William DuMouchel, PhD
Then-Chief Statistician at Oracle
Inventor of the data mining algorithms (GPS, MGPS, RGPS) that supported FDA's data mining system. Collaborated with Dr. Szarfman on the analyses underlying this report.
Timeline appearances (20)
- analysis
Szarfman organizes a virtual meeting on a new safety data mining methodology designed by DuMouchel.
- analysis
Menschik and Baer exchange about classic data mining references written by Szarfman and DuMouchel.
- analysis
Szarfman raises COVID-19 vaccine safety monitoring concerns with CBER Director Marks.
- analysis
Szarfman presents RGPS to Marks and other CBER officials, calling MGPS not state of the art.
- analysis
Szarfman shares DuMouchel's RGPS analysis showing 49 examples of extreme masking with senior FDA officials.
- analysis
DuMouchel sends analysis adjusting for the fact that 99% of 2021 VAERS reports are for COVID-19 vaccines.
- analysis
Niu asks whether DuMouchel's findings affect 2021 data mining results; Szarfman confirms they do.
- 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
Szarfman resends RGPS analysis flagging cardiac signals; Niu tells her CBER cannot collaborate.
- analysis
Szarfman circulates analysis showing MGPS undervalued acute myocardial infarction signals for Pfizer and Moderna.
- publication
Szarfman receives clearance from Stockbridge to publish her paper on masking and RGPS.
- analysis
Szarfman resends RGPS analysis on acute myocardial infarction and invites Forshee to collaborate.
- analysis
Szarfman writes Forshee that RGPS shows statistically significant mortality signals for Pfizer and Moderna vaccines.
- internal
Forshee forwards Szarfman's mortality findings to Marks, expressing concern about her interpretation.
- publication
Walinsky circulates Szarfman's preprint to FDA officials weighing Moderna's pediatric COVID-19 vaccine appeal.
- publication
Szarfman, DuMouchel, and co-authors publish 'Signaling COVID-19 Vaccine Adverse Events' in Drug Safety.
- internal
FDA officials discuss the masking effect three years after Szarfman raised it; Baer points to her published paper.
- analysis
Baer tells Menschik RGPS yields significantly higher signals than MGPS; Menschik concurs but prefers to keep MGPS.
Quotes (1)
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"[o]nly if you mix in more non-covid reports within each stratum can you get enough diversity to allow larger disproportionalities."