SUBMITTED TO:
the Board of Scientific Counselors of the National Center for Injury Prevention and Control (BSC/NCIPC) CDC, as part of the public record per guest July 16th, 2021, forum AS comment WITH supporting documentation
BY
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, JOSEPH SOLVO ESQ., REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., BRAHM FISHER ESQ., JAY K. JOSHI MD., MBA, JOSEPH WEBSTER MD., ESTER HYATT PHD., BRAHM FISHER ESQ., MICHELE ALEXANDER, BERES E. MUSCHETT, STRATEGIC ADVISOR
“No amount of marginal tinkering will help! The CDC royally messed up on basic science and its present revision writers group continues to do so.”
THE CHRONIC INTRACTABLE PAIN PATIENT REAL DANGERS ARE THE INCOMPETENCE OF THE CDC SCIENTIST AND THEIR GUIDELINES
Having attended July 16, 2021, CDC Board of Scientific Counselors we are indeed facing a public health crisis in medical prescribing for pain, “the flawed 2016 CDC Guidelines whose foundational base is the unscientifically based morphine milligram equivalents (MME).”
However, what’s more disturbing is the real danger to the chronic intractable pain patient is the incompetence of the CDC scientist of the Opioid Work Group and Board of Scientific Counselors attempting to improve what this agency has absolutely no authority to write.
The CDC Opioid 2016 Prescribing Guidelines are scientifically wrong and must be abandoned and repudiated. Improving on them would be merely a futher threat to humanity.
A Central Recommendation:
Richard Lawhern PH.D. wrote:
“Given the abject failures of MMED as a measure of merit or a viable standard of practice in administering prescription opioid therapies, I must assert that the 2016 CDC Guidelines are consequently flawed beyond any possibility of repair. Thus, the only scientifically and ethically sound action now open to the CDC is outright public repudiation and withdrawal of its 2016 guidelines – without replacement.”
Margaret Rene Blake, a pharmacist and intractable pain sufferer stated on July 21, 2021 forum:
“No matter the intent, goal or method that the CDC may desire with these guidelines and their purpose in the American healthcare system, the DEA will still manipulate them to serve their way…As long as they exist, they can and will be misapplied. The way to stop the harm to patients, providers, and the system is to repeal the guidelines.”
!!! CONGRESS MUST INVESTIGATE OR THE AMERICAN HEALTHCARE SYSTEM IS DOOMED!!!!
THE ABJECT FAILURE OF THE CBC BOARD OF SCIENTIFIC COUNSELORS
“No amount of marginal tinkering will help. The CDC royally messed up on basic science and its present revision writers group continues to do so. As evident from almost all of the public comments submitted in the July 16th meeting of the BSC, CDC must now repair the fully predictable damage that they did to millions of patients and thousands of medical practitioners. Repudiation and withdrawal of the guidelines are the only adequate mechanism for making this correction.” [see below references]
THIS VIDEO DEMONSTRATES HOW CDC SCIENTISTS “REALLY SCREWED UP”
Chronic pain patients victimized by the 2016 Opioid Guidelines encouraged the CDC Board of Scientific Counselors to take a harder look at “the other side of the opioid crisis”. That there were millions of people in pain who were being denied access to safe and effective opioid therapy and their doctors were being persecuted out of their medical practices based on 2016 CDC guidelines by an out-of-control equally incompetent DEA and DOJ.
Yet in the July 16, 2021 forum this is a distinction CDC’s Board of Scientific Counselors seem determined to utterly ignore, despite the horrid impacts these failed unscientific opioid misguided lines have had on public policy and public health.
“Lack of effective pain relief is harming millions of Americans. Racial bias exists in the health care field–it’s rampant. Kolodny is considered an expert. I hope the future sees him for what he is because the present values his killer instincts. War on Drugs is a war on people.”
VIDEO DEMONSTRATES HOW THE CDC PROCESS OF MISEDUCATION AND MISINFORMING AND DELIBERATELY MISLEADING THE PUBLIC IS DEVELOPED
A Legal Dimension ALARM FROM THE AMERICAN MEDICAL ASSOCIATION
Richard Lawhern wrote:
As one element of guideline withdrawal, CDC should act upon a recommendation by the CEO of the American Medical Association in a June 2020 letter to the Director of CDC. The AMA recommended that all State laws placing hard limits on prescription opioid dose or duration should be repealed.
I believe that CDC must now go further to recommend that the US Department of Justice and State Attorneys General conduct a judicial review for at least the last 10 years, of actions to sanction, suspend or revoke licenses, or imprison physicians for fictitious “over-prescribing” based on MME thresholds. [see references below]
Judgments involving MME as a criterion must be vacated with a monetary award of damages to physicians whose practices and lives have been ruined by this bogus pseudoscience.”
The AMA letter was sent to and received by Deborah Dowell, MD, Chief Medical Officer of the CDC’s National Center for Injury Prevention and Control (NCIPC), who co-authored the original guideline, however, it doesn’t appear she ever read or either she failed to comprehend the AMA’s concerns.
WHERE THE CDC GETS IT WRONG
Both CDC, BSC members Dr. Grant Baldwin and Deborah Dowell, MD, Chief Medical Officer of the CDC’s National Center for Injury Prevention and Control (NCIPC), who, co-authored the original guideline demonstrated in the July 16, 2021 presentations more or less their incompetence and failure to comprehend the Pathophysiology of pain.
As a chronic pain patient, I find this scary as hell. Will the government ever get out of the health business? The DEA does not have a medical license; thus, should not be practicing medicine. GET OUT OF MY LIFE!!!!!
WORKINGS OF THE OPIOID WORKGROUP
These presentations were horrifying as they represent a Federal Government and Federal Government policy. The American public is in danger.
Pat Anson Editor of Pain New Network wrote:
” Although voluntary and only intended for primary care physicians treating chronic pain, the 2016 guideline’s recommended dose limits for opioids were quickly adopted as policy by many states, insurers, law enforcement, pharmacies, and doctors of all specialties.
As a result, many pain patients who took opioids safely for years were cut off or tapered to lower doses. Many new patients who need pain relief can’t even get opioids because their doctors refuse to prescribe them. Opioid prescriptions have fallen to their lowest level in 20 years, but drug deaths continue rising.
Pat Anson Editor of Pain New Network further wrote:
One of the biggest issues for the workgroup is the revised guideline’s recommendation that initial opioid doses be limited to 50 morphine milligram equivalents (MME) per day and not be increased above 90 MME, which is essentially unchanged from the 2016 guideline. The workgroup believes the dose thresholds are arbitrary, based on poor evidence and should be “de-emphasized.”
“Many workgroup members voiced concern about the dose thresholds written into the recommendation. Many were concerned that this recommendation would lead to forced tapers or other potentially harmful consequences. Though workgroup members recognized the need to have thresholds as benchmarks, many felt that including these thresholds in the supporting text could serve to de-emphasize them as absolute thresholds, and thus recommended removing the specific MME range from the recommendation,” the report found.
Dowell said the MME thresholds are only meant to be “a rough guide” and shouldn’t been seen as “absolutes.”
Not until 2019 did the CDC publicly acknowledge the “misapplication” of the guideline and promise to make changes – although the process is unfolding slowly. The newly revised guideline is not expected to be released until late 2022.“
THE CDC HAS NO CHARTER OR AUTHORITY ISSUING GUIDELINES ON PRESCRIBING
Richard Lawhern has repeatedly informed the public, stated and written:
“I note in beginning these comments that US CDC has no legislative charter or authority for issuing guidelines on prescribing or dosing for any number of non-opioid medications used to treat infectious diseases, depression, diabetes, hypertension, or other health problems that the agency actively tracks and on which it periodically reports.
The interjection of the Agency into opioid guidelines in 2016 was grossly inappropriate in a mission that is normally addressed by FDA.
The highly negative and destructive results of this unjustified adventure in mission creep reinforce the need for CDC to be removed from all further participation in the regulation of medical practice standards for other than infectious disease.”
THE MISSION STATEMENT OF THE FDA
The Food and Drug Administration (FDA) is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use by minors.
FDA is responsible for advancing public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.
FDA also plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering the development of medical products to respond to deliberate and naturally emerging public health threats.
THE MISSION STATEMENT OF THE CDC
The Centers for Disease Control and Prevention (CDC) serves as the national focus for developing and applying disease prevention and control, environmental health and health promotion, and health education activities designed to improve the health of the people of the United States.
To accomplish its mission, CDC identifies and defines preventable health problems and maintains active surveillance of diseases through epidemiologic and laboratory investigations and data collection, analysis, and distribution; serves as the PHS lead agency in developing and implementing operational programs relating to environmental health problems, and conducts operational research aimed at developing and testing effective disease prevention, control, and health promotion programs; administers a national program to develop recommended occupational safety and health standards and to conduct research, training, and technical assistance to assure safe and healthful working conditions for every working person; develops and implements a program to sustain a strong national workforce in disease prevention and control, and conducts a national program for improving the performance of clinical laboratories.
!!! WARNING!!! DANGER!!! DANGER!!! DANGER!!!
!!! CONGRESS MUST INVESTIGATE !!!
CDC is responsible for controlling the introduction and spread of infectious diseases and provides consultation and assistance to other nations and international agencies to improve their disease prevention and control, environmental health, and health promotion activities.
In addition, CDC administers the Preventive Health and Health Services Block Grant and specific preventive health categorical grant programs while providing program expertise and assistance in responding to Federal, State, local, and private organizations on matters related to disease prevention and control activities.
WHAT DISEASE STATE CDC INCOMPETENCE OPIOID PAIN GUIDELINES FAILED TO INCLUDE
The CDC opioid guideline represents a classical failure of medicine similar to that of the Tuskegee Studies administered by the United States Department of public health. In this case, the 2016 one size fits all 90MME Opioid dosages excluded and fail to take into consideration patients suffering pain from chronic genetic disease orders such as sickle cell and terminal cancer.
In this case, the failure of the CDC to recognize the fundamental medical needs exposes Culturally Policy Bias. It has to lead to needless suffering and death to many of those who have been victims of CDC’s policies negligence.
These Guidelines became codified by States, private insurances and, as we see below, the Federal Government Center For Medicare and Medicaid Services, Office of Minority Health (CMS)
We see this medical tragedy as CMS not only adopted the CDC flawed guidelines but identified its authors which are for all intense purposes (exception of the AMA) the same culprits on the current Opioid Working Group and or the CDC’s Board of Scientific Counselors. I essence these patients receiving care one day and criminal junkies diverting medications the next day and targetted by the DEA.
Page 7 of CMS Manual
The opioid epidemic and its impact on SCD treatment
“The complex nature of pain management for people living with Sickle Cell Disease (SCD) is compounded by the ongoing opioid crisis. Policies to curb the opioid epidemic have the potential to impair access to an important treatment option for SCD pain (Dowell, Haegerich, & Chou, 2016; Murthy, 2016; AMA, 2017).
Prior work attempting to shed light on opioid utilization in Medicare beneficiaries with SCD suggests the importance of prescription opioids as a treatment option for SCD (NCQA, 2018):
- 80% of beneficiaries with SCD use prescription opioids as a treatment option for managing pain.
- Compared to non-SCD beneficiaries, beneficiaries with SCD had higher emergency department, inpatient and outpatient utilization, and prescriptions with average daily morphine milligram equivalent (MME) dosages ≥ 120.
- Average daily MME dosages ≥ 120 were associated with SCD complications, including pain crises, and higher inpatient and outpatient health care utilization. These prior findings suggest that beneficiaries with SCD have unique needs with respect to opioids:
- These prior findings suggest that beneficiaries with SCD have unique needs with respect to opioids:
- Currently, Drug Monitoring Programs (DMPs) restrict opioid analgesics by targeting behaviors associated with risky opioid use in the general population, including: (1) prescriptions for average daily MME ≥120, and (2) a high number of prescribers and/or pharmacies.
- Yet, beneficiaries with SCD have different needs than the general population. What may be “risky opioid use” in the general population may be part of the reality of living with SCD:
- SCD is marked by chronic and acute pain, requiring both a regular opioid prescription for maintenance and additional prescriptions for acute pain crises—hence, an increased likelihood of average daily MME dosages ≥ 120,
- Individuals with SCD are living longer, but there is a dearth of hematology specialists that serve adults with SCD that leads to fragmented care coordination—hence a likely increase in the number of health care providers involved in care (Bemrich-Stolz, Halanych, Howard, Hilliard, & Lebensburger, 2015; Hulihan, Hassell, Raphael, Smith- Whitley & Thorpe, 2017).
- Overarching objectives of the report
- To help inform future policy decisions related to opioid policies and their applicability to Medicare beneficiaries with SCD, and building on prior efforts, this report compares opioid utilization patterns among Medicare FFS beneficiaries with SCD and two already-exempted populations with complex pain syndromes: non-SCD beneficiaries with active cancer and non-SCD beneficiaries in hospice care. For context, this report also provides results for the general Medicare FFS population. Specifically, the report provides a comparison of beneficiaries in these three populations who use opioids at doses that equal to or exceed an average daily morphine milligram equivalent (MME) of 120 (MME≥ 120), the MME threshold that aligns with Pharmacy Quality Alliance opioid measures in effect in 2016 during the study’s measurement period, and that defined “high dose opioid use” as daily use exceeding 120 MME.
THE SICKLE CELL OPIOID GUIDELINE TRAGEDY IS ON THE SCALE OF TUSKEGEE EXPERIMENTS HAS LEAD TO NEEDLESS SUFFERING AND DEATHS
!!! WARNING!!! DANGER!!! DANGER!!! DANGER!!! WARNING!!!
!!! CONGRESS MUST INVESTIGATE !!!
@MasseyMinerd
Follows you
” Severe CPP since 2003. Advocate for all victims of the CDC, DEA, War on Drugs(=Eugenocide) & everyone’s right to choose their own life & death.
“Wtf. What’s next? Going door to door? Implanting OPIS trackers?”
In 2017 Former Utah Senator
This video exposes the nature of DEA/DOJ abuses in targeting BLACK OWN PHARMACIES: Senator Hatch on DEA and Opioid Crisis and Abuse| C-SPAN.org
https://www.c-span.org/video/?435395-3/senator-hatch-dea-opioid-crisis
BECAUSE OF THE CDC MISGUIDED OPIOID GUIDELINE AND THEIR INCOMPETENCE, THE DAMAGES TO THE HEALTHCARE DELIVERY SYSTEM HAVE BEEN HORRENDOUS
Margaret Drumheiser a chronic pain patient writes:
I have chronic painful illnesses CRPS(RSD), fibromyalgia, small nerve multifocal neuropathy, severe osteoarthritis, DJD, etc., with no cure-all that can do is treat symptoms, one being horrific debilitating intractable chronic pain. after many years of trying nonopioid tx. Opioid pain meds were started, and I finally found the right dose and meds. Finally, I had my quality of life back and tolerable pain for 10 of the 20 + years.
I’m suffering from debilitating intractable chronic pain then. The CDC guidelines came out in 2016, and my meds were immediately cut in half, then 2 months after taken away my effective meds. I’m still on a different opioid but on the way lower doses and less effective opioid now I’m suffering again horrific pain 24,/7 365 days a year, no longer tolerable, and decreased quality of life. It’s just not right.
They wouldn’t take away a diabetics med or heart med and certainly wouldn’t give everyone the same doses or meds. Then why discriminate against us and due it to those with legitimate pain. Some people have died, many from insulin or heart meds. They don’t stop their meds even when some die from not taking them correctly. Still, wouldn’t stop giving pts insulin or heart meds Then again why do it to those with legitimate debilitating intractable chronic pain !!!
Get!!! government out of our dr offices and medical care !!
Margaret Rene Blake, a pharmacist and intractable pain sufferer, wrote:
No matter the intent, goal, or method that the CDC may desire with these guidelines and their purpose in the American healthcare system, the DEA will still manipulate them to serve their way,”“As long as they exist, they can and will be misapplied. The way to stop the harm to patients, providers, and the system is to repeal the guideline.”
FOR NOW YOU ARE WITHIN THE
NORMS
END NOTES
- https://static1.squarespace.com/static/54d50ceee4b05797b34869cf/t/5fac5d699a1aef48f6f43d39/1605131626625/DEA+RFP+amendment.pdf
- https://dcbalaw.com
- https://static1.squarespace.com/static/54d50ceee4b05797b34869cf/t/5fac5d699a1aef48f6f43d39/1605131626625/DEA+RFP+amendment.pdf
- https://coloradosun.com/2019/11/11/dea-subpoena-opioid-pharmacy-board/
- https://www.painnewsnetwork.org/stories/2020/11/11/dea-planning-expanded-surveillance-of-prescription-data
REFERENCE:
Introduction:
In accordance with published announcements of the US CDC National Center for Injury Prevention and Control, this paper is submitted for inclusion in the minutes of the July 16, 2021 public meeting of the Board of Scientific Counselors. This meeting was focused on findings and concerns of an appointed advisory “Opioid Work Group (OWG),” pertaining to a revised and expanded draft of the 2016 CDC Guidelines on prescription of opioid analgesics to adults with chronic non-cancer pain.
Issues of CDC Charter: I note in beginning these comments, that US CDC has no legislative charter or authority for issuing guidelines on prescribing or dosing for any number of non-opioid medications used to treat infectious diseases, depression, diabetes, hypertension or other health problems that the agency actively tracks and on which it periodically reports. Interjection of the Agency into opioid guidelines in 2016 was grossly inappropriate in a mission that is normally addressed by FDA. Highly negative and destructive results of this unjustified adventure in mission creep reinforce the need for CDC to be removed from all further participation in the regulation of medical practice standards for other than infectious disease.
A Fundamental Issue of Medical Science: The central measure of merit for the 2016 opioid “guidelines” — and for the draft rewrite — was an intended reduction in the availability of medically prescribed opioid analgesics, employing threshold values of Morphine Milligram Equivalent Daily Dose (MMED) as criteria. In this context, an exchange between Wilson Compton of the Board of Scientific Advisors and Capt Debra Houry was exceptionally revealing.
Compton asked how outcomes of the 7-8 June 2021 FDA Workshop on “Morphine Milligram Equivalents” might affect the CDC’s understanding of the uses of MMED. Captain Houry’s comments seemed calculated to avoid substance and to indulge in meaningless generalities. She spoke in terms of needing more “nuance” in applying MME as a criterion.
The reality of the FDA workshop is vastly different from that suggested by Captain Houry. Although public comments on the Workshop remain open until August 9th, major conclusions are already clear from comments available in the Federal Register. We now know from multiple sources that MMED is junk science — scientifically invalid and deeply harmful as a criterion for limiting opioid dose or duration. This reality is (in somewhat less stark terms) confirmed in a June 2020 letter from the CEO of the American Medical Association to the Director of CDC.
The following references are drawn from my own May 2020 lFDA Workshop comments, filed in the Federal Register.
============
Jeffrey A. Singer, MD, “If Lawmakers Really Want to ‘Follow the Science’, They Will Repeal Codified Opioid Guidelines”. Cato At Liberty, May 24, 2021. https://www.cato.org/blog/lawmakers-really-want-follow-science-they-will-repeal-codified-opioid-guidelines
Josh Bloom, PhD, “Comments to the FDA – Opioid Dosing Based on Milligram Morphine Equivalents is Unscientific”, American Council on Science and Health, May 24, 2021, https://www.acsh.org/news/2021/05/24/comments-fda-opioid-dosing-based-milligram-morphine-equivalents-unscientific-15561
Sally Satel, MD, “The Truth About Painkillers” National Affairs, Nr 47, Spring 2021. https://nationalaffairs.com/publications/detail/the-truth-about-painkillers
Additional published references address the pivotal role of individual genetically mediated variations in opioid metabolism. Taken in combination, these references effectively invalidate any and all efforts to generalize standardized criteria for opioid dose across general patient populations or specific disease entities. This literature brings new urgency to the observation of the 2019 HHS Task Force on Best Practices in Pain Management, that there is no one-size-fits-all pain patient or therapy plan.
Tom Lynch, Amy Price, “The Effect of Cytochrome P450 Metabolism on Drug Response” Am Fam Physician. 2007 Aug 1;76(3):391-396. https://www.aafp.org/afp/2007/0801/p391.html
Donna J. Belle and Harleen Singh, “Genetic Factors in Drug Metabolism”, Am Fam Physician. 2008 Jun 1;77(11):1553-1560 https://www.aafp.org/afp/2008/0601/p1553.html
Andrea M. Trescot, MD, and Semyon Faynboym, MD “A Review of the Role of Genetic Testing in Pain Medicine”, Pain Physician 2014:17 ISSN 1533-3159
Bhushan A Kapoor, Prateek Lala, Julie L.V. Shaw, “Pharmacogenics and Chronic Pain Management” Clinical Biochemistry, 2014. http://dx.doi.org/10.2016/j.clinbiochem.2014.05.065
A Central Recommendation: Given the abject failures of MMED as a measure of merit or a viable standard of practice in administering prescription opioid therapies, I must assert that the 2016 CDC Guidelines are consequently flawed beyond any possibility of repair. The only scientifically and ethically sound action now open to the CDC is outright public repudiation and withdrawal of its 2016 guidelines – without replacement.
No amount of marginal tinkering will help. The CDC royally messed up on basic science and its present revision writers group continues to do so. As evident from almost all of the public comments submitted in the July 16th meeting of the BSC, CDC must now repair the fully predictable damage that they did to millions of patients and thousands of medical practitioners. Repudiation and withdrawal of the guidelines are the only adequate mechanism for making this correction.
A Legal Dimension: As one element of guideline withdrawal, CDC should act upon a recommendation by the CEO of the American Medical Association in a June 2020 letter to the Director of CDC. The AMA recommended that all State laws placing hard limits on prescription opioid dose or duration should be repealed. I believe that CDC must now go further to recommend that US Department of Justice and State Attorneys General conduct a judicial review for at least the last 10 years, of actions to sanction, suspend or revoke licenses, or imprison physicians for fictitious “over-prescribing” based on MME thresholds. Judgments involving MME as a criterion, must be vacated with a monetary award of damages to physicians whose practices and lives have been ruined by this bogus pseudoscience.
