The opioid crisis, which began in the 1990s, is worse than ever. According to the Centers for Disease Control and Prevention (CDC), for the 12 months ending in April 2021, there were over 100,000 overdose deaths, an increase of 28.5 percent over 2020 levels.
Often lost in the understandable concern about these fatalities are millions of chronic pain patients who are unable to get adequate pain relief.
In 2012, American physicians wrote the staggering number of 255 million prescriptions for opioid pain relievers. To reduce deaths and other harms, the CDC and other federal and state policymakers focused on significantly decreasing opioid prescribing and usage. By 2020, there were only 142 million opioid prescriptions, although in some parts of the country there are still exceedingly high levels of opioids being prescribed.
The reduction in opioid prescriptions, however, did not reduce overdose deaths. In fact, from 2012 to 2021, overdose deaths soared from 41,000 to 100,000, with most deaths now resulting from illegal synthetic opioids - fentanyl and its analogs. Fighting the "war on opioids" at every physician's office was a terrible mistake, and an unintended consequence has been to increase the suffering of many patients with chronic diseases whose long-term pain management depends on access to opioids. How did we get to this point?
Most of the millions of opioid pills taken by patients for pain each year are prescribed by physicians without specialized training in pain management. A study published in 2013, near the height of opioid prescribing, estimated that 20 percent of patients treated in doctors' offices for pain received an opioid prescription. To address this dangerous overprescribing of opioids, in 2016 the CDC published its Guideline for Prescribing Opioids for Chronic Pain. It "provides recommendations for the prescribing of pain medication by primary care clinicians for chronic pain . . . in outpatient settings outside of active cancer treatment, palliative care, and end-of-life care."
Some recommendations in the guideline are especially troublesome. First is the recommendation that "Nonpharmacologic therapy and nonopioid therapy are preferred for chronic pain." In following this recommendation, some doctors have prescribed ineffective over-the-counter pain medicines or talk therapy instead of opioids for patients who have serious injuries and illnesses confirmed by imaging and lab tests, and who have previously tried these measures without benefit. A recent review of the evidence found there is no scientific basis to conclude that non-drug treatments are an adequate substitute for opioids in controlling severe pain.
The CDC guideline is also being applied beyond its intended outpatient, primary care settings. Many hospitals and other large health care providers incorrectly believe that any violations of the guideline will lead to civil or even criminal liability, so they drastically restrict opioid prescribing by their physicians. Fear of losing their medical license, staff privileges, or employment, rather than sound medicine, now drives many physicians treating pain. Also, over 30 states have followed the CDC guideline by enacting laws limiting prescribing opioids, further deterring physicians from prescribing opioids, even for responsible patients in great distress.
In 2019, the CDC admitted that its guideline was being misused, but it failed to take any action. In 2020, the American Medical Association (AMA) recommended that physicians immediately suspend the use of the CDC guideline to limit, discontinue, or taper a patient's opioids. The AMA stated: "It is clear that the CDC guideline has harmed many patients."
Based on another guideline recommendation, many physicians are aggressively reducing or "tapering" long-term patients with chronic pain, sometimes at a dangerously fast rate. The main reasons doctors give for tapering are opioid guidelines, policies, and concerns about liability. In 2019, the Food and Drug Administration took the unusual step of warning doctors that sudden discontinuation of opioid pain medication should be avoided.
A recent study of more than 100,000 patients receiving opioids long-term for pain sought to determine the effects of tapering. The results were shocking. The authors found a 68 percent increase in overdoses and a doubling of mental health crises in tapered versus non-tapered patients. Tapering also causes desperate patients unable to get pain control from their physician to "self-medicate" by obtaining heroin or illicit fentanyl, often with tragic results.
Another heartbreaking outcome of improper tapering is suicide. Although the CDC overdose death data include suicides, it is likely that suicides are undercounted. One study found that up to 30 percent of all "accidental" overdoses are suicides. In 2020, there were over 45,000 deaths listed as suicides in the United States. Adding a significant percentage of the 100,000 overdose deaths would generate an extraordinarily high number clearly indicating that many people in our country are suffering. And these numbers don't include the millions of individuals whose poorly controlled pain causes extreme anxiety, depression and decreased quality of life.
The CDC guideline was never supposed to apply to cancer or end-of-life care. Sadly, even patients with a terminal prognosis and uncontrolled pain have not been spared the cruelty of the opioid crackdown. A recent study of older patients dying of cancer found a substantial reduction in the number and strength of opioid prescriptions, especially those for long-acting opioids. One consequence was a 50 percent increase in pain-related emergency department visits.
Overzealous policies to limit opioids have significantly hampered pain control for 18 million patients with moderate to severe chronic pain. Besides the CDC guideline, Drug Enforcement Administration criminal investigations, state prescription drug monitoring programs, Medicare reimbursement policies, pharmacy and insurance limits on prescriptions, and policies of hospitals and physician groups have directly or indirectly reduced access to opioids by law-abiding patients. All these policies should be reevaluated and modified or discontinued as necessary.
The CDC is expected to release a revised guideline on opioid prescribing sometime in 2022, but suffering patients cannot wait until the CDC issues a new guideline for physicians. The CDC should immediately rescind its 2016 guideline, thereby reaffirming the first principle of medical ethics: First, do no harm.
Mark A. Rothstein is the Herbert F. Boehl Chair of Law and Medicine and Director of the Institute for Bioethics, Health Policy and Law at the University of Louisville School of Medicine. Julia Irzyk, a graduate of Georgetown University Law Center, is an advocate for individuals with disabilities and coauthor of "Disabilities and the Law" (Thomson Reuters 2021).