March 14, 2018 -- In 1980, Jane Porter and Hershel Jick published in a prominent medical journal the results of their study of pain among hospital patients.
These simple words about patients who took opioids would be used -- and misused – for decades:
“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.
In 2015, a reported 2 million Americans ages 12 and older were addicted to prescription pain relievers. In 2015 and 2016, nearly 117,000 Americans died from opioid overdoses. That’s more than the number of U.S. soldiers killed in the Korean, Vietnam, Iraq, and Afghanistan wars combined.
The numbers are so massive, they’re hard to comprehend. They have led dozens of cities and states, joined by the U.S. Justice Department, to sue opioid manufacturers and distributors as the federal government tightens regulations on opioid prescribing and calls the epidemic a public health emergency.
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.
The patients that Porter and Jick observed “weren’t being treated with chronic opioid therapy for chronic pain, so the observation had no bearing at all on the risk of developing addiction” with chronic use, says Daniel Tobin, MD, medical director of Adult Primary Care at Yale-New Haven Hospital in New Haven, CT. He focuses on long-term pain management and opioid safety. “But this letter to the editor became doctrine.”
A study found that Porter and Jick’s five-sentence letter was cited 608 times in support of opioids. In 80% of those citations, the authors did not note that the patients received the drugs in the hospital.
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.
OxyContin, originally sold in 80 milligram tablets, was appropriate, its label said, “for the management of moderate to severe pain where use of an opioid analgesic is appropriate for more than a few days.”
“The drug companies were ‘educating’ the doctors,” Ling says. “But there’s a very thin line between educating doctors and promoting your product.”
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.
“The combination in these advertisements of suggesting such a broad use of this drug to treat pain without disclosing the potential for abuse with the drug and the serious, potentially fatal risks associated with its use, is especially egregious and alarming in its potential impact on the public health,” the agency wrote.
In 2007, the company agreed to pay $634 million to settle criminal and civil charges over its “long-term illegal scheme to promote, market and sell OxyContin,” according to an FDA press release issued at the time.
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.
“Our industry and our company have and will continue to take meaningful action to reduce opioid abuse,” the company says in a statement. The company says it supports efforts to limit the length of first prescriptions of opioids and vows to continue research into new, non-opioid pain medications.
But the horse was already out of the barn before the FDA’s warning to Purdue Pharma in 2003.
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.
As of October 2017, in response to comments from doctors, the U.S. Department of Health and Human Services no longer considers hospitals’ pain management scores on patient satisfaction surveys in its reimbursement decisions for Medicare and Medicaid patients. The agency also plans to take another look at pain management survey questions and may revise them, says Jones.
These policy changes are intended to cut prescribing but not end access to the drugs altogether. “There are patients who do benefit from opioids,” says Daniel Tobin, MD, medical director of adult primary care at Yale-New Haven Hospital in New Haven, CT. He focuses on long-term pain management and opioid safety. “For those patients who benefit without evidence of harm, you don’t need to just take it all away. I would hate to see the pendulum swing too far.”
But there is some evidence that the proverbial pendulum has already begun to swing too far, according to a recent article in The New England Journal of Medicine. “The increase in opioid-related mortality fueled by injudicious prescribing and increasing illicit use of both prescription and illegal opioids has led some clinicians to simplify their lives by discontinuing prescribing of opioid analgesics,” the authors of the article write.
The authors say that halting opioid prescribing altogether would cause patients to suffer and could push some to seek out illegal opioids, like heroin, on the street.
“We need to find a middle ground,” says Tobin, “where we’re being deliberate and careful about prescribing.”