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.

Michael
On Twitter @PRIUM1

Monday, November 28, 2016

The Surgeon General Missed Something

First and foremost, the Surgeon General's recently released report "Facing Addiction in America: The Surgeon General's Report on Alcohol, Drugs, and Health" is a tremendously informative and culturally important step in the fight against prescription drug misuse and abuse.  Historically, Surgeon General reports have changed our national conversation on critically important public health issues such as smoking (34 separate reports from 1964 to 2014), HIV/AIDS (3 reports from 1987 to 1992), and mental health (2 reports from 1999 and 2001).  The fact that Dr. Vivek Murthy, our current Surgeon General, has turned the attention of the public health community to the topic of addiction is certainly a sign of progress.

Among its many constructive contributions, the report attempts to re-frame our nation's struggle with addiction in 'public health' terms rather than 'criminal justice' terms.  This change in approach appears to be among the precious few issues that have garnered bi-partisan support over the last couple of years, including through our most recent (and otherwise rancorous) election cycle.  Delays have dangerous ends, so I'm hoping that a change in party occupying the White House won't lead to a reversion in the public health progress we've begun to make.  

I did, however, find one notable omission from the Surgeon General's report.

Most readers of this blog live in the world of pain management and long term opioid use.  We see our daily battle as inextricably linked to the broader issue of addiction in our society and we see, up close and personal, a lot of the underlying causes that need to be addressed (mental and behavioral health issues, unrealistic expectations of pain relief, social factors that influence healing and pain perception, etc.)  But our lens on the issue is unique: what we often see is a legitimate prescription that is medically unnecessary (and, in many cases, downright harmful).

Interestingly, in Chapter 1 of the Surgeon General's report, the classes of drugs we most often encounter (pain relievers, tranquilizers, stimulants, and sedatives) are categorized under the heading "Illicits" and sub-categorized for purposes of reporting on misuse and abuse as "non-medical use."  The Surgeon General relies on the self-reported statistics from National Survey on Drug Use and Health.  I see this as a problem.  Take an example:

Premise: Bob was injured on the job back in 2011.  He perceives himself to be disabled (because everyone in his life keeps telling him he is) and began taking, as directed by his physician, 20 mg of oxycodone 2X day immediately post-injury... and is now taking 80 mg of the same drug 4X a day five years later.

Question 1: Would Bob categorize his use of oxycodone as "non-medical"?  He would not.
Question 2: Is Bob's use of oxycodone medically necessary?  Probably not.  In fact, it's probably inhibiting his functionality and ability to recover from the original injury.
Question 3: Is this category of drug use ('medically unnecessary') an important component of the public health dialogue around misuse of drugs?  Absolutely.

So why isn't it considered in the SG's report?  Maybe the data wasn't there.  Maybe the SG didn't want to rub the physician community the wrong way (he needs to enlist them in the fight, so why tick them off or impugn their credibility by blaming them for inappropriately prescribing in a seminal report?)

Whatever the reason, there's a category missing from the report.  And it's an important one.  Every time we taper a patient off of an opioid that wasn't helping him, we contribute to the progress against prescription drug misuse and abuse.

Michael
On Twitter @PRIUM1

Tuesday, November 8, 2016

A New Regulatory Approach to Opioids

The New York Workers' Compensation Board has announced a new avenue for payers to challenge the appropriateness of long-term opioid use.  Published last week, the notice begins:
Opioid addiction is a major public health crisis in the state that deeply affects many of New York’s injured workers. The New York Non-Acute Pain Medical Treatment Guidelines (NAP MTG) adopted by the Chair in 2014 present a comprehensive approach to the management of chronic pain, and include best practice recommendations for the appropriate use of narcotics. 
As the NAP MTG makes clear, long-term opioid use is only recommended in limited circumstances, and must involve constant clinical monitoring and re-evaluation. The NAP MTG also includes best practices for safely weaning injured workers from opioids and other narcotics.
A workers’ compensation hearing can now be scheduled to determine whether continuing opioid usage is necessary or whether weaning from opioids is recommended.
This is an important development, but it's not a panacea.  This new type of hearing is specifically designed to "consider opioid weaning."  If opioid weaning is to be considered, then the payer would be well served to have a suggested weaning plan documented.  While the actual implementation of a tapering schedule may differ from the suggested plan, the prescribing physician should at least be aware of the guidelines associated with the drugs requiring weaning.  As always, the turning of the tide against opioid misuse and abuse requires preparation.  

The potential outcomes are fairly concrete.  According to the Board: 
When the WCLJ rules that the claimant must be weaned from the opioid medication, the insurer will be required to cover the cost of the claimant’s addiction treatment program or weaning protocol, as directed. If the claimant is to be weaned without addiction services, the insurer will remain liable for the claimant’s medications for the duration of the weaning process. If an addiction treatment program has been directed, then after 30 days, the insurer will only be liable for payment of narcotic prescriptions written by an addiction treatment program physician.
We'll be watching closely.

Michael
On Twitter @PRIUM1 

Tuesday, November 1, 2016

Does Restricting Opioids Lead to More Heroin Overdose Deaths?

Turns out Neonatal Abstinence Syndrome (NAS), a condition suffered by newborn babies of opioid-addicted mothers, isn't the only risk to children in the fight against opioid misuse and abuse.  A JAMA Pediatrics article published yesterday showed a more than 2-fold increase in hospitalizations among children due to opioid poisonings.  While the bulk of these hospitalizations were predictably among older adolescents, the fastest growing cohort of hospitalizations occurred among the youngest children (toddlers and pre-schoolers) who can't tell the difference between candy and OxyContin.  A follow-on piece in the Washington Post fairly equates this public health risk to the gun control debate. Lock up the guns, lock up the drugs - our kids are paying too high a price.  

In other news, this month's Health Affairs contains a really interesting article on the relationship between state laws and opioid / heroin overdose deaths (Health Affairs 35, No. 10 (2016); 1876-1883).  Here are the high level conclusions:

  • States that pass laws pertaining to mandatory physician review of PDMP data and the strict licensing of pain clinics reduced opioid amounts prescribed by 8% and opioid overdose death rates by 12%.  
  • The study also observed a large (though statistically insignificant) reduction in heroin overdose death rates.  This might be counter-intuitive to you because some believe cutting off the supply of opioids in a community creates risk of increased heroin use.  
The public policy conclusions here are important.  First, if passing these common-sense laws really does lead to decreases in opioid supply and overdose deaths, there isn't any good reason not to implement mandatory PDMP checks and strict pain clinic laws (unless you live in Missouri... in which case irrational concerns over privacy consistently inhibit adoption of sound public health policy). 

Second, the study found "no evidence to support the assertion that policies to curb opioid prescribing are leading to heroin overdoses."  This doesn't mean that heroin overdoses haven't been on the rise; in fact, they've been increasing in virtually every state in the country.  What the study authors are saying is that new opioid restrictions do not appear to be accelerating the rise in heroin overdose deaths.  

Opioid and heroin abuse is clearly a complicated public health problem.  But this data suggests we should avoid the policy trap of using the one (potential heroin overdose deaths) as an excuse to not do the other (restrict the opioid supply through mandatory PDMP checks and strict pain clinic licensing). If there is data out there to the contrary, I'd honestly love to see it.  I think it's important to litigate these studies to ensure we're moving in the right direction.
  
As the devil can cite scripture for his purpose, we all seem able to find anecdotes to support our policy views.  Stories can be powerful illustrators of truth, but let's make sure we use data to guide our public policy discussions. 

Michael 
On Twitter @PRIUM1


Monday, October 24, 2016

Keep an Eye on the Tramadol: A Global Perspective

First and foremost, John Oliver covered the opioid crisis on his HBO show Last Week Tonight and it's must-watch for anyone who deals with this issue on a daily basis:

But John Oliver, perhaps the only guy who can make opioids funny (satire really is the very soul of wit), only covered the issue from a US perspective.  The Wall Street Journal published an article last week about the global rise of tramadol abuse. I follow the opioid epidemic pretty closely, both in the US and abroad, but this phenomenon caught me off guard.  Here are a few facts that pertain to our view of tramadol here in the US:
  • Tramadol wasn't scheduled by the DEA until 2013.  It's now a Schedule IV drug.  
  • There is a debate about whether or not it's addictive.  The original German manufacturer, Grunenthal, maintains that the abuse potential is low.  This clearly isn't the case (see below), but it's important to acknowledge the fact that many clinicians believe this is true.
  • The debate can be traced back to early studies of tramadol.  Like many new drugs, tramadol was originally tested on patients in injection form.  Unlike most drugs, it turns out that the oral form of tramadol is more likely to lead to addiction than the injectable form.  Thus, early studies indicate low abuse potential while today's practical experience indicates the opposite. 
This drug is tearing communities apart in West Africa, the Middle East, and parts of Eastern Europe in much the same way that opioids and heroin have torn apart communities here in the US.  The drug isn't tightly regulated by the UN or WHO (largely due to the lack of hard data on abuse and the conflicting science outlined above).  India, the world's leading manufacturer of generic drugs, is cranking this stuff out and shipping into countries by the boatload, fueling a epidemic of addiction that has outstripped the ability of medical personnel and the law enforcement to combat it.  

Even now, in the US, I've been in conversations with clinicians and claims professionals about whether or not tramadol is even an opioid.  It's a synthetic drug, entirely man-made.  And the symptoms of tramadol overdose do differ from a traditional opioids - rather than respiratory depression, tramadol overdose tends to lead to seizures and sudden collapse.  So are there differences between tramadol and other opioids?  Yes.   

But let's straighten this out once and for all:
  • Tramadol is an opioid painkiller
  • Tramadol is addictive
  • Tramadol overdose can lead to death
Keep an eye on the tramadol and don't fall for the "it's not as bad as the opioid" line.  

Michael
On Twitter @PRIUM1

Friday, October 14, 2016

The Broken Disability Safety Net

Much has been said and written on the topic of the recent report from the US Department of Labor regarding the supposed inadequacy of the workers' compensation system.  Critics rightly point out that the report appears to reduce its own credibility by failing to exhibit a sufficient understanding of the system, by assuming that all people claiming to be disabled are actually disabled, and by frightening those who believe that the federal government's involvement in any endeavor dooms all of planet Earth to utter destruction.

To paraphrase Twain, though, reports of the death of the state-based work comp system have been greatly exaggerated.

Nevertheless, those who dismiss this report based solely on its well-deserved criticism are clearly missing the broader picture.  There is a fundamental problem in this country with disability management and the public safety net that supports it.  And when the public safety net is perceived as inadequate, the most politically expedient solutions are to neither generate revenue (i.e., raise taxes) nor to reduce expenses (i.e., cut benefits); rather, the first solution is to look for an exogenous entity to blame and from which, if luck prevails, to extract rent.  In this case, the federal government has found at least one scapegoat: workers' compensation.

And not without cause, mind you.  The relationship between work comp and Social Security Disability Insurance (SSDI) is ill-defined, but we know from an analysis of past and present "off-set payments" (wherein an individual receives payment from both work comp and SSDI) that of those currently receiving SSDI, a little over 12% of them have also received work comp payments.  While those payments are material (on the order of perhaps $10 billion of the total SSDI spend of $145 billion), this analysis fails to address the larger issue: how many SSDI recipients could have filed a work comp claim, but never did?  That's a much bigger number.

One alarming, but nonetheless informative, statistic regarding the SSDI population showed up in the May 2016 edition of Health Affairs.  If you've heard me speak on a blogger panel this summer or fall, you've heard me talk about this.  The graph below shows spending on opioids by the Medicare and Medicaid programs between 1999 and 2012.  The purple line should jump out at you... it represents opioid spending for the Medicare population that is under 65 years of age.

This is effectively the SSDI population (disabled people under 65 receive indemnity payments from SSDI and healthcare coverage from Medicare) and we're spending more than $1 billion of tax dollars per year on their opioids.  This group is about one-fifth the size of the over 65 cohort, yet we're spending more on opioids for them.  On a per person basis, opioid spend for those over 65 is $192 per year.  For the 45-65 cohort covered by Medicare (an approximation for SSDI), it's $683 per year... or nearly 4X more.  Interestingly, the opioid spend covered by private insurers for those aged 45-64 is $274/year and for Medicaid it's $251/year.  

So what the heck is wrong with the Medicare group aged 45-64?  They're disabled, that's what's wrong.  And there's the rub.  If you think it's difficult to track, measure, manage, and mitigate opioid use in work comp, it's comparably impossible today within the SSDI population.

A broken disability safety net is a dangerous political phenomenon - one we should take seriously and treat with the respect it deserves.  

Michael 
On Twitter @PRIUM1

Monday, October 3, 2016

The Guts to Buck the Lobbyists

Ohio has proposed something novel: Let's not pay for expensive naloxone prescriptions and instead invest resources in ensuring the delivery of appropriate medical care and provide help for those struggling with dependence and addiction.

The Ohio BWC's Pharmacy and Therapeutics Committee recently recommended that BWC stop paying for auto-injector pens of naloxone.  While BWC would still cover the less expensive nasal inhalation form of the opioid overdose antidote, the auto-injector pens have become prohibitively expensive (apparently, BWC recently rejected a bill from a single Florida pharmacy for $824,000 worth of naloxone auto-injector pens supplied to 208 injured workers - that's an average of nearly $4,000 per injured worker).

Instead, BWC has put controls in place to ensure that reimbursement for opioid medications is limited to instances in which best practices are being followed.  And they're willing to pay for treatment for opioid dependence for up to 18 months, including two failed attempts at recovery.

So here we have a state significantly curtailing opioid use, providing a cost-effective version of an overdose antidote, and paying for opioid dependence treatment where necessary.  

Before you dismiss Ohio's efforts as impractical in a non-monopolistic state, take a step back and ask yourself whether this isn't a rational, measured, clinically responsible series of measures that will actually promote injured worker health, wellness, and recovery?  If it is, then why isn't it practical in your state?

I think Johnnie Hanna, pharmacy program director at BWC, summed it up: "If they've got the guts to buck the lobbyists... they can get these things done."

It is said that discretion is the better part of valor.  Except, I would suggest, when it's not.  Why aren't you doing these things in your state?

Do you have the guts?

Michael
On Twitter @PRIUM1

Monday, September 26, 2016

The Solution to Every Healthcare Debate: Access vs. Cost

Two things you need to know about Suboxone (or buprenorphine) this morning highlight the essential elements of all past, present, and future healthcare debates.

First, the manufacturer is being sued by the Attorney General of Illinois (and 35 other AGs) for violation of antitrust statutes.  The states allege that Reckitt Benckiser Pharmaceuticals (now known as Indivior, because someone clearly new to marketing thought that would actually be easier to say) has effectively blocked generic competition for Suboxone by scheming to devise a new formulation (the film, an upgrade from the pill) in order to extend the patent protection of its franchise.  Believing, of course, that they are more sinned against than sinning, Indivior took to their web site to issue a statement that they will vigorously defend themselves against the charges.  I'm not sufficiently informed to weigh in on the merits of the suit.  I'll just point out that the company's actions are fairly typical of pharmaceutical companies and that were this a cholesterol medication instead of a potential addiction mitigation drug, I'm not sure we'd see this much attention paid to it by 36 state attorneys general.

Second, current physician capacity for treating opioid use disorder with Suboxone isn't being utilized.  A research letter published last week in the Journal of the American Medical Association shows that despite initial limits on the number of patients a certified physician may treat at any one time of 30 and subsequent limits (after 1 year of prescribing) of 100 patients, these doctors are treating numbers of patients far below those thresholds.  In the 7 states with the highest number of certified physicians, the monthly median patient census per doctor was found to me as follows:

  • California: 7
  • Florida: 11
  • Massachusetts: 22
  • Michigan: 7
  • New York: 11
  • Pennsylvania: 18
  • Texas: 10
Increasing the number of certified prescribers and the number of patients they may treat at any one time is a linchpin of the federal government's response to the prescription opioid epidemic.  So it's somewhat concerning that we're so focused on increasing capacity when we're clearly not even close to utilizing the capacity we have.  

Why is this?  Why the law suit?  Why the lack of utilization of existing capacity?  

Like every other debate in healthcare, when you peel back the onion far enough, you find two competing philosophical concepts that dictate nearly every public policy decision that confronts us: COST and ACCESS.  

The law suit is primarily about COST and secondarily about ACCESS (presumably, if a more affordable - read 'lower COST' - generic were to become available, more patients could potentially ACCESS therapy).  

The JAMA study is about ACCESS and it shows that despite our investment in capacity (which COSTS money), we're still not very good at ACCESS itself.  

Follow the money.  Follow the patients.  The solutions to all healthcare issues rest somewhere in the incentives, structure, and balance of the two.  

Michael 
On Twitter @PRIUM1

Monday, September 19, 2016

Bad Pharma: This is What We're Up Against

We all know that lobbyists exist.  We all know the role they play in American politics, however frustrating that fact might be to us.  We all know that pharmaceutical companies have plenty of them and they appear to be pretty good at their jobs.

But thanks to some great work by the Associated Press, we now have a better sense for the magnitude of malfeasance that has occurred over the last 10 years in the halls of state capitol buildings, the US Congress, the White House, and our federal regulatory agencies.

The articles are here and here and I recommend reading both in full. For those crunched for time, some highlights I found particularly disturbing (in form of "what we've known" and "what's new"):

We've known for quite some time that there are a lot of dollars and a lot of brains devoted to maintaining the top line revenue of pharma companies operating in the pain space.  We now know:

  • They spent $880 million over a 10 year period from 2006-20015
  • This amount is 8 times the amount the gun lobby spent in the same period (read that again... just for emphasis)
  • $140 million of this went directly to political campaign contributions, $75 million of which went to candidates for federal office
  • Various advocacy groups employed an average of 1,350 lobbyists per year in state capitols across the country
We've known for a while that there were hidden forces behind the scenes attempting to squash public policy initiatives intended to stem the tide of prescription drug misuse and abuse.  We now know:
  • Back in 2012, when New Mexico came close to becoming the first state to limit initial opioid scripts to seven days, lobbyists got in the way.  "The lobbyists behind the scenes were killing it," said Bernadette Sanchez, a Democratic state senator who sponsored the measure.  We celebrate what New York and Massachusetts have done just this year, but forget that New Mexico tried it four years ago.  In the interim, we continued down the primrose path of opioid over-prescribing.  How many preventable deaths occurred between then and now? 
We've seen influence exercised among federal regulatory agencies, particularly at FDA. Former FDA Commissioner Margaret Hamburg consistently spoke about the need to balance access to pain medication for those in need with the public health crisis that is the prescription drug epidemic.  In so doing, she often referenced the 2014 NIH report that suggested 100 million Americans suffered from chronic pain.  We now know:
  • The Pain Care Forum (aka, the lobbying group backed by pharma) spent nearly $19 million on lobbying efforts that led to the legislation requiring the creation of this NIH report
  • Almost half of the report authors had served as leaders of groups affiliated with the Pain Care Forum - all of which were supported by pharma dollars.  
We all witnessed the controversy regarding the CDC guidelines earlier this year.  While the federal government's public health agency worked to develop guidelines for opioid prescribing among primary care physicians, other groups within the federal government were not only questioning the CDC's process and conclusions, but also going so far as to call the draft version of the guidelines "horrible" and "shocking."  Who were these critics?  We now know:
  • Dr. Richard Payne, who voiced concerned about conflicts of interest within the CDC advisory group, was himself paid over $16,000 by Purdue Pharma (makers of Oxycontin) for meals, travel, and speakers fees
  • Myra Christopher, another vocal critic of the CDC who openly stated that her NIH committee could not support the CDC guidelines, is a long time participant in the Pain Care Forum and holds a chair at the Center for Practical Bioethics - a chair endowed via a $1.5 million gift from Purdue Pharma.  
The most effective lobbying efforts come not as obvious broadsides with clear agendas and transparent motives.  Rather, the most effective efforts come with the trappings of genuine concern and the suits of science.  And that's what makes them scary.

Michael
On Twitter @PRIUM1


Monday, September 12, 2016

Market Failure and Medications: The Consequences of Healthcare Economics

I have a friend who happens to be an economist.  He's a really (really) smart guy and I value his views on everything from parenting to high finance.  So when he struck up a conversation about a recent blog post of mine that covered the intersection of drug prices and basic economic principles, I was all ears.  

"You haven't identified the market failure," he said.  

I was caught a little off guard.  I needed a moment to recall the specific definition of "market failure." It's not what most people think.  If the average person hears the term "market failure," they're likely to believe the S&P 500 dropped precipitously that day.  But when an economist uses the term, he means that the supply and demand dynamics of any given market have failed to reach a market clearing price.  The market could be for guns, butter, iPhones, or medications.  Doesn't matter. Buyers are unwilling to buy, sellers are unwilling to sell.  The market isn't working.  It has failed to produce transactions of any kind.     

My friend's point was that the market for naloxone was still functioning.  Buyers were complaining vociferously (in the press, to Congress, to manufacturers, etc.) but naloxone was still being bought and sold.  Howls of protest are one thing, he was saying, but the market still looks like it's working - albeit at a significantly higher market clearing price than a few years ago.  

From a purely economic perspective, he's exactly right.  But this isn't "pure" economics.  This is healthcare economics.  And the difference isn't that we in healthcare don't get it, it's that we have to get it sooner... because the stakes are much higher.  

In my original blog post, I told the story of my son Will and his experience with the supply and demand of chocolate.  I pointed out some of the differences between his experience selling Hershey bars to 1st graders and the pharmaceutical companies raising prices of medications like naloxone.  But there's one difference I did not identify in that original post and it's critical to understanding the current public discourse around naloxone and EpiPens and other medications whose price has risen substantially as of late.  

If Will's market for chocolate fails, then kids neither buy nor sell chocolate.
If the market for EpiPens fails, a kid dies.  

Overly dramatic?  Not in the least.  If access to potentially live saving medications is inhibited by market failure, then preventable death is not only a possible consequence, it's a probable one.  Those of us who work in this space have to anticipate market failures and prevent them from happening. We cannot sit back and wait for the market to fail and then act to correct it.    

Economics is different in healthcare for lots of reasons (government participation in price setting, employer-based health coverage, third party payers, just to name a few), but ultimately, what makes the domain of healthcare economics so unique is that it carries life and death consequences at every turn.  What's past is prologue... and we have to get it right.    

Michael 
On Twitter @PRIUM1