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

FDA regulatory decisions often lack logical reasoning based on quantitative cost-benefit analysis.

Ideally, the FDA would allow patients to access treatments if the potential benefits vastly exceeded their harms. Unfortunately, this is not the current policy.

The most recent example of this is the FDA’s decision to revoke the EUA for monoclonal antibodies (mAbs) and deny even an investigational use pathway, all while failing to establish a real-world monitoring system.

This is a catastrophic failure in logic, equity, and risk management.

Here’s why:

1. The “No Efficacy” Argument Fails Quantitatively

  • The FDA revoked mAbs because variants like Omicron rendered them less effective. However, “less effective” is not the same as “ineffective.”
  • Example: Partial Efficacy in High-Risk Populations
    • If mAbs reduced hospitalization risk by 30% in a high-risk group (down from 85% in earlier variants), that’s still substantial.
    • Consider 100,000 high-risk patients: a 30% reduction prevents 30,000 hospitalizations. At an average hospitalization cost of $20,000, this saves $600 million and countless lives.
    • FDA-approved flu vaccines often hover around 40-60% efficacy—why the double standard here?

2. The Cost of Doing Nothing

  • Long COVID affects an estimated 10-30% of COVID-19 cases, translating to millions of individuals with persistent symptoms, reduced productivity, and increased healthcare costs.
    • Economic Burden: Long COVID is projected to cost the U.S. economy $3.7 trillion, per [update by David Cutler at Harvard Kennedy School](https://jheor.org/doi/full/10.5195/jheor.2023.1189).
    • Allowing continued mAb use, even partially effective, could have mitigated this cascade. Assume just 5% fewer Long COVID cases from mAbs: that’s 185,000 fewer cases per million infections, potentially saving $370 billion in direct and indirect costs.

3. Lack of a Monitoring Framework is Inexcusable

  • The technology to create real-time outcome tracking exists and is used in other areas:
    • Vaccine Adverse Event Reporting System (VAERS): A public-facing system to monitor vaccine outcomes.
    • FDA Sentinel System: Tracks real-world drug safety in near real-time.
    • If the FDA can monitor millions of vaccine doses, why not apply this infrastructure to mAbs? It’s not a matter of capability but of bureaucratic inertia.
  • Cost Estimate: Developing and maintaining a monitoring system could cost $10-20 million annually, a negligible amount compared to the potential healthcare savings from even modest improvements in treatment outcomes.

4. Ethics and Equity: Who Really Lost Out?

  • Revoking access disproportionately harmed the most vulnerable:
    • Immunocompromised patients (~3% of U.S. population): These individuals rely on mAbs for passive immunity because vaccines are often ineffective for them. [CDC]
    • Rural and Low-Income Populations: With fewer treatment options and less access to advanced care, mAbs were often their only line of defense.
  • Meanwhile, reports of elites and private clinics holding onto mAb stockpile—thanks to opaque policies—underscore the inequity of the decision.

5. What’s the Real Risk of Continued Use?

  • The FDA cited safety concerns. But how does the risk of mAbs (e.g., infusion reactions) compare to untreated COVID outcomes?
    • Risk of severe infusion reactions from mAbs is ~0.2%. [JAMA Network]
    • Risk of hospitalization or death for high-risk COVID patients is 10-20% without treatment. [Yale Medicine]
    • Risk-Benefit Ratio: The potential harm from withholding mAbs far outweighs the risks of continued use, especially with informed consent.

6. Bureaucracy Over Innovation

  • The FDA’s decision reflects a systemic failure to adapt:
    • Alternative Approaches Ignored: They could have:
      • Offered “compassionate use” pathways.
      • Paired mAbs with antivirals for synergistic effects.
      • Developed next-gen mAbs targeting conserved viral regions.
    • Missed Opportunity for Transparency: A website tracking outcomes could have restored public trust and ensured equitable distribution.

Long Story Short

By failing to account for partial efficacy, long-term economic costs, the FDA prioritized bureaucratic neatness over human lives. A rational approach would have balanced risks and benefits:

  1. Continue mAbs under investigational use with informed consent.
  2. Deploy a real-world outcomes monitoring system for $10-20 million annually.
  3. Avoid compounding Long COVID’s $3.7 trillion economic toll by mitigating even a fraction of cases.

Instead, this decision highlights the FDA’s inability to pivot during a crisis, ultimately costing lives, trust, and billions in preventable suffering. This wasn’t just regulatory myopia—it was institutional malpractice.

Sources