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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.
Corresponding Author: Joshua M. Sharfstein, MD, Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Room W1033F, Baltimore, MD 21205 (email@example.com).
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).
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Sharfstein JM, Olsen Y. Lessons Learned From the Opioid Epidemic. JAMA. Published online August 05, 2019. doi:10.1001/jama.2019.9794
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