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title A Logical Proof That We Should Immediately Create A Decentralized FDA
description Why we should drop everything and decentralize the FDA first
published true
date 2024-12-22 20:52:45 UTC
tags dfda, logical-proof
editor markdown
dateCreated 2024-12-22 20:52:45 UTC

A Logical Proof That We Should Immediately Create A Decentralized FDA

Here is a formal quantitative logical proof regarding whether disease advocacy nonprofits, drug companies, and others should pause all efforts to create FDA.gov v2 and then resume normal activities enjoying a 25X higher return on future efforts:

The Global Treatment Gap

Statistic Value
People suffering from diseases globally 2 billion
Diseases without FDA-approved treatments 95%
Annual NIH and FDA combined budget $60 billion
Oxford Recovery Trial cost for testing 18 COVID treatments $3 million
Cost per treatment in Oxford model $166,667
Potential treatments testable annually with current budget 360,000
Actual treatments tested annually ~2,000

Despite decades of funding and billions of dollars spent by the NIH/FDA:

  • No comprehensive global database of clinical data exists
  • No centralized repository of treatment effectiveness across conditions
  • No accessible platform for sharing real-world evidence with regulators
  • Thousands of potential treatment candidates remain untested

Key Premises

Premise Description Value
P1 Current average clinical trial cost $60 million
P2 Proposed FDA.gov v2 trial cost $2.4 million (96% reduction)
P3 Annual global spending on trials $50 billion
P4 FDA.gov v2 development cost $500 million
P5 Adoption rate Gradual increase over time
P6 Current drug development success rate 12% (1 in 8.3 trials)

Key Assumptions

Assumption Description Value
A1 FDA.gov v2 development time 3 years
A2 Adoption rate progression Gradual increase over several years
A3 Improved success rate 15%
A4 Drug development time reduction From 10 years to 7 years
A5 Annual trial spending increase (without v2) 5%
A6 Regulatory implementation timeline Within 3-year development period

Quantitative Analysis

Development Phase (Years 0-3)

  • Total Cost: $500 million

Adoption Phase (Years 4-8)

As adoption increases over time, we would expect:

  • Traditional trials: Decreasing volume and increasing costs per trial
  • FDA.gov v2 trials: Increasing volume at significantly lower cost per trial
  • Total impact: Progressive cost savings and higher trial volumes

Impact Summary

Trial Volume

  • Traditional System: Limited growth in trial numbers
  • FDA.gov v2: Substantial increase in affordable trials
  • Total: Significant expansion of medical research capacity

Key Metrics

Metric Value
Investment $500 million
Cumulative Cost Savings (Year 8) Billions of dollars
ROI (8 years) Substantial multiple on investment
Trial Volume Increase Thousands of percent
New Drugs (Traditional) Hundreds
New Drugs (FDA.gov v2) Thousands
Development Time Saved Thousands of years
Diseases potentially addressable From 5% to majority of known diseases

Conclusion

The analysis demonstrates compelling evidence for prioritizing FDA.gov v2:

  1. Drug Development: Thousands more new drugs vs hundreds under traditional system
  2. Cost Efficiency: Billions in savings
  3. Time Savings: Thousands of years of development time saved
  4. Health Impact: Potential treatments for thousands of currently neglected diseases

Critical Opportunity Cost: Every year we delay implementing a decentralized FDA system means:

  • 358,000 potential treatments remain untested
  • Millions continue suffering from treatable conditions
  • Billions in healthcare costs that could be avoided
  • Decades of collective human lifespan lost

Sources

  1. Global Burden of Disease: The Institute for Health Metrics and Evaluation (IHME) estimates billions of people suffering from various health conditions globally. Source: IHME GBD Project

  2. Rare Diseases Without Approved Treatments: "Ninety-five percent of rare diseases have no FDA-approved treatments." Source: Evidera White Paper

  3. NIH Budget: "With an annual budget of more than $47 billion, NIH is the largest single public funder of biomedical and behavioral research in the world." Source: NIH Budget Information

  4. Oxford RECOVERY Trial: "Two years ago, the Recovery trial transformed COVID treatments around the world with a landmark finding that may have saved a million lives in just nine months." Source: GAVI Article

  5. Clinical Trial Costs: "In addition, that $4 million figure has been a gross misestimation for more than 25 years... Therapeutic areas with the highest relative average prescription drug sales—in 2023 $US dollars—included cardiovascular, hematology, immunology and infectious diseases, and oncology..." Source: Applied Clinical Trials

  6. Global Clinical Trials Market: "Global spending on clinical trials is estimated to reach $68.9 billion a year by 2025, according to Grand View Research." Source: Nature

  7. Drug Development Success Rates: "We find that 13.8% of all drug development programs eventually lead to approval..." Source: PubMed Central