Few people would dispute that the US has an opioid problem. It is estimated that more than 100,000 Americans are dying every year from drug overdoses, and opioids are by far the most common culprit. Some 3 million US citizens suffer from opioid use disorder, and death and addiction take a toll on not only users but their families, friends, workplaces, and communities. For example, opioid use in households is responsible for about one-third of foster care placements. We can all agree that such figures point to a crisis. The origins of the crisis are less clear. Ironically, many addictions can be traced to policies and practices in our healthcare system that actually put people in harm’s way—a stark warning that people and organizations with good intentions can go badly wrong.
Opioids get their name from the opium poppy plant. Opiates refer to drugs derived from it, such as morphine, named after Morpheus, the Greek God of sleep. Opioids include both opiates, semi-synthetic opiates such as heroin, and highly potent synthetic compounds such as fentanyl. Opioids bind to endogenous receptors in the brain, where they have two principal effects: analgesia (pain relief) and euphoria. They can also cause side effects, such as nausea, itching, and constipation. Overdoses suppress breathing, leading to death by suffocation. The desirable effects of opioids tend to fade with time, requiring an escalating dose, a phenomenon known as tolerance. With time, dependence develops, meaning that a person needs to keep taking the drug to avoid withdrawal symptoms such as anxiety, gastrointestinal distress, and a racing heart. Those who develop addiction feel compelled to take the drug.
One of the most notorious actors in the opioid epidemic has been the Stamford, Connecticut-based firm Purdue Pharma. Purdue manufactured several important opioid pain relievers, including hydromorphone, codeine, and most prominently, oxycodone. In 1995, the company touted its new long-acting formulation of oxycodone, OxyContin, as less subject to addiction and abuse. Between 1996 and 2003, the company funded tens of thousands of educational programs designed to convince health professionals that pain was being undertreated, that opioids were far safer and more appropriate than many believed, and that the use of opioids should be expanded far beyond advanced cancer pain, the indication with which most health professionals were familiar. One of the most common such programs was speaker bureaus, which paid health professionals to spread the opioid gospel.
Among the healthcare organizations with which Purdue partnered and to which it provided funding were the American Academy of Pain Medicine, the American Pain Society, the Federation of State Medical Boards, and the Joint Commission, which accredits hospitals and healthcare organizations—generally trusted clearinghouses for information that often spearhead initiatives within the profession. New terms were introduced to advance this effort, including “opiophobia,” implying that health professionals and patients needed to overcome their irrational fear of opioids. One 2002 two-page ad in the Journal of the American Medical Association displayed a man and a boy in fishing gear next to the headline, “There Can Be Life with Relief,” and stated that “Purdue is fully committed to maintaining the highest standards of marketing practices in the industry, while continuing to advance the proper treatment of pain in America.” Who could object to helping patients in pain?
Yet the profession of medicine proved to be less skeptical than it should have been. For example, in 1995, a respected neurosurgeon delivered his presidential address to the American Pain Society, entitled, “Pain is the Fifth Vital Sign.” For many years, health professionals had measured heart and respiratory rate, blood pressure, and temperature. Now, they would start assessing pain with the “same zeal,” taking full advantage of opioids for patients with all kinds of pain. In an effort to enhance pain’s recognition and treatment, the Joint Commission adopted this campaign. All healthcare institutions were required to identify patients with pain in an initial screening assessment and to “recognize the rights of patients to appropriate assessment and management of pain.” Many other health professionals swallowed such arguments hook, line, and sinker.
Federal healthcare payers did the same. For example, hospitals were required to survey patients concerning whether they “never, sometimes, usually, or always” received adequate pain control. Likewise, they were required to inquire whether members of the hospital staff “never, sometimes, usually, or always” did “everything they could to help you with your pain.” Seeking to avoid the stigma and penalties that might be associated with poor performance, hospitals made pain assessment and treatment a high priority, disincentivizing and even terminating employees whose response to patient pain was deemed inadequate. Of course, one problem with such programs is the fact that pain is a largely subjective experience. It is possible to assess the other four vital signs objectively and quantitatively, but pain levels were typically assessed by simply asking patients to rate their pain on a 1-to-10 scale.
Purdue and other pain control advocates made liberal use of a study published in 1980 in the New England Journal of Medicine, which purportedly showed that the risk of opioid addiction had been dramatically overstated. The article was cited for this purpose in the professional literature well over 1,000 times. In fact, however, the “article” was actually a five-sentence letter to the editor reporting that, in a retrospective review of nearly 12,000 patients who received opioids while in the hospital, only four developed a documented addiction. Soon health professionals were being told that the rates of addiction with opioid use were well below one percent. More recently, the journal added an editor’s note stating that the letter has been “heavily and uncritically” cited. The senior author has stated publicly that he is “mortified that this letter to the editor was used as an excuse to do what the drug companies did.”
Professional organizations charged with improving medical practice and protecting the public can be misled. Because they wield substantial power in concentrated form, the multiplicative effect of their errors can wreak great harm
Misgivings notwithstanding, such marketing campaigns proved spectacularly successful. From 2000 to 2011, the number of prescriptions for some manufacturers’ opioid drugs more than quadrupled. Rates of admission to substance abuse treatment programs and opioid-related deaths began to climb apace. The problem was not merely an increase in the number of prescriptions but increases in their strength in the form of escalating dosages. And the effects were far more dire for some groups than others. For example, the adolescent brain is still developing in ways that both make it more difficult to resist impulses and enable opioids to override the sense of reward that comes from other activities such as school performance. As a result, adolescents who use opioids are more likely to become addicted.
As attention to the opioid crisis grew, many health professionals started writing fewer opioid prescriptions, leading patients to shop for prescribers. Some sought out high-volume “pill mills,” which enabled them to supply their own addiction and obtain pills to sell on the black market. Drug enforcement officials closed many such operations, and some health professionals were prosecuted for their conduct. As the crisis worsened, states began creating prescription drug monitoring programs that tracked patients obtaining opioids from multiple prescribers. Ironically, such efforts left many patients without access to prescription opioids, with the result that many turned to illicit drugs such as heroin, which was both more readily accessible and less expensive. More recently, heroin has largely been replaced by far more potent opioids such as fentanyl.
Of course, the opioid crisis is not entirely rooted in good intentions. Numerous opioid manufacturers and distributors have been named in lawsuits. Plaintiffs allege that the companies overstated the benefits of opioids and downplayed risks of addiction, made inappropriate payments to physicians and scientists to promote their products, funded professional organizations that presented an incomplete and biased view of the risks of opioids, and failed to monitor and respond to excessive opioid prescribing, allowing the diversion of billions of pills to the black market. In 2021, AmerisourceBergen, Cardinal Health, Johnson and Johnson, and McKesson agreed to a settlement with state attorneys general that will require them to pay $26 billion. A proposed settlement with Purdue Pharma was overturned in federal court because it would have released the Sackler family, which owns the company, from liability.
Legal action has also included criminal prosecution. The founder and four executives at Insys Therapeutics were convicted of bribing health professionals and lying to insurers about patients’ medical conditions. The government charged that the company’s speaker program functioned as a scheme for paying kickbacks to targeted health professionals who wrote more prescriptions and increased dosages. The founder had ordered the company’s vice president of marketing to tally up the amount of money the company paid each speaker and the amount of revenue each generated in prescriptions, to determine if each had a “positive return on investment.” The founder was sentenced to 66 months in prison. Shortly after the company agreed to pay a $225 million fine, it declared bankruptcy. Said the prosecutor, “This is about making the next company think twice about victimizing the public.”
These civil and criminal proceedings have captured the public’s attention. But they shouldn’t obscure our view of subtler but ultimately even more damaging mistakes. Pain is not a vital sign, opioids are not effective in long-term pain relief for most patients, many patients who take opioids for a prolonged period will become addicted, and the respiratory depressant effects of opioids, especially very powerful ones such as fentanyl, quickly turn tiny overdoses into fatalities. How did errors on these matters become embedded in medical practice for years? Partly because trusted organizations were taken in by false claims.
Health professions organizations charged with improving medical practice and protecting the public can be misled. Because they wield substantial power in concentrated form, the multiplicative effect of their errors can wreak great harm on patients and communities. Only by learning from such mistakes can we avoid inflicting harm from good intentions. Among the lessons: centralized organizations typically grasp local realities poorly, unintended and unforeseen consequences are unavoidable, and when magnified to a national level, poorly conceived policies only inflict harm on a national scale. At the very least, innovations should be thoroughly tested at local and regional levels before we scale them up to national policy.
At every level, a healthy dose of skepticism is just what the doctor needs to order.
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