Readers who follow my work on National Pain Report or in social media may be aware of the June 28th editorial article on Stat First Opinion. With a potential audience of 100,000 readers – many of them doctors or policy makers — “Stop Persecuting Doctors for Legitimately Prescribing Opioids for Chronic Pain”, strikes to the heart of controversies surrounding the 2016 CDC Guidelines on prescribing opioids. I show conclusive evidence that the entire public policy narrative surrounding regulation of medical opioids is fundamentally wrong on facts and assumptions. Over-prescribing by doctors to their patients is a mythology, not a fact. CDC data shows that there’s no relationship between prescribing rates and overdose mortality — and never has been.

We shouldn’t think that just because patients and doctors are right and drug regulators are wrong, that the regulators will give up without a fight. They won’t. Hundreds of Billions of dollars are at stake in city and State prosecutions of Pharma companies. DEA and State law enforcement authorities defending their empires won’t voluntarily stand down from persecuting doctors, despite lacking any rational standard for whatever it is that “over-prescribing” supposedly means.

It will take legislation from Congress and US Statehouses to clean up this mess. We need that legislation this summer, before our legislators move deeper into gridlock during 2020 election campaigns. With these issues in mind, I’ve drafted proposed legislation. The following excerpts are from a longer initial rough draft.

A BILL TO HALT DEPARTURE OF PHYSICIANS FROM

PAIN MANAGEMENT

2019 Federal Guidelines for Prescribing Opioids to Chronic Pain Patients

Purpose of this Bill: To stop departure of physicians from pain management practice by amending and clarifying Federal guidelines and regulation for prescribing opioid medications to patients in acute or chronic pain, as applied by CDC, FDA, NIH, NIDA, DoJ and DEA….

WHEREAS: CDC guidelines published in March 2016 have since been challenged broadly by many medical professional associations, individual researchers and practitioners on grounds including bias on the part of the writers, failure to conduct adequate research or establish consistent standards of research quality, and failure to address the natural variability in individual genetic profiles and responses to treatment employing opioid analgesics…

WHEREAS: Regulatory over-reach has interfered with doctor-patient relationships and usurped physicians’ authority to manage treatment regimens which include prescribing of opioids for pain…

WHEREAS: Patients with medically documented needs for management of chronic, non-cancer and non-terminal pain are being denied the only pharmaceutical products in the formulary which are effective for many of them…

WHEREAS: It is now known definitively that the declared National crisis in opioid addiction and overdose deaths is driven almost entirely by illegal street drugs rather than by medically prescribed opioids…

WHEREAS: When medically managed and used properly by patients for medically established needs, opioids have for decades been safe and effective pharmaceuticals for controlling chronic pain…

WHEREAS: The American Medical Association affirms that some patients with acute or chronic pain can benefit from taking opioid pain medications at doses greater than generally recommended in the CDC Guideline for Prescribing Opioids for Chronic Pain and that such care may be medically necessary and appropriate….

WHEREAS: DEA and other drug enforcement authorities have seized upon the CDC guideline as a standard for assessing when doctors are “over prescribing” opioids to their patients. Investigations of doctors have ruined their practices by prominent announcements in public media, attempting to coerce physician employees to disclose physician misbehavior, seizing and freezing access to patient records, and in some cases seizing civil assets — often for months before cases are brought to court…

WHEREAS: Despite significant admissions of error and misdirected policy by CDC and FDA, State regulators continue to restrict availability of opioid pain relievers as public policy. Doctors are continuing to leave pain management, fearful of losing their licenses or being ruined financially. If drug enforcement agencies are not directed to refocus their investigation efforts, this flight of skilled practitioners will continue and more patients will be forced into disability, agony and sometimes suicide by misdirected public policy…

IT IS THEREFORE DIRECTED upon CDC, NIH, FDA, NIDA, DoJ and DEA that:

(a) In Federal policy and practice for regulation of prescription opioid pain relievers, no Federal Agency shall apply MME (Morphine Milligram Equivalents) thresholds as anything more than general guidance; further, that physicians shall not be subject to professional discipline, loss of board certification, loss of clinical privileges, criminal investigation, prosecution, civil liability or other penalties or practice limitations, solely as a consequence of, prescribing opioids at quantitative levels above the MME thresholds discussed in the 2016 CDC Guideline for prescribing opioids.

(b) The 2016 CDC Guidelines on Prescription of Opioids to Adults With Chronic Pain are hereby suspended and withdrawn, pending rewrite by other US Agencies in a publicly transparent process including patient advocates as voting members of the writers group.

(c) Section 131 of the “Veterans Administration Mission Act” of 2018 is hereby repealed in total; within two years, VHA is directed to withdraw and rewrite its “Opioid Safety Initiative” and all Clinical Practice Guidelines associated therewith, to reflect Federal policy changes directed above.

(d) Within 90 days of enactment of this Act, VHA, HHS, and FDA are directed to publish letters to all medical practitioners licensed under their respective healthcare systems, summarizing mandatory changes of Federal policy above. These letters shall further be disseminated to all State Medical Boards, Pharmacy Boards, Departments of Health, Medicaid programs, Insurance Boards, drug enforcement agencies and Attorneys General.

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Note for readers: every Federal and State legislator, Governor and senior law enforcement official need to see this proposal this summer. Only you can make that happen. Start looking up phone numbers, folks. They won’t read our emails.

About the Author: Richard A Lawhern, Ph.D., is a frequent contributor to National Pain Report. He has over 22 years experience as a technically trained non-physician patient advocate, with 70+ published papers and articles in the field. He is a co-founder and former Director of Research for the Alliance for the Treatment of Intractable Pain.