Responses and Criticisms Over New CDC Opioid Prescribing Guidelines
The Centers for Disease Control and Prevention (CDC) published its own set of clinical guidelines for treating acute and chronic pain in adult patients.1 The guidelines come during a pivotal time in medical care, when doctors and lawmakers alike are working to stem the trend of opioid-overdose deaths, which have quadrupled in the past 15 years.2
However, some have not responded to the CDC’s guidelines with unconditional support. A number of criticisms have been expressed by organizations, like the American Medical Association (AMA), the American Academy of Pain Medicine (AAPM), and the American Academy of Pain Management, that question the validity and quality of the guideline’s featured recommendations.
The criticisms surround the CDC guideline’s low-quality evidence base, which excludes all data from studies investigating opioid efficacy recorded from 3 months to 1 year duration. This is a concerning omission, according to Daniel B. Carr, MD, President of the AAPM, because the guidelines are intended for treating pain that lasts longer than 3 months. By contrast, associations like the Food and Drug Administration (FDA) do accept studies in this longer range.
In a statement released by AAPM, the association said they cautiously support the efforts of the CDC to address the challenges that often accompany prescribing opioids for chronic non-cancer pain.
“We know that doctors—primary care and pain medicine specialists—are integral in treating pain wisely and carefully monitoring for signs of substance abuse. Abuse and diversion of prescription opioids must be addressed," said Dr. Carr, Professor of Public Health and Community Medicine at Tufts University. "Opioids are not the usual first choice for treating chronic non-cancer pain, but they are an important option—as part of a comprehensive multidisciplinary approach— that must remain available to physicians and appropriately selected patients.”
Dr. Carr said that society needs to address both chronic pain and its treatment as public health challenges. This view is endorsed by the National Academy of Medicine and outlined in the draft National Pain Strategy from the NIH.
"Public health problems are typically complex; well-meaning, but narrowly targeted, interventions often provoke unanticipated consequences," he said. "We share concerns voiced by patient and professional groups, and other Federal agencies, that the CDC guideline makes disproportionately strong recommendations based upon a narrowly selected portion of the available clinical evidence. It is incumbent upon us all to monitor the deployment of the guideline to ensure that it does not inadvertently encourage under-treatment, marginalization, and stigmatization of the many patients with chronic pain that are using opioids appropriately."
In a statement released by the AMA, Patrice A. Harris, MD, the AMA board chair-elect and chair of the AMA Task Force to Reduce Opioid Abuse, said that "while we are largely supportive of the guidelines, we remain concerned about the evidence base informing some of the recommendations, conflicts with existing state laws and product labeling, and possible unintended consequences associated with implementation, which includes access and insurance coverage limitations for non-pharmacologic treatments, especially comprehensive care, and the potential effects of strict dosage and duration limits on patient care.”
“We know this is a difficult issue that doesn’t have easy solutions and if these guidelines help reduce the deaths resulting from opioids, they will prove to be valuable. If they produce unintended consequences, we will need to mitigate them," she noted. "They are not the final word. More needs to be done, and we plan to continue working at the state and federal level to engage policy makers to take steps that will help end this epidemic.”
American Academy of Pain Management
Bob Twillman, PhD, Executive Director for the American Academy of Pain Management, said that "we are saddened by the apparent lack of response by CDC to comments submitted by the Academy and numerous other pain management organizations and advocates. Our review of the 12 recommendations included in each of the 3 drafts reveals that few meaningful changes took place despite more than 5,000 comments across all the comment periods. In at least one case (recommendation #7, related to acute pain), recommendations actually may have improved and then reverted to a less desirable version," he said in a note on the Academy Web site.
"Simply put, the one statement that best summarizes the goal of the CDC guideline is, 'Take all steps possible to minimize exposure to opioids when treating chronic pain.' While CDC undoubtedly is well-intentioned, achieving this goal must be done in a way that does not harm the vast majority of people using opioids to manage their chronic pain–who have a positive risk/benefit ratio and who do not misuse or abuse their vital medications," noted Dr. Twillman. "The Academy stands ready to work with anyone, including CDC, to implement education and policy advocacy efforts designed to bring about this appropriately balanced result."
CDC Defends Guidelines
On the heels of the CDC guideline’s debut in JAMA this week, Thomas R. Frieden, MD, MPH, director of the CDC, and Debra Houry, MD, MPH, director of the CDC’s National Center for Injury Prevention and Control (NCIPC) addressed such concerns raised by organizations in a new perspective piece featured in The New England Journal of Medicine.
“The guideline is designed to support clinicians caring for patients outside the context of active cancer treatment or palliative or end-of-life care,” Drs. Frieden and Houry stated. They noted that while more research is needed in the study of opioids, “the guideline uses the best available scientific data to provide information and recommendations to support patients and clinicians."
“Most placebo-controlled, randomized trials of opioids have lasted 6 weeks or less, and we are aware of no study that has compared opioid therapy with other treatments in terms of long-term [more than 1 year] outcomes related to pain, function, or quality of life,” wrote the authors.