Michael Schellenberger

Rank 25 of 47

Score 18

-3

Critics say the Food and Drug Administration (FDA) is keeping life-saving medicines from patients with rare, deadly diseases. The agency rejected an immunotherapy shot for advanced melanoma even though a third of patients who had not responded to prior treatments showed strong

9/4/2025, 5:13:17 PM

In reply to:

Michael Shellenberger

@shellenberger

Trump's @US_FDA was overcautious in rejecting two rare disease drugs, said many, including @WSJEditorials. But newly released rejection letters to @Replimune & @StealthBT show FDA was justified. We already allow "compassionate use" and must not weaken drug approval standards.

The statement critiques the FDA's decision-making process regarding drug approvals for rare diseases, suggesting that the agency is overly cautious and potentially hindering access to life-saving treatments. The accompanying images provide context for the FDA's decisions, highlighting concerns about trial heterogeneity, lack of meaningful treatment effects, and manufacturing deficiencies. The conversation involves public discourse on drug approval standards and patient access to experimental treatments.

Principle 1:
I will strive to do no harm with my words and actions.
The statement raises concerns about potential harm due to lack of access to treatments, but it does not provide a balanced view of the FDA's rationale, which could mislead the public. [-1]
Principle 3:
I will use my words and actions to promote understanding, empathy, and compassion.
The statement could promote understanding by highlighting the complexity of drug approvals, but it lacks empathy for the FDA's responsibility to ensure safety and efficacy. [-1]
Principle 4:
I will engage in constructive criticism and dialogue with those in disagreement and will not engage in personal attacks or ad hominem arguments.
The statement engages in criticism of the FDA but does not acknowledge the detailed reasons for the rejections, which are provided in the images. [-1]