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
American Medical Association July 22, 2021:
“We know that this has harmed patients with cancer, sickle cell disease, and those in hospice. The restrictive policies also fail patients who are stable on long-term opioid therapy.”
THE SICKLE CELL OPIOID GUIDELINE IS A MEDICAL TRAGEDY ON THE SCALE OF TUSKEGEE EXPERIMENTS THAT HAS LED TO NEEDLESS SUFFERING AND DEATHS
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.
Singer, Bloom, Lawhern, Clement, Borel, et al
“This is among the worst scandals in American Medical History“
CDC’S DEADLY USE OF FORCE TAPERING
According to both Josh Bloom Ph.D. and Helen Borel RN., Ph.D.:
Force tapering has proven to be deadly “is that a surprise”. The foundation of force tapering was the junk science called Morphine Milligram Equivalent (MME) which in itself developed under a private medical interest group (PROP) who have an economic stake in Reckitt Beniser the company makers of Subutex. (1)
That is the most frightening because Federal agencies, state governments, private insurances providers have codified these unscientific principles and today we literally have physicians pharmacists being imprisoned for life and patients seeking medical care literally being put to death.
In this case, the failure of the CDC to recognize the fundamental medical needs further exposes cultural policy bias which has led to forced tapering narcotic analgesic dosages based on unscientific evidence. 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)
Richard Lawhern PH.D.___
“Morphine Milligram Equivalent Daily Dose (MMEDD) is not a useful measure in defining limits on opioid dosage and as such, it has been repudiated by the American Medical Association(AMA). Its major utility is as a rough guide to the clinician in making a safe transition from one opioid to another.”
THE CRIMINALIZATION OF SICKLE CELL PAIN TREATMENT
We see this medical tragedy as Center For Medicare and Medicaid Services, Office of Minority Health (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. In essence, these patients were receiving care one day and became criminal junkies diverting medications the next day and targetted by the DEA.
Coupled with the practice of the “uncomfortable pharmacist” in withholding treatment of a patient by altering or denying medications is both dangerous and unacceptable in the field of medicine and this aberrant irresponsibility has produced one uncomfortable fact: patients’ suicide.
CDC 2016 GUIDELINES ARBITRARILY RECLASSIFIED ALL SICKLE CELL DISEASE PATIENTS INTO DRUG-SEEKING ADDICTS AND TRAFFICKERS
See Page 7 of CMS Manual
“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:
THE OPIOID EPIDEMIC AND ITS IMPACT ON SCD TREATMENT
- 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 HARM AND DEATH TOLL CAUSED BY THE CDC 2016 OPIOID GUIDELINES HAS BEEN UNSPEAKABLY HORRENDOUS
A major issue, according to the AMA’s June 2020 letter to the CDC, is that many states, health plans, and pharmacy chains misapplied the CDC guidance to institute strict, specific limits on opioid prescribing—for example, Walmart and CVS Caremark placed a 7-day hard threshold on prescribing, and more than 30 states have enacted laws with opioid prescribing restrictions ranging from 3 to 14 days, including many with morphine milligram equivalents (MME) limits and other restrictions. “CDC’s threshold recommendations continue to be used against patients with pain to deny care,” Mukkamala wrote.
WHAT DISEASE STATE CDC INCOMPETENCE OPIOID PAIN GUIDELINES FAILED TO INCLUDE
The 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 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.
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.
AMA report concluded:
“We know that this has harmed patients with cancer, sickle cell disease, and those in hospice. The restrictive policies also fail patients who are stable on long-term opioid therapy.”
FOR NOW, YOU ARE WITHIN
THE NORMS
ENDNOTES
- American Agony: The Opioid War Against Patients in Pain, By Helen Borel, RN, PhD. Chapter Twenty, pg 238, “The Suboxone Hoax,”
