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Pharmaceuticals & Society pill images Unknown, STS & CORE…
Pharmaceuticals & Society
History of Medicine
Humoral
-Diet/Lifestyle
-4 Humors
-Balance
Iatro-theology
-Sin/Providence
-Prayer/exorcism
-Religion
Rise of Medicine
-Professionalization
-Standardization
-Institutionalization
-Authority
-1890-1945
Health concept
-Harmony→ disease
-Environment→ biology
-Absence of disease
Iatro-physics / chemistry
-Syndromes
-Paracelsus
-Anatomy
-Descartes
Iatro-technical
-Measurable disease
-Pathophysiology
-Lab medicine
-Instruments
Pharma Industry & Drug Developement
Rise of Chemistry (1800s)
-Isolation of compounds
-Active Ingredients
Coal-Tar
-Chemical modification (e.g acetylation)
-Organic chemistry→ new drugs
Apothecary (Pre-industrial)
-Specialized craft knowledge
-Community role (distinct from physicians)
-Plant / Minerals
Dye Industry→ Pharma Industry
-Industrial R&D labs
-Bayer, BASF, Hoechst, Agfa
Aspirin vs Heroin
-Aspirin = success
-Heroin= addiction crisis
-Same chemistry→ different outcomes
Germ Theory Revolution
-Lab science (Pasteur & Koch)
-Cause of disease
-Koch's Postulates (Specific Causation)
New Treatments
-Hormones (Insulin)
-Antibiotics (Penicillin)
-Vaccines & Immunity
-Kill bacteria
Economies of scope
-Shared knowledge
-Shared labs
Industrial labs
-Standard model
-Phd scientists
Molecular biology
-Hormones
-Targeted drugs
-Neurotransmitters
Drug discovery
-5,000-10,000 compounds
-Universities/ public research
Pre-clinical
-Safety
-Animals
-PK/PD
Clinical Trials
-Phase 2: Efficacy
-Phase 3: Comparison
-Phase 1: Safety
-Phase 4: Long-Term
Double-blind
-Placebo
-Reduce Bias
Scientific method
-Experiment
-Data
-Hypothesis
-Replication
PRICING,COVERAGE & ACCESS
pCPA
-Price negotiation
Provinces
-Formulary
-Eligibility
QALY
-Cost vs life
-Economic value
Medicare
-Hospitals + Doctors
-Drugs excluded
CADTH
-HTA
-Value assessment
Pharmacare
-Limited
-Partial coverage
PMPRB
-Price calling
-Not affordability
System
-Inequality
-Uninsured
-Patchwork
PATENTS, FINANCIALIZATION & STRATEGY
Patents
-Monopoly
-Innovation incentive
-20 years
Criteria
-Non-obvious
-Useful
-Novel
Functions
-Exclusivity
-Disclosure
-Recover R&D
Streptomycin
-University → industry
-Patent conflict
Me-too drugs
-Similar drugs
-Small changes
Generics
-Cheaper
-After patent
-Same drug
Evergreening
-Extend patents
-Delay generics
Financialization
-Shareholder value
-Profit focus
Patents as assets
-Increase value
-Attract investors
Pricing
-Value-based
-Willingness to pay
Nichebuster
-High price
-Small market
Consequences
-Inequality
-Market-driven R&D
-High prices
Bayh-Dole Act
-Tech transfer
-Industry partnerships
-Public→private
-Commercialization
-University patents
Regulatory (Canada)
History
-Thalidomide
-Stronger laws
Health Canada
-Efficacy
-Quality
-Safety
Approval
-NOC
-Legal Market
Tools
-NOC/c
-SAP
-Priority Review
Lifecycle
-Pre + Post Market
Federal vs Provincial
-Federal: approval
-Provincial: Pay
Post-Market
-Adverse Events
-Recalls
International
-ICH
-FDA/ EMA
INDUSTRY, INFLUENCE, MARKETING & HARM
CROs
-Outsourced trials
-Global
Ethics
-Consent issues
-Inequality
Regulatory Capture
-Industry influence
-Structural
Sponsored Trials
-Positive results
-Bias
Marketing
-Promotion
-Off-label
-Doctors/ patients
Sergio Sismondo→ marketing influence
Disease mongering
-Expand illness
-Create markets
SSRIs
-Depression
-Expanded diagnosis
KOLs
-Influence doctors
Opioids
-overprescribing
-crisis
-misleading safety
-Sergio Sismondo→ "Opioid marketing"
Reforms
-Transparency
-Independent research
Ghostwriting
-Fake authorship
-Sergio Sismondo → Ghostwriting
GLOBAL ACCESS TO MEDICINES
Access 1.0
-Inequality
-Power
-HIV/AIDS
Doha
-Public health > patents
-Compulsory licensing
Access 2.0
-Innovation + Access
-Broader diseases
-System reform
TRIPS
-Restrict Generics
-Global Patents
Activism
-Human rights
-South Africa Case
-MSF
COVID
-Vaccine Inequality
-Nationalism
AFRICA
Access pathway
-Regulation
-Procurement
-Imports
-Distribution
-Patents/Pricing
-Patient access
-R&D (global)
Challenges
-Weak system
-High costs
-Imports dependence
-Poor supply chains
-Low funding
-Workforce limits
-Fake drugs
AMA
-Harmonization
-Local production
Solutions
-Global cooperation
-Stronger systems
-Local manufacturing
Alternative Innovation
Public Model
-Gov R&D
Nonprofit
-Public health focus
Open science
-Shared knowledge
PDPs
-Collaboration
Key Ideas
-Pandemics
-Equity
-Market fail
-Hybrid Systems
STS & CORE THEORIES
Technological neutrality
Depends on use
Tool only
Social constructivism
Choices
Could be otherwise
Negotiation
Technological determinism
→No human choice
→ Tech→society
Co-production
Science + society
Mutual shaping
Embedded values
Politics
Inclusion/ exclusion
Core idea
Drugs = socio-technical systems
Shaped by law/ markets / politics
Power
