Want to Decrease Disability by 53%?

According to a recent issue of Health Affairs, all we have to do is completely eliminate five risk factors: smoking, obesity, diabetes, high cholesterol, and hypertension.  

Easy, right?

I find it amazing that these risk factors contribute to (potentially, depending on the credibility you lend the study) more than half of all disability in this country.  And given that the study (Preventing Disability: The Influence of Modifiable Risk Factors On State and National Disability Prevalence) is written from a non-work comp perspective, I view this as more of challenge in our industry (where we accept the whole person and have relatively little influence over pre-injury behavior).

If the theoretical elimination of all five risk factors is a bridge too far for you, consider a more conservative analysis contained in the study: If each risk factor was reduced to the level of the "best performing" state (i.e., if all states mirrored the nation's lower obesity rate of Colorado), we would observe a decline in disability prevalence of approximately 7%.  And disability rates in regions where prevalence is highest (South, Appalachia, and Great Lakes) would drop more than 10% under such a scenario.

But our starting point is grim.  In the 18-54 age cohort, nearly 70% of US adults have more than one of the five risk factors.  In the 55-64 cohort, it's about 90%.  And in the 65-79 category, about 95%.

This isn't just clinical, it's cultural.

Michael
On Twitter @PRIUM1

Narrative Does Matter: Self-Guided Opioid Weaning

Perhaps it's obvious.  I write blog posts with regularity, I consume news voraciously, and I've never met a microphone I didn't enjoy speaking into.  But in the event it's not readily apparent, I'm happy to share that the single most important concept in contemporary communications is this: narrative.

"Narrative" is occasionally used as an epithet in political discourse (as in "you're just choosing facts that fit your narrative") and I'm as concerned as anyone else about the balkanization of modern media (which I describe as "choose your own narrative"), but the power of well-told stories to shape, change, or at least influence thinking is undeniable.  We live in a world of competing narratives and while the ability to identify such is critical, the ability to create such can be transformative.

Health Affairs understands this.  Whenever I get a new issue, I typically flip directly to my favorite section: "Narrative Matters."  Here, public health workers on the front lines share stories of what it means when platitudes turn into policy.  It's one thing to talk in the abstract about the CDC's Ebola response... it's quite another to listen to a doctor tell the story of running an Ebola clinic in Liberia.

This month's issue contains another in a long line of compelling stories, though this one hits close to home for those of us fighting to stem the tide of prescription drug misuse and abuse.  The story comes to us from Travis Rieder, a research scholar at the Johns Hopkins Berman Institute of Bioethics.  His journey, despite his role at Hopkins, doesn't have anything to do with his role in public health.  Travis likes to ride motorcycles... and his story begins with a horrific motorcycle accident.

I won't retell the story (you really should read it for yourself), but to summarize: Travis ended up deeply dependent on opioid painkillers.  Knowing he needed to stop taking them, he initiated his own weaning protocol (that was, in retrospect, far too aggressive - even thought it was suggested by one of his doctors).  He lived in agony for days, then weeks.  But he stuck to his plan.  At one point, it got so bad, he contemplated suicide.

Where were his doctors, you ask?  He found the medical profession to be some combination of afraid, inept, reluctant... perhaps all of the above... to assist in the weaning of his opioids.  And this was a motivated patient, asking to be weaned.  A highly educated, white collar academic who was begging for help... and got none.  "How could it be that my doctor's best tapering advice led to that experience?" Travis asks, "And how could it be that not one of my more than ten doctors could help?"  And think: this story found its way to Health Affairs because Travis is a known author in the field of bioethics.  How many non-bioethicists out there are suffering in this same opioid purgatory?

As my colleague Mark Pew has written about extensively, we've arrived at the hard work cleaning up the mess.  He even created a hashtag for it (#cleanupthemess), not because we're trying to score marketing points, but because we needed an organizing principle for the combined and coordinated effort its going to take to accomplish our collective goal.

Travis's story highlights the fact that the clean up may be harder than we imagine.

Michael
On Twitter @PRIUM1

Pain Acceptance: A Path Forward?

The world apparently needs more opioids, so the FDA approved another one yesterday.  Egalet Corporation's long-acting morphine formulation, Arymo ER, will hit the market here in the US before the close of Q1.  Interesting side note for those interested in the economic value of abuse-deterrence: Egalet stock initially shot up 27% on the approval news.  But when it became clear the Arymo label would only include abuse-deterrence language for dissolution and injection, but not for snorting or chewing it (because another abuse-deterrent opioid has rights to exclusivity for the particular claim), the stock dropped 16% yesterday and another 20% this morning.  By my calculations, that drop erased about $70 million in equity value.  And according to Yahoo Finance, 58% of the share are held by "insiders" (aka company executives) and one officer, Egalet CEO Robert Radie, holds nearly 50% of those insider shares.  So he's $20 million poorer this morning because he can't claim his new drug cannot be snorted or chewed.  If the mix of healthcare and high finance is a little nauseating to you, you're not alone.

In other pain management news, there's a really interesting study in this month's Journal of Pain Research regarding the relationship between "pain acceptance" and outcomes measures such as disability, mental health, and quality of life.  The study also relates this concept of "pain acceptance" to behaviors such as "pain catastrophizing," a phenomenon wherein a person "experiences exaggerated worrying and overestimation of the probability of unpleasant outcomes in response to pain." Notably, the study looks exclusively at a workers' compensation population.

Not surprisingly, higher "pain acceptance" scores were strongly correlated with less disability and greater mental and physical health.  "Pain catastrophizing" appeared to have the opposite effect - increased disability and poorer perceived health.  If you're wondering why you're hearing so much these days about cognitive behavioral therapy, this is why.

The study caused me to contemplate the broader picture of where we stand on the issues of chronic pain and opioid use.  We get lost in the statistics sometimes and fail to see the forest for the trees. Here's the real bottom line: the last quarter century has seen both an explosion in chronic pain and an explosion in opioid use.  The latter does not appear to be mitigating the former.  At all.

From another (highly clinical/technical) study that also crossed my desk last week from the Department of Palliative Care at Geisinger Medical Center, I drew this important insight: "Do not use pain intensity as the primary outcome in the management of chronic pain."  Sounds pretty simple.  But do we use, then?  Perhaps a greater focus on concepts like "pain acceptance" will help us break through the chronic pain conundrum.

Michael
On Twitter @PRIUM1

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

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 

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

When CMS and CDC Conflict: Medicare and Opioids

A few weeks back, the National Alliance of Medicare Set-Aside Professionals (NAMSAP) published a press release calling for a revised approach to MSAs that include opioid medications.  Specifically, NAMSAP stated that it supports the following changes:

1. A hard cap of 90 MED based on the CDC guidelines for no more than one month when the Work Comp MSA includes a surgical projection; and/or,
2. A hard cap of 40 MED for no more than one month, followed by a 10% per week mandatory tapering and weaning plan, as recommended by the CDC, until fully weaned from opioids

I find this attempt at hoisting the federal government with its own petard laudable.  When the federal government's public health agency says one thing, but that same government's healthcare payment policy agency says another, they ought to be called to account for it.  Just about anyone who reads this blog with any regularity is familiar with the crushing clinical and financial burden of opioids in general, but also specifically in regard to MSAs.  Long term use of expensive and potentially addictive medication is driving huge pharmacy allocations and prohibiting settlements.  So good for NAMSAP for putting this issue front and center with more than just a tired complaint, but rather with a specific call to action.  Good stuff.

Only one small problem.  I don't think it has a chance at being implemented. 

There are plenty of smart people in our industry that have forgotten more about MSAs than I will ever know.  But if I were writing the CMS response to NAMSAP, I would probably write: “We recognize that some of the treatment for which we demand allocation is outside of evidence based guidelines.  We support any and all efforts to bring care for these injured workers within those guidelines.  However, we respect the sanctity of the doctor-patient relationship and should a projection include long term use of opioids above the evidence based threshold, CMS will still demand an appropriate allocation for those medications.”  

I think the NAMSAP idea is fantastic - it should start a necessary dialogue around conflicting federal government policies and the clinical and financial risks it creates for patients and payers.  But I believe it has little hope of changing CMS policy, at least in the short term.  Hasn't CMS historically deferred to the treating physician’s approach, even when it makes no sense? 

One might argue that this is different, people are dying of opioid overdoses and the Medicare eligible population is not immune from that phenomenon.

I hope I'm wrong.  

Michael 

Follw me on Twitter @PRIUM1

President Obama at the National Rx Drug and Heroin Abuse Summit

Imagine getting the chance to hear the President speak in person.
Now imagine he comes to your home town to offer some thoughts on a given topic.
Finally, imagine the topic of his remarks is the very center of your professional life and something you eat, sleep, and breathe every day.

That was my day today.

As my legendary 12th grade English teacher Ross Friedman would say: today was a 9.9 on the groovy scale (note: there are no 10s... so this was clearly a really great day).

President Obama came to Atlanta today to talk about prescription drug and heroin abuse.  Rather than give a speech from a prepared text, he sat on a panel moderated by CNN's Dr. Sanjay Gupta along with two recovering addicts and an emergency room doctor who also serves as Baltimore City's Health Commissioner, Dr. Leana Wen (who, by the way, proved to be an incredible advocate for changing the way we view chronic pain and addiction... she issued a standing order in Baltimore so that any citizen in the city can secure a Naloxone prescription - an overdose antidote - under her name.  Just walk into any pharmacy in Baltimore and pick it up.  Beat that with a stick).

This format enabled President Obama to speak extemporaneously and candidly on a range of topics under the umbrella of prescription drug and heroin abuse.  He talked about the Affordable Care Act, mental and behavioral health, criminal justice reform, patient and physician education, addiction prevention, treatment, and recovery.  While I'm not supposed to betray my personal politics on the blog (at least according to my PR advisers), most people who know me know that I'm a fan of the president.  Despite my admitted admiration for Obama, I expected today to be filled with presidential sounding platitudes like "we need more addiction treatment in this country" and other relatively obvious and safe statements.  And he said most of the things I expected him to say along those lines.

But he said more than that.  My impression is that President Obama understands both the policy nuance and personal tragedy of this issue at a level I honestly didn't expect.  This is a guy fighting multiple battles against an array of terrorist organizations, he's steeped in a Supreme Court nomination fight, he's trying to figure out how and where to weigh in on the circus that has become the 2016 presidential election, and he's dealing with a hundred other issues on a daily basis.  But he came to Atlanta today to talk about prescription drug and heroin abuse.  And amidst all of the other issues on his desk, it's evident that he gets this.  And it shows.

When asked by Sanjay Gupta what brought him to Atlanta this afternoon, President Obama offered this: "When I show up, the cameras usually do, too."  He wasn't being arrogant.  He was suggesting that his mere presence, regardless of what he said, helps bring needed attention to this critical issue.  He was saying that he consciously chose to use the power of his office to shine a light on prescription drug and heroin abuse.  And he's right - there certainly were a lot of cameras there today.

He said "we need to think about this [drug abuse issue] as a public health problem, not a criminal justice problem."  Many of us close to this issue agree with that statement, but when the President of the United States says it out loud, it reshapes the broader public dialogue and helps further the aims of those of us who have been thinking that way for years.  Such a public statement will help reshuffle the priorities of agencies like the FBI, DEA, ATF, CDC, and NIH.

He said he was "shocked to learn how little education medical residents receive in pain management."  And as a result, 60 medical schools announced today their intention to significantly enhance pain management training in medical school residency programs.  The bully pulpit is real.

Finally, he said "we medicate... self-medicate... a lot of problems in this country."  I was floored when he said that.  We know that's true, he knows that's true, but for the president to say it out loud is to acknowledge the fundamental need for cultural change necessary to truly stem the tide of prescription drug and heroin abuse.  Perhaps the most deeply rooted of all the root cause issues behind prescription drug abuse is the notion that Americans expect to be pain free, stress free, anxiety free.  Opioids aren't ragingly popular simply because they help manage pain.  Opioids also have psychoactive attributes that make the slings and arrows of our difficult and complicated lives seem easier to handle.  And President Obama said it.  And that matters.

Today was a great day for me, personally and professionally.  I think today might also turn out to be a great day in the broader fight against prescription drug misuse and abuse.  And that's a great day for all of us.

Michael
On Twitter @PRIUM1

What the New CDC Opioid Guidelines Will Mean to Work Comp

Not much, I fear.  Allow me to explain...

What the CDC has done here is critically important to addressing the public health crisis that is opioid misuse and abuse.  While the CDC's process came under scrutiny (from, among others, me), the resulting guidelines are evidence-based, well-written, and carry the imprimatur of the preeminent public health agency in this country.  That's groundbreaking.  But I'm not sure we're going to see a significant impact in workers' compensation for three reasons.

Before we dive in, here's a link to the guidelines.
Here's a link to Dr. Tom Frieden's (CDC Director) letter regarding the guidelines in NEJM.
And here's perhaps the most practically valuable thing the CDC published earlier this week - a checklist for primary care physicians who prescribe opioids (this is excellent).

Reason #1 we're unlikely to see a significant impact in work comp: It takes a long time for new medical evidence to penetrate actual physician practice.  The guidelines have received a lot of press coverage over the last few days, but busy primary care physicians may not be immediately responsive to new medical evidence even if they see it on the front page of the local newspaper. First, not all physicians have the same faith in an agency of the federal government that I possess.  In fact, for some, the notion that the federal government published these guidelines may be the primary source of skepticism.  Second, there will armies of pharma reps to gently, diplomatically, but firmly push back, find holes, work arounds, etc. to increase the likelihood that current prescribing practices remain intact.  Third, there are obviously no enforcement mechanisms in connection with these guidelines.  A primary care doc who chooses not to follow them will face no immediate consequences (though, we should be clear, the long term consequences to the patients of such a doctor could be catastrophic).

Reason #2: Our primary cost drivers in work comp are long term, chronic pain cases.  The new guidelines offer precious little guidance for these types of cases.  Most of the guidelines focus on opioid initiation and to the extent chronic opioid therapy is addressed, the guidelines suggest avoiding it.  Well... what if we have an injured worker who has been on opioids for that past 10 years?  Whose dose has escalated regularly and dangerously over that period?  The guidelines suggest those opioids should be weaned.  Right.  Telling a primary care doc to simply wean a patient off of opioids in the midst of a long term, complicated, polypharmacy drug regimen is perhaps expecting too much.  I would have liked to have seen more detailed guidance on how to deal with such complex patients.  So why didn't the CDC go there?  Because it's really complicated, that's why.

Reason #3: Primary care docs, by and large, didn't create most of our pain management issues in work comp.  Granted, I'm dealing with a very skewed subset of cases here at PRIUM.  I recognize we suffer from adverse selection, so this might not be accurate for the entirety of the work comp universe.  But what we see is that surgeons and pain management specialists tend to initiate complex pain management drug regimens (after the profitable procedural work is done) and then, in perhaps the most unkindest cut of all, the patient is discharged back to the primary care doc... who is now overwhelmed by a monster of a drug regimen that he did not create.  Yes, primary care docs write almost 10 times more opioid scripts per year (28 million) than pain management and interventional pain management doctors combined (3 million), but will these new guidelines - aimed at primary care docs - help them much if they're not the ones making the initial prescribing decision?

I'm thrilled the CDC published these guidelines.  I think they represent useful, cogent, and practical thinking.  And I hope I'm wrong that we won't see a material impact in work comp.

Michael
On Twitter @PRIUM1 (just click the link to follow!)

States Take On Painkillers

Despite efforts at the federal level (CDC guidelines - such as they are, the Obama administration committing $1 billion to fight drug abuse, etc.), the real public policy movement on prescription drug and heroin abuse is happening at the state level.  And it's happening fast.

This morning, Massachusetts Governor Charlie Baker signed into law new restrictions on opioid prescriptions in his state.  Perhaps most notably, new opioid prescriptions are not to exceed a 7 day supply.  This is groundbreaking legislation and could lead to similar bills throughout the country. Yes, there are carve outs for cancer patients and chronic pain patients, but these are reasonable caveats necessary to maintain access to care.  Whether or not opioids are medically necessary for most chronic pain patients (they're not) is a separate discussion.  This law will help prevent dependence and addiction in new patients.  We still have a lot of work to do with the existing chronic pain population.  One more tidbit - there's no exception for work comp.  I've scoured the 42 pages of the bill and injured workers will be subject to the same protocol as everyone else.  

From today's New York Times, a recap of state-level efforts to curb painkiller and heroin abuse (highlighting the above mentioned efforts in Massachusetts).  Did you know that there are 375 proposals moving through state legislatures nationwide regarding prescription painkillers, pain clinics, and other aspects of treatment?  That's a dizzying pace of regulation.  The fault, our governors have decided, will not fall to the underlings of the federal bureaucracy - they're going to do something about this.  Now.  Governor Pete Shumlin of Vermont, who devoted the entirety of his 2014 State of the State speech to this topic, summed it up best: "The states are going to lead on this because Big Pharma has too much power."  I'd add that state medical associations have a lot of power, too, but they've come to the table across the country.  In Massachusetts, the president of the state's medical society put in plainly: "Usually we are opposed to carving anything in stone that has to do with medical practice.  But we are willing to go forward with this limitation [the 7 day supply restriction] because we recognize this is a unique public health crisis."  

The Times also has a piece today covering direct-to-consumer (DTC) advertising for pharmaceutical products, a practice that the American Medical Association has advocated be banned.  The research suggests that there may be benefits to DTC advertising.  Yes, utilization of advertised drugs goes up.  But so does utilization of competitive drugs in the same class. The article seems to think this is good news - conditions historically stigmatized (like depression) are being treated more frequently because DTC advertising is prompting doctor-patient conversations that might not have taken place otherwise.  I acknowledge this is a good thing, but can we not come up with a better way to remove stigma and treat mental health conditions than spending hundreds of millions of dollars on TV ads?  Finally, there appears to be an uptick in patient medication compliance as a result of DTC advertising (you see the ad, you're reminded to take the pill that's already been prescribed to you).  That's great, but again... can we not come up with better approaches to patient medication compliance?  I still think the risks and costs of DTC advertising outweigh the benefits.

Lots going on.  I sense progress.

Michael
On Twitter @PRIUM1

Heroin is in Your Community - You Just Don't Know It

The local NBC affiliate here in the Atlanta area, 11-Alive, has just produced an in-depth story about heroin use and overdose deaths.  It's an outstanding series of videos and if you don't have much time on your hands, at least spend 7 minutes watching the first one in the series (after which you'll probably end up watching all of them).  Those of us that follow this public health crisis closely are no longer surprised by these stories, but to have such solid reporting that is so focused on my own community offered me an opportunity to talk about this with others for whom the story might be relatively new.  

Here's what surprises people:

First, this problem is concentrated in the wealthy suburbs of our major cities, not poorer areas with which drugs and related crimes have historically been linked.  The local reporters here in Atlanta discovered a triangle that connects Marietta to the west, Alpharetta to the north, and Johns Creek to the east.  Inside this triangle, you'll find some of the wealthiest ZIP codes in the state (and among the wealthiest ZIP codes in the country, for that matter).  And these reporters also found a heroin overdose death rate inside of this triangle that has skyrocketed nearly 4,000% just since 2010.  

Second, and correlated with the first point, people so closely (and incorrectly) link drugs and crime and poverty that they are completely missing the fact that heroin dealers are making home deliveries all over the north metro Atlanta suburbs.  This is how simple it is now: you text your dealer, you leave $20 under the door mat, the dealer takes the $20 and leaves the heroin.  Done.  No shady street corners, no dark alleys, no dangerous meet ups, no abandoned houses.  It's as easy as ordering a pizza.

Third, it's about as cheap as ordering a pizza, too.  That $20 isn't a made up number - that's what it costs to get secure a supply of heroin that will keep you high for up to several days.  

Fourth, this problem usually doesn't start with other illicit drugs or alcohol (though it certainly can). Heroin addiction most often begins with prescription painkillers.  And while much of the painkiller abuse in high schools is non-prescribed, recreational use, there is a substantial portion of teenage heroin addicts that started out with a legitimate prescription for opioids from a well-intentioned doctor.  Parents I've spoken to routinely miss this critical link.  Otherwise upstanding kids can get addicted to opioids (particularly after a wisdom teeth extraction or a sports injury - see this Sports Illustrated article for a more in-depth view of opioid use among high school athletes).  And when they get hooked and can no longer access painkillers (when doctors cease prescribing them and/or they can't find or afford non-prescribed pills), they're turning to heroin.  

I don't often tell people they're wrong - it's impolite and usually counterproductive.  But... if you don't think this is happening in your community, you're wrong.  If you don't think this is going on in your kid's high school, you're wrong.  If you don't think this could potentially impact you and your family directly, you're wrong.  

Strong reasons ought to make for strong actions.  Tell your friends, share the link above with your neighbors, make sure teachers and counselors and pastors are aware.  Above all else, be vigilant.  

Michael

On Twitter @PRIUM1

As the Pendulum Swings, Governors Weigh In

June 13, 2001: In the first case of its kind, an Alameda, California jury awards the Bergman family $1.5 million for under-treatment of pain during a hospital stay.  The case facts are dense and the clinical arguments are nuanced (according to this law review article, the best summation of the case and its implications I could find), but the trial represented a referendum on pain treatment in this country and despite the treating provider's prescriptions for Demerol and Vicodin, the jury found he had not done enough to manage the patient's intractable pain.

October 30, 2015: In the first case of its kind, a California doctor is convicted of murder in the deaths of three patients who were prescribed "crazy, outrageous amounts" of painkillers.  Dr. Lisa Tseng earned $5 million in one three-year period as she built her practice around prescribing huge amounts of opioids with little record keeping and total disregard for patient safety.  "You can't hide behind a white lab coat and commit crimes," said the district attorney.

In the intervening 14 years between the Bergman case the the Tseng case, a lot has happened.  To be clear, I'm not comparing the two cases.  Nor am I suggesting that either is wholly representative of current approaches to pain management generally or opioid use specifically.  Rather, I see these two cases as sentinels - two opposing, symbolic, and instructive cases that exhibit how far the pendulum of pain management is capable of swinging.

This weekend, the National Governor's Association gathered in Washington, D.C.  To the surprise of some, the sessions have been dominated by bipartisan concerns over prescription drug abuse.  The group of governors decided over the weekend to explore creating new guidelines on painkiller prescriptions that could include restrictions on the number of prescriptions that can be written and "locking in" a doctor and pharmacy so patients can only secure painkillers at a single location.

This is a good sign.  Perhaps the governors can find the right place for the pendulum to come to rest, a balance between public health crisis and pain management access.  Governor Shumlin of Vermont, who devoted his entire State of the State address to this issue in 2014, summed it up best: "You have the most conservative Republican governors and the most liberal Democratic governors agreeing" on the urgent need to get something done.  In this winter of political discontent, when is the last time we could say that about any public policy issue?

But they face significant challenges:

First, guideline overload.  CDC, ODG, ACOEM, State of (fill in the blank), FDA labeling, NIH, and a dozen other reputable organizations all have guidelines around opioid prescribing.  If the governors add another set of guidelines, we risk alienating the very primary care physicians we're trying to reach and educate.

Second, unintended consequences.  This list is admittedly tough:

• Limiting the number of pills in circulation may prove to be correlated with an increase in heroin use; 
• Laws aims at bad docs can make good docs less willing to treat pain patients; 
• One state's successful efforts to combat prescription drug misuse and abuse can shift such activity to neighboring states.  

Despite all of these obstacles, this is obviously a fight worth fighting.  And with such bipartisan support, maybe our governors can actually lead the way toward solutions that make sense.  

Michael 

On Twitter @PRIUM1

More Than Kin and Less Than Kind: Opioids, Moms, and Newborns

In the midst of the opioid epidemic, we've encountered several important questions of medical ethics. For instance, the growing availability of Narcan for the reversal of potential overdoses and its associated widespread political support begs a question: does a ubiquitous antidote to overdose encourage risky behavior among addicts?  Public health data suggests this isn't the case, but it's still an important ethical question that deserves discussion.  Or another: Does an opioid treatment agreement (sometimes referred to - inappropriately, according to many ethicists - as an opioid 'contract') create sufficient friction in the doctor-patient relationship that such documents could do more harm than good?  The relatively sparse data on the topic suggests this isn't the case either, but again, it's a question worth exploring.

Here's a particularly thorny ethical question: How do we deal with pregnant women who are dependent on or addicted to drugs?  I carefully chose the phrase "deal with" as opposed to "treat" because whether and how we "treat" these women is among the fundamental questions we need to answer as a society.  Do we "treat" them like criminals?  Or do we "treat" them like patients?   What role should doctors and nurses play in involving state agencies like child protection services?  Should they be legally required to report expectant mothers that are misusing, abusing, or simply 'taking as prescribed' medications like opioids?  And if child protection services become involved, might these agencies remove the child from the care of the mother?  Or should they be legally prohibited from doing so, thus removing a potential ethical barrier to mandatory reporting?  

If you care about these questions and want to get closer to answers that might make sense, then this series of pieces from Reuters is required reading for you.  Leaving aside for the moment that Duff Wilson and John Shiffman deserve a Pulitzer for this work, it's the first in-depth analysis I've seen that combines public health data, public policy critique, heart-wrenching anecdote, and journalistic discipline.  Read the stories, study the graphics, watch the videos.  

We need new legislation in this area.  And we need to be enforcing legislation that already exists (like the Keeping Children and Families Safe Act of 2003, which most states and hospitals are either ignoring or they're adhering to state legislation which directly conflicts with the federal law).  

As I've written in the past, newborns suffering from Neonatal Abstinence Syndrome (NAS) are perhaps the saddest cost of the opioid epidemic.  But it's now clear the risk to these babies extends beyond the neonatal intensive care unit and into their homes, where accidental and preventable deaths are occurring at an alarming rate.  To think that a newborn can painfully but successfully deal with the effects of mom's drug use and yet still risk death at the hands of the very mother who gave them life, whose responsibility it is to care for the child, who would, under any normal circumstances, likely sacrifice her own life for the life of the child - this is tragedy, writ... small.  Even the smallest among us. 

These moms need help, not handcuffs.  They need assistance, not punishment.  They need psychological and emotional support, not the psychological and emotional destruction of having a child taken away.  

We can do better.  We have to do better.

Michael 

On Twitter @PRIUM1