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., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, 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
“WE ARE NOT POWERLESS, AND THROUGH OUR VIDEOS, WRITINGS, AND PHOTOGRAPHS WE WILL EXPOSE THE ABUSES AND TYRANNY JUST AS THE VIDEO WAS RECORDED BY THE CELL PHONE CAMERA OF YOUNG DARNELLA FRAZIER, BORE WITNESS TO THE MURDER OF GEORGE FLOYD THE BLOG youarewithinthenorms.com BARES WITNESS AND BOTH ALLOWS THE SYSTEM TO BE HELD ACCOUNTABLE”
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Shared: Thank you so much, Christinna Nunn
JUNE 4, 2022
Tulsa Shooting Shows Need to Stop Government Interference with the Treatment of Pain
“The tragic shooting of four innocent people in Tulsa on Wednesday, which included the horrific murder of two beloved physicians, was reportedly the act of a patient suffering continuing pain after back surgery. He apparently purchased his weapon hours before killing his caring physician and others, and left a letter explaining that his rampage was motivated by his post-surgery pain.
“This tragedy shows the need to examine the oppressive governmental interference with physicians’ treatment of pain,” declared AAPS Executive Director Jane Orient, M.D. “Patients can be in unbearable pain, particularly after surgery, and government should not block physicians’ efforts to help them.”
In 2018, Oklahoma limited physicians’ ability to treat pain for longer than an arbitrary seven days, in 63 OK Stat § 63-2-309I, and also limits the dosage of effective opioid painkillers during that period. The Tulsa shooting occurred 13 days after the perpetrator’s surgery, and after he complained for days about his lingering pain.
“Too often, physicians are the targets in the misguided War on Drugs,” Dr. Orient added. “This horrible killing of a caring physician should prompt nationwide soul-searching over whether suffering patients are the victims of government overreach.”
“Overzealous prosecutions of physicians who have treated pain in good faith, imposing 20-year prison sentences on some, has had a chilling effect nationwide on the treatment of pain,” observes AAPS General Counsel Andrew Schlafly. “Pending before the U.S. Supreme Court are appeals of decades-long prison sentences of physicians who treated pain in good faith,” he added.
One of those cases is Ruan v. United States, in which AAPS filed an amicus brief urging the Supreme Court to allow a good-faith defense for physicians who treat pain.
“No physician should be deterred from treating pain by the threat of prosecution having 20-year prison sentences,” Schlafly stated. “That is twice as long as imposed on an arsonist protester who burned a man to death in a pawn shop in Minneapolis.”
The Association of American Physicians and Surgeons (AAPS)is a national organization representing physicians in all specialties since 1943. Its motto is omnia pro aegroto (everything for the patient)”
THE PRESCRIPTION OPIOID CRISIS WAS A BOGUS HOAX AND STATE-FEDERAL AUTHORITIES HIDE THESE FACTS
These five deaths in Tulsa, Oklahoma June 1, 2022, were preventable and prosecutors and DOJ-DEA knew all the time that prescription opioids were causing an opioid crisis was bogus.
The Oklahoma law restricted physicians’ medical judgment and treatment and has resulted in deaths.
The bottom line is the prescription opioid pandemic was a bogus hoax, whose foundation relied upon junk science at best and persecution at the most. These families must start a class action suit…. as Malcolm X said, we have been bamboozled, hoodwinked, and led astray.
OKLAHOMA LAW FAILED HEALTHCARE AND THE PEOPLE OF OKLAHOMA
Harvey Jenkins MD, William Love, Stephaine Huesen MD, Amanda Glenn, Preston Phillips, and countless-nameless people are victims of the State of Oklahoma’s and United States Department of Justice, DEA’s madness in which thousands of Intractable Pain Patient(s) (chronic Pain patients) have killed themselves or perished suffering while being denied pain treatment.
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
Neil Anand, et al., CASE NO. 21-1635-CKK
Plaintiff, Norman Clement, Intervenor :
U.S. Department of Health Human Services et al., Defendant. :
(PAGE 35 THROUGH 40)
The Center For Disease Control Has Recently Admitted That The Algorithms Are Junk Science
Motion for Intervention of Right Pursuant to Federal Rules of Civil Procedure Rule 24 (a) and Permissive Intervention Pursuant to Federal Rules of Civil Procedure Rule 24 (b)
For years, groups like the American Medical Association (AMA) have urged the CDC to reconsider the 2016 guideline. “The CDC’s new draft guideline — if followed by policymakers, health insurance companies, and pharmacy chains — provides a path to remove arbitrary prescribing thresholds, restore balance, and support comprehensive, compassionate care,” said Bobby Mukkamala, MD, chair of the AMA board of trustees, in a statement. “The previous guidance has harmed patients with chronic pain, cancer, sickle cell disease, and those in hospice,” he noted. “The restrictive policies also failed patients who are stable on long-term opioid therapy, and it has denied care to post-surgical patients and those with an opioid use disorder.”
The old guideline did nothing to stem the drug overdose epidemic, Mukkamala added. “In fact, the epidemic has become more lethal despite the CDC’s restrictive guideline due to illicitly manufactured fentanyl, fentanyl analogs, heroin, methamphetamine, and cocaine,” he said.
(https://www.medpagetoday.com/ pain management/opioids/97133? xid=nl_mpt_DHE_2022-02-11&eun=g1767887d0r&utm_source=Sailthru&utm_me dium=email&utm_campaign=Daily%20Headlines%20Top%20Cat%20HeC%20%2 02022-02-11&utm_term=NL_Daily_DHE_dual-gmail-definition)
New draft guidelines for primary care and other clinicians proposed by the CDC no longer promote hard thresholds on opioid prescribing. The draft guidance for acute, subacute, and chronic pain is part of a proposed update to the controversial 2016 CDC opioid guideline for chronic pain. The 2016 guideline was interpreted as setting medication dose and duration limits and was misapplied by some organizations, leading CDC researchers to attempt to clarify the document in 2019.
The new guideline isn’t designed to replace clinical judgment, but is a tool to help providers and patients make safe, effective pain care decisions and provides “voluntary recommendations on the use of opioids to treat pain,” the CDC noted.
Overall, however, the proposed guidelines represent a substantial improvement on the advice the CDC gave in 2016. “The framing is better,” says Kate Nicholson, president of the National Pain Advocacy Center. She notes “much more emphasis on the importance of treating pain, individualization, patient-centered care, disparities in care, and [the point] that the guideline should not be used as the basis for policy or a substitute for clinical judgment.” She adds that “the two provisions that wreaked the most havoc—the day and dosage thresholds—have been removed from the actual recommendations.”
It is not intended to be applied as an inflexible standard, CDC added. It’s also not intended to lead to rapid opioid tapering or discontinuation and does not apply to sickle cell disease-related pain, cancer pain, and palliative or end-of-life care.
“I was very pleased to see clear language that the proposed guideline is not a replacement for clinical judgment or individualized, person-centered care,” noted pain specialist Beth Darnall, Ph.D., of Stanford University School of Medicine. “
This is crucial, as misapplications of the 2016 guideline centered around a reductive focus on dose-based limits and tapering that was associated with patient harms,” Darnall told MedPage Today.
The CDC acknowledges the concern that advice tied to specific doses might lead to suboptimal care and misguided policies, as happened with its earlier emphasis on the 90 MME/day threshold. Its solution is to omit any reference to the 50 MME/day threshold from its highlighted recommendation, relegating that discussion to the “implementation considerations.” Lynn Webster, a former president of the American
Academy of Pain Medicine, notes that the CDC does not acknowledge the weak scientific basis for MME thresholds, which do not take into account wide variation in how patients metabolize and respond to pain medication.
Webster is less impressed by the CDC’s changes. “The good thing,” he says, is that “the explicit dose limits were removed and the days of opioid supply for acute pain are not specific.” But “although they say that the guideline should not be an inflexible standard of care imposed on specific populations,” he notes, “they do not expressly state that law enforcement and policymakers should not use them to set a standard of care or to prosecute providers.”
The CDC’s bias against opioids does not seem to be justified by the addiction risk it emphasizes. In 2015, according to the National Survey on Drug Use and Health, nearly 100 million Americans used prescription opioids, including nonmedical users as well as bona fide patients. Judging from their responses to survey questions, about 2 million of them, slightly more than 2 percent, qualified for a diagnosis of “substance use disorder”—a catchall category that subsumes what used to be known as “substance abuse” and the more severe “substance dependence”—at some point during the previous year. By comparison, data from the same survey indicate that 9 percent of past-year drinkers had an alcohol use disorder in 2015.
Nor are fatal overdoses as common as the CDC implies. A 2015 study of opioid-related deaths in North Carolina, reported in Pain Medicine, found 478 fatalities among 2.2 million residents who were prescribed opioids in 2010, an annual rate of 0.022 percent. Webster notes that the CDC dubiously blames opioid prescribing for increases in drug-related deaths between 1999 and 2010 without acknowledging that the upward trend in fatalities accelerated after the government succeeded in reducing the use of opioid pain medication. As opioid prescriptions fell, opioid-related deaths, primarily involving heroin and illicit fentanyl, rose to record levels.
Webster questions why the CDC felt a need to advise doctors about pain treatment in the first place. That function “should be left to professional organizations,” he says. “Several experts in the field predicted the outcome of the 2016 CDC guidelines before they were issued…The debacle with the 2016 CDC guidelines [illustrates] the reason the CDC should not be imposing their views on how pain medicine should be practiced.”
The problems revealed by the CDC to its 2016 guidelines Opioid Guidelines have since been compounded in at least two ways. First, research has shown that the underlying rationale of the CDC guideline and the proposed revisions is grounded upon a concept that is best characterized as “junk science.” Much of the damage done by the 2016 CDC guideline was caused by daily dose recommendations based on morphine milligram equivalents (MME).
However, MME is not a single metric or even the correct one to base decisions on. In fact, there are four different models for MME which generate significantly different estimates for the “equivalence” between various opioid medications. Likewise, a June 2021 FDA Workshop on MME research revealed significant weaknesses in the methods and protocols from which these models were developed.
Finally, a recently published review of the clinical literature for opioids and chronic pain reveals a 15-to-1 range in minimum effective dose for opioids used in long-term therapy for moderate to severe pain. Much of this range appears to be caused by genetic differences in key liver enzymes which metabolize opioids. The literature also reveals very low risks of addiction among pain patients who actively managed on opioids. Many papers mistake “pseudo- addiction” for drug tolerance or addiction.
A clinical practice guideline is a clinical tool to improve communication between clinicians and patients and empower them to make informed, person-centered decisions related to pain care together. It is intended to be flexible to enable person-centered decision-making, taking into account an individual’s expected health outcomes and well-being.
A clinical practice guideline is not a replacement for clinical judgment or individualized, person-centered care. A clinical guideline is not intended to be applied as inflexible standards of care across patients, and/or patient populations by healthcare professionals, health systems, pharmacies, third-party payers, or governmental jurisdictions or to lead to the rapid tapering or discontinuation of opioids for patients.
Therefore, pharmacists should avoid abrupt discontinuation of opioids, especially for patients receiving high dosages of opioids, and should avoid dismissing patients from care.
“The use of the Milligram Morphine Equivalents is scientifically flawed because it fails to take into account even the most basic tenets of pharmacology, rendering it scientifically meaningless. Contrary to conventional wisdom, conversion values are not based on pharmacologic properties. Instead, they arose 60 years ago from small single-dose clinical studies in postoperative or cancer populations with pain score outcomes; toxicologic effects (eg, respiratory depression) were not evaluated.” See Nabarun Dasgupta, et. al.,
The Clinical Journal of Pain: August 2021 – Volume 37 – Issue 8 – p 565-574 DOI: 10.1097/AJP.0000000000000948 where all aggregate data and code used for statistical analyses are publicly available at http://www.opioiddata.org and institutionally archived at the Carolina Digital Repository (https://doi.org/ 10.17615/zst5-nc25).
THE JUNK SCIENCE OF MORPHINE MILLIGRAM EQUIVALENTS (MME) HARMS MEDINCE AND MUST BE REPUDIATED
Morphine-standardized doses are used in clinical practice and research to account for molecular potency. Ninety milligrams of morphine equivalents (MME) per day are considered a “high dose” risk threshold in guidelines, laws, and by payers. Although ubiquitously cited, the “CDC definition” of daily MME lacks a clearly defined denominator.
The Defendant’s algorithms, therefore, lack an objective way to assess denominator-dependency on “high dose” classification across competing definitions and fail to identify definitional variants.
The Defendant’s computer algorithms manners and methods of toxicologic framing where the artificial intelligence identifies the highest single-day MME exposure, irrespective of days supply or opioid tolerance is unpublished. Prescriptions dispensed pro re nata are assumed to be consumed immediately, regardless of how long the prescription is written for.
Yet, paradoxically, the “maximum” does not conceptually include consumption for intentional self-harm. MME alert thresholds are incorporated in “doctor shopping algorithms” and automated proactive reporting but are routinely devoid of diagnosis or ICD code. Thus, the law enforcement metric of using daily MME to target prescribers or pharmacists is clearly erroneous as it is not correlated to disease.
Penalizing clinicians solely on the basis of 90 MME limits is problematic because the mean is not always the message and policymakers reading PDMP reports based solely on MME averages are in danger of making decisions based on metrics that are artifactually inflated. Medians and ranges may convey a more accurate picture in these scenarios.
Dispensing data do not necessarily reflect actual consumption. About 60% of patients prescribed opioids retain unused medication. As a pharmacist and a journalist, Intervenor Clement is trying to obtain the databases to study the standard assumptions and limitations inherent to database studies of medication use.
The Defendants’ databases obtained pursuant to FOIA will allow study for specification and completeness, generic equivalence, and analysis of the presence or absence of counterfeits. Intervenor Clement seeks Defendants’ computer algorithms, formulae, conversion tables, computer code, sensitivity analyses by definition choice, and methods of treating MME exposure as a transformed continuous mathematical variable.
Identification of a clustering effect would also identify prescribing motivations at certain MME thresholds which might be used as a cap to appear in compliance with external government mandates. Clinical reasons could be identified for patients who cluster at 90 MME per day outside of policy, health system, and payer requirements; likewise, patients could be identified that might have otherwise received higher doses but are subsumed under this threshold due to U.S. Executive Agency mandates.
There is also evidence that the CDC violated its own internal standards for objectivity when it selected the writers of the opioid guideline and recent revisions. Dr. Roger Chou, one of the co-authors of the original and revised guideline, has an established history of collaboration with key figures in anti-opioid organizations.
Moreover, as pointed out by the OWG, a disproportionate number of publications where Chou was a principal author were used as source research for the guidelines as published. Chou not only led research on opioid outcomes and contributed to writing the guidelines, but also sits on the Board of Scientific Counselors that appointed the OWG. He was thus in a position to lobby actively for his own work as a national standard of care.
This is a fundamental professional conflict of interest. As we near the release of a revised draft CDC guideline, one central trend seems clear. If the writers of this guideline insist on doubling down on the errors of their original effort in 2016 – as they apparently did in July 2021 – then it will be time to remove the CDC from its oversight of the practice of pain medicine, perhaps in favor of FDA or the National Academies of Medicine.
Historically, the transition of the MME concept from pain relief to toxicology within the Defendant’s algorithms seemed to have ignored the clinical medical concept of differential tolerance. With opioid dose escalation, analgesic and unintended effects emerge asynchronously.
While 90 MME may have cautionary mnemonic benefits in the midst of broad societal concern, a renewed emphasis on opioid tolerance and definitional harmonization for daily MME and long-term therapy seems overdue.
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