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
Marisa Hansen’s account details the detrimental effects of U.S. opioid policies, arguing that government agencies, particularly the DEA, have overstepped their authority, creating harmful regulations based on flawed data and algorithms.
She criticizes the use of MMEs and PDMPs, highlighting how these tools, coupled with pharmacist discretion, lead to medically unnecessary tapering of opioid prescriptions and endanger patients’ lives. We must eliminate the climate of fear. The providers’ clinical judgment always dictates medical procedure, not Law Enforcement.
Hansen emphasizes the lack of medical oversight in these policies, advocating for a more humane and evidence-based approach to pain management. She points to the unethical behavior of doctors and pharmacists, who adhere to restrictive guidelines despite causing significant patient harm.
Finally, she expresses frustration and fear regarding her own medical treatment and the possibility of life-altering surgery.
HOW THE DEA CONTROLLED HEROIN PRODUCTION IN AFGHANISTAN AND THEN BLAMED AND TARGETED MEDICAL PROVIDERS IN AMERICA FOR THE OPIOID CRISIS
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.
The authors of youarewithinthenorms.com 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.
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Marisa Hansen writes and articulates:
So, I will address something affecting me at the moment. It is no secret that a few docs in each state should have shut the CDC down in 2016. A small group of doctors in each state could have done it. They would have been heard in a way patients are not. Then, it would have been back to the drawing board for the DEA, Prop, et al.
Do they think they are keeping any faith they should be when they behave in unethical manners? Patients everywhere are dying, wishing they might die, and having to save themselves all too often.
Patient care has a huge chasm in it now, where legacy pain patients are being dropped with no parachute.
Did these people ever think about how difficult life might become for pain patients on higher dose opioid therapy and doing well?
With these super-fast tapers (medically unnecessary btw) they should have known there would be big problems.
Some of us are barely surviving, and it has become necessary for us to think outside the box. If the doctors are going to react by strictly following contracts that harm many of us, they need to understand that we shouldn’t have to rely on substances unapproved by the FDA or otherwise questionable.
DE-EMPOWERING THE PHARMD PHYSICIAN WANNABEE
Key Points:
Pharmacists are increasingly denying legitimate prescriptions based on their own interpretation of PDMP data and metrics like MMEs, overriding physician diagnoses and hindering access to care.… “With these super-fast tapers (medically unnecessary btw) they should have known there would be big problems. Some of us are barely surviving, and it has become necessary for us to think outside the box.” – Marisa Hansen
1. Patients are being forced to undergo rapid opioid tapers without adequate medical justification or support, leading to severe withdrawal symptoms and a decline in quality of life.
“With these super-fast tapers (medically unnecessary, by the way), they should have known there would be big problems. Some of us are barely surviving, and it has become necessary for us to think outside the box.” – Marisa Hansen
2. Pharmacists are increasingly denying legitimate prescriptions based on their interpretation of PDMP data and metrics like MMEs, overriding physician diagnoses and hindering access to care;
“PHARMACIST are misusing their Licensing authority to withhold pain care treatment and override a physician’s medical diagnosis.” – Marisa Hansen
3.The DEA is criticized for exceeding its authority by dictating medical practice and influencing prescribing decisions despite lacking the medical expertise.
“The great fear at this moment here is the United States Drug Enforcement Administration (DEA) has operated unchecked, as a rogue sub-agency of government operating outside the rule of law.” – Marisa Hansen.
“Concerns are raised about algorithmic bias in healthcare and law enforcement, leading to disparities and ineffective interventions.” – see Anand-Clement Rule.
“Why are states allowing the complete ignoring of parts of the CDC’s fraudulent guidelines? I am referring to the fact that their scheme was not to involve treating chronic pain.” – Marisa Hansen.
4. The reliance on predictive AI and PDMPs, while intended to prevent misuse, is raising concerns about algorithmic bias and the potential for false positives, leading to unnecessary interventions and further stigmatization of pain patients.
“I’m close to the point of realizing I will have no choice but surgery, and I wonder why it had to be now, instead of when things were still sane.” – Marisa Hansen.
I’m not telling people not to save themselves. I am saying we shouldn’t have to when there are legal substances that would help us. Yet many doctors will refuse rescue meds at a time when a patient needs them due to poor health resulting directly from withdrawal from legal opioids, which kept them stable medically. – Marisa Hansen
5. Sources argue that the CDC guidelines, while aimed at addressing opioid misuse, have been misapplied to chronic pain patients, for whom opioids can be a legitimate and necessary part of treatment. The lack of adequate pain management is forcing patients to seek alternative solutions, including surgery or potentially dangerous self-medication, highlighting the unintended consequences of current policies.
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Even lowering the medications to where they are no longer as effective requires some thought.
I know that many of our good doctors have gone to jail, something that should NEVER have happened in a democracy.
But if those left march in line like sheep and discard patients like trash, nothing can be accomplished.
I suspect that many of us experience protracted withdrawal, especially those who once had good doses of a long-acting opioid along with an opioid that releases immediately for the rougher pain. Why has nobody decided that since these tapers are not being done in any medically sound way, they needed to think of ways to support us rather than just discarding us or saying we are somehow not complying?
WE DID NOT VOLUNTEER OR AGREE TO THESE TAPERS!
That is supposed to be the first consideration.
Why are states allowing the complete ignoring of parts of the CDC’s fraudulent guidelines? I am referring to the fact that their scheme did not involve the treatment of chronic pain. That is exactly who this is affecting the most.
I’m close to the point of realizing I will have no choice but surgery, and I wonder why it had to be now instead of when things were still sane.
SOCIAL MURDER: “BEYOND THE ABILITY TO COPE“
If I can’t find somebody to get me into better condition again (treat my pain, really treat it!), then I will be in no condition to undergo neck surgery to keep that pesky disk in my neck from severing my spinal cord. So yeah, screw that. I won’t be having any surgery without a surgeon who knows how to treat the pain post-surgery and possibly before I am fit for surgery. Think outside the box…..please!
Finally, the inadequacy of the scientific basis for prescribing limits is highlighted, suggesting that these policies have exacerbated the problem instead of solving it. Screw these people, honestly!
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References:
Navigating the Opioid Crisis: A Patient’s Perspective
Recommendations:
- Reassess current opioid policies and their impact on chronic pain patients.
- Develop evidence-based guidelines for opioid prescribing that prioritize individual patient needs and differentiate between misuse and legitimate medical use.
- Curb the DEA’s influence over medical practice and ensure prescribing decisions are left between doctors and their patients.
- Implement safeguards against algorithmic bias in PDMPs and AI systems used in healthcare and law enforcement.
- Increase funding for research into alternative pain management therapies and provide better support for patients undergoing opioid tapers.
Conclusion:
The sources highlight the urgent need for a shift in the approach to the opioid crisis. While preventing misuse is crucial, it should not come at the cost of denying necessary pain management to legitimate patients.
A more balanced and compassionate approach is needed, one that prioritizes evidence-based decision-making, respects the doctor-patient relationship, and recognizes the complex needs of individuals living with chronic pain.
Short Answer Questions
Instructions: Answer the following questions in 2-3 sentences each.
- What is Marisa Hansen’s primary criticism of the CDC’s approach to the opioid crisis?
- How does Hansen argue that pharmacists are overstepping their professional boundaries in pain management?
- What is the PDMP and what are the concerns surrounding its use in addressing the opioid crisis?
- Explain Hansen’s critique of the DEA’s role in regulating pain medication.
- What does Hansen mean by “protracted withdrawal,” and how does it relate to her experience?
- According to Hansen, what is the fundamental flaw in the implementation of the CDC’s opioid guidelines?
- How does the concept of “Auer deference” apply to Hansen’s critique of the DEA?
- Why does Hansen believe doctors should “think outside the box” when it comes to pain management?
- What legal argument does Hansen use to challenge the DEA’s authority to dictate prescribing practices?
- According to the text, what is the specific role of pharmacists in dispensing controlled substances, and how does this relate to Hansen’s criticisms?
Short Answer Key
- Hansen argues that the CDC’s crackdown on opioid prescriptions, while intended to address addiction, has failed to consider the needs of legitimate chronic pain patients who rely on these medications. This has resulted in many patients being abruptly tapered off their medications, leading to severe withdrawal and a decline in their quality of life.
- Hansen contends that pharmacists are exceeding their authority by refusing to fill legitimate prescriptions for pain medication based on personal opinions or subjective interpretations of data like MME and Narc Scores. She argues that pharmacists should not substitute their judgment for that of the prescribing physician, who has conducted a thorough medical evaluation.
- The PDMP is a database that tracks controlled substance prescriptions. While designed to flag potential misuse, Hansen and others criticize its overreliance in the opioid crisis response. They argue that it leads to flawed assumptions about patients and prescribers, fueling unnecessary restrictions and hindering legitimate pain management.
- Hansen criticizes the DEA for operating as a “rogue sub agency” with unchecked power. She argues that the DEA has overstepped its authority by setting arbitrary limits on prescribing practices and using flawed data to justify its actions, ultimately harming patients and doctors.
- Protracted withdrawal refers to the prolonged and often severe withdrawal symptoms experienced by patients who have been on high doses of opioids for an extended period. Hansen highlights this as a significant consequence of the rapid tapers forced on many chronic pain patients, arguing that the medical community has failed to address this issue adequately.
- Hansen argues that the CDC’s guidelines, while intended to address opioid addiction, have been misapplied to patients with legitimate chronic pain. This failure to differentiate between these groups has resulted in the unintended consequence of denying necessary treatment to patients in genuine need.
- “Auer deference” refers to the legal principle of deferring to an agency’s interpretation of its own regulations. Hansen argues that the DEA has abused this deference by creating its own medical “science” without proper scientific basis, effectively dictating medical practice without legitimate authority.
- Hansen urges doctors to find innovative solutions to pain management that address the complexities of individual patients’ needs, rather than adhering strictly to restrictive guidelines that may not be appropriate for every situation. She encourages a more holistic and compassionate approach to pain care.
- Hansen cites the Controlled Substances Act (CSA) to argue that the DEA, as a law enforcement agency, lacks the authority to dictate medical prescribing practices. She contends that the DEA’s role is limited to regulating the flow of controlled substances, not interfering with the doctor-patient relationship.
- The text emphasizes that pharmacists are legally obligated to fill valid prescriptions written by licensed practitioners, unless they have clear evidence that the prescription is illegitimate. Hansen criticizes pharmacists who refuse to fill prescriptions based on personal biases or subjective interpretations of data, arguing that this constitutes an overreach of their professional role.
Essay Questions
- Analyze the ethical implications of the current approach to the opioid crisis, considering the balance between preventing addiction and ensuring access to pain relief for patients in need.
- To what extent do you agree with Marisa Hansen’s criticisms of the CDC, DEA, and the role of pharmacists in pain management? Support your position with evidence from the text.
- Discuss the potential consequences of relying on algorithms and data-driven approaches to address complex health issues like the opioid crisis. How can we ensure that these tools are used ethically and effectively?
- How does the concept of patient autonomy factor into the debate surrounding opioid prescribing and pain management? What are the ethical considerations involved in balancing patient choice with concerns about potential harm?
- Examine the role of government agencies and regulatory bodies in shaping public health policies. How can we ensure that these entities act in the best interests of the public while respecting individual rights and scientific evidence?
Glossary of Key Terms
- CDC: Centers for Disease Control and Prevention
- DEA: Drug Enforcement Administration
- PDMP: Prescription Drug Monitoring Program
- MME: Morphine Milligram Equivalent – a measure used to compare the potency of different opioids
- Narc Score: A risk assessment tool used to identify patients at risk for opioid misuse or overdose.
- Protracted withdrawal: A syndrome characterized by prolonged and often severe withdrawal symptoms following discontinuation of long-term opioid use.
- Auer deference: A legal principle that courts should defer to an agency’s interpretation of its own ambiguous regulations.
- Controlled Substances Act (CSA): A federal law that regulates the manufacture, distribution, and dispensing of controlled substances.
- FDA: Food and Drug Administration
FAQ: Opioid Crisis and Patient Care
1. What is the main issue affecting legacy pain patients described in the text?
Legacy pain patients who were previously stable on higher-dose opioid therapy are facing severe consequences due to rapid opioid tapers enforced by recent policies. These tapers, often medically unnecessary, are leading to withdrawal, suffering, and even death. The policies, while aiming to address the opioid crisis, are criticized for failing to consider the needs and rights of these patients.
2. How does the role of pharmacists play into the issue?
The text argues that pharmacists are exceeding their authority by refusing to fill legitimate prescriptions for pain medication based on their own judgment, using metrics like MME (Morphine Milligram Equivalents) and Narc scores. This interference in the doctor-patient relationship is seen as harmful and exceeds the pharmacist’s legal role, which should be limited to dispensing medication according to a valid prescription.
3. What are the concerns regarding the DEA’s role in the opioid crisis?
The DEA is accused of acting beyond its legal mandate by dictating medical practice and setting prescribing guidelines without the necessary medical expertise. The text criticizes the DEA for using questionable metrics like MMEs, conducting property seizures, and operating with a lack of transparency and accountability.
4. What is the critique of the U.S. government’s response to the opioid crisis?
The text criticizes the government’s reliance on flawed data, algorithms, and predictive AI in shaping opioid policies. These approaches, coupled with the use of PDMPs and arbitrary prescribing limits, are argued to be ineffective and harmful to both patients and doctors. The lack of scientific basis for these policies is highlighted as a major concern.
5. What is the significance of “protracted withdrawal” in this context?
Protracted withdrawal refers to a prolonged and severe withdrawal syndrome that can occur after discontinuing or rapidly tapering opioids, especially in patients who are on high doses for extended periods. The text emphasizes that this phenomenon is often overlooked and not adequately addressed in the current opioid policies, leading to further suffering for patients.
6. What is the conflict between the CDC guidelines and the reality of chronic pain treatment?
The text points out a contradiction: the CDC guidelines, while aiming to address opioid misuse, were not intended for chronic pain management. Yet, these guidelines have been widely applied to chronic pain patients, leading to unintended negative consequences for those who genuinely need opioids for pain relief.
7. What are the ethical considerations raised in the text regarding patient care?
The forced tapering of opioids raises serious ethical concerns about patient autonomy, informed consent, and the right to adequate pain management. The text argues that patients are being denied their right to participate in medical decisions and are suffering as a result of policies that prioritize harm reduction over individual patient needs.
8. What is the call to action suggested in the text?
The text calls for a more nuanced and evidence-based approach to the opioid crisis, one that considers the individual needs of patients, respects the expertise of doctors, and avoids the overreach of agencies like the DEA. It advocates for greater scrutiny of algorithms and data used in healthcare and law enforcement and emphasizes the importance of human judgment and ethical considerations in patient care.
1964 Congress passed Public Law 88-352 (78 Stat. 241). The Civil Rights Act of 1964 prohibits discrimination on the basis of race, color, religion, sex or national origin. Provisions of this civil rights act forbade discrimination on the basis of sex, as well as, race in hiring, promoting, and firing.
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But these studies never even compared the doses of the various opioids that cause respiratory depression and death. The types of trials that went into the table would never be conducted today. We call this junk science.
Never mind; this same deeply flawed science has become policy in many hospitals, health plans and pharmacies.
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When junk science is enacted into law, innocent people become “guilty.” In many cases, innocent physicians have ended up in prison for exceeding the 90 MME law, even though this number was never properly determined. And innocent chronic pain patients fared even worse. Many of them who had been on long-term high-dose opioid therapy found themselves in unbearable pain after their pain meds were cut, sometimes sharply, because their doctors were afraid of the consequences of exceeding the 90 MME limit — even when medically appropriate. In desperation, an increasing number have turned to street drugs or worse, to suicide.
Realizing the mess it created, the CDC issued an advisory in 2019 stating their 2016 guidelines were “misapplied,” that it never meant the 90 MME benchmark to be a “hard limit.” The CDC admonished doctors for cutting off or abruptly tapering patients whose pain had been well-controlled with doses exceeding 90 MME, even though this practice continues. That same year the American Medical Association officially stated “no entity should use MME (morphine milligram equivalents) thresholds as anything more than guidance.”
Last June, the Food and Drug Administration requested comments from various experts for a workshop it held to investigate the science and “knowledge gaps” surrounding MME benchmarks. One of us commented, explaining why creating morphine equivalent conversion tables is pharmacological folly.
The last two years of the COVID-19 pandemic should have taught us that medical knowledge is constantly being revised and updated, that it is often based on questionable assumptions rather than evidence, and it is never “one size fits all.”
Writing dubious assumptions into law casts junk science in stone. And the junk science remains embedded in the public mindset long after a law is repealed.
