From Brownstone Institute:
When evaluating new interventions for healthy newborns, presenting the full safety record – including every death – is not optional; it is a fundamental obligation. This is always true, but in the case of Merck’s clesrovimab, it was especially critical: the FDA skipped presenting the product to its advisory committee on the grounds that it was “not first in class.”
This left ACIP as the only public forum charged with reviewing the product. Instead of two independent layers of oversight, there was only one. In such circumstances, withholding or downplaying deaths meant that ACIP – the sole safeguard – was not given the complete picture it needed to protect infants and families.
Before turning to the substantive issues, two clarifications are in order:
A large portion of the critique is devoted to personal ad hominem remarks. Such rhetoric does not honor the principles of scientific debate and is contrary to what science should represent. I will therefore not address these attacks further.
Some of the first claims in the critique actually concern an article by Dr. Maryanne Demasi, which I cited. Since I included them, I will clarify them briefly:
- “The CDC split the age groups (0-37 days vs. 38 days-8 months) for sound epidemiological reasons, not to conceal a signal.”
My article highlighted that the split erased statistical significance. A unified calculation shows a nearly fourfold increase in seizure risk, a signal that was never presented to ACIP. The split was not explained during the meeting, and it occurred exactly at the point when routine vaccinations begin. Even if additional vaccines are a confounder, that does not absolve the CDC of its obligation to present the combined analysis. An advisory committee deserves to see both the stratified and the pooled results.(Read more.)


No comments:
Post a Comment