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WITHOUT CONSENT – AMERICAN MEDICAL PRACTICE, NOT BIG PHARMA, FUELED THE OPIOID CRISIS

Decades into an increasingly lethal opioid crisis, America’s medical professionals only began protecting patient rights and health after forced to at risk of legal violation for failure to meet longstanding, established ethical requirements for any medical intervention – by providing informed consent

by Clark Miller

Published October 27, 2021

A New Jersey law requiring conversations between prescribers and patients to discuss risks of addiction before an opioid-based pain reliever is prescribed, resulted in a more than fourfold increase in the percentage of doctors warning patients about the risks of addiction and a significant drop in patients started on opioids. The study was conducted by Dr. Andrew Kolodny, medical director of opioid policy research at Brandeis University’s Heller School for Social Policy and Management. Dr. Kolodny presented the findings today at the Rx Drug Abuse & Heroin Summit, which was held virtually, rather than at its original Nashville location.

. . .

The Patient Opioid Notification Act requires that medical practitioners discuss the addictive potential of opioid-based painkillers with their patients – and parents of minor patients – as well as discuss, when appropriate, safer non-opioid pain relief alternatives.

That’s less than half the story.

All medical practitioners were already required – by the most fundamental of their ethical duties and standards of practice – to provide explanations of risks, benefits, and alternatives for any recommended or provided medical procedure or prescription. They just weren’t doing that over the decades that their opioid prescribing was leading to dependence and death for more and more Americans. It would take enactment of new state law and risk of violation to get them to follow their medical training and existing ethical standards protecting patients’ health and rights. 

Consent without being fully informed of real risks of a medical intervention – including risk of illness and death – is not consent, it’s reckless neglect, or deception. 

The Patient Opioid Notification Act requires that medical practitioners discuss the addictive potential of opioid-based painkillers with their patients – and parents of minor patients – as well as discuss, when appropriate, safer non-opioid pain relief alternatives.

. . . 

Prior to enactment, only 18% of the participants warned patients about the risk of opioid addiction when prescribing opioids. After enactment, 95% routinely warned patients about the risk of addiction.

. . . 

Dr. Andrew Kolodny said, “These findings show that very few opioid prescribers were warning patients about the risk of addiction before New Jersey required them to do so.”

From an earlier post

Not a single opioid pill provided to living or dead Americans

was supplied  to them by a member of the Sackler family, from Purdue Pharmaceuticals, from any employee of a pharmaceutical or opioid manufacturing company.

Apart from anomalous exceptions, like Sam Quinones’ unflinchingly “True Tale” in Dreamland – and a new piece in Journalist’s Resource, below – you wouldn’t get that from the necessary fabricated distortions and media focus on Big Pharma as criminal accomplice in the epidemic. As if those representatives and executives themselves were distributing the addictive Schedule II opioids, against evidence – all longstanding lines of relevant evidence – predicting harm, as if the pharmaceutical reps and execs were in the exam rooms, coercing MDs and other licensed medical providers, or forging their signatures on the prescriptions.

As if those licensed medical providers, over the course of an American medical education, would not have necessarily become aware of the evidence and their clinical and ethical obligations to practice accordingly, based on the longstanding indications against the runaway provision of those Schedule II opioids: the potential for hyperalgesia; the addictive potential of opioids; the lack of evidence for effectiveness; the psychogenic nature of common chronic pain; and the effective, durable, indicated use of cognitive behavioral therapy (CBT) for common chronic pain.

All lines of evidence that were established prior to generation of the opioid crisis and would have been part of any legitimate medical training, training that would have – one presumes – been taken as more compelling than the assurances of pharmaceutical representatives. Or not.

Sam Quinones, Chris McGreal in American Overdose, and some others have outlined the sordid confluence of forces –

deception, fabrication, submission to pressure from patients and medical organizations, and failed responsibility to vulnerable, trusting Americans – driving generation of the lethal opioid epidemic: a remarkable abdication of competence, integrity and ethical behavior by players including big pharma, America’s top medical, oversight, and research institutions, and the medical profession, with mass media along for the ride.

As McGreal describes in American Overdose, the clinical environment in medical practice settings became coercive and toxic – a collusion of patients trained by decades of programming to seek a pill for every distress including opioids, supported by the medical/hospital/insurance industrial complex to report doctors who would resist providing opioids inappropriately and threaten them with complaints and action by professional and licensing boards.

McGreal talked to Dr. Charles Lucas, a surgeon in Detroit who resisted growing pressure to overprescribe opioids, ended up being subject to a complaint and summoned before a hospital ethics committee for failure to provide adequate pain treatment.

(from American Overdose pp 88 – 89)

The case was dropped, but it was not an isolated incident. Luca has worked closely with another surgeon, Anna Ledgerwood, since 1972. She too was hauled before the ethics committee on more than one occasion on the same charge. One of the investigations, for alleged inadequate pain management after a hernia operation, went all the way up to the state medical board. It cleared Ledgerwood, but Lucas said more junior surgeons buckled to the pressure to administer opioids just to stay out of trouble. “If they will give me a hard time, then they will surely give a young resident a harder time,” he said. “I tend to be a fighter. That’s my nature. But somebody who just wants to take care of patients, they want to be a professional physician, they don’t want to put up with all this crap; they’re intimidated. They’re also frustrated by it. The medical community knows that too many pain medicines are being written. Doctors talk about it among themselves. They’re not in a position to challenge the system. But they know.”

Lucas regarded the new pain orthodoxy as a growing tyranny, and he thought it was killing patients.

Of course they knew. Or should have, or should not be practicing medicine.

But the forces driving runaway, medically inappropriate dispensing of opioids were not knowledge, competence, integrity or professional courage. There were other forces at play.

It is much less discomforting – especially for America’s journalism institutions instrumental in helping to fabricate out of nothing a bogus scientific rationale for runaway use of opioids against all evidence – to focus on Big Pharma (another example of the unfortunate excesses of corporate greed) as the reason for the lethal crisis, than to accurately indict America’s most trusted institutions including the impotent and enabling watchdog press that helped to create the needed fabrications. The more attention diverted to Big Pharma, the less on the necessary roles of media, the medical profession, research and oversight institutions. Corporate greed is a given; incompetence and betrayal by the core democratic and public health institutions trusted to protect American well-being and lives must be disguised, distracted away from.

And just as blanket Medical-Media messaging has constructed pill manufacturers, somehow, as responsible for the runaway dispensing – against all longstanding lines of evidence – of addictive opioids for the non-medical condition of chronic pain, generating the increasingly lethal opioid crisis – the same collaborating forces successfully fabricate a STORY of street fentanyl as explaining continuously mounting opioid-related deaths, those deaths correlated with increasing provision of the Medical-Media “treatment”.

It’s been working. From a recent post – 

The Sacklers weren’t the gatekeepers. No matter how nice the meals and generous the bribes, any competent medical professional using clinical and ethical judgement could have declined to prescribe for common chronic pain, based on the evidence that was available to anyone interested in verifying Purdue’s claims, evidence they would have to have been exposed to in medical school.

This evidence

There has never existed, not at any time, a body of research evidence to provide even preliminary support for the safe practice of prescribing opioid medications for chronic painor with the expectation of durable benefit for chronic pain.

See, for example:

Chou, R et al.  2015. The Effectiveness and Risks of Long-Term Opioid Therapy for Chronic Pain: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop.  Ann Intern Med. 162:276–286.

From the beginning, well prior to explosion of runaway, widespread use of prescription opioids for centralized chronic pain, all lines of evidence pointed against and contraindicated their use. There was never support for their safe, effective use due to longstanding:

I)  lack of research evidence for effectiveness long-term

 II) evidence for the potential for hyperalgesia

Hyperalgesia – increased sensitivity to pain – induced by use of opioids (OIH) is known and described extensively, beginning late 19th century.

See, for example:

Lee, Marion et al. 2011. A Comprehensive Review of Opioid-Induced Hyperalgesia Pain. Physician 14:145-161

III) established addictive potential of opioids

The high abuse and addictive potential of opioids including those prescribed for chronic pain is long-established (1), generating a history of statutory control (2) e.g. Harrison Act (1914); Boggs Act (1951) and others.

The 1970 Controlled Substances Act (3) lists opioid drugs commonly prescribed for chronic pain as Schedule II Substances (4), highly controlled as “drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence”

IV) understanding of the psychogenic nature of centralized chronic pain

Chronic pain (5) – long-lasting pain that is non-cancer, not caused by acute tissue damage or inflammation – is established by decades and multiple lines of evidence and research as psychogenic (generated by mental/emotional states) in nature and with indicated treatments that are psychological (behavioral health therapies), not biomedical.

See, for example:

Dersh, Jeffery et al. 2002. Chronic Pain and Psychopathology: Research Findings and Theoretical Considerations. Psychosomatic Medicine:  64: 773-786

[Numbers 1 – 6 in parentheses in boxes link to online sources listed at bottom of post.] 

V) evidence for cognitive behavioral therapies (CBT) as the indicated treatment for chronic pain

Extensive and longstanding research (6) establishes that effective and durable CBT treatments for centralized chronic pain (long-lasting pain that is non-cancer, not due to acute tissue damage or inflammation) are psychological (behavioral health therapies), not biomedical, fundamentally targeting underlying beliefs and mood states associated with pain. 

See, for example:

Cherkin, DC et al. 2017. Two-Year Follow-up of a Randomized Clinical Trial of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care for Chronic Low Back Pain. JAMA. 317(6):642–644. doi:10.1001/jama.2016.17814

For a critical review of the current evidence: Doxa Deconstructed:  Chronic Pain is Not What You Think

All relevant lines of evidence existed decades prior to emergence of runaway misuse of opioids and the current crisis.

(from American Overdose pp 88 – 89)

“The medical community knows that too many pain medicines are being written. Doctors talk about it among themselves. They’re not in a position to challenge the system. But they know.”

Lucas regarded the new pain orthodoxy as a growing tyranny, and he thought it was killing patients.

That lack of courage to challenge the system and practice ethically is becoming more and more costly, while American Medicine doubles down on its worsening opioid crisis. 

Why A Critical Discourse?

Because an uncontrolled epidemic of desperate and deadly use of pain-numbing opioid drugs is just the most visible of America’s lethal crises of drug misuse, suicide, depression, of obesity and sickness, of social illness. Because the matrix of health experts and institutions constructed and identified by mass media as trusted authorities – publicly funded and entrusted to protect public health – instead collude to fabricate false assurances like those that created an opioid crisis, while promising medical cures that never come and can never come, while epidemics worsen. Because the “journalists” responsible for protecting public well-being have failed to fight for truth, traded that duty away for their careers, their abdication and cowardice rewarded daily in corporate news offices, attempts to expose that failure and their fabrications punished.

Open, critical examination, exposure, and deconstruction of their lethal matrix of fabrications is a matter of survival, is cure for mass illness and crisis, demands of us a critical discourse.

Crisis is a necessary condition for a questioning of doxa, but is not in itself a sufficient condition for the production of a critical discourse.

Pierre Bourdieu - Outline of a Theory of Practice 1972

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