“..This exposes the roots of Judicial corruption that has infected every aspect of our existence..”
Dr. Clarence Verdell, MD, general adult psychiatrist, an addictionologist, and victim of government overreach
reported by youarewithinthenorms.com
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. IN THE SPIRIT OF WALTER R. CLEMENT BS., MS, MBA. HARVEY JENKINS MD, PH.D., IN THE SPIRIT OF C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., EVELYN J. CLEMENT, WALTER F. WRENN III., MD., JULIE KILLINGSWORTH, RENEE BLARE, RPH, DR. TERENCE SASAKI, MD 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., IN THE SPIRIT OF LEROY BAYLOR, JAY K. JOSHI MD., MBA,AISHA GARDNER, 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
SUMMARY
This article critiques the U.S. government’s response to the opioid crisis, arguing that policies based on flawed data and algorithms have led to unintended negative consequences. The overreliance on predictive AI and prescription drug monitoring programs (PDMPs), coupled with the use of questionable metrics like Morphine Milligram Equivalents (MMEs), is criticized for harming patients and doctors alike.
Concerns are raised about algorithmic bias in healthcare and law enforcement, which can lead to disparities and ineffective interventions. The sources advocate for greater scrutiny of AI systems in these sectors and a more evidence-based approach to addressing the opioid crisis, emphasizing the importance of human judgment and ethical considerations.
Finally, the inadequacy of the scientific basis for prescribing limits is highlighted, suggesting that these policies have exacerbated the problem instead of solving it.
U.S. Government Responses to the Opioid Crisis, 2006–2019
[ A-I (alg*)= A-S ] AND INTIMATE KNOWLEDGE OF DESIGN AND ABUSE IN LAW ENFORCEMENT
Most Important Ideas/Facts:
- AI (alg) = AS:* This formula, referred to as the Anand-Clement Rule, highlights that Artificial Intelligence using a biased algorithm (alg*) generates Artificial Stupidity (AS). This concept underlines the importance of using unbiased data in AI systems, especially in law enforcement, where wrong assessments can have severe consequences.
- Misuse of PDMPs: Prescription drug monitoring programs (PDMPs), originally intended to monitor controlled substance prescriptions, are used by law enforcement to identify and prosecute healthcare practitioners suspected of “overprescribing.” This has created a chilling effect on legitimate pain management practices.
- Flawed CDC Guidelines: The CDC’s 2016 guidelines for opioid prescribing, while intended to be voluntary, have been adopted as rigid rules by many states. These guidelines have been criticized for their lack of scientific basis, particularly the use of MMEs as a measure of opioid potency.
- Impact on Pain Patients: The crackdown on so-called opioid prescribing is further ill-defined and has resulted in the mistreatment by pharmacists engaged in “academic authoritative power tripping,” thus undertreatment of chronic pain patients, leading to a rise in “pain refugees” struggling to find adequate care. This has pushed some patients towards dangerous alternatives like the black market or suicide.
- The Eliminating Bias in Algorithmic Systems Act of 2024: This legislation seeks to address the risks of algorithmic bias by requiring federal agencies to establish civil rights offices specifically tasked with identifying and mitigating such bias in AI systems.
- alg = unbiased algorithm, AI= Artificial Intelligence, alg*= bias or defective algorithm THUS AI(alg*) = AS The AC Rule: this supports the saying garbage in anywhere can only generate garbage out or garbage in is garbage out and exposes the limitation draw upon conclusion using bias algorithms
THE AC RULE
- “The Anand-Clement Rule or The AC Rule simply states Artificial Intelligence AI using an unbiased Algorithm alg generates Artificial Intelligence; however, Artificial Intelligence using a defective or biased alg* generates Artificial Stupidity or AS.”
- “Thus providing the Federal and local law enforcement use these PDMPs to screen for health care practitioners suspected of ‘overprescribing’ or operating so-called ‘pill mills.'”
- “MME dosing was designed in an attempt to examine opioids with similar analgesic effects and should not be used to determine an exact mathematical dosing conversion.”
- “These interventions have cast a chilling effect on the prescribing practices of healthcare providers.”
- “The Eliminating Bias in Algorithmic Systems Act of 2024, introduced by Rep. Summer Lee (D-PA) and Sen. Markey (D-MA), is designed to bring much-needed oversight to AI systems used by federal agencies.”
Overall, the document paints a concerning picture of the increasing use of AI in law enforcement and the unintended consequences of government policies aimed at addressing the opioid crisis. It calls for a more nuanced and human-centered approach to both issues, emphasizing the need for unbiased data, ethical considerations, and the recognition of the complex realities of chronic pain management.
So it was that the bison came upon a family of mice who were all sick, but they had nothing with which to pay for the doctor’s aid. “But without my care, your children will die. I must help; it is my duty,” he said.
DR. MARK IBSEN: THE SOUNDS OF PAIN CARE SUFFERING AND PHARMACISTS ABUSES
“Without a thought, the doctor gave them his aid, one after the other, and each mouse he healed was grateful. Soon, however, he began to tire and eventually became exhausted, yet still more mice came. “Surely, though, this deed will be worth it in the end,” he thought, strengthening his resolve.”
1.
2. Her primary care doctor would only give her 10 mg of oxycodone four times a day as a maximum dose.
On those doses, she could not consistently get to work and care for her six-year-old daughter. Since she’s been under my care, she hasn’t missed any work.
This is a nine-month time frame.
There are multiple errors in this pharmacist’s logic, and you can tell he sounds like a hostage in a video. He’s calculated that she has a nine times increased risk of overdose.
This is categorically false. Of course, she’s facing job loss, housing loss, income loss, etc.
I will provide another video in which the patient herself is weeping uncontrollably because of fear. I have the patient’s permission to share this. Unfortunately, the Pharmacist must remain anonymous for now.
THE DANGERS OF EXPANDING GLADWELLEAN PROTOCOLS
The rise in opioid-related overdose deaths in the latter part of the first decade of the 21st century—referred to as an “epidemic” or a “public health crisis”—gained considerable public attention. The government responded on the federal and state levels.
A summary From STEPHEN Nadeau, Richard Lawhern, BELINDA PARKER BROWN, JEFF SINGER, BARBARA MARINO WALTER F. WRENN, LINDA CHEEKS, PHARMACIST STEVE, Nabraun Disgupta, ANGELA GREEN, FOREST TeNnANt, ET AL.,
In 2016, the CDC issued its Guidelines for Prescribing Opioids for Chronic Pain Patients.82 In publishing the guidelines, the CDC explicitly stated that they were meant to be voluntary and “not prescriptive,” stating that healthcare practitioners should know their patients’ unique clinical situation and weigh the potential risks and benefits when prescribing opioids.
Many of its recommendations were based on what the CDC characterized as “Type 3” or “Type 4” evidence, categories of less probative evidence with a significant risk of inaccuracy. The guidelines thus came under considerable criticism from many pain and addiction specialists for lacking a strong basis in the evidence.83
Prescription drug monitoring programs (PDMPs), initially developed in the early 20th century, were made more productive by technological advances. The DEA and the U.S. Department of Justice encouraged and supported their proliferation.
Today, they exist in all 50 states (although the Missouri PDMP is underdeveloped), the District of Columbia, and Guam, the U.S. territory.69
PDMPs have served as data banks, where all transactions involving the prescription and delivery of controlled substances are stored.
This network, connected to this nation’s Pharmacies, provides information regarding the frequency and number of prescriptions filled by individual patients and the amount and dosages of prescriptions written by providers.
Thus, Federal and local law enforcement use these PDMPs to screen for health care practitioners suspected of “overprescribing” or operating so-called “pill mills,” described as clinics operated by corrupt practitioners who have abandoned their role as health care providers in favor of simply prescribing controlled substances.70
PDMPs are also used to detect “doctor shopping” by patients seeking prescriptions for pain from multiple providers in short periods. (As will be discussed later, some cases of “doctor shopping” are, in reality, pain patient “refugees” who have been undertreated or dismissed by their providers.)
Using PDMPs, law enforcement has conducted numerous raids on medical practitioners, many of whom have been indicted and sentenced to prison.71 Some have claimed that these raids are conducted indiscriminately
THE FORT BRAGG CARTEL: HOW D.E.A. HAS FAILED AMERICA AND PROMOTED THE PRODUCTION AND GROWTH OF HEROIN
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REFERENCE:
Using PDMPs, law enforcement has conducted numerous raids on medical practitioners, many of whom have been indicted and sentenced to prison.71 Some have claimed that these raids are conducted indiscriminately.72 States have undertaken questionable initiatives to scrutinize providers in conjunction with medical licensing boards. For example, in 2019, California instituted the “Death Certificate Project,” in which any opioid overdose death prompted California Medical Board investigators to go back three years through the PDMP database to find any practitioner who prescribed opioids to the decedent, even if the prescription was not believed to be the fatal dose and to consider reprimanding the provider or revoking the provider’s license.73 California physicians complained to the state licensing board that the project disrupted their ability to practice medicine properly. In late 2020, the California Medical Board changed the name of the project to the more benign “Prescription Review Project” and announced plans to look at the “entire prescription profile of the physician” during postmortem investigations.74
CATO INSTITUTE: AI AND LAW ENFORCEMENT HUMAN VS MACHINE A DECEPTION OF MEDICAL SCIENCE:
These interventions have cast a chilling effect on the prescribing practices of healthcare providers. The total number of opioid prescriptions dispensed peaked in 2012 (see Figure 3).75 Data from the National Survey on Drug Use and Health show that non-medical use of prescription opioids also peaked in 2012. The prescription rate is now below the 2002 rate, and total opioid use, including heroin, was lower in 2014 than in 2012.76 High-dose opioid prescribing (90 morphine milligram equivalents or greater) fell by 58 percent from 2008 to 2017.77 Total opioid prescribing fell 29 percent from 2010 to 2017.78 Multiple reviews of the efficacy of PDMPs have shown their association with the drop in prescription volume, but they have failed to demonstrate any effect on the overdose rate, and it has been suggested that they have directly increased the rate of overdoses from heroin.79
The Food and Drug Administration has encouraged the development of abuse-deterrent formulations of prescription opioids to prevent them from being crushed for consumption by snorting or dissolved for injection. Considerable evidence suggests that this has only served to induce non-medical users to migrate to cheaper and more available heroin and now to mixtures of heroin and fentanyl.80
The DEA is tasked with establishing quotas on the production of all types of prescription opioids for medical use, in all situations, allocated to individual manufacturers. This assignment presumes that a federal agency can accurately predict how many specific formulations of opioids are necessary to serve a population of 330 million people in hospital and nonhospital settings in the coming year. The agency has reduced these quotas since 2016, announcing in late 2019 plans to reduce the production of opioids to 53 percent of 2016 levels (see Figure 4).81
Others criticized the use of morphine milligram equivalents (MMEs) in determining the appropriate dosing of different opioids. As Fudin and others have argued,
MME dosing was designed in an attempt to examine opioids with similar analgesic effects and should not be used to determine an exact mathematical dosing conversion. The pharmacology and unique properties of each opioid and patient individuality must be considered when a therapeutic opioid conversion is contemplated. Conversion should not simply rely on a mathematical formula embedded within the CDC calculator software. Furthermore, the current calculation for methadone employed by the calculator could allow for potentially dangerous conversions. This is especially problematic considering this calculator is intended to target nonspecialist, general practitioners. We expect a higher level of scientific accuracy and integrity from an agency entrusted to protect citizens’ health and welfare.84
Recognizing the controversy surrounding MMEs, in August 2021, the FDA held a “public workshop” entitled “Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions.” The workshop’s stated purpose was to “provide an understanding of the science and data underlying existing MME calculations for opioid analgesics, discussing the gaps in these data, and discussing future directions to refine and improve the scientific basis of MME applications.”85
During the workshop, Nabarun Dasgupta of the University of North Carolina Injury Prevention Research Center presented research stating: “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 (e.g., respiratory depression) were not evaluated.” The research concluded: “The overlooked inconsistency among daily MME definitions revealed by our study calls into question the clinical validity of a single numerical risk threshold.… Our findings call into question state laws and third-party payer MME threshold mandates. Without harmonization, the scientific basis for these mandates may need to be revisited.” 86 Some critics consider the use of MMEs as “junk science.”87
Nevertheless, many states implemented statutory or regulatory limits on the dose (in MMEs) and number of opioids that may be prescribed to patients in acute, chronic, and postoperative situations, respectively, and they encouraged policies promoting the rapid or abrupt tapering of chronic pain patients off the opioid therapies on which they had been maintained long-term. In 2018, Oregon proposed a mandatory reduction to zero opioids in Medicaid patients over 12 months.88 The state reversed itself after receiving fierce criticism from pain management and addiction specialists.89
The 2016 CDC guidelines were adopted and cast in stone by many state regulatory agencies, pharmacies, and health insurers. Thirty-eight states have, to date, codified CDC guidelines by imposing limits on the dosage, number, and length of time of opioids prescribed for the treatment of pain (see Figure 5).90 Repeated complaints and criticisms from the American Medical Association and numerous health care professionals, including some who played a role in developing the CDC guidelines, led the CDC to issue a clarification against “the misapplication of the guidelines.”91Despite the clarification, no state has revised or repealed dosage and supply restrictions.
In February 2022, the CDC published a draft of a proposed revision of its 2016 guideline that no longer promoted hard thresholds for opioid prescribing.92 However, the draft proposal still used the pharmacologically unsound morphine milligram conversion table in its methodology. The CDC accepted public comments until mid-April 2022 and is expected to publish a final revised guideline before the end of 2022.93 One of this paper’s authors submitted comments that argued that, regardless of its revisions, the CDC guideline will “inevitably become interpreted and adopted as hard and fast rules by state and local governments, pharmacies, health plans, and third-party payers, despite guideline warnings against doing so.” Furthermore, the comments contended that the CDC should not be in the business of issuing opioid prescribing guidelines. “Professional specialty organizations, overseen by practicing clinicians and clinical educators, are the institutions that should be issuing standard of care and best practices guidelines.”94
On November 3, 2022, the CDC published the final draft of the revised 2016 guideline, titled “2022 Clinical Practice Guideline for Prescribing Opioids for Pain.”95 The document emphasizes that its “recommendations related to opioid dosages are not intended to be used as an inflexible, rigid standard of care; rather, they are intended to be guideposts to help inform clinician-patient decision-making.” The recommendations are still primarily based on “Type 3” and “Type 4” evidence.
The guideline abandoned MME-based dosage thresholds. Unfortunately, it continued to recommend that prescribers use an MME conversion table to calculate opioid dosages. It cautioned that “before increasing total opioid dosage to ≥50 MME/day, clinicians should pause and carefully reassess evidence of individual benefits and risks. If a decision is made to increase the dosage, clinicians should use caution and increase the dosage by the smallest practical amount.” If the past is prologue, expect that the suggestion that clinicians use caution prescribing an opioid dose approaching 50 MME will morph into a de facto threshold mandate as lawmakers, pharmacies, and third-party payers fixate on that metric. Perhaps most egregiously, the 2022 guideline rationale remained predicated on the flawed assumption that overprescribing opioids caused the overdose crisis.96
Reacting to the 2022 guideline release, opioid policy expert and patient advocate Dr. Richard A. Lawhern commented:
Despite some conciliatory wording, the November 2022 CDC practice guidelines on prescribing opioids remain fatally flawed in basic science and medical ethics. The document profoundly over-hypes asserted “risks” of opioid prescribing. It relies on weak medical evidence, cherry-picked research, and outright junk science in 12 “recommendations” that will predictably drive even more clinicians out of pain management and more patients into suicide or street drugs.97
Finally, state and local governments have taken legal action against opioid manufacturers, accusing them of fueling the overdose crisis through aggressive marketing and by understating the overdose and addictive potential of prescription opioids.98
Does the Analogue Act’s Pragmatic Approach Conflict With Leibniz’s Law?
Yes, the Analogue Act’s pragmatic approach, which prioritizes function over structure, conflicts with a strict interpretation of Leibniz’s Law.
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Leibniz’s Law, or the Identity of Indiscernibles, states that two things are identical only if they share all the same properties.
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The Analogue Act criminalizes substances “substantially similar” to banned substances, focusing on comparable effects rather than identical chemical structures. This is similar to the MME (Morphine Milligram Equivalents) metric, which equates opioids with different properties based solely on their painkilling effects.
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The sources argue that this functional equivalence approach contradicts Leibniz’s Law because substances with different chemical structures cannot be truly identical. For instance, morphine and oxycodone, despite both being opioids, have different solubilities, metabolic pathways, and potencies.
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However, the sources also acknowledge that the Analogue Act utilizes a more pragmatic interpretation of Leibniz’s Law, prioritizing the practical goal of controlling potentially harmful substances over strict adherence to the principle of identical properties.
In essence, while the Analogue Act’s focus on function over structure might technically violate a strict reading of Leibniz’s Law, it reflects a pragmatic legal approach that prioritizes practical outcomes over theoretical consistency.
MME Impact on Opioid Prescribing and Patient Care
The MME (Morphine Milligram Equivalents) metric, while intended to simplify opioid prescribing, has had unintended negative consequences for both doctors and patients. Here’s how:
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Arbitrary Thresholds and Doctor Criminalization: The MME metric has led to the establishment of arbitrary thresholds, which are used to judge whether a doctor is overprescribing opioids. This has created a climate of fear among physicians, who are now hesitant to prescribe opioids even for patients in genuine need. The fear of exceeding these thresholds and facing legal repercussions has resulted in doctors undertreating pain or even abandoning their long-term pain patients. The sources describe this situation as turning U.S. medicine into a “dystopian farce,” where doctors are criminalized and patients are left to suffer.
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Neglect of Patient Individuality and Context: The MME metric fails to account for the significant differences in how individuals respond to various opioids. Factors like metabolism, route of administration, and individual sensitivity can dramatically alter the effects of a given opioid dose. However, the MME system treats all opioids as functionally equivalent based solely on their perceived potency relative to morphine. This disregard for individual variation and context reduces patients to mere numbers on a chart and ignores the ethical principle of considering both intended and unintended consequences of medical actions.
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Creation of “Pain Refugees” and Black Market Reliance: The crackdown on opioid prescribing, fueled by the MME metric, has created a population of “pain refugees” – patients who have lost access to legitimate pain management and are left desperate for relief. This has driven many to seek opioids on the black market, exposing them to dangerous and unregulated substances.
The sources utilize the analogy of Goldilocks and the three bears to highlight the flaws in the MME system. Just as Goldilocks found each bowl of porridge to be different, patients experience different effects from different opioids, despite what the MME metric suggests. The sources argue that the MME system’s oversimplification of opioid pharmacology leads to a situation where patients are denied individualized care based on their unique needs and responses.
Thank you for your advocacy work Dr Norm! Merry Christmas and Happy Holidays!