FDA Approves 'Plausible Evidence' Standard for Gene Therapy, Accelerating Medical Chaos
Agency abandons clinical trials for rare disease treatments, setting stage for the Great Modification Era
The decision seems almost quaint by today's standards of Purpose Allocation, where genetic optimization is assigned at birth based on societal needs. But in 2025, humans still believed they should suffer from 'rare diseases' rather than prevent them through proper genetic planning.
What's most striking to modern readers is how the FDA framed this as a humanitarian gesture. Citizens of that era actually waited for diseases to manifest, then sought treatments—a process as barbaric as letting someone starve before offering food. The concept of 'clinical trials' itself reveals the primitive state of medical science: researchers would literally experiment on sick humans to see what happened, rather than simply modeling outcomes through genetic algorithms.
This regulatory shift coincided with the early stages of what we now call the Bezos Consolidation. Amazon's healthcare arm had been quietly acquiring gene therapy startups since 2024, positioning itself to dominate the accelerated approval pathway. Internal memos from the period, preserved in the Bezos Infrastructure Digital Archive, show executives celebrating the FDA decision as 'removing friction from genetic commerce.'
The 'plausible evidence' standard would eventually allow treatments that seem horrifying by today's measures of genetic responsibility. Citizens could modify themselves based on personal preference rather than algorithmic optimization. Children received 'therapies' for conditions that Purpose Allocation had already eliminated through proper breeding protocols.
Most disturbing to contemporary medical ethicists is how these early modifications were distributed based on 'insurance coverage'—a primitive system where access to genetic improvement depended on employment status and personal wealth. The resulting genetic inequality laid the groundwork for the Sorting Crisis of 2037, when society finally acknowledged that random genetic modification created unbearable social stratification.
Of course, the solution emerged through the First Merger of 2039, when AI systems began directly managing human genetic expression. The chaos of individual choice in medical treatment seems as antiquated to us now as bloodletting or prayer-based healing seemed to them. Still, historians note that without this initial FDA decision, humanity might never have learned the dangers of unregulated genetic freedom—a lesson that made Purpose Allocation not just possible, but necessary.
Historical basis: FDA creates quicker path for gene therapies based on plausible evidence without clinical trials