On Wednesday, September 9, 2026, the author spoke briefly at a hybrid conference conducted by the Reagan-Udall Foundation for the U.S. Food and Drug Administration in Washington, D.C. This was only the most recent such “listening session” conducted over a ten-year period. And from the first government speaker onward, the meeting reflected many of the historical biases and misdirection of U.S. health care agencies with respect to the so-called “opioid crisis.”
Fundamentally, the framing of this meeting was from the perspective of an assumed (and hugely false) association between prescription opioid analgesics used in the management of severe pain, and an asserted high incidence of iatrogenic substance use disorder in patients. This framing was contradicted by about three-quarters of the non-government speakers, many of whom were longtime pain patients or doctors.
In an effort to create at least an appearance of fairness, the Reagan-Udall Foundation has created an online portal for additional comments from the public following the meeting. This portal will remain open through September 19, 2026, and it is vital that more patient voices be heard. Comments are organized around four questions. There is a limit of 2,000 characters in each. The following comment by the author expands the 150-second (300-word/1-chart) presentation allowed during the hybrid meeting itself.
Q1: What would you like us to know about your perspective regarding the use of opioid medications for the management of pain or addiction?
The idea that doctor over-prescribing is sustaining the U.S. opioid crisis, or ever has, is outright silly. It is directly contradicted by data published by the U.S. Centers for Disease Control and Prevention (CDC) itself, in the State Unintentional Drug Overdose Reporting System (SUDORS) database.
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Among 43 jurisdictions covering 66 percent of U.S. population in 2024, only 1,031 accidental drug overdose deaths were found in which “only” a prescription opioid was reported. However, this is a reporting artifact. Labs in many rural counties are not funded to detect the constantly evolving analogues of illegal fentanyl.
Thus 1,031 are over-reported as “only” a prescription opioid. If even half of those reports are from rural counties, then the number of prescription-only deaths may be as few as 500.
Among the remaining 500, CDC does not record the sources of the prescriptions involved. Some are undoubtedly stolen, provided to the decedent by relatives, or purchased from street sources. Without further analysis, we cannot know if any of those deaths were among patients treated by a doctor. And we won’t know until CDC requires reporting of this data.
Q2: Please provide specific comments or information about the scientific evidence regarding conditions of use, safety concerns, or benefit-risk assessment (including consideration of the public health effects) of opioid medications
Opiate medications to manage pain have been known and used for two millennia. The great majority of current scientific evidence supports the conclusion that prescription opioid analgesics are both safe and effective in the context of an ongoing doctor-patient relationship. As noted in my virtual presentation during the meeting, multiple published sources reveal that the real incidence of iatrogenic substance use disorder may be as low as one patient in one thousand who are treated for pain.
Both versions of the CDC guidelines were fatally flawed on ethics as well as science, and were known to be fatally incorrect by the writers before publication. CDC and other guidelines and FDA REMS documents fundamentally misuse the concept of morphine milligram equivalent daily dose (MMEDD) to exclude patients from pain treatment and to endanger doctors who employ these medications in pain management. MMEDD is a statistical mythology, not a clinical method, and doctors throughout the world know it.
Despite at least 25 years of research that has long been taught in medical schools, present guidelines fail utterly to address the genetic mediation of opioid metabolism in the liver and the consequent wide range in individual minimum effective dose and side effects between patients. Since 70 to 90 percent of all clinically significant medications are metabolized in the liver, this reality suggests that huge numbers of clinical trials need to be done over on multiple medications, at a potential cost of tens of billions of dollars.
Similar concerns contradict the scientifically vacuous efforts of AHRQ and CDC to assert that non-invasive, non-pharmaceutical therapies are “preferable” to opioids. Among 5,000+ published trials, only 230 passed AHRQ quality review; pain improvement when these therapies were added to usual and customary treatment was 2 levels on a visual analog scale of 10. Improvements were temporary and marginal. And none of the trials addressed replacement of opioids on an either/or basis, as implied by CDC.
Q3: Please provide specific comments regarding FDA’s regulation of opioid medications
FDA’s over-regulation of opioid medications must be fundamentally redirected on the basis of science rather than opinion or (worse) financial self-interest among anti-opioid zealots. As I have written in published papers, almost everything the government thinks it knows about the opioid crisis is wrong. If you are ever again to be trusted by the American public, then you must read and embrace the many scientific contradictions to your present policy. The following are required:
- One of the first: Stephen A. Martin, MD, EdM; Ruth A. Potee, MD, DABAM; and Andrew Lazris, MD, “Neat, Plausible, and Generally Wrong: A Response to the CDC Recommendations for Chronic Opioid Use,” Medium, September 7, 2016.
- “Drug Use and Substance Abuse Disorder versus Chronic Pain.”
- “When Regulators Turn Suspicion into Proof.”
- A featured author page mounted by the European Society of Medicine lays out the case supporting this commentary in a 30-minute review, with a slide deck that has been invited by at least seven international conferences and summits in the coming year.
- “Opioid Pain Contracts Turn Doctors Into Parole Officers.”
These will get you started. There are many more if you simply open your minds and go looking for them. Start with a Google search on the question, “What authors have written in contradiction to the conclusions of U.S. CDC, VA, FDA, and NIDA concerning the causes of the U.S. opioid crisis?”
Q4: Please provide specific comments regarding additional actions that could be considered to address the public health effects of opioid medications
Speakers from the National Campaign to Protect People in Pain addressed needed actions to correct disinformation and misdirection of health care policy before an FDA/CDER listening session in July 2024. The presentation was repeated before the chief of staff for the National Institute on Drug Abuse (NIDA) in October of that year. Highlights of that presentation are available online.
Two years ago, we had hope that FDA and NIDA might eventually wake up and smell the coffee. That hope has since been dashed by your persistent refusal even to discuss in interagency forums, the widespread and valid patient and clinician concerns in the vast over-regulation of pain-relieving medications and denial of pain care to millions.
Following the current meeting of September 9, you have one last chance to correct course. If you can’t get it right this time after ten years, then you never will. In that case, your best additional action should be to personally resign and go looking for a more honest line of work.
The public may enter comment on these questions at the Reagan-Udall Foundation gateway through September 19, 2026.
Richard A. Lawhern is a nationally recognized health care educator and patient advocate who has spent nearly three decades researching pain management and addiction policy. His extensive body of work, including over 300 published papers and interviews, reflects a deep critique of U.S. health care agencies and their approaches to chronic pain treatment. Now retired from formal academic and hospital affiliations, Richard continues to engage with professional and public audiences through platforms such as LinkedIn, Facebook, and his contributions to KevinMD. His advocacy extends to online communities like Protect People in Pain, where he works to elevate the voices of patients navigating restrictive opioid policies. Among his many publications is a guideline on opioid use for chronic non-cancer pain, reflecting his commitment to evidence-based reform in pain medicine.
