This is the first piece in a four-part series about the negative effects and unintended consequences of government policies regarding prescription opioids.
The number of accidental drug overdose fatalities crossed 100,000 in 2021, an increase of almost 15% over the previous year, which itself was an increase of 30% over the year before. The Centers for Disease Control and Prevention (CDC), in its press release, called these deaths “opioid overdoses.” This framing of drug overdose fatalities as an “opioid crisis” is both misleading and counterproductive. The term “opioid” evokes prescription medications in popular imagination and ramps up fear of medications that have been used for centuries. The overdose death numbers, however, mostly reflect street drugs, ranging from heroin to illicit fentanyl analogs; 85% of 2019 deaths were from these drugs, and the increase in 2020 can be attributed almost entirely to them.
The conflation of all opioids has resulted in an unwarranted focus on prescription opioids and medical use as the root cause of the “problem” of accidental drug overdoses, even though overdose deaths from prescription opioids are a small and decreasing fraction of the total. The result is policies that fail to address the problem they were intended to solve—illicit drug use and accidental drug overdoses. Further, these policies have harmed medically fragile patients with chronic, high-impact, intractable pain who need prescription opioid medication to maintain quality of life and basic function levels.
Why did a narrative that is at odds with science become dominant, despite the harm it causes to people with substance use disorder and to medically fragile patients? The answer lies in the complex incentives that face policymakers, law enforcement and families of overdose victims, particularly as illicit drugs have edged into upper-income suburbs. The result of the “opioid crisis” narrative has been disastrous for the most vulnerable and powerless: Americans struggling with complex medical conditions and constant pain.
The Tidy but Inaccurate Narrative
The dominant narrative runs something like this: Doctors overprescribed opioids from the late 1990s through approximately 2012, resulting in addiction to prescription painkillers. When prescriptions ran out, these patients turned to street drugs. This overprescribing was responsible for an increase in substance use disorder rates and overdose fatalities. The appropriate policy response was, therefore, to tighten restrictions on opioid prescribing. Very plausible, very straightforward—and almost entirely contradicted by the facts.
According to the U.S. Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health, substance use disorder rates have remained steady; if anything, the rate of illicit drug use disorder declined slightly, from 1.2% in 2002 to 1.0% in 2014. A significant body of peer-reviewed medical literature suggests that it is recreational use of alcohol and other factors, not taking prescribed opioids, that play a role in developing substance use disorder.
Medical use often results in dependence, but rarely in substance use disorder. Many classes of medicines result in physical dependence—statins for hypertension, gabapentin for neuropathy and a host of others. Dependence simply means that stopping the medication requires a gradual taper to prevent unpleasant side effects. I was involuntarily tapered off my opioid prescription, but it was done carefully. Consequently, I suffered the return of pain, but nothing else. Substance use disorder, by contrast, is complex, and the National Institute on Drug Abuse defines it as “compulsive use despite harmful consequences.”
In a study of all accidental overdose fatalities in Massachusetts, only about 1% of those who died had had a prescription for an opioid. Studies from other states, such as Tennessee and North Carolina, where even fewer decedents had opioid prescriptions, confirm that accidental overdoses tend to be the result of using or abusing multiple substances. Focusing on prescription opioids is unlikely to get at the real root of the problem.
Further, data from the CDC show that cuts in opioid prescribing did not result in fewer overdose fatalities. Instead, overdose fatalities have continued to rise, even as opioid prescriptions have declined by more than 60% since their peak in 2012. If anything, this number understates the decline in prescriptions because refills are no longer permitted on opioid prescriptions. So, what would have been one prescription with two refills in 2012 is now three prescriptions, with each one generally requiring a separate doctor’s visit.
Most overdose fatalities are caused by illicit fentanyl analogs; they were responsible for more than 70,000 of 107,000 such deaths in 2021. Fentanyl is a synthetic opioid that is available by prescription, but these “fentalogues” are not prescription opioids—they are never a part of the medical/pharmaceutical distribution system. They are street drugs, distributed through illicit channels. It makes no sense for the government to monitor physicians, patients, pharmacies and prescription records; it is akin to searching for keys lost in an alley under the streetlight, not because the keys are likely to be under the light but simply because it’s easier to search there.
Nonetheless, the push to restrict prescription opioids is strong and multi-pronged: It comes from elected officials, law enforcement, regulators, advocates for drug control and even the media. News stories report prescriptions in terms of billions of pills, even when a rough breakdown of the numbers gives a result of 1.5 pills per day per high-impact chronic pain patient, at the very most; the actual numbers are likely much lower. Or the media report stories of police officers needing treatment for fentanyl exposure just by being in the same room, despite the fact that adverse effects from such “exposure” are chemically impossible.
Baptists and Bootleggers
In creating morality-based public policies, seemingly strange alliances can emerge. Economist Bruce Yandle calls this the “Baptists and bootleggers” phenomenon. Baptists favored Sunday closure of liquor stores due to their principles; bootleggers because it increased their liquor sales; elected officials and law enforcement because the prohibition was visible and easy to administer. But the result of such laws was greater consumption of bootlegged, and presumably less safe, liquor. The same is true with respect to opioid policy.
Placing restrictions on opioid prescriptions is an easy and visible policy move for elected officials, signaling their serious intent to tackle the “opioid crisis.” Prescriptions are easily tracked, and restrictions are relatively easy to enforce. Further, it is not government officials who bear the costs of enforcement, but rather patients, physicians and other providers such as pharmacists.
Law enforcement, from the federal Drug Enforcement Administration to local police, also finds it easier to focus on prescriptions than street drugs. Federal law has been regrettably vague on what exactly is punishable in terms of opioid prescribing for the past 46 years. The term “overprescribing,” or prescribing “outside the usual course of professional practice,” had never been defined as a matter of law until the U.S. Supreme Court handed down its decision last month in Ruan v. United States. Prior to this decision, the DEA was free to decide what constituted prescribing outside “the usual course of professional conduct,” giving the agency broad discretion.
The DEA and other law enforcement agencies track prescribing levels through the Prescription Drug Monitoring Program (PDMP), which is managed by the states. Law enforcement can access healthcare information in the PDMP without getting a warrant or showing probable cause in the majority of states. Law enforcement also does not typically distinguish between specialties, although, for example, palliative care physicians typically prescribe higher levels of opioids than pediatricians.
Further, suspicion of unlawful prescribing has been sufficient to trigger civil asset forfeiture, allowing law enforcement to seize the physician’s assets—not just the medical practice, but the family home, vehicles and retirement funds. Acquittal was not sufficient to reverse the forfeiture; in 2017, Michigan physician Joseph Oesterling needed a separate court order to get the DEA to return $6 million of assets previously seized.
The “Baptists” in this scenario are families who have lost someone to addiction or people in recovery; they tend to push for greater restrictions on prescription opioids. Shatterproof and the HOPE network are examples of such organizations. They fail to either see or acknowledge the harm their policies might cause, focusing instead on their personal experiences.
Another influential group in this mixture of Baptists and bootleggers is Physicians for Responsible Opioid Prescribing (PROP). The one opioid PROP favors is buprenorphine, which is generally prescribed as a treatment for heroin and methadone dependence. It can also be used as a pain reliever, but patients develop a strong physical dependence rapidly, and, like all medications, it is effective only for a limited population. PROP has an extraordinary influence in policy, from its input into the CDC’s 2016 Opioid Prescribing Guideline, to the revised guideline the CDC is considering currently, to the testimony of senior PROP members on behalf of the states in ongoing multistate opioid litigation.
Meanwhile, the illicit drug trade has flourished—the equivalent of bootlegging during Prohibition. As the DEA itself reports, the fentalogue supply increased more than 18-fold between 2014 and 2019, and the associated deaths increased more than tenfold. Meth, cocaine and heroin continued to flow into the country as well, contributing proportionally to accidental overdose fatalities. Prescription opioids were the only category in which accidental overdoses decreased—but other deaths might well have increased as pain patients were cut off from their medication.
The benefits of these restrictive opioid prescription policies are quite concentrated, while the burdens are diffused among millions of pain patients, physicians and other healthcare providers. Restrictions on prescriptions are easy for government officials to announce and enforce. Civil asset forfeiture—in which the confiscated assets of offending individuals are added to the law enforcement agency’s budget—is a powerful incentive to pursue prosecution of physicians. These benefits are large and concentrated among a small group of powerful interests, which strengthens the incentive to keep such policies intact.
The Burden on Pain Patients
The costs of restrictive opioid prescription policies are dispersed over a large group of people—perhaps as large as 50 million Americans who suffer from some degree of chronic pain. At least 20 million Americans depend on opioids to maintain quality of life as they cope with high-impact chronic pain. And these Americans are both vulnerable and largely powerless.
High-impact chronic pain covers a wide range of diagnoses. Most of these diseases are progressive, and they can only be managed, not cured. Diagnoses can include sickle cell anemia, Ehler-Danlos syndrome, complex regional pain syndrome, fibromyalgia, trigeminal neuralgia, cluster headaches, hemiplegic migraine and a host of other debilitating conditions.
The tightening restrictions have forced millions of people who suffer from these conditions to stop taking the opioid pain relievers they need. Often, these forced tapers are extremely rapid. Unrelieved pain following a forced taper is disastrous for quality of life. Too often, it is fatal. As of now, at least 10 studies document adverse effects from forcing chronic pain patients to stop opioid therapy.
Patients who still have access to opioid medication have to meet onerous and expensive requirements, such as monthly doctor visits, monthly drug testing and random pill counts. The cost of these restrictions is high, but organizing a large, dispersed group to advocate for themselves is difficult—perhaps almost impossible for chronic pain patients, who are already dealing with complex medical conditions, constant pain and limited financial resources.
Adding insult to injury, I found out that, at least in Virginia, opioids prescribed to your pet also go on your PDMP report, without distinguishing the prescriber. This can make obtaining prescriptions more difficult through an obscure, opaque metric called the Narxcare Score, which is supposed to measure patient risk factors in prescribing controlled substances such as opioids. How the Narxcare Score works is obscure, but it is easy to visualize a situation where your medication might prevent you from getting appropriate care for your pet—or, conversely, where your pet’s prescriptions might make it harder for you to obtain your own. This surely was not the intended effect of Virginia’s policy, but it was entirely foreseeable.
Patients and Disabled Individuals Are Not Acceptable Collateral Damage
Current policies, driven by the “War on Drugs,” have become a war on pain patients, their physicians and even their pets. The narrative of “dangerous opioids,” where street drugs and medical use are conflated, persists despite scientific and medical evidence of sharp distinctions between medical and nonmedical users. Worse, dependence is increasingly being swept into a single category of “abuse and dependence” in newer studies and data. This erases the critical difference between physical dependence, which is a common side effect of many medications, and substance use disorder, a complex condition that occurs in a relatively small share of the population.
As the CDC ponders the latest iteration of its opioid prescribing guideline, it cannot ignore how the DEA and other law enforcement agencies really used its 2016 guideline. The guideline provided the wrong incentives to law enforcement personnel, encouraging them to pursue physicians and patients with a legitimate need for opioids, instead of the dealers of illicit drugs who are responsible for the vast majority of opioid-related deaths.
Any new guideline the CDC issues should be in line with the Ruan decision. Rather than focusing on the relatively small risk of addiction, the CDC should consider the large risk of untreated pain—and leave decisions about the best types and doses of medication to the treating physician and the patient.