“We conclude,” the doctors wrote in a letter to the editor, “that despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction.”
Nearly four decades later, Jick said he regrets that he and Porter ever published their work. But they are hardly to blame for what would come.
Pain, Pills, and Death
An estimated 100 million Americans live with long-term pain. For decades, medicine’s overwhelming response has been prescription opioids like hydrocodone and fentanyl. Retail pharmacies dispensed more than 214 million opioid prescriptions in 2016. That’s more than 66 prescriptions for every 100 people and more prescriptions than any other country in the world.
And it started with the mistaken idea that opioids were not addictive.
There’s plenty of blame to go around, from companies that used questionable marketing to make opioids the go-to for pain treatment, to the doctors who failed to change their habits even as patients’ bodies piled up, to the insurance companies that may not cover alternatives to opioids.
Because the drugs are so addictive, some patients, too, played a role in the crisis. Lax regulation and tracking allowed some to “doctor shop”: If one doctor refused to prescribe opioids, there’s another just down the street who might.
War on Pain
In their 1980 study, Jick and Porter wanted to find out whether hospital patients who received narcotics for acute pain for a short time became addicted to them. They reviewed the medical records of about 39,000 hospital patients. Nearly 12,000 of them received opioids while they were in the hospital. Four developed addiction to them. They reported their findings in a letter to the editor in the New England Journal of Medicine.
A 1986 study in the journal Pain, which observed 38 patients, concluded again that opioid addiction was extremely rare.
“If we were talking about (blood pressure) medication, doctors would want rigorous evidence from long-term trials. We were ready to use opioids more freely before we had that data. I’d say physicians should take some of the responsibility,” says William Becker, MD, a core investigator in the Pain Research, Informatics, Multimorbidities & Education (PRIME) Center of Innovation at the VA Connecticut Healthcare System in West Haven, CT.
The ‘Fifth Vital Sign’
Around the same time, the medical community started paying more attention to the treatment of pain.
In the 1980s, the HIV epidemic called the medical profession’s attention to the under treatment of pain. “It triggered a worldwide outcry about the underutilization of opioids in the treatment of pain and how doctors needed to do a better job of treating chronic pain,” says Walter Ling, MD, a psychiatrist and founding director of the Integrated Substance Abuse Programs at the University of California-Los Angeles.
In 1996, increasing concern about untreated pain led the American Pain Society, a group of health care professionals and scientists that promote changes in public policy and medical practice to reduce pain-related suffering, to declare pain the “fifth vital sign.” That suggests it’s just as important for health care professionals to evaluate and address pain in every patient visit as it is to address the four common vital signs: temperature, pulse, breathing rate, and blood pressure.
While patients’ perception about their own pain is important, there is no test or instrument to verify it.
“Of course, pain is not a vital sign. There’s no objective test for it,” Tobin says. “We only have patients’ self-reports.”
That same year, Purdue Pharma released a new opioid prescription medication called OxyContin. In the 1998 OxyContin promotional video “I Got My Life Back,” targeted at doctors, a doctor explains that opioid painkillers are the best pain medicine available, they have few if any side effects, and fewer than 1% of people who use them get addicted.
At the same time, drug reps were everywhere. They traveled from clinic to clinic, promoting their drugs while offering doctors gifts such as travel and lodging at expensive medical conferences in exchange for a visit to their booth. “They were literally throwing money at us,” says Joji Suzuki, MD, a psychiatrist who specializes in substance abuse at Brigham and Women’s Hospital in Boston. “These were the Wild West days when drug reps had free rein.”
Other Options Cheaper, Safer
Opioid painkillers aren’t the only pain medications available. They were just more aggressively marketed. Studies have shown that over-the-counter ibuprofen or a combination of ibuprofen and acetaminophen may treat pain better than opioids. Topical creams, certain antidepressants called SNRIs, and nerve pain medications such as gabapentin can ease chronic pain in some people, too. Other therapies, like yoga, acupuncture, physical therapy, and exercise, have also shown benefit for some.
While opioid manufacturers were “educating” doctors, American medical schools offered little or no training in the management of long-term pain. In 2010, only 1 in 5 American medical schools had any formal instruction on the topic. Among those, some schools required fewer than 5 hours of instruction. “In the absence of adequate education, pharmaceutical manufacturers stepped into the void with the message that long-term opioids were unquestionably safe and effective,” Becker says.
In 2003, the FDA warned the company its advertisements and promotional materials, which claimed OxyContin was less addictive than other opioids, were breaking federal law.
Today, Purdue Pharma publicly supports state and federal programs to fight the opioid epidemic, including encouraging prescribers to consult prescription-drug-monitoring program databases and repeating the CDC’s call to shorten the duration of first opioid prescriptions. The drug company distributed the CDC’s guidelines to prescribers and pharmacists when they were first released.
Both the Veterans Administration and the Joint Commission, the independent organization that accredits American hospitals, had also declared pain the fifth vital sign. Health care professionals took notice when, soon after, a doctor was fined $1.5 million for under treatment of pain in an 85-year-old patient who died of lung cancer. “Under treatment of pain became a form of malpractice, of medical abuse,” Ling says.
By 2006, the Centers for Medicare and Medicaid Services launched a patient-satisfaction survey that would affect how much reimbursement hospitals got. Among other questions, the survey asked patients whether their pain was well managed.
“It behoved hospitals to push opioids as much as they could to keep patients happy,” Becker says.
A Way Forward?
Though opioid prescribing is still high, it peaked in 2010 and has continued to fall. In 2014, there was a steeper decline in opioid prescriptions after new laws took effect that required patients to see their doctor every time they wanted a refill of certain painkillers, Jones says.
The requirement made it a little harder for people to get opioids, and it may have raised doctors’ awareness of how much of the medication their patients were taking.
“We need to find a middle ground,” says Tobin, “where we’re being deliberate and careful about prescribing.”