Monday, February 29, 2016

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.  

On Twitter @PRIUM1

Monday, February 22, 2016

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.  

On Twitter @PRIUM1

Monday, February 15, 2016

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.

On Twitter @PRIUM1


Tuesday, February 9, 2016

A New Approach to Opioids From FDA?

After we were all inundated with direct-to-consumer advertising from the pharma industry on Sunday evening, I thought I'd share some potentially good news from federal regulators (the same regulators that would do us all a favor by banning DTC advertising from pharma).  The emphasis here is on the word "potentially."

Last week, three physician leaders at the Food and Drug Administration (FDA) published an article in the New England Journal of Medicine that suggests a new approach to how FDA should deal with opioids as a medication class.  The article concisely lays out new steps, clear priorities, and a commitment to better handling issues around pain management.  While the paper is characterized as part of a larger initiative on the part of the Department of Health and Human Services (HHS), those who follow FDA activities closely know that this is also a response to significant criticism over the last several years regarding FDAs unpredictable and haphazard responses to new drug applications in the opioid class.  FDA mandated necessary and positive label changes to all extended release / long acting opioids... and also approved Zohydro and generic Opana ER... Clearly, the agency has suffered from a lack of a clear and comprehensive strategy.

While it's been forever and a day, FDA finally appears to be crafting one.  The key quote: "... the United States much deal aggressively with opioid misuse and addiction, and at the same time,... it must protect the well-being of people experiencing the devastating effects of acute or chronic pain.  It is a difficult balancing act, but we believe that the continuing escalation of the negative consequences of opioid use compels us to comprehensively review our portfolio of activities, reassess our strategy, and take aggressive actions when there is good reason to believe that doing so will make a positive difference."

FDA will now reexamine the role of pharmaceuticals in pain management, encourage the development of non-opioid alternatives, focus on abuse-deterrent formulations of new drugs, support the development of evidence-based guidelines for opioid use, and ensure that the approach to pediatric pain management is the right one.

But to me, the most important commitment FDA appears to make in this announcement is a willingness to "balance individual needs for pain control with the risk of addiction, as well as the broader public health consequences of opioid abuse and misuse."  

This the first time, to my knowledge, that FDA has acknowledged public health concerns as part of its mandate related to pain management medications.  Should FDA develop a rational, repeatable, replicable approach to balancing the safety and efficacy to an individual patient with the safety and efficacy to the broader public, this will represent a major step forward in the fight against opioid misuse and abuse.

This is promising.  But now the hard work begins.  FDA actually has to implement this.

On Twitter @PRIUM1

Monday, February 1, 2016

The Flu, My Inbox, and Opioids

I found myself felled by the flu last week.  I'm glad to be back on my feet and figured it would make my life easier if I caught up on my inbox and blogged about what I found there at the same time... Here's what popped in there while I couldn't stand to stare at a screen:

Vicodin scripts plummeted due to the rescheduling of hydrocodone from SIII to SII.  There were over 26 million fewer scripts (a 22% drop) and over 1 billion fewer tablets (a 16% drop) as a result of the change.  That's a dramatic shift.  But did those scripts disappear?  Or were they replaced by other opioids?  Yeah, that's what I think, too.

US Senator Ed Markey (D-MA) is holding up confirmation of a new FDA Commissioner over some of the practices that appear to have caused the last FDA Commissioner to resign.  Markey wants a reformed approach to opioid approvals and for FDA to rescind its approval of oxycodone for pediatric populations.  These are tough tactics.  Whether or not you agree with him, here's a Senator using the power of his office to shine a light on a major issue and trying to create change in an agency that desperately needs it.

Any high school in the US that wants Narcan on hand in case of a drug overdose can now have it free of charge (thanks to the the drug's manufacturer and the Clinton Foundation).  I'm not supportive of a Narcan script along with every opioid script, but having this drug on hand in high schools as standard operating procedure is good public policy.  Why would a high school turn this down?  Any principal that does so risks being hoist by his own petard... and on the front page of his local paper trying to explain why the poor kid died when he might have been saved.

The US Preventative Services Task Force has recommended that all adults >18 be screened for depression.  Some of you are thinking, "whoa... that's gonna be expensive!"  And you're right, it will be.  But you know what the only thing more expensive than diagnosed depression is?  Undiagnosed, untreated depression.  So let's start getting used to this being a good idea.  Quote to take away on this one is from Dr. Keith Humphreys, a professor of psychiatry at Stanford: "The reality of American healthcare is that mental health has to be done in primary care."

So I guess I didn't miss much.

On Twitter @PRIUM1