RE: American Medical Association Comments on Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids
Richard Lawhern
Subject Matter Expert in public policy for regulation of opioid pain relievers and physicians who prescribe them. 28 years experience and thousands of contacts in social media support groups for people in pain.
RE: American Medical Association Comments on Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids
Emailed to
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For the personal attention of
Dr James L Madera
Executive Vice President and CEO, American Medical Association
Sitting members of the AMA Opioid Task Force
and
Sitting members of the Board of Scientific Counselors, NCIPC
BCC: ~800 knowledgeable clinicians, patient advocates, journalists and patients. Cross-posted to social media that generate ~200,000 impressions per day.
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I have recently read the April 11, 2022 letter signed out over Dr Madera's signature to the Acting Director of the National Center for Injury Prevention and Control, forwarding extensive comments on the proposed 2022 CDC clinical practice guideline for prescribing opioids. As a technically trained healthcare writer and patient advocate, I believe your letter represents significant progress on behalf of people in pain and clinicians who manage their pain.
However, I must suggest respectfully that you are not yet done. On behalf of millions of patients and clinicians who have been profoundly damaged by the CDC -- with no viable end to the damage in sight -- I must point out some areas that require your further timely efforts. Some of these issues are addressed in my published work prior to your letter and others have emerged or clarified in the months since.
领英推荐
The Devil in the Details of Revised CDC Opioid Guideline — Pain News Network
By Richard Lawhern,
From the reference above, three areas of further emphasis emerge:
Your acceptance of the CDC premise that nob-opioid therapies are "preferable" to opioids is both unfortunate and scientifically unsupportable. Among thousands of non-pharmacological and non-invasive trials reports surveyed by the Agency for Healthcare Research and Quality (AHRQ) and referenced in the 2022 draft, not one actually compares non-opioid versus opioid therapy on a head-to-head basis for treatment of chronic pain. AHRQ reviews of non-opioid versus opioid drug therapy in acute pain were fatally flawed by unacknowledged anti-opioid bias and methodological errors, relying principally on short-term comparisons of a weak opioid (Codeine, now falling largely out of use due to its limited effectiveness) versus NSAIDS in dental surgeries. Yet CDC is seriously proposing to replace opioid therapy with scientifically weak methods of demonstrated marginal effectiveness. At best, non-pharmaceutical therapies can contribute only at the margins of a carefully monitored program of opioid and non-opioid analgesic therapy, combined with therapy as needed for depression and anxiety which often complicate pain management.
Both the draft 2022 guideline and the AMA letter address the need for clinicians to assess risks versus benefits on an individualized basis for each patient. AMA has pointed out that CDC largely ignored benefits of opioid therapy while over-emphasizing risk. However, AMA writers appear to have missed a nuance in the CDC draft that is pointed out in Reference 1 above: CDC acknowledges that there are presently no validated patient profiling instruments that offer realistic prospect of identifying patients who are especially at risk, versus those for whom opioid therapy may offer predictable benefit. Lacking such a measure, the unacknowledged hidden meaning in the CDC draft is plain: any clinician who prescribes any opioid at any dose for any reason is seriously at risk of sanctions if the slightest thing later goes wrong for that patient downstream. This policy and enforcement conundrum must be addressed and corrected by the AMA.
Unmentioned in both the CDC draft guideline and AMA comments is a central principle that must in principle directly impact US National policy with regard to management of pain. There is a wide natural range in minimum effective opioid dose between individuals. My co-author Steve Nadeau and I estimate this range as at least 13 to one (see reference). There is ample evidence in medical literature for genetic polymorphism in six key liver enzymes as a significant mediating factor affecting opioid metabolism. Yet neither the CDC draft nor the AMA comments thereto mention either "genetic" or "genomic" in any context. The glaringly obvious implication of genetic polymorphism is that opioid doses and/or combination therapy must be tailored to the patient's needs by gradually titrating dose levels to effective levels, while monitoring for and managing side effects. This reality drives a figurative stake through the heart of any claim to scientific rigor for one-size-fits-all prescribing criteria.
As a longtime critic of the 2016 and 2022 CDC opioid guidelines, I find it disappointing that you have not called for the outright repudiation and withdrawal of these fatally flawed documents without replacement. Perhaps you are laboring under the belief that returning the practice of pain medicine to those most expert in its methods is no longer a policy option. And certainly, your April 2022 comments in some ways amount virtually to the same discrediting outcome. However, I strongly suggest that you engage with two recently published and highly publicly visible references, before reconsidering your position.
The first paper (Audry and Carr) comprises a landmark reexamination of relationships between opioid prescribing, hospital admissions for opioid toxicity, and overdose-related mortality. This paper has been viewed over 73,000 times in the 40 days since August 4, 2022 -- a record of public visibility that is almost unheard of for work in a mainstream medical journal. Using data published by US CDC itself, the authors find that there is no direct cause-and-effect relationship between opioid prescribing and either hospital admissions or overdose mortality -- and there hasn't been since 2010. This finding directly contradicts CDC assertions in 2016 of a direct cause and effect relationship, justifying the current war against people in pain on grounds of mortality and addiction risk. Moreover, it is plain that CDC either knew or should have known when they made such an assertion that it was factually untrue.
A second and equally disqualifying paper (Kollas, Schectman and Judy) establishes that CDC violated its own standards for scientific objectivity when it selected writers for the 2016 CDC guidelines. To quote from the paper:
"Our results suggest that advocates for unfocused reductions in opioid prescribing propagated a false narrative that physician overprescribing drove increases in overdose deaths over the last two decades. Using this false narrative, these advocates facilitated a corresponding moral panic that produced flawed national opioid policy that has increased drug overdose deaths and harmed patients in pain but has also served the competing financial and intellectual interests of the CDC, health insurers, mass tort litigation attorneys, state attorneys general and anti-opioid stakeholders."
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We may attribute these results to either deliberate policy malfeasance or otherwise an almost criminal carelessness and incompetence. It seems to me that either condition argues for immediate legislation removing from CDC, the development of practice guidelines for other than communicable disease. As a minimum, it warrants public withdrawal of the guidelines from CDC, for completion by an unbiased group of medical professionals engaged in community practice of pain medicine, directly supported by qualified patients and their advocates, engaged as voting members of the working group.
Undisclosed Conflicts of Interest by Physicians Creating the CDC Opioid Prescribing Guidelines: Bad Faith or Incompetence?
Be advised that this open letter will be shared on multiple social media platforms with the email addresses visible above. You may each receive follow-up inquiries from persons on my BCC list
Although I understand that the addressed agencies and individuals may not choose to reveal the internal processes of the AMA or of government agencies, I would appreciate the courtesy of a reply acknowledging receipt of this correspondence.
Sincere best regards,
Unemployed Research Scientist
2 年Great response! Thanks!
Business Owner at Peachy Clean, Pottstown PA Post construction/renovation cleanup & rental turnovers.
2 年Well stated, as usual. Thanks, again.