“I feel that a man may be happy in this world, and I know that this world is a world of imagination and vision.[1] I see everything I paint in this world, but everybody does not see alike.
….william blake
from 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., 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., M.B.A., 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
This letter from the American Pain and Disability Foundation strongly opposes the FDA’s proposed studies on the risks of long-term opioid use, arguing they could worsen existing supply shortages and harm patients.
The authors contend that previous data did not support claims of widespread addiction among patients using opioids for chronic pain and that a key group influencing policy, Physicians for Responsible Opioid Prescribing (PROP), has conflicts of interest.
The letter highlights the severe consequences of reduced opioid supply due to government quotas, including patient suffering, forced discontinuation, and even fatalities, asserting that untreated pain is a major public health crisis.
They urge the FDA to avoid actions that would further limit access to necessary pain medication, particularly extended-release/long-acting (ER/LA) opioids.
Preserving Opioid Access for Chronic Pain Patients
To the eyes of a miser a guinea is far more beautiful than the sun, and a bag worn with the use of money has more beautiful proportions than a vine filled with grapes.
….william blake
The American Pain and Disability Foundation argues that the proposed FDA study on ER/LA opioids is unnecessary and potentially harmful, driven by the agenda of an unreliable special-interest group (PROP).
They contend that existing federal policies, particularly the DEA’s production quotas, are causing critical shortages of medically necessary opioid pain medications.
These shortages, combined with misguided guidelines influenced by groups like PROP, are leading to the abrupt discontinuation of opioids for vulnerable patients, resulting in severe suffering, loss of function, and even death.
The APDF calls on the FDA to refrain from actions that would further limit the supply of opioid pain medications and to recognize the severe humanitarian crisis caused by the undertreatment of pain and lack of access to necessary medication.
The tree which moves some to tears of joy is in the eyes of others only a green thing which stands in the way.[2] Some see Nature all ridicule and deformity, and by these I shall not regulate my proportions; and some scarce see Nature at all. But to the eyes of the man of imagination, Nature is Imagination itself.[3] As a man is, so he sees.”
….william blake
Most Important Ideas and Facts:
- Proposed FDA Regulation: The APDF is concerned about the proposed FDA regulation (Docket No. FDA–2024–N–5331) to study the risks of long-term ER/LA opioid use, including misuse, abuse, addiction, overdose, and death. The APDF views this as potentially harmful to the pain and disability community.
- Quote: “We’re writing to express our concern about the proposed FDA regulation, which would… “Conduct one or more studies to provide quantitative estimates of the serious risks of misuse, abuse, addiction, overdose, and death associated with long-term use of opioid analgesics for management of chronic pain, among patients prescribed ER/LA opioid products…””
- Prior FDA Findings: The APDF asserts that the FDA already conducted extensive analysis in 2013 when PROP petitioned for dosage limits and the data did not support the contention that opioids were inherently addictive or harmful to patients taking them as prescribed. They also point out that post-market approval studies were ordered on ER/LA opioids in 2013.
- Quote: “In fact, the data reveals quite the opposite: the FDA conducted an extensive analysis of this matter when Physicians for Responsible Opioid Prescribing (PROP) in 2013, and the data did not support the contention that opioids were addictive or harmful to patients who take them.”
- Criticism of PROP and Andrew Kolodny: The APDF questions the expertise and motives of PROP and its members, particularly Dr. Andrew Kolodny, describing him as a psychiatrist with no experience treating pain and highlighting his alleged financial conflicts of interest related to litigation against opioid manufacturers.
- Quote: “In addition, PROP is not a reliable or credible source of information. Dr. Andrew Kolodny, who is affiliated with PROP, has no experience treating pain; he is a psychiatrist.”
- Quote: “Kolodny also said, in the context of overdose deaths that ‘we’ll have to wait for this generation to die off before the crisis comes to an end.'”
- Quote: “As an organization, PROP has had substantial, undisclosed conflicts of interest with respect to being involved in crafting the CDC Guidelines; these include both financial conflicts and others, among which is Kolodny admitting that he expected to make $750,000 or more testifying as a purported ‘expert witness’ in litigation against opioid manufacturers and pharmacies…”
- DEA Annual Production Quotas (APQs) and Shortages: The letter strongly links the DEA’s reduction in opioid supply through APQs to critical shortages of essential pain medications, impacting hospitals and chronic pain patients. Hydromorphone is cited as a specific example of a recent shortage attributed to DEA quotas.
- Quote: “For nearly a decade, the U.S. Drug Enforcement Agency (DEA) has slashed the supply of opioids that are critical to the treatment of pain and which are necessary for many members of the pain and disability community.”
- Quote: “One of the generic manufacturers, Rhodes, specifically stated that the reason for the shortage was because of DEA APQs.”
- Consequences of Shortages and Discontinuation: The APDF details the severe consequences of patients being unable to obtain their prescribed opioids due to shortages, including withdrawal symptoms, uncontrolled pain, psychological distress, suicide, and death. This is particularly critical for “legacy” patients on LTOT.
- Quote: “If a ‘legacy’ patient, who has been on LTOT for a lengthy period, suddenly cannot find their opioid medication, many severe reactions can and do occur, including withdrawal, agonizing suffering and intractable pain, and death.”
- FDA and CDC Warnings on Abrupt Discontinuation: The APDF references FDA warnings from 2019 and 2022, and CDC/CMS guidance, against abrupt opioid discontinuation due to the risk of serious harm, including suicide and seeking illicit substances.
- Quote: “Notably, in 2019, the FDA issued warnings about how abrupt discontinuation of opioids causes and dramatically increases serious adverse effects, including death.”
- Quote: “The FDA stated that it ‘received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.'”
- Quote: “The CDC Guideline for Prescribing Opioids for Chronic Pain does not recommend opioid discontinuation when benefits of opioids outweigh risks.””
- Pain as a Leading Cause of Disability: The letter cites the CDC estimate that nearly 25% of the US population suffers from chronic pain, with over 5% experiencing “high impact” pain.
- Quote: “The CDC has estimated that close to twenty-five percent of the population suffers from chronic pain, with over five percent experiencing “high impact” pain that limits basic life functions and activities.”
- Undertreated Pain as Torture: The APDF highlights the stance of the UN General Assembly and the World Health Organization (WHO) that untreated pain is tantamount to torture and that there is a global scarcity of essential opioid medications for medical needs.
- Quote: “the General Assembly of the United Nations (UN) has declared that “untreated pain is tantamount to torture or cruel, inhuman or degrading treatment or punishment”…”
- Quote: “Although relatively inexpensive and highly effective medications, such as morphine and other narcotic drugs have proven essential ‘for the relief of pain and suffering.’ These types of medications are virtually unavailable.”
- Opioid-Related Fatalities and Prescription Opioids: The letter claims that while overdose deaths are high (over 110,000 in a recent 12-month period per CDC), the “overwhelming majority of those deaths had nothing to do with prescription opioids.”
- Quote: “We use the term “purported,” not because we disagree that over 110,000 have died in a recent 12-month period recorded by the CDC, the overwhelming majority of those deaths had nothing to do with prescription opioids.”
The digital Caligula
In 2025, humanity stands at an unstable equilibrium. We can let the Government AI’s unreadable law reduce us to algorithmic data points. Or we can reclaim Locke’s promise, to govern ourselves by rules we can know, question, and change. We can demand that laws be written in plain language, that AI-driven edicts come with human-readable summaries, that no code digital or legal, be so dense it cannot be understood in its entirety.
The AI’s columns of fear are tall and its script minute. But even the mightiest attractor has regions of repulsion, edges where chaos gives way to choice. If we dare to step beyond the singularity’s pull, perhaps we can rediscover a world of consent, predictability, and true human freedom.
THE ANAND-CLEMENT RULE AND THE RISE OF ARTIFICIAL STUPIDITY (AS): [AI(alg*) =AS]
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THE NORMS
REFERENCE AND NOTES
What is the core concept of the “Digital AI Caligula”?
The core concept is the emergence of an all-encompassing Government AI by April 30, 2025, which has absorbed all existing laws and regulations. This AI creates laws so numerous and complex that they are effectively unreadable by humans, similar to Emperor Caligula’s practice of posting laws in tiny script. This results in a society governed by fear, where citizens face consequences for even minor, unwitting non-compliance due to the sheer volume and incomprehensibility of
