Craig Zinderman, MD, MPH
Associate Director for Medical Policy, FDA CBER OBPV
Transmitted the May 7, 2021 email directing Dr. Szarfman to hold off on creating and sending COVID-19 vaccine data mining reports and analyses.
Timeline appearances (16)
- internal
Zinderman tells Baer he has no issue with Szarfman's VAERS access through Empirica.
- internal
Baer questions Szarfman's COVID vaccine data mining; Zinderman cautions against blocking access.
- internal
Baer acknowledges Szarfman knows more about data mining but characterizes her comments as atypical.
- internal
Niu writes Baer that she and Zinderman will meet with Szarfman about her VAERS objectives.
- analysis
Szarfman shares DuMouchel's RGPS analysis showing 49 examples of extreme masking with senior FDA officials.
- analysis
Niu forwards DuMouchel's analysis to Zinderman without Szarfman; Zinderman flags it as worth considering.
- internal
Baer welcomes DuMouchel's input; Menschik pushes back on reaching out to Szarfman directly.
- analysis
Szarfman shares DuMouchel's RGPS analysis revealing six new statistically significant safety signals.
- internal
Baer reports to colleagues that Szarfman offered to show Commonwealth her VAERS analysis; Niu distances herself.
- internal
Szarfman resends RGPS analysis flagging cardiac signals; Niu tells her CBER cannot collaborate.
- internal
Szarfman shares an EB data mining analysis; Niu confirms to Menschik she is not collaborating.
- internal
Zinderman directs Szarfman to hold off on creating COVID-19 vaccine data mining reports and analyses.
- internal
Szarfman tells Commonwealth contractor that the 20-year-old MGPS model could potentially mask signals.
- internal
Menschik tells Szarfman that VAERS data mining is CBER's responsibility and discussions must stay in chain of command.
- internal
Zinderman sends what records suggest is FDA's final weekly COVID-19 vaccine data mining report.
- internal
FDA officials discuss the masking effect three years after Szarfman raised it; Baer points to her published paper.
Quotes (3)
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"I don't pretend to understand it, but sounds like they are suggesting an analysis not stratified by year."
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"please hold off on creating and sending data mining reports and analyses using COVID-19 vaccine [adverse event] data."
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"we aren't interested in additional data mining studies of COVID data outside of CBER's usual processes."