By Richard “Red” Lawhern, Ph.D.
The fundamental errors which the Oregon Health Authority is trying to make policy can be traced to unproven or simply wrong assumptions around which the 2016 CDC Guidelines on prescription of opioids to chronic pain patients were based. These assumptions were:
(1) The US is said to have a public health crisis in opioid addiction and overdose mortality caused by physicians over-prescribing medical opioids to their patients. Restrictions and enhanced oversight of medical opioid prescriptions are therefore deemed to be warranted to prevent further exposure of both patients and their untreated family members to such potential sources of addiction and death.
(2) Opioid pain relievers are said to be ineffective for chronic pain, when used for months or years.
(3) Safe and reliable alternatives to opioid therapy are said to exist and are declared preferable as substitutes for opioid therapy.
A fourth fundamental weakness of the Guidelines is expressed as a systematic omission.
(4) The Guidelines are silent with respect to the practical impact of significant variations in opioid metabolism between individual patients, due to genetic polymorphism in six key liver enzymes affecting 90% of all prescription medication metabolism.
However, published medical evidence deeply contradicts all four errors in the CDC paper.
(1) Data published by the CDC itself reveals that over-prescribing by doctors to their patients did not create our opioid crisis and is not sustaining it. The contribution of medically managed opioid pain relievers to opioid overdose mortality is so small that it gets lost in the noise.
(2) If opioids are ineffective then why are at least 1.6 million Medicare patients being maintained on doses exceeding the CDC guideline trip wire at 90 MMED — many of them for years?
(3) If safe and reliable alternatives to opioid analgesics exist, then why have none of them ever gone through large scale Phase II trials required for certification by FDA? And why have none of them ever been trialed as actual “replacements” rather than as adjuncts (additions) to usual therapy with analgesics?
(4) A well-established literature on opioid metabolism establishes a very wide range of minimum effective dose that greatly exceeds the CDC 90 MMED criterion. There is no one-size fits all patient or therapy plan.
The Oregon proposals basically lack medical and ethical support. As discussed by Beth Darnall PhD, there are no published studies to establish any positive outcome from mandated tapering of legacy patients who are already stable with controlled pain. But there are multiple reasons for concern that patients coerced to taper may experience medical and psychological collapse.
The Oregon Commission is engaged in a fools’ errand that will damage thousands of patients — both those on Medicare and those on private insurance — by denying them the only therapies which actually work, in favor of outright quackery or unproven experimental protocols.
Richard Lawhern is Director of Research, Alliance for the Treatment of Intractable Pain and a frequent contributor to the National Pain Report.