no hint of opinion here

SecondOpinion400

To me, the most important line in the NY Times Suboxone series was this one, “[Dr. Sullivan] considered opioid addiction “a hopeless disease'”.

We believe that maintenance approaches are rooted in the belief that most opiate addicts are not capable of recovering in the same manner that doctors recover.

Most of the arguments for maintenance treatments focus on reduced harm and its relative risks, very few focus on quality of life or achieving full recovery.

It’s also worth remembering that Suboxone compliance rates aren’t what they used to be.

The post below was originally published on 6/26/13. I decided to repost it to accompany the posts from the last few days.

*   *   *

From an article about a new report on medications for opiate treatment:

The report also examined studies that evaluated buprenorphine, methadone, injectable naltrexone, and oral naltrexone and concluded a benefit in patient outcomes as well as costs.

“I can say with no hint of opinion here, it’s simple fact, they are all effective,” McLellan said. “They’re effective not just in reducing opioid use, they’re effective in so many other ways that are important to societies and families.”

Effective. It’s a fact. No opinion here. Hmmm.

Effective at what? These drugs are effective at reducing opiate use. If that outcome is all one wants, they may be a good option.

The problem is that it’s a palliative response, when we know that full recovery is possible if the right resources are made available. (Of course these treatment approaches are not the ones physicians choose for themselves and their peers.)

Let’s see what the report says about another outcome that might speak more directly to quality of life, say, employment [emphasis mine]:

These studies have also measured various types of related outcomes such as reductions non-opioid drug use, employment and criminal activity. Here the literature is quite mixed and appears to be a result of the particular patient population, the clinical approach of the methadone maintenance program and the available counseling and social services provided.

and

As with methadone, the literature is quite mixed with regard to reducing non-opioid drug use, improving employment and reducing crime.

and

He also found improvements within the methadone maintenance group across various time periods on HIV risk behaviors, employment and criminal justice involvement. [My note: In this study, employment increased from approximately 21% to approximately 31%.]

So…while there’s little doubt that these medications reduce opiate use and overdose deaths, the quality of life evidence is considerably weaker.

With the increases in opiate ODs, I understand families and individuals struggling with these decisions. I struggle to come up with the best analogy for informed consent. Maybe something like this?

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.

no hint of opinion here

SecondOpinion400From an article about a new report on medications for opiate treatment:

The report also examined studies that evaluated buprenorphine, methadone, injectable naltrexone, and oral naltrexone and concluded a benefit in patient outcomes as well as costs.

“I can say with no hint of opinion here, it’s simple fact, they are all effective,” McLellan said. “They’re effective not just in reducing opioid use, they’re effective in so many other ways that are important to societies and families.”

Effective. It’s a fact. No opinion here. Hmmm.

Effective at what? These drugs are effective at reducing opiate use. If that outcome is all one wants, they may be a good option.

The problem is that it’s a palliative response, when we know that full recovery is possible if the right resources are made available. (Of course these treatment approaches are not the ones physicians choose for themselves and their peers.)

Let’s see what the report says about another outcome that might speak more directly to quality of life, say, employment [emphasis mine]:

These studies have also measured various types of related outcomes such as reductions non-opioid drug use, employment and criminal activity. Here the literature is quite mixed and appears to be a result of the particular patient population, the clinical approach of the methadone maintenance program and the available counseling and social services provided.

and

As with methadone, the literature is quite mixed with regard to reducing non-opioid drug use, improving employment and reducing crime.

and

He also found improvements within the methadone maintenance group across various time periods on HIV risk behaviors, employment and criminal justice involvement. [My note: In this study, employment increased from approximately 21% to approximately 31%*.]

So…while there’s little doubt that these medications reduce opiate use and overdose deaths, the quality of life evidence is considerably weaker.

With the increases in opiate ODs, I understand families and individuals struggling with these decisions. I struggle to come up with the best analogy for informed consent. Maybe something like this?

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.

CORRECTION: This post originally stated that the Anglin study found an increase in employment from 21% to 21%. It has been corrected to 21% to 31%.

UPDATE: I added the following to option 1 –  but we do know that discontinuation of the medication leads to “near universal relapse“, so getting off it is extremely difficult.

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.)”]

Balancing pain management and public health

Advertisement for curing morphine addictions f...
Advertisement for curing morphine addictions from Overland Monthly, January 1900 (Photo credit: Wikipedia)

I blogged before about the availability of opiates for pain management and the need to try to limit their diversion. While others have complained about draconian limitations on the prescribing of opiates and being too afraid to treat pain, I pointed out the explosion in opiate prescriptions and overdoses. It’s a complex problem that demands a solution that balances the needs of pain patients with the public health risks of easily available opiates.

Here’s a new study looking at the issue [emphasis mine]:

While overdose death rates related to heroin, cocaine, sedative hypnotics, and psychostimulants increased between 1999 and 2009, deaths related to pharmaceutical opioids increased most dramatically, nearly 4-fold. In 2000, the Joint Commission on the Accreditation of Health Care Organizations introduced new standards for pain management which focused on increased awareness of patient’s right to pain relief which contributed to an increase in prescribing of opioid analgesics (Phillips, 2000 and Federation of State Medical Boards of the US, 1998). The average milligrams of morphine prescribed per patient per year increased more than 600% from 1997 to 2007, which led to an increased availability of pharmaceutical opioids for illicit use (US Department of Justice, 2012). From 1999 to 2007, substance abuse treatment admissions for pharmaceutical opioid abuse increased nearly 4-fold and emergency department visit rates related to pharmaceutical opioids increased 111% from 2004 to 2008; visit rates were highest for oxycodone, hydrocodone, and methadone (SAMHSA, 2009aSAMHSA, 2009b and SAMHSA, 2011). Risks associated with pharmaceutical opioid related overdose included taking high daily doses of opioids and seeking care from multiple healthcare providers to obtain many prescriptions (Paulozzi et al., 2012 and Hall et al., 2008). “Doctor shopping” has also been associated with opioid diversion and illicit use (SAMHSA, 2010 and Rigg et al., 2012). National survey data showed that 75% of pharmaceutical opioid users were using opioids prescribed to someone else (Substance Abuse and Mental Health Services Administration, 2010).

2012′s most popular posts #9 – What Vietnam taught us

Da Nang, Vietnam. A young Marine private waits...
Da Nang, Vietnam. A young Marine private waits on the beach during the Marine landing, August 3, 1965. (Photo credit: Wikipedia)

 

I seem to have noticed an uptick in book, news and blog references to heroin addiction among returning Vietnam vets. (A Google news search suggests that this perception is accurate. I suspect it’s because it offers a narrative that’s consistent with the current monoculture.) It’s claimed that this offers important lessons about addiction and behavior change.

 

In May of 1971 two congressmen, Robert Steele from Connecticut and Morgan Murphy of Illinois, went to Vietnam for an official visit and returned with some extremely disturbing news: 15 percent of U.S. servicemen in Vietnam, they said, were actively addicted to heroin.

Soon a comprehensive system was set up so that every enlisted man was tested for heroin addiction before he was allowed to return home. And in this population, Robinsdid find high rates of addiction: Around 20 percent of the soldiers self-identified as addicts.

Those who were addicted were kept in Vietnam until they dried out. When these soldiers finally did return to their lives back in the U.S., Robins tracked them, collecting data at regular intervals. And this is where the story takes a curious turn: According to her research, the number of soldiers who continued their heroin addiction once they returned to the U.S. was shockingly low.

“I believe the number of people who actually relapsed to heroin use in the first year was about 5 percent,” Jaffe said recently from his suburban Maryland home. In other words, 95 percent of the people who were addicted in Vietnam did not become re-addicted when they returned to the United States.

This flew in the face of everything everyone knew both about heroin and drug addiction generally. When addicts were treated in the U.S. and returned to their homes, relapse rates hovered around 90 percent. It didn’t make sense.

 

Studies of this cohort do offer some important lessons, in particular, that exposure to opiates does not create addicts on a large scale. But the lesson is not this:

 

It’s important not to overstate this, because a variety of factors are probably at play. But one big theory about why the rates of heroin relapse were so low on return to the U.S. has to do with the fact that the soldiers, after being treated for their physical addiction in Vietnam, returned to a place radically different from the environment where their addiction took hold of them.

 

These stories often ignore the fact that:

 

there was that other cohort, that 5 to 12 per cent of the servicemen in the study, for whom it did not go that way at all. This group of former users could not seem to shake it, except with great difficulty.

 

Hmmmm. That range….5 to 12 percent…why, that’s similar to estimates of the portion of the population that experiences addiction to alcohol or other drugs.

 

To me, the other important lesson is that opiate dependence and opiate addiction are not the same thing. Hospitals and doctors treating patients for pain recreate this experiment on a daily basis. They prescribe opiates to patients, often producing opiate dependence. However, all but a small minority will never develop drug seeking behavior once their pain is resolved and they are detoxed.

 

My problem with all the references to these vets and addiction, is that I suspect most of them were dependent and not addicted.

 

So…it certainly has something to offer us about how addictions develops (Or, more specifically, how it does not develop.), but not how it’s resolved.

 

Why is it so frequently cited and presented without any attempt to distinguish between dependence and addiction? Probably because it fits the preferred narrative of the writer.

 

It’s worth noting that this can cut in both directions. There’s a tendency to respond to problem users (people who drink too much, but are not alcoholics.) and dependent non-addicts (most pain patients or these returning vets) as though they are addicts. This results in bad treatment for those people, bad research and it manufactures resentment toward treatment, mutual aid groups and recovery advocates.

 

Two stories on methadone

English: Methadone structure, animation

First,

DEATHS among drug users have hit a record high in Scotland, increasing by a fifth in 2011, the latest government figures reveal.

Last year 584 people died from drug use, which means that drugs now account for one in every 100 deaths in Scotland.

The heroin substitute, methadone, was at the heart of the increase, with almost half of the drugs-related deaths involving the prescription drug.

Second,

How I Learned to Stop Worrying and Love Methadone

Just like ex-junkie Russell Brand, I used to believe that “maintenance” was as bad—if not worse—than active addiction. Here’s how I came to understand how fatally wrong I was.

I have no quarrel with any addict receiving methadone maintenance, IF they’ve been provided with accurate information and quality drug-free treatment.

I wish that, rather than describing methadone as, “the most effective treatment for opioid addiction,” they would be more specific about what they mean by effective:

…study after study shows that when methadone prescribing increases, addict deaths drop. It is superior to abstinence-only treatment in terms of fighting HIV and overdoses, and many studies find it superior in cutting crime.

Those things are important, but methadone is not the only way to achieve those goals and they’re not the only things that are important.

Of course, as we’ve pointed out many times, there is one group of opiate addicts that are not treated with opiate maintenance. Doctors are not treated with opiate maintenance and they have terrific outcomes.

Are we really denying addicted doctors “the most effective treatment for opioid addiction”?

Of course not. We’ve decided that, for them, we’re going to aim a little higher than reducing overdose risk, crime and HIV.