As a patient advocate and healthcare writer for 26 years, I read a lot of medical literature and mass media. One of the most brilliant recent analyses of public health confusion and outright governmental fraud in the field of pain medicine was by Dr. Shravani Durbhakula in a New York Times editorial on March 22, 2024. “The D.E.A. Needs to Stay Out of Medicine”
Dr. Durbhakula called to mind my 2021 submission, responding to an announcement in the US Federal Register. The Food and Drug Administration (FDA) was at the time conducting a workshop intended to refine the concept of Morphine Milligram Equivalent Dose (MMED).MMED limitations on opioid use had become a central and disabling issue in the US Centers for Disease Control (CDC) guidelines on pain management. It’s one of the most controversial healthcare policy issues today.
The work of Jeffrey Fudin, Jeffrey A. Singer, Michael Schatman and Josh Bloom is. 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:
Jeffrey A. Singer, MD, “If Lawmakers Really Want to ‘Follow the Science’, They Will Repeal Codified Opioid Guidelines” Cato At Liberty, May 24, 2021.
Josh Bloom, PhD, “Comments to the FDA – Opioid Dosing Based on Milligram Morphine Equivalents is Unscientific”, American Council on Science and Health, May 24, 2021,
and something a little later, also by Singer and Bloom: “We’re Measuring Opioid Strength the Wrong Way”, Cato Institute, February 1, 2022.
Sally Satel, MD, “The Truth About Painkillers” National Affairs, Nr 47, Spring 2021.
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. Furthermore, these studies align with the 2019 HHS Task Force on Best Practices in Pain Management, indicating there’s no single ideal treatment for chronic pain. This supports the idea that healthcare system management must evolve to consider individual patient needs rather than rigid guidelines that often do more harm than good.
Tom Lynch, Amy Price, “The Effect of Cytochrome P450 Metabolism on Drug Response” Am Fam Physician. 2007 Aug 1;76(3):391-396.
Donna J. Belle and Harleen Singh “Genetic Factors in Drug Metabolism”, Am Fam Physician. 2008 Jun 1;77(11):1553-1560
Andrea M. Trescot, MD, and Semyon Faynboym, MD “A Review of the Role of Genetic Testing in Pain Medicine”, Pain Physician 2014:17 ISSN 1533-3159
Bhushan A Kapoor, Prateek Lala, Julie L.V. Shaw, “Pharmacogenics and Chronic Pain Management” Clinical Biochemistry, 2014.
The Federal Register announcement includes an objective to define “future directions to refine and improve the scientific basis of MME applications.” However, references herein reveal such refinements to be a fools’ errand due to the wide range of metabolic and drug interaction effects which operate in determining each individual’s minimum effective dose levels and side effects. It is unlikely that any algorithm or model can ever be developed that meaningfully generalizes a common dose standard, even as a “guideline”. Dose selection will always be a trial-and-error process.
MME represents junk science and the CDC 2016 and 2022 guidelines on prescription of opioids to adults with chronic non-cancer pain were equally ill-founded. No less an authority than the American Medical Association recommends that all Federal and State legislation based on the CDC guidelines as a standard should be repealed.
There is ample evidence that CDC guideline writers were improperly influenced by anti-opioid propaganda. They deliberately chose to ignore well known confounds in assumed relationships between opioid prescribing, addiction, and overdose mortality. However, as no less authority than the Director of the National Institute on Drug Abuse informed us as early as 2016,
“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” This perspective needs more attention in health policy topics discussions.
See Nora D Volkow, MD and Thomas A McLellan, Ph.D., “Opioid Abuse in Chronic Pain — Misconceptions and Mitigation Strategies” . NEMJ 2016; 374:1253-1263 March 31, 2016].
I urge the FDA Workshop to conclusively repudiate MMED as a metric in practice guidelines or standards. Moreover, I urge you to repudiate all applications of this metric by law enforcement or licensure authorities (DEA, DoJ, State drug control authorities, State Medical Boards) as a basis for prosecutions or license sanctions against physicians. Thousands of doctors have lost their licenses or been sent to prison for “improper prescribing” based on this bogus made-up metric. Millions of patients have been force-tapered or denied safe and effective opioid therapy. Thousands have committed suicide. Given these realities, FDA should recommend a DoJ judicial review for all cases of “improper prescribing” processed by DEA over at least the past ten years.
The implications of MMED are significant and impact the broader issue of healthcare policy. It is essential to address these shortcomings and create a more equitable system that serves the needs of patients and healthcare professionals without resorting to punitive and unjust practices.
This input to the FDA workshop appears to have been utterly ignored – and is still being ignored by FDA, CDC, the Veterans Administration, and DEA. It can be argued compellingly that DEA is now a Racketeer Influenced and Corrupt organization under the meaning of the law. And as Dr. Durbhakula suggests, it is very much time to remove them from the practice of medicine. More broadly, it is time to remove political influence from the practice of evidence-based medicine., as US organizations representing over 500,000 doctors and students have advocated.
– Please – see the ‘updated’ CDC guidelines wherein the conversion table CITED as deriving from:
Clin J Pain. 2008 ; 24(6): 521–527. doi:10.1097/AJP.0b013e318169d03b.
Defacto Long-term Opioid Therapy for Non-Cancer Pain
has CHANGED the conversion 4mg hydromorphone / 16mg morphine to 4mg hydromorphone/ 20mg morphine, a change that has replaced my 20+ yr PCP managed rx regimen w/ an OUD/SUD “care team” program, where – I quote – they “have no time” for discussing my medical status which, deteriorating under their “care”, they’re attributing to my 20+ yrs of *absolutely ‘compliant’* pain management!
Please? Is there light at this tunnel’s end OTHER than the light reported in back-from-the-dead testimonials? or is that a moot irrelevancy inasmuch as literally? It appears they’re killing me!
Excellent article by Dr. Lawhern and thanks for posting. MME was used historically to help clinicians change opioids. In some but not all studies MME inspite of it’s flaws, does correlate with risk of overdose, but like any risk factor should be factored into clinical decision making and not reason to deny opioids or prosecute a physician. The DEA would use this metric to target where too many pills are going (i.e. pill mill). Unfortunately, the CDC has highlighted MME as an inflection point and is being used as a cut off for standardization of practice. One chronic pain patient suggested MME may be a marker for how severe a disease is or according to Dr. Lawhern, a metabolic issue. It should not be used to judge an appropriate dose or prescribing practice. Fortunately Colorado has passed a law in this regard not to prosecute a physician or pharmacy based on dose dispensed.