INTRODUCTION
Your author is an unpaid volunteer patient advocate and medical literature analyst. I have 27 years of hands-on experience and tens of thousands of patient interactions as a moderator for pain community support groups in social media. I have authored or co-authored over 250 papers, articles and interviews in a mix of peer-reviewed medical journals and mass media.
From deep study, I have become convinced that authors and reviewers of the 2016 and 2022 CDC guidelines on prescribing of opioid pain relievers have committed deliberate fraud and disseminated known disinformation to the public. Likewise, CDC guidelines and derivative Veterans Administration guidelines have become a major support for a nationwide unjustified and unscientific witch hunt by the US Drug Enforcement Administration against doctors who prescribe opioids to their patients for severe pain.
I am not alone in this conviction. I am joined by ten other prominent patient advocates in what we call the “Speakers Bureau” of the National Campaign to Protect People in Pain. We jointly combine hundreds of years of hands-on experience in clinical practice, patient safety education and patient advocacy. We have developed mailing lists of over 1200 clinical professionals, patient advocates, chronic pain patients and family caregivers. These correspondents have tens of thousands of years of lived experience with the unacceptable consequences of bad public regulatory policy on safe and effective opioid therapies in pain medicine.
In mid-May 2024, the Speakers’ Bureau filed formal complaints with the Civil Rights Office of the US Department of Justice and with the Office of the Inspector General for the Secretary of Health and Human Services. These complaints are directed against the Chief Medical Officer and Deputy Director for Programs and Science of the US Centers for Disease Control and Prevention, plus five authors of the 2022 CDC opioid prescribing guidelines.
Our complaint alleges both civil rights violations and knowing criminal fraud. It is our contention that US CDC authors and senior management knew well in advance of publication, that their prescribing guidelines would be responsible for the destruction of millions of American lives due to denial of safe and effective pain management, and for the departure of thousands of clinical professionals from the field of pain medicine, deserting their patients. This government madness and malfeasance beg major correction.
What follows below is most of the text of our formal complaint. We urge readers to read the document to verify that it reflects your own experience of government misdirection and denial of pain care. At the end of this article, you will find email addresses of key officials of DHHS-OIG, and a short endorsement text that may be included in your messages to these officials.
REPORT OF CIVIL RIGHTS VIOLATIONS AND CRIMINAL FRAUD
Formal complaint is hereby filed against:
Debra Houry, MD, MPH, Chief Medical Officer and Deputy Director for Program and Science US Centers for Disease Control and Prevention
Deborah Dowell, MD, MPH, National Center for Injury Prevention and Control, US Centers for Disease Control and Prevention
Kathleen R. Ragan, MSPH, Division of Overdose Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (CDC)
Christopher M. Jones, PharmD, DrPH, Director of the Center for Substance Abuse Prevention (CSAP) at the Substance Abuse and Mental Health Services Administration (SAMHSA)
Grant T. Baldwin, PhD, Director, Division of Overdose Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (CDC)
Roger Chou, MD, Board of Scientific Counselors, National Center for Injury Prevention and Control, US Centers for Disease Control and Prevention
Substance of Complaint:
By their authorship of and advocacy for fatally flawed and unscientific CDC opioid prescribing guidelines in 2016 and 2022, defendants named above are directly and knowingly responsible for denial of safe and effective pain care to millions of US citizens. The defendants’ acts have also resulted in malicious persecution of hundreds of US professional clinicians engaged in the practice of pain medicine. Thousands of US citizens have been driven into medical collapse or suicide.
The acts of the defendants comprise in the aggregate:
- violations of civil rights under the Americans with Disabilities Act, and
- criminal fraud in publication of US public health policies on pain medicine that were known before publication to contain substantial disinformation, errors of methodology and politically motivated bias.
Supporting Evidence for Violations of Civil Rights:
- Treatment of chronic pain is a civil right under provisions of the Americans with Disabilities Act
- [Ref 1] US Department of Justice Civil Rights Division, “Laws, Regulations and Standards” https://www.ada.gov/law-and-regs/ accessed May 2, 2024
- US National Academies of Medicine estimate that over 100 million Americans are affected by clinically significant pain each year, with a cost in medical insurance and lost productivity of hundreds of billions of dollars per year. Of these Americans, at least 8% are affected by disabling high-impact pain that severely restricts quality of life and qualifies them for disability under prevailing Social Security Disability Insurance and regulations of the US Centers for Medicare and Medicaid.
- [Ref 2] Pizzo, Philip, et al, Committee on Advancing Pain Research, Care, and Education, Board of Health Sciences Policy, Institute of Medicine of the National Academies, “Relieving Pain in America – A Blueprint for Transforming Prevention, Care, Education and Research”, National Academies Press, 2016, https://nap.nationalacademies.org/read/13172/chapter/2
- CDC has publicly admitted that their (and by extension, US Veterans Administration and Department of Defense) public health policy guidelines on prescription of opioids have caused millions of Americans to be needlessly denied effective pain management employing prescription opioid pain relievers.
- [Ref 4] Paige Wyant, “CDC Admits That Its Opioid Prescribing Guidelines have Hurt Chronic Pain Patients”, The Mighty, updated May 2, 2024, https://themighty.com/topic/chronic-pain/cdc-opioid-guidelines-hurt-chronic-pain-patients/
- Thus, the defendants by their persistent disinformation and scientifically invalid support for denial of pain care by the most effective means available have violated the civil rights of millions of US citizens.
Supporting Evidence of Fraud by the Defendants:
In each point offered below, references are selected from a large body of supportive evidence in multiple published sources. Each reference below in turn contains other references to authoritative publications that should be read and digested by the US Department of Justice and the DHHS Office of the Inspector General, in processing this criminal complaint.
There is abundant published evidence of conflicts of interest, bad faith and incompetence on the part of authors and reviewers of the 2016 and expanded/revised 2022 CDC guidelines on prescription of opioids.
[Ref 5] Chad Kollas, MD FACP FAAHPM, “In Bad Faith – The Influence of PROP and CDC on Failed National Opioid Policy”, American Academy of Hospice and Palliative Medicine, 7/21.2022, https://learn.aahpm.org/content/bad-faith-influence-prop-and-cdc-failed-national-opioid-policy#group-tabs-node-course-default1
Abstract: “Over the last 2-3 years, diligent analyses of the causes of overdose deaths attributed to opioids have shown that illegal drug – especially illicit fentalogues and heroin – are the driving force behind these deaths, rather than prescription pain medications. Despite this, the anti-opioid group, Physicians for Responsible Opioid Prescribing (PROP) has persistently supported a false narrative that prescription opioids drive overdose deaths in the United States. An insider’s examination of the creation of the Centers for Disease Control 2016 Pain Guidelines reveals a lack of transparency and disproportionate influence by PROP in a way that suggests the Guidelines were conceived in bad faith. This analysis examines the creation of the Pain Guidelines and describes material conflicts of interest downplayed by the CDC until harms from the Guidelines became clear and were brought to light by stakeholders, including those in the palliative care community. The discussion explores the negative effects of the CDC Pain Guidelines for patients in chronic pain, including those receiving palliative care, and it offers insight into serious concerns and hopes for balanced national opioid policy in the future.”
It is also now established beyond any rational contradiction that CDC authors and the NCIPC BSC Opioid Workgroup deliberately ignored an established 25-year clinical literature that invalidates the entirety of trials literature on safety and effectiveness of opioid pain relievers, including trials and studies referenced in CDC Guidelines. Due to polymorphism in expression of the CYP450 enzyme series in the human liver, there is a natural range of at least 15-to-1 in minimum effective opioid dose between individuals. Some hyper-metabolizers or poor metabolizers of opioids do very well on doses exceeding 2,000 MMED. Yet none of the trials cited in the CDC opioid guidelines employed protocols that account for this wide variability.
Thus the recommendations of the CDC guidelines were based entirely upon unscientific opinion, broadly contradicted by published facts and data in other sources.
[Ref 6] Tom Lynch and Amy Price, “The Effect of Cytochrome P450 Metabolism on Drug Response, Interactions, and Adverse Effects”, American Family Physician, 2007;76(3):391-396
[Ref 7] Jeffrey Fudin, Jacqueline Pratt Cleary, Michael E Schatman “The MEDD myth: the impact of pseudoscience on pain research and prescribing-guideline development”, Journal of Pain Research, March 4, 2016, https://www.dovepress.com/the-medd-myth-the-impact-of-pseudoscience-on-pain-research-and-prescri-peer-reviewed-fulltext-article-JPR
[Ref 8] Lawhern, RA, “Oversight on Revision of US CDC Guidelines – A Process Pre-Destined to Fail”, Nursing and Primary Care. ISSN 2639-9474, 2023 7(5): 1-10. https://www.scivisionpub.com/pdfs/oversight-on-revision-of-us-cdc-opioid-guidelines-a-process-pre-destined-to-fail-2988.pdf
- It is equally established that the primary measure of patient risk employed by CDC guideline writers (i.e. Morphine Milligram Equivalent Daily Dose –(MMEDD)) is junk science unsupported by any trials data whatsoever – a scientific fact that was known to the Defendants before publication of the CDC opioid guidelines.[Ref 9] Lawhern R, “No Clinical Basis for MMEs” Daily Remedy, April 25, 2024 https://www.daily-remedy.com/no-clinical-basis-for-mmes/[Ref 10] Nadeau SE, DelRocco NJ, and Wu SS, “Opioid Trials: Time for a New Approach? Enriched Enrollment Randomized Gradual Withdrawal Designs” Future Medicine, (Pain Management), Volume 12 No 3, January 10, 2022, https://doi.org/10.2217/pmt-2021-0112
The US CDC guidelines as published, assert that non-opioid therapies are “preferable” to opioids in treatment of severe acute or chronic pain. However, sources referenced in the guidelines do not establish a basis for this preference. None of the nearly 5,000 published trials discussed in the Systematic Outcomes Review of the Agency for Healthcare Research and Quality (AHRQ) for non-pharmaceutical, non-invasive therapies addressed either-or comparison of opioids and non-opioid therapies. Full description of “usual and customary therapy” was also completely missing from the AHRQ report.
Appendices to the AHRQ report demonstrate that non-pharmacological therapies offer at most an adjunct to programs of pharmaceutical therapy. Such non-pharmacological therapies contribute only temporary and marginal improvement in pain levels or quality of life for some patients, some of the time. Medical evidence is almost universally evaluated as “weak” even for that improvement.
[Ref 11] Skelly AC, Chou R, et al, “Noninvasive Nonpharmacological Treatment for Chronic Pain: A Systematic Review Update [Internet]” Agency for Healthcare Research and Quality (US); 2020 Apr. Report No.: 20-EHC009, https://www.ncbi.nlm.nih.gov/books/NBK556229/
[Ref 12] Lawhern RA and Nadeau SE, “Behind the AHRQ Report” Practical Pain Management, October 3, 2018, https://www.medcentral.com/pain/behind-ahrq-report
The US CDC guidelines placed a disproportionate emphasis on risk of addiction or overdose mortality as outcomes of opioid therapy administered by clinicians to their patients. “Risk” appears in the CDC guidelines over 400 times. Clinicians are repeatedly directed to evaluate risks versus benefits in initial prescriptions and ongoing patient management. However, CDC writers provided no validated framework for clinicians to actually perform the directed assessment. The entirely predictable result of this omission has been to drive clinicians out of pain medicine, resulting in desertion of their patients.
As Carl Sagan suggested, “One of the saddest lessons of history is this: If we’ve been bamboozled long enough, we tend to reject any evidence of the bamboozle. We’re no longer interested in finding out the truth. The bamboozle has captured us. It’s simply too painful to acknowledge, even to ourselves, that we’ve been taken.”
Authors of the CDC guidelines also persistently ignored data generated by their own organization that demonstrate no significant cause-and-effect relationship between clinical prescribing and either patient addiction or overdose deaths. Incidence of iatrogenic substance misuse or mortality from prescription opioids is in fact too low to accurately measure. The so-called “opioid crisis” has never been dominated by prescription drugs since 1978. These realities were known to the CDC authors and reviewers before publication of the guidelines, but were ignored in favor of pursuing a politically driven anti-opioid agenda unsupported by science.
[Ref 13] Aubry, L, and Carr, BT, “Overdose, Treatment Admissions and Prescription Opioid Pain Reliever Relationships: United States 2010-2019” Frontiers in Pain Research, August 4, 2022, DOI 10.3389/fpain.2022.884674, https://www.academia.edu/90492152/Overdose_opioid_treatment_admissions_and_prescription_opioid_pain_reliever_relationships_United_States_2010_2019
[Ref 14] Lawhern RA, “CDC Data Refute the Notion That Overprescribing Caused the Opioid Cisis”, Reason Magazine, May 15, 2024, https://reason.com/2024/04/15/government-data-refute-the-notion-that-overprescribing-caused-the-opioid-crisis/
[Ref 15] Peppin JF and Coleman JJ, “CDC’s Efforts to Quantify Opioid Prescription Deaths Fall Short” Pain Ther. 2021 Jun; 10(1): 25–38. 2021 Mar 24. doi: 10.1007/s40122-021-00254-z
[Ref 16] Lawhern RA, and Pho, K, “Opioid Prescribing, Pain Management, and Patient Advocacy” , PODCAST on KevinMD.com, March 19, 2024, https://www.kevinmd.com/2024/03/opioid-prescribing-pain-management-and-patient-advocacy-podcast.html
[Ref 17] Jalal, H, Buchanich JM, et al, “Changing Dynamics of the drug overdose epidemic in the United States from 1979 through 2016”, Science, September 21, 2018. https://www.science.org/doi/10.1126/science.aau1184
[Ref 18] Oliva EM, Sara Tavikoli, et al, “Development and Applications of the Veterans Health Administration’s Stratification Tool for Opioid Risk Mitigation (STORM) to Improve Opioid Safety and Prevent Overdose and Suicide” US Veterans Administration Psychological Services, 2017, Vol. 14, No. 1, 34 – 49, http://dx.doi.org/10.1037/ser0000099
[Ref 19] Lawhern RA, “US Opioid Guidelines 2022 – More and Less Than Meets the Eye” Medical Research Archives of the European Society of Medicine, September 1, 2023, https://esmed.org/MRA/mra/article/view/4379
[Ref 20] Lawhern RA and Nadeau SE, “The Two Opioid Crises, Problems, Causes, and Potential Solutions: An Analytic Review,” Medical Research Archives of the European Society of Medicine, December 26, 2023, https://esmed.org/MRA/mra/article/view/4846
Corroborating Evidence
Defendants in this complaint cannot claim ignorance of the concerns raised herein. A six-year record of email communications is available between the principle complainant (Richard A Lawhern PhD) and multiple US government Agencies and organizations including the CDCInfo public gateway, the CDC Office of Public Health Ethics and Regulations, the office of the CDC Executive Secretary, the administrative office of the Board of Scientific Counselors of the National Center for Injury Prevention and Control, the Acting Director of the Agency for Healthcare Research and Quality, and the Immediate Office of the Assistant Secretary of Health. These offices have uniformly stone-walled the issues, choosing not to respond on the merits of the issues or evidence of factual errors.
Two final sections of the complaint as submitted provide contact data for the Speakers’ Bureau of the National Campaign to Protect People in Pain, and for ~150 initial endorsers, including over 40 clinical professionals. Those wishing to add their endorsements may do so by sending email to:
Christian Schrank, Deputy Inspector General for Investigations, [email protected]
Juliet Hodgkins, Principle Deputy Inspector General, [email protected]
Administrative Assistants
Isabel Rangle [email protected] and
Tamieka Water [email protected]
BCC copy to: [email protected]
Your endorsement might read “This email is to endorse the May 2024 formal complaint of Richard A Lawhern PhD and the Speakers’ Bureau of the National Campaign to Protect People in Pain, against employees of the Department of Health and Human Services who wrote and approved the 2016 and 2022 CDC opioid prescribing guidelines. Please expedite investigation and adjudication of this complaint.”
Provide your name, qualifications if any, (MD, BSN, RN, chronic pain patient, family caregiver) city, state and email address in the body of your endorsement email.
Be aware that DHHS has in the past set up their email servers to delete incoming mail that they identify as spam or letter-bombing. They might do this with your mail, and they won’t tell you if they do. But if anyone gets a “bounce” message, please send it along to the author at [email protected].
We Are A Nation In Pain and We Will Not Be Silent!
