tag:blogger.com,1999:blog-45700352851099251512024-03-13T01:17:04.022-04:00Evidence BasedMichael Gavin, President of PRIUM, focuses on healthcare issues facing risk managers in the workers' compensation space and beyond. He places particular emphasis on the over-utilization of prescription drugs in the treatment of injured workers.PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.comBlogger345125tag:blogger.com,1999:blog-4570035285109925151.post-25197477445330716982017-07-10T13:36:00.001-04:002017-07-10T13:36:23.212-04:00Which Arm of the Trial Would You Pick? For years, critics of opioid guidelines have argued that the absence of evidence on long term efficacy of opioids wasn't a sufficient reason to declare such long term use "medically unnecessary." Advocates of opioid therapy have been frustrated by the notion that because we didn't have a randomized clinical trial (RCT) showing the drugs to be helpful, we all assumed them to be harmful. While practical experience led to this totally plausible conclusion, detractors still saw hypocrisy in our dependence on documented medical evidence... that still didn't exist.<br />
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That RCT has finally arrived. <br />
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The study is to be published soon, but Dr. Erin Krebs recently presented her findings at the 2017 meeting of the Society for General Internal Medicine in Washington, DC. You can <a href="http://journals.lww.com/backletter/Fulltext/2017/07000/Landmark_Trial_Punctures_the_Myth_That_Opioids.1.aspx">read a synopsis and commentary</a> in one of my favorite monthly medical newsletters, The Back Letter (subscription required). Here's the key take-away:<br />
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<i>Opioids provided no advantage in terms of function at the 12-month follow-up mark, and patients in the opioid wing of the study actually reported marginally more pain at 12 months than those in the non-opioid group. </i></blockquote>
There are really two key points there: the first, that opioids don't appear to increase functionality, is obvious to most of us who have been living and breathing this issue for the last decade. The second, though, refutes the most fundamental argument of opioid advocates - that the drugs at least control pain. Turns out, they don't do a good job of that either. To sum up, the opioid creates the exact opposite of its intended effect: it fails to increase function and instead actually increases pain. <br />
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Perhaps the most interesting characteristic of the study was its design. It was <u>randomized</u> (patients are chosen by chance to participate in one or more clinical interventions - in this case, opioids for pain relief) and <u>controlled</u> (the clinical intervention was compared to a standard practice - sometimes placebo, sometimes not - as in this case - a non-opioid drug regimen).<br />
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<b>But it wasn't blinded. </b>A blind trial indicates that the participants don't know which arm of the study they've been assigned to. In this study, patients getting opioids knew they were getting opioids and patients not getting opioids knew they weren't getting opioids. To me, that makes the results even more compelling. Patients who <i>knew they were receiving opioids</i> to manage their pain still reported higher pain levels at the 12-month mark. And patients who <i>knew they were <u>not</u> getting opioids</i> still reported increased functionality vs. the opioid group.<br />
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Apparently, there was some ethical debate regarding this study before its launch. It was assumed by some that such a trial would be impossible because people in chronic pain would simply refuse to join the non-opioid arm of the trial if that's where they were randomly assigned. Further, some assumed it would be unethical to not provide opioids to people in chronic pain - that by instituting a non-opioid control group, patients would be deprived of necessary medical care. <br />
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As it turns out, the arm of the trial some ethicists assumed would be, in the first place, impossible to fill, and secondly, inhumane... well that's the arm of the trial you actually wanted to be in.<br />
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Michael<br />
On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a><br />
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<br />PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-53126949506330945822017-07-05T11:52:00.000-04:002017-07-05T12:01:12.751-04:00Detox and Marshmallows: Dealing with Addiction<div class="tr_bq">
On Monday, NPR's Morning Edition ran two pieces back-to-back that while ostensibly not intended to be related, nonetheless struck me as providing important insights into opioid misuse and abuse. </div>
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The first story (<a href="http://www.npr.org/sections/health-shots/2017/07/03/533793801/without-medical-support-diy-detox-often-fails">read and/or listen here</a>) was about the potential perils of Do-It-Yourself detoxification from drugs of addiction. While there's plenty in this story for the schadenfreude crowd ("he says his stomach cramps felt like 'having Freddy Krueger inside you trying to rip his way out.'"), I was struck by the comments of a doctor interviewed for the story:<br />
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<i>So can detoxing on your own be the solution? In most cases, the answer is no.</i> </blockquote>
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<i>In fact, a growing movement within the field of addiction medicine is challenging the entire notion of detox and the assumption that when people cleanse themselves of chemicals, they're on the road to recovery.</i> </blockquote>
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<i>"That's a really pernicious myth, and it has erroneous implications," says Dr. Frederic Baurer, president of the Pennsylvania Society of Addiction Medicine.</i></blockquote>
<b>"Detox" does <u>not</u> equal "treatment." Treatment may, of necessity, start with detox, but without counseling and the potential use of other medications, recovery is rare. In fact, the relapse rate from detox alone is upwards of 90%. We have to do more than just detox if we want long term results for injured workers suffering from addiction. </b><br />
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The second story (<a href="http://www.npr.org/sections/goatsandsoda/2017/07/03/534743719/want-to-teach-your-kids-self-control-ask-a-cameroonian-farmer">read and/or listen here</a>) was about marshmallows. More accurately, it was about a child psychology experiment involving marshmallows. In the the 1960s, a Stanford psychologist named Walter Mischel designed this experiment to study children's self-control. Kids ages 3 to 5 have a marshmallow placed before them. Then researchers give the child the following instructions: You can eat the marshmallow now, but if you can wait for me to return, you'll get two marshmallows.<br />
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More than half of kids dig in. And among those who don't gobble up the treat but instead exercise self-control, there appears to be a correlation to superior future academic performance and achievement. (The story is interesting because new research deploys the experiment outside of western culture for the first time and the results are interesting, if not concerning). <br />
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The objective of the experiment is to study a psychological phenomenon called "delayed gratification." Can one put off immediate gratification in return for greater, albeit delayed, reward? Even among 3 to 5 year olds, the delay creates physical and emotional distress. They whine, they squirm in their seats, their heart rates go up, they feel real stress. <br />
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Am I comparing a 4 year old who eats the first marshmallow to an opioid addict who can't go a day without a fix? Absolutely not. Addiction is a disease and it requires treatment. It's not a simple failure of willpower. <br />
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<b>Rather, I'm comparing the 4 year old who eats the first marshmallow to some insurers, employers, government regulators and politicians who want a simple, cheap, fast, pop-the-balloon solution for an injured worker who has been on opioids for 10 years. Relying on detox alone is like gobbling up that first treat. Instead, we need to squirm, face hard choices, make investments in sound treatment, and exercise patience. </b><br />
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We could use a little more delayed gratification in the fight against opioid misuse and abuse. <br />
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Michael<br />
On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a>PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-11625470326270902092017-06-21T14:10:00.000-04:002017-06-21T14:10:31.003-04:00Will Opioids Kill the AHCA?As a small group of Senators toil away in secrecy on an effort to recast a sixth of the American economy, one of the sticking points in the legislative negotiation is <a href="https://www.nytimes.com/2017/06/20/us/politics/health-care-medicaid-opioid.html?smid=tw-share">funding for the opioid crisis</a>. <br />
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While substantial cuts in Medicaid seem destined to make it into the bill in one form (a basic cut in funding) or another (a shift to state-level block grants), several Senators from both parties are lobbying to include $45 billion over 10 years for the fight against opioid misuse and abuse, primarily aimed at availability and access to addiction treatment. Moderate Republicans like Rob Portman of Ohio, Shelley Moore Capito of West Virginia, and Susan Collins of Maine have made this a central issue in work toward a Senate healthcare bill. A few of their Democratic colleagues, namely Joe Manchin of West Virginia and Bob Casey of Pennsylvania, are arguing for even more funding - the $45 billion over 10 years isn't nearly enough in their view. <br />
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Note those states: Ohio, West Virginia, Maine, Pennsylvania. These Senators are doing what Senators are supposed to do: represent their constituents. Portman has gone so far as to state publicly that he won't be able to vote for a bill that doesn't include this funding. Keep in mind that to pass the American Healthcare Act (AHCA), Republicans can only afford to lose two of their 52 votes. If they lose three, the bill won't pass. <br />
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The opioid crisis has created one of the precious few areas of bipartisanship I can recall over the last several election cycles. We might see legitimate arguments over appropriate funding levels, but the necessity of action is unquestioned and the focus on prevention and treatment is almost universally shared. (Notably, one person who doesn't appear to share the view that prevention and treatment are superior tactics to criminal justice solutions is former Senator and current Attorney General Jeff Sessions: <a href="https://www.theatlantic.com/politics/archive/2017/05/sessions-sentencing-memo/526029/">he'd rather return to a set of failed policies that have done nothing to stem drug-related crime in this country</a>). <br />
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Personally, I'm torn. I want to see substantial funding for prevention and treatment of addiction. At the same time, if the AHCA dies in the Senate over this issue, it will serve to shine a very bright light on opioid addiction and simultaneously prevent a very bad bill from becoming law. <br />
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Michael<br />
On Twitter @PRIUM1<br />
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PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-79645523628971315712017-06-12T14:20:00.000-04:002017-06-12T14:20:33.885-04:00Want to Decrease Disability by 53%?According to a recent issue of Health Affairs, all we have to do is completely eliminate five risk factors: <b>smoking, obesity, diabetes, high cholesterol, and hypertension. </b><br />
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Easy, right? <br />
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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 (<a href="http://content.healthaffairs.org/content/36/4/626.abstract">Preventing Disability: The Influence of Modifiable Risk Factors On State and National Disability Prevalence</a>) 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). <br />
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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. <br />
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But our starting point is grim. In the <b>18-54 age cohort, nearly 70% of US adults have more than one of the five risk factors</b>. In the 55-64 cohort, it's about 90%. And in the 65-79 category, about 95%.<br />
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This isn't just clinical, it's cultural. <br />
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Michael<br />
On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a><br />
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<br />PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-30363585205238281132017-04-11T09:41:00.000-04:002017-04-11T09:41:10.018-04:00Demanding Better PsychotherapyPsychotherapy is undergoing a veritable revolution. And if you're not paying attention, you could miss opportunities to change attitudes, spend less, and save lives. <br />
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For nearly a century, the field of psychotherapy (which includes cognitive behavioral therapy and other modalities common in the treatment of chronic pain) has been deemed a subjective and ethereal art based on human relationships, perception of progress, and patient self-reported outcomes. Therapists argued such things couldn't be measured, objectified, or codified. This feels intuitive to most of us - how can the assessment and treatment of behaviors, thoughts, emotions, and reactions be reduced to mere data points, bar graphs, or pie charts. Contemporary medical evidence appears to suggest these modalities are efficacious and that's sufficient for most of us to accept the status quo in the field.<br />
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The latest issue of The Atlantic Monthly contains an article by Tony Rousmaniere, <i><a href="https://www.theatlantic.com/magazine/archive/2017/04/what-your-therapist-doesnt-know/517797/">What Your Therapist Doesn't Know</a></i>. Recognize that last name? Only after reading the article and penning the first draft of this post did it occur to me to reach out to the estimable <a href="http://rousmaniere.com/">Peter Rousmaniere</a> to ask if Tony was any relation. In fact, Tony is Peter's oldest son. I should have guessed. <br />
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<b>In the article, we learn about feedback-informed treatment (or FIT)</b>. In a space where 25 percent of patients drop out of therapy (likely higher among chronic pain cases, but that's just a guess on my part) and 5 to 10 percent of patients actually get worse during the course of treatment, wouldn't it be nice to be able to quantify, and perhaps even predict, patient progress? Turns out, over 50 different (and, I suppose to some extent, competing) feedback systems have been developed over the past 20 years. Most involve detailed questionnaires administered to patients and designed not only to measure progress, but also to help therapists identify blind spots (like when a patient might be offering less than truthful feedback directly to the therapist... or about to drop out of treatment... or getting worse). <b>One such feedback system was able to predict - with 85% accuracy and after only three sessions of therapy - which patients would deteriorate. </b><br />
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New medical technologies, practice techniques, and methodologies can take a long time to be adopted into every day clinical application. Rousmaniere discusses the history of the thermometer - at one point, taking a patient's temperature and using that data as a tool in diagnosis was considered heretical and potentially dangerous to the practice of medicine (in that it might make doctors lazy and dull their skills as diagnosticians).<br />
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The time has clearly come for injecting data, metrics, and objective performance feedback into psychotherapy. And since payers are hearing the constant drum beat of "psychosocial... mental health... CBT...", the thought occurs to me that the <b>least we can do, if we're going to pay for this apparently efficacious intervention, is demand feedback-informed treatment for injured workers. </b> We would demand no less in virtually every other area of medicine. <br />
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Why settle here?<br />
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Michael<br />
On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a>PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com1tag:blogger.com,1999:blog-4570035285109925151.post-45507215430315068942017-03-28T13:57:00.000-04:002017-03-28T13:57:33.827-04:00US System Lags in Back Pain Treatment The US healthcare system is, in a word, dysfunctional. We know this. Many of us have experienced it first hand. We spend a lot and have relatively little show for it:<div>
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There are many reasons for this that will require a plethora of future blog posts (political reasons, economic reasons, cultural reasons, etc.) But today, we'll take a quick look at what happens in a country that adopts evidence-based guidelines in a rigorous, widespread, methodical way and tracks the results of those changes over time.</div>
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The Netherlands is a relatively small country northwest of Germany, making up the southern border of the North Sea. Known for the laissez-faire reputation of its largest city, Amsterdam, the country's healthcare system has a few notable features that are anything but: health insurance is mandatory, the country has a well-established and well-organized network of 160 primary care centers, and both insurers and hospitals are mostly for-profit and compete for business among consumers.</div>
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Back in 2011, <a href="https://www.ncbi.nlm.nih.gov/pubmed/21150697">the Netherlands decided to address the rising cost and complications associated with low back pain</a>. They did so by essentially mandating adherence to evidence-based guidelines (through highly differential reimbursement - pay for the things that work, pay little/nothing for things that don't) and simultaneously incentivizing return-to-work within the social security and disability programs available to citizens. Because of its relatively small size and well-organized primary care system, the country was able to gain real traction around evidence-based guidelines within the clinical community. They reduced spend by 20% over 5 years (this included both direct spend - like clinical services - and indirect spend - like social insurance and disability payments). </div>
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The closing paragraphs of a recent story addressing this study found in the pages of one of my favorite public health newsletters, <a href="http://journals.lww.com/backletter/pages/default.aspx">The Back Letter</a>, summarizes the potential obstacles and opportunities that the US healthcare system presents:</div>
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<i>When these reforms were enacted, some providers and patients worried that they would negatively impact outcomes—by limiting their treatment options. But there has been no evidence that these changes have had a negative impact on the health and well-being of the general public. </i></blockquote>
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<i>However, some of these policies might be difficult to enact in the US. <b>Any suggestion of limiting treatment options in the US sparks protests about “rationing” and “denial of care.” And wholesale limitations on ineffective treatments for back and neck would draw huge opposition from drug and device companies, healthcare systems that employ ineffective treatments profitably, and professional societies whose members routinely offer ineffective or unproven care. </b></i></blockquote>
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<i>How does one get a society with an entitlement mentality, with mistrust of any form of regulation, to accept evidence-based limitations on care? <b>Perhaps the recent saga with opioids provides some insights</b> – as the consumer tide has clearly turned against the excessive and deadly prescription of opioids for back and other chronic pain problems.<br />The key elements in bringing about this transformation in attitudes were vocal public advocates, compelling stories of bad outcomes, easily-understood information, and credible scientists taking strong public stands. These same elements might be brought to bear to reduce inappropriate levels of surgery, injections, pain interventions, and ineffective non-invasive treatments. </i></blockquote>
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<i>However, the opioid debacle is an extreme situation, given its heavy death toll and destructive impact in every US state. Will healthcare providers, patients, policy makers, and payers be willing to make similar cutbacks to all forms of excessive back care? There is certainly a growing consensus that spine care has to be a primary target in efforts to dramatically reduce spending. However, how that process will play out remains to be seen.</i></blockquote>
Who knew healthcare was this complicated?<br />
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Michael<br />
On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a></div>
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PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-79601622527453948812017-03-20T10:47:00.002-04:002017-03-20T10:47:39.387-04:00A 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 <a href="https://www.wsj.com/articles/scientists-target-new-painkillers-from-spider-venom-1429537621">spider venom</a> that may hold the key to a more effective non-opioid painkiller. There's the <a href="http://www.nature.com/articles/nature19112.epdf?referrer_access_token=axHoemXI0HfWC1VCGk2NBdRgN0jAjWel9jnR3ZoTv0MZKhp05sS-lLfXOsHBybMArt58G9V4djWs6lyrq4gzcISa98nJcMXu4us3SXSLQE05pK-XdZkDzrR_iyoJkUxZIe7VtvsliS1IW52Afuxjm5Rt8qivbGmOv6a-th0OoSwBMUiyOY7rOu-4OOjX1DM8r8Xd6NJBaKJKfOeiSGKN3qymkM90rtJEvXIfMNkY4wLIfWRgvVz3vDuQXDc-ZcwXcqf3e-4zMayNFg9qYK2ILVeQwkcLRB9yfn7yzCNYKQU%3D&tracking_referrer=www.cnbc.com">big-data, molecular-lottery</a> approach that promises to identify medications capable of delivering pain relief without opioid side effects. There's the on-going debate regarding <a href="https://www.theatlantic.com/health/archive/2016/11/a-new-test-of-pots-potential-to-replace-painkillers/507200/">medical marijuana's</a> 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.<br />
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<b>The theme that sticks out to me is the collective focus we seem to have on fixing a drug problem with more drugs. </b><br />
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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 <a href="https://addiction.surgeongeneral.gov/">his critical efforts to combat addiction</a> in all its forms. And I'm not even sure his plan isn't exactly what we need. <b>I was simply struck, again, by this theme of fixing a drug problem with more drugs.</b> It seems somehow counter-intuitive to me or, at least, not getting at root-cause issues.<br />
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So I was intrigued last week when I read about a <a href="http://online.liebertpub.com/doi/10.1089/ten.tea.2016.0441">study out of the University of Utah, Duke University, and Washington University in St. Louis</a>. <b>The collaborating bioengineers have figured out a way to potentially manipulate our genetic code to suppress chronic pain.</b> 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. <br />
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Three quick observations:<br />
1) This is at least 10 years away from human application.<br />
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?)<br />
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. <br />
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Michael<br />
On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a><br />
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<br />PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-1764214135267728762017-03-07T14:13:00.003-05:002017-03-07T14:13:58.509-05:00What's Past is Not Prologue: Formularies Differ by StateI've recently heard predictions regarding California's forthcoming formulary that are based on the experience of Texas over the last five years. Both are large states. Both have well recognized, embedded utilization review processes. And they have tertiary dispute resolution processes that, while not precise analogs, nonetheless look similar to one another (the Texas IRO process and the California IMR process). <br />
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So we might expect California, when it adopts it's drug formulary on or about July 1, to exhibit behaviors and results that are similar to the results Texas has achieved with its formulary (see my colleague <a href="https://www.linkedin.com/pulse/ca-formulary-update-mark-rxprofessor-pew">Mark Pew's recent blog posts for insight into the CA timeline</a>). In Texas, prescriptions for "N" drugs fell by 81% and the costs for those same drugs dropped by 80%. Total opioid scripts dropped by 8% and total drug costs in the state's work comp system fell by 15%. All of this occurred with no discernible increase in loss adjustment expense (primarily, utilization review). So we might expect the same from California, right? <br />
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I don't think so. I offer three key data points in defense of that view:<br />
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First, the formularies are not the same. Texas relies on Work Loss Data Institute's Official Disability Guidelines, Appendix A (which lists medications are either "N" or "Y" based on whether they are recommended for first-line therapy). California has used as its starting point Reed Group's MDGuidelines in order to incorporate a formulary into MTUS. The list of "non-preferred" drugs in these guidelines is a different, and frankly more restrictive, list than the ODG list of N drugs. For instance, ODG has some opioid analgesics in the "Y" category. The MDGuidelines categorized all opioid analgesics as "non-preferred." The two organizations take different approaches and I'm careful to avoid expressing preference for one or the other (PRIUM works closely with both sets of guidelines). The important take-away here is that the two states are relying on different formulary approaches. <br />
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Second, about 38% of CA's lost-time claims have attorney representation. That number for TX is 6%. There are lots of reasons for this (attorney fee schedules come immediately to mind) that have nothing to do with formularies. But adopting a formulary in a state with injured worker representation in the single digits is a fundamentally different proposition than adopting it in a state where 4 out of every 10 injured workers on indemnity have a lawyer. <br />
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Finally, loss adjustment expense in CA is already running at about 35% of total losses (which is 83% higher than the median in WCRI's latest study on LAE). When the TX formulary came into full effect in 2013, the number of IRO decisions from 2013-2015 ranged in the 1200-1400 range per year over that three year period post-formulary implementation. The number of IMR decisions in CA in 2016? 164,136. And this is before the adoption of a formulary. Long term, as the prescriber community adjusts to the formulary list and its associated rules, the number of medication-related IMRs may in fact moderate. But for the latter half of 2017, I wouldn't count on that happening.<br />
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Two different states, two different formularies, two different environments. Beware of drawing conclusions regarding one based on the other.<br />
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Michael<br />
On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a> PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-53542996924294985132017-02-27T10:15:00.000-05:002017-02-27T10:15:19.477-05:00What if We Hypothesized Instead of Diagnosed? The 19th century Romantic poet John Keats was also trained as a physician. And it's his definition of a "man of achievement" that gives Arabella Simpkin and Richard Schwartzstein their jumping off point in a fascinating essay in the New England Journal of Medicine. Wrote Keats regarding the necessary quality of such a person: "...when a man is capable of being in uncertainties, mysteries, doubts, without any irritable reaching after fact and reason." <br />
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How many physicians do you know who would agree with that sentiment? <br />
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Simpkin and Schwartzstein go on to make a <a href="http://www.nejm.org/doi/full/10.1056/NEJMp1606402#t=article">noble and necessary argument</a> for the place of uncertainty in modern medical practice. While the proposal is made for the entirety of the profession and the full span of specialties, I was struck by the applicability of the argument to chronic pain management, specifically.<br />
<blockquote class="tr_bq">
<i>Too often, we focus on transforming a patient’s gray-scale narrative into a black-and-white diagnosis that can be neatly categorized and labeled. The unintended consequence — an obsession with finding the right answer, at the risk of oversimplifying the richly iterative and evolutionary nature of clinical reasoning — is the very antithesis of humanistic, individualized patient-centered care.</i></blockquote>
This is how non-specific low back pain turns into a 15 year old work comp claim.<br />
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The authors make several recommendations, each of which targets the very heart of medical education and clinical practice culture. We need to cease viewing uncertainty as a threat, but rather embrace it as part of the iterative nature of care. We need to move away from multiple choice tests in medical education that require definitive answers and instead focus on evaluating medical students' tolerance for uncertainty and ability to posit based on incomplete information. <br />
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Perhaps the most daunting recommendation they make, though, is the idea of moving away from concept of <i>diagnosis</i> and instead focusing doctor-patient conversations on the concept of <i>hypothesis</i>.<br />
<blockquote class="tr_bq">
<i>We can speak about “hypotheses” rather than “diagnoses,” thereby changing the expectations of both patients and physicians and facilitating a shift in culture. This shift may entail discussing uncertainty directly with patients, intentionally reflecting on its origins — subjectivity in the illness narrative, diagnostic sensitivity and specificity, unpredictability of treatment outcomes, and our own hidden assumptions and unconscious biases, to name a few. We can then teach physicians specifically how to communicate scientific uncertainty, which is essential if patients are to truly share in decision making, and we can reduce everyone’s discomfort by reframing uncertainty as a surmountable challenge rather than as a threat.</i></blockquote>
This requires treating the whole patient. This requires recognizing the psychological and social contributors to pain perception and tolerance. This requires seeing through the psychotropic effects of opioids and other addictive medications to get to the root cause issues of chronic pain. This requires not just patient advocacy, but truly shared decision making. <br />
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Of course, this would also require us to move away from the dilapidated and counter-productive world of fee-for-service billing. This would also require payers and employers to pay for quality, a genuine willingness to pay more dollars for less <i>care</i> (in the traditional sense) and more <i>shared decision making</i> (which will inevitably lead to better outcomes). <br />
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So there's a little slice of utopia for you, this Monday morning... with a heaping side helping of reality.<br />
<br />
Michael<br />
On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a> <br />
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PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-79002031172509341302017-02-20T12:11:00.003-05:002017-02-20T12:11:44.485-05:00Narrative Does Matter: Self-Guided Opioid WeaningPerhaps 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. <br />
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"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. <br />
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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. <br />
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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. <br />
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I won't retell the story (<a href="http://content.healthaffairs.org/content/36/1/182.full.pdf+html">you really should read it for yourself</a>), 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. <br />
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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?<br />
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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. <br />
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Travis's story highlights the fact that the clean up may be harder than we imagine. <br />
<br />
Michael<br />
On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a><br />
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<br />PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-1764765615073263762017-02-13T10:53:00.001-05:002017-02-13T10:53:41.221-05:00We're Skipping the Simple Steps in Chronic Pain Management"Take deep breaths. Drink lots of water. Get some extra sleep." <br />
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This is the prescription I tend to apply, at least initially, to all complaints of illness emanating from my three children. I find it's effective approximately 90% of the time. For the 10% of the time it's not effective, we escalate to mom... and occasionally from there, we head to the doctor. Nothing special here, just basic triage for childhood illness. <br />
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The problem I see is that adults often skip a step or two (or three) in this process. And there's a lot of scientific data to support the reliance on these initial steps in the management of chronic pain.<br />
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<b>Take Deep Breaths</b><br />
There's ample evidence to suggest that relaxation techniques and mindfulness exercises can significantly influence chronic pain management. This study, among dozens of high quality studies available (and hundreds more of lower quality), showed a >50% decrease in Total Pain Rating Index for 50% of the patients involved in the study. Granted, small sample... but really compelling results. Why did I pick this study to highlight? It was published in April 1982. This isn't new, folks.<br />
<b><a href="http://www.ghpjournal.com/article/0163-8343(82)90026-3/abstract?cc=y=">An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: Theoretical considerations and preliminary results.</a></b><br />
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<b>Drink Lots of Water</b><br />
The link between dehydration and chronic pain is a little more recent, but still compelling. A recent study from the journal Psychophysiology linked hypohydration (not as severe as dehydration, but still not healthy... essentially, most of us are walking around hypohydrated) with lower pain sensitivity thresholds. We also know that the discs in the lower back require proper hydration for optimal functionality. Getting enough water also effects are immune system response. We've been told since we were kids to drink lots of water, it's just that none of us actually do that. <br />
<a href="http://onlinelibrary.wiley.com/doi/10.1111/psyp.12610/abstract"><b>A preliminary study on how hypohydration affects pain perception</b></a><br />
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<b>Get Some Sleep</b><br />
Sleep hygiene is among the most overlooked elements of chronic pain management. This topic is admittedly made complicated by the 'chicken and egg' nature of problem - to manage chronic pain, one needs to get more sleep, but sleep is often inhibited by chronic pain symptoms. This nasty cycle is often addressed by sleep aid medications which are not indicated for long term use (and, as we well know, that doesn't stop them from being used long term). One way off of this hamster wheel is ensuring that relaxation and hydration are incorporated into daily habits. Along with mindfulness techniques, one must also incorporate a simple set of sleep management tips that are hard for people to come to grips with: going to bed and waking up at the same time every day, no television or other electronic devices in the bedroom, no alcohol or caffeine assumption. How many Americans, in chronic pain or not, can pull of that bedtime routine?<br />
<a href="https://sleepfoundation.org/sleep-disorders-problems/pain-and-sleep"><b>Pain & Sleep: Information from the National Sleep Foundation</b></a><br />
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No, not all chronic pain can be managed by taking deep breaths, drinking lots of water, and getting plenty of sleep. Some chronic pain has to be escalated to the care of medical professionals and these patients deserve the best, evidence-based care available. But far too often, chronic pain is diagnosed and immediately treated with surgery and/or medications without an attempt at patient self-regulation based on simple principles of mindfulness, proper diet, and good sleep hygiene - all three of which, when missing, significantly contribute, even exacerbate, chronic pain. <br />
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Take deep breaths. Drinks lots of water. Get some sleep.<br />
<br />
Michael<br />
On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a>PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-45603606036935576912017-01-30T13:29:00.001-05:002017-01-30T13:29:12.687-05:00Chronic Pain: Do We Even Know What We Don't Know?My wife is currently training to become a yoga instructor. Our conversations have begun to revolve around concepts like "being present" and "finding my center." I'm a somewhat reluctant participant in such conversations and even though I understand all of the individual words being used, I admit the concepts are largely lost on me. One thing that has resonated with me, though, is the humility that one can derive by recognizing what one does not know. We can start to develop more rational and realistic responses to life's problems when we step back and question the basis of our views.<br />
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Two studies caught my attention recently and reminded me of this important principle. In the swirl of debate and conjecture surrounding contemporary approaches to pain management, I think it's critical for us to distinguish what we know and what we don't know. <br />
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First, from the joint efforts of radiology service provider Spreemo and the Hospital for Special Surgery (HSS), we learned that <a href="http://spreemo.com/new-study-hospital-special-surgery-reveals-diagnostic-error-rates-43/">objective diagnoses for low back pain aren't as straightforward as one might think</a>. A single patient was sent to 10 different centers to get an MRI of the lower back. Of the 49 distinct objective findings identified across the 10 centers, not a single finding was identified by all 10 centers. <b>The study points to a potential diagnostic error rate of up to 43%. </b><br />
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Next, from the Proceedings of the National Academy of Sciences, we learned that opioids might actually prolong neuropathic pain. The paper titled <a href="http://www.pnas.org/content/113/24/E3441.long">"Morphine paradoxically prolongs neuropathic pain in rats by amplifying spinal NLRP3 inflammasome activation"</a> is a technical piece, to say the least and I won't claim to have comprehended all of it. But here's a snippet from the conclusion of the paper that I did understand (mostly):<br />
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<blockquote class="tr_bq">
<i>In summary, the mechanisms underlying the transition from acute to chronic pain are poorly understood. We discovered that a short course of morphine administered upon expression of neuropathic pain remarkably doubled the duration of CCI-allodynia. This process was dependent upon dorsal spinal microglial reactivity and NLRP3 inflammasomes. These findings comport with prior demonstrations that repeated immune challenges induce a transition from acute to chronic pain, which may also underpin pain comorbidities. An evaluation of the long-term consequences of opioid treatment for chronic pain will identify whether this phenomenon manifests clinically.</i></blockquote>
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It's really astounding to think about how much we don't know when it comes to chronic pain. <b>For all the time we spend debating the use of opioids for the treatment of low back pain, it's both frightening and illuminating to realize we get the diagnosis wrong almost 50% of the time and the drugs we use to treat it might actually make it worse. </b><br />
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Long way to go...<br />
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Michael<br />
On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a>PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com1tag:blogger.com,1999:blog-4570035285109925151.post-41898064754911120042017-01-16T11:02:00.000-05:002017-01-16T11:02:54.365-05:00The Mistakes That States MakeAs 2017 gets rolling, state legislatures are convening all over the country. <b>Several of them are about to make mistakes in the area of medication management in workers' compensation. </b><br />
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My colleague, Mark Pew, and I have written and spoken extensively on the topic of drug formularies. And we're currently working, formally and informally, with regulators and other stakeholders in jurisdictions across the country on approaches that make sense for employers, doctors, pharmacists, and, most importantly, injured workers. While there's not a lot to be gained for any of us in calling out individual states, there's a great deal at stake for all of us in the successes and failures of drug formulary implementations. A failure (perceived or real) in one jurisdiction can lead another jurisdiction to delay its own attempt at a formulary - or to scrap it altogether. <br />
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So how can we tell if a law or rule set is headed in the right direction? Or, alternatively, if a state's efforts are more likely to lead to sub-optimal results? Here's a quick litmus test that you can apply to make your own determination:<br />
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<b>1) Will the formulary rely on independent, 3rd party medical treatment guidelines? </b><br />
There's a great deal of industry discussion surrounding this topic, mostly focused on the definition of 'evidence-based medicine.' While that conversation is interesting, it's not the critical factor in overall formulary success. The crucial questions are two-fold: <i>First, will there be room for political influence in the formation of the guidelines? Second, will the guidelines be updated with sufficient frequency? </i><br />
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<b>2) Does the formulary process build off of existing dispute resolution processes?</b><br />
States that have successfully implemented drug formularies thus far have done so by relying on existing rules regarding resolution of medical treatment disputes. States that try to simultaneously create a formulary and new dispute resolution processes to support it are, in reality, trying to do two things at once. <i>Not impossible, but certainly creates execution risk. </i><br />
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<b>3) Does the formulary allow for a remediation period for legacy claims? </b><br />
On the one hand, a single effective date creates chaos as employers and physicians try to figure out how to address legacy claims, which tend to be more complicated. On the other hand, only applying new rules to new injuries creates two standards of care within a workers’ compensation system, where an injured worker’s treatment plan is driven entirely by the date on which they were injured (which makes no clinical sense). <i>I look for regulatory language that takes a balanced approach – an initial implementation date for new injuries, followed by a remediation period for legacy claims, followed by a fully effective date for new rules and all claims. </i><br />
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<b>4) Is the formulary process scalable? </b><br />
I always look to see if the dispute resolution process can stand up to a significant volume of cases. While the goal of any formulary adoption should be to streamline access to medically necessary medications for injured workers, states should take a 'hope for the best, plan for the worst' approach. Dispute resolution processes that rely on one individual or one office for ultimate resolution may lead to bottlenecks and, in a worst case scenario, undue influence. <i>I always ask myself - what will this look like if there are more disputes than the state expects? </i><br />
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One bad apple can spoil the bunch. Let's get this right.<br />
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Michael<br />
On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a> PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-28183676119624810592017-01-10T10:43:00.001-05:002017-01-10T10:43:09.781-05:00Pain Acceptance: A Path Forward?The world apparently needs more opioids, so <a href="http://www.reuters.com/article/us-egalet-fda-idUSKBN14T209">the FDA approved another one yesterday</a>. 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. <br />
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In other pain management news, there's a really <a href="https://www.dovepress.com/pain-acceptance-potentially-mediates-the-relationship-between-pain-cat-peer-reviewed-fulltext-article-JPR">interesting study in this month's Journal of Pain Research</a> 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. <br />
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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. <b>If you're wondering why you're hearing so much these days about cognitive behavioral therapy, this is why. </b><br />
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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. <br />
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From another (highly clinical/technical) <a href="https://www.ncbi.nlm.nih.gov/pubmed/27812860">study that also crossed my desk last week from the Department of Palliative Care at Geisinger Medical Center</a>, I drew this important insight: <b>"Do not use pain intensity as the primary outcome in the management of chronic pain."</b> 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.<br />
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Michael<br />
On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a><br />
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<br />PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-89231947039375702542016-12-19T10:41:00.000-05:002016-12-19T10:41:32.983-05:00The Tobacco Playbook: Opioids Go GlobalRemember 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? <a href="http://www.businessinsider.com/how-big-tobacco-keeps-growing-2014-4">They went global</a>. 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. <br />
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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 <i>outside</i> the US. Would you have the moral courage to resist that investment temptation? <br />
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From the <a href="http://www.latimes.com/projects/la-me-oxycontin-part3/">great work of the LA Times, we know that's exactly the plan</a> 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. <br />
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Two key questions over the next decade:<br />
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?<br />
2) Will those developing countries listen? <br />
<br />
Michael<br />
On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a><br />
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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, <a href="http://schoolsofthought.blogs.cnn.com/2012/05/11/the-best-teacher-ive-ever-known/">Ross Friedman</a>. 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. <br />
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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. <br />
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Happy Holidays! And thanks for reading!PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-11639573090465270542016-12-12T10:52:00.001-05:002016-12-12T10:52:26.948-05:00Surveys Says? We Still Have a Long Way To Go On OpioidsLast week, I referred all of you to <a href="https://medium.com/@stmartin/neat-plausible-and-generally-wrong-a-response-to-the-cdc-recommendations-for-chronic-opioid-use-5c9d9d319f71#.aouw6v82a">a piece by Dr. Stephen Martin</a> 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."<br />
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Both those positions appear to be refuted by survey data collected by the <a href="https://www.washingtonpost.com/national/health-science/one-third-of-long-term-users-say-theyre-hooked-on-prescription-opioids/2016/12/09/e048d322-baed-11e6-91ee-1adddfe36cbe_story.html?utm_term=.927ae2985e2b">Washington Post and Kaiser Family Foundation and published in the Post on Friday</a>. <br />
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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. <br />
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We learn, among many other interesting things, that...<br />
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<ul>
<li>34% of long-term opioid users say they are/were addicted or dependent on opioids</li>
<li>54% of household members say the opioid user is/was addicted or dependent</li>
<li>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. </li>
<li>Just 3 percent said that they started as recreational users.</li>
</ul>
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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. </div>
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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. </div>
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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, <a href="http://nationalpainreport.com/the-numbers-game-ii-how-many-americans-have-chronic-pain-8825066.html">we have to start with the facts</a>. </div>
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Michael </div>
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On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a></div>
PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-54174553343504844342016-12-06T13:09:00.001-05:002016-12-06T14:53:25.577-05:00Confirmation Bias: A Critique of Opioid GuidelinesIf 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. <br />
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<b>I suggest we take a similar approach in the fight against prescription drug misuse and abuse. </b></div>
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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. </div>
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With this in mind, I recommend reading <a href="https://medium.com/@stmartin/neat-plausible-and-generally-wrong-a-response-to-the-cdc-recommendations-for-chronic-opioid-use-5c9d9d319f71#.lbxrq4upf">"Neat, Plausible, and Generally Wrong: A Response to the CDC Recommendations for Chronic Opioid Use"</a> 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. <br />
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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." <br />
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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.<br />
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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.<br />
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Michael<br />
On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a></div>
PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-37653264405318171372016-11-28T11:25:00.000-05:002016-11-28T11:25:39.708-05:00The Surgeon General Missed SomethingFirst and foremost, the Surgeon General's recently released report <a href="https://addiction.surgeongeneral.gov/">"Facing Addiction in America: The Surgeon General's Report on Alcohol, Drugs, and Health"</a> 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.<br />
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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. <br />
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I did, however, find one notable omission from the Surgeon General's report. <br />
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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 <u>legitimate prescription</u> that is <u>medically unnecessary</u> (and, in many cases, downright <u>harmful</u>). <br />
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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:<br />
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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.<br />
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Question 1: Would Bob categorize his use of oxycodone as "non-medical"? He would not. <br />
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. <br />
Question 3: Is this category of drug use ('medically unnecessary') an important component of the public health dialogue around misuse of drugs? Absolutely. <br />
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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?) <br />
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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. <br />
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Michael<br />
On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a>PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-68735362972171988892016-11-08T12:38:00.000-05:002016-11-08T12:38:20.427-05:00A New Regulatory Approach to OpioidsThe New York Workers' Compensation Board has announced a <a href="http://www.wcb.ny.gov/content/main/SubjectNos/sn046_892.jsp">new avenue for payers to challenge the appropriateness of long-term opioid use</a>. Published last week, the notice begins:<div>
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<i>Opioid addiction is a major public health crisis in the state that deeply affects many of New York’s injured workers. The New York Non-Acute Pain Medical Treatment Guidelines (<abbr style="border-bottom: 1px dotted; box-sizing: border-box; cursor: help;" title="Non-Acute Pain Medical Treatment Guidelines">NAP MTG</abbr>) adopted by the Chair in 2014 present a comprehensive approach to the management of chronic pain, and include best practice recommendations for the appropriate use of narcotics.</i> </blockquote>
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<i>As the NAP MTG makes clear, long-term opioid use is only recommended in limited circumstances, and must involve constant clinical monitoring and re-evaluation. The NAP MTG also includes best practices for safely weaning injured workers from opioids and other narcotics.</i></blockquote>
<blockquote class="tr_bq" style="box-sizing: border-box; font-family: Arial, Helvetica, sans-serif;">
<i><b>A workers’ compensation hearing can now be scheduled to determine whether continuing opioid usage is necessary or whether weaning from opioids is recommended.</b></i></blockquote>
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<span style="font-family: "Times New Roman";">This is an important development, but it's not a panacea. This new type of hearing is specifically designed to "consider opioid weaning." If opioid weaning is to be considered, then the payer would be well served to have a suggested weaning plan documented. While the actual implementation of a tapering schedule may differ from the suggested plan, the prescribing physician should at least be aware of the guidelines associated with the drugs requiring weaning. As always, the turning of the tide against opioid misuse and abuse requires preparation. </span></div>
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<span style="font-family: "Times New Roman";">The potential outcomes are fairly concrete. According to the Board: </span></div>
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<span style="font-size: 16px;"><i>When the WCLJ rules that the claimant must be weaned from the opioid medication, the insurer will be required to cover the cost of the claimant’s addiction treatment program or weaning protocol, as directed. If the claimant is to be weaned without addiction services, the insurer will remain liable for the claimant’s medications for the duration of the weaning process. If an addiction treatment program has been directed, then after 30 days, the insurer will only be liable for payment of narcotic prescriptions written by an addiction treatment program physician.</i></span></blockquote>
We'll be watching closely.<br />
<br />
Michael<br />
On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a> </div>
PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-85077594560441975822016-11-01T13:20:00.001-04:002016-11-01T14:23:02.389-04:00Does Restricting Opioids Lead to More Heroin Overdose Deaths? Turns out Neonatal Abstinence Syndrome (NAS), a condition suffered by newborn babies of opioid-addicted mothers, isn't the only risk to children in the fight against opioid misuse and abuse. A <a href="http://jamanetwork.com/journals/jamapediatrics/fullarticle/2571466">JAMA Pediatrics article</a> published yesterday showed a more than 2-fold increase in hospitalizations among children due to opioid poisonings. While the bulk of these hospitalizations were predictably among older adolescents, the <i>fastest growing</i> cohort of hospitalizations occurred among the youngest children (toddlers and pre-schoolers) who can't tell the difference between candy and OxyContin. A <a href="https://www.washingtonpost.com/news/to-your-health/wp/2016/10/31/opioid-pills-like-guns-more-than-13000-children-were-poisoned-during-six-year-period/">follow-on piece in the Washington Post</a> fairly equates this public health risk to the gun control debate. <b>Lock up the guns, lock up the drugs - our kids are paying too high a price. </b><br />
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In other news, this month's Health Affairs contains a really interesting article on the relationship between state laws and opioid / heroin overdose deaths (<a href="http://content.healthaffairs.org/content/35/10/1876.abstract?sid=00c96fc9-dce1-48ba-92db-9f880ac91054">Health Affairs 35, No. 10 (2016); 1876-1883</a>). Here are the high level conclusions:<br />
<br />
<ul>
<li>States that pass laws pertaining to mandatory physician review of PDMP data and the strict licensing of pain clinics reduced opioid amounts prescribed by 8% and opioid overdose death rates by 12%. </li>
<li>The study also observed a large (though statistically insignificant) reduction in heroin overdose death rates. This might be counter-intuitive to you because some believe cutting off the supply of opioids in a community creates risk of increased heroin use. </li>
</ul>
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The public policy conclusions here are important. First, if passing these common-sense laws really does lead to decreases in opioid supply and overdose deaths, there isn't any good reason not to implement mandatory PDMP checks and strict pain clinic laws (<a href="http://prium-evidencebased.blogspot.com/2014/07/pdmps-at-least-someone-in-missouri-is.html">unless you live in Missouri</a>... in which case irrational concerns over privacy consistently inhibit adoption of sound public health policy). </div>
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Second, the study found "no evidence to support the assertion that policies to curb opioid prescribing are leading to heroin overdoses." This doesn't mean that heroin overdoses haven't been on the rise; in fact, they've been increasing in virtually every state in the country. <b>What the study authors are saying is that new opioid restrictions do not appear to be accelerating the rise in heroin overdose deaths. </b></div>
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Opioid and heroin abuse is clearly a complicated public health problem. But this data suggests we should avoid the policy trap of using the one (potential heroin overdose deaths) as an excuse to not do the other (restrict the opioid supply through mandatory PDMP checks and strict pain clinic licensing). If there is data out there to the contrary, I'd honestly love to see it. I think it's important to litigate these studies to ensure we're moving in the right direction. <br />
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As the devil can cite scripture for his purpose, we all seem able to find anecdotes to support our policy views. Stories can be powerful illustrators of truth, but let's make sure we use <i>data</i> to guide our public policy discussions. </div>
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Michael </div>
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On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a></div>
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PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-68529372778581177502016-10-24T13:13:00.001-04:002016-10-24T13:13:44.265-04:00Keep an Eye on the Tramadol: A Global PerspectiveFirst and foremost, John Oliver covered the opioid crisis on his HBO show Last Week Tonight and it's must-watch for anyone who deals with this issue on a daily basis:<br />
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<a href="https://www.statnews.com/2016/10/24/john-oliver-opioid-epidemic/">https://www.statnews.com/2016/10/24/john-oliver-opioid-epidemic/</a><o:p></o:p></div>
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But John Oliver, perhaps the only guy who can make opioids funny (satire really is the very soul of wit), only covered the issue from a US perspective. The Wall Street Journal <a href="http://www.wsj.com/articles/tramadol-the-opioid-crisis-for-the-rest-of-the-world-1476887401">published an article last week</a> about the global rise of tramadol abuse. I follow the opioid epidemic pretty closely, both in the US and abroad, but this phenomenon caught me off guard. Here are a few facts that pertain to our view of tramadol here in the US:</div>
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<li>Tramadol wasn't scheduled by the DEA until 2013. It's now a Schedule IV drug. </li>
<li>There is a debate about whether or not it's addictive. The original German manufacturer, Grunenthal, maintains that the abuse potential is low. This clearly isn't the case (see below), but it's important to acknowledge the fact that many clinicians believe this is true.</li>
<li>The debate can be traced back to early studies of tramadol. Like many new drugs, tramadol was originally tested on patients in injection form. <i>Unlike</i> most drugs, it turns out that the <i>oral form</i> of tramadol is more likely to lead to addiction than the injectable form. Thus, early studies indicate low abuse potential while today's practical experience indicates the opposite. </li>
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This drug is tearing communities apart in West Africa, the Middle East, and parts of Eastern Europe in much the same way that opioids and heroin have torn apart communities here in the US. The drug isn't tightly regulated by the UN or WHO (largely due to the lack of hard data on abuse and the conflicting science outlined above). India, the world's leading manufacturer of generic drugs, is cranking this stuff out and shipping into countries by the boatload, fueling a epidemic of addiction that has outstripped the ability of medical personnel and the law enforcement to combat it. </div>
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Even now, in the US, I've been in conversations with clinicians and claims professionals about whether or not tramadol is even an opioid. It's a synthetic drug, entirely man-made. And the symptoms of tramadol overdose do differ from a traditional opioids - rather than respiratory depression, tramadol overdose tends to lead to seizures and sudden collapse. So are there differences between tramadol and other opioids? Yes. </div>
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<b>But let's straighten this out once and for all:</b></div>
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<ul>
<li><b>Tramadol is an opioid painkiller</b></li>
<li><b>Tramadol is addictive</b></li>
<li><b>Tramadol overdose can lead to death</b></li>
</ul>
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Keep an eye on the tramadol and don't fall for the <i>"it's not as bad as the opioid"</i> line. </div>
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Michael</div>
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On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a></div>
PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-70329830955174707582016-10-14T09:39:00.002-04:002016-10-14T10:31:22.731-04:00The Broken Disability Safety NetMuch has been said and written on the topic of the recent report from the US Department of Labor regarding the supposed inadequacy of the workers' compensation system. Critics rightly point out that the report appears to reduce its own credibility by failing to exhibit a sufficient understanding of the system, by assuming that all people claiming to be disabled are actually disabled, and by frightening those who believe that the federal government's involvement in any endeavor dooms all of planet Earth to utter destruction. <br />
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To paraphrase Twain, though, reports of the death of the state-based work comp system have been greatly exaggerated. <br />
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Nevertheless, those who dismiss this report based solely on its well-deserved criticism are clearly missing the broader picture. <b>There is a fundamental problem in this country with disability management and the public safety net that supports it. </b> And when the public safety net is perceived as inadequate, the most politically expedient solutions are to neither generate revenue (i.e., raise taxes) nor to reduce expenses (i.e., cut benefits); rather, the first solution is to look for an exogenous entity to blame and from which, if luck prevails, to extract rent. In this case, the federal government has found at least one scapegoat: workers' compensation.<br />
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And not without cause, mind you. The relationship between work comp and Social Security Disability Insurance (SSDI) is ill-defined, but we know from an analysis of past and present "off-set payments" (wherein an individual receives payment from both work comp and SSDI) that of those currently receiving SSDI, a little over 12% of them have also received work comp payments. While those payments are material (on the order of perhaps $10 billion of the total SSDI spend of $145 billion), this analysis fails to address the larger issue: how many SSDI recipients could have filed a work comp claim, but never did? That's a much bigger number.<br />
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One alarming, but nonetheless informative, statistic regarding the SSDI population showed up in the <a href="http://content.healthaffairs.org/content/35/5/824.full">May 2016 edition of Health Affairs</a>. If you've heard me speak on a blogger panel this summer or fall, you've heard me talk about this. The graph below shows spending on opioids by the Medicare and Medicaid programs between 1999 and 2012. The purple line should jump out at you... it represents opioid spending for the Medicare population that is <u>under</u> 65 years of age. <br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjU3f9mI8ifpYP_swZx-M05BiofCGmUFwGHwV2QE8s-CF8WgsAPnpcPwvuDzUvPVVl-GF47NhnepJc0NLvapUEmvPP04ANzI3tEt4eL2LM-XE_1ecaK6pevaOHF4hiGcR9ZK-lzpB91OLI/s1600/Health+Aff+2016+May+35%25285%2529+824-31+Exhibit+2.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="480" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjU3f9mI8ifpYP_swZx-M05BiofCGmUFwGHwV2QE8s-CF8WgsAPnpcPwvuDzUvPVVl-GF47NhnepJc0NLvapUEmvPP04ANzI3tEt4eL2LM-XE_1ecaK6pevaOHF4hiGcR9ZK-lzpB91OLI/s640/Health+Aff+2016+May+35%25285%2529+824-31+Exhibit+2.jpg" width="640" /></a></div>
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This is effectively the SSDI population (disabled people <u>under</u> 65 receive indemnity payments from SSDI and healthcare coverage from Medicare) and we're spending more than $1 billion of tax dollars per year on their opioids. This group is about one-fifth the size of the <u>over</u> 65 cohort, yet we're spending more on opioids for them. On a per person basis, opioid spend for those <u>over</u> 65 is $192 per year. For the 45-65 cohort covered by Medicare (an approximation for SSDI), it's $683 per year... or nearly 4X more. Interestingly, the opioid spend covered by private insurers for those aged 45-64 is $274/year and for Medicaid it's $251/year. </div>
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So what the heck is wrong with the Medicare group aged 45-64? They're disabled, that's what's wrong. And there's the rub. If you think it's difficult to track, measure, manage, and mitigate opioid use in work comp, it's comparably impossible today within the SSDI population.</div>
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A broken disability safety net is a dangerous political phenomenon - one we should take seriously and treat with the respect it deserves. </div>
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Michael </div>
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On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a></div>
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PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-86143731632771933922016-10-03T09:42:00.000-04:002016-10-03T10:11:45.555-04:00The Guts to Buck the LobbyistsOhio has proposed something novel: Let's not pay for expensive naloxone prescriptions and instead invest resources in ensuring the delivery of appropriate medical care and provide help for those struggling with dependence and addiction. <br />
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The <a href="https://www.workcompcentral.com/news/story/id/75ed08cecff7d1b485ec0fd7d3453b86ac0123c2">Ohio BWC's Pharmacy and Therapeutics Committee recently recommended</a> that BWC stop paying for auto-injector pens of naloxone. While BWC would still cover the less expensive nasal inhalation form of the opioid overdose antidote, the auto-injector pens have become prohibitively expensive (apparently, BWC recently rejected a bill from a single Florida pharmacy for $824,000 worth of naloxone auto-injector pens supplied to 208 injured workers - that's an average of nearly $4,000 per injured worker). <br />
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Instead, BWC has put controls in place to ensure that reimbursement for opioid medications is limited to instances in which best practices are being followed. And they're willing to pay for treatment for opioid dependence for up to 18 months, including two failed attempts at recovery. <br />
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<b>So here we have a state significantly curtailing opioid use, providing a cost-effective version of an overdose antidote, and paying for opioid dependence treatment where necessary. </b><br />
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Before you dismiss Ohio's efforts as impractical in a non-monopolistic state, take a step back and ask yourself whether this isn't a rational, measured, clinically responsible series of measures that will actually promote injured worker health, wellness, and recovery? If it is, then why isn't it practical in your state? <br />
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I think Johnnie Hanna, pharmacy program director at BWC, summed it up: "If they've got the guts to buck the lobbyists... they can get these things done." <br />
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It is said that discretion is the better part of valor. Except, I would suggest, when it's not. Why aren't you doing these things in your state? <br />
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Do you have the guts?<br />
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Michael<br />
On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a>PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0tag:blogger.com,1999:blog-4570035285109925151.post-78777018845224850042016-09-26T11:39:00.001-04:002016-09-26T11:39:03.516-04:00The Solution to Every Healthcare Debate: Access vs. CostTwo things you need to know about Suboxone (or buprenorphine) this morning highlight the essential elements of all past, present, and future healthcare debates. <br />
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First, the <a href="https://www.workcompcentral.com/news/story/id/de606c125f202a8447d320f3081e21368a5d1485">manufacturer is being sued</a> by the Attorney General of Illinois (and 35 other AGs) for violation of antitrust statutes. The states allege that Reckitt Benckiser Pharmaceuticals (now known as Indivior, because someone clearly new to marketing thought that would actually be easier to say) has effectively blocked generic competition for Suboxone by scheming to devise a new formulation (the film, an upgrade from the pill) in order to extend the patent protection of its franchise. Believing, of course, that they are more sinned against than sinning, Indivior took to their <a href="http://www.indivior.com/investor-news/indivior-notified-civil-complaint-filed-state-attorney-generals/">web site to issue a statement</a> that they will vigorously defend themselves against the charges. I'm not sufficiently informed to weigh in on the merits of the suit. I'll just point out that the company's actions are fairly typical of pharmaceutical companies and that were this a cholesterol medication instead of a potential addiction mitigation drug, I'm not sure we'd see this much attention paid to it by 36 state attorneys general. <br />
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Second, current physician capacity for treating opioid use disorder with Suboxone isn't being utilized. A <a href="http://jama.jamanetwork.com/article.aspx?articleid=2553439">research letter published last week in the Journal of the American Medical Association</a> shows that despite initial limits on the number of patients a certified physician may treat at any one time of 30 and subsequent limits (after 1 year of prescribing) of 100 patients, these doctors are treating numbers of patients far below those thresholds. In the 7 states with the highest number of certified physicians, the monthly median patient census per doctor was found to me as follows:<br />
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<ul>
<li>California: 7</li>
<li>Florida: 11</li>
<li>Massachusetts: 22</li>
<li>Michigan: 7</li>
<li>New York: 11</li>
<li>Pennsylvania: 18</li>
<li>Texas: 10</li>
</ul>
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Increasing the number of certified prescribers and the number of patients they may treat at any one time is a linchpin of the federal government's response to the prescription opioid epidemic. So it's somewhat concerning that we're so focused on increasing capacity when we're clearly not even close to utilizing the capacity we have. </div>
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Why is this? Why the law suit? Why the lack of utilization of existing capacity? </div>
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<b>Like every other debate in healthcare, when you peel back the onion far enough, you find two competing philosophical concepts that dictate nearly every public policy decision that confronts us: COST and ACCESS. </b> </div>
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The law suit is primarily about COST and secondarily about ACCESS (presumably, if a more affordable - read 'lower COST' - generic were to become available, more patients could potentially ACCESS therapy). </div>
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The JAMA study is about ACCESS and it shows that despite our investment in capacity (which COSTS money), we're still not very good at ACCESS itself. </div>
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Follow the money. Follow the patients. The solutions to all healthcare issues rest somewhere in the incentives, structure, and balance of the two. </div>
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Michael </div>
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On Twitter <a href="https://twitter.com/PRIUM1">@PRIUM1</a></div>
PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com1tag:blogger.com,1999:blog-4570035285109925151.post-18214571279731316642016-09-19T14:53:00.000-04:002016-09-19T14:53:15.491-04:00Bad Pharma: This is What We're Up AgainstWe all know that lobbyists exist. We all know the role they play in American politics, however frustrating that fact might be to us. We all know that pharmaceutical companies have plenty of them and they appear to be pretty good at their jobs. <br />
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But thanks to some great work by the Associated Press, we now have a better sense for the magnitude of malfeasance that has occurred over the last 10 years in the halls of state capitol buildings, the US Congress, the White House, and our federal regulatory agencies. <br />
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The articles are <a href="http://bigstory.ap.org/4d69f4b41cbc475ca42f424524003d21">here</a> and <a href="http://bigstory.ap.org/3d257452c24a410f98e8e5a4d9d448a7">here</a> and I recommend reading both in full. For those crunched for time, some highlights I found particularly disturbing (in form of "what we've known" and "what's new"):<br />
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<b>We've known</b> for quite some time that there are a lot of dollars and a lot of brains devoted to maintaining the top line revenue of pharma companies operating in the pain space. <b>We now know:</b><br />
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<li>They spent $880 million over a 10 year period from 2006-20015</li>
<li>This amount is 8 times the amount the gun lobby spent in the same period (read that again... just for emphasis)</li>
<li>$140 million of this went directly to political campaign contributions, $75 million of which went to candidates for federal office</li>
<li>Various advocacy groups employed an average of 1,350 lobbyists per year in state capitols across the country</li>
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<b>We've known</b> for a while that there were hidden forces behind the scenes attempting to squash public policy initiatives intended to stem the tide of prescription drug misuse and abuse. <b>We now know:</b></div>
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<li>Back in 2012, when New Mexico came close to becoming the first state to limit initial opioid scripts to seven days, lobbyists got in the way. "The lobbyists behind the scenes were killing it," said Bernadette Sanchez, a Democratic state senator who sponsored the measure. We celebrate what New York and Massachusetts have done just this year, but forget that New Mexico tried it four years ago. In the interim, we continued down the primrose path of opioid over-prescribing. How many preventable deaths occurred between then and now? </li>
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<b>We've seen</b> influence exercised among federal regulatory agencies, particularly at FDA. Former FDA Commissioner Margaret Hamburg consistently spoke about the need to balance access to pain medication for those in need with the public health crisis that is the prescription drug epidemic. In so doing, she often referenced the 2014 NIH report that suggested 100 million Americans suffered from chronic pain. <b>We now know:</b></div>
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<li>The Pain Care Forum (aka, the lobbying group backed by pharma) spent nearly $19 million on lobbying efforts that led to the legislation requiring the creation of this NIH report</li>
<li>Almost half of the report authors had served as leaders of groups affiliated with the Pain Care Forum - all of which were supported by pharma dollars. </li>
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<b>We all witnessed</b> the controversy regarding the CDC guidelines earlier this year. While the federal government's public health agency worked to develop guidelines for opioid prescribing among primary care physicians, other groups within the federal government were not only questioning the CDC's process and conclusions, but also going so far as to call the draft version of the guidelines "horrible" and "shocking." Who were these critics? <b>We now know:</b></div>
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<li>Dr. Richard Payne, who voiced concerned about conflicts of interest within the CDC advisory group, was himself paid over $16,000 by Purdue Pharma (makers of Oxycontin) for meals, travel, and speakers fees</li>
<li>Myra Christopher, another vocal critic of the CDC who openly stated that her NIH committee could not support the CDC guidelines, is a long time participant in the Pain Care Forum and holds a chair at the Center for Practical Bioethics - a chair endowed via a $1.5 million gift from Purdue Pharma. </li>
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The most effective lobbying efforts come not as obvious broadsides with clear agendas and transparent motives. Rather, the most effective efforts come with the trappings of genuine concern and the suits of science. And that's what makes them scary.</div>
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Michael</div>
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On Twitter @PRIUM1</div>
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<br />PRIUMhttp://www.blogger.com/profile/08312762637862278622noreply@blogger.com0