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NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, IN THE SPIRIT OF WALTER R. CLEMENT MS., MBA., 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., IN THE SPIRIT OF ERLIN CLEMENT SR., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., 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 NDJOU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
THE MYTH OF MORPHINE MILLIGRAM EQUIVALENT DAILY DOSE
Jeffery Fudin, Jacquelin Pratt Cleary, and Michael Schatman
Morphine Milligram Equivalent (MME) dosing was designed in an attempt to examine opioids with similar analgesic effects and should not be used to determine an exact mathematical dosing conversion. However, it is based on zero science and has been debunked in numerous articles in the literature.
“…MME/MEDD ARE NOT STANDARDIZED CLINICAL METRICS…”
Thus law enforcement has adopted a false equivalency to define (or redefine) medical science, something they are not entitled to do. At the same time, prosecutors use these errant standards to establish false jurisprudence.
Unfortunately, prosecutors and the DEA have learned when facts don’t support the charges; one just fabricates the facts. Thus the phrase garbage in is garbage out, or the legal term false en Uno false en Omnibus is applicable. It would have been expected a higher level of scientific accuracy and integrity from an agency such as the DEA entrusted to protect citizens’ health and welfare.
THE MORPHINE MILLIGRAM EQUIVALENT (MME) IGNORES THE FACTS
The problem with all the conversations about MME ignoresthe fact that no one knows what MME has to do with drug absorption and addiction. The lack of knowledge of opiate receptors and the belief that addiction is dose-dependent continues to be the missing link. The reason for the need for increasing doses in addiction is due to the increase in the metabolic rate of detoxification by the liver.
According to Jeffery Fudin, Jacquelin Pratt Cleary, and Michael Schatman The Myth of Morphine Milligram Equivalent:
“The impact of pseudoscience on pain research and prescribing-guideline development published March 23, 2016. Articles from the Journal of Pain Research and Schatman’s youtube video Myth of Morphine Milligram Equivalent Daily dose:
“ ..Based on the marked variability of dosing conversions from one opioid to another, the lack of a distinct risk threshold, and various patient variabilities, the concepts of MEDD and daily limits are grossly flawed. How any agency, clinician, or lawmaker can claim a daily limit on total morphine equivalence and/or dispensed dosage units is mind-boggling when there is obviously no accurate, validated or universally accepted way to calculate total MEDD. Tragically, this is what the United States Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain has done. Simply put, it is scientifically, ethically, and morally inexplicable.
Therefore, the flawed concept of MEDD should not necessarily be used to guide clinicians when adjusting opioid doses or rotating from one to another. In our opinion, impressionist lawmakers and anti-opioid zealots are basing clinical policy decisions on flawed concepts that could ultimately adversely affect positive outcomes for legitimate pain patients.
Let us hope that pain researchers will lead the way in developing a much-needed and ethical paradigmatic revision, as the MEDD myth must be dispelled.. “
“…MME/MEDD is a deeply flawed science used by DEA as a way to calculate the total amount of opioids, accounting for differences in opioid drug type and strength…”
FROM THE FILES OF THE CATO INSTITUTE
THE MYTH OF MORPHINE MILLIGRAM EQUIVALENT DAILY DOSE
BY TREVOR BURRUS AND SENIOR FELLOW JEFFEREY SINGER MD
In 2016, the CDC issued its Guidelines for Prescribing Opioids for Chronic Pain Patients. In publishing the guidelines, the CDC explicitly stated that they were meant to be voluntary and “not prescriptive,” stating that healthcare practitioners knew their patients’ unique clinical situation and should weigh the potential risks and benefits when prescribing opioids. Many of its recommendations were based on what the CDC characterized as “Type 3” or “Type 4” evidence, which are categories of evidence that are less probative and carry a significant risk of inaccuracy. The guidelines thus came under significant criticism from many pain and addiction specialists for lacking a strong basis in the evidence.
Others criticized the use of morphine milligram equivalents (MMEs) in determining the appropriate dosing of different opioids. As Fudin and others have argued, MME dosing was designed in an attempt to examine opioids with similar analgesic effects and should not be used to determine an exact mathematical dosing conversion.
The pharmacology and unique properties of each opioid and patient individuality must be considered when a therapeutic opioid conversion is contemplated. Conversion should not simply rely on a mathematical formula embedded within the CDC calculator software.
Furthermore, the current calculation for methadone employed by the calculator could allow for potentially dangerous conversions. This is especially problematic, considering this calculator is intended to target nonspecialist general practitioners. We expect a higher level of scientific accuracy and integrity from an agency entrusted to protect citizens’ health and welfare.
THE MYTH OF MORPHINE MILLIGRAM EQUIVALENT DAILY DOSE
NABARUN DASGUPTA et al. DOES THE MATH
Recognizing the controversy surrounding MMEs, in August 2021, the FDA held a “public workshop” entitled “Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions.” The workshop’s stated purpose was to “provide an understanding of the science and data underlying existing MME calculations for opioid analgesics, discussing the gaps in these data, and discussing future directions to refine and improve the scientific basis of MME applications.”
During the workshop, Nabarun Dasgupta of the University of North Carolina Injury Prevention Research Center presented research stating: “Contrary to conventional wisdom, conversion values are not
based on pharmacologic properties. Instead, they arose 60 years ago from small single-dose clinical studies in post-operative or cancer populations with pain score outcomes; toxicologic effects (e.g., respiratory depression) were not evaluated.”
The research concluded: “The overlooked inconsistency among daily MME definitions revealed by our study calls into question the clinical validity of a single numerical risk threshold. . . . Our findings call into question state laws and third-party payer MME threshold mandates. Without harmonization, the scientific basis for these mandates may need to be revisited.”86 Some critics consider the use of MMEs to be “junk science.”
Nevertheless, many states implemented statutory or regulatory limits on the dose (in MMEs) and number of opioids that may be prescribed to patients in acute, chronic, and postoperative situations, respectively, and they encouraged policies promoting the rapid or abrupt tapering of chronic pain patients off the opioid therapies on which they had been maintained long-term.
In 2018, Oregon proposed a mandatory reduction to zero opioids calculation for methadone employed by the calculator could allow for potentially dangerous conversions. This is especially problematic, considering this calculator is intended to target nonspecialist general practitioners. We expect a higher level of scientific accuracy and integrity from an agency entrusted to protect citizens’ health and welfare in Medicaid patients over 12 months. The state reversed itself after receiving fierce criticism from pain management and addiction specialists.
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THE MYTH OF MORPHINE MILLIGRAM EQUIVALENT DAILY DOSE
BY MARKS IPSEN MD
FROM THE STATE OF MONTANA
“Narcotics Analgesics medications are no different, as they, too, carry with them the dangers of any other types of drug medications when abused or taken in numbers beyond the prescribed doses or, for that matter, their FDA-approved therapeutic dose. Morphine Milligram Equivalent or MME is not a standard or guide used by the FDA for dosing. Specifically, it is well established because of genetic pleomorphism; the fact that humans metabolize opiates at variable rates through the CYP 450 system indicates that MME is irrelevant to physician practice and physiology.
In addition, it has no statutory basis at all. Once we have dosed a patient, we reevaluate to see the effect. This is the scientific model in action. Using MME to inform medical practice is more dangerous than a coin flip and makes a mockery of all of our Hippocratic Oaths.
Morphine Milligram Equivalent (MME) dosing was designed in an attempt to examine opioids with similar analgesic effects and should not be used to determine an exact mathematical dosing conversion. However, it is based on zero science and has been debunked in numerous articles in the literature. Thus law enforcement has adopted a false equivalency to define (or redefine) the medical science of Narcotic prescribing, treatment, and dispensing.”
CONCLUSION
This again represents a profound set of intervening circumstances of which both substantial and controlling effects are serious displays of the preponderance of other substantial scientific factual grounds not previously presented.”
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FOR NOW, YOU ARE WITHIN
THE NORMS
AUSA WAYNE F. PRATT, SOUTHEASTERN MICHIGAN
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As a victim Of opioid over prescribing 20 years ago I have been amazed at the ignorance regarding dosage. To begin with there was absolutely no plan in place to titrate me Down from 100 MG of Hydrocodone daily nor to assist with the resulting abdominal damage culminating in a ruptured colon. But most disturbing was the ignorance since that time regarding dosages of Narcotics. I find it to be absolutely true that most people that have struggled with SUD often have a higher tolerance, needing higher dosage. I have had numerous abdominal surgeries, hospitalizations for abdominal infections and dental work all of which required opioids. Taking opioids for pain when needed have a different effect than when used for recreation. I have not struggled with cravings nor dependency and find it extremely offensive when a doctor glances through my chart and then refuses prescribing opioids because of an issue 17 years ago. It’s lazy and self serving, ignoring patients’ needs