NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. 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, LESLY POMPY MD., NANCY SEEFEDLT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., RICHARD KAUL, MD., 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 NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
“..PDMPs have not shown they’VE reduce overdose deaths nor improve patient outcomes“
CATHLEEN LONDON, MD CIPP/US, Class of 2022
“IS A PRACTICING PHYSICIAN AND 3 YEAR LAW STUDENT AT THE UNIVERSITY OF MAINE SCHOOL OF LAW”
THE ALGORITHMS OF DEATH
Algorithms such as Appriss’s NarxCare are marketed as clinical decision support tools which makes them subject to FDA regulation.
The FDA regulates medical devices, and software as a medical device is part of Clinical Decision Support tools.Section 3060 of the twenty-first Century Cures Act exempts five categories of Clinical Decision Support tools.
For Software as a Medical Device, the FDA seeks a valid clinical association between the software’s output and its targeted clinical condition.
“NarxCare scoring failS FDA safety and effectiveness criteria”
The company must show that the software processes input data to generate accurate, reliable output that achieves the intended purpose in the context of clinical care for the target population.
Since PDMPs have not shown that they reduce overdose deaths nor improve patient outcomes, NarxCare scoring would fail these FDA safety and effectiveness criteria. (1)
In Section 3060, software is exempt from regulation if it is administrative support software, unrelated to diagnosis, cure, mitigation, prevention or treatment of a disease or condition, an electronic health record or used to store and transfer lab data – as long as it does not analyze the data.
There is a final exemption concerning software that aggregates patient data and provides recommendations to health care professionals about prevention, diagnosis, or treatment of a disease or condition. This exemption depends on the health care professional being able to “independently review and reject the recommendations that such software presents.”
The key is that health care professional needs to not rely on the software for decision-making for the vendor to avoid regulation.NarxCare scores are presented to prescribers in an unavoidable fashion in the PDMP. Laws are in place to mandate checking the PDMP prior to prescribing and many are now integrated into electronic health records.
EVERY PHARMACY IS NOW A PART OF THE POLICE DEPARTMENT AND YOUR HEALTHCARE DATA IS UNCONSTITUTIONAL COLLECTED AND MAINTAINED
Professor Oliva contends that the FDA should be regulating this data analytic software, as the NarxScore is simply presented to prescribers as a risk score without any way to independently evaluate its veracity.
Given the harms from PDMP use, the increased overdoses, the difficulty for chronic pain patients to obtain needed medications, PDMPs are certainly ripe for regulation.
Most importantly, the intrusion upon privacy by these entities, without any consent from patients is concerning. Receiving a prescription should not mean giving the government your medical history. It certainly should not mean giving it to Equifax.
CONGRESS MUST CLEAN UP THIS MESS
“NEMESIS IS THE MOTHER OF KARMA”
FOR NOW, YOU ARE WITHIN
- Mr Lasker and Ms Lu,
Washington Legal Foundation and Hollingsworth LLP
|Oklahoma Opioid Ruling: Another Instance of Improper Judicial Governance through Public Nuisance Litigation | Washington Legal FoundationBy Eric G. Lasker, a Partner, and Jessica L. Lu, an Associate, with Hollingsworth LLP in Washington, DC. Plaintiffs have long utilized the doctrine of public nuisance as a judicial avenue to force corporations to bear the costs of addressing social harms. In recent years, however, such claims have proliferated as a result of high-profile […]www.wlf.org|
This note is to share with you a letter that is being sent to all 50 US State Departments of Health and State Medical Boards. I believe that the resources offered below may be pertinent to the future activities of your firm and others in defense of major pharmaceutical firms now being vilified and persecuted by badly misinformed prosecutors and State Attorney Generals.
It is my contention that not only does public nuisance law NOT apply to prescribing of opioid analgesics to patients in pain, but the entire US and State policy concerning these issues is grounded on nothing more than junk science and deliberate distortions by financially self-interested anti-opioid zealots.
I am available by phone at 703.216.0724 Eastern Time if you would like to chat briefly about the issues raised here. My qualifications to comment are included in the text below. I can also put you in touch with an open collaborative network of highly knowledgeable medical professionals, patients and caregivers who have first-hand knowledge of the impact of irresponsible actions such as were overturned by the recent Johnson and Johnson appeal in Oklahoma
I write to offer information and to request your assistance in a matter of direct concern to all US State Departments of Health and State Medical Boards (see correspondence copied below).
Significant numbers of Americans are committing suicide because they have erroneously been denied treatment for agonizing chronic pain. This denial results directly from misdirected State and Federal policy on regulation of prescription opioid pain relievers and the draconian persecution of doctors who dare to employ these proven therapies in treating their patients. Correction of this sorry situation requires nothing less than public repudiation of the 2016 Opioid Guidelines by government officials such as yourselves.
You may verify my qualifications to comment by scanning papers filed at the publications link in my signature below. I have 25 years of hands-on experience in patient advocacy and public policy analysis, with about 150 published papers, articles, and interviews in this area of public policy. Feel free to reach out to me for further discussions by email or phone, 703.216.0724 Eastern US Time weekdays.
I hope you will take time to scan the references offered below, and to forward this letter to other key policymakers in your State. Versions of this letter are being filed with State Departments of Health and State Medical Boards throughout the US. I would appreciate the courtesy of a timely and substantive (non-form letter) reply. Be advised that others on distribution for this letter may choose to add their endorsements to the policy changes outlined herein.
Thanks for your time and attention.
Richard A “Red” Lawhern PhD
The following letter was sent on October 29, 2021, to several named US National decision makers in public health policy.
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 Levine, 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
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.
Disseminated under separate cover to chronic pain support groups on social media platforms that generate over 200,000 impressions per day.
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 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.
Deborah Dowell, MD Kathleen Ragan, MSPH Christopher M. Jones, PharmD, DrPH
Grant T. Baldwin, PhD 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.
|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 regulation of prescription opioid pain relievers and of doctors who prescribe them. My name will be familiar to many in US government as a sharp critic of the CDC opioid guidelines. I have 25 years’ 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.
In addition to the letter above, I draw your attention to two other references of central importance. Specifically, a California Supreme Court judge has found against several government plaintiffs attempting to collect billions of dollars from four pharmaceutical companies alleged to have created the US “opioid crisis”. This decision casts into significant doubt, the recent multi-billion dollar coerced “settlements” against Purdue Pharma, Johnson and Johnson, and other pharma companies accused of similar “offenses”. I believe it is arguable that these court actions comprised a government-sanctioned legal gang rape of Big Pharma — one which utterly lacks real merit on any basis of medical science.
|A Scathing Rejection of the Case Against Four Drug Companies Highlights Misconceptions About the ‘Opioid Crisis’ – Reason.comOpioids. A Scathing Rejection of the Case Against Four Drug Companies Highlights Misconceptions About the ‘Opioid Crisis’ A California judge said the four jurisdictions that filed the lawsuit …reason.com|
Also important is the recognition that US CDC has for years deliberately distorted and inflated mortality statistics attributed to prescription opioid pain relievers. Moreover, they are presently in violation of US Federal legislation requiring that they “modernize” overdose mortality statistics to correct these errors.
|CDC’s Efforts to Quantify Prescription Opioid Overdose Deaths Fall Short | SpringerLinkIn a 2018 report titled, Quantifying the Epidemic of Prescription Opioid Overdose Deaths, four senior analysts of the Centers for Disease Control and Prevention (CDC), including the head of the Epidemiology and Surveillance Branch, acknowledged for the first time that the number of prescription opioid overdose deaths reported by the CDC in 2016 was erroneous. The error, they said, was caused …link.springer.com|
I look forward to hearing from you in the near future.
Richard A “Red” Lawhern PhD