NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., IN THE SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, SHELLEY HIGHTOWER, BS., PHARMD., LEROY BAYLOR, WALTER L. SMITH BA., ADRIENNE EDMUNDSON, WALTER L. SMITH BS., LEROY BAYLOR, BS., MS., MS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER, CUDJOE WILDING BS, MARTIN NDJOU, BS., RPH., DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
FROM THE LAWHERN FILES:
“Prepared Remarks to the July 16, 2021 Meeting of The US CDC National Center for Injury Prevention and Control Board of Scientific Advisors, MME MUST BE REPUDIATED AND WITHDRAWN“
My name is Richard Lawhern PhD. I am a volunteer advocate for chronic pain patients, with 25 years experience and over 125 published papers in journals and mass media.
Today I draw your attention to a June 7-8, 2021 FDA Workshop on “Morphine Milligram Equivalents.” Although public comments remain open until August 9th, major conclusions are already clear. The central metric and rationale of the 2016 CDC opioid guidelines was Morphine Milligram Equivalent Daily Dose (MMED). We now know from multiple sources that this metric is junk science — scientifically invalid and deeply harmful as a criterion for limiting opioid dose or duration. The 2016 CDC Guidelines are consequently flawed beyond possibility of repair.
I also note that CDC has no charter for issuing guidelines on prescribing and dosing any number of other non-opioid medications used to treat infectious diseases, depression, diabetes, hypertension or other health problems the agency tracks. Interjection of the Agency into opioid guidelines was highly inappropriate in the first place. This mission is normally addressed by FDA.
The only scientifically and ethically sound action now open to the CDC is outright repudiation and withdrawal of its 2016 guidelines – without replacement. No amount of marginal tinkering will help. You royally messed up and you must repair the fully predictable damage that you did to millions of patients and thousands of medical practitioners.
As one element of guideline withdrawal, you should recommend that US Department of Justice and State Attorneys General conduct a judicial review for at least the last 10 years, of actions to sanction, suspend or revoke licenses, or imprison physicians for fictitious “over-prescribing” based on MME thresholds. Judgments involving MME as a criterion, must be vacated with a monetary award of damages to physicians whose practices and lives have been ruined by this bogus pseudoscience.
Thank you for your time.==========================
Fact Sheet on Prescription Opioid Pain Relievers in the “Opioid Crisis”
Richard A Lawhern, PhD, Patient Advocate [Lawhern@hotmail.com]
Over-prescribing by doctors to their patients did not cause the “Opioid Crisis”
“Unlike tolerance and physical dependence, addiction is not a predictable result of opioid prescribing… Addiction occurs in only a small percentage of persons who are exposed to opioids — even among those with pre-existing vulnerabilities.”
* [*Nora Volkow MD, Director National Institute on Drug Abuse, and Thomas A McLellan PhD — NEMJ, 2016]
“We can no longer afford to view increasing drug-related mortality through a prescription opioid-myopic lens… A CDC Guideline only focused on “opioid prescribing” will perpetuate the fallacy that by restricting access to opioid analgesics, the nation’s overdose and death epidemic will end.” [AMA letter to Director CDC – Press Release, June 17, 2020]
There is no cause-and-effect relationship between prescribing and overdose mortality – But millions of patients are being denied safe and effective pain care.
Seniors over age 62 are prescribed opioids for pain three times more often than youth under age 19. But youth have overdose rates three times higher than seniors. No medical model can explain these demographics.
YOU ARE WITHIN THE NORMS
- Richard A “Red” Lawhern PhD., Patient Advocate
2. Friends and Colleagues,
As I noted last week, I am registered to speak during the public comments segment in the July 16th meeting of the National Center for Injury Prevention and Control, Board of Scientific Advisors. I believe that a few others on our email distribution lists and who know me from social media may have registered to speak at the same meeting. This note will share with you, my prepared remarks. If you are also registered to speak, please don’t copy, of course. This shares some ideas that any of us can develop in our own way and from our own experiences, in our own voices. The core message is “repudiate and retract the 2016 opioid guidelines — and don’t replace them.”