NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. SPIRIT OF REV. IN THE SPIRIT OF WALTER R. CLEMENT BS., MS, MBA. HARVEY JENKINS MD, PH.D., IN THE SPIRIT OF C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., EVELYN J. CLEMENT, WALTER F. WRENN III., MD., JULIE KILLINGSWORTH, RENEE BLARE, RPH, DR. TERENCE SASAKI, MD LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., RICHARD KAUL, MD., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
The Centers for Disease Control and Prevention (CDC) issued Guidelines for Prescribing Opioids for Chronic Pain in 2016, which were updated in 2022. The DEA has used those guidelines as the standard for whether or not a doctor has acted in an illegal manner, and law enforcement has made the guidelines into hard limits.
These guidelines were flawed in both issuances, as they relied on the concept of Morphine Milligram Equivalents, or MME. This concept had been debunked by the scientific community in the 1990s but was put into play again when one special interest group acted as the CDC’s “expert workgroup,” seeking virtually no feedback or participation from stakeholders. MME is a flawed concept, and it is unscientific.
It was based on small, single trials from 60 years ago that were done on terminally ill patients to test toxicity only, not equal analgesic effect.
These “studies” would not pass for clinical trials today and are functionally junk science, but states, insurers, pharmacy benefit managers, and others have used these limits to the detriment of both doctors and patients.
For example, the National Council of Independent Living (NCIL) explains why MME is a flawed concept in a letter submitted to the FDA in 2021.
See NCIL Letter, attached.
In addition, the data indicates that tapering or discontinuing pain medicine to reach certain fixed morphine milligram equivalent guidance has increased fatal overdoses and other health harms.
See, e.g., id. See also Agnoli et al., “Association of Dose Tapering With Overdose or Mental Health Crisis Among Patients Prescribed Long-term Opioids,” Journal of the American Medial Association, Vol. 326(5), 411–419, https://doi.org/10.1001/jama.2021.11013.
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