A Rising Storm: Preparing for Revised CDC Opioid Guideline
/By Richard Lawhern, PNN Contributor
Last month, the U.S. Centers for Disease Control and Prevention announced that a revised draft of its 2016 guideline for prescribing opioid pain relievers would soon be posted in the Federal Register and be available for public comment for 60 days. For patients in pain, their caregivers and their doctors, CDC might as well have issued an invitation to a gunfight at the OK Corral.
Revisions to the CDC opioid guideline have been underway since 2019. During this period, much has changed in public awareness about chronic pain and addiction. Much more may change in the coming year as the CDC finalizes its draft revisions.
Despite the 2019 CDC admission that the opioid guideline has been “misapplied” by many states, insurers and physicians as hard limits on opioid prescribing, the Department of Justice (DOJ) and Drug Enforcement Agency (DEA) have continued selectively targeting doctors for prosecution when they prescribe opioids at high doses. As a result, the number of physicians still willing to treat pain with opioid analgesics has dropped precipitously. And many thousands of patients have been involuntarily tapered or withdrawn from opioid therapy.
DOJ, state and local prosecutors have recently announced multi-billion dollar settlements with major pharmaceutical companies for false advertising and promoting opioid pain relievers. However, a judge in Orange County, California threw out an opioid lawsuit against four Pharma companies. The Oklahoma Supreme Court also overturned a lower court verdict on appeal. In both cases, judges found no evidence to establish that the use or advertising of opioid painkillers is a “public nuisance.” These cases offer precedents that might overturn other settlements or deny other government lawsuits against pharmaceutical companies.
Two physicians convicted of inappropriate prescribing have taken their appeals to the US Supreme Court. Their case will be heard in March. Prominent medical associations and law firms have submitted “Friend of the Court” (amicus curae) briefs, pointing out that there is presently no accepted “standard of practice” for prescription of opioids, against which to evaluate appropriateness. Thus, a presumption of physician good faith should prevail in the absence of conclusive evidence of intentional opioid misuse. If accepted, this premise will significantly narrow the grounds under which a physician can be prosecuted by DEA or DOJ for inappropriate opioid prescribing.
On July 16, 2021, the Board of Scientific Counselors of the CDC National Center for Injury Prevention and Control met in an online session to consider the report of their appointed Opioid Workgroup (OWG) evaluating progress in revising the 2016 CDC opioid guidelines. The OWG report provided a top-level “sneak peak” into the content of the proposed revisions, without the supporting data or references used by five authors rewriting the guideline. For patients and advocates, this peek revealed a little shop of horrors. The OWG voiced fundamental concerns for unsupported or incorrect assertions concerning underlying science and medical practice.
The problems revealed six months ago have since been compounded in at least two ways. First, research has shown that the underlying rationale of the CDC guideline and the proposed revisions is grounded upon a concept that is best characterized as “junk science.”
Much of the damage done by the 2016 CDC guideline was caused by daily dose recommendations based on morphine milligram equivalents (MME). However, MME is not a single metric or even the correct one to base decisions on. In fact, there are four different models for MME which generate significantly different estimates for the “equivalence” between various opioid medications. Likewise, a June 2021 FDA Workshop on MME research revealed significant weaknesses in the methods and protocols from which these models were developed.
Finally, a recently published review of the clinical literature for opioids and chronic pain reveals a 15-to-1 range in minimum effective dose for opioids used in long term therapy for moderate to severe pain. Much of this range appears to be caused by genetic differences in key liver enzymes which metabolize opioids. The literature also reveals very low risks of addiction among pain patients actively managed on opioids. Many papers mistake “pseudo-addiction” for drug tolerance or addiction.
Conflict of Interest
There is also evidence that CDC violated its own internal standards for objectivity when it selected the writers of the opioid guideline and recent revisions. Dr. Roger Chou, one of the co-authors of the original and revised guideline, has an established history of collaboration with key figures in anti-opioid organizations.
Moreover, as pointed out by the OWG, a disproportionate number of publications where Chou was a principal author were used as source research for the guidelines as published. Chou not only led research on opioid outcomes and contributed to writing the guidelines, he also sits on the Board of Scientific Counselors that appointed the OWG. He was thus in a position to lobby actively for his own work as a national standard of care. This is a fundamental professional conflict of interest.
As we near the release of a revised draft CDC guideline, one central trend seems clear. If the writers of this guideline insist on doubling down on the errors of their original effort in 2016 – as they apparently did in July 2021 – then it will be time to remove CDC from its oversight of the practice of pain medicine, perhaps in favor of FDA or the National Academies of Medicine.
As an advocate for people in pain and their doctors, it is from this frame of reference that I will approach my reading of the Federal Register. I’m going into the review process “loaded for bear.” I hope patients and their physicians will join me.
Richard “Red” Lawhern, PhD, has for over 25 years volunteered as a patient advocate in online pain communities and a subject matter expert on public policy for medical opioids. Dr. Lawhern has written or co-authored over 150 papers and articles published in medical journals and mass media.
