Tag Archives: suboxone

Feds raid Reckitt Benckiser offices; criminal probe underway

b547Hmmm. All is not well with the manufacturer of Suboxone.

Reckitt Benckiser’s offices in Richmond, Va., were raided by a team of IRS and Office of Inspector General (OIG) agents on December  3rd.

No one is saying what the feds are investigating, but here is some legal analysis.

The search warrant, which company officials say was issued from the U.S. Attorney’s Office for the District of Western Virginia, is a stunning development.  When the Government decides to investigate a company, the normal practice is to issue a lengthy subpoena identifying the records it wants the company to produce.  With the assistance of outside counsel, the company produces the records on a rolling basis and, at some point, there is a negotiated settlement involving civil and sometimes criminal charges.

On the other hand, a search warrant is normally issued and executed only when the prospective charges are quite serious and, more importantly, when the Government strongly suspects that records may be destroyed and simply can’t trust the company to comply with the subpoena.  Although we can’t speculate on the criminal charges the Government may be contemplating, we can be fairly certain that Reckitt and at least a few of its executives are facing some tough times ahead.

via Feds raid Reckitt Benckiser offices; criminal probe underway – Lexology.

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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.

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What makes treatment effective?

This will be my post in response to the NY Times’ series on Suboxone.

This post originally ran on 7/19/13 and addressed a lot of our concerns.

*   *   *

postcard---heroin-lie

I’ve been catching a lot of heat recently for posts about Suboxone and methadone. (For the sake of this post, lets refer to them as opioid replacement therapy, or ORT, for the rest of this post.

One commenter who blogs for an ORT provider challenged my arguments that we should offer everyone the same kind of treatment that we offer doctors and questioned the “it works” argument from ORT advocates. He dismissed the treatment model

Another commenter is an opiate addict who objected to a post about Hazelden’s announcement that they started providing ORT maintenance. She reported suffering greatly from cravings and relapsing after drug-free treatment at Hazelden. She’s been on Suboxone for 50 days and feels like it is a better solution for her.

Another post, that has nothing to do with me, blames abstinence-oriented treatment for the recent overdose death of an actor. (Among the other problems with the article are that she slanders abstinence-based treatment by suggesting that abuse is common. She misleads readers into thinking that ORT is not widely available when federal surveys find that ORT admissions accounted for 26% of all admissions. [Not 26% of opioid addiction admissions. 26% of all addiction treatment admissions.]

So, I thought I’d take a step back and try to address the big picture in one post.

The wrong paradigm?

Red_Drug_Pill---recoveryTo some extent, these arguments remind me of hearing Bill White comment on arguments about cognitive-behavioral therapy vs. motivational interviewing vs. 12 step facilitation. He commented that, “these are all arguments within the acute care paradigm.”

I talk often about the success of health professional recovery programs and their remarkable outcomes. What makes these programs so successful? I’d boil it down to a few factors:

  1. They are recovery-oriented. They treat patients with the expectation that they can fully recover and focus on facilitating and supporting recovery rather than just extinguishing symptoms of addiction.
  2. They have a chronic care model. They continue to provide care and support long after the acute stage of treatment (5 years). They also focus on lifestyle changes the will support recovery and look for ways to embed support for recovery in the patient’s environment.
  3. They provide adequate care. The provide multiple levels of high quality care of the appropriate intensity and duration at different stages of the patient’s recovery.

Many abstinence-oriented treatment providers have provided the first, but not the second and third. (Though one could argue that 12 step facilitation offers a long term recovery maintenance model.) They provide 10 days of inpatient care or 2 weeks of intensive outpatient and offer a passive referral to outpatient care. (Only 2% of all treatment admissions were for long term [more than 30 days] residential.) The end product looks something like a system that treats a heart attack with a few days or weeks of emergency care and then discharges the patient with no long term care plan. (Or, a weak long term care plan.) Then, we’re surprised when the patient has another cardiac event.

Many ORT providers have offered the second element, but not the first or third. The long term nature of ORT could be considered a chronic care model. However, the end product look something like palliative care for a treatable condition. It reduces opiate use (not necessarily other drug use), criminal activity and over dose. But these benefits are only realized as long as the patient is on ORT and drop-out rates are not low. And, ORT research has not been able to demonstrate the improvements in quality of life (employment, relationships, housing, life satisfaction, etc.) that we see in those health professionals who get all three elements. (Also note that opiate addicted health professionals often use VERY large doses and go undetected for long periods of time. Any neurological damage from their use does no appear to interfere with their achieving drug-free recovery in very impressive numbers.)

It’s effective!

photo credit: ntoper

photo credit: ntoper

One of the recurring arguments that I hear is that ORT is effective and there is tons of research that it’s effective. I don’t question that it’s effective at achieving some outcomes–reducing criminal activity, reducing opiate use and reducing overdose. If those are the only outcomes you care about, then you can say it’s effective without any qualifications.

Even with my bias for abstinence-oriented treatment, I can imagine circumstances where ORT might be the least bad option. (For example, if your child had been offered high quality treatment of adequate quality and duration more than once and they continue to relapse and be at high risk for fatal overdose.) A few weeks ago I offered an analogy that attempted to offer an approach to informed consent:

Maybe the choice is something like a person having incapacitating (socially, emotionally, occupationally, spiritually, etc.) and life-threatening but treatable cardiac disease. There are 2 treatments:

  1. A pill that will reduce death and symptoms, but will have marginal impact on QoL (quality of life). Relatively little is known about long term (years) compliance rates for this option, but we do know that discontinuation of the medication leads to “near universal relapse“, so getting off it is extremely difficult. The drug has some cognitive side-effects and may also have some emotional side effects. It is known to reduce risk of death, but not eliminate it.
  2. Diet and exercise can arrest all symptoms, prevent death and provide full recovery, returning the patient to a normal QoL. This is the option we use for medical professionals and they have great outcomes. Long-term compliance is the challenge and failure to comply is likely to result in relapse and may lead to death. However, we have lots of strategies and social support for making and maintaining these changes.

The catch is that you can’t do both because option 1 appears to interfere with the benefits of option 2.

Fixing treatment

Hazelden Monument2_2WEBHazelden’s adoption of ORT has provided fuel to a lot of these arguments.

Hazelden was confronted with poor outcomes for their opiate addicted patients. They saw a problem and decided to act.

One option would have been to declare that a 30 day model for opiate addiction treatment is doomed to fail and build a recovery-oriented, chronic care system that delivers high quality care of the appropriate intensity and duration.

ORT seems to be the easier response, particularly with the market and cultural currents flowing in that direction.

Bill White has argued that ORT can be compatible with a recovery orientation. I’m skeptical, but I’m watching and am willing to learn from any success they have.

However, if you can get what the doctor’s having, why would you want anything else? And, shouldn’t we want every patient to get the same kind of care the doctor would get if she were the patient? If you can’t get that, you’ve got some tough decisions to make.

I’m looking for others to implement the health professional model with others, finding ways to build upon it and make it less expensive, as we have.

UPDATE: In an email exchange with a friend who disagrees, I clarified Hazelden’s options, as I see them. If it were Dawn Farm, I’d imagine we’d look at things like:

  • improving our aftercare referral process–asking ourselves if we can make better active linkages to communities of recovery;
  • evaluating whether the intensity, duration and quality of our aftercare recommendations were appropriate;
  • embedding recovery coaching in cities around the country to provide assertive recovery support;
  • improving post-treatment recovery monitoring and re-intervention.

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“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. 

 

 

 

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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.

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“The Situation” with PHARMA

see filename

see filename (Photo credit: Wikipedia)

Here are two sentence fragments (not taken out of context) from After Party Chat that show just how broken the pharmaceutical industry is:

…in 2012 Big Pharma spent 19 times as much on marketing as they did on research.

…Jersey Shore’s Mike “The Situation” Sorrentino is now shilling for Suboxone.

It’s hard to know where to start with this one. So many angles are troubling. Among them, is this guy even an addict? Or, did he suffer from pseudoaddiction.

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What makes treatment effective?

postcard---heroin-lie

I’ve been catching a lot of heat recently for posts about Suboxone and methadone. (For the sake of this post, lets refer to them as opioid replacement therapy, or ORT, for the rest of this post.

One commenter who blogs for an ORT provider challenged my arguments that we should offer everyone the same kind of treatment that we offer doctors and questioned the “it works” argument from ORT advocates. He dismissed the treatment model

Another commenter is an opiate addict who objected to a post about Hazelden’s announcement that they started providing ORT maintenance. She reported suffering greatly from cravings and relapsing after drug-free treatment at Hazelden. She’s been on Suboxone for 50 days and feels like it is a better solution for her.

Another post, that has nothing to do with me, blames abstinence-oriented treatment for the recent overdose death of an actor. (Among the other problems with the article are that she slanders abstinence-based treatment by suggesting that abuse is common. She misleads readers into thinking that ORT is not widely available when federal surveys find that ORT admissions accounted for 26% of all admissions. [Not 26% of opioid addiction admissions. 26% of all addiction treatment admissions.]

So, I thought I’d take a step back and try to address the big picture in one post.

The wrong paradigm?

Red_Drug_Pill---recoveryTo some extent, these arguments remind me of hearing Bill White comment on arguments about cognitive-behavioral therapy vs. motivational interviewing vs. 12 step facilitation. He commented that, “these are all arguments within the acute care paradigm.”

I talk often about the success of health professional recovery programs and their remarkable outcomes. What makes these programs so successful? I’d boil it down to a few factors:

  1. They are recovery-oriented. They treat patients with the expectation that they can fully recover and focus on facilitating and supporting recovery rather than just extinguishing symptoms of addiction.
  2. They have a chronic care model. They continue to provide care and support long after the acute stage of treatment (5 years). They also focus on lifestyle changes the will support recovery and look for ways to embed support for recovery in the patient’s environment.
  3. They provide adequate care. The provide multiple levels of high quality care of the appropriate intensity and duration at different stages of the patient’s recovery.

Many abstinence-oriented treatment providers have provided the first, but not the second and third. (Though one could argue that 12 step facilitation offers a long term recovery maintenance model.) They provide 10 days of inpatient care or 2 weeks of intensive outpatient and offer a passive referral to outpatient care. (Only 2% of all treatment admissions were for long term [more than 30 days] residential.) The end product looks something like a system that treats a heart attack with a few days or weeks of emergency care and then discharges the patient with no long term care plan. (Or, a weak long term care plan.) Then, we’re surprised when the patient has another cardiac event.

Many ORT providers have offered the second element, but not the first or third. The long term nature of ORT could be considered a chronic care model. However, the end product look something like palliative care for a treatable condition. It reduces opiate use (not necessarily other drug use), criminal activity and over dose. But these benefits are only realized as long as the patient is on ORT and drop-out rates are not low. And, ORT research has not been able to demonstrate the improvements in quality of life (employment, relationships, housing, life satisfaction, etc.) that we see in those health professionals who get all three elements. (Also note that opiate addicted health professionals often use VERY large doses and go undetected for long periods of time. Any neurological damage from their use does no appear to interfere with their achieving drug-free recovery in very impressive numbers.)

It’s effective!

photo credit: ntoper

photo credit: ntoper

One of the recurring arguments that I hear is that ORT is effective and there is tons of research that it’s effective. I don’t question that it’s effective at achieving some outcomes–reducing criminal activity, reducing opiate use and reducing overdose. If those are the only outcomes you care about, then you can say it’s effective without any qualifications.

Even with my bias for abstinence-oriented treatment, I can imagine circumstances where ORT might be the least bad option. (For example, if your child had been offered high quality treatment of adequate quality and duration more than once and they continue to relapse and be at high risk for fatal overdose.) A few weeks ago I offered an analogy that attempted to offer an approach to informed consent:

Maybe the choice is something like a person having incapacitating (socially, emotionally, occupationally, spiritually, etc.) and life-threatening but treatable cardiac disease. There are 2 treatments:

  1. A pill that will reduce death and symptoms, but will have marginal impact on QoL (quality of life). Relatively little is known about long term (years) compliance rates for this option, but we do know that discontinuation of the medication leads to “near universal relapse“, so getting off it is extremely difficult. The drug has some cognitive side-effects and may also have some emotional side effects. It is known to reduce risk of death, but not eliminate it.
  2. Diet and exercise can arrest all symptoms, prevent death and provide full recovery, returning the patient to a normal QoL. This is the option we use for medical professionals and they have great outcomes. Long-term compliance is the challenge and failure to comply is likely to result in relapse and may lead to death. However, we have lots of strategies and social support for making and maintaining these changes.

The catch is that you can’t do both because option 1 appears to interfere with the benefits of option 2.

Fixing treatment

Hazelden Monument2_2WEBHazelden’s adoption of ORT has provided fuel to a lot of these arguments.

Hazelden was confronted with poor outcomes for their opiate addicted patients. They saw a problem and decided to act.

One option would have been to declare that a 30 day model for opiate addiction treatment is doomed to fail and build a recovery-oriented, chronic care system that delivers high quality care of the appropriate intensity and duration.

ORT seems to be the easier response, particularly with the market and cultural currents flowing in that direction.

Bill White has argued that ORT can be compatible with a recovery orientation. I’m skeptical, but I’m watching and am willing to learn from any success they have.

However, if you can get what the doctor’s having, why would you want anything else? And, shouldn’t we want every patient to get the same kind of care the doctor would get if she were the patient? If you can’t get that, you’ve got some tough decisions to make.

I’m looking for others to implement the health professional model with others, finding ways to build upon it and make it less expensive, as we have.

 

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