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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., 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., M.B.A., 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., IN THE SPIRIT OF RICHARD KAUL, MD., IN THE SPIRIT OF LEROY BAYLOR, JAY K. JOSHI MD., MBA, AISHA GARDNER, 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 TERM OPIOID USE DISORDER IS HUGELY ERRONEOUS
The Analogy: One can compare the historical diagnosis of OUD in pain patients to a faulty car alarm. Old studies were like a sensitive car alarm that went off every time a heavy truck drove by (pain returning), causing neighbors to think the car was being stolen (addiction).
The public narrative surrounding the “opioid crisis” in the United States is one of widespread addiction driven by over-prescription of pain medication. However, a body of critical research argues that this story is fundamentally wrong.
This critical perspective is outlined in a collection of 23 papers by Richard A. Lawhern, PhD, who is an author and Subject Matter Expert on Chronic Pain, and in the FDA petition of Dr. Stefan Kertesz, MD, a Professor of Medicine at the University of Alabama at Birmingham Heersink School of Medicine, and an attending physician at the Birmingham, Alabama VA Health Care System (Docketed FDA-2024-N-5331-0003).
The petition urges modernization of opioid labeling and public safety communications. Both authors’ works address the escalating crisis in American pain medicine, highlighting how administrative burdens and government overreach have resulted in physician burnout and restricted patient access to vital treatments.
These authors argue that the term “opioid use disorder” is a scientifically flawed classification that fails to distinguish between biological physical dependence and psychological addiction.
According to the text, current CDC and DEA policies rely on inaccurate research, leading to the criminalization of doctors and the abandonment of millions of chronic pain sufferers. Their analysis draws from a knowledge base of over 15,000 clinical sources. Their work contends that prevailing U.S. policy is built on a foundation of flawed assumptions that are actively harming millions of patients and their doctors.
Furthermore, the source claims there is no direct link between medical prescriptions and the broader addiction epidemic, asserting that severe mental health history is a much stronger predictor of overdose.
The text in this publication calls for the removal of restrictive prescribing guidelines to prioritize evidence-based care and patient quality of life.
OUD DIAGNOSIS: A FAULTY CAR ALARM
The new “pain-adjusted” data is like upgrading to a modern security system that can distinguish between a thief breaking glass and normal environmental vibrations, revealing that actual theft attempts (true addiction) are rare, whereas the previous alarms were mostly false positives.
Based on the submission by Dr. Stefan Kertesz to the FDA, the scientific understanding of Opioid Use Disorder (OUD) in the context of long-term pain management has been distorted by flawed historical data. Dr. Kertesz argues that to ensure patient safety, the FDA must correct these misconceptions with the “latest scientific evidence” from recent Post-Marketing Requirement (PMR) studies.
This perspective hinges on a central claim: that U.S. opioid policy is a product of deep-seated bias, not sound science, leading to dire and unintended consequences.
WEAPONIZATION OF FLAWED SYSTEM SCIENCE
“the overestimation of risk”
The Overestimation of Risk Dr. Kertesz states that the medical community has long depended on “poor-quality claims” about how likely patients are to develop addiction. He references older studies indicating that up to 26% of chronic opioid patients have “current” OUD. Dr. Kertesz claims this number overstates the actual risk by a factor of 10 because it relied on a “blind application” of diagnostic checklists without accounting for the realities of chronic pain.
According to the new FDA PMR study (3033-1), which uses “pain-adjusted” estimates, the actual incidence of moderate-to-severe OUD in long-term opioid therapy is approximately 1.4% to 1.6%.
Distinguishing Pain from Addiction. A primary driver of these inflated statistics was the failure of older diagnostic models (DSM-IV and unadjusted DSM-5) to distinguish between addiction behaviors and physiological responses to pain. Dr. Kertesz notes that patients often endorsed diagnostic items such as “difficulty cutting down,” which researchers interpreted as a sign of OUD.
the Kertesz Lawhern protocols
(KLOP)
However, for a pain patient, the difficulty in reducing medication is often because their pain worsens when the dose is lowered, not because they are addicted.
Risk Factors and Dosage Dr. Kertesz highlights two critical findings from the recent FDA analysis regarding who is actually at risk for OUD:
1. Dose Independence: The risk of developing new-onset OUD is not related to the prescribed dose. This challenges the common assumption that higher doses inevitably lead to higher addiction rates.
2. Prior History: The study confirms that patients with prior non-opioid use disorders are at higher risk for developing OUD, a factor that should guide screening rather than blanket refusals of care.
Conclusion Dr. Kertesz urges the FDA to update product labeling to reflect these lower, more accurate numbers. He warns that maintaining the inflated narrative of addiction risk fuels the mistreatment of patients and justifies aggressive tapering policies that, as discussed in our previous exchange, lead to destabilization and suicide.
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THE DASGUPTA FACTORS PROVE “MME” A HUGELY ERRONEOUS METRIC ILLUSION
“..The application of Knowledge is only as sound as the Foundation it is built upon..”
Background
Dr. Nabarun Dasgupta received a 2025 MacArthur Fellowship, known as the “genius grant.” The honor, announced on Oct. 8 by the John D. and Catherine T. MacArthur Foundation, recognizes Dasgupta’s work as an epidemiologist and harm reduction advocate who combines scientific research with community involvement to decrease deaths and other harms from drug use and overdose. Dasgupta and his team have played a key role in the national response to the opioid epidemic.
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