improve treatment retention rates and that quitting buprenorphine often leads to relapse.
Betty Jo Cumberledge, a home health aide in West Virginia, said her insurer paid “forever” for the potent narcotics she took for back pain. But it cut her off this fall after two years of Suboxone treatment for her resulting addiction. “That’s just not humanly respectful in my opinion,” she said.
She handwrote an impassioned letter, complaining that she was being “discriminated against for seeking treatment” and “saying it would be on them when I ended up relapsing and dead.” She won a six-month reprieve.
“The whole situation is a big old mess,” she said.
At Clinics, Tumultuous Lives and Turbulent Care
By Deborah Sontag : NY Times : November 17, 2013
The patient is an addict. His doctor is an addict, too. Over the last decade, both men hit their own versions of rock bottom. For the patient, it was the concrete floor of a jail where he writhed in withdrawal. For the doctor, it was the food stamp office where, his career as a child psychiatrist in tatters, he ashamedly sought help.
Then they both found buprenorphine, the patient as a user, the doctor as a prescriber. And because of that drug, an opioid used to treat opioid addiction, they both rebounded, even thrived.
The patient, Todd Smith, 27, who had developed a painkiller addiction because of a kidney disorder and — “I ain’t gonna lie” — moved on to mainlining heroin, built a life with solidity: a car, a townhouse, a job as a mine safety inspector, a live-in fiancée and “knees worn out from praying.”
The doctor, Allan W. Clark, 52, despite losing his Ohio medical license and being on probation in Pennsylvania for eight years, built a buprenorphine business so bustling that five doctors now work under him. His South Hills Recovery Project, tucked behind a 7-Eleven and beneath a hair salon, vibrates with the hubbub of the 600 addicts treated there.
Over the last couple of years, their fates have entwined, with Mr. Smith dependent on “Doc” for the treatment that keeps him stable at an out-of-pocket cost of $7,200 a year and Dr. Clark on “Smitty” and all the other cash-paying patients whose recovery he champions with an us-against-the-world fervor. They have shared, too, a keen awareness that their stability could be precarious.
“In recovery, you’re constantly facing down your demons and dealing with the echoes of your past,” Dr. Clark said. “But in the crazy world of buprenorphine, where this medicine that saves lives is harder to get and afford than the drugs that ruin lives, you’re battling outside forces, too.”
It is indeed a crazy world, or at least a vibrant, volatile subculture of people who see “bupe” as a lifeline, often difficult to reach, in an era when drug deaths outnumber those from car crashes. They scramble to find legitimate, affordable treatment even as buprenorphine is increasingly available on the street, with rising indicators of misuse and abuse tainting its reputation.
Buprenorphine was developed as a safer alternative to methadone for treating heroin and painkiller addiction, a take-home medication that could be prescribed by doctors in offices rather than dispensed daily in clinics. But in some areas a de facto clinic scene, unregulated, has developed, and it has a split personality — nonprofit treatment programs versus moneymaking enterprises built by individual doctors, some with troubled records.
The clinics serve as a crossroads where the tumultuous lives of recovering addicts converge and collide with a turbulent treatment environment.
Since March, The New York Times has visited and tracked the patients of two of the largest buprenorphine programs in this region, where addiction rates are high, for-profit clinics have proliferated, doctors go in and out of business and the black market is thriving.
Dr. Clark’s hectic, cluttered office in suburban Pittsburgh is an entrepreneurial venture with heart where the rumpled doctor dresses in sweatsuits, the boundary between patients and employees is razor thin, the requirements are minimal and the tolerance for missteps is maximal.
“I know on the surface it might look like a pill mill,” he said. “We’re seeing a fair number of patients, and they’re primarily receiving a prescription. But if you look deeper, you’ll see that we don’t use the medication in a vacuum. We encourage, we support, we don’t judge. There’s a kind of love.”
Sixty miles away, the more formal, structured treatment center at West Virginia University in Morgantown sits atop a hill, ensconced in a hospital complex and presided over by Dr. Carl R. Sullivan III, a career addictionologist who wears a white lab coat and stands professorially at the front of a classroom when he meets his patients in groups: “Are you clean? How many meetings have you been to?” he asks them.
Dr. Sullivan, 61, primarily treated alcoholism until “a spectacular explosion of prescription opioid drugs” starting around 2000. He considered opioid addiction “a hopeless disease,” with patients leaving rehab and then relapsing and sometimes dying, until he started prescribing Suboxone, the brand-name drug whose main ingredient is buprenorphine, as a maintenance therapy in 2004.
He became a paid treatment advocate for the manufacturer, Reckitt Benckiser, delivering, he estimated, 75 talks at $500 each. But, he said, “If the company didn’t pay me a nickel, I’d still promote Suboxone because in 2013, it’s the best thing that’s happened for the opioid addict.”
Dr. Sullivan is skeptical of the buprenorphine “empires” in Pittsburgh — though not of Dr. Clark specifically, whom he does not know — believing that they feed the black market and tar the medication’s reputation. Dr. Clark, in turn, is skeptical of “ivory tower” addiction programs with rigid rules and of doctors who, in his view, collude with the pharmaceutical industry.
“Big Pharma is in it for the super profits; we should be in it for the patients,” said Dr. Clark, who nonetheless became a buprenorphine doctor partly because he needed to dig himself out of a financial hole.
An Unlikely Savior
Tall and lumbering, his balding head covered by a plaid cap, Mr. Smith strode into Dr. Clark’s office last spring with the familiarity of a clinic V.I.P., somebody whose urine is so consistently clean that he does not need to have his “pee tests” observed.
“Hey, Smitty, good to see you, my friend,” Dr. Clark said, propping his sneakered feet on his desk and swigging from his habitual can of Red Bull. By his side, a harness whip, a gift from a patient, sat beneath the framed diplomas hanging crookedly on the wall.
“Hey, Doc,” Mr. Smith said, settling his 270-pound frame into an armchair. He had hurried back from a job building windmills in Alaska just in time to get his next month’s prescription: four 8-milligram tablets a day, the highest dose recommended, that stave off withdrawal, eliminate his cravings for heroin, keep his mood balanced and alleviate his chronic pain.
Growing up in the hilltop town of Meyersdale — “Pennsylvania’s High Point” — Mr. Smith had aspired to follow his grandfather into the family business. “All I wanted to do was towing, in my Pap’s footsteps,” he said.
A rare kidney condition, treated with surgery and potent painkillers, knocked him off course. After several years, he told his doctor that he wanted to wean himself off the pills.
He said: “The doctor stopped dead like I had my pants on backward, and said, ‘You’re admitting you’re addicted?’ I said, ‘Well, it ain’t no news flash.’ ” The doctor ripped up his prescription and threw it in the air.
Mr. Smith spent the next week “dope sick,” shivering, sweating and vomiting. A friend proposed a solution: heroin, cheap and easy to find. “Things started going south,” Mr. Smith said. Then his grandfather died, and he learned that the towing business would be sold.
“I went clean off my rocker,” he said. To finance his habit, he burned through $12,000 in savings and finally drove off to sell the contents of his gun safe, including weapons of disputed ownership. A police officer was waiting when he returned to arrest him for theft. Agonizing on that jailhouse floor, he promised himself he would never use again.
A week later, essentially under house arrest in the custody of his father, a corrections officer, he called Dr. Clark’s office, crying.
“He saved my life,” Mr. Smith said.
That was two years ago. In his session last spring, Mr. Smith told his unlikely savior: “I’m sort of pissed at you. I hear you’ve been shooting Airsoft without me.” (The game involves fake guns and pellets.)
“Yeah, sorry, buddy,” the doctor said. “I know you’d be into that. What we all do in getting better is to switch to different ways of getting our ya-yas out, right?”
They talked motorcycles. The doctor drives a Harley-Davidson Fat Boy. Mr. Smith fantasizes about “barreling down the highway on a Big Dog” but is in too much debt to buy one. “You know how it is,” he said.
Dr. Clark nodded. “I thought losing my credit was the worst thing in the world, but it was the best thing in the world because now I’m living on a cash basis,” he said. “Credit is a big scam, man. It uses our addictive nature against us: ‘I want it now. I want it now.’ ”
Mr. Smith loves it when Dr. Clark talks to him addict to addict. “I’ve heard patients say he ain’t no better than we are or he’s just in it for the money,” he said. “But I think being an addict makes him a better doctor. He’s been in our shoes.”
Defending the Disparaged
With tattoos commemorating his recovery, Dr. Clark runs the office with his girlfriend, Natalie Tombs, also a recovering addict. Emotive and animated, Ms. Tombs has festooned the walls with inspirational messages on butterflies and hearts and signs warning against sharing, trading or selling medication: “ANY PATIENT CAN BE SUBJECTED TO RANDOM PILL COUNTS.”
The couple portray themselves as the defenders of a disparaged segment of society with which they commiserate. Their patients see them that way, too.
“As you know, my pharmacist thinks you’re pretty much a joke, and he’s not filling your prescriptions,” one patient, James Markeley, said recently. “I brought one in, handed it to him and said, ‘How long will it be?’ He said, ‘It won’t be.’ ”
Dr. Clark giggled. “What’d he say again?” he said. “I’m an old hippie? I like that one.”
It was not always so.
A graduate of the University of Cincinnati College of Medicine, Dr. Clark did a fellowship in child psychiatry at Yale, served as an Air Force doctor in Germany and then took a job at a Pennsylvania hospital.
In the late 1990s, unhappy and overwhelmed by his patient load, he prescribed himself Adderall, a stimulant. His mood improved, and he focused better. But he kept taking more to get the same effect. After two years, he was a wreck.
Dr. Clark checked himself into a rehabilitation program in 1999.
“I had to cold-turkey it,” he said. “Withdrawal from amphetamines is different. It’s much more tolerable than from opioids. After detox, though, the obsession and craving for the drug are similar. The relapse rates are similar. The triggers are similar. I had to learn to manage stress better, to rest better, to improve my self-esteem.”
Dr. Clark also had to meet the demands of Pennsylvania’s physician recovery program: therapy as well as five 12-step meetings and two random urine screens a week.
After a few sober years, he relapsed when his marriage was breaking up. He wrote himself a prescription for painkillers in his son’s name. His wife notified his program advocate.
“Just how much pain is your son in?” the advocate asked.
In 2002, a second residential program gave him a diagnosis of depression and narcissistic personality disorder — he disagreed — and discharged him early with a poor prognosis. He agreed to take a reprieve from practicing medicine in Pennsylvania; Ohio suspended his license.
Deeply in debt, Dr. Clark was reduced to collecting food stamps until Pennsylvania let him return to medicine as a prison doctor in 2003.
That same year, after a positive drug test, Dr. Clark entered his third treatment program and promised himself it would be his last. He has been sober since, he said.
His troubles did not end with sobriety, though.
Pennsylvania suspended him for a month in 2010 because he failed to submit to three unannounced drug tests while on vacation. Ohio revoked his license in 2011 because he forged signatures verifying his attendance at 12-step meetings.
In 2008, a Reckitt Benckiser representative approached Dr. Clark at a children’s hospital, saying: “There’s this great medicine, Suboxone. Why not get certified? It doesn’t take much, and it’s a nice thing to add to your practice,” he said.
Dr. Clark devised a treatment program based on federal guidelines, except he tailored it to what his working-class patients could afford. He mostly prescribed generic buprenorphine rather than the higher-priced Suboxone, which has an additive meant to deter abuse and is favored, though not mandated, by the guidelines.
And he established monthly, rather than more frequent, office visits unless patients violated the rules. He decided to “cut out the middleman” by declining to accept insurance and set his fee at $150 a visit, with a couples’ price of $100 a person.
“I made sure my price was the lowest of any of the clinics, and that’s why people liked us in the beginning,” he said. “Many of my competitors were gouging them.”
With his caseload limited to 100 by law, Dr. Clark quickly found himself turning away patients and searching for doctors who wanted to supplement their income by working part-time for him.
He hired the walk-in clinic doctor who monitored his urine drug screens, and an alternative medicine specialist who sees patients by Skype from Virginia. He also hired a 53-year-old internist shortly after a 25-year-old woman died of “acute combined drug toxicity” at the internist’s home following an evening together at the Wicked Googly bar in Ligonier, Pa.
“He told me he was feeling some heat in his area and needed to get out of town for a while,” Dr. Clark said.
After filing for bankruptcy protection with $1.5 million in debt early this year, the internist quit in May to run his own buprenorphine practice, saying he needed to make money fast, Dr. Clark said.
Dr. Clark scrambled to replace him so his patients would not be abandoned. They often are in this volatile field. Many of Dr. Clark’s patients showed up on his doorstep after the authorities had put their previous doctors out of business.
That happened with both Angela Scotchel, 25, and Amanda Rogers, 32. They are like before and after pictures. Ms. Scotchel, a former basketball star, is relatively fragile in her recovery, while Ms. Rogers appears firmly entrenched in hers despite a tempestuous personal life.
‘A Classy User’
In certain lights, Ms. Rogers, with her long blond hair and cornflower blue eyes, looks like the cheerleader she was, before the people closest to her started dying from drugs and she developed a yearslong habit.
“I never shot up; I always snorted,” she said in March at her home in Toronto, Ohio. “I called myself a classy user. I always made sure the kids were taken care of and the bills were paid first.”
In Steubenville, where Ms. Rogers grew up, drugs were everywhere, and almost everybody in her life was an addict: her mother and stepfather, who suffered fatal overdoses; her younger sisters; her best friend; and her boyfriend.
“That town is like poison,” she said. “I’ve probably lost close to 25 friends in the past 10 years.”
She was 21 and devastated by her mother’s death when she started seeking solace in the “nerve pills” her mother left behind. She became so dysfunctional that she lost custody of her first child to relatives, she said, then quit the pills, had a second child and sought help for back pain and fibromyalgia from a local doctor.
“I didn’t know he was a pill pusher at the time,” she said of the doctor, who was forced into retirement by the medical authorities in 2010. “He’d get people hooked and then kick them out to hunt for drugs on the street. And once you’re on the street, heroin is cheaper than pills and lasts longer. I loved it.”
Fearful she would end up killing herself, she found a Suboxone doctor she could afford and placed her first tablet under her tongue on Sept. 21, 2009. She has been clean since, she said proudly, despite traumas that tested her resolve.
In June 2012, her younger sister Tiffany was released from a court-mandated, abstinence-based rehabilitation program. She glowed, Ms. Rogers said. But returning to Steubenville, with temptation all around, proved too much for her. Ms. Rogers said, “She was crying and crying, bawling, saying, ‘Mandy, I’m craving.’ ”
Within a week, Tiffany was dead at 26 of “acute cardiac and respiratory distress due to opioid abuse and dependency,” her death certificate said.
“When I got that news, it was like with my mom,” Ms. Rogers said. “I just wanted to get in bed and stop trying.”
This time, though, she ran a household filled with the grief and need of her sister’s traumatized children and of her own. So she coped. Then her Suboxone doctor lost his license for excessive narcotics prescribing, and she had to forage for medication on the street until Dr. Clark’s office called in April with an unexpected opening.
Before Ms. Rogers’s first appointment with him, her 2-year-old played boisterously as she described feeling achy and nauseous. Her buprenorphine supply had run out and withdrawal had begun.
“If it wasn’t for my pain, I might tough it out,” she said. “But if I went off the Subs, I’d have to go back on painkillers, and I’m not going back down that road.”
A few hours later, clasping a heart pendant containing a vial of her sister’s ashes, she told Dr. Clark with tearful defiance that she would not let her children or her sister’s children follow in their parents’ and grandparents’ footsteps.
“I want to break that cycle,” she said.
A Basketball Star’s Fall
Angela Scotchel was a first-generation user, but her family clung to her as she self-destructed. For her mother, Connie, that included lying by her side on the nights she overdosed to make sure she did not stop breathing. “You couldn’t call an ambulance every single time,” Connie Scotchel said.
Once a week, Mrs. Scotchel, a small-business owner with her husband, drives her daughter to Dr. Clark’s office outside Pittsburgh from Morgantown to ensure she gets there and uses their hard-earned cash to pay the doctor and buy the medication. At home, Mrs. Scotchel keeps the buprenorphine in a locked safe and dispenses it dose by dose.
In her daily uniform of basketball shorts, Angela looks more like the point guard who used to squat 300 pounds than the scrawny addict who worked for an escort service to pay for her substantial heroin habit.
“I would never do anything like that sober in a million years,” Angela said. “It was always men in their 40s, 50s and 60s, doctors and lawyers. Me being gay, it was especially disgusting. But I didn’t care as long as I got high.”
During her senior year of high school, playing a rival team in a packed gym, Angela stole a ball right before halftime, tore down the court, leapt for a layup and was smacked down by an opposing player. A hush blanketed the crowd. She had torn an anterior cruciate ligament. And though she recovered to start on a college team, she soon tore another ligament. After two surgeries, she felt she had lost her game. She also developed a taste for painkillers.
“A lot of people said I could go pro, play overseas,” she said. “But I gave it all up for drugs. Every time I used, I hated myself. I felt like I had let everybody down. I wanted to die.”
Over lasagna at their home, her parents talked about how bad things got: the times she disappeared, stole money from them, crashed cars, dangerously mixed heroin and Xanax. “I can’t count the number of times the police and the municipality walked up these steps,” Mrs. Scotchel said. “They assisted us with her overdoses time and time again. I’d have to follow her to the hospital. They’d shackle her. I’d be there all night waiting.”
Putting down her fork, Angela Scotchel cried. “I went from a superstar to this lowdown dirty addict,” she said.
She first tried Suboxone in Dr. Sullivan’s clinic, which is 10 minutes from her home. But it made her ill. She thought she might be allergic to the additive in Suboxone and asked for plain buprenorphine. The clinic said no. She dropped out.
“They lived by the white coat there,” her mother said, “while Dr. Clark is like one of the addicts.”
Angela’s heroin dealer stocked plain buprenorphine, so she tried it. It made her feel great, not sick, she said, so she found a doctor willing to prescribe it last year. After six months, she and her mother arrived at his office to find federal agents in windbreakers.
“We watched the D.E.A. go in and out, and I said, ‘Angela, he’s busted,’ ” Mrs. Scotchel said. “Poor Angela was crying, thinking she was going to get sick again.”
They drove to Dr. Clark’s office, even though they knew his waiting list was long. Seeing how distraught Angela was, the doctor took her on. Early this year, Angela confessed to Dr. Clark that she was injecting her buprenorphine and mixing it with Xanax. He threatened to discharge her unless she stopped immediately. She did.
Mrs. Scotchel insisted that Dr. Clark see her daughter weekly, even though they are uninsured and it adds $3,000 to the yearly cost. The doctor gives her a $20 discount for each Narcotics Anonymous meeting she writes up in her journal.
During her daughter’s appointments, Mrs. Scotchel prefers to wait outside in her Subaru Forester, reading her Bible. “When I go in there, I gawk,” she said. “It should be a reality show.”
On a typical day last spring, Dr. Clark’s waiting room was a tangle of mothers and babies, interlocked girlfriends and boyfriends, bikers in leather and miners with their names on their shirts. As conversation snippets made clear, they were wrestling with eviction notices and restraining orders, insurance headaches and custody problems, parole officers and abusive spouses.
“If he comes back and says, ‘I’ve got a gun,’ I’ll load up my 12-gauge and it will be war! ” said a patient with purple-streaked hair, mascara dripping down her cheeks.
Another woman, juggling two small children, car keys and a lit cigarette, told the office manager she was broke.
“I just gave you guys my last money, and I’m out of diapers and don’t got gas,” she said. The manager returned $25 to her and told her to get home safely.
Employees wandered about in shorts and flip-flops, shouting, “Can I have a pee cup, please?” Many are recovering addicts themselves, like Thomas Walleck, who staffs the drug testing station, in front of the Wall of Lost Souls — a collage of celebrities who died of overdoses.
Mr. Walleck, gentle and raspy-voiced, said he led patients to believe that his tests were all powerful so they would be forthright.
“I’ll also tell them Doc has kicked out 180 people for dishonesty; I exaggerate,” he said. “But we got to know if they’re dirty for their own good. And if they admit it, it’s good for the bottom line, too. Because then they have to come back in two weeks, and that’s another $100.”
Monitoring patients is a delicate task. Dr. Clark summons them for surprise pill counts; a sign in his office offers “CASH and FREE VISIT rewards for information leading to the prosecution of those who are engaging in illegal activity regarding their Suboxone/Subutex prescriptions.”
Yet this policing clashes with the doctor’s fierce instinct to take his patients’ side and to confide in them about, say, his own reliance on antidepressants or his girlfriend’s routine of reading recovery books while eating licorice in bed.
Ms. Tombs, the girlfriend, gets frustrated with his penchant for giving his patients second, third and fourth chances. After he wrote a 30-day buprenorphine prescription for a young man who had admitted to dealing cocaine, Ms. Tombs angrily drew 1,000 stick figures to illustrate those on their waiting list.
“I had to sleep in the office for three days,” Dr. Clark said.
Usually the two are united against outside forces: the police who keep a too-watchful eye on their parking lot, the child protection workers who do not consider buprenorphine users drug free, the pharmacists who hassle their patients.
Dr. Clark has frequently felt under siege. He said a Reckitt Benckiser representative cautioned him that he was courting trouble with the authorities by prescribing generic buprenorphine and not Suboxone. Last year, Dr. Clark wrote the Drug Enforcement Administration to ask whether he was indeed tempting fate.
A senior D.E.A. official responded that “what drug to prescribe, what formulation, what quantity” was a doctor’s prerogative.
“It is unfortunate to learn that physicians in Western Pennsylvania have received incorrect information,” the official wrote, “and that such misinformation may potentially be inhibiting legitimate treatment.”
Feeling vindicated, Dr. Clark circulated the letter to pharmacists. But they were concerned, too, about the amounts he was prescribing. While within federal guidelines, his doses were on average twice those of Dr. Sullivan’s.
Many of his patients, having flooded their bodies with potent opioids for years, need high doses, Dr. Clark said. Indeed, he noted, studies have shown higher treatment retention rates for people getting higher doses.
Dr. Sullivan, though, spoke with frustration about “prescribing wars” in Pittsburgh between “entrepreneurial doctors” who were “naively or maliciously overprescribing.”
“Which is terrible,” he said. “Patients will take what they need and sell the rest. And once the medicine is on the street, for the D.E.A., it looks just like heroin: part of the problem. It blows back on all of us.”
A Structured Program
Early this year, Dr. Sullivan invited the United States attorney for the Northern District of West Virginia to visit his clinic, which with its mushroom-colored walls and white-coated professionals inspires a kind of institutional hush.
The federal prosecutor, William J. Ihlenfeld II, said he was eager to be “enlightened” given that West Virginia has the country’s second highest rate of overdose deaths and that a fifth of its babies have been exposed to drugs or alcohol in the womb.
“We’ve taken the approach in our office that we can’t just arrest our way out of the problems we’re facing with prescription drugs and heroin,” Mr. Ihlenfeld said. Before his visit, he felt “somewhat close-minded about how effective something like this can be” given that he had “heard a lot of people in law enforcement complain” about buprenorphine.
What he saw inspired him, though, he said: “People benefiting, from a coal miner to a restaurant owner to somebody who had had ankle surgery and got sucked into addiction.”
Dr. Sullivan’s program, a showcase for buprenorphine treatment, is as regimented as Dr. Clark’s is free form. New patients must attend one 90-minute session at the hospital plus four 12-step recovery meetings a week until they achieve 90 continuous days of sobriety, which usually takes half a year.
“There’s no data to support it, but people who go to meetings get better,” Dr. Sullivan said. “You can’t just give addicts a pill, pat them on the head and expect them to turn things around for themselves. These people live very complicated and messy lives.”
The new patients often inquire how long they will have to take buprenorphine. Once stable, though, they stop asking, realizing the answer is “maybe forever,” Dr. Sullivan said.
“Forever seems like a nice alternative to dead,” his patient Joellen Trippett, 48, said dryly.
At a staff meeting one day last spring, a case manager asked Dr. Sullivan how he wanted to handle a younger woman who was vigorously denying her pharmacy’s report that she had sought to fill a prescription for Oxycodone.
“I guess we’ll do an observed on her,” Dr. Sullivan said, referring to a monitored urine test.
“An observed?” the case manager said. “How about a discharge?”
Relapses are plentiful — 12 of 50 patients that day — but patients are expelled only if they lie. Confronting the woman in her therapy group, Dr. Sullivan said that “surreptitious use of opioids is not permitted” and dismissed her with a prescription for one week of Suboxone.
Unlike Dr. Clark, Dr. Sullivan does not meet with patients individually. It would not be cost-effective; more than half of the clinic’s patients are covered by Medicaid. Instead, he relies on therapists like Katie Chiasson, whose “advanced” group — those clean of drugs for at least a year and therefore required to come only monthly — was full of angst one day last spring.
Betty Jo Cumberledge, 47, announced in a trembling voice that she had just gotten a text from a fellow patient seeking to buy some of her Suboxone.
“Tell them that if they don’t stop, you will expose them in group,” Ms. Trippett said.
Ms. Chiasson asked how they could set boundaries.
“We all need to protect our medicine,” Ms. Trippett said. “It gets stolen out of our cars and homes.” She added that while selling Suboxone would be profitable, she did not want to return to the life she used to lead: “I don’t want to be a cheat. I don’t want to be a thief. I don’t want to be a liar.”
Chelsea Kennedy, 21, skinny and pregnant with her second child, reported that seven Suboxone dealers had been arrested in her town the previous week, and talked about her friend who gets a Suboxone prescription in Pittsburgh without even seeing the doctor — “and she’s selling, shooting, buying, running the streets.”
Ms. Cumberledge threw up her hands: “It’s these kind of people who are hurting us.”
A Disease’s Tentacles
In late spring, Dr. Clark, still on probation, got an anxiety-provoking visit from a state medical investigator. Some pharmacists had complained about his prescribing practices, which led to the discovery that Dr. Clark had violated his 2010 suspension by continuing to write prescriptions for three buprenorphine patients he had not been able to place with other doctors.
When the investigator arrived, Mr. Smith was there. It made him nervous. He was already rattled, dealing with a job change and a custody battle, and did not want to contemplate losing Dr. Clark. “I’d be tossed right back out onto the street to buy drugs,” he said.
Addiction is a tenacious disease with tentacles — family problems, legal problems, financial problems — that do not disappear with sobriety. Recovery has its zigs and zags, which many of the patients interviewed experienced this summer and fall.
Angela Scotchel, overwhelmed by anxiety about her future, constantly craved and sometimes gave in to her desire for Xanax. She also heard the siren call of opiates even as she set out to engage in life-affirming pursuits like lifting weights, working for her parents, dating.
“This one dealer called me today and said he got some fire in,” she wrote in an email, referring to high-potency heroin. “I can’t get it out of my head. I’m not gonna act on it, though. Just threw me off. I needed to tell someone about it.”
Ms. Rogers rode a roller coaster of life changes. She broke up with her partner of 21 years and got involved with another man. She found a job as a cashier and lost it because of unreliable babysitters. She placed her late sister’s children in a therapeutic foster home. She reluctantly moved back to Steubenville for lower-priced housing. She became pregnant with her fourth child.
Dr. Clark, meanwhile, prepared himself for the possibility that he could lose his license. He aggressively recruited other doctors, figuring he could manage the clinic. He watched the movie “Lincoln” twice; it helped him “deal with ‘the negativity.’ ”
“I figure if Lincoln could fight for the rights of slaves during a time when many people thought this was practically criminal,” he wrote in an email, “the least I can do is continue to fight for the rights of a few people suffering from the disease and stigma of addiction in my little part of the world.”
At summer’s end, though, his probation was lifted. He hired two New Jersey doctors, one a recovering addict, to see patients by Skype. His business grew fatter while he grew leaner, shedding 20 pounds and his sense of dread.
“I feel like I got de-stigmatized,” Dr. Clark said. “Like now I got nothing to hide, nothing to fear, and there’s hope for me and hope for all my patients. But we’ll see.”