Spring 2019: The Tides Begin to Turn

Three years after the official release of the CDC Opioid Prescribing Guidelines there was the beginning of a glimmer of hope for people in pain and their medical providers.  

March 3, 2019:  Five qualified, dedicated health professionals formed a new advocacy group:  Health Professionals for Patients in Pain, or HP3.

Daniel P. Alford, MD, MPH is Professor of Medicine, Associate Dean of Continuing Medical Education and Director of the Safe and Competent Opioid Prescribing Education (SCOPE of Pain) program at Boston University School of Medicine.
Dr. Richard Dart is an emergency medicine physician and toxicologist who directs the Rocky Mountain Poison and Drug Center. He is the Executive Director of Researched Abuse, Diversion, and Addiction-Related Surveillance (RADARS®) System.
James DeMicco, PharmD is Adjunct Professor at Long Island University College of Pharmacy and Pharmacist in Charge of J&J Pharmacy in Hackensack, NJ
Stefan G. Kertesz, MD, MSc is a physician in internal medicine and addiction medicine. Presently based at the Birmingham Veterans Affairs Medical Center, he is also Professor at University of Alabama at Birmingham School of Medicine.
Dr. Sally Satel is a resident scholar at AEI and the staff psychiatrist at a local methadone clinic in D.C. Dr. Satel was an assistant professor of psychiatry at Yale University from 1988 to 1993 and remains a lecturer at Yale.

These five health professionals had already been speaking up about the misinformation and misdirection of collective efforts to combat the addiction/overdose crisis in the United States.  But they formed HP3 for a very specific purpose:  to call on the CDC to address the Misapplication of its Guideline on Opioids for Chronic Pain.  In other words:  Patients are being harmed because of the CDC guidelines and 3 years in, the CDC has yet to say anything of substance to clarify, amend, or retract their language. The HP3 letter called out specific problems and issues which arose after the guidelines were released:

  1. Healthcare professionals and administrators treated the guidelines as if they endorsed mandated involuntary dose reduction or discontinuation.
  2. Within a year of the Guideline publication there was evidence of widespread misapplication of some of the Guideline recommendations – specifically, the 90 MME limit. Anyone prescribing or taking above that dose came under suspicion.
  3. Payer-imposed payment barriers, pharmacy chain demands for medical charts, explicit taper plans as a precondition for filling prescriptions, high-stake metrics imposed by quality agencies, and legal or professional risks for physicians.
  4. In combination, these actions have led many health care providers to perceive pain patients as liabilities instead of patients needing care.

The HP3 letter was co-signed by more than 300 medical professionals and advocates, and received some positive press attention. Before even a month had passed the CDC responded. CDC Director Robert Redfield, MD “has for the first time suggested that his agency may be preparing to make changes to its controversial opioid prescribing guideline.”

For the first time, CDC admits that .. . those guidelines have NOT produced the intended results. Dr. Redfield admits as much in his response to the HP3 letter, in a letter which CDC releases publicly.

April 4, 2019: FDA Warns About Fast Opioid Tapers

In a highly unusual move, the Food and Drug Administration issued a warning cautioning doctors NOT to abruptly discontinue or rapidly taper patients on opioid pain medication. The report states that the FDA “has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.” It the first of federal agency statements which seem to acknowledge … . that the CDC guidelines have caused more harm than good.

April 24, 2019: CDC Statement in New England Journal of Medicine: No Shortcuts to Safer Opioid Prescribing

CDC Guidelines Lead Author Deborah Dowell writes a Perspective piece in the NEJM in which she defends the trustworthiness of the guidelines, and surmised that “Difficulties faced by clinicians in prescribing opioids safely and effectively, growing awareness of opioid-associated risks, and a public health imperative to address opioid overdose underscored the need for guidance and probably facilitated uptake (of the guidelines).”

“Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations. A consensus panel has highlighted these inconsistencies,5 which include inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drug dosages, resulting in sudden opioid discontinuation or dismissal of patients from a physician’s practice. “

In other words . . . the guidelines are great! But everybody misinterpreted and mis-implemented them! The pain community had mixed reactions.

Pain News Network: “The pain community is reacting with a fair amount of skepticism to efforts by the CDC to address the widespread misuse of its 2016 opioid prescribing guideline.
A CDC commentary published Wednesday in The New England Journal of Medicine warns against the “misapplication” of the guideline, which has resulted in hard dosing limits, forced tapering and the medical abandonment of thousands of chronic pain patients. ”


April 26, 2019: AMA Makes Statement “How the CDC’s opioid prescribing guidance went astray”

The American Medical Association makes a strong and clear statement:

“The AMA appreciates that the CDC recognizes that patients in pain require individualized care and that the agency’s 2016 guidelines on opioids have been widely misapplied. The guidelines have been treated as hard and fast rules, leaving physicians unable to offer the best care for their patients.
“The CDC’s clarification underscores that patients with acute or chronic pain can benefit from taking prescription opioid analgesics at doses that may be greater than the guidelines or thresholds put forward by federal agencies, state governments, health insurance companies, pharmacy chains, pharmacy benefit managers and other advisory or regulatory bodies.


June 1, 2019: HHS releases “Pain Management Best Practices Inter-Agency Task Force Report”

A federal advisory panel has released its final report on best practices for acute and chronic pain management. The 116-page report is a comprehensive roadmap to treat the nation’s pain crisis.

“The Task Force recognizes the utility of the 2016 CDC Guideline for many aspects of pain management and its value in mitigating adverse outcomes of opioid exposure. Unfortunately, misinterpretation, in addition to gaps in the guideline, has led to unintended adverse consequences. Our report documented widespread misinterpretation of the CDC Guideline — specifically, the recommendation regarding the 90 morphine milligram equivalents (MME) dose,” the report found.

The task force did not call for a repeal of the CDC’s controversial opioid prescribing guideline, but said the guideline should be clarified and updated with better evidence to supports its recommendations..


So are we out of the woods?

Not yet. While this series of developments and headlines from various federal agencies is encouraging, there are still certain people still working to limit access to pain medicines – even in light of all that we now know. For example, you’ll recognize this individual:

Concern from Dr. Andrew Kolodny, who heads the Opioid Policy Research Collaborative at Brandeis University and is executive director of Physicians for Responsible Opioid Prescribing (PROP), an education and advocacy group.“I think the CDC is simply reiterating what is in the guidelines,” he said. “But the only thing that troubles me is they might be accepting these reports of misapplication of the guidelines as accurate, when I believe they’ve been exaggerated. There’s been an effort to ‘controversialize’ the guidelines.”


The vast and comprehensive reports of patients suffering, of patients attempting suicides due to untreated pain, of medical providers feeling afraid to treat patients in pain due to fears of punitive oversight . .. they’ve been . . . exaggerated?! Well, that IS what Dr. Kolodny has to say.