Please enable JavaScript.

Coggle requires JavaScript to display documents.

Pharma pharma, Week 6, maxresdefault (1), images (2), whistleblower,…

- - - - Meaning of “Iatro”
      - → Relates to physician / medical treatment→ Used to classify historical forms of medicine→ Shows medicine is shaped by: beliefs, knowledge, and social needs
        
        Health = balance & harmony
        
        Disease explained by nature
        
        social needs
        
        Individual patient symptoms important
      - Scientific / Iatro-Technical Medicine
        
        Rise of lab science & technology
        
        Disease becomes measurable
        
        Health = absence of disease
        
        Patient becomes a “case”
        
        Medicine linked to industry
        
        Rise of Medicine (1890–1945)
        
        Professionalization of doctors
        
        Growth of hospitals & research
        
        Medicine seen as modern & scientific
        
        Stronger authority of experts
        
        Pharmaceuticals & Capitalism
        
        Drug development shaped by:
        
        economics
        
        culture
        
        infrastructure
        
        Modern medicine supports productivity
        
        keeps people healthy enough to work, produce, and be a part of the economy.
        
        Today medicine also drives economic growth
      - Technology Theories
        
        Technological Determinism
        
        Criticism → ignores human responsibility
        
        Technology shapes society
        
        Technological Neutrality
        
        Technology is just a tool
        
        Limitation → ignores how tech shapes future choices
        
        Social Constructivism
        
        Technology shaped by social values
        
        Multiple outcomes possible
      - Future: Molecular Medicine
        
        Focus shifting → genes & personalization
        
        May reshape identity, risk & healthcare systems
      - "labisch-history of western medecine"
  - - - Pre-Industrial Medicine
        
        Sold herbs, minerals, remedies
        
        Craft knowledge + preparation skills
        
        Community health shops
        
        Separate from physicians but essential for public health
      - Coal-Tar & Organic Chemistry
        
        MOTHER SUBSTANCE
        
        Chemists could break down modify molecules to create new drugs or dyes
        
        Enabled:
        
        synthetic drug production
        
        patenting of chemical processes
        
        industrial scale manufacturing
        
        Synthetic Dye Industry / Pharma Industry
        
        Same infrastructure used to make drugs
        
        Dye firms had:
        
        large chemical factories
        
        quality control systems
        
        research labs
        
        First Major Pharma Firms
        
        BASF
        
        Bayer
      - Economies of Scope
        
        Dye chemistry knowledge reused for pharmaceuticals
        
        Firms saved costs in:
        
        research
        
        testing
        
        production
        
        standardization
        
        Shared industrial inputs increased innovation speed
        
        "Wang_The_modern_Pharmaceutical_Industry"
      - Industrial Research Laboratories
        
        Dye industry created first systematic R&D labs
        
        Collaboration:
        
        universities
        
        industry
        
        Model became standard for modern drug discovery
        
        Standardization → Regulation
        
        Dye production required:
        
        chemical purity
        
        batch consistency
        
        These practices later shaped:
        
        pharmaceutical quality control
        
        early drug regulation
        
        "Wang_The_modern_Pharmaceutical_Industry"
      - Heroin vs Aspirin
        
        Heroin
        
        Marketed as:
        
        Help get off Opiods
        
        Cough Suppresant
        
        non-addictive painkiller
        
        Caused widespread addiction
        
        Led to regulation like opiate restrictions
        
        Aspirin
        
        Produced using same chemical logic
        
        Became one of most successful drugs
        
        Showed that same technology can have different social outcomes
        
        This History Brought To Light
        
        Technological optimism
        
        Limits of scientific knowledge
        
        Unintended consequences
        
        Social responsibility in drug innovation
        
        Industrial systems can create both life-saving and harmful medicines
      - Industrialization of Pharmaceuticals
        
        Shift from craft medicine → factory production
        
        Systematic experimentation
        
        Patents encouraged competition & innovation
        
        Growth of large pharmaceutical corporations
      - Social Constructivism & Pharmaceuticals
        
        Drug development shaped by:
        
        societal values
        
        regulation
        
        economic incentives
        
        addiction crisis → stricter drug laws
  - - - Drug Development Process
        
        Pre-Clinical Research
        
        Lab + animal studies
        
        Study:
        
        Mechanism of drug
        
        Toxicity & safety
        
        Effectiveness
        
        Funding:Primarily public sector
        
        universities
        
        government
        
        Regulatory Approval
        
        Evaluation of safety, efficacy, quality
        
        Market authorization
        
        Clinical Trials
        
        Phase I (Safety)
        
        Small group
        
        Tests safety & dosage
        
        Phase II (Efficacy)
        
        Medium group
        
        Tests effectiveness + side effects
        
        Phase III (Comfirmation)
        
        Large group
        
        Compares to existing treatments
        
        Gold standard:
        
        Double-blind
        
        Placebo-controlled
        
        Phase IV (Post-Market)
        
        After approval
        
        Long-term effects & real-world data
        
        Selection process
        
        3-6 Years
        
        Drug Discovery(5,000-10,000 compounds)
        
        Preliminary Studies (250 compounds)
        
        6-7 Years
        
        Clinical Studies : Phase 1,2,3 (5-10 compounds)
        
        .5-2 Years
        
        Regulatory Review (1-2 compunds)
        
        Drugs Lifetime
        
        Post - Marketing Activities (1 new drug)
        
        Ethics in Clinical Trials
        
        Protect participants
        
        Enable knowledge production
        
        Key principles:
        
        Informed consent
        
        Minimizing harm
        
        Ethical study design
        
        Double-Blind, Placebo-Controlled Trials
        
        Importance:
        
        Minimizes bias
        
        Establishes causation
        
        Identifies true side effects
        
        Most reliable evidence
        
        Scientific Method & Clinical Trials
        
        Observation → unmet medical need
        
        Hypothesis → treatment effect
        
        Experiment → trial design
        
        Data collection → standardized protocols
        
        Analysis → statistical testing
        
        Replication → multiple trial phases
        
        Key Regulatory Tools
        
        Priority Review
        
        Fast-track (180 days) for urgent needs
        
        Notice of Compliance with Conditions (NOC/c)
        
        Early approval with required follow-up data
        
        Advanced Therapeutic Pathway (ATP)
        
        Flexible system for innovative therapies
        
        Rolling Reviews
        
        Submit data in stages (faster approvals)
        
        Special Access Program (SAP)
        
        Access to unapproved drugs for serious cases
        
        International Council for Harmonisation (ICH)
        
        Global standards (safety, quality, efficacy)
        
        Post-Market Regulation
        
        Monitoring drug safety after approval
        
        Real-world evidence collection
        
        Stronger powers under Vanessa’s Law
        
        Recall unsafe drugs
        
        Improve safety oversight
        
        Funding & Industry Roles
        
        Pre-clinical: mostly public funding
        
        Clinical trials: mostly industry-funded (~70%)
        
        Public research:
        
        Identifies biological targets
        
        Industry:
        
        Develops and commercializes drugs
        
        Trends in Drug Regulation
        
        Increasing:
        
        International harmonization
        
        Lifecycle regulation (pre + post market)
        
        Use of real-world evidence
        
        Balancing:
        
        Speed vs safety
        
        Innovation vs affordability
        
        COVID-19 impact:
        
        Faster approvals
        
        Use of interim orders
  - - - Post-Approval: Delivering Drugs to Society
        
        Focus: what happens after regulatory approval (Notice of Compliance)
        
        Drug approval ≠
        
        Public coverage
        
        Affordable price
        
        Equal access
      - Pricing Oversight
        
        Patented Medicine Prices Review Board (PMPRB)
        
        Regulates maximum introductory prices of patented drugs
        
        Prevents excessive pricing
        
        Does NOT:
        
        Negotiate prices
        
        Decide coverage
        
        Control final patient price
      - Value Assessment
        
        Canadian Drug Agency (CDA / CADTH)
        
        Conducts Health Technology Assessments (HTAs)
        
        Evaluates:
        
        Clinical benefit
        
        Cost-effectiveness
        
        Comparative value
        
        Issues non-binding reimbursement recommendations
      - QALY (Quality-Adjusted Life Year)
        
        Combines length of life + quality of health (0–1 scale)
        
        Used to determine value for money in public drug spending
        
        4 months of good health ≈ 0.33 QALYs
        
        Shows how healthcare decisions involve economic optimization and social judgement
      - Price Negotiation
        
        pan-Canadian Pharmaceutical Alliance (pCPA)
        
        Negotiates drug prices for provinces & territories
        
        Uses collective bargaining power
        
        Acts after positive HTA recommendation
      - Final Coverage Decisions
        
        Provincial / Territorial Drug Plans
        
        Decide:
        
        Whether drug is listed
        
        Who qualifies
        
        Conditions of access
      - Canadian Healthcare & Pharmacare
        
        Historical Development
        
        1947 → Saskatchewan introduces public hospital insurance
        
        1966 → Medical Care Act expands physician coverage
        
        1984 → Canada Health Act establishes principles:
        
        Public administration
        
        Comprehensiveness
        
        Universality
        
        Portability
        
        Accessibility
      - Pharmacare Act (2024)
        
        Creates framework for universal public drug coverage
        
        Initial focus:
        
        Contraceptives
        
        Diabetes medications
        
        Related devices (e.g., glucose monitors)
      - "Light & Lixchin - Cost of drugs"
        
        Current Drug Coverage System (Patchwork Model)
        
        Mix of public + private insurance plans
        
        Coverage varies by province and eligibility
        
        About:
        
        ~46% drug spending = public plans
        
        ~40% = private plans
        
        ~14% = out-of-pocket payments
        
        Key issue:
        
        ~1 in 5 Canadians lack prescription coverage
        
        Some do not fill prescriptions due to cost
        
        Economic & Political Issues in Pharmacare Expansion
        
        What drugs should be covered
        
        Who should be eligible
        
        How to fund universal coverage
        
        Balancing:
        
        Innovation incentives
        
        Public affordability
        
        Equity of access
- - - - Contract Research Organizations (CROs)
        
        Definition
        
        Companies that provide outsourced research services to pharmaceutical firms
        
        Emergence
        
        Began in 1970s–1980s
        
        Shift from fully internal pharma R&D → outsourcing model
        
        Evolution
        
        Early: service providers (toxicology, trial management)
        
        Today: strategic partners in innovation ecosystem
        
        Modern Capabilities
        
        Adaptive trial design
        
        Digital data analytics
        
        Specialized CROs (oncology, rare diseases, advanced therapies)
      - Functions of CROs in Clinical Trials
        
        Preclinical
        
        Toxicology testing (animal studies)
        
        Clinical Trial Management
        
        Site coordination
        
        Patient recruitment
        
        Data & Analysis
        
        Biostatistics
        
        Data handling & reporting
        
        Regulatory Support
        
        Submissions for drug approval
        
        Navigating international regulations
      - Rise of CROs
        
        Economic Factors
        
        Rising cost of drug development
        
        Lower labor costs in developing countries
        
        Regulatory Factors
        
        Increasing bureaucratization of clinical trials
        
        Complex compliance requirements
        
        Operational Efficiency
        
        Faster patient recruitment
        
        Shorter timelines
        
        Scientific Factors
        
        Need for larger sample sizes
        
        “Drug pipeline explosion”
        
        Market Expansion
        
        Access to emerging markets (e.g., India, China)
        
        "Glickman - Ethical and Scientific Implications Internationalization"
      - Globalization of Clinical Trials
        
        Key Trend
        
        Shift from US/Europe → global locations
        
        Evidence
        
        U.S. trial site share dropped (52% → 43%)
        
        Characteristics
        
        Trials increasingly multinational
        
        Recruitment global even if trials “based” in US/EU
        
        Drivers
        
        Cost savings
        
        Faster recruitment
        
        Large treatment-naïve populations
        
        Goal
        
        Increase innovation + global access to therapies
      - Ethical Concerns
        
        Participant Vulnerability
        
        Economic and social inequalities
        
        Limited understanding of trials/placebos
        
        Financial Coercion
        
        Payments may exceed annual wages
        
        Participation = only access to healthcare
        
        Ethical Oversight Issues
        
        Weak or inconsistent IRB review
        
        Lack of informed consent in some cases
        
        Therapeutic Misconception
        
        Participants confuse research with treatment
        
        Exploitation Risks
        
        Use of vulnerable populations
        
        Ethical Variability
        
        Standards differ across countries
        
        "Glickman - Ethical and Scientific Implications Internationalization"
      - Scientific Concerns
        
        Data Quality & Transparency
        
        Limited oversight outside home countries
        
        Generalizability
        
        Results may not apply to Western populations
        
        Biological Differences
        
        Drug-drug interactions
        
        Genetic variability
        
        Study Population Issues
        
        Treatment-naïve patients → unrealistic outcomes
        
        Ecological Validity
        
        Different healthcare environments affect results
      - Equity & Justice Issues
        
        Mismatch in Research Focus
        
        Trials focus on Western diseases
        
        Ignore local health issues (e.g., tuberculosis)
        
        Access Inequality
        
        Benefits don’t return to host communities
        
        Global Power Imbalance
        
        Pharma companies vs vulnerable populations
      - Disease Mongering & Pharmaceuticals
        
        Risks
        
        Overdiagnosis
        
        Poor treatment decisions
        
        Economic waste
        
        Focus on pharmaceutical solutions
        
        Ignoring social/political causes of illness
      - Benefits of CROs & Global Trials
        
        Faster drug development
        
        Lower research costs
        
        Increased innovation
        
        Access to larger and more diverse populations
        
        Potential global collaboration in science
      - Challenges & Future Needs
        
        Key Challenge
        
        Ensuring ethical + scientific integrity globally
        
        Needed Solutions
        
        Strong international regulatory frameworks
        
        Harmonized ethical standards
        
        Better transparency in data
        
        Balancing Goal
        
        Innovation vs protection of human subjects
      - "Petryna - Ethical variability Drug development and Clinical trials"
  - - - Regulatory Capture:
        
        When regulators begin to serve industry interests instead of the public
      - Two Views of Capture
        
        Traditional View
        
        Bribery
        
        Lobbying
        
        Revolving doors
        
        STS View
        
        Structural influence
        
        Epistemic (knowledge-based) influence
        
        Cultural alignment
      - Pathways to Capture
        
        Information asymmetry → industry knows more
        
        Revolving doors → career movement
        
        Lobbying → political influence
        
        Cultural alignment → shared assumptions
        
        Dependence on industry data
      - Evidence Bias (Key Concept)
        
        Industry funding influences research outcomes
        
        Lexchin et al. (2003)
        
        Industry-sponsored studies more likely to show favourable results
        
        No clear drop in “quality” → bias is subtle
      - Mechanisms of Bias
        
        Study design choices
        
        Selective publication
        
        Framing of conclusions
        
        Research agendas shaped by profit
        
        Bias is often built into systems, not individuals
        
        From Evidence → Capture
        
        Regulators rely on company-submitted data
        
        Limited resources to verify independently
        
        Pressure for fast approvals
      - Systemic Vulnerabilities
        
        1. Information Dependence
        
        Regulators depend on industry knowledge
        
        2. Shared Epistemic Frameworks
        
        Same training, same assumptions
        
        Agreement on “what counts as evidence”
        
        3. Institutional Design
        
        Systems favor:
        
        gradual responses
        
        industry input
        
        continued drug use
      - Case Example: Vioxx
        
        Drug withdrawn due to safety risks
        
        Little evidence of direct corruption
        
        Strong evidence of:
        
        systemic vulnerability
        
        delayed regulatory response
      - Global Clinical Trials Context
        
        Internationalization driven by:
        
        cost differences
        
        global inequality
        
        Challenges:
        
        ethical variability
        
        exploitation risks
      - "Lexchin - Pharma Sponsorship"
      - "Heims and Moxon - Mechanism of regulatory capture"
- - - - Pre-clinical Studies
        
        Lab and animal testing for safety and toxicity
      - Clinical Trials
        
        Phase 1: safety and dosage (small group)
        
        Phase 2: effectiveness and side effects
        
        Phase 3: large trials confirming effectiveness
      - Regulatory Decisions
        
        Approval by agencies like the U.S. Food and Drug Administration (FDA)
      - Market Integration
        
        Price negotiations
        
        Insurance coverage decisions
        
        Integration into healthcare systems
      - Marketing
        
        Promotion to doctors, pharmacists, and patients
    - - Role of Regulators
        
        Ensure drugs are safe and advertisements are not misleading.
      - Traditional View of Regulatory Capture
        
        Bribery
        
        Lobbying
        
        Revolving doors between regulators and industry
      - STS View
        
        Influence occurs through:
        
        Structural factors
        
        Shared scientific assumptions
        
        Cultural relationships
      - Key Vulnerabilities
        
        Information asymmetry (regulators depend on industry data)
        
        Shared epistemic frameworks
        
        Institutional and procedural design
    - - Industry-funded studies are more likely to show favorable results.
      - Bias can occur through:
        
        Study design
        
        Selective reporting
        
        Withholding negative results
      - This affects the evidence regulators rely on.
    - - Examples:
        
        Advertising
        
        Sales representatives
        
        Sponsored research
        
        Medical conferences and education
      - The industry spends about one-third of sales revenue on marketing.
      - "Mulinari - Unhealthy Pharma Marketing"
    - - Influencing Doctors
        
        Gifts and travel
        
        Sponsored events
        
        Free samples
        
        Paid speaking engagements
      - Key Opinion Leaders (KOLs)
        
        Influential physicians recruited to promote drugs
        
        Give lectures, publish research, and shape prescribing behavior.
    - - Definition
        
        Pharmaceutical companies write scientific articles but publish them under academic authors’ names.
      - Purpose:
        
        Increase credibility
        
        Promote favorable interpretations of evidence
        
        Influence medical guidelines and prescribing.
    - - Marketing strategy that expands drug markets by promoting new or broader disease definitions.
      - Goal:
        
        Increase demand for treatments.
    - - Promoting drugs for uses not approved by regulators.
      - Example:
        
        Illegal promotion of Neurontin by Pfizer’s subsidiary.
      - Risks:
        
        Patient harm
        
        Increased healthcare costs
        
        Weakening evidence-based medicine.
    - - Misleading marketing can cause:
        
        Overuse of medicines
        
        Higher healthcare costs
        
        Patient harm
        
        Loss of trust in medical institutions
      - Large marketing campaigns have influenced medical opinion, including in opioid prescribing.
      - "Bernissons and Sisomondo - Promoting Opiods"
    - - Whistle-blower Laws
        
        Under the False Claims Act, whistle-blowers can receive 15–30% of recovered funds.
      - From 2009–2012:
        
        U.S. recovered $10.5 billion from pharmaceutical fraud cases.
      - Possible Solutions
        
        Register all clinical trials
        
        Share clinical study data
        
        Strengthen marketing regulations
        
        Improve transparency in pharmaceutical research.
      - "Mulinari - Unhealthy Pharma Marketing"
- - - - Legal rights giving exclusive production & sale (~20 years)
      - Functions
        
        Incentivize R&D
        
        Allow cost recovery
        
        Encourage knowledge disclosure
        
        Create temporary monopolies
      - Types of Patents
        
        Product patents → protect the drug itself
        
        Process patents → protect how it’s made
      - Generics
        
        Same drug, cheaper, enter after patent expiry
        
        Increase access & reduce prices
      - Patent Strategies
        
        Evergreening → extend patents via small changes
        
        Me-too drugs → similar drugs with new patents
    - - Shift toward maximizing shareholder value
      - Key Features
        
        Profit extraction
        
        Stock buybacks & dividends
        
        High investor control
      - Finance dominates decisions over health needs
      - Companies prioritize profits over innovation
      - Pricing in Financialized Pharma
        
        Key Idea
        
        Prices based on “value” (willingness to pay)
        
        NOT based on:
        
        production cost
        
        actual therapeutic benefit
    - - OLD: Blockbuster Model
        
        Drugs for large populations
        
        Profit from high volume
      - NEW: Nichebuster Model
        
        Drugs for small populations
        
        Extremely high prices
        
        Consequences
        
        Access depends on ability to pay, not need
        
        Prices disconnected from reality
        
        Healthcare systems under pressure
        
        Extremely high drug prices
      - "Gueennif - Impact of Financialization on Access to Medecine"
    - - 3 Requirements
        
        Availability
        
        Affordability
        
        Quality
      - "Gueennif - Impact of Financialization on Access to Medecine"
    - - Drugs exist but are:
        
        too expensive
        
        unequally distributed
      - Leads to global health inequality
    - - Focus on patents as financial assets
      - Mergers & acquisitions for profit
      - Less investment in real innovation
      - More focus on:
        
        repositioning drugs
        
        maximizing lifecycle profits
    - - Innovation
        
        Focus on profitable diseases
        
        Neglect of less profitable conditions
      - Economics
        
        Rising healthcare costs
        
        Strain on public systems
      - Society
        
        Inequality in access
        
        Medicines become commodities, not public goods
    - - Innovation vs Access
        
        Patents → encourage innovation
        
        Financialization → increases profits
        
        BUT → reduces accessibility
- - - - Stages of developing and delivering medicines:
        
        Pre-clinical research
        
        Lab and animal testing for safety and toxicity
        
        Clinical trials
        
        Phase 1: safety and dosage
        
        Phase 2: effectiveness and side effects
        
        Phase 3: large-scale testing
        
        Regulatory approval
        
        Agencies like the U.S. Food and Drug Administration review evidence
        
        Market entry
        
        Price negotiations
        
        Insurance coverage decisions
        
        Integration into healthcare systems
        
        Marketing
        
        Promotion to doctors and patients
    - - Definition
        
        Activities used to promote medicines and increase prescriptions.
      - Strategies
        
        Advertising and sales representatives
        
        Sponsored conferences and education
        
        Free drug samples
        
        Disease-awareness campaigns
      - Influence on Doctors
        
        Gifts and travel
        
        Paid speaking events
        
        Sponsored research
      - Key Opinion Leaders (KOLs)
        
        Influential physicians used to promote drugs through research, lectures, and conferences.
      - Ghostwriting
        
        Companies write scientific papers that are published under academic authors’ names.
    - - Traditional View
        
        Bribery
        
        Lobbying
        
        Revolving doors between industry and regulators
      - STS Perspective
        
        Influence occurs through:
        
        Shared scientific frameworks
        
        Institutional structures
        
        Cultural relationships
      - Key Vulnerabilities
      - Information asymmetry (regulators rely on industry data)
      - Shared epistemic frameworks
      - Institutional design
      - Industry-funded research is more likely to report favourable results.
    - - Disease Mongering
        
        Expanding markets by redefining or promoting diseases.
      - Off-Label Promotion
        
        Promoting drugs for uses not approved by regulators.
      - Public Health Risks
        
        Overuse of medicines
        
        Increased healthcare costs
        
        Harm to patients
        
        Loss of trust in medicine
      - The pharmaceutical industry spends about one-third of sales revenue on marketing.
      - "Moonand Hoen- Global Access to meds"
    - - Medicines are essential for treating disease and supporting health systems. Access is considered part of the right to health.
      - Key components
        
        Availability – medicines exist in supply
        
        Accessibility – people can reach them
        
        Affordability – prices are manageable
        
        Acceptability – culturally trusted
      - "Adebisi - Revisiting the issue of acces to medecines"
    - - Access debates focus on:
        
        Drug prices
        
        Pharmaceutical patents
        
        Intellectual property rights
      - The global pharmaceutical market is worth over $1 trillion.
      - "Moonand Hoen- Global Access to meds"
    - - Important developments:
        
        Essential Medicines List (1977)
        
        Declaration of Alma-Ata (1978)
        
        Activism by NGOs like Health Action International
        
        TRIPS Agreement (1995) under the World Trade Organization strengthening pharmaceutical patents
    - - Access 1.0 (1990s–2000s)
        
        Focus: HIV/AIDS medicines
        
        Issue: high drug prices
        
        Solution: generic drugs and compulsory licensing
      - Access 2.0
        
        Broader focus on cancer, biologics, and chronic diseases
        
        Examines the innovation system and pricing structure
    - - Africa faces major challenges:
        
        High burden of infectious and non-communicable diseases
        
        Limited pharmaceutical manufacturing
        
        Heavy reliance on imported medicines
        
        Weak supply chains
        
        Limited research and development
      - Many countries depend heavily on imported medicines and raw materials.
      - "Adebisi - Revisiting the issue of acces to medecines"
- - - - Expansion of treating life problems with drug solutions
      - Key Ideas
        
        Example:
        
        Erectile dysfunction expansion
        
        Hypertension becomes a disease
        
        Conditions are defined in terms of drug treatments
      - Goes beyond medicalization → more driven by pharmaceutical companies
    - - Actor-Network
        
        Companies build networks of:
        
        drugs
        
        clinical trials
        
        doctors
        
        regulators
        
        patients
      - All aligned to support drug use
      - "Sisomondo - Pharmaceuticalisation"
    - - Advertising
      - Shapes:
        
        disease definitions
        
        treatment norms
        
        public perception
      - Social media & patient influencers
      - Sponsored research & publications
      - "Sisomondo - Pharmaceuticalisation"
    - - Physicians
        
        Patient groups
        
        Regulators
        
        Governments
      - Creates “drug-centered systems”
    - - Access =
        
        availability
        
        affordability
        
        accessibility
        
        acceptability
      - "Slovenski - Developing globally pharma"
    - - Structural Barriers
        
        Weak local pharmaceutical industry
        
        Heavy dependence on imports (~94%)
        
        Limited R&D capacity
        
        Poor supply chains
        
        Lack of infrastructure & funding
    - - High drug prices
      - Out-of-pocket payments common
      - Global patent systems affect affordability
    - - Limited healthcare workforce
      - Regulatory delays
      - Unequal urban vs rural access
      - Additional Issues
        
        Counterfeit medicines
        
        High disease burden
        
        Limited government investment
    - - Global–Local Tension
        
        Drugs developed globally
        
        Access problems locally
      - Need:
        
        stronger regulation
        
        local production
        
        international cooperation
      - African Medicines Agency (AMA)
        
        Regulatory harmonization
        
        Improve drug quality
        
        Support local pharma industry
    - - 1.0
        
        Focus on price & patents
      - 2.0
        
        Focus on systems & infrastructure
        
        Includes:
        
        supply chains
        
        governance
        
        local production
    - - Equity vs Profit
        
        Pharma seeks profit
        
        Public health seeks access
    - - Dominant Model (Current System)
        
        Private firms
        
        Patent-protected
        
        Profit-driven
      - Problems:
        
        High prices
        
        Neglect of low-income diseases
        
        Lack of transparency
    - - Public Model
        
        Government-led R&D
        
        Shared risk
      - Public-Private Partnerships (PDPs)
        
        Collaboration
        
        Knowledge sharing
      - Open / Nonprofit Models
        
        Open-source drug discovery
        
        Less IP restriction
    - - Markets fail when:
        
        demand is uncertain
        
        profits unclear
      - Need:
        
        public funding
        
        global cooperation
        
        new innovation system
- - - - Example: SSRIs (Antidepressants)
        
        Market expanded through:
        
        redefining conditions
        
        Used for depression, anxiety, etc.
      - Pharma companies shape:
        
        how it should be treated
        
        how common it is
        
        what counts as disease
  - - - Social Level
        
        Ignores sociopolitical issues
        
        Focus on drugs over root causes
        
        Obsession with health
      - System Level
        
        Threat to public healthcare systems
        
        High drug costs
        
        Economic waste
      - Individual Level
        
        Iatrogenic illness
        
        Poor treatment decisions
        
        Unnecessary labeling & stigma
      - "Moynihan-Health-Henry-Selling_Sickness"
  - - - Exaggerated prevalence
        
        erectile dysfunction
      - Risk → disease
        
        high blood pressure, osteoporosis
      - Social problems → medical
        
        social anxiety
      - Mild symptoms → serious illness
        
        IBS
      - Ordinary life → disease
        
        baldness
    - - Incentivize behavior change
      - Produce “scientific” persuasive info
      - Promote treatments
      - Create awareness & fear
      - Build alliances
        
        doctors, pharma, media, patient groups
  - - - Link to Pharmaceutical Industry
        
        Shift: “from life → drugs”
        
        More conditions = more treatments
        
        Medicalization creates new markets for drugs
      - Institutional Control
        
        Medicine expands into new domains
        
        Professional authority increases
        
        Knowledge Control
        
        Medical knowledge controlled by professionals
        
        Limited access → reinforces authority
        
        Bodies & Identity
        
        Normalization of bodies
        
        “One-size-fits-all” treatments
        
        Standardized (“Taylorized”) bodies
    - - Childbirth, menopause → later:
        
        ADHD
        
        PMS
        
        PTSD
    - - Examples:
        
        drug abuse
        
        homosexuality
        
        alcoholism
      - From “badness” → “sickness”