11/16/2013, Addiction Treatment With a Dark Side

http://www.nytimes.com/2013/11/17/health/in-demand-in-clinics-and-on-the-street-bupe-can-be-savior-or-menace.html?pagewanted=all

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…

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…

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…

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…

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…

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…

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…

“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.”

…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).

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…

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…

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.)…

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.

Early Successes

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.”

Reckitt Benckiser gradually built a stable of doctors paid to advocate use of the treatment, Dr. Salsitz among them…

“That’s how buprenorphine became a street drug in our area.”

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…

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…

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…

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…

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…

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.”

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.”

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…

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 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…

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…

If you don't comment, I'll just assume you agree with me

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s