“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. 

 

 

 

Addiction Treatment With a Dark Side

money-pillsThe NY Times has a new piece on Suboxone.

First, on its blockbuster status:

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 . . .

Next, on the dark side of the business:

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.

Suboxone diversion?

Ah subutex!
Ah subutex! (Photo credit: nicolasnova)

A recent study looking at diversion of buprenorphine finds that:

While 9% reported recent street-obtained buprenorphine use, only a small minority reported using buprenorphine to get high, with the majority reporting use to manage withdrawal symptoms.

The use of street-obtained buprenorphine primarily to avoid withdrawal fits with Dawn Farm’s experience, though the percentage would be much higher than 9%.

We know that the experience in Europe has been different. For example, a 5 year study there found:

In 2007, 60.2% of the respondents claimed heroin or morphine as their first injected drug. This percentage had declined to 51.3% in 2010, but in contrast the incidence of buprenorphine as the first injected or abused drug by the study population increased from 30.5% (2007) to 44.4% (2010).

Why the difference? Well, a few possibilities come to mind:

  • That Europe adopted the drug earlier than the US.
  • That the brand most widely used in the U.S. includes naloxone, which is less desirable as a street-obtained drug.
  • That the American study was done in 2008, and things have changed rapidly since then.

The big question is whether we’ll see the kind of misuse that Europe has seen.

[Hat tip: Substance Matters]

Buprenorphine compliance rates

Choose you evidence carefully by rocket ship
Choose you evidence carefully by rocket ship

The following abstract popped up today.

The purpose of the study was to look at factors associated with completion of the 6 month, primary care based program.

What struck me was the completion rate–35.7%. For all the crowing about ORT, this seems really low. (And, they said this completion rate is consistent with prior studies.) This is particularly underwhelming when the researchers identify physical injury as a predictor of completions and speculate that this is related to chronic pain. These subjects constitute 71.7% of completers. So…when you omit those with injuries, the completion rate drops to 24%.

Primary care patient characteristics associated with completion of 6-month buprenorphine treatment

BACKGROUND: Opioid addiction is prevalent in the United States. Detoxification followed by behavioral counseling (abstinence-only approach) leads to relapse to opioids in most patients. An alternative approach is substitution therapy with the partial opioid receptor agonist buprenorphine, which is used for opioid maintenance in the primary care setting. This study investigated the patient characteristics associated with completion of 6-month buprenorphine/naloxone treatment in an ambulatory primary care office.
METHODS: A retrospective chart review of 356 patients who received buprenorphine for treatment of opioid addiction was conducted. Patient characteristics were compared among completers and non-completers of 6-month buprenorphine treatment.
RESULTS: Of the 356 patients, 127 (35.7%) completed 6-month buprenorphine treatment. Completion of treatment was associated with counseling attendance and having had a past injury.
CONCLUSIONS: Future research needs to investigate the factors associated with counseling that influenced this improved outcome. Patients with a past injury might suffer from chronic pain, suggesting that buprenorphine might produce analgesia in addition to improving addiction outcome in these patients, rendering them more likely to complete 6-month buprenorphine treatment. Further research is required to test this hypothesis. Combination of behavioral and medical treatment needs to be investigated for primary care patients with opioid addiction and chronic pain.

Buprenorphine and emotional reactivity

The following article was shared with me by a reader. Not surprisingly, the emphasized portion below caught my eye. [emphasis mine]

Abstract

Addictions to illicit drugs are among the nation’s most critical public health and societal problems. The current opioid prescription epidemic and the need for buprenorphine/naloxone (Suboxone®; SUBX) as an opioid maintenance substance, and its growing street diversion provided impetus to determine affective states (“true ground emotionality”) in long-term SUBX patients. Toward the goal of effective monitoring, we utilized emotion-detection in speech as a measure of “true” emotionality in 36 SUBX patients compared to 44 individuals from the general population (GP) and 33 members of Alcoholics Anonymous (AA). Other less objective studies have investigated emotional reactivity of heroin, methadone and opioid abstinent patients. These studies indicate that current opioid users have abnormal emotional experience, characterized by heightened response to unpleasant stimuli and blunted response to pleasant stimuli. However, this is the first study to our knowledge to evaluate “true ground” emotionality in long-term buprenorphine/naloxone combination (Suboxone™). We found in long-term SUBX patients a significantly flat affect (p<0.01), and they had less self-awareness of being happy, sad, and anxious compared to both the GP and AA groups. We caution definitive interpretation of these seemingly important results until we compare the emotional reactivity of an opioid abstinent control using automatic detection in speech. These findings encourage continued research strategies in SUBX patients to target the specific brain regions responsible for relapse prevention of opioid addiction.

I started out skeptical of the methods and researchers, but, from what I can tell, the methods don’t seem to be fringe pseudoscience.

I don’t know what to make of the associations of Blum, it looks like he was involved in very important research on the genetics of alcoholism in 1990. Since then, it looks like he’s been involved in a lot of entrepreneurial ventures. Bios say that he’s on faculty at Department of Psychiatry and McKnight Brain Institute, but I could find no reference to him on  their website.

Berman appears to have a robust academic career and is affiliated with NIAAA, VA, Boston University and ATTC.

The article was also peer reviewed.

What do you think?

 

Not available?

Another study finds no benefit from cognitive behavioral therapy and contingency management with opiate replacement treatment. [CORRECTED: See below]

Background and aims
The Controlled Substances Act requires physicians in the United States to provide or refer to behavioral treatment when treating opioid-dependent individuals with buprenorphine; however no research has examined the combination of buprenorphine with different types of behavioral treatments. This randomized controlled trial compared the effectiveness of 4 behavioral treatment conditions provided with buprenorphine and medical management (MM) for the treatment of opioid dependence.

Design
After a 2-week buprenorphine induction/stabilization phase, participants were randomized to 1 of 4 behavioral treatment conditions provided for 16 weeks: Cognitive Behavioral Therapy (CBT=53); Contingency Management (CM=49); both CBT and CM (CBT+CM=49); and no additional behavioral treatment (NT=51).

Setting
Study activities occurred at an outpatient clinical research center in Los Angeles, California, USA.

Participants
Included were 202 male and female opioid-dependent participants.

Measurements
Primary outcome was opioid use, measured as a proportion of opioid-negative urine results over the number of tests possible. Secondary outcomes include retention, withdrawal symptoms, craving, other drug use, and adverse events.

Findings
No group differences in opioid use were found for the behavioral treatment phase (Chi-square=1.25, p=0.75), for a second medication-only treatment phase, or at weeks 40 and 52 follow-ups. Analyses revealed no differences across groups for any secondary outcome.

Conclusion
There remains no clear evidence that cognitive behavioural therapy and contingency management reduce opiate use when added to buprenorphine and medical management in opiates users seeking treatment.

The question remains, why do patients on opiate replacement receive no benefit from these additional treatments? Particularly when they have been repeatedly shown to benefit addicts not on opiate replacement?

A recent post mentioned an expert’s observation that patients on opioids seem to “opt out of life.”

Are these patients less available to participate in other treatments? We asked this question in our position paper on buprenorphine maintenance.

[Correction: I appear to have had too many tabs open and made a stupid mistake. Thanks to Ian McLoone for pointing out the error. The prevous version erroneously said: “This time the drug is methadone. (It’s worth noting that the study received funding from the manufacturer of Suboxone. There have been similar findings about Suboxone and behavioral therapies. I guess they wanted to show that methadone is no better in this respect.)”]

The spirituality of addiction treatment

English: A woman walking a prayer labyrinth
English: A woman walking a prayer labyrinth (Photo credit: Wikipedia)

I was listening to On Being this morning and was struck by this one quote. I think this could be paraphrased into something that fits perfectly with why we have such great staff who put so much ourselves into our work here:

For me, thinking about living in a city like Chicago where you just — honestly, in a society like the one that we’re in and the world that we’re in with such extraordinary disparities between those who, you know, if you’re in a block in Chicago, you’re born in one ZIP code, you are, you know, destined for a school that has over 50 percent dropout rate, you’re destined to be four times more likely to be incarcerated, three more times to be, you know, unemployed. So I think, for me, this work is in part a way to deal with the anxiety, the spiritual anxiety, of those disparities that I can’t feel religiously comfortable in simply accepting that type of division in the way we live our lives.

 How would it sound for Dawn Farm? Here’s a stab at it:

For us, thinking about being an addict in a society like the one that we’re in and the world that we’re in with such extraordinary disparities between the kinds of help that addicts get, you know, if you aren’t from a wealthy family you’re destined to be referred to a crappy once a week public outpatient office (if you’re lucky) that has no hope, no love for addicts and no connection to the recovering community, or, if you’re opiate addicted, referred to a methadone program based on the assumption that you’re not capable of full, drug-free recovery. Even if you are from a wealthy family, it can be dumb luck whether you end up in a hopeful, compassionate treatment setting or a program that takes $25,000 for you and does little more than pump you full of Suboxone. So I think, for us, this work is in part a way to deal with the anxiety, the spiritual anxiety, of those disparities that I can’t feel spiritually comfortable in simply accepting that type of division in the way addicts live their lives and receive help.

2012′s most popular posts #3 – Hazelden to start opioid maintenance

This has gotten a lot of attention [emphasis mine]:

…for the first time, Hazelden will begin providing medication-assisted treatment for people hooked on heroin or opioid painkillers, starting at its Center City, Minnesota facility and expanding across its treatment network in five states in 2013.  This so-called maintenance therapy differs from simply detoxifying addicts until they are completely abstinent. Instead, it acknowledges that continued treatment with certain medications, which can include some of the very opioid drugs that people are misusing, could be required for years.

What’s their case? [italics mine]

The science, however, is getting harder to ignore. Studies show that people addicted to opioids more than halve their risk of dying due to their habit if they stay on maintenance medication.  They also dramatically lower their risk of contracting HIV, are far less likely to commit crime and are more likely to stay away from their drug of choice if they continue maintenance than if they become completely abstinent.

The first 3 points are not in dispute. Maintenance does reduce risk of overdose, contracting HIV and committing crimes.

However, the last point makes it sound like people put on maintenance are less likely to use heroin than people in drug-free treatment. In truth, she’s referring to the fact that once people are put on maintenance, there was “nearly universal relapse” when researchers tried to taper them off the drug.

Why opiate replacement?

“For most people using opioids daily, they are no longer getting high, even when they are still using.  It’s just become maintenance,” Seppala says. The effect is similar to the tolerance people experience with caffeine.  “If you drink caffeine on a daily basis, after a while, you don’t notice the effect of one cup of coffee,” he says, “But if you drank two, you would.”

Really? They weren’t getting high before they entered treatment? It’s like coffee?

Ok, moving on, but why do they think maintenance is a good idea for opiate addicts?

…with opioids, there is no significant mental, emotional or physical impairment if someone  regularly takes the exact same dose. In fact, research shows that patients addicted to opioids who are on maintenance doses of anti-addiction drugs like buprenorphine can drive safely, work productively and engage emotionally like those who aren’t addicted.

This isn’t our reading of the research. For example, the data on driving is mixed, at best.

On the issue of emotional engagement, the data doesn’t look too convincing either. Further, we know that opioid addicts benefit from talk therapy based addiction treatment, UNLESS they are on buprenorphine.

How long will patients be on the drug? [emphasis mine]

Hazelden will start using buprenorphine maintenance cautiously at first.  The drug will not be provided to people who have been addicted to opioids for less than a year and complete abstinence will remain the ultimate goal for most patients, even as the program recognizes that years or even lifetime maintenance on the drug may sometimes be needed.

Keep in mind, that there’s more than a little money involved:

If an addict is fully informed and wants buprenorphine, I have no objection. But this is a terrible direction for the field to take. As we’ve pointed out before, opioid addiction is relatively common among health professionals, we DO NOT treat them with opioid maintenance, they get 12 step and abstinence oriented treatment and they have great outcomes.

Read our position paper for more on why Dawn Farm does NOT use opioid maintenance treatment.

 

2012′s most popular posts #8 – Another Reaction to Hazelden’s Adoption of Suboxone

Perhaps I’m the Wrong Tool by Tall Jerome

Mark Willenbring, a former Director of the Treatment and Recovery Research Division of the National Institute on Alcohol Abuse and Alcoholism/National Institutes of Health weighs in on Hazelden’s embrace of Suboxone

Hazelden’s new approach is a seismic shift that is likely to move the entire industry in this direction. I told Marv that it was like the Vatican opening a family planning clinic! However, although this is a major positive step, they continue to be wedded to a strictly 12-Step approach along with the medication. I don’t see this ever changing. Hazelden has always seemed to operate like a Catholic hospital: science was ok as long as it didn’t conflict with ideology, and when it did, ideology won out.

His post betrays the trope that 12 steppers control the treatment world.

What are the beliefs driving his celebration of buprenorphine maintenance? In another post he offers what he believes should be the informed consent statement offered to opioid addicts entering treatment. [emphasis mine]

The only treatment proven effective for treating established opioid addiction is maintenance on a medication such as Suboxone or methadone, often with adjunctive counseling. Studies show that maintenance treatment reduces illness, mortality and crime, and is highly cost-effective. Therefore, it is the first-line treatment and the treatment of choice. There is no evidence of effectiveness for abstinence-based treatment.”

Wow. “The only treatment proven effective“? “There is no evidence“?

Mark Willenbring is a doctor. What kind of treatment would he receive if he became an opioid addict? Would he get Suboxone maintenance?

No. He would not.

Why? We don’t treat doctors with Suboxone maintenance. They get abstinence-based treatment.

Wait, what!?!?!? They get treatment for which there is “no evidence of effectiveness”?!?!?!?

Actually, there’s evidence that they have great outcomes with abstinence-based treatment.

All of the finger wagging about maintenance as the treatment approach with the strongest evidence-base raises some important questions:

  • Why do the most culturally empowered opiate addicts with the greatest access to the evidence base reject this evidence base with respect to their own care and the care of their peers?
  • What does this say about the evidence and its designation as an evidence-based practice? That this evidence doesn’t offer a complete picture?
  • What does it say that health professionals get one kind of treatment and give their patients another?
  • Why are some addiction physicians and researchers so indignant when others question their advocacy of a treatment approach that they and their peers refuse to use on themselves?
  • Does this advocacy of a medicalized approach have anything to do with the fact that they are indispensable in this medicalized approach?

 

Lines are being drawn

English: Caron Treatment Centers logo

 

A major treatment provider, Caron, weighs in on Hazelden’s adoption of buprenorphine maintenance treatment:

 

We use buprenorphine (Suboxone) to assist with the detoxification process from opioids and the length of time can vary depending on the patient’s progress and additional medical issues, such as chronic pain. However, unlike Hazelden’s goal as stated in the article, Caron’s treatment goal is to completely withdraw the patient from buprenorphine.  We do not use burprenophine as an ongoing maintenance medication. Caron has been treating addicts and their families for more than 50 years and our evidence-based practices show that treatment requires medical, physical, behavioral, spiritual and psychological intervention.

At this time, we don’t believe there is sufficient evidence that remaining on a controlled substance, like buprenorphine, for the long term is a healthy approach to recovery. Instead, we focus on the critical role the 12-Steps play in helping individuals and families achieve and retain long-term sobriety and wellness.

 

It’s going to be interesting to see where the lines get drawn.

 

One neglected fact is that there are treatment programs that have already gone the buprenorphine maintenance route and abandoned it because the outcome did not resemble recovery and clients and their families were not satisfied.