Definitely not a silver bullet

e1drugThe Christian Science Monitor recently published an article about the growing misuse of buprenorphine.

Police reports of bupe-related seizures increased nationwide from 90 reports in 2003 to more than 10,500 by 2010, according to the DEA. Meanwhile, the number of emergency room visits involving bupe increased tenfold over a five-year period, reaching more than 30,000 incidents in 2010, with over half of them involving nonmedical use of bupe, according to the Drug Abuse Warning Network.

“It just kept ballooning and snowballing,” says Linda Ryan, executive director of the Samaritan House, a homeless shelter in St. Albans, Vt., who became an advocate of stricter regulation of the drug after abuse rose at her shelter over the past three years. “Actually, it’s kind of a nightmare.”

Reckitt Benckiser says it is “greatly aware” of such issues and is “concerned about misuse and/or diversion of our products” that deviate from the drug’s intended use solely as part of a regulated, broader treatment program. The company says it funds an “extensive risk management program” to monitor and intervene in instances of abuse and that it maintains “open communication” with doctors to educate them how to avoid abuse.

To be sure, rates of bupe abuse pale in comparison to abuse rates for prescription painkillers, heroin, and methadone. In 2009, emergency-room visits for methadone-related incidents hit more than 63,000, almost double the number five years earlier, and more than 60 percent were for nonmedical use, according to federal data.

But experts also say they don’t know the full scale of the bupe problem, because bupe has yet to become a drug for which medical examiners regularly test. A pilot program to better gauge the rate of bupe abuse found that 98 of 1,061 urine samples collected by Maryland parole and probation agents tested positive for bupe. Almost half of those samples tested positive for at least two other drugs, suggesting abuse.

 

we can heal

hopeJennifer Matesa has a new piece up at the recently reincarnated The Fix. It’s a response to the recent NY Times series on Suboxone and goes directly after the underlying assumption and its implications for her.

Reckitt can get away with convincing doctors that addicts need to be maintained on Suboxone because—as the Times story notes—common belief holds that painkiller addicts can never be drug-free. We’re told we’ve permanently screwed up our neurology. Popular thinking goes: Once you junkies take drugs, you might as well stay on drugs for life.

To support this belief, Reckitt and its growing army of reps offer twisted interpretations of research studies and anecdotal evidence about addiction and Suboxone. They claim studies “prove” that replacing painkillers with buprenorphine (the opioid drug in Suboxone) helps us stay “clean.” Ditch the old drug for the new drug and we stop shooting, snorting, stealing, doctor-shopping, tricking.

. . .

If my “Sub doc” had believed—as so many doctors do—that somebody like me could never be drug-free, I’d without a doubt still be on drugs today. Hell, which of us inside active addiction believes we can do without drugs? I’d also be experiencing nasty side-effects for which people who read my addiction-and-recovery blog write in asking for help.

For me, what’s so important about her voice is that she’s one addict speaking directly to other addicts around the chorus of experts chanting, “research shows that maintenance treatments are the most effective treatments we have.” She’s offering hope that other addicts don’t have to limit themselves to the definition of success that these experts offer (reduced death, disease and drug use).

She’s also become a collector of stories about the lived experience of people who have tried Suboxone and found it to be incompatible with full recovery and very difficult to discontinue.

Just like doctors who can’t detox their patients off painkillers, most doctors who prescribe Suboxone don’t know how to help their patients quit. So the patients wind up asking me to be their doctor. One woman recently begged me to manage her detox in exchange for payment. I declined, but I was left shocked at the desperation of some folks out there to live a drug-free life, so much so that they will contact a total stranger and offer cash for an amateur detox. This speaks to the sorry state of treatment (not to mention the general health-care system) in this country.

These folks read my blog, they know I got off drugs including Suboxone, and they can see I’m living a productive drug-free life. I write them back, but I can’t be their doctor. The best I can do is keep writing stories like these, and letting policymakers, researchers, and practitioners know that they need to open their minds about how well most addicts can live, how much we can heal.

“a hopeless disease”

English: Suboxone tablet - both sides.
English: Suboxone tablet – both sides. (Photo credit: Wikipedia)

 

The NY Times has another article in its series on Suboxone.

 

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 Times profiles two practices [emphasis mine]:

 

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.

 

A little more on Dr. Carter:

 

“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.

. . .

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.

 

Both doctors are concerned about corruption in the business.

 

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.

 

One more example of the financial incentives. This is Dr. Clark discussing one of his staff physicians:

 

“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.

 

For its part, Reckitt Benckiser recruited Sullivan (who believes opiate addiction to have been hopeless before Suboxone) as a paid advocate and courted the shady Clark to prescribe, while also giving dark warnings about prescribing generics:

 

[Dr. Sullivan] 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.”

. . .

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] said a Reckitt Benckiser representative cautioned him that he was courting trouble with the authorities by prescribing generic buprenorphine and not Suboxone. 

 

 

 

Suboxone Strategy: Protecting Patients Or Profits?

Reckitt Benckiser
Reckitt Benckiser (Photo credit: Wikipedia)

I’m a little late on posting this one, but it still seems worth sharing.

Reckitt Benckiser has decided to pull Suboxone tablets from the market. Why? It’s an evidence-based decision and an expression of their desire to be a good corporate citizen and their concern for children.

Late last month, Reckitt Benckiser created a stir by unexpectedly announcing that its Suboxone tablet for treating opioid dependence will be withdrawn from the US market sometime over the next six months. The reason? The drugmaker, which is based in the UK and actually best known for household cleaning products, expressed concern that children could be accidentally harmed by easy access to tablets that are marketed in bottles.

In making its case, Reckitt cited specially commissioned data showing “consistently and significantly higher rates of accidental unsupervised pediatric exposure” with Suboxone tablets than with Suboxone Film, a newer version of its drug that dissolves under the tongue and can only be accessed by tearing open individual blister packaging. Specifically, the rates for Suboxone tablets were roughly eight times greater (read here).

What’s the big business picture?

To generic drug makers, some physicians and Wall Street analysts, however, the moves amounted to a transparent one-two punch designed to delay lower-cost generic tablets from reaching the market. The patent on Suboxone tablets, in fact, expired two years ago, while patent on Suboxone Film expires in 2022, according to the Reckitt spokesman. “If Reckitt is so concerned about safety,” says one industry source, who asked not to be named, “then why not take the tablets off the market right away? Their tablets are still on the market without blister packing, which they themselves say is unsafe.”

Meanwhile, Reckitt has gradually raised the price of Suboxone Tablets in order to switch patients. The current wholesale average cost (WAC) for a bottle of 30 Suboxone Tablets is $161.70 for the 2 mg dose and $289.80 for the 8 mg dose, according to the Reckitt spokesman. In July, however, the same bottle of the 2 mg dose cost $140.00 and the 8 mg WAC was $252.00, industry sources say. Meanwhile, Suboxone film pricing has held steady: WAC pricing for a carton of 30 Suboxone Film strips remains $117.85 for the 2 mg dose and $211.15 for the 8 mg dose.

More recently, sales of Suboxone tablets fell 19 percent between August 2011 and August 2012, to $658.5 million, according to IMS Health, while sales of Suboxone film doubled to more than $764 million during the same period. “They are (removing the tablets) because generics are expected in 2013 on the tablet,” says Sanford Bernstein analyst Ronny Gal. “The critical question is whether their argument that film is always safer for children will convince FDA not to approve any oral solid generic.”

For these reasons, the back-to-back announcements have been met with outrage. “They have known for years that a generic tablet could destroy their golden calf — and Suboxone is Reckitt Benckiser, from an earnings standpoint. If they do not destroy the tablet, it destroys them,” Jeff Junig, a psychiatrist at the University of Wisconsin Oshkosh Student Health Service and an assistant clinical professor of Psychiatry at the Medical College of Wisconsin, wrote in a letter to Alcoholism & Drug Abuse Weekly.

“I’m sure I sound… paranoid? Cynical?,” wrote Junig, who also authors a blog about Suboxone. “But it is so frustrating when you see marketing trump science. This will discourage generics from making buprenorphine, which will keep the price high, which will cause deaths. Shame on them.”