Monday, December 19, 2016

The Tobacco Playbook: Opioids Go Global

Remember when the full weight of federal and state governments, along with support from advocacy and public health groups, finally came crashing down on the heads of the tobacco industry?  Do you remember what the tobacco industry did?  They went global.  Today, 75% of the world's smokers live in developing countries. The growth of tobacco use in the developing world hinges on the lack of regulatory controls at each critical step in the value chain: manufacturing, distribution, marketing, retail sales, consumption - it's just easier to get people hooked in the developing world.

A refresher on an oft-quoted statistic: the US is less than 5% of the world's population, but we consume 80% of the world's opioid supply.  As regulatory scrutiny grows around opioid manufacturers, we might expect them to behave as the tobacco industry has over the last quarter century or more.  Imagine if, at some future date, 80% of opioids were consumed outside the US. Would you have the moral courage to resist that investment temptation?

From the great work of the LA Times, we know that's exactly the plan our old friends at Purdue Pharma (makers of Oxycontin) are carrying out.  Through an international subsidiary (with a different name, of course), Purdue is pursuing overseas markets with much the same strategy as they did the US market in the late 1990s (and we can count on a similar result: foul deeds will rise).  They pay medical "experts" to give seminars to doctors that suggest opioids should be used more for pain management, not less.  In one instance cited in the article, Purdue was paying Dr. Joseph Pergolizzi to give such seminars.  Dr. Pergolizzi appears to have some credentialing issues, though.  He claimed an affiliation with Temple University as well as my own alma mater, Georgetown University.  When challenged on those affiliations, he claimed he was having "paperwork issues" at Temple and was "in discussions" with Georgetown.  I was heartened by my alma mater's response: "We are not in discussions with that gentleman."  Good stuff.

Two key questions over the next decade:
1) Will the public health infrastructure in the US, having learned from its experience with Big Tobacco, get out ahead of this potential international opioid crisis and warn developing countries about the dangers they face?
2) Will those developing countries listen?

On Twitter @PRIUM1

PS: As this will be the last post of 2016 for Evidence Based, I thought I'd take a moment to let you in on a little secret.  This past year was the 400th anniversary of the death of William Shakespeare (that's not a secret... hang with me a second...)  I have a great love of Shakespeare that was instilled in me by the greatest AP Lit teacher on planet Earth, Ross Friedman. He's retired now, but his love of language, culture, art, and great writing lives on in the thousands of students he taught through his career.

And that brings me to the secret of the Evidence Based blog in 2016: To honor The Great Bard (and my great teacher, Mr. Friedman), I have included an allusion to one of Shakespeare's plays or sonnets in every blog post I wrote in 2016 (above: "foul deeds will rise"is from Hamlet, Act I, Scene 2).  If you noticed, well then bonus points for you.  I had fun doing it and learned along the way that Shakespeare had something to say about everything... even healthcare, regulatory policy, and pharma companies.

Happy Holidays!  And thanks for reading!

Monday, December 12, 2016

Surveys Says? We Still Have a Long Way To Go On Opioids

Last week, I referred all of you to a piece by Dr. Stephen Martin wherein he offers a critique of the CDC opioid guidelines as well as the overall public health approach to opioid misuse and abuse. While I disagreed with most of his views, I thought the article represented the kind of informed dialogue in which we need to engage in order to move the public policy discussion forward (and I further suggested that our collective ability to engage in rational, data-driven debate will make us or mar us as a society). In the article, Dr. Martin sites a range of studies that put the risk of addiction to opioids somewhere between 2% and 10%.  He also suggests that the CDC's lack of focus on diversion - wherein lawful prescription drugs end up being 'diverted' from their intended purpose and routed into illegal drug trafficking - is a major issue.  He writes: "...the threat of addiction largely comes from diverted prescription opioids, not from long-term use with a skilled prescriber in a longitudinal clinical relationship."

Both those positions appear to be refuted by survey data collected by the Washington Post and Kaiser Family Foundation and published in the Post on Friday.

The Post and KFF surveyed 622 long term opioid users (defined as use for 2 months or longer) and 187 household members of long term opioid users.  The survey was taken over a roughly 5 week period from October 3 through November 9 and the overall results have a margin of sampling error of +/- 4 points.

We learn, among many other interesting things, that...

  • 34% of long-term opioid users say they are/were addicted or dependent on opioids
  • 54% of household members say the opioid user is/was addicted or dependent
  • Nearly all long-term users (95 percent) said that they began taking the drugs to relieve pain from surgery, an injury or a chronic condition. 
  • Just 3 percent said that they started as recreational users.
Further, the presumption of safety within a "longitudinal clinical relationship" is called into question by the fact that while the survey suggests a largely positive relationship between patients and doctors, only 33% of patients reported that their doctors discussed a plan for getting off of the medication at the onset of therapy.  That's a standard best practice... and two-thirds of doctors aren't doing it.  

Despite all of this data, the vast majority of survey respondents say these drugs have dramatically changed their lives for the better.  While their household members appear to have a different view, this highlights the difficult public health position in which we find ourselves. Benefits and risks aren't as clear cut as we wish they could be.  

Finally, I'm struck by staying power of the "100 million Americans in chronic pain" statistic.  The Post uses it here and it remains a pervasive data point for the justification of long term opioid use. But to steal a phrase from Dr. Martin himself (who stole it from Mencken), this statistic is "neat, plausible, and wrong." If we're going to have a debate about chronic pain, we have to start with the facts.  

On Twitter @PRIUM1

Tuesday, December 6, 2016

Confirmation Bias: A Critique of Opioid Guidelines

If you've bothered to keep track of the drama that's unfolded since the election last month (no one would blame if you haven't...), you've no doubt heard the phrase "confirmation bias."  We tend to seek out, the theory goes, news and information that confirms our current view of the world. Opposing views create cognitive dissonance, making us feel less sure about ourselves and forcing us to confront the possibility that we might be wrong (perish the thought). Confirmation bias is something we should all strive to avoid.  Whether its a citizen consuming political news, a fund manager picking a stock, or a GM signing a player... when we pick and choose our data set, we're more likely to make bad decisions.  

I suggest we take a similar approach in the fight against prescription drug misuse and abuse.  

If one truly believes that the best available research, data, studies, and thinking should guide our approach to this public health issue, then one cannot be offended by alternative points of view offered by those who share the same goal.  If one wants to solve the problem, one must consider the other side's view.  There may be more in Health Affairs and JAMA than is dreamt of in our philosophies.  And it's in understanding the critique of our position that we find the nuanced, balanced, and sustainable solutions required to mitigate prescription drug misuse and abuse.  

With this in mind, I recommend reading "Neat, Plausible, and Generally Wrong: A Response to the CDC Recommendations for Chronic Opioid Use" by Stephen Martin, MD, a practicing family physician in Massachusetts who treats chronic pain patients (in other words, the very target of the new CDC guidelines).  Dr. Martin lays out a case against the CDC guidelines that is well written, well researched, and likely to be not well received by readers of this blog.

And that's the point.  If we're going to make progress, let's engage with the sharpest and most well-reasoned points our critics have to offer.  Dr. Martin's arguments boil down to three main bones of contention: First, that the CDC is inappropriately conflating public health initiatives and individual treatment decisions.  Second, that with respect to studies regarding long term use of opioids for chronic pain, "absence of evidence is not evidence of absence."  And third, that opioids can be used safely, even over the long term, in the context of what Dr. Martin calls a "skilled, longitudinal, patient-clinician relationship."

Disagree?  Good.  I mostly do, too.  But I'm not going to do your homework for you.  Read the article, think through his positions, examine his data.  Then develop rational, data-driven responses.  Be prepared to listen to an equally rational and data-driven response back.  And before you know it, you'll be engaged in a legitimate, fruitful dialogue that may, in fact, identify common ground and lead to better solutions than either position might have achieved on its own.

For those that perceive a broader theme to this post, I admit an ulterior motive.  Let's practice data-driven dialogue across our professional, personal, and political spheres and see if we can't mend some broken fences.

On Twitter @PRIUM1