What’s Causing the Opioid Epidemic: How Irrational Decision-Making Has Created the Epidemics of Chronic Pain and Opioid Overdose

The bad decision to direct the Titanic into frozen waters killed 1,500.[1] The bad decision to allow the Trojan Horse into the City of Troy possibly killed 10,000.[2] The bad decision of Napoleon to invade Russia killed 52,000 at Waterloo.[3] The bad decision to escalate the Vietnam War killed over 58,000 Americans.[4] But numerically, based on death toll, worse than all of these historically awful decisions, is the irrational decision-making behind the opioid abuse epidemic which has killed over 64,000 Americans in 2016 alone.[5]

Irrational decision-making has consequences.

Just in the last week alone, we continue to read stories that opioid overdose-related emergency room visits have increased 35% in just the last year alone. According to continued reports by the CDC, everything that the government is doing to address the opioid epidemic is making things worse. This epidemic is going to become a pandemic as the same approaches that led to the epidemic in the United States are being spread across the globe.

Until we address the root causes of these problems, the problems will just worsen. Over the past several years, I’ve been working on the front lines of actually solving this epidemic and I’d like to share some insights to clarify the underlying problem, as well as summarize what needs to be done to save lives and end this insanity.

Societal “Stasis” Sets the Stage

Since the year 2000 when computers were supposedly going to experience the Y2K problem of just recognizing two digits, it seems our popular culture has been awash with new reasons to experience stress. Terrorism and the 9/11 attacks have made traveling by plane a more stressful experience. Wars in the Middle East seem perpetual and many heroes return home with physical and emotional wounds that never go away. The recessions of 2001 and 2008–9 have made economic circumstances for most Americans worse — especially in areas where manufacturing used to be the primary source of economic growth as those factories have moved overseas leaving cities and their resident families behind. Twenty-four by seven news cycles bring us alarming images of tsunamis, floods, earthquakes, and other natural disasters across the globe. With the advent of “reality television”, entertainment is consumed with content designed to make conflict and controversy pleasurable to watch. This “reality tv” culture has even driven what used to be credible news organizations to engage in “fake news” based on false allegations to compete for ratings. And all during this period of time involving heightened stress and conflict, our population is aging rapidly as the “baby boomer” generation enters retirement with its accompanying pain as joints and other body parts get older.[6] Baby boomers are leaving the workforce in record numbers, joining the ranks of those receiving federal entitlements of healthcare, retirement, and physical disability claims.

While baby boomers are aging, the younger generations are working more and more hours, some working multiple jobs. This added stress is also placing stress on workers’ bodies. Musculoskeletal disease is now the leading cause of physical disability in America,[7] and many Americans are living the science fiction dream of the 1970’s with bionic hips, shoulders, and knees with titanium joints replacing their natural bones. As the healthcare system tries to rapidly treat over 100 million Americans in chronic pain,[8] the costs are spiraling out of control. Chronic pain is now the largest and most expensive health condition in America — larger than cancer, diabetes, and heart disease combined.[9] Because chronic pain is so debilitating and affects every aspect of a patient’s life,[10] it is no surprise that there is about a 50% overlap between chronic pain and mental health disorders.[11],[12],[13],[14] These neuropsychiatric conditions are the leading cause of overall disability in America.[15]

This epidemic of chronic pain is figuratively and literally “dis-abling” Americans with mental health conditions and musculoskeletal disease.

Physicians are doing the honorable thing by trying to help these patients by prescribing, treating, and procedurally doing more. The problem is the decision-making guiding these treatments.

Most of this “doing more” is not working. Most patients fail to control their pain with existing treatment. Over the same 18-year period, we’ve seen a dramatic increase in the number of opioid pain medications being prescribed,[16] as they are very effective in providing pain relief for many patients. Some object to this increase in prescribing as a problem, but that is foolishness. Obviously, as you increase the exposure to something, you also increase the negative effects of that exposure.

As we hear reports of the dueling public health crises of chronic pain and opioid overdose, the sides in this debate generally miss the point. One side argues that “opioids are bad and killing people” suggesting that somehow, an inanimate object can grow legs and hurt somebody.[17] And the other side suggests that because opioids are beneficial for so many that we should just develop more medications to treat opioid abuse and allow the irrational decision-making to continue with pharmaceutical companies profiting from the medications causing addiction and those treating addiction.[18] Both sides miss the point because the debate is framed poorly. The underlying problem creating the opioid epidemic is the decision-making involved in assessing pain and how we prescribe pain medications.

Contributing Factor 1: The Rulemakers Have Broken the Game

The dueling public health crises of chronic pain and opioid overdose begins with the foolishness of the government. Like most of our society’s problems, this issue begins with outdated government structures, laws creating unintended consequences, and detrimental regulations. Government is the rulemaker, and the rules are contributing to these dueling public health crises.

First, the rulemaker (i.e. the government) creates a negative bias through funding. Among all of the institutes at the National Institutes of Health (NIH), there is no institute focused on pain — the nation’s largest and most expensive health condition (see a list here: https://www.hhs.gov/about/budget/budget-in-brief/nih/index.html). The structure of NIH is outdated, but because there are so many universities and researchers who depend upon this antiquated structure, it will not change to meet the needs of our society. The research into pain is spread across various institutes, and not focused.

So, let’s “follow the yellow brick road” and see how this structure creates the problem. These institutes target research dollars. Academic centers create research centers around those funding sources, and the industry commercializes technologies, in collaboration with these research centers. This is the “funnel” that drives innovation. At NIH, there is a Pain Consortium, but until just recently, ironically at the urging of President Trump, it was never given any real attention. Therefore, there is no federally-targeted structure to aim research dollars and projects at the nation’s most prevalent and expensive health condition, and thus no corresponding academic centers of research receiving those dollars, and no large pipeline of new discoveries to improve the diagnosis and treatment of pain by industry.

Second, the rulemaker creates a problem by creating laws or regulations which hurt innovation and rationale decision-making. Federal law enforcement has far too much discretionary authority to overreact on false allegations. And since so many people are being hurt by this epidemic, law enforcement is trying to do something. They are going after anyone accused of being a bad actor. Unfortunately, their efforts are misguided as well. There have been numerous mistaken investigations which have hurt “the good guys” in this field, including former AAPM President Lynn Webster who is an industry leader in helping develop technologies and tools to help patients, the recent raid of Forrest Tennant who is a well-respected physician who helps the “hardest of the hard” chronic pain patients, or the governmental inquiry into Proove Biosciences which was a successful, award-winning research-based genetics diagnostics company that had the only technology with published evidence in peer-reviewed medical journals to both reduce pain and opioid use disorder. All of these missteps by the government did not find any wrongdoing and certainly did more harm than good — not only to patients, but to the goals of the federal government and society at large.

Third, the rulemaker creates perverse reimbursement incentives that drives misdiagnosis, inappropriate treatments, and no accountability for outcomes.[19] With coding established by CMS for Medicare and Medicaid which is then followed by private payers, the system is set up to incentivize clinicians to spend less time with patients, prescribe more inexpensive and addictive pain medications, and drive unnecessary procedures and tests.[20]

So, what does this irrational decision-making by the government’s “invisible foot” do? It hurts people and wastes billions of dollars. With the rulemaker irrationally establishing a broken system, the major fallout creates a system of irrational decision-making by those in the private sector who must follow their rules.

Solutions:

1. Re-structure NIH so that it’s institutes are designed to address a priority list of diseases and conditions which reflect the needs of society and the trends of the future. This includes having a National Institute of Pain

2. Change laws and regulations, as well as administrative priorities to reduce discretionary power and actually address real waste, fraud, and abuse in the system, rather than punish the good actors for political expediency

3. Change the reimbursement system to a system of “pay for performance” so that instead of reimbursing for diagnosis (ICD codes) and treatment (CPT codes), we start reimbursing for outcomes (a code that is yet to be invented yet).

Contributing Factor 2: Science by EmojiTM — Irrational Diagnostic Decision-Making

In 2001, the Joint Commission rolled out its Pain Management Standards, which helped grow the idea of pain as a “fifth vital sign.”[21] It required healthcare providers to ask every patient about their pain, given the perception at the time was that pain was undertreated. However, the problem with this mandate was not that pain shouldn’t be evaluated — it should — the problem is that there was not an effective tool to evaluate pain.

For the nation’s most prevalent and expensive health condition, it is considered the “standard of care”, if you can even use the word “care”, to diagnose and measure pain by a series of facial expressions, like emoji’s, or using a 0 to 10 numerical rating scale. Now, of course, despite the fact that the published evidence suggests that it is not accurate, and even makes things worse,[22],[23],[24] such a tool is well-adopted and accepted. Literally, we practice “Science by Emoji”, a phrase I coined myself, as the diagnostic tool for the nation’s most prevalent and expensive health condition.

Thus, with such a subjective, inaccurate, and ineffective form of diagnosis, we are left with a situation where clinicians must make a determination about a patient’s pain based on their self-reported perception. They must determine whether they are understating their pain to be brave or macho, overstating their pain because they are lonely or drug-seeking, or accurately representing their pain. All of this ambiguity creates a mess for diagnosing pain, and thus clinicians take a “pain by complaint” approach — the more the patient complains about the pain, the worse it is and thus the more it is treated. And then the inverse is true, the less they complain, the less severe, and the less it is treated. By doing this, the most important thing is that the patient’s “emoji’s” are getting happier or their numerical rating is getting lower. Science by EmojiTM is failing because it sets the stage for irrational decision-making.

Solutions:

1. Invest in research to better understand pain. Like cancer was misunderstood 50–60 years ago, we categorize pain by location in the body (low-back pain, neck pain, shoulder pain, etc.) just like we used to categorize cancer (breast cancer, liver cancer, lung cancer, etc.). Pain is a complex neurological condition where molecular targeting and understanding its pathophysiology should guide treatment.

2. Develop more objective assessments of pain that include genetic markers, blood markers, and other more consistent ways to assess pain.

3. Through public health efforts, we must change societal attitudes about pain and mental health conditions. Society has a “gladiator” bias where people suffering from pain, anxiety, depression, and addiction are somehow blamed for their condition and told to “toughen up.” Yet, a cancer patient is called a victim. It’s a very different perspective if we start seeing patients in chronic pain or suffering from anxiety, depression and addiction with sympathy so we can help them. If we can change societal attitudes, we can be honest about how we are addressing underlying conditions that are populating our prisons, driving up our healthcare costs, threatening our military readiness, reducing our nation’s workforce, disrupting our classrooms, motivating mass shooters, and breaking up our families.

Contributing Factor 3: Trial and Error Prescribing — Irrational Treatment Decision-Making

As clinicians feel a moral imperative to help patients — and they should — clinicians have been treating more, as patients have been experiencing more pain. The problem is that clinicians lack widespread access to tools to help them assess risk for side effects or to be able to predict efficacy. With the tremendous risk for opioid misuse and abuse, clinicians generally rely on survey instruments that patients answer. Currently utilized screening tools include the Screener and Opioid Assessment for Patients with Pain®-Revised[25],[26], the Opioid Risk Tool (ORT)[27] and the Brief Risk Interview.[28],[29] These screening assessments, however, are based completely on subjective information. Published data states the specificity of the SOAPP-R® to determine aberrant drug-related behavior is 52.0%, with a sensitivity of 80%.[30] The ORT describes its specificity and sensitivity using a single statistical measure known as a c statistic and found the ORT c statistic to equal 0.82 for men and 0.85 for women. However, clinical utility data describes the sensitivity of the ORT to be much lower, at 45%.[31]

Listen, it’s not rocket-science to realize why these instruments are failing. It’s pretty simple logic. If a patient is willing to lie about their prescription or their pain levels to get a particular prescription, chances are they are going to lie on the survey you give them. Thus, clinicians are faced with a dilemma and it’s not their fault. With less than 10% of patients really at-risk of becoming an opioid abuser, or at-risk for overdose, how do they identify them? Do they provide life-saving pain relief to the 95% and risk life-threatening side effects for the 5%? Or do they protect the 5% by not prescribing pain medications and punish the 95% who need the pain relief? These are really tough questions that are not being answered well right now. With the government’s foolishness in restricting opioid prescribing, many patients are now moving to illicit drugs and the rates of opioid deaths and emergency room visits are only increasing. The government has created the problem and the government is only making the problem worse.

Yet, clinicians need help because they are on the front line everyday trying to help patients. They need tools to help them know who is at risk and who is not. For if you know who’s at risk, you can protect them and give them an alternative. For those who are not at risk, you can use standard precautions and give them the life-saving medications they need. The problem isn’t an inanimate object of a pill, it’s prescribing that inanimate object to a patient at-risk.

Solutions:

1. Standardize best practices that are clinically-proven to work. A few years ago I invented an algorithm that involves both environmental, behavioral, and genetic factors to stratify risk for opioid use disorder (ICD F.11). Mathematically, this algorithm is better at identifying patients who are low, moderate, or high risk for opioid use disorder than any other tool on the market. More peer-reviewed published studies with more patients show that this algorithm has better accuracy (up to 97%) than any alternative.[32],[33],[34] Beyond its accuracy, three published clinical utility studies evaluating over 12,000 patients show that when clinicians use the information to make treatment changes, 90% of patients have a 40% to 50% reduction in their pain within 90 days.[35],[36],[37] Now that this data is published and publicly-available, it should become the standard of care to protect patients from opioid abuse and allow most patients to obtain the life-saving medications they need to regain their quality of life. Further research should occur to continuously improve this tool to include more factors and make it even more accurate.

2. Pharmacogenetic testing can provide value for psychotropic and pain medications, as well as many of the co-morbidities that these patients face, including cardiovascular disease and diabetes. A few years ago, I saw a presentation by Dr. Mark Ratain, the Leon O. Jacobson Professor of Medicine and Director, Center for Personalized Therapeutics at the University of Chicago School of Medicine who explained the following hypocrisy. With CMS reimbursing about $98.38 for a family medical history (Level 3 to Level 4 office visit) which is only supported by one published, peer-reviewed study showing that it increases awareness of disease, pharmacogenetics testing is supported by far more peer-reviewed, published evidence and has far more value and impact on outcomes. In 2005, the Royal Dutch Pharmacists Association’s Dutch Pharmacogenomics Working Group initiated its activities and eventually rolled out guidelines for drug use and dosage while undertaking a pilot study that saw Dutch patients genotyped and their relevant data entered into local electronic healthcare records. A new consortium called the Ubiquitous Pharmacogenomics Consortium (U-PGx) seeks to implement preemptive pharmacogenomic testing at seven healthcare systems across Europe by 2020. Backed by €15 million ($16.1 million) in EU Horizon 2020 funding, U-PGx members will genotype 8,100 patients at sites in Austria, Greece, Italy, the Netherlands, Slovenia, Spain, and the UK with a panel of genes relevant to drug dosage. Half of those patients will have their genetic data stored in local electronic medical systems to help physicians advise on drug selection and dosage, while the other half will serve as controls. By the end of the study, the U-PGx consortium members hope to show a decline in adverse drug reactions and improvement in drug efficacy among genotyped participants. They also hope the results will spur healthcare systems across Europe to adopt pharmacogenetic testing as part of routine patient care.[38] The FDA has had this type of data in package inserts for medications for many years. Many laboratories are providing pharmacogenetics testing, but limited reimbursement from private insurers and federal health programs — thus limiting patient access to this life-saving technology. Like The Netherlands, we should have universal pharmacogenetics testing available to all which will provide clinicians with added insights to guide therapeutic selection and dosing to improve outcomes and reduce side effects.

3. Most pain is still treated by compounds derived from 2,000-year old morphine. As part of the solutions to fix the “rulemaker”, we need more research dollars in a new National Institute of Pain to invent new modalities and compounds to target a better understanding of pain — rather than just opioids.

Conclusion

Our nation needs to wake up to the underlying issues of irrational decision-making that have caused the dueling public health crises of chronic pain and opioid overdose. The government has made foolish rules that are causing “Titanic” harm to our people. “Science by Emoji”TM is a “Trojan Horse” preventing the accurate diagnosis and understanding of pain. And trial and error prescribing, along with subjective questionnaires, are a “Waterloo” only resulting in treatment failures or worse — abuse and addiction. With the best of intentions, society is doing a lot to address the opioid epidemic. Unfortunately, everything being done is only making things worse and what has been an epidemic in North America is going to become a pandemic worldwide. We must address the underlying causes of this epidemic — by improving decision-making — to save the lives of millions and spare millions of families the pain and suffering of losing a loved one to what has become the leading cause of preventable death in America.

Personal Note: I will continue to be part of the solution

Over the past several years, I’ve worked hand-in-hand with the leading researchers in the field, physicians, and policy makers to develop solutions to these dueling public health crises. In tackling opioid abuse, I was a keynote speaker for the NIH’s National Institute of Drug Abuse Annual Richard Denisco Seminar on Opioid Abuse in 2016 to discuss how genetics and big data can help solve this epidemic, served as a Co-Chair of the Annual Dinner of the Community Anti-Drug Coalitions of America (CADCA) to support community efforts, spoke on Capitol Hill about innovative technologies to tackle the opioid abuse epidemic for the Coalition for Effective Prescription Opioid Policies led by former Congresswoman Mary Bono, and I founded a company ranked as one of the fastest growing companies in North America by the Deloitte Technology Fast 500 and the Inc. 500, with the largest biobank in chronic pain and largest big data set in chronic pain worldwide which commercialized innovative technologies that won research recognitions from leading medical societies including the American Society of Interventional Pain Physicians (ASIPP), American Academy of Neurology (AAN), and the American Society of Regional Anesthesia (ASRA).

Despite my clear record of success, in 2017, there was a concerted attempt by those who would thwart solutions to these epidemics to spread easily disproven allegations about a company I started called Proove Biosciences. Despite the damage done due by these false allegations irresponsibly spread in the media which triggered a subsequent governmental inquiry which found no wrongdoing, I haven’t given up the mission to help solve these epidemics. My life’s work — since I was a teenager — underscores my commitment and passion to saving lives and preventing injury with solutions involving new technologies, partnerships with academic centers and industry, and policy changes. The science lives on and the mission continues.

[1] http://www.titanicfacts.net/titanic-victims.html

[2] https://www.quora.com/How-many-people-died-in-the-Trojan-War

[3] https://www.cbsnews.com/news/opioids-drug-overdose-killed-more-americans-last-year-than-the-vietnam-war/

[4] https://www.archives.gov/research/military/vietnam-war/casualty-statistics

[5] https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates

[6] US Department of Health and Human Services; Centers for Disease Control & Prevention, National Center for Health Statistics. Health, United States, 2006. Hyattsville, MD; 2006.

[7] http://www.boneandjointburden.org/

[8] Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research.

Washington, DC: The National Academies Press, Institute of Medicine; 2011.

[9] http://www.painmed.org/files/facts-and-figures-on-pain.pdf

[10] American Pain Foundation. Overview of American Pain Surveys: www.painfoundation.org/Voices/VoicesSurveyReport.pdf.

[11] Rosenblum A et al. JAMA. 2003;289:2370–2378.

[12] Peles E et al. Pain. 2005;113:340–346.

[13] Potter JS et al. Am J Drug Alcohol Abuse. 2008;34:101–107.

[14] Sheu R et al. Pain Med. 2008;9:911–917.

[15] https://www.nimh.nih.gov/health/statistics/disability/us-leading-categories-of-diseases-disorders.shtml

[16] http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6043a4.htm.

[17] http://www.supportprop.org/

[18] https://theacpa.org/Partners-Contributors

[19] https://www.theatlantic.com/magazine/archive/2011/06/perverse-incentives/308489/

[20] Weeks J. “Perverse incentives” and the triple aim: overcoming the troubled path to economic integration for integrative medicine and health. Glob Adv Health Med. 2015 Mar;4(2):7–9. doi: 10.7453/gahmj.2015.005.

[21] https://www.jointcommission.org/assets/1/6/Pain_Std_History_Web_Version_05122017.pdf

[22] Krebs, E.E., Carey, T.S. & Weinberger, M. Accuracy of the pain numeric rating scale as a screening test in primary care. J Gen Intern Med 22, 1453–8 (2007).

[23] Lorenz, K.A. et al. How reliable is pain as the fifth vital sign? J Am Board Fam Med 22, 291–8 (2009).

[24] Mularski, R.A. et al. Measuring pain as the 5th vital sign does not improve quality of pain management. J Gen Intern Med 21, 607–12 (2006).

[25] Butler, S.F., et al., Cross-Validation of a Screener to Predict Opioid Misuse in Chronic Pain Patients (SOAPP-R). J Addict Med, 2009. 3(2): p. 66–73.

[26] Butler, S.F., et al., Spanish translation and linguistic validation of the screener and opioid assessment for patients with pain-revised (SOAPP-R). Pain Med, 2013. 14(7): p. 1032–8.

[27] Webster, L.R. and R.M. Webster, Predicting aberrant behaviors in opioid-treated patients: preliminary validation of the Opioid Risk Tool. Pain Med, 2005. 6(6): p. 432–42.

[28] Jones, T. and T. Moore, Preliminary data on a new opioid risk assessment measure: the Brief Risk Interview. J Opioid Manag, 2013. 9(1): p. 19–27.

[29] Jones, T., et al., Further validation of an opioid risk assessment tool: the Brief Risk Interview. J Opioid Manag, 2014. 20(6): p. 353–64.

[30] Butler, S.F., Budman, S. H., Fernandez, K. C., Fanciullo, G. J. & Jamison, R. N. , Cross-Validation of a Screener to Predict Opioid Misuse in Chronic Pain Patients (SOAPP-R). J Addict Med, 2009. 3 p. 66–73

[31] Moore, T.M., et al., A comparison of common screening methods for predicting aberrant drug-related behavior among patients receiving opioids for chronic pain management. Pain Med, 2009. 10(8): p. 1426–33.

[32] Farah R et al. Evaluation of a Predictive Algorithm that Detects Aberrant Use of Opioids in an Addiction Treatment Centre. J Addict Res Ther 2017, 8:2 DOI: 10.4172/2155–6105.1000312

[33] Brenton AR et al. Observational Study to Calculate Addictive Risk to Opioids: A Validation Study of a Predictive Algorithm that Detects Opioid Use Disorder. Pharmacogenomics and Personalized Medicine 2017.

[34] Sharma, M., et al. Observational Study to Calculate Addictive Risk to Opioids: A Validation Study of a Predictive Algorithm to Evaluate Opioid Use Disorder in a Primary Care Setting. Health Services Research and Managerial Epidemiology, May 2017.

[35] Brenton A et al. A prospective, longitudinal study to evaluate the clinical utility of a predictive algorithm that detects risk of opioid use disorder. Journal of Pain Research, 2018:11 119–131

[36] Lewis, K., et al., An Observational Study to Evaluate the Clinical Utility of a Predictive Algorithm to Detect Opioid Use Disorder. Health Services Research and Managerial Epidemiology, June 2017.

[37] Lee C, et al. A Predictive Algorithm to Detect Opioid Use Disorder: What Is the Utility in a Primary Care Setting? Health Services Research and Managerial Epidemiology, Volume 5: 1–8, 2018.

[38] https://www.genomeweb.com/molecular-diagnostics/pharmacogenomics-consortium-aims-make-testing-ubiquitous-european-patients