Showing posts with label research. Show all posts
Showing posts with label research. Show all posts

Monday, March 20, 2017

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


Tuesday, January 10, 2017

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


Monday, January 4, 2016

When Opioids Almost Kill You, Chances Are You'll Get More Opioids

I really wanted the first post of 2016 to be positive, uplifting, inspiring... but a study I read over the break was so unnerving, I had to go and ruin "return to work" day, already a day that lives in infamy, with even more depressing news.

Researchers at Boston Medical Center used a national database of prescription information to assess the likelihood of continued opioid prescriptions after a non-fatal overdose.  They looked at prescription information from 3,000 patients who experienced a non-fatal overdose between 2000 and 2012.  These patients were all prescribed opioids for chronic, non-cancer pain. 

Think about this: These 3,000 patients have already overdosed on prescription opioids. They are lucky to be alive. Surely, their healthcare providers will find another way, another mechanism, another approach to managing their pain. The risk here isn't illness or infection or a change in blood pressure... it's death.  

The bad news:
  • Over 90% of these patients continued to receive opioids after their non-fatal overdose event
  • 50% of these continued to receive the prescriptions from the same doctor
  • 7% of the original group experienced a second overdose
  • Two years after the first overdose, those with continuing opioid prescriptions were twice as likely to experience a second overdose event compared to those who were no longer receiving opioids. 
Why is this is happening?  

First, our fragmented healthcare system doesn't make it easy for prescribing physicians to discover the clinical events experienced by their patients outside of their immediate purview.  And patients may not want to disclose an overdose event for fear of having their medications discontinued.  I get that.  And it makes we wonder whether PDMPs should also include the ability for inpatient settings to report both fatal and non-fatal overdose events to the database so doctors can see this information whether its reported by the patient or not.  Linking electronic health records to PDMP systems would be a good start down this path.    

The second phenomenon driving these sorry statistics is that doctors are not comfortable weaning opioid (and other) medications.  No one, least of all me, would ever suggest immediate cessation of opioid therapy in light of a non-fatal overdose.  That's clinically irresponsible and potentially dangerous for the patient.  But the necessary steps forward are complicated: If the patient is on multiple medications that require weaning, which should we weaned first?  What titration steps should be used?  Is medication-assisted-therapy (MAT) an option?  Should I refer the patient or try to handle this myself?  These are hard questions and the primary care community, by far the most frequent prescribers of opioids, is currently ill-equipped to handle them.

Welcome to 2016.  Once more unto the breach, dear friends.  

Michael 
On Twitter @PRIUM1  





Monday, November 9, 2015

The Case for Physician Education in Light of Rising Death Rates

Two recent and related op-ed pieces in the NY Times lay out the logic I articulated in my last blog post on addiction and mental health.  The two pieces, taken together, offer a glimpse of the crushing reality of contemporary social and cultural circumstances for some population groups in this country as well as at least one clear imperative for how we might begin to fix it.  I don't have the bully pulpit of the Times editorial page (I wish), so I'm happy to defer to a Nobel prize winning economist and a professor from Cornell's medical school, respectively, to lay out this critical message to a much broader audience.

Paul Krugman (he's the Nobel prize winner) puts the recent research on rising death rates of white middle-aged Americans into political and economic context.  While he is a unapologetic liberal, his ultimate conclusion is that our politics didn't necessarily cause this despair, at least not in any direct sense.  Rather, the issues are more existential in nature.  One of the study's authors, Angus Deaton, offers a hypothesis: this group, he says, has "lost the narrative of their lives."  Krugman puts it in his own words this way: "we're looking at people who were raised to believe in the American Dream and are coping badly with its failure to come true."  And one of the most significant and negative coping mechanisms employed by this group?  Prescription painkillers.

Richard Friedman (he's the professor from Cornell medical school) builds a case for mandatory physician education for pain management and does so by building on the same Deaton-Case research from which Krugman's piece is derived.  He writes:
"All medical professional organizations should back mandated education about safe opioid treatment as a prerequisite for licensure and prescribing. At present, the American Academy of Family Physicians opposes such a measure because it could limit patient access to pain treatment with opioids, which I think is misguided. Don’t we want family doctors, who are significant prescribers of opioids, to learn about their limitations and dangers? 
It is physicians who, in large part, unleashed the current opioid epidemic with their promiscuous use of these drugs; we have a large responsibility to end it."
The more I read and write about chronic pain issues, the clearer it becomes to me that when we focus on root case issues, we increase the probability of making a dent in the problem.  This can be hard and depressing work, though.  Tracing chronic pain and drug abuse to root causes remains elusive - the answers are tied to social, cultural, economic, and historical forces we're just beginning to understand and unravel.

But one thing we must certainly do is ensure that the medical professionals charged with the health and well-being of their patients are, in fact, helping and not hurting our progress.

Michael
On Twitter @PRIUM1

Wednesday, November 4, 2015

Mental Health and Addiction: What if We Had What We Really Need?

Consider several seemingly unrelated articles that all ended up in my stack of "articles to read" just in the last three days:

First, a report from the Proceedings of the National Academy of Sciences that found that the death rate among white, middle-aged Americans has grown since the 1990s, while death rates among the same age cohort within other ethnicities and countries has continued to decline.  From the report: "Rising midlife mortality rates among non-Hispanics were paralleled by increases in midlife morbidity.  Self-reported declines in health, mental health, and ability to conduct activities of daily living, and increases in chronic pain and inability to work, as well as clinically measured deteriorations in liver function, all point to growing distress in this population."  The researchers speculated that relatively easy access to opioid pain killers may be linked to the rise in incidence of mental illness.  While I think they have the cause and effect backward, there's little doubt in my mind that the two are related.

Second, a report from WESH in Orlando on a US government study that estimates there are 4 million baby boomers struggling with addiction.  "Baby boomers," the group of Americans born within the 19 year period following WWII, are now in their 50s and 60s and they're suffering from drug and alcohol addiction at a rate that rehabilitation and recovery services cannot accommodate.  "It's hard to imagine grandma with a heroin problem," says Dr. Heather Luing, medical director at Recovery Village, "but that's the reality we sometimes see."

Third, there was a lot of international coverage of a controversial paper from the United Nations Office on Drugs and Crime (UNODC) that suggested UN-member countries should consider "decriminalizing drug possession for personal consumption."  The paper was retracted by UNODC leadership with an explanation that it was written by a mid-level policy person simply expressing a viewpoint and was never sanctioned or adopted as a formal UNODC position.  This public policy approach, however, has been tested, perhaps most notably in Portugal.  Despite warnings of potentially dire consequences, Portugal decriminalized the simple possession of all drugs back in 2001.  Since that time, Portugal has seen overall drug use fall, it has the second lowest overdose death rate in all of Europe, and HIV infections among drug users are dramatically lower,  The resources formerly focused on arresting and prosecuting simple drug possession were instead poured into mental and behavioral health, education, and job training/placement programs.  And if you think such a program wouldn't be possible in the US, check out what Worcester, MA is doing.  

What are the common themes here?

  1. People are dying.  That much is statistically evident.  
  2. These deaths appear to be correlated with chronic pain, drug use, mental illness, and addiction. 
  3. Efforts over the last three decades to deal with the issue from a criminal justice standpoint appear to be at least ineffective and at most counterproductive.  
  4. The current supply of mental and behavioral health resources in the US is nowhere near sufficient to meet demand.  

So if the demand is there, why don't we have the mental/behavioral health resources we need? Because we've never devoted the reimbursement dollars necessary, either public or private, to ensure such programs were economically viable.  But now, with the Affordable Care Act's parity provisions, we have legislatively mandated reimbursement policies around mental health coverage offered by private insurers.  The resources haven't yet caught up to the demand, but billions of dollars of private equity investment is being poured into the sector.  Hopefully, it's just a matter of time before the number of trained professionals and the facilities and technologies they need to practice are in place.

And that leads us to an interesting thought experiment: What if we did have the mental and behavioral health infrastructure we so desperately need? Could we fundamentally change how we approach drug abuse in our society?

Michael
On Twitter @PRIUM1
 

Tuesday, October 27, 2015

Low Back Pain: What's the Best Medication Approach?

Wouldn't it be great if there was a study that compared patient outcomes among several groups based on a single, common diagnosis but several potential medication regimens?  How might such a study be designed?

Perhaps you could identify 300 patients, all of whom presented in the emergency department of a hospital with acute low back pain.  We might assess their level of disability utilizing a widely used health status measure like, say, the Roland Morris Disability Questionnaire (RMDQ).  We might divide the patients into three groups based on their medication regimen:
1. Naproxen + placebo
2. Naproxen + cyclobenzaprine
3. Naproxen + oxycodone/acetaminophen

We'd make sure the initial RMDQ scores were roughly similar across all three groups.  We'd also make sure all three groups were similar demographically and that each patient received education on management of low back pain prior to discharge from the hospital.    Then we'd call the patients at the 1 week mark and the 3 month mark to re-assess their level of disability.  That would tell us which of the three various medication regimens provides for the best patient outcomes.

Such a study would be helpful, right?

Well, researchers at Montefiore Medical Center and Albert Einstein College of Medicine conducted just such a study and the results are compelling.


It appears that "take two Aleve and get some rest" may, in fact, be the best (and certainly the safest) course of action when it comes to preventing acute LBP from becoming chronic LBP.

Michael
On Twitter @PRIUM1

Tuesday, July 7, 2015

1 in 4 Opioid Scripts Ends Up "Long Term"

The Mayo Clinic wanted to assess the risk factors associated with opioid use.  They started by asking, "How many opioid prescriptions end up leading to long term use?"

Turns out, 1 in 4.  

Specifically, the researchers found that 21% of first-time prescriptions led to use for 3-4 months and 6% of first-time scripts led to use longer than 4 months.

Those time intervals are silly, aren't they?  From our perspective in work comp, we're seeing material numbers of injured workers progress (or, perhaps, regress) to 3-4 years of opioid use after the first script.  Personally, I'd like to see a study that tests use patterns over much longer duration intervals.  I also suspect that the work comp population exhibits a higher "long term use conversion rate" than a randomly selected patient population.  System design tends to reward certain stakeholders for disability duration.

The research is also intriguing because it examined the specific risk factors that lead to long term use. Nicotine use and prior substance abuse issues were the top risk factors.  While this isn't necessarily surprising, we see scant evidence that these risk factors are being taken into account at the time of the first opioid script.  The best predictive models in our industry are certainly telling us that these patients are at higher risk, but if the prescribing doctors aren't taking this information seriously and using it to inform an alternative, non-opioid treatment plan... what's the use?

Faster, more focused interventions with prescribers will be key to preventing long term opioid use.

Michael
On Twitter @PRIUM1

Thursday, June 25, 2015

What Primary Care Docs Don't Know Can Hurt You

Caleb Alexander is an associate professor at Johns Hopkins Bloomberg School of Public Health and the co-director of school's Center for Drug Safety and Effectiveness.  He and some of his colleagues decided to ask 1,000 primary care physicians about their beliefs and attitudes about opioids.  The results are both unsurprising and unsettling:

First, the good news:

  • More than half of doctors recognize prescription drug abuse as a "big problem" in their community; 
  • 90% strongly supported requiring patients to get opioids from a single doctor and single pharmacy; 
  • Two-thirds supported the concept of physician-patient "pain contracts"; 
  • More than half supported the use of urine drug monitoring for chronic opioid patients.  

However, the survey also uncovered significant gaps in knowledge among primary care docs:
  • About one-third said they thought most prescription drug abuse occurs by means other than swallowing the pills.  (In fact, crushing/snorting/injecting/etc. happens with far less frequency than simple ingestion.  Multiple studies suggest ingestion accounts for anywhere from 64% to 97% of prescription drug abuse.) 
  • Almost 50% believe that abuse-deterrent pills are less addictive than the standard formulation. (In fact, there's absolutely no difference.)  
This last data point is scary.  To me, it shows the success that pharmaceutical companies are having in creating a "halo" of safety around new abuse-deterrent formulations.  There is no "halo" and there's still a great deal of harm that can occur with the use of these medications.  

The primary issue isn't the kind of abuse against which abuse-deterrent formulations can protect patients.  The primary issue 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. 

Michael 
On Twitter @PRIUM1



Tuesday, April 21, 2015

The Worst Kind of "Whack-a-Mole"

I've heard the "whack-a-mole" analogy applied to nearly every facet of business.  Frankly, it's a tired and worn out analogy.  But it's also an image that paints a clear picture of a common issue and, thus, we can't seem to escape its constant use.  We're always solving one problem only to create a myriad of unanticipated and unintentional consequences that require ever greater effort to address.  Hit one "mole" on the head and another quickly pops up elsewhere to take its place.

Yesterday, the Journal of the American Medical Association released a study that highlights the worst kind of "whack-a-mole" imaginable.

The good news: After the introduction of an abuse deterrent formulation of Oxycontin and the discontinuation of propoxyphene in the latter half of 2010, overall opioid prescriptions appear to have declined 19% vs. where we would have expected them to be.  Mind you, that's not a 19% reduction in scripts; rather, it's a 19% reduction vs. a statistical forecast of a line that was trending up.

So where did the next mole pop its head up?

During the same period, there was a 23% increase in heroin overdose.  

We can add this to the list of reasons abuse deterrent opioids are not the answer.

The study does not establish a causal link between the reduction in opioid scripts and the increase in heroin overdoses, but this phenomenon has been a recurring theme in various reports and studies across the country for some time now.  When Massachusetts Governor Deval Patrick declared a public state of emergency in March of 2014, he cited both prescription opioid abuse and heroin overdoses as grounds for his decision.  Is it any wonder that just a week later, Blue Cross Blue Shield of Massachusetts released an 18 month "check up" on its first-in-the-country program requiring pre-authorization for prescription opioids?  In it, BCBS brags that, starting in July 2012, they decreased claims for short acting opioids by 20% and long acting opioids by 50%.  And yet, the Governor is declaring a state of emergency in early 2014?  Could that be due to at least some portion of BCBS members whose Oxycontin was cut off turning to cheap street drugs?  Perhaps because the insurer, in an effort to stem the tide of prescription drug spend (instead of prescription drug abuse) failed to address the underlying medical issues faced by its members?

PRIUM's own parent company, Ameritox, produced a very compelling piece of research based on our own data that shows:

  • 4 out of 5 heroin users abused prescription drugs first
  • 56% of the time, in heroin positive samples, the opioid prescribed to the patient was not found
  • 66% of heroin users abused both heroin and prescription painkillers in the last month
The most cynical among us in workers' compensation will think (though never say publicly), "Fine with me.  I'm not paying for heroin and I can either settle or cease benefits on this claim with relative ease."  

Those of you that care about injured workers will see this data for what it really is - a warning.  A warning that we must be careful and measured and caring in our approach to issues of prescription drug misuse and abuse in workers' compensation. 

We haven't really solved a problem until we've addressed the underlying issues of dependence and addiction.   

Michael
Follow us on Twitter @PRIUM1 

Monday, March 23, 2015

Data Suggests We Still Have a Long Way To Go

A quick scan of this morning's news shows we have a long way to go in the fight against prescription opioid misuse and abuse.

From a survey conducted by the National Safety Council we learned that:

  • Nine in 10 opioid painkiller users are not concerned about addiction as a side effect, though 60 percent of users have at least one addiction risk factor 
  • 69 percent of opioid painkiller users feel opioids are the most effective medications to treat pain, though research shows this is not true
  • Americans mistakenly believe gun violence, severe weather and commercial airline travel are more significant threats to their safety than opioid painkillers
  • Many Americans do not realize they have taken opioids


  • 42.9% of the 1,285 patients on long term opioid therapy had signed a treatment agreement
  • 62.8% of those patients had been subject to a urine drug test within the last year. 
  • The study's lead author, Laila Khalid, told workcompcentral, "It should be 100% adherence."  

So once more unto the breach, dear friends, once more.  Another week in the battle against prescription drug abuse.  Lots of work to do.  

Michael
Follow us on Twitter @PRIUM1  

Wednesday, February 25, 2015

The Research is Catching Up to our Experience

I see a theme among recent posts: pointing to new research that confirms things we already knew because we see them in claims every day.  This is good news.  The science is catching up to our practical experiences with opioids, addiction, and chronic pain.

The latest confirmation comes from the Cleveland Clinic.  In an article published in the Journal of Pain late last year, researchers assessed the likelihood of opioid abuse based on past history of non-opioid substance abuse.  For those of us close to complex chronic pain cases, we know that a history of, say, alcohol abuse, is correlated with opioid abuse.  But until now, we didn't have compelling data from peer reviewed literature to back our intuition.  Granted, cross-substance abuse is a well known research area... but this study focused specifically on opioids among patients with chronic, non-cancer pain.  

Among other important conclusions, here's what I thought was most important: In a pain rehab program, participants with a history of a nonopioid substance use disorder had 28 times the odds of having an addiction to prescribed medications.   

What does this mean for you?  
  1. Every injured worker, every claim, every doctor... must have an opioid risk assessment performed prior to any potentially addictive prescriptions are written.  
  2. Doctors must be educated on how to interpret the opioid risk assessment and use it to tailor treatment to the individual needs (and risks) of the injured worker.  

Failure to complete these two steps will invite tragedy.  

Michael
Follow us on Twitter @PRIUM1 

Thursday, February 19, 2015

The Right Target in Chronic Pain Cases: The Brain

Need convincing that the key to chronic pain management lies in behavioral health?  NPR has a great piece today on the human brain's ability to deal with pain signals and what this might mean for chronic pain management.

"The brain also determines the emotion we attach to each painful experience, Linden says. That's possible, he explains, because the brain uses two different systems to process pain information coming from our nerve endings.
One system determines the pain's location, intensity and characteristics: stabbing, aching, burning, etc.
"And then," Linden says, "there is a completely separate system for the emotional aspect of pain — the part that makes us go, 'Ow! This is terrible.' "
Linden says positive emotions — like feeling calm and safe and connected to others — can minimize pain. But negative emotions tend to have the opposite effect." 

The article also references a study published in 2011 that found 8 weeks of "mindfulness" practice appeared to enhance a subject's ability to manage pain.

These articles and studies add to a growing body of evidence that suggests that when workers' compensation payers ignore the link between behavioral health and chronic pain, they do so at their own peril.  We must begin to routinely incorporate these modalities into chronic pain care, at every stage of the claim.  We have to stop being scared of psych diagnoses and begin addressing the route causes of chronic pain.

If you're focused on relief of non-specific low back pain and ignoring what's going on in the injured worker's brain (including the injured worker's emotional state), you're shooting at the wrong target.

Michael
On Twitter @PRIUM1