The FDA's new pathway for rare disease drugs, based on causal biology, is scientifically promising. However, the name "plausible mechanism" is a critical flaw. The term sounds weak, creating doubt for patients and giving payers powerful leverage to deny coverage by implying a lower standard of evidence.

Effective vaccines eradicate the visible horror of diseases. By eliminating the pain and tragic outcomes from public memory, vaccines work against their own acceptance. People cannot fear what they have never seen, leading to complacency and vaccine hesitancy because the terrifying counterfactual is unimaginable.

An ideologically driven and inconsistent FDA is eroding investor confidence, turning the U.S. into a difficult environment for investment in complex biologics like gene therapies and vaccines, potentially pushing innovation to other countries.

Despite strong observational evidence from Israel suggesting early allergen exposure was beneficial, medical guidelines didn't change. It required the "gold standard" of a randomized controlled trial (the LEAP study) to definitively prove the link and force institutions to formally reverse their harmful avoidance recommendations.

Regulating technology based on anticipating *potential* future harms, rather than known ones, is a dangerous path. This 'precautionary principle,' common in Europe, stifles breakthrough innovation. If applied historically, it would have blocked transformative technologies like the automobile or even nuclear power, which has a better safety record than oil.

The FDA is shifting policy to no longer allow reliance on immunogenicity data (immunobridging) for approving new or updated vaccines. This move toward requiring full clinical efficacy trials will make it harder to combat evolving pathogens and would have prevented past approvals of key vaccines like those for HPV and Ebola.

A CDC website statement questioning the evidence base for the "vaccines do not cause autism" claim is now being leveraged by anti-vaccine advocates. The campaign is expanding to target vaccines containing aluminum adjuvants, potentially threatening essential public health programs for polio, measles, and pertussis by weaponizing scientific nuance.

The FDA's current leadership appears to be raising the bar for approvals based on single-arm studies. Especially in slowly progressing diseases with variable endpoints, the agency now requires an effect so dramatic it's akin to a parachute's benefit—unmistakable and not subject to interpretation against historical data.

A two-step analytical method to vet information: First, distinguish objective (multi-source, verifiable) facts from subjective (opinion-based) claims. Second, assess claims on a matrix of probability and source reliability. A low-reliability source making an improbable claim, like many conspiracy theories, should be considered highly unlikely.