Sweeping changes in chronic pain

Carol and Hank Skinner of Alexandria, Va., can talk about pain all day long.

Carol, 77, once had so much pain in her right hip and so little satisfaction with medical treatment she vowed to stay in bed until she died.

Hank, 79, has had seven shoulder surgeries, lung cancer, open-heart surgery, a blown-out knee and lifelong complications from a clubfoot. He has a fentanyl patch on his belly to treat his chronic shoulder pain. He replaces the patch every three days, supplementing the slow-release fentanyl with pills containing hydrocodone.

But to the Skinners’ dismay, Hank is now going through what is known as a forced taper. That’s when a chronic pain patient has to switch to a lower dosage of medication. His doctor, Hank says, has cut his fentanyl dosage by 50 percent — and Hank’s not happy about it. He already struggles to sleep through the night, as Carol can attest.

“He’s moaning, he’s groaning, he’s yelling out in pain,” Carol says.

“Why am I being singled out? I took it as prescribed. I didn’t abuse it,” Hank says.

He is part of a sweeping change in chronic pain management — the tapering of millions of patients who have been relying, in many case for years, on high doses of opioids. With close to 70,000 people in the U.S. dying every year from drug overdoses, and prescription opioids blamed for helping ignite this national catastrophe, the medical community has grown wary about the use of these painkillers.

Chronic pain patients form a vast constituency in America and millions of them take opioids for relief. Changes in medical guidance covering opioids have left many of them frustrated, confused and sometimes howling mad. They feel demonized and yanked around.

Hank Skinner has been tapered gradually over the course of the year. The situation is worse for people forced to cut back their medication too quickly. Even medical experts who advocate a major reduction in the use of opioids for chronic pain have warned that rapid, involuntary tapering could harm patients who are dependent on these drugs.

There is little doubt among medical experts that opioids have been prescribed at unsound and dangerous levels, particularly in their misuse for chronic pain. But at this point there’s no easy way to dial those dosages back. Long-term use of opioids creates dependency. Tapering can cause extreme pain from drug withdrawal, regardless of the underlying ailment.

The United States is now in the midst of a “national experiment” as misguided as the one it conducted 20 years ago, when doctors put millions of patients on opioids with little understanding of the consequences, says Tami Mark, senior director of behavioral health financing and quality measurement for RTI International, a North Carolina think tank. She has conducted one of the few formal studies of “forced tapering” of opioid patients.

“This national effort at ‘de-prescribing’ is again being undertaken with limited research on how best to taper people off opioid medications,” Mark says. “You can’t just cut off the spigot of a highly addictive medication that rewires your brain in complex ways and not anticipate negative public health consequences.”

Many people who rely on these drugs are scared. In interviews and correspondence with The Washington Post in recent days, chronic pain patients have described their anxiety about the national reversal on opioids. They say they’re not drug addicts or criminals, they’re just people in pain who were following the doctor’s orders.

And then the orders changed.

“I’m scared. I’m scared of the pain. Because it’s coming back now, little by little,” says Nicole Acuña, 41, of Flemington, N.J., who has severe back and neck pain from arthritis and has so far been tapered from 120 milligrams of oxycodone a day to 105, with more tapering coming.

Many doctors have stopped prescribing opioids altogether, and some patients have become “opioid refugees,” traveling long distances to find anyone willing to write a script.

Other chronic pain patients complain of how hard it is to get any pills at all. Pain management clinics have closed. Many doctors have stopped prescribing opioids altogether, and some patients have become “opioid refugees,” traveling long distances to find anyone willing to write a script.

Valerie Nordstrom, 56, of Sandia, Tex., who has been on opioids since a novice driver ran a red light and slammed into her car during her lunch hour eight years ago, is furious that her 30-day opioid prescription can’t be transferred to a different state. That caused her to miss being with her daughter recently when she gave birth.

“I’m angry. I’m hurt. I’m not out there selling my pills. I’m not out there doing anything other than what they’re prescribed for,” Nordstrom said.

Sarah Ward, 37, of Chattanooga, Tenn., has been taking opioids since having complications from ankle surgery in 2011. Last year she was tapered to zero, because her insurance company wouldn’t pay for the drug testing required by the pain clinic.

So she hurts, a lot: “I describe my pain as walking in lava while on fire being dipped in acid and my bones being pulverized by a jackhammer. That’s what it feels like every single second.”

‘An experiment gone wrong’

Pain is not easily measured. The main way doctors gauge the degree of pain is to ask a patient how it rates on a scale of 1 to 10.

In the 1980s and early 1990s, influential researchers and doctors began pushing the idea that opioids had been underused because of their association with street heroin — the drug of “junkies.” They spoke of pain as the fifth vital sign, a measure of health as important as blood pressure, pulse, temperature and respiration. Pain relief became accepted as a fundamental human right.

This philosophical evolution did not take place in a vacuum. A handful of research studies in the 1990s seemed to support a benign view of opioids as a chronic pain treatment, but the research was often funded by drug companies. Some of the most vocal advocates for opioids were doctors who accepted fees from drug companies for speeches.

Some of those companies marketed their opioids aggressively and made false claims about their safety and effectiveness. Pharmaceutical company representatives were regular visitors to the offices of general practitioners, by tradition buying lunch for everyone on the staff.

Documents cited in a massive lawsuit by the state of Oklahoma against Johnson & Johnson showed the company targeted physicians that prescribed high volumes of opioids: “Our objective is to convince them that DURAGESIC is effective and safe to use in areas such as chronic back pain, degenerative joint disease, and osteoarthritis,” the company wrote.

In 1996, Purdue Pharma introduced and heavily promoted OxyContin, a slow-release formulation of oxycodone that soon was bringing in more than a billion dollars of revenue annually — and then two billion. The company claimed OxyContin would be less likely than fast-acting opioids to be abused or lead to addiction.

That underestimated human ingenuity. People discovered that they could crush a pill and snort it for an immediate, powerful high. Or they could mix the crushed powder with water and inject it.

In a plea deal in federal court in 2007, Purdue Pharma and three executives pleaded guilty to deceptive marketing of the drug and paid $635 million in fines. But by that point an entire generation of pain doctors had been trained to view opioids as a safe, effective, relatively nonaddictive treatment for chronic pain from common ailments such as bad backs, torn rotator cuffs, headaches and arthritis — and millions of pain patients had become dependent on opioids.

“You practice according to what you’re taught and according to the textbooks you read and according to the lectures you go to,” said Jane Ballantyne, who came to the U.S. in 1986 from Britain, trained as a pain specialist and became chief of the pain program at Massachusetts General Hospital. “You don’t really have time to look into it deeply. As soon as I began looking it into it more deeply it was clear the evidence is weak.”

What she and many others found was that opioids simply didn’t work very well when it came to relieving pain over long periods of time. Patients developed tolerances and needed greater dosages. Opioid patients weren’t thriving in general.

“It was an experiment gone wrong,” Ballantyne said.

A flood of opioids

In July, The Post published a Drug Enforcement Administration database that revealed drug companies had flooded the U.S. with 76 billion oxycodone and hydrocodone pills in a seven-year period, from 2006 to 2012. The database was unsealed after The Post and HD Media of West Virginia, publisher of the Charleston Gazette-Mail, won a legal battle in connection with a lawsuit against drug companies filed by roughly 2,000 cities, counties and other local jurisdictions and pending in federal court in Cleveland.

Other government records show that individual opioid prescriptions in the United States peaked at 255 million in 2012. After that, the numbers fell steadily, to 199 million by 2017.

As the dosages dropped, drug deaths didn’t, because the epidemic mutated. Some people addicted to the opioid high turned to street heroin when they couldn’t get pills. A surge of heroin into the United States was followed by an even deadlier arrival of illicit fentanyl. In 2017 in the United States, 47,000 people died of opioid overdoses — more than the death toll from traffic accidents, and more than all the gun deaths, including by suicide.

The drug industry now faces a reckoning. A state judge in Oklahoma ruled on Aug. 26 that drugmaker Johnson & Johnson must pay $572 million to the state for the company’s role in the opioid epidemic. The next day came the news that Purdue Pharma has offered to settle state and local lawsuits by paying up to $12 billion and filing for bankruptcy.

Most of the drug companies targeted in lawsuits have mounted a vigorous legal defense, and some have released statements defending their actions and denying that they are the source of today’s opioid drug epidemic. Although the companies do not speak with one voice, in general they have argued that they were manufacturing and selling legal drugs that have legitimate medical uses, and the companies have sometimes blamed the crisis on overprescribing by doctors, illicit diversion to street markets and abuse by patients or recreational drug users.

By October of last year, 33 states had imposed some kind of legal limit on opioid prescribing. In January of this year, Medicare Part D enacted a limit for some new opioid patients. Veterans Affairs reduced the number of patients receiving opioids by 52 percent between 2012 and 2019. Under orders from the DEA, the pharmaceutical industry cut the quantity of opioids it produced by 38 percent between 2016 and 2018.

In March 2016, the U.S. Centers for Disease Control and Prevention published a new guideline on the prescribing of opioids for chronic pain. It proved confusing.

The guideline said doctors should not increase an opioid dose to more than 90 MME (morphine milligram equivalents). But many patients already were taking far more than 90 MME and doctors — thinking the CDC number was a hard cap — were tapering them back to 90.

Hundreds of doctors and other experts, including three former U.S. drug czars, signed a letter to the CDC in March of this year saying that the guideline had been widely misinterpreted, and the CDC concurred. In an article in the New England Journal of Medicine, the guideline authors acknowledged that medical experts don’t really know what happens to people forced to taper suddenly from high dosages: “We know little about the benefits and harms of reducing high dosages of opioids in patients who are physically dependent on them.”

In a remarkable study of Vermont Medicaid patients who used large daily doses of opioids for at least 90 consecutive days, Mark’s team found that half the patients were cut off with just a single day’s notice and 86 percent were discontinued in less than 21 days. Though 60 percent had an opioid use disorder before tapering, fewer than 1 percent of the patients in the study were given anti-addiction medication such as buprenorphine when their opioids were taken away. Predictably, 49 percent of them were hospitalized or visited an emergency room after they were cut off.

“People shouldn’t be forced to taper,” Mark said.

Stefan Kertesz, an addiction medicine specialist at the University of Alabama at Birmingham, said some patients forced to taper will suffer anhedonia, the inability to feel pleasure.

“Some people will be fine. Some people will actually thank you and say, ‘I feel a little more awake now,’ ” said Kertesz, one of the leaders of the group that petitioned the CDC to clarify its pain opioid guidelines. “The cases that draw my concern are the cases where the patient says, ‘I don’t think I can survive what you’re going to do to me.’ ”

When researchers surveyed 194 primary care clinics in Michigan in 2018, they found that 79 of them would not accept new patients taking opioids, according to a study published last month in JAMA Network Open.

“We’ve entered a new era of opiophobia,” said Sally Satel, a psychiatrist and resident scholar at the American Enterprise Institute who is critical of the way some chronic pain patients are being treated. Some “have the kind of pain that’s unbearable. Every day of your life. Unbearable. And those are the people who are suffering. And their doctors are terrified.”

Ballantyne, the pain specialist, is now a professor of anesthesiology and pain medicine at the University of Washington and also president of Physicians for Responsible Opioid Prescribing. She is among the most influential leaders of the movement to cut down America’s dependency on opioids. The United States still is the world leader in the reliance on opioids.

But even she says that “the pendulum did swing too rapidly.” Some patients who have been taking high doses of opioids for a long time may be better off sticking to what’s worked for them, she said. The most important change in medical practice — one adopted by Veterans Affairs— is to cut down on “new starts,” the patients taking opioids for the first time for ailments that might not require that kind of painkiller.

There’s no simple fix to the drug epidemic, no simple rule that can apply to every patient. So many of the big questions about opioids and chronic pain can be answered only with palms facing straight up: It just depends.

“Unfortunately, very few things in medicine are quite that clear, and pain management is certainly not one of them,” says Suzanne Amato Nesbit, a clinical pharmacist at Johns Hopkins Hospital in Baltimore and the president of the American College of Clinical Pharmacy.

For Hank and Carol Skinner, medical care has been one long struggle, sometimes a comedy of errors. They joke that the hospital is their second home.

Carol has had her own bizarre experiences with opioids. At one point during the ordeal with her infected right hip she took a high dose of morphine that caused her to hallucinate. She thought she saw the neighbor’s house on fire and called 911. At least a dozen firetrucks showed up, for real. She could swear she saw the firefighters walking atop her fence like gymnasts on a balance beam. She cut her dosage and then later went off opioids for good.

They don’t like the term “opioid crisis.” But they also know the stuff that Hank needs every day can be dangerous. He’s careful never to leave one of his fentanyl patches lying around where a child might pick it up.

And there’s another shadow hanging over their home: Hank’s great-nephew overdosed on heroin, possibly laced with illicit fentanyl, earlier this year, they say. His name was Kevin Samuel Crathern. He was 26. The Skinners say the young man’s parents decided to scatter his ashes along his favorite trail in Yosemite National Park.

IRW intern Meryl Kornfield contributed to this report.