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The President's Commission: A Narrative

Origins of the Current Crisis

The federal government has been a central player in the opioid epidemic. Shortly after being elected, President Trump declared the opioid epidemic a national emergency and tasked THE PRESIDENT’S COMMISSION ON COMBATING DRUG ADDICTION AND THE OPIOID CRISIS to develop recommendations to combat the addiction crisis that is rampantly impacting our country. The report offers a narrative of the causes of the current state of the epidemic. After reviewing past epidemics, the report concludes that, “over 30 years ago, a sequence of events eroded fears of opioids, and the medical community once again relapsed into liberal use of medicinal opioids. Triggered by excessive prescribing of opioids since 1999, the current crisis is being fueled by several factors that did not exist in the 19th century: the advent of large scale production and distribution of pure, potent, orally effective and addictive opioids; the widespread availability of inexpensive and purer illicit heroin; the influx of highly potent fentanyl/fentanyl analogs; the transition of prescription opioid misusers into use of heroin and fentanyl; and the production of illicit opioid pills containing deadly fentanyl(s) made by authentic pill presses. Prescription opioids now affect a wide age range, families both well-off and financially disadvantaged, urban and rural, and all ethnic and racial groups. Historical precedent demonstrated that this crisis can be fought with effective medical education, voluntary or involuntary changes in prescribing practices, and a strong regulatory and enforcement environment. The recommendations of the Commission are grounded in this reality, and benefit from modern systematic epidemiological and large data analytics, evidence-based treatments, and medications to assist in recovery or rescue of an overdose crisis”.

Contributors to the Current Crisis.

A widely held and supportable view is that the modern opioid crisis originated within the healthcare system and have been influenced by several factors:

• Unsubstantiated claims:

One early catalyst can be traced to a single letter to the Editor of the New England Journal of Medicine published in 1980, that was then cited by over 600 subsequent articles.1,2 With the headline “Addiction Rare in Patients Treated with Narcotics,” the flawed conclusion of the five-sentence letter was based on scrutiny of records of hospitalized patients administered an opioid. It offered no information on opioid dose, number of doses, the duration of opioid treatment, whether opioids were consumed after hospital discharge, or long-term follow-up, nor a description of criteria used to designate opioid addiction. Six years later, another problematic study concluded that “opioid maintenance therapy can be a safe, salutary and more humane alternative to the options of surgery or no treatment in those patients with intractable non-malignant pain and no history of drug abuse.”3 High quality evidence demonstrating that opioids can be used safely for chronic non-terminal pain did not exist at that time. These reports eroded the historical evidence (see Appendix 2) of iatrogenic addiction and aversion to opioids, with the poor-quality evidence that was unfortunately accepted by federal agencies and other oversight organizations.

• Pain patient advocacy:

Advocacy for pain management and/or the use of opioids 4,5,6 by pain patients was promoted, not only by patients, but also by some physicians. One notable physician stated: “make pain ‘visible’… ensure patients a place in the communications loop… assess patient satisfaction; and work with narcotics control authorities to encourage therapeutic opiate use… therapeutic use of opiate analgesics rarely results in addiction.”7

• The opioid pharmaceutical manufacturing and supply chain industry:

One pharmaceutical company sponsored over 20,000 educational events for physicians and others on managing pain with opioids, claiming their potential for addiction was low.8 Yet, warning signs of the addictive potential of oxycodone and similar opioids long predated this period: in 1963, Bloomquist wrote that dihydrohydroxycodeinone (oxycodone, Percodan®), “although a useful analgesic retains addiction potential comparable to that of morphine. This fact should be considered when it is prescribed. Because of increasing numbers of addicts to this drug in the State of California, the California Medical Association Committee on Dangerous Drugs and the House of Delegates has recommended that oxycodone-containing drugs be returned to the triplicate prescription list as they were originally in 1949.” This recommendation failed to pass the legislature.9 Similar warnings followed. Aggressive promotion of an oxycodone brand from 1997-2002 led to a 10-fold rise in prescriptions to treat moderate to severe noncancer pain, and increases in prescribing of other opioids. Subsequently, the highest strengths permissible was increased for opioid-tolerant patients, likely contributing to its misuse. Extended-release (ER) formulations and delayed absorption were marketed as reducing abuse liability, but crushing the pills allowed users to snort or inject the drugs. 10,11

There are now at least five marketed opioids that carry abuse deterrent labeling. It has been hypothesized that the marked rise in heroin and other illicit synthetic opioids is, in part, associated with unintended consequences of reformulation of OxyContin, and a reduced supply and greater expense of prescription opioids.12,13 To this day, the opioid pharmaceutical industry influences the nation’s response to the crisis.14 For example, during the comment phase of the guideline developed by the Centers for Disease Control and Prevention (CDC) for pain management, opposition to the guideline was more 21 common among organizations with funding from opioid manufacturers than those without funding from the life sciences industry.15

• Rogue pharmacies and unethical physician prescribing:

The key contributors of the large number of diverted opioids were unrestrained distributors, rogue pharmacies, unethical physicians, and patients whose opioid medications were diverted, or other patients who sold and profited from legitimately prescribed opioids.16

• Pain as the ‘fifth vital sign’:

The phrase, “pain as the ‘fifth vital sign,’” was initially promoted by the American Pain Society in 1995, to elevate awareness of pain treatment among healthcare professionals; “Vital Signs are taken seriously. If pain were assessed with the same zeal as other vital signs are, it would have a much better chance of being treated properly. We need to train doctors and nurses to treat pain as a vital sign. Quality care means that pain is measured and treated.”17 The Veteran’s Administration (VA)18 and then the Joint Commission on Accreditation of Healthcare Organizations (the Joint Commission) designated pain as a ‘fifth vital sign.’ 19,20 The Joint Commission accredits and certifies health care organizations. Certification has implications for objective assessment of clinical excellence, and for contracting and reimbursement. The Joint Commission’s standards for pain assessment in 2000 “were a bold attempt to address widespread underassessment and undertreatment of pain,”21 even though the health care community was not advocating for a regulatory approach to pain management.22

The standards raised concerns that requiring all patients to be screened for the presence of pain and raising pain treatment to patients’ rights issue could lead to over-reliance on opioids. The Joint Commission received sponsorship for developing educational materials from an opioid pharmaceutical company, one of over 20,000 pain-related educational programs through direct sponsorship or financial grants. It was “unaware that the science behind their claims and the advice of experts in the field were erroneous.”23 This designation set in motion a growing compulsion to detect and treat pain, especially to prescribe opioids beyond traditional boundaries of treating acute, postoperative, procedural pain and end-of-life care. The surge in opioid supply escalated into opioid-related misuse, diversion, use disorder, and overdose deaths. Administrators, regulatory bodies, and insurers collectively pressured physicians to address patient satisfaction with aggressive pain management.24 However, the concept that iatrogenic addiction was rare and that long-acting opioids were less addictive had been widely repeated, and studies refuting these claims were not published until years later. The Joint Commission has since eliminated the requirement that pain be assessed in all patients, except for patients receiving behavioral health care and established much stricter processes to review any corporate sponsorship of educational programs. In 2016, the Joint Commission began to revise its pain standards,25 which will go into effect in January 2018.

• Inadequate oversight by the Food and Drug Administration (FDA):

The FDA is the sole federal authority responsible for protecting public health by assuring the safety, efficacy, and security of human drugs, biological products, and medical devices. It approves medications to diagnose, treat, and mitigate illnesses, after assessing their safety and efficacy. It safeguards the nation’s medications by setting standards for proper prescribing of approved drugs and post-approval surveillance. The FDA provided inadequate regulatory oversight. Even when overdose deaths mounted and when evidence for safe use in chronic care was substantially lacking, prior to 2001, the FDA accepted claims that newly formulated opioids were not addictive, did not impose clinical trials of sufficient duration to detect addiction, or rigorous post-approval surveillance of adverse events, such as addiction. The FDA also failed to assess the risks associated with deliberate diversion and misuse of opioids, risks that conceivably outweighed the intended benefits for patients if used as directed. They accepted the pharmaceutical industry’s claim that iatrogenic addiction was “very rare” and that the delayed absorption of OxyContin reduced the abuse liability of the drug.26

By 2001, the FDA removed these unsubstantiated claims from OxyContin’s labeling. In March 2016, the FDA requested from the National Academies of Sciences, Engineering, and Medicine (NASEM) and received on July 13, 2017, a summary of the current status of science regarding prescription opioid abuse and misuse, and the role of opioids in pain management.27 The current FDA Commissioner has stated a strong commitment to using the regulatory authority of the FDA to mitigate the adverse consequences of opioid use. 28

• Reimbursement for prescription opioids by health care insurers:

Sales of prescription opioids in the U.S. nearly quadrupled from 1999 to 2014,29 largely paid for by insurance carriers. It is estimated that 1 out of 5 patients with non-cancer pain or pain-related diagnoses are prescribed opioids in office-based settings. 30 From 2007 to 2012, the rate of opioid prescribing steadily increased amongst specialists more likely to manage acute and chronic pain (pain medicine [49%], surgery [37%], physical medicine/rehabilitation [36%]). Insurance carriers, including Medicare Part D plans, did not serve as a stop-gap to the huge influx of opioid prescriptions.

• Medical education:

Medical education has been deficient in pain management, opioid prescribing, screening for, and treating addictions.31 During the 1990’s, the pain movement should have alerted medical education institutions and creators of continuing medical education courses to address this issue. In some medical schools and some specialties, it remains inadequate to this day.32 One strategy promoted 10 years ago to stratify patients’ risk for opioid misuse and overdose was the screening of patients for substance use disorders (SUDs), especially pain patients.33 Implementation of Screening, Brief Interventions, and Referral to Treatment (SBIRT) in healthcare systems was incentivized with billing codes.34 SBIRT was mainstreamed into health care reform, but has yet to be incorporated nationally into medical curricula, or applied as routine care. Nor do core curricula necessarily address addictions, treatment options, or stress the need to screen for substance use and mental health.

• Lack of patient education:

Patients and their families are not often fully informed regarding whether their prescriptions are opioids, the risks of opioid addiction or overdose, control and diversion, dose escalation, or use with alcohol or benzodiazepines.

• Public demand evolves into reimbursement and physician quality ratings pegged to patient satisfaction scores:

Today, the use of opioids for chronic non-cancer pain remains controversial for the same reasons their use declined and was avoided at the turn of the 20th century: the potential for misuse and addiction, insufficient high-quality evidence of efficacy with long-term use, poor functional outcomes, overdose and death. Yet, a strong public demand for opioids continues to pressure clinicians to prescribe opioids persists. As an example, a recent survey of Emergency Department (ED) physicians indicated that 71% reported a perceived pressure to prescribe opioid analgesics to avoid administrative and regulatory criticism. Uniformly, they voiced concern about excessive emphasis on patient satisfaction scores by reimbursement entities as a means of evaluating their patient management. The physician requirement to address pain as the "fifth vital sign" persists,35 and reimbursement metrics based on patient satisfaction may have inadvertently created an environment conducive to exploitation by prescription opioid abusers.36 There are legitimate circumstances for which opioids are an appropriate therapy. But many current institutional and societal issues continue to pressure physicians to prescribe opioids when they are not clinically appropriate. Prior to this year, poor patient satisfaction with pain care could lead to reduced hospital reimbursement by Medicare through Value-Based Purchasing (VBP). There are often higher costs or no specific reimbursements for alternative pain management strategies, alternative pain intervention strategies, or spending time to educate patients about the risks of opioids. Further, failing to provide adequate pain relief can be grounds for malpractice claims or medical board action.

• Lack of foresight of unintended consequences:

As prescription drugs came under tighter scrutiny and access became more limited (via abuse-deterrent formulations and more cautious prescribing), market forces responded by providing less expensive and more accessible illicit opioids. Increases in overdose death numbers due to prescription opioids have transitioned to overdoses largely due to heroin and, increasingly, fentanyl. 37 Locally, this trend may have been driven, in part, by tightening controls on prescription opioids. Physicians curtailed opioid prescriptions without guidelines on tapering and without determination of whether patients had developed an opioid use disorder (OUD), and if so, how to respond. 38 The availability of cheaper heroin also drove prescription opioid misusers to illicit opioids. Black market heroin is currently much less expensive than diverted prescription opioids, and fentanyl is even much less expensive per dose than heroin. Predictable from the economics of the two drug categories, the prescription drug overdose problem has decreased, but not the overall number of opioid-related deaths.

• Treatment services insufficient to meet demand and to provide medication-assisted treatment (MAT):

As OUDs increased dramatically over the past 15 years, quality treatment services and the associated workforce did not expand in response to the growing crisis.

Lack of national prevention strategies:

Prevention strategies focusing on specific illicit drugs for vulnerable populations - adolescents, college age youth, pregnant women, unemployed men, and other - and for influencers, (parents, families) don’t exist or have not been tested adequately.

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