This was a very long article in the NY Times on Sunday, exposing the difficulties of managing an opiate addiction with yet another opiate.
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.
Again, they are promoting a newer opioid to “cure” addiction to an older one, a strategy that has failed many times. (see History of Synthetic Opioids – Cures for Addiction?)
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
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.
available to addicts by prescription, though only from federally authorized doctors with restricted patient loads [100 patients per doctor].
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.
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,
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.
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.
But buprenorphine is not being monitored systematically enough to gauge the full scope of its misuse, some experts say.
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.
over the last few years, the company’s aggressive campaign to protect its lucrative franchise has alienated some of its customers and allies.
Though far more potent than morphine, buprenorphine appeared in animal tests to be unusually safe even in very high doses.
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.
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.
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.
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.
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.
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.
All addictions? Considering what a lucrative practice it has become, it seems this doctor is a crusader for the recovery business. We should not forget that putting opiate-prescribing doctors out of business simply moves the profits from doctors to recovery clinics (with their pathetic success rates), or street dealers.
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.
Pain patients have always been at the mercy of the mercenary manipulations of the pharmaceutical industry, and these days we face opposition from the recovery business as well. Their insistence on abstinence isn’t useful for patients that will have to take pain medications for the rest of their lives.
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.
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.
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.
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.
It only seem logical that a pain patient would turn to a street supply:
- anywhere and anytime availability: multiple local sources, late night and weekend hours, deliveries
- less threat of supply interruption: when one dealer is caught another always takes his place
- lower cost: multiple vendors compete for business, no associated medical expenses
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.
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.
In late 2009… when 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.
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.
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,
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.
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.
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.
This is familiar to pain paiients because they face the same kinds of problems. Once again, legitimate users are harassed, restricted and punished, while street users seem to have free access. It only seem logical that a pain patient would turn to a street supply: anywhere and anytime availability, and lower cost, with no associated medical expenses.
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.
This is another thing recovering addicts have in common with pain patients: facing the stigma of taking opiates.