Concluding Recommendations
Our results strongly suggest that CDC disregarded or disobeyed its own rules and ethical guidelines (111-113) by allowing PROP members and allies to help create the 2016 Guideline, thereby compromising its ethical integrity (1, 4, 23, 34, 36, 119-123). Those physicians acted entrepreneurially to facilitate a moral panic (9-11) about opioid-involved overdose deaths, using a false narrative about overprescribing that successfully changed opioid policy nationally. These policies have unacceptably increased risks of harm for patients in pain (43-45, 48-52, 67-73). Unfortunately, abolishing or repealing the 2016 Guideline and 2022 Draft Guideline, while ethically justifiable, now seems like an impossible task. The federal government has invested too much time and too many resources into the Guidelines to abandon them, especially while MDL suits against opioid manufacturers and distributers are still pending.
What can be done to undo the harms created by the 2016 Guideline and prevent further harm from the 2022 Draft Guideline? We strongly recommend abolishing hard dosing thresholds from the 2022 Draft Guideline, because their misapplication has emboldened involuntary and/or rapid opioid tapers, contributing to patient harms (43-45, 48-52, 67-73). These hard dosing thresholds have been improperly translated into “mandatory policies and laws throughout the country, becoming, in effect a standard of care used by states, payers, pharmacy benefit plans, health care systems and providers (162).” Next, while the 2022 Draft Guideline offers some improved language toward that goal, CDC must unequivocally denounce the false narrative that overprescribing still drives the opioid crisis, as “the particular focus around reduced opioid prescribing has met with limited success and contributed to subsequent waves of the crisis (163).” CDC’s Opioid Workgroup for the 2022 Draft Guideline cited similar concerns about hard dosing thresholds, but also acknowledged the inherent tension between patient versus public or societal health benefits (74). In addition, we call on policymakers to correct the current policy imbalance between patients’ medical autonomy and society’s benefit, acknowledging that physicians have an individualized, fiduciary duty to act in their patients’ best interests which may sometimes reasonably conflicts with public health goals (164). Patients are not monoliths, and physicians cannot treat them individually using a broad policy brush. Physicians’ primary responsibility is to attend the individualized needs of the patients they are treating. Thus, we envision creating an ethics-based, education-focused informed consent process that allows patients to weigh treatment risks versus potential benefits collaboratively to enhance opioid prescribing safety (165).
Furthermore, we identified a 72% rate of nondisclosure of COIs in our study group, which we find ethically unacceptable, considering the purported importance of transparency when creating clinical guidelines (107-110). CDC itself has acknowledged this moral imperative, but hasn’t adhered to its own ethical rules (111-113). Given the apparent inability of the study group authors and the CDC to transparently self-regulate the conflict disclosure process, we encourage medical journals to become more vigilant about identifying authors’ financial and intellectual COIs in submitted manuscripts about opioid policies. This includes holding editors accountable when they deliberately ignore relevant competing interests (123, 126-128).
Finally, if these recommendations fail to restore balanced U.S. opioid policy, we call upon the U.S. House Committee on Oversight and Government Reform to convene a hearing to scrutinize CDC’s use of a Core Expert Group to write its opioid guidelines instead of complying with the supervisory requirements of Federal Advisory Committee Act (166). Alternatively, we would invite the U.S. Department of Justice to investigate why CDC has repeatedly violated internal rules and ethical policies while creating the 2016 Guideline and 2022 Draft Guideline (111-113). Permitting ongoing patients harms from these Guidelines desecrates the sacred trust between prescribing physicians and patients afflicted by chronic pain.