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

Drug Abuse and the 2016 Presidential Election

In last week's State of the Union address, President Obama mentioned prescription drug abuse as an issue where he saw opportunity for bipartisan compromise.  Notably, he mentioned this in the first three minutes of the speech.  And not coincidentally, he mentioned it in the same breath as another, related issue that will be a necessary component of prescription drug abuse mitigation: criminal justice reform.

Governor Chris Christie has made prescription drug abuse a centerpiece of his stump speech.  He regularly shares a personal experience of losing a close friend from law school to an overdose.  Just last week, Christie made headlines by shutting down a New Jersey prison in order to convert it to a drug addiction treatment facility.  "The victims of addiction deserve treatment..." he said.

In last night's Democratic primary debate, Secretary Clinton and Senator Sanders both touched on the subject.  After noting that she hears of horrible stories wherever she goes on the campaign trail and after advocating for first responders to carry and be authorized to use Narcan, she closed her comments along the same lines as Governor Christie: "We have to move away from treating the use of drugs as a crime and instead, move it to where it belongs, as a health issue.  And we need to divert more people from the criminal justice system into drug courts, into treatment, and recovery."  Senator Sanders added, after placing at least some of the blame at the feet of the pharmaceutical companies, that "we need a revolution in this country in terms of mental health treatment."

This is clearly going to be a 2016 presidential campaign issue.  Beyond the mere fact that crises often make for strange bedfellows (Clinton and Christie offering nearly interchangeable quotes?!?!), why are we hearing more about prescription drug abuse from candidates now than ever before?

First, New Hampshire.  Everyone knows the Granite State figures prominently as the first primary - on February 9 - in both parties' nomination process (Iowa - on February 1 - is a caucus, not a primary).  What many may fail to recognize is that New Hampshire's citizens have been hit especially hard by the opioid/heroin epidemic over the last several years.  A quarter of New Hampshire voters believe prescription drug and heroin abuse is the single most important issue of the 2016 election, marking the first time in eight years a plurality of voters have ranked any issue more important than jobs and the economy.  If you're going to win the New Hampshire primary - from either party - you better be prepared to address prescription drug misuse and abuse.  

Second, it's not an exaggeration to say that we're losing a material portion of entire generation of Americans to this epidemic.  First, we saw the findings of a recent study from the National Academy of Sciences indicating that the death rate among white, middle-aged Americans has grown over the last two decades while the death rate among almost all other groups has declined.  Now, the New York Times has analyzed nearly 60 million death certificates collected by the CDC and found that the death rate among young, white adults has risen to levels not seen since the AIDS epidemic of the late 1980s and early 1990s.  This generation will be the first since the Vietnam War to experience higher death rates in early adulthood than the generation that preceded it.  The figures indicate that the 2014 death rate from prescription drug and heroin overdose among 25 to 34 year olds was five times its level in 1999.  

We have presidential candidates talking about this issue because it is the preeminent public health issue of our time.  If there's any comfort for us at all, it's that both parties appear to be taking it seriously.  If there's to be a concern, it's that whoever wins will need to make difficult decisions and real progress.  We're losing a generation of Americans.  

Michael
On Twitter @PRIUM1

Another New Opioid: Cheeky, This One

Yesterday, I wrote about generics and the distraction of cheap, but still potentially dangerous, medications.  Never fear: there's always an expensive new brand name drug with which to contend.

On December 23, Endo Pharmaceuticals put out a press release announcing that the company has filed a New Drug Application with the FDA for Buprenorphine HCI Buccal Film for the "management of pain severe enough to require daily, round the clock, long-term opioid treatment and for which alternative options were inadequate" (the precise language required on the labeling of any extended release/long acting opioid).  The buccal film will be a strip placed on the inside of the patient's cheek.

According to Endo, this medication is a "partial opioid agonist and a potent analgesic."  Let's break those phrases down so you know what you'll be dealing with if this gets approved.

A partial opioid agonist means that although buprenorphine is an opioid, and thus can produce effects similar to other opioids (more on that next), its effects are less than those of "full agonists" like heroin or methadone.  Many of you will recall buprenorphine as a primary ingredient of Suboxone, a medication indicated for helping patients wean off of other opioids.

But Endo isn't intending this medication to assist in the weaning process.  Rather, Endo is also describing this as a "potent analgesic," with all of the issues associated with other long acting opioids.  The press release does say that the medication demonstrated a "low incidence of typical opioid like side effects."  No mention of the specific side effects or what "low incidence" actually means.

Next, look for the marketing folks to put an inspiring and cool-sounding trade name on this.  For now, we have Exalgo... Nucynta...  Opana... Zohydro... Hysingla... Palladone... This list would be hilarious if it wasn't so tragically true.

Any guesses for this new one?

Michael
On Twitter @PRIUM1

Generic Drugs Are Not the Answer

I've written on several occasions that I believe abuse-deterrent opioids to be a potentially dangerous distraction.  Specifically, I've said:

I am 100% supportive of abuse-deterrent formulations of prescription opioids.  To me, though, this conversation is a distraction. The problem as we see it is lack of medical necessity.  In most cases, it doesn't matter if the patient's opioid is abuse-deterrent or not.  If it's medically unnecessary, if it's leading to loss of function, if it's leading to dependence and addiction... it needs to go away.  The doctor will be better educated.  The patient will get better.  The cost of care will go down.  Everyone wins.  Abuse deterrent technology is great, but if we focus on technology over medical necessity, we will have missed the mark and the crisis will continue.  

We saw in 2014 a plethora of drug trend reports noting cost savings associated with generic medications.  We'll see more of the same in 2015.  Like abuse-deterrent technology, generic medications represent a potential Pyrrhic victory in the battle against misuse and abuse of prescription drugs.  Yes, we're saving money.  No, we're not really solving the problem.  Here's a reprise of the language above with GENERIC substituted for ABUSE-DETERRENT.

I am 100% supportive of GENERIC formulations of prescription opioids.  To me, though, this conversation is a distraction. The problem as we see it is lack of medical necessity.  In most cases, it doesn't matter if the patient's opioid is GENERIC or not.  If it's medically unnecessary, if it's leading to loss of function, if it's leading to dependence and addiction... it needs to go away.  The doctor will be better educated.  The patient will get better.  The cost of care will go down.  Everyone wins.  GENERICS [are] great, but if we focus on GENERICS over medical necessity, we will have missed the mark and the crisis will continue.  

Don't let a single digit % drop in drug costs fool you.  There is a lot of work to be done.  Cheap drugs can still be dangerous drugs.

Michael
On Twitter @PRIUM1