As an unpaid healthcare writer and patient advocate, I’ve written for 27 years on opioid prescribing, pain management, and patient advocacy. Several of my shorter articles appear on Pain News Network or here on the American Council on Science and Health. Until recently, my work and that of many others had been met with official governmental silence (aka “stonewalling” by government authorities).
The silence might be about to change.
On July 23, 2024, I joined six other members of the Speakers Bureau of the National Campaign to Protect People in Pain, to offer a one-hour “listening session” to senior officials of the US FDA Center for Drug Evaluation and Research (CDER). A 25-page summary of the proceedings has been posted to social media platforms and shared with the US FDA Office of Communications, Professional Affairs and Stakeholder Engagement (PASE). Under the session rules, what follows below does not represent a commitment on the part of FDA, either to validate our stated findings or to take action thereon.
The one-hour FDA presentation was titled “The Real Opioid Crisis in Three Charts”. Our key points included these:
- If the FDA audience carries away nothing else from this session, they should remember this: There is no such thing as opioid use disorder. The term originated in 2013 with the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) – a document rejected by the National Institute for Mental Health as a framework for organizing research. Data published by the CDC itself completely discredits the notion that doctors prescribing to their patients are or ever were responsible for the US opioid crisis. And both CDC and DEA have known this reality for years.
- US CDC and US DEA are usurping missions delegated to the FDA by law, in the establishment of safety standards for prescription drugs. The consequence of this usurpation is the ongoing destruction of American pain medicine.
- CDC prescribing guidelines can be shown to incorporate outright fraud including failure to address genetically mediated opioid metabolism, misrepresentation of the effectiveness of non-opioid alternative therapies, one-size-fits all MMED dose criteria unsupported by science, and misrepresentation of opioid therapy, especially high-dose opioid therapy, as ineffective for long-term use.
- DEA prosecutions are grounded on non-representative "expert witnesses" who testify to anything DEA wants, no matter how false. Likewise, Administrative Law Judges deny defendants adequate representation by pre-trial asset confiscations and by rulings biased in favor of the DEA.
- It is now known beyond contradiction that incidence of addiction and overdose in pain patients treated by a doctor is too small to measure accurately within confounds of diagnosis and poor clinician training. Law enforcement is particularly ill-equipped to comment on this issue. It is also known to CDC and DEA that doctors overprescribing to patients was never a significant cause of the US opioid crisis -- and is not now.
- Our speakers appealed to FDA to take public action to repudiate and demand the withdrawal of horrendously damaging injunctive relief provisions imposed by the National Opioid Settlement. We also encouraged the Agency to take immediate action to correct its own databases concerning shortages of prescription opioids created by the US National Opioid Settlement injunction.
- We asked FDA to publicly repudiate and demand withdrawal of CDC/VA/DoD opioid prescribing guidelines, without replacement. In a spirit of transparency, we also disclosed that stakeholder participants in the session are co-complainants in formal complaint actions filed May 21, 2024 with the US Department of Justice Office of Civil Rights and the Office of the Inspector General of DHHS. We allege criminal fraud and denial of US citizens' civil rights on the part of CDC authors and approving officials for the 2016 and 2022 published opioid prescribing guidelines.
Findings briefed in the FDA Listening Session are being disseminated widely to US government Agencies including the National Institutes of Health, National Institute on Drug Abuse, National Centers for Injury Prevention and Control, and the Offices of the Surgeon General and the Inspector General in the Department of Health and Human Services. Online meetings are being requested with the Federation of State Medical Boards and all State Medical Boards, Boards of Pharmacy and Departments of Health.
It is time for the war on chronic pain patients, doctors and pharmacists to end. This Listening Session may be a first step in finally getting government authorities to hear our urgent pleas.
Richard A. Lawhern PhD is a volunteer subject matter expert on public health policy for regulation of prescription opioid analgesics and clinicians who employ them. Over 27 years, he has authored or co-authored over 250 papers, articles, and interviews in a mixture of peer-reviewed medical journals and mass media. He is also a member of the Scientific Advisory Board of ACSH,
The National Campaign to Protect People in Pain is an informal alliance of hundreds of experienced pain management clinicians, patients, family caregivers and advocates. The National Campaign is lobbying for major changes in public health policy governing the practice of pain medicine in America.
