The CDC has released its , urging clinicians not to use the painkillers as first-line therapy for chronic pain and suggesting limits on dose and duration when they do have to be prescribed.
The guidance, although voluntary, is perhaps the strongest federal statement on opioids to date, a step taken to help stop the bleeding from the nation's opioid crisis. There were nearly 19,000 overdose deaths in 2014.
"Put simply, the risks of opioids are overdose and death, and the benefits are transient and generally unproven," , director of the CDC, said during a press briefing. "The epidemic of opioid overdose deaths is doctor-driven, and it can be reversed in part by doctors' actions."
Department of Health and Human Services Secretary also joined the call, noting that the opioid epidemic has hit hard in her home state of West Virginia, and that the crisis "is one of the most pressing public health issues in the U.S. today."
The guidelines generated controversy earlier this year when groups such as the American Medical Association, the American Cancer Society's Cancer Action Network, the U.S. Pain Foundation, and the American Chronic Pain Association charged that the CDC developed them in secret, with the help of a "biased" core expert group.
The agency then published a draft guidance in the Federal Register in order for various groups to submit additional comments, beyond those made during a stakeholder meeting that included several of these groups in September.
Some addiction advocates were concerned that political pressure might weaken the final guidance, but the version released Tuesday is similar to the one put forward for public review, with some refinements such as using a range instead of a fixed number regarding dose and duration.
The guideline does not come with teeth, however. It's "intended to improve communication between clinicians and patients about the risks and benefits of opioid therapy for chronic pain," according to its preamble, which stresses that it is not prescriptive.
"Clinical decision making should be based on a relationship between the clinician and patient and an understanding of the patient's clinical situation, functioning, and life context."
What it does have is 12 recommendations -- chief among them that opioids shouldn't be used as first-line therapy in chronic pain, because there is no evidence that they work for long-term chronic noncancer pain.
Other evidence-based options include exercise therapy, weight loss, cognitive behavioral therapy, and interventions to improve sleep, the agency said.
It also advises physicians that when opioids are necessary, they should use the lowest dose possible. They should also carefully assess the risks and benefits when increasing to doses of 50 morphine milligram equivalents (MMEs) and beyond, and that they should avoid increasing the dose to 90 MME per day or more.
For acute pain, physicians probably won't need more than 3 days' worth of opioids, and more than 7 days will rarely be needed, the guidance says. It also calls for starting with immediate-release opioids rather than extended-release long-acting (ER/LA) opioids like OxyContin.
In terms of assessing risk and mitigating harms, the agency wants doctors to review PDMP data, use urine drug testing, and avoid co-prescribing opioids and benzodiazepines, which have been found together in nearly a third of opioid overdose deaths.
Frieden noted that the CDC had a "stringent" conflict of interest policy, and it did not let anyone with ties to pharmaceutical companies on the guideline writing committee.
He said that while industry has tried to make abuse-deterrent opioid formulations, these are not the final solution to the problem.
"These formulations make it harder to melt down and shoot up, but it's important to be clear that abuse-deterrent formulations are no less addictive" because they can still be abused orally, he said. "Unfortunately, there has been no medication yet discovered that can separate the pain-relieving efficacy of an opioid from the addictive nature of opioids. It would be great if a company could come up with that."
When pressed by reporters on the differences in opioid policy between the CDC and the FDA, Frieden said the FDA is bound by law solely to make decisions about drug safety and efficacy, and that he couldn't comment further.
Earlier this month, the FDA convened a meeting of its Science Board on opioid policy as a concession to advocates who opposed the nomination of its new commissioner Robert Califf, MD, citing concerns about some of the agency's recent decisions about opioids. FDA will hold additional advisory committee meetings about pediatric opioid policy and a review of its REMS (risk evaluation and mitigation strategy) program for long-acting opioids.
The American College of Physicians said it supported the new guidelines, but the American Medical Association remained critical.
In a statement, AMA board chair-elect Patrice Harris, MD, said that while the group shares the goal of reducing harm from opioid abuse, it is still concerned “about the evidence base informing some of the recommendations, conflicts with existing state laws and product labeling, and possible unintended consequences” including insurance coverage limitations for non-pharmacotherapeutic options for chronic pain.
, executive director of the American Academy for Pain Management, said the guidance “leaves much to be desired,” particularly regarding the limitations on dose and duration.
“Our concern is that, based on experience when states have implemented similar guidelines, some clinicians will interpret these ‘soft limits’ and thresholds as absolute ceiling doses, and that people with pain will suffer needlessly as a result,” Twillman said.
The guidelines were simultaneously published , and Frieden along with National Center for Injury Prevention director Debra Houry, MD, MPH, wrote a strongly-worded perspective in the New England Journal of Medicine about the need for such guidance.
"Management of chronic pain is an art and a science," Frieden and Houry wrote. "The science of opioids for chronic pain is clear: for the vast majority of patients, the known, serious, and too-often-fatal risks far outweigh the unproven and transient benefits."
JAMA co-published several other papers on opioids, including two research letters on areas where overprescribing may come into play -- tooth extraction and low-risk surgical procedures -- and an editorial by , who called the guidance "the most important guideline for primary care clinicians on prescribing opioids for chronic pain outside of active cancer and palliative care that exists today."