_quarto-drug-development-cost.yml

project:
  type: book
  output-dir: _site/drug-development-cost
  execute-dir: project
  resources:
    - knowledge/data/
    - assets/
    - _redirects
    - robots.txt
    - llms.txt

# Custom fields for render-quarto.py
dih-render:
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  emoji: "💊"
  index-source: knowledge/appendix/drug-development-cost-analysis.qmd
  redirect-from: https://drug-cost.warondisease.org
  fallback-404-redirect-domain: https://manual.WarOnDisease.org
  pdf-output-file: drug-development-cost-analysis.pdf
  show-confidence-intervals: true
  concept-terms:
    - term: "Drug Development Cost Increase Analysis"
      manual-target: knowledge/problem/fda-is-unsafe-and-ineffective.qmd
  favicon-prompt: "A pill capsule split open showing dollar signs spilling out"

profiles:
  default:
    dotenv:
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book:
  title: "Drug Development Cost Increase Analysis"
  author:
    - name: Mike P. Sinn
      email: m@warondisease.org
      orcid: 0009-0006-0212-1094
      affiliations:
        - name: "Institute for Accelerated Medicine"
          url: https://acceleratedmedicine.org
  description: 'Rigorous analysis of the 105x increase in drug development costs from pre-1962 to 2024, using Baily (1972) academic study with CPI adjustments and sensitivity analysis'
  abstract: "Drug development costs have increased approximately 105x in real terms since the 1962 Kefauver-Harris Amendment. This analysis uses the Baily (1972) academic study as the primary source, adjusts for inflation via Bureau of Labor Statistics CPI data, and validates the finding against six independent real-world price comparisons: generic vs. brand-name drugs, supplements vs. prescriptions, compounding pharmacies vs. FDA-approved products, veterinary vs. human drugs, orphan drug pricing, and historical antibiotic economics. Monte Carlo sensitivity analysis confirms the estimate is robust across plausible input ranges. The magnitude is consistent with independent estimates of 100-400x from multiple research groups."
  site-url: https://manual.warondisease.org/knowledge/appendix/drug-development-cost-analysis.html
  favicon: assets/icons/economics-favicon.png
  page-navigation: true
  chapters:
    - index.qmd
    - knowledge/appendix/parameters-and-calculations.qmd
    - knowledge/references.qmd
  navbar:
    right:
      - text: "Calculations"
        href: knowledge/appendix/parameters-and-calculations.qmd
      - text: "Full Manual"
        href: https://manual.WarOnDisease.org
  sidebar:
    collapse-level: 1
    style: "floating"
    search: true
    contents:
      - section: "Analysis"
        contents:
          - href: index.html
            text: "Drug Development Cost Analysis"
          - href: knowledge/references.qmd
            text: "References & Citations"

      - section: "Appendices"
        contents:
          - href: knowledge/appendix/parameters-and-calculations.qmd
            text: "Parameters & Calculations"

      - section: "Related Materials"
        contents:
          - href: https://manual.warondisease.org
            text: "Full Manual →"
          - href: https://impact.warondisease.org
            text: "1% Treaty Economic Analysis →"
          - href: https://invisible-graveyard.warondisease.org
            text: "Invisible Graveyard Paper →"

execute:
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  freeze: auto
  daemon: 300
  daemon-restart: false
  env:
    PYTHONPATH: "."

metadata:
  doi: "10.5281/zenodo.19077569"
  # Zenodo Concept DOI (stable across all versions - use for citations and new versions)
  importance: 20
  creator: "Mike P. Sinn"
  orcid: "0009-0006-0212-1094"
  primary-author: "Mike P. Sinn"
  byline: "Mike P. Sinn"
  human-author: "Mike P. Sinn"
  author-email: "mike@warondisease.org"
  author-url: "https://mikesinn.com"
  author-website: "https://mikesinn.com"
  contact: "mike@warondisease.org"
  language: "en-US"
  subject: "Drug Development, Health Economics, Regulatory Analysis, FDA Policy"
  category: "Non-fiction, Health Economics, Regulatory Analysis"
  coi-statement: "The author declares no competing interests, beyond a strong personal preference for being alive, which may bias conclusions toward 'we should spend less money on things that explode and more on things that cure.'"
  data-availability: "All data and code used in this analysis are publicly available at https://github.com/wishonia/earth-optimization-protocol"
  ethics-statement: "This research did not involve human experimentation. Spending 105x more on regulatory paperwork than actual drug manufacturing while diseases remain untreated is, however, arguably an uncontrolled experiment in bureaucratic homicide."
  funding: "This research received no funding. The annual cost of producing it was less than the FDA charges for a single pre-submission meeting."
  github-profile: "https://github.com/mikepsinn"
  linkedin: "https://www.linkedin.com/in/mikesinn"
  orcid-url: "https://orcid.org/0009-0006-0212-1094"
  twitter-creator: "https://x.com/warondisease"
  twitter-site: "https://x.com/warondisease"
  google-scholar: "https://scholar.google.com/citations?user=RjDd_qcAAAAJ"
  keywords:
    - drug-development-cost
    - fda-regulation
    - kefauver-harris-amendment
    - clinical-trials
    - pharmaceutical-economics
    - regulatory-burden
    - health-economics
    - baily-1972
    - tufts-csdd
    - orphan-drugs
  version: "1.0.0"
  edition: "First Edition"
  copyright: "© 2025 The Institute for Accelerated Medicine"
  copyright-year: "2025"
  license: "CC BY-NC 4.0"
  license-url: "https://creativecommons.org/licenses/by-nc/4.0/"
  rights: "Creative Commons Attribution-NonCommercial 4.0 International License"
  publisher: "Institute for Accelerated Medicine"
  publisher-url: "https://acceleratedmedicine.org"
  publisher-name: "Mike P. Sinn"
  publisher-email: "mike@warondisease.org"
  repo-url: "https://github.com/wishonia/earth-optimization-protocol"
  issue-url: "https://github.com/wishonia/earth-optimization-protocol/issues"
  source-url: "https://github.com/wishonia/earth-optimization-protocol"
  geographic-coverage: "Global"
  audience: "Policy Makers, Health Economists, Pharmaceutical Researchers, Regulatory Reform Advocates"
  format: "Working Paper"
  type: "Economic Analysis"
  genre: "Health Economics, Regulatory Analysis"
  medium: "Digital"
  open-graph: true
  image: "https://manual.warondisease.org/assets/og/drug-development-cost-og-1200x630.jpg"

# Remove "Appendix" prefix from appendix chapters
language:
  crossref-apx-prefix: ""
  section-title-appendices: ""

# Bibliography: Single source of truth for all citations
bibliography: references.bib
csl: nature-annotated.csl

jupyter: dih-project-kernel

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