Pharmaceutical Ethical Practices Act (PATA-Subsection 08)

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Pharmaceutical Ethical Practices Act (PATA-08)

[*Draft Work in Progress]

Executive Summary

The Pharmaceutical Ethical Practices Act (PATA-08) seeks to bolster ethical standards in healthcare by emphasizing informed consent, bodily autonomy, and justice. It addresses significant ethical violations including suppression of information by medical and scientific communities, censorship of dissenting views, harm to individuals from pharmaceutical products with subsequent denial of claims, and censorship of support groups for those injured. PATA-08 specifically tackles issues arising during the SARS-CoV-2 response, like misleading terminology and substandard reporting systems, aiming to establish clear ethical guidelines, increase transparency, safeguard individual rights in medical interventions, and enhance judicial oversight to address criminal activities in the pharmaceutical sector. The act also focuses on providing remediation for those harmed by pharmaceutical products, ensuring justice for affected individuals and families.

Purpose

To ensure healthcare practices align with ethical principles, addressing:

  • Upholding true informed consent: By implementing strict guidelines where consent forms must detail potential risks, benefits, and alternatives in layman’s terms. Mandatory training for healthcare providers on consent procedures and the introduction of electronic consent with multimedia for better comprehension will be established. Legal recourse will be available for breaches of consent.

  • Ensuring accurate health information dissemination: Through legislation requiring precise language in health communications, with penalties for disseminating misleading information. An independent body will oversee public health communications to ensure accuracy.

  • Protecting against coercive medical mandates and unethical suppression of information: Laws will be enacted to ensure no mandates can be enforced without clear, ethical justification, and protections will be put in place to prevent censorship of scientific debate or patient experiences.

  • Promoting equitable health policy impacts: By using actuarial data to analyze and adjust policies to ensure they do not disproportionately affect any group, with specific focus on alternative treatments being considered equally.

  • Empowering judicial action against pharmaceutical malfeasance: By expanding judicial oversight to include the ability to review and nullify mandates not meeting ethical standards, and by providing clear legal pathways to challenge pharmaceutical companies.

  • Bringing remediation for the injured: A better compensation fund than the failed COVID-19 Vaccine Injury Compensation Program (CVIP)0 will be created, funded by seized profits from unethical practices, to offer medical, funeral, and damage compensation for those harmed.

Historical Context

  • Ethical Principles in Healthcare: The ethical principles in healthcare, rooted in the Nuremberg Code, have faced continuous challenges. From the WWII violations like those by Dr. Mengele, to modern-day issues like the SARS-CoV-2 response, there’s a clear continuity in the need for stringent ethical oversight. Recent health crises have seen redefinitions of medical terms (e.g., mislabeling gene therapies as vaccines), suppression of support groups, and liability shields for pharmaceutical companies, echoing past ethical failures and highlighting the ongoing necessity for robust ethical frameworks1112.

Problems

  • Misleading Terminology: PATA-08 will mandate clear definitions and classifications in medical communication to avoid confusion and ensure valid consent2.

  • Coercive Mandates: The act will introduce legislation to protect bodily autonomy, preventing mandates without ethical justification10.

  • Failure to Inform: Enhanced public education campaigns, along with the use of digital tools for consent, will ensure better understanding of interventions7.

  • Suppression of Information and Support Groups: By establishing legal protections for support groups and ensuring transparency in any attempts to suppress them, PATA-08 aims to restore trust and provide ethical support networks16.

  • Liability Shielding: PATA-08 will challenge and reform current agreements that protect pharmaceutical companies from accountability, ensuring they are legally responsible for harms caused9.

  • Quality Assurance Failures: Inconsistencies with batches and lot numbers and the amount of harm signal recorded by each suggest that specific lots were more toxic than others, either by gross negligence at best or by design at worst18, to carry out studies on unsuspecting recipients, which is in direct violation of international common law as espoused in both the Helsinki Declaration, and the Nuremberg Code post World War II. 17

  • Harm Mitigation: PATA-08 will establish a fund for compensation, ensuring that evidence of harm is not only acknowledged but acted upon, providing necessary remediation.

Key Components

  • Nuremberg Legacy:

    • Example: In a scenario where a new pharmaceutical product is being tested, PATA-08 would require explicit informed consent, detailing all known risks in a manner understandable to all participants, backed by legal enforcement11.

  • Suppression of Support Groups:

    • Example: If a tech company attempts to censor a support group for vaccine-injured individuals, PATA-08 would ensure legal action, public disclosure, and penalties for the company, safeguarding the group’s right to exist16.

  • Duty to Inform:

    • Example: During a new health crisis, PATA-08 would ensure that all public health communications are vetted for accuracy, with an independent body reviewing content before dissemination2.

  • Bodily Autonomy:

    • Example: If a mandate for a new treatment is proposed, PATA-08 would require judicial review to ensure it respects individual autonomy and has public health justification10.

  • Justice:

    • Example: Analysis of health outcomes post-mandate could show disparities; under PATA-08, policy adjustments would be mandated to address these inequities, ensuring fair treatment across demographics5.

  • Seizure of Unethical Profits:

    • Example: If a pharmaceutical company is found to have engaged in unethical practices, PATA-08 would facilitate the seizure of related profits to fund victim compensation16.

  • Legal Actions:

    • Example: If a pharmaceutical company mislabels a product to mislead consumers, PATA-08 would expand legal definitions to include this as false advertising, allowing for stricter enforcement and accountability. For instance, if a gene therapy is marketed as a vaccine without clear differentiation, legal proceedings could be initiated to correct this misrepresentation6. Additionally, PATA-08 would strengthen protections against coercion, ensuring that individuals have the legal right to refuse treatments without repercussions, with the judiciary empowered to enforce these rights15.

Key Observations

  • Observation-01: PATA-08 recognizes that the suppression of information, safety signals, and support groups is unethical. It proposes legal reforms to ensure transparency and the free flow of information, which is crucial for public trust and informed decision-making16.

  • Observation-02: The absence of accountability due to liability waivers has led to ethical breaches. PATA-08 would empower courts to intervene, ensuring that pharmaceutical companies are held accountable for their actions7.

  • **Observation-03: Global ethical standards emphasize the importance of integrity, accountability, and justice in pharmaceutical practices. PATA-08 aligns with these standards, aiming to set a precedent for ethical conduct worldwide8.

Related Bills

  • H.R.10077 - University Forced Vaccination Student Injury Mitigation Act of 2024: Introduced in the House 10/29/2024: This bill focuses on compensation for students injured by mandatory vaccinations at universities. PATA-08 complements this by broadening the scope to include all individuals affected by pharmaceutical products, not just students, and by addressing the root causes of such injuries through ethical reforms.

  • Gosar Introduces Legislation to Sue Big Pharma for Vaccine Injuries: AZ Congressman, Paul Gosar D.D.S. introduces HR 9828 - End the Vaccine Carveout Act cosponsored by 30 representatives. About: Introduced by Congressman Paul Gosar, this act seeks to remove liability protections for vaccine manufacturers. PATA-08 goes further by not only removing these protections but also by introducing mechanisms for compensation, legal accountability, and prevention of future ethical breaches, providing a more comprehensive approach to justice and remediation.

Appendix

  • Appendix A: Ethical Framework for Healthcare - (Forthcoming by Q2 2025, subject to change) This will provide detailed guidelines, ensuring that PATA-08’s principles are actionable within healthcare settings.

  • Appendix B: Case Studies on Ethical Lapses - (Forthcoming by Q2 2025, subject to change) Including examples of suppression of support groups, this will illustrate the need for and impact of PATA-08.

  • Appendix C: Legal and Ethical Analysis of Liability Waivers - (Forthcoming by Q2 2025, subject to change) This will examine current practices and propose legal reforms to align with PATA-08’s goals.

Resources

Public Input

Your insights are crucial for ethical healthcare reform:

  • How can we legally and ethically prevent the suppression of support groups for vaccine-injured individuals?
  • What mechanisms should be in place to ensure compensation for those harmed by unethical pharmaceutical practices?
  • How should we empower the judiciary to enforce ethical practices in the pharmaceutical industry?
  • Share your thoughts, experiences, or additional observations here.

Footnotes

[0]: Letter “Re: COVID-19 Vaccine Injury Compensation Program,” signed by Fourteen Attorney Generals to Xavier Becerra at the Department of Health and Human Services

[1]: The Four Principles of Biomedical Ethics

[2]: Impact of Terminology on Consent - Deontological Analysis of Public Health Actions During the SARS-Cov-2 Pandemic - Terminology Shift and Ethical Implications

[3]: VAERS Design Critique - Is the US’s Vaccine Adverse Event Reporting System broken? - British Medical Journal (BMJ)

[4]: Need for Reporting System Reform - Hearing Wrap Up: Physicians and Patients Need Improved, Effective, Up-to-Date Vaccine Safety Systems - Committee on Oversight & Accountability

[5]: Actuarial Data as Evidence - Information Resources on COVID-19 in Life Insurance Mortality by the American Academy of Actuaries Life Experience Committee (June 15, 2022)

[6]: Ethical Implications of Mislabeling - Deontological Analysis of Public Health Actions During the SARS-Cov-2 Pandemic - Terminology Shift and Ethical Implications

[7]: Balancing Public Health and Rights TBD

[8]: Scientific Misconduct, the Pharmaceutical Industry, and the Tragedy of Institutions Academia

[9]: Consumer Protection in Healthcare TBD

[10]: Legal Challenges to Coercion - “Judicial Decisions Constraining Public Health Powers During COVID-19: Implications For Public Health Policy Making” presented at the 47th Annual Health Law Professors Conference in Philadelphia, Pennsylvania, June 6, 2024

[11]: Nuremberg Code - The Nuremberg Military Tribunal’s decision in the case of the United States v Karl Brandt et al. includes what is now called the Nuremberg Code, a ten-point statement delimiting permissible medical experimentation on human subjects. | The Significance of the Nuremberg Code Alliance for Human Research Protection: Advancing Voluntary, Informed Consent to Medical Intervention

[12]: Common Rule - Federal Policy for the Protection of Human Subjects (‘Common Rule’)

[13]: Belmont Report - Ethical Principles and Guidelines for the Protection of Human Subjects of Research; Office of the Secretary, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 1979)

[14]: FDA Regulations on Informed Consent Protection of Human Research Subjects: Additional Protections for Specific Populations Posted by the Department of Health and Human Services on Oct 24, 2024 (Note: This publication states the following: “HHS finds that there is good cause to issue these amendments without advance notice and an opportunity for public comment.”)

[15]: Canterbury v. Spence Justia US Law - “Canterbury v. Spence, No. 22099 (D.C. Cir. 1972)”

[16]: Evidence of Harms, Censorship of the Injured, & Suppression of Support Groups - mRNA Vaccine Adverse Reactions Collection.pdf

[17]: Batch Codes of Coronavirus 2019 Injectables - Reports as evidence of increased severity and lethality of specific batches and lots of mRNA gene therapy injections from Pfizer, Moderna, Janssen, & NovaVax.

[18]: Non-Enforcement of Pharmaceutical Law Revealed Intent to Harm - Sasha Latypova

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