from youarewithinthenorms.com
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
Review of Stefan G. Kertesz’s Submission to FDA Docket REVISING OPIOID LABELING
This article summarizes a formal submission plan by Dr. Stefan G. Kertesz et al., urging the FDA to modernize opioid labeling and public safety communications. He argues that current warnings significantly overestimate addiction risks while failing to address the severe dangers associated with involuntary dose reductions.
By citing updated research, the author demonstrates that opioid use disorder occurs at much lower rates than previously claimed, yet tapering patients too quickly can lead to overdose or suicide.
Dr. Stefan Kertesz specifically advocates for better protection of long-term pain patients who face medical abandonment when attempting to transition to new doctors. He and other medical scientists, researchers, and paincare advocates call for science-based guidance to ensure that clinicians prioritize patient stability over rigid, high-risk prescribing mandates.
——————————————————————————–
Briefing Document: Review of Stefan G. Kertesz’s Submission to FDA Docket FDA-2024-N-5331-0003
Date: May 4, 2025
Source: Excerpts from “Kertesz Docket FDA 2025
Author: Stefan G. Kertesz, MD, MSc, Professor of Medicine, University of Alabama at Birmingham Heersink School of Medicine, Principle Investigator: CSI:OPIOIDs
Subject: Submission for Docket FDA-2024-N-5331-0003 “Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Amendment of Notice—Extended-Release/Long-Acting Opioid Analgesic Postmarketing Requirement”
Purpose: To urge the FDA to update opioid product labeling and public communication to promote science-based care, offer more accurate information on risks, and vastly improve communication on the risks of opioid reduction, thereby mitigating the mistreatment of patients prescribed opioids for long-term pain.
Key Themes and Important Ideas/Facts:
1. Inaccurate and Outdated Information on Opioid Use Disorder Risk:
- Problem: Dr. Kertesz argues that current communication and understanding of the risk of new onset opioid use disorder (OUD) in patients receiving long-term opioid therapy is based on outdated and poor-quality research, leading to significant overestimation.
- Specific Detail: He highlights a cross-sectional study from nearly 20 years ago that reported up to 26% of patients on chronic opioids had “current” OUD based on “blind application” of DSM-IV criteria. This figure was routinely presented as the likelihood of new-onset OUD, which Dr. Kertesz states it “overestimated the risk by a factor of 10.”
- Improved Data (PMR 3033-1): The FDA’s PMR Study 3033-1 provides more accurate, pain-adjusted estimates. This study utilizes prospective follow-up and a more sensitive and specific instrument to capture OUD.
- Recommendation: The FDA should update product labeling to show the absolute risk of moderate-to-severe OUD using the pain-adjusted estimates from PMR 3033-1. These are 1.4% and 1.6% for extended-release and overall long-term opioid therapy, respectively.
- Important Caveat: The labeling should also state that individuals with prior non-opioid use disorders are at higher risk.
- Quote: “Estimates that are ‘pain-adjusted’ in PMR 3033-1 are far better. The risks of misuse, abuse and OUD are still important. Going forward, I urge the FDA to cite the incidence of moderate-to-serve OUD, using the ‘pain-adjusted’ esitmates. These are 1.4% and 1.6% for extended release and overall long-term opioid therapy, respectively, as shown on Table 8 on page 43.”
2. Underestimated and Misrepresented Risks of Opioid Overdose:
- Problem: While acknowledging that overdose events are real and not negligible, Dr. Kertesz implies that current communication on overdose risk may not fully capture the cumulative incidence.
- Improved Data: The FDA’s analysis of 5-year cumulative incidence based on the Kaplan Meier curve, ranging from 1.49% to 4.05%, should be shared.
- Clarification Needed: The FDA should underscore that its overdose estimates include nonfatal as well as fatal overdoses.
- Quote: “In the case of overdose risk (Table 43, page 209), the FDA should share information derived from its analysis of 5 year cumulative incidence based on the Kaplan Meier curve, ranging from 1.49% to 4.05%. This is not neglible. But the information provided by FDA should underscore that its estimates include nonfatal as well as fatal overdoses.”
3. Substantial and Under-Communicated Risks of Opioid Reduction:
- Problem: Dr. Kertesz strongly emphasizes that the FDA’s current guidance on opioid reduction, particularly the 2019 warning about “sudden discontinuation” or “rapidly decreased” doses, is insufficient and does not reflect emerging science. The emphasis on acute withdrawal is too narrow.
- Key Finding: Emerging evidence from multiple research teams indicates that modest dose variations (as little as 15%) and discontinuations are statistically correlated with additional medical harm, overdose, or suicide events.
- Duration of Risk: The period of excess risk tends to extend for at least several months or longer, significantly beyond the period of acute opioid withdrawal. Studies have shown increased risk for more than a year after dose reductions.
- Lack of Safety Signals: There are “very few signals in retrospective studies that prescription opioid reduction confers safety.”
- Recommendation: The FDA must improve its guidance to reflect that dose reduction alone, regardless of pace, may incur serious health risks to patients. Clinicians should consider that involuntary reductions and stoppages are “more likely to cause harm than benefit.”
- Quote: “Since 2019, evidence developed by many diferent research teams indicates that that modest dose variations (as little as 15%) and discontinuations are both statistically correlated with additional medical harm, overdose or suicide events… Further, within this body of evidence, the period of excess risk tends to extend for at least several months or longer, which is far beyond the period of acute opioid withdrawal.”
4. High Vulnerability and Mistreatment of Patients Transitioning Prescribers:
- Problem: Patients on long-term prescribed opioids who need to transition between prescribers due to geographic moves, physician retirement, or practice changes face a period of “high vulnerability” for their pain control and safety. Many medical practices (as many as 40%) refuse to accept such patients.
- Reasons for Refusal: Prescriber discomfort, mistaken belief that continuing opioids is inherently harmful, professional fears, and pressure from regulators, pharmacies, and distributors that penalize prescribers for taking on these patients.
- Tragic Outcomes: Dr. Kertesz’s ongoing federally funded study (CSI:OPIOIDs) on suicides after prescription opioid reduction reveals a pattern where patients with complex disabilities and long-term pain are forced to transition, new prescribers refuse or involuntarily taper opioids, the patients deteriorate, and subsequently die by suicide.
- Quote: “In recent research, as many as 40% of medical practices refuse to receive a new patient if that patient is on long-term prescribed opioids.”
- Quote: “In the stories we have collected through in-depth interviews, the ‘new prescribers’ often accept the patient but then either refuse all opioids or initiate an involuntary taper. The patients deteriorate and at delay, often of months to a year, they die by suicide.”
- Recommendation: The FDA must offer specific guidance for prescribers seeing patients who have lost their previous prescriber. The FDA should urge providers not to refuse continuation “across the board” and advocate for the correction of measures that punish prescribers for taking on these patients.
🔓 🔓 🔓
ALL WATCHED OVER BY MACHINES OF LOVING GRACE
DONATE THIS HOLY DAY SEASON TO MAINTAINING THIS BLOG. YOU ARE WITHIN THE NORMS FIGHT FOR PAIN CARE JUSTICE TO ZELLE 3135103378
OR TO CASH APP:$docnorm
BE SURE TO DONATE TO THE MARK IBSEN GOFUNDME DEFENSE FUND, WHERE THE SON ALWAYS RISES!!!
OUR TREE OF KNOWLEDGE SHALL NEVER BE SURPRESSED
FOR NOW, YOU ARE WITHIN
THE NORMS
REFERENCES:
