Recording-2025-04-02T14:36:15.494Z

Final Exam Reminder

• Emphasis on importance of the final exam in class

• No more time for make-up assessments

Main Topic: Understanding and Measuring Harms in Medical Research

• Focus on a paper discussing the perception of harms resulting from pharmaceuticals

• Exploration of the potential dangers of medical interventions

• Key argument: Pharmaceutical harms often more significant than known, due to the structure of biomedical research obscuring these harms.

Why is This Important?

• Previous discussions of failures within medical research lead to examining ethical evaluation

• Critical to understand and measure harm to avoid it in medical interventions

Defining Harm

• Saguenya's central claim: Judgments of harm are influenced by social values

  • Example: Ritalin for ADHD

    • Descriptive claim about effects (less movement, fewer social interactions)

    • Judgment of benefit/harm based on societal values and expectations for childhood behavior

    • Different perspectives (teacher vs. child health advocate) lead to divergent views on harm and benefit.

Measurement of Harm with Depressive Suicidality

• Hamilton rating scale used to assess potential harms of antidepressants from 0 (absence) to 4 (suicidal ideation)

• Studies conducted cross-culturally reveal varied perceptions of harm.

Pharmaceutical Testing Phases

• Phase 1: Testing on healthy individuals; results rarely published, leading to hidden harm information.

  • Consequence: Lack of transparency in safety assessment of experimental drugs.

• Publication Bias: Only successful drugs are reported, potentially underestimating harm; many drugs cause harm but do not progress past Phase 1.

• Phase 2 and 3: Focus on individuals most likely to benefit; ethical concerns arise from exclusion of those likely to react negatively or benefit from placebo.

  • Enrichment Strategies: Excluding certain subjects to enhance data has ethical implications and leads to misrepresentation of drug benefits and harms.

Consequences of Trial Design

• Population differences between trial participants and real-world patients lead to varying assessments of safety and effectiveness.

• Studies often too short-term to capture long-term harm, which may arise after prolonged use.

• Post-market observational studies crucial for detecting harm but often lack patient-to-physician reporting connections.

Insidious Elements of Pharmaceutical Research

• Private company data often withheld, limiting public oversight and understanding of drug safety

• Publishing biases extend beyond Phase 1; less incentive to publish unfavorable results.

• Threats and legal action against researchers exposing drug harms hinder scientific accountability.

Public Health Implications

• Undetected harms lead to inadequate assessments of drugs by policymakers and healthcare providers

• Importance of recognizing structural flaws in pharmaceutical research that prevent informed decision-making about medications.

Call for Solutions

• Consider creating databases for negative results to enhance transparency and accountability in drug trials

• Emphasizing the need for consent in observational studies where risks may be higher.

Philosophical Considerations on Values in Science

• Acknowledgment of contextual values (social and political) versus epistemic values (truth, accuracy) in scientific research

• Debate on whether science can be free from values; authors argue it's essential to recognize how values impact research.

Context of Discovery vs. Justification

• Discovery allows for creativity; justification must depend on empirical methods

• Social values should inform error acceptance in studies, particularly around impactful health risks.

Conclusion

• Scientific research cannot escape the influence of values, especially regarding the ethics and consequences of medication use

• Current systems may be unintentionally designed to overlook harm, requiring reform to ensure ethical treatment and informed policymaking.