Response to CDC guidelines on opioids

Drugwonks | CDC gets it transparently wrong on opioids

Peter Pitts posted a strongly worded letter from pain organizations in response to the secretive CDC actions of Sept 18th:

The pain community is not happy with the CDC. And who can blame them?

But the agency’s definition of “transparency” has many up in arms. It’s a travesty. Here’s what the leading pain organizations had to say to CDC Director Tom Frieden and Debra Houry, Director of the National Center for Injury Prevention and Control:  

Dear Drs Frieden and Houry:

As members of U.S. chronic pain management professional associations and patient advocacy organizations, we, the undersigned, are profoundly invested in any and all efforts undertaken that could impact either the positive or negative outcomes of pain treatment. We have been anxiously awaiting CDC’s draft opioid prescribing guidelines, now revealed September 16th.

It was our expectation that the prescribing guidelines would have been:

  1. Developed in a transparent manner, consistent with best-known evidence
  2. Or, where there is no evidence, by incorporating the common elements of long-accepted clinical expert consensus guidelines developed by a dozen organizations dedicated to the safe and effective treatment of patients with chronic pain
  3. Consistent with those aspects of opioid medication prescribing and risk mitigation efforts that are actually supported with rigorous clinical trials, i.e. the FDA-approved indications for the full range of opioid formulations.

We were disappointed on all counts and now are deeply concerned that, not only are the CDC draft guidelines inconsistent with established best practices, they will potentially make it difficult for patients who rely on them for pain control to access them from clinicians who are clear on how best to use them.  

The CDC slides presented on Wednesday were not transparent relative to process and failed to disclose the names, affiliations, and conflicts of interest of the individuals who participated in the construction of these guidelines. The presenters refused to provide any information other than to read exactly what was written on the slides even when asked directly by audience members to disclose the processes and people who had developed these prescribing guidelines. Since CDC has traditionally not involved itself in developing and disseminating medication prescribing guidelines, and these recommendations are not consistent with current established guides for managing chronic pain with opioids, these process and participant questions are essential to understand.

A statement was made early in the presentation that it is acceptable and common practice to develop clinical recommendations even when there is a limited or non-existent base of evidence for (or against) the recommendation. In those cases, the standard is to convene expert clinicians with vast experiences in the condition and develop consensus around optimal approaches. CDC itself developed and published an analysis of existing guidelines that logically should have been the foundation for these new guidelines.

While there may be slight variances among organizations on specific guideline inclusions or recommendations, there is a broad conformity that extends beyond the focus of the new guidelines. By addressing only how to limit or avoid opioids, the new guidelines will inevitably result in fewer prescriptions overall – including those needed by patients with legitimate medical needs. Chronic pain advocacy organizations hear daily from increasing numbers of constituents who are not being able to access the opioid medications they’ve relied on to live with their chronic painful conditions. That is not an outcome that anyone involved in chronic pain and prescription opioid diversion and abuse wants but this guideline will produce.

In fact, it is CDC’s singular focus on prescription opioid diversion, abuse, addiction, and overdose over any improved understanding of chronic pain incidence, prevalence, trends, and optimal interventions that reveals within CDC an extreme imbalance in its own risk-benefit sensibilities when it comes to this class of medications. In evaluating new medications for approved uses, FDA requires safety and efficacy trials that all approved opioid medications have met. Detailed prescribing instructions are developed based on proven studies. Yet the new guidelines ignore the FDA’s prescribing expertise, recommending different maximum daily doses that appear in no guidelines or package inserts.

We call on CDC to immediately compile, analyze, and report any and all chronic pain data it possesses, managed with or without opioids. Certainly any health condition that impacts one third of our country’s population should, by definition, have a place of priority in CDC’s mission and mandate. CDC has a Center for Chronic Disease Prevention and Health Promotion that reports on arthritis as part of its annual chronic disease monitoring. Diabetes, interstitial cystitis, inflammatory bowel disease are all programs within this center that have, at their core, chronic pain components and may contain useful data. CDC also fields an Annual CDC/NCHS National Health Interview Survey that reports on severe headache or migraine, low back pain, and neck pain among adults. Obviously, a better understanding of how to effectively treat chronic pain should be an essential component to any treatment prescribing guideline. What CDC presented this week is not that.

If the new CDC guidelines reinforced existing recommendations of experts who agree there are tried and true approaches to safely and effectively using opioids to treat chronic pain, it would be a welcomed addition to clinical practices nationwide. Equally important, we need CDC to glean from its prescription opioid addiction and overdose data which cases actually involve chronic pain patients and which involve patients with active substance use disorder so we can help providers better differentiate the two.

The unmet challenge in chronic pain management with opioid treatment is to identify the conditions for which, and patients for whom, opioid use is most appropriate; the regimens that are optimal; the alternatives for those who are unlikely to benefit from opioids; and the best approach to ensuring that every patient’s individual needs are met by a patient-centered health care system. We need CDC to provide some context around the incidence and prevalence of undertreated pain and the related adverse consequences of undertreated chronic pain on all body systems. With these insights it may actually be possible to improve pain care rather than restricting one treatment based on perceived, not quantified, harms to legitimate patients.

We believe the most important outcome of treatment for chronic pain is pain control sufficient to enable people with pain to maintain a high level of patient-determined quality of life and functionality while avoiding or minimizing potential negative outcomes that could outweigh pain control benefits. We believe it is up to the patient, informed by a comprehensive and ongoing discussion with his or her providers, to decide if risks of opioid use apply to them and are acceptable to bear, when compared with the adverse physical, psychological, and quality of life impacts if pain cannot be adequately controlled without opioids. Our concern is ensuring that further stigma and physical harm to patients does not result from policies and guidelines that address only the risk of harm from inappropriately prescribed or used opioids, when what healthcare providers most require are affirmative strategies to help patients manage their pain.

Sincerely,  

  • Alliance for Patient Access*
  • American Academy of Pain Management*
  • American Cancer Society, Cancer Action Network, Inc.*
  • American Chronic Pain Association
  • Center for Lawful Access and Abuse Deterrence
  • Chronic Pain Research Group at the Clinical Pharmacokinetics Laboratory, University at Buffalo School of Pharmacy and Pharmaceutical Sciences*
  • Hospice and Palliative Nurses Association
  • Interstitial Cystitis Association
  • Massachusetts Pain Initiative
  • National Fibromyalgia & Chronic Pain Association
  • Pain Connection
  • Project Lazarus
  • The Pain Community
  • US Pain Foundation
  • Virginia Cancer Pain Initiative

* Participant in the FDA August 6 meeting

This unfair, unjust, and ill-considered CDC action must not stand.

Advertisements

5 thoughts on “Response to CDC guidelines on opioids

  1. Doc Anonymous

    Ironically, the Institute of Medicine just published their report on “Improved Diagnosis in Health Care” on the same day. The report refers to “chronic pain” in only 2 locations. Both of these cite physician bias as a cause of misdiagnosis of chronic pain and the impact of that biased misdiagnosis on the victim. It appears to me that the CDC and PROP (a vehemently anti-chronic-pain treatment group) who had an inside route into the writing of the CDC’s guidelines, are very much guilty of precisely the kind of bias that the Institute of Medicine report is talking about.

    CDC and PROP both spend a lot of time equating chronic pain treatment with opioids and abuse of drugs. They use a lot of rules to “rule OUT addiction and abuse of meds” but they spend no time on affirmative diagnosis. THere is absolutely no mention of how to “RULE IN A TRULY PAINFUL DISEASE!” Back in the old days when I went to medical school, you would never get by with only a RuleOUT set of diagnostic assessments.

    PROP and now CDC also seem to continue to perpetuate a sophomoric error of logic. They continue to purport that there is no EVIDENCE of benefit of long term use of opioids. They ignore the fact that there are plenty of patients to study but no one wants to do the studies. PROP and now the CDC use the logical fallacy that “Absence of proof of benefit” is logically equivalent to “Proof of absence of benefit”!

    One has to ask also for a full disclosure by PROP of where they get their funding!

    Liked by 2 people

    Reply
  2. Pingback: Setting Opioid Dosage Limits in Clinical Practice | EDS Info (Ehlers-Danlos Syndrome)

Other thoughts?

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s