Bethany Baer, MD
Official, Division of Pharmacovigilance, FDA CBER OBPV
CBER official who questioned Dr. Szarfman's access to VAERS data and acknowledged in 2024 that the RGPS model yielded significantly higher signals than MGPS.
Timeline appearances (16)
- analysis
Menschik and Baer exchange about classic data mining references written by Szarfman and DuMouchel.
- 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
Menschik requests a special MGPS run apparently adjusting for masking with COVID-19 vaccines.
- 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 shares an EB data mining analysis; Niu confirms to Menschik she is not collaborating.
- internal
Szarfman tells Commonwealth contractor that the 20-year-old MGPS model could potentially mask signals.
- analysis
Szarfman clarifies masking concerns to Commonwealth and reiterates RGPS advantages over MGPS.
- 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 (4)
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"I understand the theory behind masking and trying to adjust for it, but I feel that comprehending the details of the approach and, importantly, which approach is 'better,' is beyond my training and experience. I think someone with more data mining expertise would have to be involved in that decision."
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"I know that she knows a lot more about data mining than I do!"
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"I know Ana [Szarfman] worked to develop the data mining system"
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"I know Ana [Szarfman] worked to develop the data mining system and this might be a special circumstance due to her knowledge and experience."