NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., IN THE SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., WALTER F. WRENN III., MD., JULIE KILLINGWORTH, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NDJOU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
From: WALTER F. WRENN III, MD., Philadelphia, Pa., a convicted pain doctor felon write:
There have been several errors made by the CDC that has led to misinformation resulting in harm to patients on opiate pain medication and physicians who prescribe opiate pain medication.
When the CDC started to result in opiate overdose deaths from fentanyl, they failed to differentiate between prescription fentanyl and illegal fentanyl.
This led to the belief that physicians were responsible for overprescribing and therefore causing the opiate epidemic.
The second and more serious event was the issuing of the 2016 CDC guidelines for the prescribing of opiate pain medication. Before you issued a clarification in the April 24 2019 issue of the New England Journal of Medicine, patients on opiate pain medication had suffered irreparable harm.
Deaths from an opiate overdose had increased as well as deaths from suicide. Physicians Who prescribed opiate pain medication were arrested and incarcerated.
Insurance companies required prior authorizations that prevented patients from continuing on their opiate pain medication.
The only way to correct this wrong and restore sanity to the treatment of chronic pain patients with opiate pain medication is to issue a public statement admitting to your errors. Anything less will continue to cause harm to patients and health care providers.
US chronic pain patients and thousands of US clinicians who have been substantively harmed:
From: Richard A “Red” Lawhern Ph.D., Patient Advocate:
Dear Doctor Walensky, et.al:
I write this letter on behalf of 50 million US chronic pain patients and thousands of US clinicians who have been substantively harmed by the 2016 CDC Guidelines on Prescription of Opioids to Adults With Chronic Non-Cancer Pain.
In at least hundreds of cases, patients have predictably been killed not only by “misapplication” of these guidelines, but by their long-known errors of medical ethics, science, methodology, and deliberate cherry-picking of data to support a fringe element anti-opioid political agenda.
Hundreds of physicians have been forced out of pain medicine and in some cases imprisoned by a Drug Enforcement Administration which persists in conducting an unjustifiable witch hunt against doctors — for no crime other than trying to alleviate pain by means of safe and effective prescription opioid therapies.
The very definition of madness is “trying to do the same things over and over again, expecting outcomes to be different.” With regard to national policy on the treatment of chronic and acute pain, this is precisely what the US CDC and DEA have been doing.
It is time for the madness to stop before the little remaining credibility of the CDC is irrevocably trashed.
On behalf of the patient communities that I serve as an unpaid volunteer advocate, I thus propose the following needed measures for immediate consideration and action:
- The following named individuals must resign immediately from all participation in the CDC guidelines process, or otherwise be terminated from Government service and academic employment, for cause.
a)Deborah Dowell, MD b) Kathleen Ragan, MSPH c)Christopher M. Jones, PharmD, DrPH d) Grant T. Baldwin, PhD e) Roger Chou, MD
- Proposed “revisions” to the 2016 CDC guidelines generated by these authors and reviewed in the July 16, 2021 public meeting of the NCIPC BSC — must be publicly repudiated and withdrawn immediately.
- CDC must convene a timely and publicly transparent National Consensus Review on the practice of pain medicine, to generate not only “opioid guidelines” but instead, a scientifically supported standard of practice for use of prescription opioids. One way to hasten this process may be to re-convene the BSC Opioid Workgroup for a period of not more than one year and charge them with definitive and documented resolution of the many issues and concerns expressed in their July 2021 report to the BSC, before circulation of a redirected practice standard for public review in the Federal Register. I also strongly advise that the Workgroup be augmented by nomination of additional qualified patient advocates.
In support of these proposals, I commend three references for reading by all addressees of this letter.
The first reference establishes beyond any possible contradiction that the US CDC has violated its own rules and procedures in the nomination of professionally unqualified and financially self-interested “experts” both to write the original CDC guidelines and to revise them to address their many and well-documented negative (sometimes fatal) consequences.
These so-called “experts” do not represent patients. They instead represent fringe-element anti-opioid zealots whose influence on pain medicine and national policy has been disproportionate and uniformly negative. (4),(5),(6)
CONGRESS: CLEAN UP THIS MESS
THE COMMITTEE ON GOVERNMENT OPERATION. 1990
“WHAT THEY FOUND ACROSS THE BOARD THE WAR ON DRUGS WAS HAVING A DISPROPORTION IMPACT ON BLACK PEOPLE”
It is past time for Congress to correct the mess they have made of the regulation of opioid pain relievers. Here is contact information for your Senators, Representatives, and governor’ offices. Call them and demand that they:
- familiarize themselves with the problems they have created by reading this article in STAT news.
- begin work on legislation to force the repeal of the CDC Guidelines
- reign in regulators and drug enforcement authorities from their senseless and unfounded persecution of doctors.
“To make it easy for them here is model legislation that, if enacted, will do all of the above.”
FOR NOW, YOU ARE WITHIN
- Richard A “Red” Lawhern Ph.D., Patient Advocate Twitter: @Lawhern1
2. To the personal attention of
Dr Rochelle Walensky, Director, CDC David Myers, PhD, Acting Director, US Agency for Healthcare Research and Quality Regina LeBelle, Acting Director, Office of National Drug Control Policy, Office of the President
Admiral Rachel L Divine, MD, US Assistant Secretary of Health
Janet Woodcock, Commissioner, US FDA
Seema Verma, Director US HHS Centers for Medicare and Medicaid Services
CDC Executive Secretary
CDC-Info public inquiries gateway
CC: Administrators, Board of Scientific Counselors, US CDC National Center for Injury Prevention and Control. Please disseminate to all sitting members of the BSC, and all former members of the BSC Opioid Workgroup (OWG) including Chinzano O. Cunningham, MD (chair)
American Medical Association Substance Use and Pain Task Force
Office of the Chief of Staff, US CDC
Nora Volkow, MD, Director, National Institute On Drug Abuse
Five members of the NCIPC CDC Opioid Guidelines revision writing group
BCC: ~500 knowledgeable chronic pain patients, caregivers, and medical professionals.
Dear Dr Aragon:
A professional colleague recently shared with me a letter published by your organization to all healthcare providers in the State of California.(attached). I write to follow up on your letter and to recommend further action on behalf of California medical patients, caregivers, and clinicians.
I regard your letter to be a vast improvement over the misdirection of healthcare policy that has nearly destroyed the practice of pain medicine in America, caused directly by the fatally flawed 2016 CDC guidelines on the prescription of opioids to adults with chronic non-cancer pain. However, I believe you are still temporizing in the face of conclusive evidence that the CDC guidelines are fundamentally wrong on both medical ethics and clinical science.. Thus, I wish to share wit.
|Roger Chou’s Undisclosed Conflicts of Interest: How the CDC’s 2016 Guideline for Prescribing Opioids for Chronic Pain Lost Its Clinical and Professional Integrity ~ PallimedThrough his participation in these PROP activities, Chou established himself as a significant contributor to PROP efforts. Yet he never formally served as a leader or member of PROP, and until the CDC NCIPC-BSC Meeting on July 16, 2021, Chou avoided all allegations of conflicts of interest (COI) between his opioid research and co-authorship of the 2016 Guideline, unlike several other PROP …www.pallimed.org|
The second reference — of which I am one co-author — reviews the clinical evidence concerning use of opioid analgesics in chronic pain. This paper incorporates over 120 references. Given that the paper has effectively “gone viral” in the three months since publication, it may eventually become one of the most widely cited in the literature of pain medicine. We believe it is at least a viable point of departure for discussions of a national practice standard that protects both patients and doctors.
|Frontiers | Opioids and Chronic Pain: An Analytic Review of the Clinical Evidence | Pain ResearchWe conducted an analytic review of the clinical scientific literature bearing on the use of opioids for treatment of chronic non-cancer pain in the United States. There is substantial, albeit not definitive, scientific evidence of the effectiveness of opioids in treating pain and of high variability in opioid dose requirements and side effects. The estimated risk of death from opioid treatment …www.frontiersin.org|
The third reference — of which I am principal author — proposes substantive redirections of the 12 guideline recommendations briefed by the CDC writers’ group on July 16th. Stephen E. Nadeau MD and I seek to correct the rampant anti-opioid bias of those recommendations by offering [evidence-based and patient-centric] changes and additions. We fully expect that any final practice standard must reflect the input of many other qualified medical professionals — but it must also reflect the lived experience of millions of patients and caregivers, which the current draft guidelines decidedly do not.
|CDC Opioid Prescribing Guideline Revisions: How to Fill the Gaps Once and for AllDrs. Lawhern and Nadeau propose additional revisions to the CDC’s 12 draft updates to the Guideline for Prescribing Opioids for Chronic Pain, including on managing depression in patients with chronic pain, and on protecting pain specialists from sanctions.www.practicalpainmanagement.com|
Full disclosure: I speak and write widely as a non-physician subject matter expert on public policy for the regulation of prescription opioid pain relievers and of doctors who prescribe them. My name will be familiar to many in the US government as a sharp critic of the CDC opioid guidelines. I have 25 years of experience as a developer and moderator for chronic pain patient support sites and as an analyst of advanced technologies. The publications link in my signature provides access to the most recent of almost 150 published papers, articles, and media interviews.