I write widely as a subject matter expert on U.S. policy for the regulation of prescription opioid pain relievers and of clinicians who employ them in managing their patients’ chronic pain. Because I am a patient advocate and the spouse of a chronic pain patient, I hear from a lot of suffering people. In one form or another, many of their pleas amount to, “My doctor has deserted me, and I am in agony. Please help!”
Many patients and commentators directly attribute this state of affairs to the misdirection of prescribing guidelines published by the Centers for Disease Control and Prevention in 2016 and revised in 2022. In my informed view, the critics are right: CDC royally messed up.
Following very contentious public challenges by hundreds of U.S. doctors, the CDC announced its intention in December 2019 to review and revise its 2016 opioid guidelines. CDC also established an independent “Opioid Workgroup” of consultants charged with reviewing interim guideline drafts and identifying issues and concerns. The Workgroup Committee made its final report to the Board of Scientific Counselors in July 2021. Revised CDC guidelines were published 16 months later.
During its deliberations, the Opioid Workgroup operated under non-disclosure agreements with regard to their internal discussions and conclusions. Workgroup members of whom I’ve inquired concerning these agreements regard them as still binding even after deliberations have been closed. But there is reason to regard such restrictions as a potential abuse of confidentiality and a denial of public transparency in policy-making processes that underly a vitally important and damaging public health issue.
I suggest that the revised U.S. CDC opioid guidelines of 2022 incorporate at least two grossly fundamental and disqualifying errors that anyone familiar with statistical methods in clinical trials should have recognized as glaringly obvious long before publication. Both the CDC writers and Workgroup members must have known that these errors were being incorporated. But the Workgroup report was silent on both issues, and CDC went on to publish these major errors, knowing exactly what they were doing:
1. The guidelines fundamentally misconstrue the implications of their repeated direction to clinicians that they must balance “risk versus benefits” in prescribing decisions for individual pain patients. Risk is a predictive demographic measure applicable only to large cohorts of patients. Clinicians understand that a past history of opioid exposure or mental health issues may prompt them to exercise more frequent oversight of their patients’ response to pain treatment. But at the present state of science, it is impossible to extrapolate from large-scale demographic risk estimates to assess risks in individuals.
There is presently no consensus in clinical communities concerning the incidence of opioid addiction caused by medical treatment itself, although there is ample evidence that such incidence is too low to measure accurately. The impact of this error on clinicians and patients is major. If clinicians deny pain treatment because of concerns for generic “risks,” then they may harm patients by under-treatment and desertion. However, if they treat at effective dose levels above those asserted in the CDC guidelines, then they risk unjustified persecution by state medical boards and the U.S. Drug Enforcement Administration. Their dilemma is unresolvable. As a result, clinicians are leaving pain medicine in droves, and deserted patients are dying of suicide.
2. It has been known for 25 years — and was known to guideline writers and the Opioid Workgroup in 2021 — that the minimum effective opioid dose is mediated by the genetics of individual opioid metabolism. Polymorphism in the expression of cytochrome P450 liver enzymes generates a wide range of minimum effective dose levels for individuals, perhaps as large as 15-to-1.
The large variability in patient response to opioids effectively invalidates the entire clinical trial literature on the safety and side effects of opioid analgesics. None of the present literature employs protocols that address variation in minimum effective doses. Randomized double-blind trials also fail to incorporate the extensive titration and clinical monitoring necessary to determine the effective dose for each individual.
Arguably, the whole clinical trial literature on the treatment of pain employing opioids needs to be burned to the ground and done over with different protocols. But if this reality had been acknowledged, then CDC guideline writers would have had nothing to publish. It appears that they instead refused to acknowledge the problem and imposed a gag rule on other experts who could have done so.
We should recognize that, especially in contentious issues like the U.S. opioid “crisis,” it is necessary that contributors to public health policy be able to deliberate and debate in private before policy is published. However, this arrangement has a downside after the policy is published. When policymakers screw up as massively as CDC did, contributors are protected from the professional consequences of their errors. Public health is damaged by biased, scientifically invalid public health policy.
Thus, I call upon the U.S. Congress, the director of CDC, and the secretary of Veterans Affairs to pursue one of two courses of action. Either:
1. CDC and the Department of Veterans Affairs should publicly repudiate the 2016 and 2022 opioid guidelines and withdraw them without replacement or
2. Congress should legislate the removal of the CDC and the Department of Veterans Affairs from all future policy-making roles in the practice of pain medicine.
It is time for U.S. policymakers to take seriously the 2019 announcement of six professional clinical academies and societies representing over 560,000 clinicians and medical students. It is time to “end political interference from the practice of evidence-based medicine.”
Richard A. Lawhern is a patient advocate.