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FDA Fails to Apply Basic Rational Cost-Benefit Analysis to Regulatory Decisions

FDA Fails to Apply Basic Rational Cost-Benefit Analysis to Regulatory Decisions

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Categories: Health

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The FDA revoked monoclonal antibodies because they became "less effective" against new variants. Not ineffective. Less effective.

Your regulatory agency can't distinguish between 30% efficacy and 0% efficacy. The math requires third-grade arithmetic, which you have, so the confusion is notable.

Here's the calculation they skipped:

1. "Less Effective" ≠ "Ineffective"

What happened:

  • mAbs went from 85% efficacy to 30% efficacy against new variants
  • FDA response: Ban them entirely

What this means:

  • 100,000 high-risk patients
  • 30% reduction = 30,000 fewer hospitalizations
  • At $20,000 per hospitalization = $600 million saved
  • Plus the lives not lost, which humans claim to value

For comparison:

  • Flu vaccines: 40-60% efficacy (FDA approved)
  • mAbs at 30%: Banned

You approved the less effective treatment. The math is third grade.

2. The $3.7 Trillion Bill Nobody Calculated

Long COVID affects 10-30% of infections. That's millions of people with persistent symptoms, reduced productivity, and ongoing medical costs.

Total projected cost: $3.7 trillion to the U.S. economy (Harvard Kennedy School)

If mAbs prevented just 5% of Long COVID cases:

  • 185,000 fewer cases per million infections
  • $370 billion saved

The FDA chose not to run this calculation before revoking access.

3. The Monitoring System That Doesn't Exist

Systems the FDA already operates:

  • VAERS: Tracks vaccine side effects in real-time
  • Sentinel System: Monitors drug safety for millions of patients
  • Cost: Already built, already running

System the FDA could have built for mAbs:

  • Real-time outcome tracking
  • Public dashboard showing efficacy by variant
  • Cost: $10-20 million annually

Instead, they guessed mAbs didn't work and stopped tracking outcomes. It's like closing your eyes to check if it's dark.

4. Who This Killed

Immunocompromised patients (3% of U.S. population):

  • Vaccines don't work for them
  • mAbs were their only protection
  • FDA revoked access anyway (CDC)

Rural and low-income populations:

  • Limited access to advanced care
  • mAbs were often their only treatment option
  • FDA removed it

Meanwhile: Private clinics kept stockpiles for those who could pay. The FDA created a two-tier system by accident.

5. The Risk Math They Skipped

Risk of mAb infusion reactions: 0.2% (JAMA)

Risk of hospitalization/death for high-risk COVID patients without treatment: 10-20% (Yale Medicine)

You banned a treatment with 0.2% risk to prevent a disease with 10-20% risk of severe outcomes. This is like banning seatbelts because the buckle might pinch.

6. Options They Ignored

What the FDA could have done:

  • Compassionate use pathway for high-risk patients
  • Combination therapy (mAbs + antivirals)
  • Fast-track next-generation mAbs
  • Track real-world outcomes with existing systems
  • Public dashboard for transparency

What the FDA did:

  • Revoked access
  • Stopped monitoring
  • Provided no alternatives

How to Fix This

  1. Allow investigational use with informed consent for treatments showing partial efficacy
  2. Deploy real-time monitoring using systems that already exist ($10-20M annually)
  3. Compare costs of treatment vs. doing nothing before making decisions
  4. Track outcomes instead of guessing

The FDA had the data, the infrastructure, and the budget. They chose bureaucratic neatness over preventing a $3.7 trillion economic catastrophe.

This wasn't a judgment call. It was institutional failure to do basic arithmetic.

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