By Richard A Lawhern, Ph.D.
On May 25, 2016, National Pain Report ran an opinion article titled “Stop The War On Chronic Pain Patients” [Link: http://
The NPR op ed and the 76 comments it generated have proven to be prophetic. Despite ample evidence that America’s so-called “opioid epidemic” is caused by street drugs (some of them diverted prescription drugs) rather than by prescriptions made by doctors to chronic pain patients, CDC has continued to double-down on its errors. They have thus far refused even to consider withdrawing the guidelines for a major and very needed rewrite. The US Veterans Administration has compounded this mess by publishing practice standards which declare opioid analgesics don’t work for chronic pain and shouldn’t be prescribed — ignoring the long record of effectiveness reported by patients, as well as hundreds of suicides which have already resulted from VA withdrawal of pain care from Veterans.
Among many other developments in this war on pain patients, the US Food and Drug Administration (FDA) has published a proposed “Risk Evaluation and Mitigation Strategy”, laying out proposals for FDA participation in combating addiction and the opioid crisis. Comments on this REMS can be entered until March 16th, starting from [link: https://www.federalregister.g
On Tuesday January 30, 2018, the FDA will hold public hearings on eight questions related to their REMS. I will speak second among a long list of contributors. My presentation is titled “An Appeal to the FDA: Cease, Halt and Refocus”. The major take-away points are these:
* FDA is chasing the wrong opioid crisis
* The FDA REMS will harm many, help almost none
* FDA should stand down from further regulation
– Take a breath before doing even more harm
– Focus on recall and revision of the CDC opioid guidelines
** Politically biased against opioid therapy
** Weak evidence for most recommendations
** Dangerously incomplete on opioid metabolism
The FDA hearings will be streamed in real time, beginning at 0830 Eastern time, Tuesday January 30. For information see
You’ll be hearing from me again after the hearings are concluded. Wish me luck.