REPORTED IN
Original November 25, 2022
youarewithinthenorms.com
NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, IN THE SPIRIT OF WALTER R. CLEMENT MS., MBA., BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., IN THE SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF WILLIE GUINYARD BS., IN THE SPIRIT OF ERLIN CLEMENT SR., JOSEPH WEBSTER MD., MBA, IN THE SPIRIT OF RICHARD KAUL, MD., BEVERLY C. PRINCE MD., FACS., IN THE SPIRIT OF LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, IN THE SPIRIT OF WALTER F. WRENN III, MD., ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NDJOU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
FROM THE FILES OF THE CATO INSTITUTE
Senior Fellow, Cato Institute
BY TREVOR BURRUS AND SENIOR FELLOW JEFFEREY SINGER MD
“Using PDMPs, law enforcement has conducted numerous raids on medical practitioners, many of whom have been indicted and sentenced to prison.”
Since the early 20th century, U.S. drug policy has increasingly shifted the oversight of opioids and other psychoactive substances from the medical community to law enforcement. This “demedicalization” has occurred in two primary waves: Drug War I, following the 1914 Harrison Narcotics Act, and Drug War II, beginning in the 1970s and intensifying during the 21st-century “opioid crisis.”
“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). Data from the National Survey on Drug Use and Health show that nonmedical 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. High-dose opioid prescribing (90 morphine milligram equivalents or greater) fell by 58 percent from 2008 to 2017. Total opioid prescribing fell 29 percent from 2010 to 2017.
Multiple reviews of the efficacy of PDMPs have shown their association with the drop in prescription volume. Still, 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.”
THE WAVES OF DEMEDICALIZATION AND DESTRUCTION
The First Wave: Drug War I
The criminalization of medical practice began in earnest following the Harrison Narcotics Act of 1914. While originally intended as a tax and transparency measure, federal Treasury agents transformed it into a de facto prohibition by taking it upon themselves to define what constituted “legitimate” medical treatment.
AUSA WAYNE F. PRATT, SOUTHEASTERN MICHIGAN
GOLLUM’S PERCH DEFINE-1
• Persecution of Doctors: Thousands of physicians were arrested and prosecuted for providing maintenance doses of opioids to compulsive users, a practice the agents deemed illegitimate regardless of the doctor’s medical opinion.
• Judicial Definitions: Through a series of Supreme Court cases, law enforcement successfully argued that maintenance doses were a “perversion” of medical practice, effectively authorizing tax agents to practice medicine.
• Linder v. United States: Although the Supreme Court later ruled in 1925 that the Harrison Act protected good-faith prescribing for addiction, the Treasury Department largely ignored the ruling, and the medical profession remained cowed into submission
The Second Wave: Drug War II
A second wave of criminalization emerged in the 1970s and intensified during the 21st-century “opioid crisis”. This era is characterized by massive surveillance and the use of law enforcement as a primary regulator of medical decision-making.
• Surveillance Tools: Law enforcement uses Prescription Drug Monitoring Programs (PDMPs) to scan for “overprescribing” practitioners, often without a warrant.
• Codification of Guidelines: Voluntary CDC guidelines for prescribing were codified into law by many states, removing clinical nuance and criminalizing practitioners who deviate from these rigid standards.
• Felony-Murder Charges: In recent years, prosecutors have increasingly charged doctors with homicide or felony-murder when patients succumb to overdose deaths, even if the doctor followed their best clinical judgment.
GOLLUM’S PERCH DEFINE-2
The Lack of Clear Definitions
A central issue in the criminalization of medicine is the stunningly vague nature of the charges.
• Undefined Standards: There is no universal legal or medical consensus on what constitutes “overprescribing” or “inappropriate prescribing.”
• The PharmD Physician want be: The American Medical Association emphasizes the critical distinctions between the education and professional responsibilities of physicians and pharmacists. While pharmacists possess extensive expertise in medication management, the text argues they lack the thousands of hours of clinical residency and diagnostic training required to safely practice medicine independently.
• Bias-Driven Enforcement: Without clear definitions, law enforcement often relies on paid medical consultants who may have a financial incentive to conclude that a practitioner’s behavior was illegitimate.
• Chilling Effect: This legal uncertainty has created a “reign of terror” where doctors fear for their licenses and freedom, leading many to abruptly taper or abandon chronic pain patients.
FOR MORE OPEN AND, READ THE LINK BELOW
FDA
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 induced nonmedical users to migrate to cheaper and more available heroin and now to mixtures of heroin and fentanyl. “
DEA
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).”
THE MYTH OF MORPHINE MILLIGRAM EQUIVALENT DAILY DOSE
As pointed out by authors such as Richard Lawhern, Josh Bloom, Jeff Singer, et al., in 2016, the CDC issued its Guidelines for Prescribing Opioids for Chronic Pain Patients. In publishing these guidelines, the CDC explicitly stated that they were meant to be voluntary and “not prescriptive,” stating that healthcare practitioners knew their patients’ unique clinical situation and should 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, which are categories of less probative evidence with a significant risk of inaccuracy. The guidelines thus came under significant criticism from many pain and addiction specialists for lacking a strong basis in the evidence.
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 scientific accuracy and integrity level from an agency entrusted to protect citizens’ health and welfare.
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.”
NABARUN DASGUPTA et al. DOES THE MATH
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 post-operative 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 to be “junk science.”
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 calculation for methadone, but the calculator could allow for potentially dangerous conversions. This is especially problematic because this calculator is intended to target nonspecialist general practitioners.
We expect a higher level of scientific accuracy and integrity from an agency entrusted with protecting citizens’ health and welfare in Medicaid patients over 12 months. The state reversed itself after receiving fierce criticism from pain management and addiction specialists.
FOR MORE OPEN AND, READ THE LINKS BELOW
THE MYTH OF MORPHINE MILLIGRAM EQUIVALENT DAILY DOSE
BY MARKS IBSEN MD
FROM THE STATE OF MONTANA
“Narcotics Analgesics medications are no different, as they, too, carry with them the dangers of any other types of drug medications when abused or taken in numbers beyond the prescribed doses or, for that matter, their FDA-approved therapeutic dose. Morphine Milligram Equivalent or MME is not a standard or guide used by the FDA for dosing. Specifically, it is well established because of genetic pleomorphism; the fact that humans metabolize opiates at variable rates through the CYP 450 system indicates that MME is irrelevant to physician practice and physiology.
In addition, it has no statutory basis at all. Once we have dosed a patient, we reevaluate to see the effect. This is the scientific model in action. Using MME to inform medical practice is more dangerous than a coin flip and makes a mockery of all of our Hippocratic Oaths.
Morphine Milligram Equivalent (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. However, it is based on zero science and has been debunked in numerous articles in the literature. Thus law enforcement has adopted a false equivalency to define (or redefine) the medical science of Narcotic prescribing, treatment, and dispensing.”
CONCLUSION
This again represents a profound set of intervening circumstances of which both substantial and controlling effects are serious displays of the preponderance of other substantial scientific factual grounds not previously presented.”
FOR NOW, YOU ARE WITHIN
THE NORMS
