FROM THE LAWHERN FILES
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, LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NDJOU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
Opioid Dosing Based on Milligram Morphine Equivalents is Unscientific: Comments to the FDA
Josh Bloom, Ph.D.
Director of Chemical and Pharmaceutical Science American Council on Science and Health,
New York, NY, he writes:
Nearly three years ago I wrote how the science behind US opioid policies was deeply flawed, in particular, the use of Morphine Milligram Equivalents (MME) to quantify recommendations, policies, or laws.
“…..clueless CDC and lawmakers pick up the baton – a shameful and disastrous chapter in American medical history, which has resulted in millions of un- or undertreated pain patients in addition to a stark increase in overdose deaths as fentanyl has “filled the gap..”
I argued that any use of MME was automatically flawed because it ignored even the most basic tenets of pharmacology, the absence of which made it impossible to rationally determine the relative strength of one drug to another.
Unfortunately, this methodology, which became the foundation of the CDC’s catastrophic 2016 publication Prescribing Guideline for Prescribing Opioids has metastasized ever since as one state after another has passed laws limiting the prescribing of the opioid analgesic, often based on the Guideline’s erroneous conclusions. In retrospect, it is not surprising that such a baseless document was created.
First, the CDC lacks both the authority and expertise to regulate drugs; that is the function of the FDA. Second, the anti-opioid group Physicians for Responsible Opioid Prescribing (PROP), which also lacks expertise in drugs and pharmacology, has undue influence with the CDC – a relationship that remains nebulous to this day.
It was almost a foregone conclusion that the CDC “recommendations” would become law. Indeed, this is now the case in 36 states. Sadly, drug abusers, pain patients, and their physicians have paid a very steep price for this ill-conceived document.
It is incomprehensible that the CDC would put out a series of guidelines without bothering to consider even the most fundamental tenets of pharmacology. But this is what happens when a woefully uninformed group like PROP feeds advice to an equally clueless CDC and lawmakers pick up the baton – a shameful and disastrous chapter in American medical history, which has resulted in millions of un- or undertreated pain patients in addition to a stark increase in overdose deaths as fentanyl has “filled the gap” created by the tightening of prescription of analgesic opioid drugs.
The failure to consider even these simple metabolic differences is a primary reason why the CDC table fails as a useful guide and why the concept of morphine milligram equivalents is scientifically faulty. Poor science will necessarily lead to poor policy. We have enough of both.
Richard Lawhern PH.D____
“I endorse comments submitted by Jeffrey Fudin, Jeffrey A. Singer, Michael Schatman, and Josh Bloom. References provided by these professionals are devastating to any attempt to dress up the concept of Morphine Milligram Equivalent Dose (MMED) as anything more than pseudo-scientific and grossly negligent over-generalization. I also commend the following published work; see endnotes (1) (2),(3),(4), (5), (6)”
YOU ARE WITHIN THE NORMS
1.Jeffrey A. Singer, MD, “If Lawmakers Really Want to ‘Follow the Science’, They Will Repeal Codified Opioid Guidelines” Cato At Liberty, May 24, 2021. https://www.cato.org/blog/lawmakers-really-want-follow-science-they-will-repeal-codified-opioid-guidelines
2. Josh Bloom, Ph.D., “Comments to the FDA – Opioid Dosing Based on Milligram Morphine Equivalents is Unscientific”, American Council on Science and Health, May 24, 2021, https://www.acsh.org/news/2021/05/24/comments-fda-opioid-dosing-based-milligram-morphine-equivalents-unscientific-15561
3. Sally Satel, MD, “The Truth About Painkillers” National Affairs, Nr 47, Spring 2021. https://nationalaffairs.com/publications/detail/the-truth-about-painkillers
4. Additional published references address the pivotal role of individual genetically mediated variations in opioid metabolism. Taken in combination, these references effectively invalidate any and all efforts to generalize standardized criteria for opioid dose across general patient populations or specific disease entities. This literature brings new urgency to the observation of the 2019 HHS Task Force on Best Practices in Pain Management, that there is no one-size-fits-all pain patient or therapy plan.
5. Tom Lynch, Amy Price, “The Effect of Cytochrome P450 Metabolism on Drug Response” Am Fam Physician. 2007 Aug 1;76(3):391-396. https://www.aafp.org/afp/2007/0801/p391.html
6. Donna J. Belle and Harleen Singh “Genetic Factors in Drug Metabolism”, Am Fam Physician. 2008 Jun 1;77(11):1553-1560 https://www.aafp.org/afp/2008/0601/p1553.html