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.

Quality of life and death

English: Graveyard in Barnes
English: Graveyard in Barnes (Photo credit: Wikipedia)

A study out of Australia looks at death rates among opioid addicts receiving opioid substitution treatment (OST, for short. It’s methadone.) in New South Wales between 1985-2005. It’s a HUGE sample–43,789 people. If fact, the paper says:

This cohort is likely to represent the majority of opioid dependent people in that State during this period, perhaps as high as 80%.

To my mind, the strongest argument for methadone and buprenorphine has been overdose prevention–that dead addicts can’t recover and drug-free treatment isn’t going to work for everyone at every point in time. If I’m the parent of a heroin addict and they’ve refused drug-free treatment or relapsed after high quality drug free treatment of the adequate dose and duration, maintenance might look like the least bad option. At least they’ll be alive, right? (Of course, my concern is that these drugs have become the first line treatment and access to better options is diminishing.)

So, what did they find in this cohort?

Well,  8.8% of the cohort died. (9.4% of men.)

There were 3,685 deaths in the cohort between 1985 and 2005 for a crude mortality rate of  894 per 100,000py (95% CI: 865, 923) (Table 1).

How did they die?

The majority of deaths were drug-related  (n=1932; 52%), with most of these (n=1574; 82% of all drug-related deaths) coded as accidental opioid deaths. The bulk of remaining deaths were due to unintentional injuries (n=975; 26% of all deaths) and suicide (n=484; 13% of all deaths).

Did they at least live long lives?

Using the Australian life tables approach, there was an estimated 160,055 Years of Potential Life Lost (YPLL) in this cohort, an average of 44 YPLL per person who died, and 29 years of YPLL before age 65 (Table 4). Just under half (45%) of the YPLL were due to accidental opioid-related deaths (an average loss of 46 years of potential life, or 31 years prior to age 65). Motor vehicle accidents accounted for the highest average YPLL, 47 years, or 33 years before age 65.

How does this compare with the rest of the population?

The overall age-, sex- and year-standardised mortality ratio was 6.5 (95% CI: 6.3-6.7) indicating that our cohort had 6.5 times the rate of mortality than that expected in the population.

Is this unique to Australia?

The average of 44 years of potential life lost for each fatality in the cohort highlights the fact that deaths in opioid users often occur at a young age. This was particularly the case for avoidable causes of death such as drug overdose and injuries. The pattern of YPLL was broadly similar to previous analyses of a Californian male cohort (n=581) in the US, followed from 1962 to 1997 (10). Both studies found that opioid overdoses were the largest contributor to YPLL but suicides made a larger contribution to YPLL in our cohort, and homicide a larger contribution in the Californian cohort.

Now, this doesn’t mean that methadone doesn’t reduce death rates. It means that the death rate is still very high.

It also means that quality of life questions shouldn’t be dismissed with snarky quips like, “What kind of QOL do dead people have?“, because methadone patients die in large numbers too.

If you’re thinking that those were the bad old days, before we had buprenorphine, think again. Retention rates for methadone and buprenorphine are not great. When put head to head, methadone has higher retention rates.

I’ll also throw in a reminder from a previous post about were I stand on ORT:

Just to be sure that my position is understood. I’m not advocating the abolition of methadone.

Here’s something I wrote in a previous post: “All I want is a day when addicts are offered recovery oriented treatment of an adequate duration and intensity. I have no problem with drug-assisted treatment being offered. Give the client accurate information and let them choose.”

Another: “Once again, I’d welcome a day when addicts are offered recovery oriented treatment of an adequate duration and intensity and have the opportunity to choose for themselves.”

It’s also worth noting that there is a link between AA and methadone.

 

Indescribable horror turned into advocacy

Bill White appears to have started blogging!

His most recent post touches upon an issue that is close to my heart.

People in recovery and their family members are leading what is rapidly becoming an international recovery advocacy movement, but there are faces and voices notably absent from the frontlines of this movement:  the families who experienced death of a loved one from addiction before recovery was achieved.  These family members are now seeking each other out for mutual support and are adding their voices to calls for enhanced access and quality of addiction treatment and recovery support services in local communities.

He then introduces a video made by a bereaved father, Jim Contopulos, in memory of his son, Nick.

The following is attributed to Jim and reportedly from his eulogy for Nick.

For those of us here today, who have had a “front  row seat” to this disease over these past 13 years, or even to those sitting further back and have continued,  as it were, to hear “reports form the front line” we can confirm without any hesitation that addiction is truly a “cunning, powerful and baffling” disease.

Some of us sitting here today know nothing of Nick other that this courageous struggle, and it is my hope that as we allow Nick to “speak” through the songs he loved; the movies he loved; his love for animals; his love for children, especially his love for his daughter Hailey; his irreverent humor; his love and admiration for his sister Vanessa, his mom and myself; his strong desire for justice as well as his struggles with addiction coupled with mental illness, what’s known as a dual diagnosis, that you will have a much larger context for his life.

Perhaps with this better understanding, Nick would ask you simply to love, rather than judge; the addict, the mentally ill the diseased, the imprisoned, the homeless, the poor, the unlovable and the lonely, because Nick himself was, at one time or another, all of these.

None of us sitting here today wants only to be remembered for our failures and certainly not Nick, which is why he so loved the final verse to the song “These Days” by Jackson Browne, which says. “don’t confront me with my failures, I have not forgotten them”.

The worst part of this work is the terrible loss of life, often young lives. Among the parents that are left behind are some of the bravest and most admirable men and women I have ever met.

liv.townhall-2Diane Montes turned the loss of her son, Brian, into a mission to prevent deaths and support families going through a similar loss.

It was the evening of June 29, 2006, when Diane Montes returned home from work and went to her son’s room to speak with him. When she opened his bedroom door, she witnessed “an indescribable horror.” Brian Montes, a 22-year-old education major at Michigan State University, was lying dead on his bed. Police told the grieving mother that her son died from heroin use.

The family later learned that the fatal dose was mixed with the pain-killer Fentanyl, which caused respiratory failure. Brian’s family had not been aware he had a drug abuse problem. They later found out he had only been using heroin for 6 weeks when he died.

After Brian’s death, Diane and her husband Andy learned that there were more Livonia teenagers and young adults using heroin than they had ever imagined. Diane talked to a number of people who said they knew of young heroin users who either died, were hospitalized, or sent to drug rehabilitation. In addition, it was reported that Livonia police suspected the drug could have played a role in a dozen deaths in Livonia over the previous year.

Diane looked for information and support in Livonia but found little. She learned of the Royal Oak Save Our Youth Task Force, a group of school, police, medical and political leaders focused on spreading word about the dangers of heroin and other drugs and how users and families can find help. The Royal Oak group formed in response to a number of drug deaths in that community.

On October 18, 2006, Diane convened a community meeting to try and build community support for a Livonia Save Our Youth Task Force. Over 140 people with questions and stories to share attended that initial meeting. From that meeting, a group formed and the first meeting of the Livonia Save Our Youth Task Force was held on November 15, 2006.

Since 2006, Livonia Save Our Youth continues to grow and expand. In 2012, the name was changed from “Task Force” to “Coalition” to reflect the longevity of the group and intent to continue its mission and activities in the community.

I’ve called on Diane over and over again to ask if she’d be willing to speak with a parent who just lost a child. She’s never hesitated to make her self available to them.

Mark Rudolph also lost his son, Ryan, in 2007 and has been relentless in building a coordinated community response to the problem of addiction in his “safe” suburban community.

He made this video in memory of Ryan. (The voice mail he included at the end is heartbreaking and horrifying.)

mark anna beach animatedMore recently, I met Mark S. who lost his son, Andrew, just one year ago.

He’s been sharing his difficult journey on his blog and in his podcast. He recently marked Andrew’s birthday with a 12 hour podcast to raise money to provide treatment for others.

DSC00291Here’s his introduction to that 12 hour podcast.

[audio http://traffic.libsyn.com/talktherapy/Hour_1_of_12_Hour_Podcast_Mark.mp3]

These are just a few of the people I’ve met who have turned their tragedy into a heroic journey. Sadly, we’re in the midst of another wave of overdoses.  I hate this part of the job but I am so grateful to have met people like Diane, Mark and Mark.

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.

Prescription drug overdose statistics visually

drug_overdose

Popular Science has a chart with US overdose deaths by drug:

…the rate of reported overdoses the U.S. more than doubled between 1999 and 2010. About half of those additional deaths are in the pharmaceuticals category, which the CDC has written about before. Nearly three-quarters of the pharmaceuticals deaths are opioid analgesics—prescription painkillers like OxyContin and Vicodin. And while cocaine, heroin and alcohol are all responsible for enough deaths to warrant their own stripes on the chart, many popular illegal drugs—including marijuana and LSD—are such a tiny blip as to be invisible.

A recently published study confirms the relationship between prescription opioid sales and opioid overdoses.

And, SAMHSA reports on the growing role of prescription opioids in treating opioid addiction.

  • …the number of clients receiving methadone on the survey reference date increased from about 227,000 in 2003 to over 306,000 in 2011
  • The percentage of OTPs offering buprenorphine increased from 11 percent in 2003 to 51 percent in 2011; the percentage of facilities without OTPs offering buprenorphine increased from 5 percent in 2003 to 17 percent in 2011
  • The numbers of clients receiving buprenorphine on the survey reference date increased between 2004 and 2011: at OTPs, from 727 clients in 2004 to 7,020 clients in 2011, and at facilities without OTPs, from 1,670 clients in 2004 to 25,656 clients in 2011

Road traffic crashes and prescribed methadone and buprenorphine

Last year, a study questioned whether buprenorphine patients should be allowed to drive because 60% tested positive for other drugs.

Now, another study reaches similar findings:

Background

Opioids have been shown to impair psychomotor and cognitive functioning in healthy volunteers with no history of opioid abuse. Few or no significant effects have been found in opioid-dependant patients in experimental or driving simulation studies. The risk of road traffic crash among patients under buprenorphine or methadone has not been subject to epidemiological investigation so far. The objective was to investigate the association between the risk of being responsible for a road traffic crash and the use of buprenorphine and methadone.

Methods

Data from three French national databases were extracted and matched: the national health care insurance database, police reports, and the national police database of injurious crashes. Case–control analysis comparing responsible versus non responsible drivers was conducted.

Results

72,685 drivers involved in an injurious crash in France over the July 2005–May 2008 period, were identified by their national health care number. The 196 drivers exposed to buprenorphine or methadone on the day of crash were young, essentially males, with an important co-consumption of other substances (alcohol and benzodiazepines). Injured drivers exposed to buprenorphine or methadone on the day of crash, had an increased risk of being responsible for the crash (odds ratio (OR)=2.02, 95% confidence interval (CI): 1.40 and 2.91).

Conclusions

Users of methadone and buprenorphine were at increased risk of being responsible for injurious road traffic crashes. The increased risk could be explained by the combined effect of risky behaviors and treatments.