A Way to Fix a Drug Problem Without More Drugs?

Like many of my colleagues here at PRIUM and acquaintances outside of PRIUM who focus on chronic pain day in and day out, I get all manner of articles forwarded to me from friends about opioids and related medical treatment advances.  There's the spider venom that may hold the key to a more effective non-opioid painkiller.  There's the big-data, molecular-lottery approach that promises to identify medications capable of delivering pain relief without opioid side effects.  There's the on-going debate regarding medical marijuana's potential to stem opioid use.  This is just a sampling of the many studies, articles, ideas, and whims that appear in my inbox on a regular basis.

The theme that sticks out to me is the collective focus we seem to have on fixing a drug problem with more drugs.  

This reminds me of the unsettling moment at last year's National Prescription Drug Abuse and Heroin Summit here in Atlanta when Surgeon General Dr. Vivek Murthy offered some opening remarks prior to the arrival of President Obama at the conference.  In those remarks, he outlined a five-step strategy to combat prescription drug abuse and heroin and the first two steps were medication-based (#1 was expanding access to naloxone and #2 was expanding access to suboxone).  I think highly of Dr. Murthy and applaud his critical efforts to combat addiction in all its forms.  And I'm not even sure his plan isn't exactly what we need.  I was simply struck, again, by this theme of fixing a drug problem with more drugs.  It seems somehow counter-intuitive to me or, at least, not getting at root-cause issues.

So I was intrigued last week when I read about a study out of the University of Utah, Duke University, and Washington University in St. Louis.  The collaborating bioengineers have figured out a way to potentially manipulate our genetic code to suppress chronic pain.  For those rightly uncomfortable with the idea of messing with human DNA, the researchers are not editing or replacing genes.  Instead, they're using something called the CRISPR (Clustered Regularly Interspaced Short Palindromic Repeat) system to modulate the way genes turn on and off in order to protect cells from inflammation and tissue breakdown.  Early experiments point toward the possibility of eliminating the inflammation, cell death, and tissue damage associated with, say, low back pain caused by a herniated disc.  Sounds useful.  

Three quick observations:
1) This is at least 10 years away from human application.
2) Even then, it's not a panacea.  Surgery may still be required to fix underlying, biological causes of pain (though wouldn't it be nice to isolate that from non-biological, psycho-social contributors to pain?)
3) This work was funded by a National Institutes of Health grant, the likes of which could disappear if the current draft White House budget were to be adopted.

Michael
On Twitter @PRIUM1

Physician Education is Key to Chronic Pain Management

Two themes to which I find myself frequently returning:

1. Primary care doctors are overwhelmed by and ill-equipped to deal with chronic non-cancer pain patients and related long-term opioid therapy; and
2. Mandatory physician education would make a significant difference in the fight against opioid misuse and abuse. 

A paper just published from the University of Missouri puts some data around both of these themes and offers an encouraging path forward on physician training (online link not yet available).

Hariharan Regunath, MD, and some colleagues in the Department of Medicine at the University of Missouri conducted a survey asking 45 internal medicine residents about outpatient chronic non-cancer pain management with opioids.  Some unsettling, but not altogether surprising, results:

• 77.8% reported lack of training in this area
• 86.7% reported lack of consistent documentation from other providers
• 62.2% had at least 1 patient about whom they had concerns for misuse or addiction
• On the bright side, 86.7% believed that focused education could make a difference

So the researchers decided to try some focused education!  After reviewing the results of the initial survey, Dr. Regunath and his team put together a series of educational modules specifically targeting the areas of identified knowledge deficits among the surveyed residents.  

The results were fantastic:

(on a scale of agree to neutral to disagree, % that "agreed" is reported in the table below)

The authors note that despite these compelling results (albeit among a small sample), progress is slow.  "Even at this time, medical education in chronic pain management is still not a mandatory Accrediting Council of Graduate Medical Education (ACGME) component..."  This attitude among the medical education establishment - what's done cannot be undone... or revised, or updated, or improved, even in the midst of a public health crisis - is utterly ridiculous.  

I guess if we can't get mandatory education in place for currently practicing doctors, we might at least start with medical schools and residency programs?  The doctors of the future deserve it.  And so do their patients.   

Michael 

On Twitter @PRIUM1

Mandatory Education for Prescribers

Massachusetts Governor Charlie Baker and the deans of state's four medical schools are teaming up to educate medical school students about misuse and abuse of opioids.  Boston University, Tufts University, Harvard University, and the University of Mass. will collaborate to develop a curriculum around pain management that balances the need for pain relief with the risks of opioid addiction.  As far as I can tell, this effort is the first of its kind in the nation.

A week before this announcement from Mass., Dr. Douglas Grant, registrar of the college of Physicians and Surgeons of Nova Scotia, told a Canadian audience of doctors that physicians should be subject to mandatory continuing medical education in the appropriate prescribing of opioids.

"With respect to opioids, there's been in my view a general loss of awareness, a growing casual attitude about the risks of these medications," he said.  He also noted there's been a shift in expectations among patients to be not only treated for pain, but to be pain-free.  "That's created a positive feedback loop which I think has led to the present rates of high prescribing," said Grant, observing that Canada now exhibits the second highest per capita usage of prescription opioids in the world.

Yeah, we're still #1 here in the U.S.

Some observations in light of these recommendations:

1. A Canadian study suggests that veterinarians still receive 5X the number of hours of pain management training than physicians.  
2. The American Medical Association (AMA) task force on opioid prescribing has been weak thus far in its recommendations.  
3. The voluntary educational programs available today are valuable, but they're only capturing the good docs that have a sincere desire to do this right and make the time to learn best practices. 

If we're going to make real and rapid progress in the fight against prescription drug misuse and abuse, the AMA needs to get behind mandatory prescriber education.  Now.  

Michael
On Twitter @PRIUM1

We Have to Do Better Than Statistically Significant

Researchers from the Bloomberg School of Public Health at Johns Hopkins have published a paper in the Journal of the American Medical Association looking at the impact of opioid prescribing in Florida after PDMP and pill mill reforms were put in place.  The results are "statistically significant." But statistical significance and public health impact are clearly two different things.

(You can read the abstract and purchase the study here.  You can read a synopsis here.)

The study compared opioid prescribing in Florida and Georgia, an attempt to measure one state's behavior vs. a "control" state that did not implement the reforms that Florida did (at least during the period of study from July 2010 to September 2012).  The results, in a nutshell:

• 1.4% decrease in opioid prescriptions
• 2.5% decrease in opioid volume
• 5.6% decrease in MED per transaction

While we should be celebrating any decrease in opioid use, these statistically significant reductions aren't altogether different than the data we're seeing from our industry's PBM drug trend reports measuring national changes in opioid use.  My reaction to both this study and the PBM drug trend reports is the same: We need to be doing much more to reduce medically unnecessary medications in the treatment of chronic pain.  

Leaving aside some of the shortcomings of this study (the data is from retail pharmacies only) and the frequent confusion among media and industry readers between correlation and causation (something the researchers address, but which is often ignored)... is this really the best we can do?  

It's possible the decreases will accelerate over time.  I'm hopeful that will be the case.  But the detailed results of the study show an interesting phenomena: the reduction in opioid prescriptions written by docs and the reduction in opioid use among patients is very much isolated to high prescribers (80th percentile and above) and high utilizers (80th percentile and above), respectively.  Docs and patients below the 80th percentile actually showed small increases in scripts and use.  

Maybe this shows we're striking the right balance.  Those with legitimate needs still have access while pill mills are being shut down?  Or maybe it shows we still have a lot of work to do... and that PDMPs and pill mill legislation, while absolutely necessary, will be nowhere near sufficient to fix the problem.  

Michael  

On Twitter @PRIUM1

It's Not About the Meds, It's About the Pain

We are a nation in pain.  

According to the National Health Interview Survey conducted by the Centers for Disease Control and Prevention here in Atlanta, more than 25 million of us experience pain on a daily basis for a minimum of 90 days. That's 11.2% of adults in this country.  And a full 126 million adults (that's nearly 56% of us) reported some type of pain in the 90 days leading up to the interview.  

We try to fix it with drugs.  

Once upon a time, acetaminophen was a wonder drug.  And then we realized it carries significant risk of liver damage at high doses and with long term use.  At one point we thought ibuprofen was the answer.  And then we learned that heart attack and stroke risk significantly increase with its use.  At one point (hard as it is to believe), we thought opioids were the long-sought-after solution to the problem of pain.  That's led to the largest man-made epidemic in history: thousands of overdose deaths per year, more Americans addicted to pain meds, entire generations disappearing from some towns, and a lot of other scary statistics and awful outcomes.

And when those don't work, we pin our hopes to potential future drugs.  

Researchers at Memorial Sloan Kettering Cancer Center are working on an investigational compound, IBNtxA.  It's an opioid derivative that appears to provide the analgesic effects of an opioid without the risk of respiratory suppression or the "high" that comes with typical opioid use.  While this is great news for cancer patients (where pain medication is not only useful, but critical to compassionate treatment... which is why Sloan Kettering is working on it), it begs the question: what side effects and unintended consequences will result from the long term use of IBNtxA?  And to what extent are the psychotropic effects of our current opioids the real drivers of use (vs. their perceived analgesic effect)?  We have no idea, but history tells us we should proceed cautiously.

So what do we do?  

We have to find ways to manage the vast majority of chronic pain without pharmacological assistance.  Should some people with chronic pain be allowed to benefit from sustained use of medication therapy?  Absolutely.  But too many millions of patients are relying on dangerous and ineffective medications to manage an underlying issue that is only partially explained by biological factors, completely ignoring the social and psychological barriers to recovery.

Our pain, collectively and individually, is here to stay until we start thinking less about the pain and more about the person.  

Michael
On Twitter @PRIUM1

 

Non-medical Use and Addiction: Distinctions in the Opioid Crisis

A new study coming out soon in the Annual Review of Public Health attempts to reframe our discussion regarding the opioid crisis.  Often, we focus attention on nonmedical use of opioids.  Those of us in the insurance world know that while nonmedical use is a serious societal issue, it's only one part of the opioid problem.

From the study (among the authors of which is Andrew Kolodny, one of the most well known and recognized voices of reason in the public dialogue around the opioid crisis):
"Policy makers and the media often characterize the opioid crisis as a problem of nonmedical opioid pain reliever abuse by adolescents and young adults.  However, several lines of evidence suggest that addiction occurring in both medical and nonmedical users, rather than abuse per se, is the key driver of opioid-related morbidity and mortality in medical and nonmedical opioid pain reliever users."  

This distinction is critical because it focuses our attention, our resources, and our solutions in a different direction (or, at least, in more directions) than if we were to simply assume that opioid overdose deaths are driven by diversion, misuse, and abuse among young people.

The reality is that there are likely as many as 5 million people in this country addicted to prescription opioids and as many as half of them are receiving legitimate prescriptions from legitimate doctors for legitimate pain.  Not all chronic pain patients on long term opioid therapy will exhibit drug seeking or otherwise aberrant behavior.

Another important insight from the paper is the analogy that Dr. Kolodny and his colleagues draw between the methods of combating other public health crises and the approach we should consider taking toward the opioid crisis:
"... our purposes is to demonstrate that prevention strategies employed in epidemiologic responses to communicable and noncommunicable disease epidemics apply equally well when the disease in question is opioid addiction.  Interventions should focus on preventing new cases of opioid addiction (primary prevention), identifying early cases of opioid addiction (secondary prevention), and ensuring access to effective addiction treatment (tertiary prevention)."  

We have a long way to go in all three categories, but papers like this push our collective thinking in the right direction.  Worth a read.

Michael
On Twitter @PRIUM1

Physicians and Painkillers: A Tale of Two Statistics

See if you can reconcile the following two sets of data points from a survey published by the Journal of the American Medical Association last week regarding physician perceptions of prescription drug abuse:

1) 90% of doctors report prescription drug abuse is a moderate to large problem in their communities and 85% think prescription drugs are overused in clinical practice.

2) 88% of those same doctors are confident in their skills related to prescribing painkillers and almost half of them are comfortable using the drugs for chronic, non-cancer pain.

And there's the rub.  Call this the old "there's a problem, but I'm not contributing to it" phenomenon.  Doctors who profess confidence and comfort prescribing prescription painkillers for chronic, non-cancer pain may be contributing the problem of misuse and abuse, albeit unwittingly.  The study doesn't offer any insights into dosage levels or medication classes or individual drugs, so one cannot draw conclusions.  And I'm certainly not suggesting that painkillers can't be used appropriately for time limited, function-focused management of chronic, non-cancer pain.  But the contrast between the data points struck me.  85% think the drugs are overused... 50% are confident using them with a group of patients for which there's little to no evidence of long term efficacy.  

And this is a commonly observed phenomenon.  Rewind the clock five, six, seven years and a material number of work comp payers (from carriers to TPAs to self-insured employers) were saying the same thing.  "There's a problem, but I'm not contributing to it." I personally heard it at least a dozen times in my first year here at PRIUM (which was five years ago... time flies).  I don't hear it much these days.  As an industry, we're beginning to make concerted, strategic effort to combat prescription drug misuse and abuse and we largely recognize that all payers have a role to play.  While there's still A LOT of work to be done, we've passed through the first step on the road to recovery: payers are not only admitting they have a problem, they're recognizing their past contributions to that problem.

The physician community appears to have the first half down - they're clear we have a problem.  I wonder if they recognize their past and current contributions to the problem.  I know many physicians do.  I hope more come to recognize the need to change patterns of practice in light of the largest man made epidemic in history.

Michael

On Twitter @PRIUM1