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August 5, 2019

Lessons Learned From the Opioid Epidemic

Author Affiliations
  • 1Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
  • 2Institutes for Behavior Resources Inc, Baltimore, Maryland
JAMA. Published online August 5, 2019. doi:10.1001/jama.2019.9794

Oklahoma’s recent settlements with Purdue Pharma and Teva Pharmaceuticals, and the trial in the state’s lawsuit against Johnson & Johnson, signal that the opioid epidemic is entering a new era of accountability. Hundreds of cities and counties and about 2 dozen states are also pursuing litigation against opioid manufacturers.

The legal system should hold the pharmaceutical industry responsible for the overzealous, misleading, and, at times, illegal marketing of opioids. Regulators should consider new ways to monitor drug manufacturers to reduce the chances of such conduct in the future. Yet the lessons of the opioid epidemic go further. It is important for physicians, payers, hospitals, and accreditors—as well as for patients and their families—to consider what else went wrong and what can be fixed moving forward, so that a tragedy of this scale does not occur again.

Four critical lessons for the health care system have become clear, and others may emerge as the epidemic continues to evolve.

First, beware of simple solutions for complex problems. Excessive prescribing of opioids for pain began with good intentions, as evidence made clear that chronic pain is a serious problem that affects millions of individuals in the United States and wide disparities exist in access to treatment. Even though chronic pain was understood to be multifactorial and quite subjective, physicians (and the health care system) too often offered little more than writing prescriptions and hoping for the best.

Quality metrics, inspections, and accreditation focused on the question of whether patients were reporting pain, symbolized by the smiling face questionnaire. Insurers routinely paid for medication treatment of pain but rarely covered the additional time for clinicians to understand the problem, pursue other modalities of treatment, and holistically work with patients to improve function. These steps helped push prescribing of opioids far past the point of prudence in many settings.

For the future, the health care system should provide a variety of tools to clinicians and patients to manage complex chronic illnesses. Medications have an important role in the treatment of depression, anxiety, diabetes, chronic pain, and other common conditions, but they will be most effective when used as needed and in coordination with other therapies. Patients and families benefit from education, understanding, and support as they co-manage their conditions.

Second, accept no substitutes for high-quality clinical evidence. In 1995, Purdue Pharma convinced the US Food and Drug Administration (FDA)—in the absence of compelling clinical evidence—to add to the label of Oxycontin that “delayed absorption as provided by Oxycontin tablets is believed to reduce the abuse liability of the drug.” After removing this language several years later, the FDA permitted the label to read that the medication was indicated for “pain severe enough to require daily, around the clock, long-term opioid treatment.” In recent years, both the Centers for Disease Control and Prevention and the Agency for Healthcare Research and Quality have concluded that evidence supporting the effectiveness of opioids for chronic pain is limited.1,2

The FDA did not accept these label claims in a vacuum. Many experts served on advisory committees and participated in other conferences and proceedings that supported the agency’s actions. Academic articles that expressed caution, while seemingly prescient in retrospect, did little to affect ongoing shifts in clinical care.3

Eventually, enthusiasm for unproven therapies succumbs to the logic of science and evidence; unfortunately, many people may be harmed before high-quality data become available. This concern is worth considering in the rush to embrace other new modalities of care with little objective evidence to support them, such as medical cannabis and many stem cell treatments. The medical community should support the vital role of the FDA in ensuring the collection of high-quality data and in carefully considering the potential benefits and harms of medical products, including drugs and devices, both before and after approval.4,5

Third, teach physicians about addiction. When the current opioid epidemic started, few physicians could recognize, screen for, diagnose, or treat addiction, and many embraced the social stigma that treats hazardous substance use as primarily a moral failure, rather than a chronic disease. As a result, prescribers were vulnerable to the erroneous claim, put forward by the pharmaceutical industry, that opioid addiction in patients with “genuine pain” was virtually nonexistent. Many physicians accepted that patients who misused prescription opioids were at fault and could be quickly discharged from care.

Embracing this lesson may help save many lives from opioid addiction and other substance use disorders. An especially neglected area of medical training is the care of patients at risk for both chronic pain and addiction. Physicians should learn to recognize the difference between those individuals who are losing control over prescription opioid use (and may need treatment for opioid use disorder) and those who are clinically stable (and would be harmed by an abrupt taper). Physicians should also be able to provide compassionate and nonjudgmental care for acute and chronic pain as well as addiction in emergency departments, primary care settings, specialty medical programs, and hospital wards. The Accreditation Council for Graduate Medical Education can take a major step forward by requiring training in the basics of addiction treatment for residents in all clinical disciplines.6

Fourth, recognize that some conflicts of interest require a stronger response than disclosure alone. The opioid epidemic has demonstrated that the source of funding matters. Some physicians who served as speakers have since admitted spreading misinformation, with one later recounting, “I gave innumerable lectures in the late 1980s and ‘90s about addiction that weren’t true.”7 Organizations that took significant funding from opioid manufacturers include the Federation of State Medical Boards, the American Pain Society, the American Geriatrics Society, and the American Academy of Pain Medicine. All supported statements or reports that encouraged physicians to prescribe opioids for chronic pain.8,9

It will not be easy for the warnings about financial conflict of interest to be heeded broadly within US medicine, where opportunities for personal and organizational enrichment through the successful development and marketing of medical products abound. There appears to be a trend toward accepting disclosure and transparency of financial conflict of interest as sufficient. A more serious discussion of what roles should be protected from conflict of interest is overdue. For certain critical educational, regulatory, and policy development functions, it may be necessary to prohibit financial conflicts of interest entirely.

When the current round of court cases reach their conclusions, there may be some justice delivered. But there should be little satisfaction. Hundreds of thousands of individuals in the United States have died of opioid-related causes, millions have become addicted, and billions of dollars of economic value have been lost. The sheer scale of this immense burden should spark reflection across the health care system and lead to thoughtful efforts to learn the lessons of the opioid epidemic.

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Article Information

Corresponding Author: Joshua M. Sharfstein, MD, Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Room W1033F, Baltimore, MD 21205 (joshua.sharfstein@jhu.edu).

Published Online: August 5, 2019. doi:10.1001/jama.2019.9794

Conflict of Interest Disclosures: Dr Sharfstein reported serving as an unpaid expert witness in Baltimore City’s lawsuit against opioid manufacturers. Dr Olsen reported serving as vice president of the American Society of Addiction Medicine (ASAM); receiving an honorarium from ASAM and Providers’ Clinical Support System for providing trainings on addiction treatment; and receiving salary support for treating patients with opioid use disorder. Drs Sharfstein and Olsen are coauthors of, and receive royalties from Oxford University Press for, The Opioid Epidemic: What Everyone Needs to Know (2019).

References
1.
Dowell  D, Haegerich  TM, Chou  R.  CDC guideline for prescribing opioids for chronic pain—United States, 2016.  JAMA. 2016;315(15):1624-1645. doi:10.1001/jama.2016.1464PubMedGoogle ScholarCrossref
2.
Chou  R, Deyo  R, Devine  B,  et al The Effectiveness and Risks of Long-Term Opioid Treatment of Chronic Pain: Evidence Report/Technology Assessment No. 218. Rockville, MD: Agency for Healthcare Research and Quality; September 2014. AHRQ publication 14-E005-EF. doi:10.23970/AHRQEPCERTA218
3.
McGreal  C. The making of the opioid epidemic. The Guardian. November 8, 2018. https://www.theguardian.com/news/2018/nov/08/the-making-of-an-opioid-epidemic. Accessed June 16, 2019.
4.
Redberg  RF, Jacoby  AF, Sharfstein  JM.  Power morcellators, postmarketing surveillance, and the US Food and Drug Administration.  JAMA. 2017;318(4):325-326. doi:10.1001/jama.2017.7704PubMedGoogle ScholarCrossref
5.
Rollman  JE, Heyward  J, Olson  L, Lurie  P, Sharfstein  J, Alexander  GC.  Assessment of the FDA risk evaluation and mitigation strategy for transmucosal immediate-release fentanyl products.  JAMA. 2019;321(7):676-685. doi:10.1001/jama.2019.0235PubMedGoogle ScholarCrossref
6.
Sharfstein  JM, Olsen  Y.  Making amends for the opioid epidemic.  JAMA. 2019;321(15):1446-1447. doi:10.1001/jama.2019.3505PubMedGoogle ScholarCrossref
7.
Catan  T, Perez  E. A pain-drug champion has second thoughts. Wall Street Journal. December 17, 2012. https://www.wsj.com/articles/SB10001424127887324478304578173342657044604. Accessed June 16, 2019.
8.
Fauber  J. Follow the money: pain, policy, and profit. Milwaukee Journal Sentinel/Medpage Today. February 19, 2012. https://www.medpagetoday.com/neurology/painmanagement/31256. Accessed June 16, 2019.
9.
Ranking Member’s Office, U.S. Senate Homeland Security and Governmental Affairs Committee. Fueling an epidemic: exposing the financial ties between opioid manufacturers and third party advocacy groups. Homeland Security Digital Library website. https://www.hsdl.org/c/. Published February 12, 2018. Accessed June 16, 2019.
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    3 Comments for this article
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    Opioids and Addiction
    Steven King, M.D., M.S. |
    The authors fail to mention several important issues:

    1. Most doctors receive little education on pain management either in medical school or postgrad training. This problem was identified at least 30 years ago yet little has been done in the interim to remedy it.

    2. We know very little about iatrogenic opioid abuse where patients were started on these meds for legitimate pain complaints and ended up abusing and becoming addicted to them. We don't know if this is the same disorder as opioid use disorder stemming from nonmedical use of prescription of opioids.
    In fact, as far as I'm aware, this isn't even part of any diagnostic classification system. And there are virtually no studies on the best way to manage it.

    3. if one wants to know the major reasons why pain management doctors know so little about substance abuse simply look at what department pain management is part of in most medical schools and hospitals: anesthesiology. Probably few clinical specialties receive less training in substance abuse than anesthesiologists and the doctors who receive the most training in substance abuse, psychiatrists, usually receive little training in pain management because psychiatry departments don't consider pain management to be part of their specialty. There is absolutely no reason why the management of chronic pain should be part of anesthesiology and not psychiatry.
    CONFLICT OF INTEREST: None Reported
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    Complicity of the Three Big Fish in the Opioid Epidemic
    Umbrine Fatima, MD, FACP | Kenmore Mercy Hospital, Buffalo, NY
    First, sincere thanks to the authors of this article.

    With deep regret I, too, have been watching the opioid epidemic. I find it disturbing that news of some physician colleagues and healthcare professionals have frequently splashed the media outlets. There seems to be some dark gratification in shaming and naming the physician community by the media for some reason. I have also seen the trend to shame and litigate the pharmaceutical industry in their role in promoting the epidemic as well. However, I think there are more important and seriously complicit players in the field that no one
    is paying any attention to. These are the medical organizations that have been regarded highly for their role of creating and implementing the supposed disease treatment "guidelines" as well as the payors who have historically and habitually denied payment of costly yet safe and effective treatments.

    I have attended hundreds of CMEs from the most prestigious organizations and peer-reviewed outlets and taken my board exams three times in my practice lifetime. With many pain management options available worldwide, including interventional pain management with massage therapy, low level laser treatments, trigger-point injections, PRP, LED treatments, acupuncture, and others, none have ever been presented as even an option to consider in pain management guidelines or algorithms. Instead these modalities have always had a dark shadow of doubtful benefit cast over them (minimized with "small, generally low-quality studies") by any number of guidelines that a majority of physicians are pressured to follow by their regulatory organizations.

    Unfortunately, treatment guidelines have cost savings as the driving force of all care delivered. Nowhere in the Triple Aim is individual health a part of the equation. Scapegoating physicians and other health care providers for this epidemic is too simplistic and rather naïve. Physicians are merely puppets trained by the organizations responsible for their curriculum, and kept under an ever-tightening cost-saving leash by the payors (insurance companies, Medicare, Medicaid). The main culprits in this horrific epidemic are Three Big Fish: 1) the payors that refused to cover interventional pain management because it is so much cheaper to give 100 Vicodin or percocets, 2) organizations churning the pain management guidelines and algorithms that focused only on pharmaceutical options, and 3) the pharmaceutical players that provided the ammunition to fuel this epidemic.

    While I am extremely sad for the loss of lives with the opioid addictions, I remain reluctant to accept prescribers as the sole perpetrators. I believe they acted in their concern to alleviate pain and suffering of their patients within the constraints noted above. I believe that most prescribers had no intention of causing addiction, and even less, of causing death. I also find it sad that most are reluctant to hold responsible the Three Big Fish in the pond which were the driving forces of this outcome.
    CONFLICT OF INTEREST: None Reported
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    Why Not in Italy?
    Luca Puccetti, Medical Doctor | University of Pisa
    The apocalyptic scenario described in the paper is far from the italian situation. We had strict regulatory rules for prescribing opioids in the last decades of the last century. As result we had a high volume of NSAIDs prescriptions which in turn causes heart attack, deaths, renal impairment, serious GI complications with hospitalizations and excess morbidity and mortality. The levels of opioid prescriptions were so low as to create embarrassment in comparison with other European countries. In the last decades opioid prescription regulations became similar to that of other medications and the number of opioid prescriptions increased but we did not experience significant abuses. I feel that the abuse described in the paper is caused by social, political issues and grading of values in US society. The mantra about competition as a fundamental cornerstone in US society causes guilt and inadequacy in those who fail and push to find comfort in drinking and drugs. It should pursue the achievement of a more inclusive society rather than blaming those who produce drugs. Otherwise it is like weapons, the culprit is not who produces the weapon but who shoots.
    CONFLICT OF INTEREST: None Reported
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