In March 2016, the Centers for Disease Control and Prevention (CDC) issued a new set of guidelines for prescribing opioids for chronic pain.1 In April, several health care organizations, led by Physicians for Responsible Opioid Prescribing, petitioned the Joint Commission for Accreditation of Health Care Organizations, calling for “an end to mandatory pain assessment,” suggesting that this practice “foster[s] dangerous pain control practices,” leading to overprescription of opioids.2 These actions reflected a reversal in the trend toward more liberal prescribing of opioids for nonacute, nonterminal pain; but far from resolving this long-disputed question, they only signaled a new round of the debate.
“We must appreciate that severe constant pain will destroy the morale of the sturdiest individual. . . . But . . . we are often loathe to give liberal amounts of narcotics because the drug addiction itself may become a hideous spectacle,” surgeon Warren Cole wrote 60 years ago in a small book on cancer pain.3 Cole’s dilemma was reflected daily in doctors’ offices and inpatient wards across the United States through the 1970s; physicians and nurses were trained to give minimal opioids for pain, often even less than prescribed, unless death seemed imminent. Chronic pain, a few studies noted, was badly undertreated, in part because of the “special emotional significance [of opioids] that interferes with their rational use.”3
Kathleen Foley at Memorial-Sloan-Kettering Cancer Center in New York City was one of a small group of pain management specialists to whom the strictures against opioids made little sense. Foley was influenced first by the work of her mentor Raymond Houde, whose extensive crossover studies of analgesics in cancer patients had repeatedly shown the superiority of morphine and challenged the “misconception that drugs with this capability enslave, demoralize, and lead the unwitting patient down the primrose path to addiction.”3 She was also impressed by the hospice studies of Cicely Saunders and Robert Twycross in the United Kingdom, who used regular heroin dosage to “[free the patient] from the day- and nightmare of constant pain,” which they viewed as far more disabling than dependence on the drug.3
Foley published two highly influential articles in 1981 and 1986, reporting on the low incidence of addictive behavior in small groups of cancer and noncancer patients. These articles, along with a one-paragraph 1980 letter reporting addiction to be rare among inpatients, became the rather fragile foundation of a 20-year campaign for the long-term use of opioids in chronic noncancer pain led by Foley and her close colleague Russell Portenoy. As Foley pointed out, there were “no published long-term data” that gave evidence of high addiction rates among pain patients; but there had been in fact no long-term controlled studies of opioids for chronic pain at all. Furthermore, Foley and Portenoy observed that “the intensive involvement of a single physician” was essential to successful treatment; the prescription alone was not enough.3
For many physicians and chronic pain patients, however, the idea that long-term opioids were potentially safe and that patients could be trusted to manage their prescriptions was a welcome revelation. As one patient stated, “The doctor trusts me . . . he’s also given me back my self-esteem and the ability to control myself. I’m empowered.”4 Opioid manufacturers such as Purdue Pharma supported presentations by Portenoy and other respected authorities championing chronic opioid therapy; when the US Drug Enforcement Administration prosecuted physicians who wrote high-dosage prescriptions, some for known addicts, colleagues rallied to their defense in the media and in medical journals.4
The dimensions of the problem were and are immense. An estimated 25 million adult Americans, according to the most recent data, suffer daily from pain, and 23 million others suffer from severe recurrent pain, resulting in disability, loss of work productivity, loss of quality of life, and reduced overall health status. The best-known alternative to opioids is a multidisciplinary team approach involving reliance on physical and psychological therapies, including cognitive-behavioral therapy, relaxation and pain coping skills training, and self-hypnosis. While such methods can be highly successful, many third-party payers regard them as too costly; insurance coverage is usually inadequate, and only major medical centers can support such programs. Fewer than 200 000 patients currently participate in multidisciplinary treatment.
But even among pain management specialists, many challenged the idea that chronic opioid therapy was safe, pointing to continuing instances of addictive behavior; the danger of overdose and risks not just of minor side effects, but of cognitive damage; and mirroring Foley’s argument back to her, the lack of randomized controlled trial evidence supporting long-term treatment. The debate created an ongoing and serious fracture within the field.
The fracture became a seismic shock in the 2000s when Purdue’s aggressive marketing of its controlled-release opioid Oxycontin as safe for chronic pain intersected with the trafficking of cheap, very pure heroin in smaller cities across the West, Midwest, and Appalachia. Purdue advertised Oxycontin as nonaddictive because the drug was released within the body over 12 hours; recreational users quickly learned to get high by crushing or dissolving the pills, or simply taking very high doses. Overstressed and well-intentioned general practitioners, and a number of unscrupulous “pill mill” operators, wrote liberal prescriptions for the new analgesic. The ready supply of Oxycontin made diversion and sale, particularly by low-income patients on Medicaid or Medicare, attractive and easy; but when pill addicts found their drug too expensive, they sought an alternative. Traffickers of black-tar heroin had meanwhile arrived in Middle America with a new marketing approach, driving to meet buyers in safe locations and offering inexpensive product, often giving free samples to encourage customer loyalty.6 “When you’re paying 40 dollars a pill and then you hear you can pay 10 dollars for the same effect, of course you’re going to do it.” Hundreds of Oxycontin abusers, many of them middle-class adolescents and young adults, began to see heroin as “a less and less scary and taboo thing.”7 The result has been an alarming increase in heroin use across the country and an epidemic of drug overdose deaths, which increased 137% between 2000 and 2014; overdoses involving prescription opioids and heroin increased 200% in that period.
Many who championed liberalized opioid therapy for chronic pain, including Portenoy, have now retreated from that position, acknowledging that their stance led to unanticipated abuse and tragedy. But as the CDC guidelines demonstrate, patients with severe chronic pain will still need opioids, and physicians will be called on to prescribe it, albeit with more caution and as Foley and Portenoy wrote 30 years ago, the physician’s “intensive involvement.” Prescription under strict guidelines may finally provide the evidence for or against long-term opioid therapy for chronic pain that has been so long lacking. In its absence, the availability and use of opioids, with often deadly results, has been too far governed by other factors: the shrewd targeting of a market niche by a pharmaceutical manufacturer, the cost-benefit calculations of insurance carriers, and the creative entrepreneurship of drug traffickers.