As a health care writer and data analyst, I hear frequently from patients who are being denied safe and effective pain care due to unscientific bias on the part of U.S. health care agencies—and sometimes on the part of otherwise once-reputable medical journals. These are among millions of U.S. citizens who are now being deserted by the medical profession.
Thousands, overcome by their pain and depression, have already committed suicide. Thousands of their physicians are leaving pain medicine, fearful of sanctions by state medical boards or ruinous—though frequently unfounded—prosecution by the U.S. Drug Enforcement Administration or Department of Justice.
In this context, one of my network contacts recently drew to my attention an editorial in the November 2024 issue of New England Journal of Medicine, by Andrew Kolodny, MD, and Robert M. Bohler, PhD, MPH, titled “Screened out — how a survey change sheds light on iatrogenic opioid use disorder.” The central premise of this paper is that the number of Americans who suffer from addiction due to over-prescription of opioids by doctors is vastly underreported in national surveys conducted by the Department of Health and Human Services.
Such a premise is to be expected from Dr. Kolodny. He has been active as an anti-opioid writer and advocate for over 15 years. He has also made a small fortune in paid testimony as an asserted “subject matter expert” in multiple lawsuits against large pharmaceutical companies. This, despite the fact that his only board certification is in psychiatry rather than pain medicine. In online chronic pain communities, Dr. Kolodny is sometimes compared to Joseph Mengele of Nazi death camp fame, due to the damage he has done to people in pain. Like Dr. Kolodny, his coauthor is also affiliated with “Physicians for Responsible Opioid Prescription—PROP”—an organization that is similarly viewed by patients.
Having read the NEJM editorial, my long-time colleague and collaborator Stephen E. Nadeau, MD, contacted the editors of that publication to propose that they also publish a counterpoint to editorial positions taken by Kolodny and Bohler. NEJM refused to do so. It does not seem unreasonable to point out that such a position is at the very least unbalanced, if not unscientific and biased.
Thus, Dr. Nadeau and I went looking for a publication venue that would consider the extensive science that contradicts Kolodny and Bohler. We found one in the peer-reviewed open-access journal Medical Research Archives of the European Society of Medicine, which has published several of our previous papers. The result was an extensively referenced letter to the editors, “Use of opioids for chronic noncancer pain: a recapitulation of the science.” This article is available for unrestricted use, distribution, or reproduction in any medium, so long as the original authors and source are credited.
Among the points we offered were the following:
“Vast clinical experience testifies to the high efficacy of opioids for treatment of chronic pain, provided such important comorbidities as depression have also been effectively treated.”
“Retrospective cohort studies published 10 years ago established that annual opioid-associated mortality among clinic populations was approximately 0.25 percent with dosage greater than 100 mg morphine equivalent/day (MMED).”
Not explicit in our letter narrative was the reality that such incidence is so small and the conceptual confounds in diagnosis of substance use disorder are so large, that there can be no reliable advance prediction of addiction risk in individuals seen by pain management clinicians. None.
Oliva et al., in a large retrospective cohort study of Veterans Administration hospitals, demonstrated that [patient overdose and suicide] risk was not evenly distributed: It mainly accrues to patients with severe psychiatric disease, defined by multiple inpatient psychiatric admissions and multiple overdoses/suicide attempts.
“Previously documented opioid use disorder (OUD) did make a substantial contribution to the odds ratio of a morbid outcome. However, the DSM-5 scale defining OUD is fraught with recognized problems, not the least being that any patient with severe, inadequately treated chronic moderate to severe pain seeking relief would qualify as having at least moderate OUD. In addition, the discriminant value of the scale has never been determined. In the Oliva et al. study, opioids themselves, in any dosage, explained very little additional variance. Thus, one could reasonably interpret the results of this study as showing that opioids are incriminated as innocent bystanders.”
We also addressed the question “Have prescription opioids contributed to the opioid overdose crisis?” Our answer is a qualified “yes and no.”
“Between 1999 and approximately 2011, pill mills, supplied by major drug distribution firms, distributed vast quantities of pharmaceutical-grade opioids to vulnerable populations, thereby creating a large population of people with drug addiction.”
However, “… between 2010 and 2012, states shut down the pill mills through direct legal action and, most importantly, by expansion of use of Prescription Drug Monitoring Plans (PDMP) to 49 states (now 50). PDMPs rendered and still do render pill mill operations transparent. People with addiction had to turn to Mexican heroin and [far deadlier] Chinese fentanyl.”
We also documented several other points from published science that conclusively contradict and discredit the positions taken by Dr. Kolodny and his colleague. But still, NEJM editors refused to allow publication. The process of science depends importantly upon reasoned, evidence-based public argument to resolve and refine its understandings and form the basis for public health policy. NEJM has failed in its duty of care in this process.
Richard A. Lawhern is a patient advocate.
