Quality Assurance Issues: lackluster protections for product quality and safety. 14
Liability Protections: Blanket immunity from liability for harms and deaths attributed to pharmaceutical products threatens the life and liberty of all Americans.
Healthcare Access: Limitations like CON laws affecting rural areas.
Pharmaceutical Industry Reform Act (PATA-Subsection 07)Agency Reforms: Eliminate or Majorly Reform Foundations: Like CDC; Cooling-off Period: 10 years for officials moving to industry; NIOSH Reforms: Focus on public health, grant NIOSH independence.
Pharmaceutical Ethical Practices Act (PATA-Subsection 08)Ethical Considerations: Informed Consent: Emphasize true consent. 8; Duty to Inform: Accurate health information. 9; Bodily Autonomy: Protect against coercive mandates. 10; Justice: Equitable health policy impact. 11 Remediation for harms endured both by censorship and mistreatment of the adversely affected whether injured directly or to aid the families affected by the death of their loved ones due to specific pharmaceutical products.
Challenges
Lobbying: Anticipated industry pushback.
Regulatory Balance: Protecting consumers while supporting innovation.
If you disagree with this proposal or have reservations, explain your reasoning and what should be changed where, and why. This will help to refine the proposal for a greater consensus.
More on Regulatory Capture and Fundamental Ethics with Regard to Health Care
Regulatory Capture:
How Regulatory Bodies are Influenced:
Financial Dependency: Agencies like the FDA receive a significant portion of their budget from user fees paid by the industries they regulate. This financial relationship can subtly encourage regulators to be more accommodating to those industries to ensure continued revenue.
Revolving Door Phenomenon:
Post-Employment Opportunities: Regulators often move into high-paying jobs within the industries they once oversaw after their government service, creating an incentive to keep industry interests in mind during their tenure.
Future Employment Considerations: The knowledge that lucrative industry jobs might be available can influence current regulatory decisions.
Lobbying and Influence Campaigns:
Direct Lobbying: Companies spend heavily on lobbying efforts to influence legislation and regulatory decisions directly.
Indirect Influence through Political Contributions: Funding political campaigns can lead to the appointment of sympathetic individuals to regulatory bodies or influence policy through elected officials.
Industry-Friendly Policies:
Fast-Track Approvals: Programs designed to speed up the drug approval process can sometimes lead to less rigorous review under pressure from the industry for quicker market entry.
Advisory Committees: The inclusion of industry experts in advisory capacities can bias discussions towards industry perspectives.
Censorship and Narrative Control:
Influence Over Information: By funding research or through direct influence on media, industries can shape public and regulatory perceptions, reducing scrutiny or criticism.
Effective Conflict of Interest Policies:
Cooling-Off Periods:
Extended Duration: Increase the time former regulators must wait before they can work in the industry they regulated. A longer period (e.g., 5 years or more) could significantly reduce the incentive for regulatory favoritism.
Stricter Employment Restrictions:
Lifetime Bans on Certain Sectors: For key decision-makers, prohibiting them from ever working in industries related to their regulatory oversight.
Public Service Commitment: Require senior officials to commit to a period of public service or education post-tenure, where they cannot engage in for-profit activities related to their regulatory experience.
Transparency and Disclosure:
Real-Time Disclosure: Implement systems where all meetings, communications, and gifts between industry representatives and regulators are logged and made publicly accessible in real-time.
Financial Disclosure: Require detailed annual disclosures of all financial relationships, including those of family members, with regulated industries.
Funding Reform:
Increased Public Funding: Eliminate the reliance on industry fees by increasing government funding. This could involve lobbying for legislative changes to secure a more independent financial base for regulatory agencies.
Independent Financial Oversight: Create an independent body to manage regulatory budgets, ensuring funds are allocated in a manner that prioritizes public interest over industry needs.
Advisory Committee Reform:
Balanced Representation: Ensure advisory panels include a broad range of stakeholders, not just industry representatives, with a focus on public health experts and consumer advocates.
Conflict of Interest Screening: Implement rigorous vetting processes for committee members to exclude those with direct industry ties or significant financial interests in the outcomes of regulatory decisions.
Whistleblower Protections:
Strong Legal Safeguards: Enhance protections for whistleblowers within regulatory agencies who report undue industry influence or unethical practices.
Cultural Shift within Agencies:
Training and Awareness: Regular training on ethics, conflict of interest, and the importance of public health over corporate interest.
Ethics Enforcement: Establish or empower an independent ethics board within the agency with real authority to investigate and sanction violations.
Public Involvement and Oversight:
Citizen Advisory Panels: Create panels with ordinary citizens to review and comment on agency operations, increasing public accountability.
Open Forums: Regular public forums where regulatory decisions can be openly discussed, challenging the narrative control by the industry.
These policies aim to create a regulatory environment where the focus remains on public health and safety, minimizing the influence of corporate profit motives. However, implementing such reforms would likely face resistance from the industries involved and would require significant political will and public support.
Key takeaways in light of the spread of Sars-Cov-2 and the subsequent response:
Substandard Reporting Systems:
Design Flaws: If reporting systems like VAERS or EudraVigilance are designed in a way that leads to under-reporting or obfuscation, this could indeed be intentional or at least negligent, especially when dealing with public health on such a scale.
Improvement Need: There’s a clear call for:
Enhanced Reporting Mechanisms: Active surveillance systems that proactively seek out data, rather than relying on passive reporting.
Standardization: Globally consistent reporting standards to allow for better comparison and analysis across different countries and systems.
Transparency: Full disclosure of data, including raw data for independent analysis, and clear methodologies for how data are collected and interpreted.
Actuarial Data as Evidence:
Life Insurance Claims: An increase in life insurance claims, particularly among younger demographics who traditionally have lower mortality rates, is compelling evidence for further investigation into the correlation between therapeutics incorrectly named and administered as vaccines and unexpected health outcomes for their mandated use without proper Pharmacovigilance.
Statistical Analysis: Actuarial data can provide a statistical basis for examining unexpected increases in mortality or morbidity that might not be captured in voluntary adverse event reporting systems.
Pursuing Legal Action:
False Advertising:
Misrepresentation: If these therapeutics were marketed with claims of preventing infection (as is typical with vaccines) but only mitigating severity, this could be argued as false advertising. Legal action here would require proving that the marketing was misleading and caused harm or influenced consumer behavior detrimentally.
Informed Consent:
Lack of Proper Consent: The change in the definition and the subsequent misunderstanding about the products’ functions could form the basis for claims that informed consent was not adequately obtained. This could potentially lead to civil lawsuits or, if negligence or gross misconduct is proven, criminal charges.
Bodily Sovereignty and Coercion:
Violation of Rights: Mandates or coercive measures (like job loss or travel restrictions for non-compliance) could be challenged as violations of bodily sovereignty if it’s shown that individuals were not fully informed about the true nature of what was being administered.
Ethical and Legal Grounds: This could be pursued on both ethical grounds (invasion of autonomy) and legal grounds where laws protect against such coercion.
Steps for Reform and Legal Action:
Advocacy for Systemic Change:
Campaign for legislative changes to ensure better transparency and accountability in pharmaceutical product deployment during health emergencies.
Legal Challenges:
Class Action Lawsuits: Organize or support class actions focusing on false advertising, lack of informed consent, and violations of bodily autonomy.
Whistleblower Encouragement: Protect and incentivize whistleblowers who can provide insider information on how these products were developed, tested, and marketed.
Public Awareness Campaigns:
Raise awareness about the importance of transparency in medical products, the rights to informed consent, and the implications of coercion in medical treatment.
Policy Advocacy:
Push for policies that ensure:
Clear Communication of a product’s function and limitations.
Robust Informed Consent Processes, especially in emergency situations.
Protection of Bodily Autonomy with clear legal frameworks that prevent coercive medical mandates.
Scientific Inquiry and Data Science:
Encourage independent research into the health outcomes associated with these therapeutics, using comprehensive databases that go beyond passive reporting systems.
Reform in Regulatory Bodies:
Demand reforms in bodies like the FDA or EMA to prevent conflicts of interest that might skew regulatory decisions towards commercial interests rather than public health.
Legislative Proposals:
**1. ** Reform of Informed Consent:
Legislation for Clarity in Terminology:
Mandate that all medical interventions, especially those under EUA, must use precise and scientifically accurate terminology in all communications. This includes distinguishing between preventive vaccines and therapeutic interventions.
Require explicit mention of whether a product prevents infection, reduces severity, or both, in all consent forms and public health announcements.
Enhanced Consent Procedures:
Introduce a standardized, detailed consent form for new medical interventions, particularly those with EUA, that explains the product’s mechanism of action, potential side effects, and limitations in plain language.
**2. ** Transparency and Accountability:
Public Disclosure Act:
Require pharmaceutical companies to disclose all clinical trial data, including methodology and adverse events, within a defined period after trials conclude.
Establish a public database for all data related to products under EUA, accessible for independent scientific review and public scrutiny.
Independent Review Boards:
Legislation to create or empower independent bodies to oversee pharmaceutical practices, with a mandate to ensure ethical compliance and transparency, free from industry influence.
Liability Reforms:
Amend existing laws to include conditional liability for pharmaceutical companies in cases where misinformation or misleading terminology led to public harm or misinformed consent.
**3. ** Protection of Autonomy and Against Coercion:
Anti-Coercion Legislation:
Prohibit mandates for medical products unless they meet strict criteria for public safety, with exemptions for those with ethical, medical, or religious objections.
Ensure that any public health mandate must be accompanied by clear evidence of direct public safety benefits, not just therapeutic benefits.
Right to Choose:
Legislation ensuring individuals have the right to choose alternative treatments or opt-out from receiving a product if it’s not a traditional vaccine, emphasizing informed choice over coercion.
**4. ** Duty to Inform and Warn:
Mandatory Reporting:
Strengthen regulations around post-marketing surveillance, requiring immediate and public reporting of adverse events to platforms like VAERS or similar systems.
Public Health Communication Standards:
Implement standards for public health communication that prioritizes clarity, accuracy, and the duty to inform, rather than acts to silence others in the healthcare sector that challenge narratives that support monied interests at the expense of the health of Americans.
**5. ** Ethical Oversight and Governance:
Ethical Oversight Committees:
Legislation to establish or enhance ethical oversight within health agencies, ensuring policies align with ethical standards, particularly during health crises.
Review of Emergency Use Authorizations:
Require post hoc ethical reviews of EUA decisions to assess if the urgency justified the measures taken, including terminology used in public discourse.
**6. ** Research and Development Integrity:
Conflict of Interest Management:
Enforce strict policies on conflicts of interest for individuals involved in approving or promoting medical interventions.
Public Funding Accountability:
Ensure that products developed with public funding are subject to additional scrutiny regarding their classification, marketing, and distribution.
**7. ** Justice and Fairness:
Equitable Access:
Legislation to ensure that all health interventions are distributed with an eye toward equity, particularly in global health emergencies, balancing profit motives with public health needs.
Ethical Priority Setting:
Establish frameworks for prioritizing health interventions that consider ethical implications, including the impact on different socio-economic groups.
Implementation:
Legislative Review: Begin with a comprehensive review of current laws and regulations, identifying gaps where ethical considerations were not adequately addressed.
Stakeholder Engagement: Engage with a broad spectrum of stakeholders including ethicists, public health experts, legal scholars, and civil society to draft legislation.
Pilot Programs: Consider implementing pilot programs or amendments to test the feasibility of these reforms in real-world scenarios before full-scale legislative changes.
International Standards: Work towards aligning these policies with international health ethics standards to promote global coherence in addressing pharmaceutical practices during pandemics.
This legislative approach aims to restore trust, ensure ethical practices, protect individual rights, and promote a health system that values transparency and justice over profit.
Hello everyone who visits here and reads the proposal and comment thread…
I have a lot more drafts I’ve yet to add that go more into a lot of these different topics. Rather than using the dropdown feature, as that hit the character limitations of the Discourse policy proposal interface. I’ve since added the additional content I wanted to include as addendums, which link to my comments in this proposal thread as the workaround.
Considering this framework, any who were to provide additional resources specific to any respective areas of the primary proposals or addendums, I can link directly to your post comments below. for integration into the policy proposal.
Be sure to make your comment follow the same formatting style and outlines, for inclusion, and I will add your comments as links for reference.
Legislation Proposal: Comprehensive Pharmaceutical Accountability and Transparency Act (PATA) Version 3
Executive Summary:
The Comprehensive PATA integrates health freedom principles with the need for accountability and transparency in the pharmaceutical industry. It aims to:
Uphold the right to informed consent in all medical interventions.
Realign regulatory focus towards public health over industry profit.
Promote competition and access in healthcare, particularly in underserved areas.
Enhance transparency, minimize conflicts of interest, and foster ethical healthcare practices.
Historical Context/Lessons:
Legislation Impact: The 1986 NCVIA, ACA, Bayh-Dole Act, CON laws, and others have historically skewed the balance toward industry, often at the expense of health freedom and accountability.
Ethical Principles: Emphasize the need for ethical standards in public health, focusing on autonomy, consent, and equity.
Problem:
Loss of Health Freedom: Individuals are often not given true choices in healthcare due to coercive measures and mandates.
Regulatory Capture and Misalignment: The influence of pharmaceutical companies has led to regulatory decisions favoring corporate interests.
Healthcare Access: Monopolistic practices have reduced access, particularly in rural settings.
Solution:
Ban on Medical Mandates:
No medical intervention can be mandated without informed consent.
Repeal of Acts:
Repeal or amend acts like ACA, Bayh-Dole, PDUFA, PREP, and NCVIA to restore accountability, protect public interest, and ensure innovation includes responsibility.
Certificate of Need (CON) Laws:
Incentivize states to repeal CON laws, or face federal funding cuts, to encourage competition and improve rural healthcare access.
Agency Reforms:
Eliminate Agency Foundations: Prevent conflicts of interest by removing entities like the CDC Foundation.
Cooling-off Period: A mandatory 10-year wait for senior health officials before industry employment.
Conflict of Interest: Strengthen regulations to prevent conflicts within decision-making roles.
Restructuring of Public Health Agencies:
CDC Refocus: Return to core public health missions, eliminate unrelated programs.
NIOSH Independence: Allow NIOSH to operate without overarching agency influence.
Public Health Service Reassignment: Deploy officers to provide care in rural communities.
Environmental Health:
Prohibit forced interventions like water fluoridation or GMO insect releases, promoting health freedom.
Challenges:
Industry Resistance: Lobbyists and stakeholders with vested interests may oppose these reforms.
Implementation Complexity: Reforming entrenched systems requires strategic planning.
Public Education: Vital for acceptance and understanding of new health policies.
Implementation:
Legislative Process: Draft legislation with detailed amendments, seek bipartisan support for passage.
Oversight Establishment: New bodies or reforms to existing ones to enforce the act.
Public Education: Extensive campaigns to inform and train on new healthcare rights and responsibilities.
Continuous Monitoring: Establish mechanisms for regular review and adaptation of the legislation.
Appendices:
Appendix A: Analysis of health freedom policy impacts.
Appendix B: Legal frameworks for amendments, CON law case studies.
Appendix C: Economic models for agency restructuring.
Appendix D: Ethical guidelines on consent, transparency, and public health.
Appendix E: Plans for health service officer redeployment.
Critical Review: Incorporate insights on the real-world implications of policy changes, potentially focusing on how these reforms align with or challenge current healthcare dynamics.
Public Sentiment: Reflect on how these legislative changes might be perceived by the public, addressing any points raised about misinformation, skepticism, or the need for public trust in health policy.
This draft version now aims to create a legislative environment where health freedom is paramount, regulatory bodies serve public interest over industry, and the healthcare system is both ethical and accessible, informed by both Manookian’s policy imperatives and the nuanced commentary by @LarryMazz regarding public perception and policy effectiveness.
1 Like
LarryMazz
(Lawrence Mazzuckelli CDR US PHS (Ret))
9
First, thank you for incorporating my comments. I want to spend just few moments on why CDC needs to be “restructured”. The simple answer is because they cannot be trusted to tell the truth. CDC is agency that still lying about COVID-19 and its effects on children and the efficacy of their so-called vaccine which by their own definition is just a different treatment. But because CDC is aligned with pharmaceutical industry we are not allowed access to more effective, substantially less harmful, and cheaper over the counter treatments.
I spent the better part of this morning looking at childhood COVID-19 mortality data from CDC with the goal of writing another Substack article until it became clear that it will change nothing. Only the complete disruption of CDC will bring the needed change. Despite presentations of their own data to contrary CDC continues to insist that children be inoculated with dangerous mRNA “stuff”.
We need find the original legislative mandate and start from there. Then we need to review subsequent legislative mandates and determine if those functions are still needed. Anything that doesn’t fit into those two boxes is fair game for shutting down.
If some want to call that an extreme position so be it. But I am to my core weary of watching CDC officials and employees harm children without consequence. Whether it is through their COVID policies or their acceptance of “gender affirming care” it needs to stop.
I was a professional medical representative, that was witness to 1. No Informed consent. 2. Breaking privacy and HIPPA laws. 3. Pressuring employees with employment threats under the mandates and speech. 4. Mandates had no standards or structure, only to enhance fear marketing, huge profits from fear marketing. 5. Manipulation of VAERS and OSHA logs…
Deontological Analysis of Public Health Actions During the SARS-Cov-2 Pandemic
Terminology Shift and Ethical Implications:
Clarification of Function:
Vaccine: Traditionally, a vaccine prevents or significantly reduces the likelihood of infection by stimulating an immune response. If the product doesn’t prevent infection but reduces severity or transmission, calling it a “therapeutic” might more accurately describe its function as something that treats or mitigates the disease after exposure rather than preventing it.
Public Perception and Consent:
Informed Consent: Changing the terminology could lead to a clearer understanding that these products might not confer traditional immunity but rather offer a level of treatment or symptom reduction. This clarity is crucial for informed consent, ensuring individuals understand what they are consenting to.
Ethical Analysis Adjustments:
Utilitarianism:
With “therapeutics,” the discussion might shift from preventing infection to managing disease outcomes. The greatest good would then be evaluated based on reducing severity, hospital load, or long-term health implications rather than outright prevention.
Deontology:
The duty to inform would now emphasize the therapeutic nature, highlighting that these products will not stop one from getting infected but could help in recovery or reducing the disease’s impact. This could change the ethical conversation around mandates, focusing on treatment rights rather than prevention.
Virtue Ethics:
Honesty would require leaders to use precise language to describe these products. If marketed as vaccines but functioning as therapeutics, this could be seen as misleading and lacking in integrity.
Regulatory and Policy Implications:
Regulatory Standards: Therapeutics often undergo different regulatory scrutiny compared to vaccines. The emergency use authorization would be critiqued differently if viewed through the lens of therapeutic approval processes.
Policy Making: Policies like mandates would be seen differently; if these are therapeutics, the justification for compulsion changes from preventing public harm to ensuring treatment availability, which would not carry the same ethical weight.
Public Health Strategy:
Health Communication: Public health messages would need to adapt, focusing on how these therapeutics work within the broader health strategy, possibly leading to different approaches in public compliance and acceptance.
Disease Management: Viewing these products as therapeutics would encourage a broader health strategy that includes other forms of treatment, preventive measures, and health system readiness for managing cases rather than solely preventing them.
Critique of Language Use:
Misleading Terminology: If public health officials and manufacturers have used the term “vaccine” knowing the product’s primary function was therapeutic, this could be seen as a manipulation of public perception, influencing consent and policy acceptance.
Legal and Ethical Precedents: The terminology issue might affect legal challenges related to mandates, liability, and consumer protection laws. If products were marketed with claims akin to traditional vaccines, but act more like therapeutics, this could lead to legal disputes over advertising, consent, and the rights of individuals.
Suggestions for Addressing Terminology:
Clear Definitions: Establish and communicate clear definitions for “vaccine,” “therapeutic,” and other relevant terms in public health discourse.
Regulatory Clarity: Regulatory agencies should clarify their stance on these products, perhaps creating subcategories or new classifications that reflect the nuanced roles these products play.
Ethical Communication: Ensure all public health messaging reflects the true nature of the product, avoiding language that implies traditional vaccine-like immunity when that’s not the case.
Policy Reevaluation: Public health policies, especially those involving mandates, should be revisited in light of this terminology, ensuring they align with the ethical implications of the product’s actual function.
This shift in terminology can lead to a more precise ethical, legal, and public health conversation, potentially altering how we view the responsibilities of regulators, manufacturers, and the rights of individuals in the context of health emergencies.
When considering the ethical and deontological arguments in light of the fact that the definition of “vaccine” was changed to fit the characteristics of the COVID-19 injectables, several key points emerge:
Deontological Perspective:
Informed Consent:
Original Definition: If the traditional definition of a vaccine was altered, this directly impacts the principle of informed consent. Individuals were potentially misled about what they were consenting to since the expectations typically associated with vaccines (prevention of disease) were not fully met.
Ethical Implication: From a deontological standpoint, consent given under false pretenses is not true consent. This could be seen as a violation of the principle of autonomy and respect for persons.
Duty of Truthfulness:
Public Health Responsibility: There’s a duty for public health officials and pharmaceutical companies to be truthful about the nature of the product. Changing definitions to fit a narrative can be viewed as a breach of this duty, undermining the moral integrity of health communications.
Duty to Protect:
Public Health vs. Individual Rights: If the product’s primary function was therapeutic rather than preventative, the justification for mandates will be ethically questionable unless it’s clearly communicated that it’s about treatment rather than prevention.
Ethical Critique:
Honesty and Transparency:
Virtue of Honesty: Leaders and regulators are expected to uphold virtues like honesty. Altering definitions to fit a product could be interpreted as a lack of honesty, which undermines public trust and the ethical framework of public health policy.
Transparency: The change in definition without clear public acknowledgment or debate could be seen as a lack of transparency, which is crucial for ethical governance.
Moral Consistency:
Consistency in Application: Ethical consistency requires that definitions and policies align with scientific understanding. Changing the definition to include products that do not traditionally fit the vaccine model disrupts this consistency, potentially for economic or political reasons rather than scientific or ethical ones.
Justice:
Fairness in Information: Altering definitions to favor one set of interventions over others (like excluding other treatments) could be seen as an injustice, especially if other potentially effective treatments were sidelined because they didn’t fit the new narrative around what constitutes a “vaccine.”
Language and Ethical Arguments:
Reframing Consent: Ethically, the language used should now reflect the true nature of the product. Discussions about informed consent should use terms like “therapeutic” to clarify that individuals are consenting to a treatment, not a traditional vaccine.
Clarifying Public Health Goals: Ethical arguments should pivot to frame these products as part of a broader therapeutic strategy rather than solely a preventive one. This changes the discourse around public health measures, focusing on treatment equity and access rather than just prevention.
Highlighting Ethical Breaches: When discussing the ethical issues, emphasize how the change in terminology was used to:
Manipulate public perception
Influence policy decisions
Potentially bypass rigorous scrutiny that other treatments might have been subjected to
Policy Language: Policies and mandates need to be written or rewritten with precise language that reflects the actual function of these products. This would align with deontological principles of truthfulness and respect for autonomy.
Public Discourse: Encourage a public discourse that critically examines the role of terminology in health policy, advocating for clear, honest communication as a fundamental ethical requirement.
Deontological Analysis:
1. Informed Consent:
Change in Definition:
Issue: The alteration of the definition of therapeutics to be classified under vaccines led to an assumption of traditional vaccine benefits (prevention) when the actual effect was more therapeutic (mitigation of symptoms or severity).
Ethical Implication: True informed consent requires full disclosure. If individuals consented to these therapeutics under the guise of traditional vaccines, their consent could be seen as invalidated, violating the Kantian principle of autonomy.
Coercion and Mandates:
Issue: Mandates for these therapeutics under the label of vaccines could be critiqued as coercive, especially if individuals believed they were opting for prevention rather than treatment.
Ethical Consideration: The duty to respect autonomy suggests that mandates for therapeutics should be scrutinized more closely, ensuring individuals have a real choice, not just an illusion of one due to misleading nomenclature.
2. Duty to Inform:
Transparency in Product Nature:
Issue: There was a failure to clearly communicate that these were therapeutics rather than traditional vaccines, which might not prevent infection but could lessen disease severity.
Ethical Implication: The duty to inform includes explaining the true nature, risks, benefits, and limitations of the product. Mislabeling affects this duty, potentially breaching the ethical obligation to provide complete information.
Public Health Communication:
Issue: If public communications used the term “vaccine” to describe therapeutics, this could have swayed public opinion and policy acceptance.
Ethical Consideration: Deontology would argue for clear, honest communication as a moral imperative, especially when public health is concerned.
3. Bodily Autonomy:
Mandates for Therapeutics:
Issue: Mandating therapeutics under the label of vaccines could be seen as an overreach, especially if the justification for mandates is based on prevention rather than treatment.
Ethical Implication: From a deontological perspective, bodily autonomy is paramount. Mandates should only be justified by a clear, direct threat to public safety, not by therapeutic benefits alone unless those benefits are clearly communicated and consented to.
4. Duty to Warn:
Emergency Use Authorization (EUA):
Issue: The EUA process for these therapeutics did not adequately highlight their therapeutic nature, focusing instead on the vaccine narrative.
Ethical Consideration: There’s a duty to warn about all known risks and the nature of the product. If side effects or the limitations of these therapeutics were not fully disclosed due to their misclassification, this duty was not upheld.
5. Duty of Paternalism vs. Autonomy:
Public Health Strategy:
Issue: The strategy leaned towards paternalism by promoting these therapeutics as vaccines, potentially undermining individual autonomy in health decisions.
Ethical Implication: While public health sometimes requires paternalistic actions, these must be balanced with respect for autonomy. The language used can skew this balance if not carefully managed.
6. Justice:
Equity in Health Measures:
Issue: If other treatments were marginalized due to the focus on these therapeutics under the vaccine label, this could represent an injustice.
Ethical Consideration: Justice in deontology involves fairness in the distribution of benefits and burdens. Mislabeling could lead to an unjust prioritization of one intervention over others without clear medical or ethical justification.
Ethical Recommendations Based on Deontology:
Reinstatement of True Terminology: Use precise language in all future public health communications, clearly distinguishing between preventive vaccines and therapeutic interventions.
Public Acknowledgment and Apology: Acknowledge any misleading terminology used, offering an apology for the confusion this caused.
Policy Revision: Review and possibly revise mandates and policies to reflect the therapeutic nature of these interventions, ensuring they respect individual rights and autonomy.
Enhanced Informed Consent Processes: Develop and enforce stricter guidelines for informed consent that account for nuanced differences between vaccines and therapeutics.
Ethical Oversight: Strengthen or establish ethical oversight bodies to ensure that future public health strategies do not compromise deontological principles through misleading information or terminology.
By reframing the discussion with the correct terminology, we can better align public health actions with ethical standards that prioritize truthfulness, autonomy, and justice.
Post-Marketing Surveillance:
Issue: Once vaccines were rolled out, continuous monitoring for adverse effects is essential.
Ethical Consideration: Reporting mechanisms like VAERS should be proactive in informing the public about any emerging issues, balancing the need for vigilance with the duty to prevent public panic.
Ethical Implications:
Respect for Autonomy: Deontology emphasizes the respect for individual autonomy as an end in itself, not merely as a means to an end like public health. Policies that coerce vaccination infringe upon this principle.
Duty of Paternalism vs. Autonomy: In public health, there’s often a tension between a paternalistic duty to protect citizens’ health and the duty to respect their autonomy. Finding the ethical balance is key.
Justice and Fairness: Even within deontological ethics, there’s a concern for fairness. Were vulnerable groups, who had less access to information or resources to consent fully, treated justly in the process of vaccine distribution and policy enforcement?
Conclusion:
The alteration of the definition should be a central point in ethical discussions, highlighting:
A need for ethical language: The use of precise and honest terminology in health policy and communication.
Critical review of public health strategies: Ensuring that definitions are not manipulated to serve non-health related goals.
Restoration of trust: Ethical practices must aim to restore public trust through transparency and truthfulness, which includes reevaluating past decisions in light of this terminology shift.
Potential Ethical Failings:
If information was withheld or downplayed to increase pharmaceutical product uptake, this would be a significant ethical lapse from a deontological standpoint.
If mandates were enacted without providing viable alternatives or exemptions for those with genuine ethical, religious, or health-based objections, this could be seen as disregarding the principle of respect for persons.
Suggestions for Upholding Deontological Ethics:
Enhance Informed Consent: Develop comprehensive educational campaigns detailing therapeutic vs. vaccine information, ensuring individuals have access to all necessary data without coercion.
Balanced Policy Making: Implement mandates with clear, narrow justifications, exemptions, and alternatives that respect individual rights.
Strengthen Post-Marketing Surveillance: Ensure there are robust systems in place to report and act on adverse events swiftly, maintaining a duty to warn throughout the lifecycle of the vaccine.
Ethical Oversight: Establish or empower ethical review boards with the authority to oversee these aspects, ensuring decisions align with deontological principles during public health emergencies.
Here’s my message to help foster collaboration with others to refine policies by including additional talking points for a more thorough redress of grievances. I recently invited Dr.'s who run clinics to weigh in, also. I believe there are also areas in relation to Insurance companies incentivizing pharmaceutical products that should be addressed as well, so feel free to draft what you believe should be included and where.
I appreciate your first-hand testimony @NicktothePLUS and invite you to help build upon what I have to add information to the proposal. I can incorporate your information in any respective area in the outline as a direct link to your comment (just format it as I have in my addendum comments).
If you can organize your additions to the proposal in the areas of the outline where your key talking points can be more thoroughly addressed, I invite you to collate them with a similar format as the posts I’ve added in the comments and used as an addendum. As I can link directly to comments in this comment thread to build upon the proposal, this seems the most efficient way to collaborate in ways that make this proposal more comprehensive in addressing the problems and solutions to address the problems. I look forward to incorporating your additional observations and feedback into the proposal. Just comment with specific areas that can be incorporated into each respective section of the outline for possible refinement/ inclusion.
This is unclear because it is a lot of concepts that actually become detailed. How they are approached can cause them to improve or worsen. What is an Independent Commission for auditing and sanctioning? That sounds like terminology a health insurance carrier would use. Like preferred provider and quality care. Which doesn’t mean that at all. What they really mean is cut all payouts to the detriment of the doctor and patient so we can keep more money to invest in the stock market to decrease risk of payout. A preferred provider is one that agrees to accept the cuts in order to get the patients by being listed as a preferred provider. So a lot of outline presented here are similar to this type of terminology. We don’t really know what it means.
There are also too many topics in your presentation. They need to be separated out and talked about in more detail. This may be a good outline but without knowing what the one liners actually mean it is difficult to say.
What is enhance regulatory oversight to prioritize public health? What oversight? Who is doing the oversight? What are the guidelines? Having too much government has turned out to be a bad thing. There would have to be clear separation and not allowance of future employment - revolving door - between oversight and Pharm.
These are all separate topics.
Kennedy is already going to be working on Corporate Capture. I also believe they will be implementing rules to combat the revolving doors. He knows how to do it. He has been fighting for decades. But still worth talking about.
I suggest separating out the issues that you are presenting so we can tell what each is going to be and talk about them in detail.
This needs to be separated into different policies.
There is too much here.
Instead of using comments edit your original policy so it can be read in one spot.
If you separate things out and want to reference another policy you can attach it to your original post also. I cannot support it because it is too many separate issues in one post and too many comment posts. So I don’t know what I would be supporting.
It looks impressive because it is an outline and has some good wording but that isn’t what we need to be supporting. So a pretty presentation. However, we need to support what is going to play out in reality. In order for anyone to really do that it cannot be overwhelming with just an outline.
Thank you for your feedback on the PATA proposal, @DRSE.
I agree that clarity is essential for these points, as you can see in the proposal, it is a DRAFT in progress. I suggest others provide ways to improve upon the draft.
Here’s a more detailed explanation of these areas that could be proposed in answer to your request for more input:
Enhancing Regulatory Oversight to Prioritize Public Health:
Who does the oversight? I propose an independent body, possibly composed of or advised by a coalition similar to the Frontline COVID-19 Critical Care Alliance (FLCCC) or an independent researchers coalition. This body would not be directly tied to government agencies to avoid conflicts of interest but would work in tandem with existing regulatory frameworks.
What oversight? This would include:
Transparency in drug approval processes: Public access to all data and trials used for drug approvals.
Conflict of Interest Management: Implementing strict rules to prevent the “revolving door” between pharmaceutical companies and regulatory bodies. This could mean mandatory waiting periods before former regulators can work for the pharmaceutical sector and vice versa.
Guidelines: These would aim at:
Reducing bureaucratic inertia by focusing on health outcomes rather than industry profits.
Ensuring that only scientifically validated and independently reviewed data influences regulatory decisions.
Promoting a system where public health is the primary concern, potentially through public consultations or advisory panels made up of medical professionals, ethicists, and patient advocates.
If these look good to you, I could incorporate them into the proposal draft.
I recognize the concern about excessive government involvement. The idea here is not to expand government power but to realign the focus of existing regulatory structures towards public health. To further refine these ideas, your suggestions on what specific definitions or mechanisms should be included would be invaluable.
I’m currently limited by the character count here. Still, I plan to elaborate on this proposal in a Substack post where I can provide a more comprehensive draft including all feedback received. I’m also inviting those in the healthcare field to submit their lists of case studies in the appendix, to make a more robust case for the need to implement this most timely and important Act.
If you have any specific recommendations or definitions, please share them, and I’ll integrate them into the proposal. Thanks for engaging in this critical conversation for reform.
I believe Trump is already implementing a 7 or 10 year waiting period between ability to get a job - revolving doors - for other departments. So this is similar. The waiting period has to be long enough that it isn’t a revolving door.
If you are going to have Independent oversight these are also subject to corruption. So there would have to be something in place for these also including preventing revolving doors at independent entities. Also, they should involve more than providers from the AMA. They need to have alternative care providers on such as Chiropractic Physicians (yes Chiropractic Physicians in New Mexico have partial prescribing licenses) and Naturopathic Doctors who maintian the philosophy of least invasive to most invasive as part of their professions and practice wellness. This would help with over use.
I will have to think about the rest for now. It is still a monster - meaning a lot in one place. It’s hard to follow.