Doctors will soon have new guidelines from the Centers for Disease Control and Prevention on how and when to prescribe opioids for pain.
Those guidelines – currently under review as a draft – will serve as an update to the agency's previous advice on opioids, issued in 2016. That advice is widely blamed for leading to harmful consequences for patients with chronic pain.
Federal officials have acknowledged their original guidance was often misapplied; it was supposed to serve as a roadmap for clinicians navigating tricky decisions around opioids and pain — not as a rigid set of rules.
But the 2016 version was used as the basis for sweeping policy decisions, as lawmakers and health leaders struggled to contain the nation's overdose crisis. Many states adopted laws and regulations that set limits on prescribing, and health insurers also crafted policies to that effect.
And doctors grew wary of giving opioids at all, which often led to sudden disruptions of treatment, resulting in physical and mental agony, and even a heightened risk of suicide.
The restrictive climate around prescribing has persisted, says Cindy Steinberg, director of national policy and advocacy for the U.S. Pain Foundation.
"I hear from patients every week and doctors just don't even want to see pain patients," she says. "It's a really tough situation out there."
This is why the agency's revised guidance is now under scrutiny. The public comment period ends on Monday, and then the agency will weigh its final recommendations.
Some experts see the proposed changes as a promising step toward addressing the harms suffered by pain patients in the wake of the previous guidelines. And yet many others, including patients with chronic pain, argue that the guidance is still flawed — with the potential of being misinterpreted and misapplied.
A step in the right direction
The new proposed guidelines — a sprawling, 200-page document — continue to advise against using opioids for pain when possible and to take a cautious approach when it's necessary, given the risks of opioid misuse and overdose.
But there are some notable changes from the old guidance.
The topline recommendations — often the takeaways for clinicians and policymakers — no longer include specific limits on the dose and duration of an opioid prescription that a patient can take.
"That's an important change," says Dr. Stefan Kertesz, a professor of medicine at the University of Alabama at Birmingham.
With the original guidelines, "it turned out that insurance companies and regulators seized on those numbers as simple tools to force changes to care that often were not safe for patients," he says.
The new guidelines also emphasize that clinicians should use their own judgment in deciding what will be a safe and effective dose for each patient. The authors state upfront that it's not "intended to be applied as inflexible standards of care" or as "law, regulation or policy that dictates clinical practice."
Kertesz believes that is a much needed recognition of how the previous guidelines were misapplied, especially to patients already on a stable regimen of opioids for chronic pain.
"The CDC's changes are really an effort to ameliorate that without losing track of the fact that these medicines were vastly overused and oversold for a period of decades," he says.
Indeed, the proposed guidelines steer doctors away from using opioids as a first-line therapy for many common acute pain conditions — among them, lower back pain, musculoskeletal injuries and pain related to minor surgeries. It also discourages using opioids for chronic pain, but acknowledges that opioid therapy can play a role in treatment, in particular if other approaches have been tried.
"We're trying to be very explicit about the fact that these are not meant to be hard thresholds," says Dr. Roger Chou at Oregon Health & Science University and an author of the 2016 guidelines and the updated version.
Chou notes the evidence still shows an increased risk of opioid misuse and overdose as the dose goes up and that the benefits seem to be pretty small. However, he says their 2016 guidelines were often applied in ways that they had warned against, for instance for patients who had cancer pain.
"It's sometimes difficult to see how you can blame the guideline for that?" he says. "We've tried our best this time to be clear — even clearer than before."
'Not far enough'
Some patients and clinicians say the updated version still falls short of fixing the problems chronic pain patients face.
"I don't think it goes far enough to protect patients from really the egregious inhumane harms these guidelines have caused over the past six years," says Steinberg.
The new proposed guidelines lack balance when discussing decisions around starting and stopping opioid therapy, she says, by focusing mostly on the "harms of opioids, not the benefits when medically supervised, or the risks and harms of poorly managed pain."
Steinberg would also like to see stronger language against abandoning patients who rely on opioids for pain.
Dr. Sally Satel, who has studied the impact of opioid prescribing rules on pain patients, says she worries about the instructions on lowering patients' doses, or tapering. They generally advise not to reverse a taper once in progress, which she believes could lead to harm.
In addition, the "sweeping pronouncement" that opioids are not the preferred treatment for non-acute pain "undermines physician discretion and tailored care that the guideline already affirmed," says Satel, a senior fellow at the American Enterprise Institute.
Satel does see some positive changes in the new document, but ultimately she believes it runs into some of the same issues as the earlier version — citing specific doses throughout the document that could give the impression of a "hard ceiling" when prescribing opioids.
"Any mixed message has high potential for being interpreted in a harmful way," she says.
Questions about the guidelines' impact
Many of the problems resulting from the old guidance had to do with interrupting treatment for those who were already on long-term opioids.
But removing recommendations on the number of days a prescription should be filled for acute or post-operative pain and the clear dosing thresholds could be "problematic," says Dr. Gary Franklin, a research professor at the University of Washington.
He defends the 2016 guidelines, saying they were effective because they gave clear parameters to doctors who may have been uncomfortable prescribing opioids, and unsure how to navigate decisions around pain management.
"If you take that help away by removing the specific guidance, it's going to make them uncomfortable again. They're not going to know what to do," says Franklin.
Rather than softening its guidance, CDC should issue two different sets of recommendations, he says, one for those starting opioids and the other for those already on opioids.
Franklin, who's also medical director of Washington state's workers' compensation program, was among the first to raise alarm about the escalating use of opioids and its link to overdose deaths.
"It's the worst man-made epidemic in the history of modern medicine — and it's made by us, by physicians, by surrogates for the drug companies," he says. "We're trying to figure out, how do you reverse this?"
Yet some argue that the prescribing guidelines may have had little effect on the overdose crisis. Opioid prescriptions have declined by more than 40% over the past decade — a trend that began before the CDC issued its 2016 guidelines. Meanwhile, annual U.S. drug overdose deaths have increased, reaching an all-time high last year, with more than 100,000 people dying.
It's now illicit street drugs like fentanyl that are primarily driving the increase. Prescription opioids were involved in about 16,400 of the more than 91,000 fatal overdoses in 2020.
While the CDC's guidelines may have reduced prescribing, "what they didn't do in the long term was reduce overdose death rates," says Dr. Sebastian Tong, who's an addiction medicine specialist in Washington D.C.
'Unbearable pain' for patients
Experts caution that even with an update to the guidance, the effect on prescribing practices could be hard to unravel, effects that include forcing some patients to suffer intensely.
Amanda Votta says she started having trouble getting doctors to prescribe her any opioids at all "pretty much coinciding almost exactly with the CDC guidelines."
Votta, 41, was diagnosed with juvenile onset rheumatoid arthritis, an autoimmune disease, when she was 10 years old. Her particular form of the disease does not respond well to treatment.
"I have damage that causes constant pain from bone grinding on bone," says Votta, who's had to take opioids to manage her pain on and off throughout her life. "I always took them as directed, and have never been flagged as misusing my prescriptions."
After the CDC guidelines came out, her primary care doctor wasn't comfortable prescribing oxycodone and finding anyone who would give her enough to manage her pain proved difficult. She was a graduate student and working several jobs on campus.
"There were times when I would go and sit in one of the small cubbies in the library and just cry because I was in so much pain," she recalls "It was unbearable."
Pain patients like Votta still struggle to get prescribed opioids. In many places, primary care physicians won't accept new patients who require the medication.
Just last year, about 20,000 patients in California were left without pain management when their clinics shut down, and those on long term opioid therapy were given only a 30-day supply, according to a recent article in the New England Journal of Medicine.
"Many patients quickly found that their primary care clinicians were unwilling to prescribe opioids. Patients without a current clinician learned that almost none would prescribe opioids to new patients, and some would not prescribe opioids at all," the authors write.
The reluctance among physicians also relates to increased monitoring of their prescribing practices in state electronic databases. State medical boards and federal law enforcement agencies can investigate those who are flagged as prescribing more opioids than their peers.
Kertesz says he's seen the Drug Enforcement Administration warrants explicitly reference opioid prescribing doses that were part of the CDC's 2016 guidelines (although Kertesz was never involved in any cases himself).
"You could imagine that would have a chilling effect," he says.
However, he says, the CDC guidelines cannot be held responsible for all the "chaotic mistreatment" of patients because doctors, policymakers, regulators and insurers all reacted in a way that went well beyond what the document called for.
He hopes the new guidance will lead to meaningful changes in the laws and policies that are in effect but says it's hard to predict.
"Obviously, bureaucracies don't unwind what they've done quickly," he says.