_quarto-invisible-graveyard.yml

project:
  type: website
  output-dir: _site/invisible-graveyard
  execute-dir: project
  resources:
    - knowledge/data/
    - assets/
    - _redirects
    - robots.txt
    - llms.txt
  render:
    # Paper is copied to index.qmd by render script
    - index.qmd
    - knowledge/appendix/parameters-and-calculations.qmd

# Custom fields for render-quarto.py
dih-render:
  emoji: "⚰️"
  index-source: knowledge/appendix/invisible-graveyard.qmd
  redirect-from: https://invisible-graveyard.warondisease.org
  fallback-404-redirect-domain: https://manual.WarOnDisease.org  # Redirects here if path doesn't exist on this site
  pdf-output-file: invisible-graveyard.pdf
  netlify-site-id: "ef37ca63-13e5-4403-bf47-173763af79ab"
  netlify-cname: "invisible-graveyard-warondisease-org.netlify.app"
  show-confidence-intervals: true  # Show 95% CI ranges for calculated values in academic papers
  concept-terms:
    - term: "Invisible Graveyard"
      manual-target: knowledge/problem/fda-is-unsafe-and-ineffective.qmd
      aliases:
        - "mortality cost of FDA efficacy lag"
  # Image generation prompts (used by scripts/images/generate-project-branding-images.ts)
  favicon-prompt: "A gravestone with a pill on it."

profiles:
  default:
    dotenv:
      allowEmptyValues: true

author:
  - name: Mike P. Sinn
    email: m@warondisease.org
    orcid: 0009-0006-0212-1094
    affiliations:
      - name: "Institute for Accelerated Medicine"
        url: https://acceleratedmedicine.org

website:
  title: "The Invisible Graveyard: Quantifying the Mortality Cost of FDA Efficacy Lag"
  description: 'After proving a drug is safe, the FDA requires 8.2 years to prove it works before patients can access it. We estimate this delay cost 102 million deaths among people waiting for approved drugs (1962-2024). The human cost in death and disability of blocking good drugs is 3.07k higher than the cost of approving bad ones.'
  site-url: https://manual.warondisease.org/knowledge/appendix/invisible-graveyard.html
  favicon: assets/icons/invisible-graveyard-favicon.png
  page-navigation: true
  page-footer:
    left: "© 2025 [Institute for Accelerated Medicine](https://acceleratedmedicine.org) | [CC BY-NC 4.0](https://creativecommons.org/licenses/by-nc/4.0/)"
    center: "[PDF](/invisible-graveyard.pdf) | [All Papers](https://manual.warondisease.org/knowledge/papers.html)"
    right: "[VOTE](https://WarOnDisease.org)"
  navbar:
    right:
      - text: "dFDA Framework"
        href: https://dfda-spec.warondisease.org
      - text: "Calculations"
        href: knowledge/appendix/parameters-and-calculations.qmd
      - text: "VOTE"
        href: https://WarOnDisease.org

execute:
  fig-path: "knowledge/figures/"
  cache: false
  freeze: auto  # Only re-run cells when content changes
  daemon: 300
  daemon-restart: false
  env:
    PYTHONPATH: "."

metadata:
  importance: 92
  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: "Regulatory Economics, FDA Policy, Drug Lag, Mortality Analysis, Cost-Benefit Analysis"
  category: "Academic Paper, Health Economics, Regulatory Policy, Public Health"
  coi-statement: "The author would like to disclose a personal bias against 102 million preventable deaths, which some may consider a conflict of interest in regulatory policy analysis. Beyond this, the author declares no competing interests."
  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 subjects. The FDA's post-1962 efficacy requirements, which are its subject, involved 102 million of them."
  funding: "This research received no funding from any agency. The FDA, whose policies are examined herein, did not offer to sponsor a review of its own mortality footprint."
  github-profile: "https://github.com/mikepsinn"
  linkedin: "https://www.linkedin.com/in/mikesinn"
  orcid-url: "https://orcid.org/0009-0006-0212-1094"
  google-scholar: "https://scholar.google.com/citations?user=RjDd_qcAAAAJ"
  keywords:
    - fda-regulation
    - drug-lag
    - kefauver-harris-amendments
    - regulatory-delay
    - type-ii-errors
    - mortality-analysis
    - cost-benefit-analysis
    - pharmaceutical-regulation
    - dalys
    - efficacy-requirements
    - peltzman
    - regulatory-economics
  version: "1.0"
  edition: "Working Paper"
  copyright: "© 2025 Mike P. Sinn"
  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: "Regulatory Economists, Health Policy Researchers, FDA Reform Advocates, Public Health Officials, Pharmaceutical Industry Analysts"
  format: "Working Paper"
  type: "Academic"
  genre: "Health Economics, Regulatory Policy, Cost-Benefit Analysis"
  medium: "Digital"
  twitter-site: "https://x.com/warondisease"
  twitter-creator: "https://x.com/warondisease"
  og-site-name: "The Invisible Graveyard"

  # Identifiers (update when paper is published)
  # Zenodo Concept DOI (stable across all versions - use for citations and new versions)
  doi: "10.5281/zenodo.18356231"

  # Open Graph metadata
  open-graph: true
  image: "https://manual.warondisease.org/assets/og/invisible-graveyard-og-1200x630.jpg"

  # Publication tracking
  publishing:
    own-site:
      url: "https://manual.warondisease.org/knowledge/appendix/invisible-graveyard.html"
      status: pending
    preprints:
      - platform: zenodo
        status: auto-uploaded
        url: "https://zenodo.org/record/18356231"
        doi: "10.5281/zenodo.18356231"
      - platform: ssrn
        status: pending
        url: ""
      - platform: medrxiv
        status: pending
        url: ""
    journals:
      - name: "Journal of Law and Economics"
        tier: 1
        status: target
        url: ""
      - name: "Regulation (Cato Institute)"
        tier: 2
        status: target
        url: ""
      - name: "Health Economics"
        tier: 2
        status: target
        url: ""

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

# Bibliography: Single source of truth for all citations
bibliography: references.bib
csl: nature-annotated.csl  # Renders 'abstract' field (quotes) in bibliography

jupyter: dih-project-kernel

format:
  html:
    lightbox: auto
    theme:
      - cosmo
    mermaid:
      theme: neutral
    echo: false
    number-sections: true
    toc: true
    toc-depth: 3
    css:
      - styles.css
      - economics-overrides.css
    include-before-body:
      - file: assets/html/page-loader.html
    include-after-body:
      - file: assets/html/site-enhancements-loader.html
    include-in-footer:
      - file: assets/html/generated-footer.html
    include-in-header:
      - text: |
          <!-- Icons (project-specific) - TODO: Generate invisible-graveyard-specific icons -->
          <link rel="icon" type="image/png" sizes="32x32" href="/assets/icons/favicon-32x32.png">
          <link rel="icon" type="image/png" sizes="16x16" href="/assets/icons/favicon-16x16.png">
          <link rel="apple-touch-icon" sizes="180x180" href="/assets/icons/apple-touch-icon.png">
          <link rel="icon" type="image/png" sizes="192x192" href="/assets/icons/android-chrome-192x192.png">
          <link rel="icon" type="image/png" sizes="512x512" href="/assets/icons/android-chrome-512x512.png">
      - file: assets/html/google-analytics.html
      - file: assets/html/hypothesis.html
      - file: assets/html/fonts-preload.html
    citation-hover: true
    code-fold: true
    link-citations: true
    smooth-scroll: true
    code-tools: false
    filters: [assets/filters/live-version-note.lua]
  pdf:
    output-file: "invisible-graveyard.pdf"
    documentclass: article
    institute: "Institute for Accelerated Medicine"
    echo: false
    toc: true
    toc-depth: 3
    number-sections: true
    colorlinks: true
    link-citations: true
    include-in-header:
      - callout-bw.tex
      - institute-header.tex
      - text: |
          \paperurl{https://manual.warondisease.org/knowledge/appendix/invisible-graveyard.html}
    geometry:
      - top=1in
      - bottom=1in
      - left=1in
      - right=1in
    fontsize: 11pt
    date: ""
    filters: [assets/filters/live-version-note.lua]