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?

Michael
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!

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.  

Michael 

On Twitter @PRIUM1

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

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

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 

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

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:

https://www.statnews.com/2016/10/24/john-oliver-opioid-epidemic/

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

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

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

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

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

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

FDA and Off-Label Drug Use: Danger Ahead

The FDA has scheduled hearings for November (and a public comment period that will extend to January) regarding the agency's current approach to the marketing of off-label uses of FDA-approved medications.  Drug and device manufacturers have been waiting years for this opportunity to change the agency's stance on off-label marketing.  

This is not good news.    

First, a definition: Drugs approved by the FDA are approved only for the specific conditions for which they were tested in clinical trials conducted by the manufacturer.  These approved medications have an FDA "label" which stipulates those conditions for which the drug has been approved.  FDA approval, however, does not govern the practice of medicine.  Doctors are free to prescribe FDA approved drugs for conditions not included on the "label" (thus, off-label use of FDA approved drugs).  While the practice is common among doctors, pharmaceutical and medical device companies are restricted from "marketing" off-label uses of drugs.    The 1938 Food, Drug, and Cosmetic Act gave the FDA the power to regulate promotional materials on medications and to this day, they do. Very closely.  

Second, some basic statistics:

• 1 in 5 medications prescribed today is for off-label use. (Example relevant to you: tricyclic antidepressants do not have FDA approval as a treatment for neuropathic pain, yet this class of drugs is considered by many physicians to be a first-line treatment option.) 
• In recent years, antipsychotic drug use for unapproved FDA indications has increased. One study estimated that the cost of off-label antipsychotic drug use in 2008 was $6.0 billion.
• The fines connected to illegal off-label marketing by pharmaceutical companies appear material (though this is debatable in light of the annual sales of some of these drugs): 
• 2009: Eli Lilly paid $1.4 billion off-label marketing of olanzapine for dementia
• 2009: Pfizer paid $2.3 billion for alleged off-label marketing of 4 of its medications
• 2012: GSK paid $1.3 billion for off label marketing of paroxetine
• 2012: Abbott paid $1.6 billion for off label marketing of valproic acid 

So here's the core question: Should the FDA allow pharmaceutical and medical device companies to market to doctors off-label uses of medications?

In a word, no.  But let's dig a little deeper into the argument the pharma companies are making.

Their position is summed up best by the quote in the Bloomberg article (linked above) from Deborah M. Shelton, deputy general counsel for healthcare at the Biotechnology Innovation Organization (BIO):  “Removing current regulatory barriers, and clarifying the ability of companies to share truthful and non-misleading information [emphasis added] about medicines, is essential to our collective ability to realize the full potential of 21st century medicines and helping to ensure that patients are able to get the right medicines at the right time for them,” 

Two key words here: truthful and non-misleading.  Leaving aside that the use of both terms appears redundant, we're still left the the fundamental question of who decides what is truthful and non-misleading.  

We have three choices available to answer that question: the FDA, the drug companies, and broad clinical experience.  

The FDA seems like the most logical answer.  They approved the drug in the first place, why can't they be responsible for approving additional indications (or uses) of that same medication?  The reply from the drug companies to this idea is understandable: it's really expensive.  The FDA requires a similar level of data and similar level of rigor from clinical trials to approve an additional indication as they do to approve the initial indication.  In many cases (though not all), the costs are clearly prohibitive.  

The drug companies cannot be trusted to decide what's truthful.  If you can't see the obvious conflicts of interest here, then you should stop reading.  You're not worth another word.    

Broad clinical experience, or the general body of knowledge developed as a result of actually practicing medicine, is a valuable source of information and the means by which some portion of off-label prescribing comes to occur in the first place.  When such knowledge is documented in well-respected, peer reviewed journals, the medical community gains a trusted and codified source that might prove valuable to other clinicians.  But how to get that information disseminated?  Could the pharma companies do that?  Isn't that what they're asking for here?  To relay "truthful and non-misleading information" to doctors about off-label uses of medications?  

Here's the thing: they can already do that.  From the Mayo Clinic's article by Chistopher Wittich, et al [emphasis added]: "The 1997 FDA Modernization Act allowed manufacturers to distribute to health care providers peer-reviewed journal articles about unapproved uses of medications.  If a given drug company chose to engage in distribution of this type of information, it was required to submit an application for approval of that indication within a rigid and pre-specified period. These requirements were subsequently revised in 2009 with the approval of new FDA guidelines. The new guidelines clarified existing rules and allowed distribution of information on off-label uses by pharmaceutical manufactures if specific regulations were followed.  After 2009, pharmaceutical manufacturers could distribute information, including journal articles and textbook chapters, describing unapproved uses for their medications. The FDA demanded that the information in these... publications be accurate, the relationship between the distribution of information and the sponsoring drug manufacturer be disclosed, and the published material not be edited or presented in an abridged form. In addition, the manufacturer is no longer required to submit an application for approval for that indication."

Sounds reasonable to me.  What do the drug companies want to be able to do beyond this?  Makes me very, very nervous.  

Michael 

On Twitter @PRIUM1

Standing Orders: Are You Prepared?

The Missouri PDMP watch goes on... I think CNN should have a clock for it.  Instead of counting down to an event, the clock would continually count up, marking the years, months, days, hours, and minutes since Missouri became the only state without a law creating a Prescription Drug Monitoring Database.  For the record, the District of Columbia enacted its own PDMP legislation on Saturday, February 22, 2014.  So by my count, the clock would read: 2 years, 6 months, 7 days, 10 hours, 59 minutes, 32 seconds... 

But the state did make some progress recently.  Missouri HB 1568 creates a "standing order" for naloxone.  There's a legitimate debate regarding standing orders for naloxone, but regardless of where you stand in that debate, there's little doubt we're going to see more and more of these across the country.  So let's establish some definitions and pose some interesting questions for the payer community.

First, looking up "standing order" in an average dictionary isn't terribly useful.  We're looking for a clinically oriented definition and I found the best one at medical-dictionary.com:

"a written document containing rules, policies, procedures, regulations, and orders for the conduct of patient care in various stipulated clinical situations. The standing orders are usually formulated collectively by the professional members of a department in a hospital or other health care facility. Standing orders usually name the condition and prescribe the action to be taken in caring for the patient, including the dosage and route of administration for a drug or the schedule for the administration of a therapeutic procedure. Standing orders are commonly used in intensive care units, coronary care units, and emergency departments."

Translation: Pre-approved treatments that can be dispensed and administered by non-physicians because a doctor said it was ok ahead of time.

The language in Missouri is indicative of what we're likely to see elsewhere: "Notwithstanding any other law or regulation to the contrary, any licensed pharmacist in Missouri may sell and dispense an opioid antagonist under physician protocol" and "Notwithstanding any other law or regulation to the contrary, it shall be permissible for any person to possess an opioid antagonist."  Additonally, the bill also contains language that relinquishes pharmacists from any liability associated with dispensing naloxone as well as protection of individuals who administer naloxone.  This is an important component of any legislation in this area.

Translation: Want naloxone?  Show up at a pharmacy in Missouri with some money and you can have some.  No questions asked.  And no one is going to get arrested or sued for dispensing or administering the drug.  

But this begs several important questions for the work comp payer community.

First: How much is naloxone going to cost?  Are we talking generic syringes?  Or EVZIO auto-injector pens?  This "standing order" in Missouri spells out the ingredient a patient can obtain, but not any preferred form of administration.  Notably, the cost of this stuff is skyrocketing.

Second: Who is going to pay for this, ultimately?  If an injured worker pays for EVZIO pens out of pocket via a standing order, will he submit for reimbursement to the employer/carrier?  How will this be handled?

Third: Will we submit this to utilization review?  Are the guidelines sufficiently thorough to cover this type of scenario?  (I can answer that one, actually: no, they're not).  So where does that leave us? Do we really want to deny payment and then have the unthinkable happen?  Imagine the headlines. "Work Comp Screws Up Again: Injured Worker Dies of Overdose After Employer Denies Payment for Life Saving Antidote."

No one wants that.  But we also want to ensure we're addressing the underlying issue.  Why do we have injured workers on sufficiently high doses of opioid medications that the patient (or, likely, a loved one) feels the need to take advantage of a "standing order" and obtain naloxone from the local pharmacy?

Which brings us to a fourth question: Does the employer have an obligation (ethically, not necessarily legally) to inform the prescribing physician that the injured worker has obtained naloxone via a standing order?  "Hey doc, just thought you'd be interested to know... Injured Worker Joe?  Yeah, his wife just picked up a pack of two EVZIO pens at Walgreens.  We're going to reimburse them the $800, but thought you might interested in your patient's perception of overdose risk."  That's a pickle: the reality is that the adjuster may be the only one that knows about both the opioid scripts and the naloxone secured via a standing order.

Unintended consequences abound.

Michael
Follow me on Twitter @PRIUM1

Health Literacy and Pain Management: How to Do Patient Education

Whether or not opioid pain medication might actually worsen pain is a legitimate clinical discussion and an important claims management topic.  While the phenomenon is researched and written about in medical journals, talked about at various conferences, and acknowledged among physicians, I had not yet seen a committed attempt by a state regulator to educate injured workers about what might be happening to them.

And then New York State Workers' Compensation Board published this gem.  The brochure was developed in cooperation with the New York State Office of Alcoholism and Substance Abuse Services (smart move by the WCB) and posted on the "Workers" section of the www.wcb.ny.gov website under the link "Pain Medication Dependence Fact Sheet."  

The brochure is appropriately titled: "Is My Pain Medication Making Me Worse?"

The brochure starts with the story of Jim, a 55-year-old construction worker with a low back injury who is prescribed pain medication... and experiences a steady decline in functionality and engagement.  It also includes a list of common medications, a phone number to call for help, a list of common side effects, a phone number to call for help, a list of FAQs, and last, but not least... you guessed it, a phone number to call for help.  The number appears multiple times in multiple locations on a relatively simply brochure.  And that's the point.    

Educational pieces like this are harder to create than you might think.  I recall when PRIUM created our own injured worker education piece (which you can download and use for free here).  I was so proud of the first few drafts.  I thought we had nailed it.  Then our Medical Director, Dr. Pamela Thomas, got a hold of it.  She tore our draft to shreds.  

Dr. Thomas is an expert in health literacy.  She helped us understand that patient education messages have to be aimed at the lowest common denominator.  Too many big words, too many messages, too much clinical language, too few attempts to engage at the patient's level... all lead to poorly executed patient education materials.  Which is not to say that all injured workers require reading materials at a remedial level.  But the reality is that some do and good patient education ensures that the maximum number of patients can comprehend the information being conveyed.  These things are hard to put together.  

I give the New York piece one and half "thumbs up" (a couple of infographics for visually-geared learners would have taken taken it all the way to two thumbs up).  The fact that they published this at all is fantastic and the bold title (Is My Pain Medication Making Me Worse?) is engaging, educational, provocative, and appropriate - all at the same time.  

Well done, New York State Workers' Compensation Board.  

Now... where is every other jurisdiction on injured worker pain management education?  

Michael 

On Twitter @PRIUM1

So Why is Naloxone Getting So Expensive?

Last week, I posted a piece on the public health debate around naloxone.  Since then, I've received a stream of new and interesting data to share.  

First, a report showing that naloxone scripts led to fewer ED visits... of the 2,000 patients in this study focused in safety-net clinics around San Francisco, those receiving naloxone along with long-term opioid prescriptions had 47% fewer visits to the emergency department.  That appears to be compelling evidence to suggest co-prescribing naloxone makes sense (though the focus on the safety net clinic population begs the question of how translatable the conclusions might be to other populations).

We also saw the release of a white paper from Fair Health that suggests diagnosis of opioid dependence is skyrocketing.  Fair Health is a non-profit organization dedicated to transparency in health care costs.  They analyzed their database of 20 billion privately insured healthcare claims and found a 3,203% rise in opioid dependence diagnosis between 2007 and 2014.  So maybe we need to focus more on the underlying issue of opioid dependence after all?   

Third, the price of naloxone is rising... this excellent an in-depth piece from Business Insider details the controversy surrounding the price increases.  Out there in social media land, I've seen several comments regarding the price increase that indicate a basic understanding of microeconomics, but that lack the depth necessary to understand what's happening here.  "Demand has gone up," read many of these comments, "so price goes up, right?"

Not necessarily.  A personal story to illustrate the point:     

Some of you have heard me tell one of my favorite “Will stories".  Will is my 10 year old and the kid is a natural entrepreneur.  Back when he was in 1st grade, his school had an activity called Economics Day.  Each of the six 1st grade classrooms in Will's school had to make a simple product and then sell it to their peers in an open “marketplace” (which, in this case, was a series of tables in the school gym).  One class made puppets out of brown paper bags.  Another class made pet rocks.  One class did the classic lemonade stand.  Will’s class made “S’more packs” (two graham crackers, a marshmallow, and a small Hershey’s chocolate bar all in a small plastic sandwich bag).  Each kid had earned “money” to spend through good behavior and acts of service to others over the course of the semester. 

All the first graders gathered in the gym and awaited the signal from one of the teachers.  When she blew her whistle, nearly all of the children would begin freely “shopping” the various tables of merchandise around the gym.  Only a small group of students from each class would remain at their respective “cash registers” to do the actual selling.  William volunteered for this duty first.  While everyone else shopped, Will would be in charge of selling his class’s S'more Packets.  I stood behind him and made sure order was maintained.  Easy duty… or so I thought.

The whistle blows.  Nearly every kid in the gym makes a run for Will’s table.  There’s chocolate there, right?  The kids who don’t run for the chocolate instead go for the lemonade.  The Pet Rock and hand puppet kids are immediately bored.

Suddenly, Will finds himself in the middle of an old fashioned Wall Street trading pit.   He’s surrounded by kids, each holding out $5 of play money and shouting for chocolate.  Initially, Will is collecting money and handing out ‘Smore Packets just as he’s supposed to do. He’s happy his class’s product is popular and he’s clearly grateful for the business.  But as the crowd thickens and the kids grow louder, I begin to notice what Alan Greenspan once called “irrational exuberance.”  The kids are frantic.  Markets are psychological and this one is getting crazy.  Kids are elbowing for position.  They’re screaming Will’s name in an attempt to get his head to swivel in their direction, potentially increasing the probability they’ll be the next to walk away with chocolate.  He’s getting bumped, jostled, and hit.  I’m getting worried about him and I wonder if he’s going to lose it under the pressure.  Should I step in?  Be an adult?  Organize this chaos?  It’s getting out of control…

And at that moment, Will did something both courageous and, to him, completely logical.  Without permission from his teacher, without encouragement from me, without any warning at all…

He raised the price.

“These aren’t $5 anymore,” he yelled over the din, “they’re $10!”  Only a few kids drop out of the crowd.  The rest simply reach into their pockets and pull another $5 of play money out to add to the $5 they’ve already been waving in Will’s face.  He sells a few packets at $10 and realizes he can go higher.  “Now they’re $15!” he yells.  I glance over at his teacher, Ms. Foster, who takes one step toward Will.  I can see she’s a little unsure of what to make of this scene and I have a moment of panic that she’s going to shut down the most perfect example of an efficient market I’ve seen in my life.  Then she pauses, steps back, looks at me, and smiles.  Thank goodness, I think, she gets what’s happening.  This is Economics Day… and these kids are learning economics!

Little did anyone know that the laws of supply and demand would be as intuitive to Will as eating, sleeping, and breathing are to you and me.

By the time I turn my attention back to Will, he’s at $30 and the flow of ‘Smore Packets into the greedy hands of first graders is starting to ebb.  He senses he’s neared the market price, the equilibrium between supply and demand.  This is what economists call it, economists who have studied this phenomenon and only this phenomenon, for longer than Will’s been alive.  To Will, though, there are no fancy terms or theories.  There’s just a point, he says later, that “felt right.”

So how do pharma companies justify jacking up the price of naloxone?  It’s just supply and demand, right?  What’s the big deal? 

Here’s the key difference: Will had a finite supply of chocolate.  Once it was gone, it was gone.  When supply is fixed and demand rises, price increases.  But that’s not true of naloxone.  This stuff is easy to make and has been around for 40 years.  When demand rises (and it certainly has), supply should increase commensurately and price should remain relatively stable over the long term.  That’s how economics works.  Anticipating objections from the "econ major" crowd who will argue we're experiencing a "shift in the demand curve" for naloxone (which is different than a simple increase in demand), I would argue that a commensurate shift in the supply curve is not only possible, but easily achievable given the nature of the underlying molecule.  

"We're not talking about a limited commodity. Naloxone is a medicine that is almost as cheap as sterile sodium chloride — salt water," said Dan Bigg, the executive director of the Chicago Recovery Alliance.

Unless you’re a pharma company.  Then you get to smile and smile... and be a villain.  You get to exploit the average American's lack of understanding of microeconomic theory and suggest that a rise in demand logically leads to an increase in price. 

Supply and demand, right?   

Michael
On Twitter @PRIUM1

Nuance is Necessary in the Naloxone Debate

American Medical Association white paper headline: "Help save lives: Increase access to naloxone"
New York Times headline: "Naloxone Saves Lives, but Is No Cure in Heroin Epidemic"

These headlines aren't inconsistent, but they do hint at the evolving national dialogue around naloxone.  I would say there's a debate brewing around the appropriateness of naloxone access, but the truth is that the debate isn't new - it's been going on for decades.  What makes it feel new to many of us is that the prescription drug and heroin epidemic is pushing our medical and public health professionals to more aggressively pursue any and all possible solutions at our disposal. And with every solution comes a critique.

Let's start with a few basic facts:

• Naloxone was approved by the FDA in 1971.  
• Naloxone is an opioid antagonist, which means (in layman's terms) that the drug kicks opioids off of the receptors in the brain and replaces them, eliminating the "high" and reviving the patient (and also sending them into immediate withdrawal).
• Naloxone works quickly (approximately 2-3 minutes) and its effects last between 30 and 90 minutes depending on the type of opioid that was used; sometimes, more than one administration of naloxone is necessary to reverse an overdose.  
• There is virtually zero potential for abuse of naloxone and virtually zero effect on an individual given naloxone who is not experiencing an overdose.  
• Naloxone comes in various forms: generic via syringe, branded injector pens (EVZIO), nasal spray (Narcan or naloxone w/ atomizer).

Now to the debate, literally an existential one at that (you might say naloxone is the "to be or not to be" drug... that is the question...)   

There are many (Centers for Disease Control, American Medical Association, Substance Abuse and Mental Health Services Administration, American Society of Addiction Medicine) who support widespread access to naloxone.  According to the CDC (and quoted in the AMA's white paper), from 1996 to 2014, the lives of more than 26,000 people were saved by naloxone.    

There are others who express concern that widespread access to naloxone will give addicts a safety net, encouraging risky behavior.  Governor Paul LePage (R) of Maine, never shy and certainly never concerned about causing offense, summed up the argument this way (in light of his veto of naloxone-related legislation): "Naloxone doesn't truly save lives; it merely extends them until the next overdose.  Creating a situation where an addict has a heroin needle in one hand and a shot of naloxone in the other produces a sense of normalcy and security around heroin use that serves only to perpetuate the cycle of addiction."  

As so often occurs in complicated policy debates, blanket assumptions and blunt statements lead to poor dialogue and lack of action.  So let's explore the nuance by segmenting the population of potential naloxone beneficiaries.  Note that this isn't the only way to segment the population nor is it the most detailed, but it's better than lumping everyone together.

1. First responders: Here, there is little debate.  First responders should be equipped with naloxone. They have a professional duty to save lives and naloxone will help them do that.  They are trained medical professionals and to withhold a vital life-saving antidote in the midst of a prescription drug and heroin epidemic is blatantly irresponsible.  

2. Drug abusers: Whether its prescription drugs or heroin, this is obviously a group at high risk for overdose. What Gov. LePage is missing in his inelegant portrait quoted above is that the person who overdoses will not be the one who administers the naloxone (having naloxone "in the other [hand]" doesn't do one any good if one is unconscious).  He also misses the reality that naloxone administration leads to immediate withdrawal - rather than experiencing "normalcy and security," the addict, while thankfully alive instead of dead, is thrust directly into hell on Earth.  

This segment of the patient population actually highlights two axes along which the debate takes place:  First, should drug abusers have access to naloxone at all?  Second, should we enable non-medically trained people (possibly fellow addicts) to administer the drug? If you believe in LePage's premise, that naloxone "merely extends [lives] until the next overdose," well, then... you are a cold and callous person who doesn't believe in the basic human aspiration toward redemption and recovery.  Might it be a long and hard road?  Yes.  Might there be relapses and multiple overdoses requiring naloxone?  Yes.  If it was your loved suffering from the addiction, would you want to give them every possible chance at recovery?  Yes.  As to whether non-medically trained people should be able to administer it... if I can give my kid an EpiPen injection when he gets stung by a bee, then I can administer naloxone.  No medical degree necessary.  

Thank goodness the Maine Legislature had the good sense to override LePage's veto, allowing Maine to count itself among the 34 states with a standing order for naloxone.   

3. Legitimate prescription drug users: This group is tricky.  These patients are under the care of a doctor, receiving legal prescriptions for opioids, and securing those medications at a pharmacy. I note there could be overlap between this group the group 2 (drug abusers), but this group has the benefit of a doctor overseeing their prescription regimen. The CDC and AMA guidance on naloxone prescribing among primary care doctors is fairly consistent.  A co-prescription for naloxone should be considered if the patient has a history of overdose, a concomitant script for a benzodiazepine, a history of substance use disorder, a mental health condition, or a medical condition that might make the patient susceptible to respiratory distress.  

But wait. Aren't these all the same factors that should cause the doctor to reevaluate the appropriateness of prescribing opioids at all?  Should a doctor manage the risk of overdose by prescribing an overdose antidote?  Or should the doctor be more diligent in exploring non-opioid alternatives first?  

This isn't just theory.  We're seeing it in PRIUM cases.  It's expensive, the cost is rising, and the benefit is unclear.  Surely, there are circumstances in which naloxone will be appropriate for co-prescribing (perhaps immediately post-injury or post-surgery when opioids are indicated for acute pain and the patient has a history of overdose, for example).  But the practice of co-prescribing naloxone for chronic pain patients is troubling.  

When it comes to high dose opioid therapy for chronic pain, we need to demand more from prescribing doctors than a "just in case" antidote.  Chronic pain care requires rigorous exploration of alternatives, difficult conversations with patients, careful management of medications, and a commitment to patient safety.  

Michael 

On Twitter @PRIUM1 

Mental Illness: What Are We Going To Do About It?

My family and I just got back from a trip to our nation's capital (read: I just dragged my three children through a three day, 25 mile hike that will forever be known as The Monument March).  I wanted them to see the White House, the Capitol, the Supreme Court... I wanted them to see our founding documents - The Declaration of Independence, the Constitution, the Bill of Rights... I wanted them to see my alma mater, Georgetown University, and the places I lived and worked during my years in DC.  And we did all of that and more in 95 degree heat with surprisingly few complaints.

There were some surprises on our trip, too, things we had not planned to see.  I happened upon Thomas Jefferson's personal library on display at the Library of Congress.  We encountered a free live jazz concert inside of the Smithsonian Museum of Art and I played checkers with my seven year old daughter while listening to great music and sitting amidst the original portraits of most of the founding fathers.  And at the Smithsonian National Air and Space Museum, we found a full sized Douglas A4 Skyhawk suspended from the ceiling, the plane my father-in-law flew in combat in Vietnam.

And my children encountered homelessness and mental illness for the first time.

Sitting on a bench in Union Station, a woman close by was engaged in a heated argument regarding Social Security, the banking system, and the wisdom of 30 year mortgages.  She was gesticulating wildly and was clearly talking to someone she believed was sitting next to her.  In this age of gadgetry, my kids initially assumed she was talking on a blue tooth head set.  But I knew better.  All of her belongings were in a shopping cart next to her and she clearly hadn't bathed in quite some time.  While we walked from Union Station to the Capitol building, I tried to explain to my kids what they had seen.  At twelve, ten, and seven years old, this was a new experience and they were having trouble processing it.  They began to notice that many of the benches on the US Capitol grounds were occupied by homeless people.  The following conversation with my ten year old ensued:

Will: "How do you become homeless?"
Me [thinking hard about how to explain this to a 10 year old]: "There are a lot of ways people end up homeless... but many people become homeless due to mental illness."
Will: "What's mental illness?"
Me [definitely not a clinician]: "The human brain is a really complex thing... and sometimes, it breaks... it doesn't work right... and the person suffering from mental illness loses touch with reality. They have a really hard time doing normal things like sleeping, working, and talking with others."
Will: "So they're sick?"
Me: "Yes."
Will [thinking this over and jumping right to the heart of the matter]: "What are we going to do about it?"

This incredibly insightful question was put to me by my ten year old in the literal shadow of the US Capitol building.  His timing couldn't have been better.  "A big part of the answer," I told him, "starts right here with the people who were elected to sit in this building."

I'll spare you the detailed policy proposal, but suffice it to say that homelessness and mental illness have become problems we deal with predominantly through the criminal justice system.  Therein, the patient must minister to himself, giving us little to no hope of long term recovery for the mentally ill, including (perhaps especially) those suffering from addiction disorders.  Instead, we need to treat mental illness through the healthcare system, including the appropriate funding (enter Congress) that will entail.

Mental health parity provisions in the Affordable Care Act are a start.  The Comprehensive Addiction Recovery Act is a start.  But to really answer my ten year old's question (what are we going to do about it?), we're going to need broad social, moral, and political commitment to helping those who cannot help themselves.

Michael
On Twitter @PRIUM1

What Will $180 Million Buy Us?

The Senate just voted 92-2 to pass a piece of legislation, one already passed by the House 407-5.  Can you remember the last time you saw a vote tally like that in Congress?

The President will now sign the Comprehensive Addiction and Recovery Act (CARA), a new law intended to stem the tide of drug misuse and abuse in this country.  Given the ubiquitous and devastating nature of the epidemic, it's no wonder the vote was such a slam dunk.  Better three hours too late than a minute too soon, I suppose, but this Congress after all.

And yet, this bill nearly died an ignominious death before reaching the President's desk.  Even though we all agree that something must be done (and our representatives in Congress see it the same way, at least in principle), there remained the issue of how to pay for it.  Obama asked for $1 billion.  Lots of numbers were tossed around with respect to appropriations... $500 million... $300 million... $600 million.  This surprised even those who watch the sausage making process as a full time profession (from thehill.com: "But the fight over funding threatened to doom the bill, surprising longtime policy watchers who expected the legislation to coast through both chambers as the country faces an epidemic of opioid overdose deaths.")

The final bill allows for $180 million per year for the programs it creates.  The Department of Health and Human Services will dole out grants to treatment programs, law-enforcement assisted diversion, prisons, educational programs, and increase the number of patients able to receive medication assisted treatment (MAT).

So how far can we stretch $180 million?  What can we expect the public health impact to be? Let's do some simple math.

If we just take the 16 million people in the US who suffer from some form of substance use disorder... that leaves us with about $11 per person per year.

If we just look at the most vulnerable subset of the substance use disorder population, those with concomitant mental health disorders - of which there are 8 million in the US - we're left with about $22 per person per year.  

If we take the number of counties (the public health departments of which often compete for and implement these grants), of which there are about 3,000, we get $60,000 per county per year, probably enough to hire a single new public health worker to help those struggling with addiction.

And if we take the population of chronic, non-cancer pain patients in the US, a group at high risk for opioid dependence and addiction - of which there are approximately 38 million - well, that's a little less than $5 per person per year.

Think the math is unfair?  Think my analysis isn't framed correctly?  I'd love to see an alternative approach that shows this investment can and will make a difference.  From my perspective, it's woefully insufficient.

But it's a start... which is why President Obama is going to sign it.

Michael
On Twitter @PRIUM1

Lawmakers Dictate to Doctors: New Legislative Approaches to Opioids

Amidst all the talk of 7-day initial opioid script limits in New York, Massachusetts, and New Hampshire (with New Jersey, Connecticut and others likely not far behind), we appear to have missed a piece of legislation that, in my view, represents the single most stringent legal construct for opioid prescribing in the country.   Before we get to Maine's new law, a quick aside on the new approach sweeping the northeastern US: These new limits are extremely helpful, but not the panacea some are making them out to be.  A 7-day limit for new scripts (in most states, for acute pain only) will absolutely help limit black market diversion and over-utilization generally... but we'll also see more office visits (on day 8!) and not enough progress on long term chronic pain cases.  A necessary step, no doubt, but insufficient to address the entirety of the problem.  

Back to Maine: Guess what they did back in April that no one noticed?  They put a statutory cap on morphine equivalent dosage per day.  The state legislature passed it, the governor signed it, it goes into effect on January 1, 2017... and not a lot of people are talking about it.

The cap is 100 mg MED per day.  Specifically, a licensed practitioner in Maine "may not prescribe... to a patient any combination of opioid medication in an aggregate amount in excess of 100 morphine milligram equivalents of opioid medication per day."  But what if a patient is already on more than 100 mg MED per day?  Doctors cannot prescribe to such individuals opioid pain medication in excess of 300 mg MED per day between January 1, 2017 and July 1, 2017.  But starting July 1, 2017, even those individuals need to be weaned down to at or below 100 mg MED per day.

Enforcement mechanisms?  They thought of that, too.  "An individual who violates this section commits a civil violation for which a fine of $250 per violation, not to exceed $5,000 per calendar year, may be adjudged. The Department of Health and Human Services is responsible for the enforcement of this section."    

The bill also includes several other requirements including mandatory PDMP checks, mandatory electronic prescribing, and mandatory education for prescribers (3 hours of CE) to be renewed every 2 years.  There are exceptions, of course, but the exceptions are logical and do not undermine the intent and broad application of the bill (active treatment for cancer, hospice care, inpatient settings, etc. are all exempt - as they well should be).

What does all of this mean?

Some will see this as a huge step forward in fighting the most significant public health crisis of a generation.  Some will see this as a vast government overreach into the practice of medicine.

It's both, really,  And it's what we get when the clinical community fails to educate and police itself. "Our remedies oft in ourselves do lie..."  And when they don't, we get new laws.  Look for this approach in a state legislature near you...

Michael
On Twitter @PRIUM1

The Bio-psycho-social Model: Challenges in Application

Hardly a day, a conference, a meeting, or a case goes by without a serious discussion about the need for a 'biopsychosocial' approach to injury resolution.  In fact, I've recently heard griping in some circles that the discussion has run its course.  "We get it... can we talk about something else now?"

Sigh.  We don't get it.  And we still have a lot of work to do.  I offer the following observation as proof of such...

A study hit my desk this past week from the Journal of Occupational and Evironmental Medicine and I'd like to ask for your forbearance as I share the abstract:

"The cost and prevalence of chronic work-related musculoskeletal pain disability in industrialized countries are extremely high.  Although unrecognized psychiatric disorders have been found to interfere with the successful rehabilitation of these disability patients, few data are currently available regarding the psychiatric characteristics of patients claiming work-related injuries that result in chronic disability.  To investigate this issue, a consecutive group of patients with work-related chronic musculoskeletal pain disability (n = 1595), who started a prescribed course of tertiary rehabilitation, were evaluated.  Psychiatric disorders were diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders.  Results revealed that overall prevalences of psychiatric disorders were significantly elevated in these patients compared with base rates in the general population.  A majority (64%) of patients were diagnosed with at least one current disorder, compared with only 15% of the general population. However, prevalences of psychiatric disorders were elevated in patients only after the work-related disability.  Such findings suggest that clinicians treating these patients must be aware of the high prevalence of psychiatric disorders and be prepared to use mental health professionals to assist in identifying and stabilizing these patients.  Failure to follow a biopsychosocial approach to treatment will likely contribute to prolonged pain disability in a substantial number of patients."  

Great study, right?  Isn't that the right message?  And we couldn't ask for a more specific sample set: Work related!  Musculoskeletal pain!  Disability!

Here's the kicker: this study was published in 2002 (J Occup Environ Med, 2002; 44:459-468).

I thought that had to be a typo.  It's not.  Sadly, even in these modern times in which information flows freely and ubiquitously, contemporary healthcare and insurance models still take close to two decades to translate research into clinical practice.  Some see this phenomenon as madness without method.  My own view is that the disconnect is driven not by laziness, lack of awareness, or lack of desire to apply new clinical knowledge.  Rather, the time lag between the establishment of evidence and its clinical application is created by the very hard work of leaping from intellectual recognition to actual clinician behavior change.  We sometimes fall victim to the assumption that chronic pain patients are the only constituency in need of behavior modification.  In fact, all stakeholders must adapt to evolving notions of clinical best practices; adjusters, nurses, claims leadership, doctors, attorneys, service providers, therapists, pharmacists, injured workers, actuaries, underwriters, brokers... all must adapt to both the clinical and economic realities of (what should be contemporary) chronic pain management.

I hear near unanimous intellectual recognition of the need to apply a biopsychosocial model to chronic pain care.  We must now do the hard work of applying this new knowledge.  For knowledge itself is insufficient to solve the problem.  One can know something to be factually true and yet fail to apply that knowledge.  Ever know it's raining... and still forget your umbrella?  Knowledge, when applied, is wisdom.  

And we have work to do.

Michael
On Twitter @PRIUM1

A Tax on Opioids: Who Pays? And Why?

A new bill was introduced last week by US Senator Joe Manchin (D-WV).  The bill calls for a tax on opioids to the tune of 1 cent per milligram.  This tax will fall primarily to the payor community.

Manchin compares this newly proposed tax to current taxes on alcohol and cigarettes.  This analogy is a poor one: the alcohol and cigarette taxes are born by consumers with the express consequence of changing use patterns.  In the case of the opioid tax (as with most economic propositions in a 3rd party payor system), the tax will likely be paid by an entity (the insurer) that is not a party to the originating transaction (the doctor writing a prescription for the patient).  It is therefore doubtful that the proposed tax will have any material impact on utilization.

There are two notable exceptions to this line of logic.  First, cash-based transactions whereby patients pay for the entirety of the opioid prescription will now be more expensive.  At 1 cent per milligram, a standard prescription for Oxycontin 40 mg q12h would lead to a monthly tax of approximately $25. That might not seem like much, but for the patient paying cash, that adds up quickly.  The second possible exception may occur if certain insurers choose to structure plans such that this tax is passed along to the patient in the form of co-pays, deductibles, co-insurance, etc.  This will surely be the case in many health plans and may cause at least certain patients to seek alternative, non-opioid medications from their doctors.

Neither of these potential exceptions will be available to workers' compensation payers.  For work comp payers, the entirety of the tax will be paid by the insurer and neither the doctor nor the patient will have any financial incentive to do anything differently as a result.  A tax, if you will, on all your houses.  

The other interesting consequence of the proposed tax is that it treats a milligram of a brand name drug and a milligram of a generic drug as equivalent for tax purposes despite the fact that the underlying cost of the generic is significantly less than the brand.  This proposed tax will be yet another factor pushing the cost of generics up for payers, a trend that we've already seen unfold over the last 24 months.

If the proposed tax passes, it's expected to raise somewhere in the neighborhood of $1.5 to $2.0 billion.  These dollars will be used to fund outpatient and residential addiction recovery programs, an increase in the number of doctors certified to provide medication-assisted treatment, and other services to support addiction recovery (like housing and employment assistance for those in recovery).

Candidly, lack of access to these programs today is a major barrier to injured worker recovery. If the bill passes, workers compensation payers will bear the brunt of this new tax burden. Perhaps rather than fighting against the tax, we should collectively lobby to ensure that injured workers can easily access any and all of the new programs/centers/providers funded by the new tax?  

Just a thought...

Michael
On Twitter @PRIUM1