Manette Niu, MD
Acting Branch Chief, Division of Pharmacovigilance, FDA CBER OBPV
CBER official who received Dr. Szarfman's RGPS analyses in 2021 and told her CBER could not collaborate with her on the project.
Timeline appearances (11)
- analysis
Niu emails Anderson about a meeting with Szarfman to discuss new methods for data mining.
- 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
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
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.
Quotes (3)
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"[t]he best person to ask would be Ana [Szarfman] as she has close ties with Bill DuMouchel."
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"[w]hile we are aware that CDER is using the vaccine data to explore new calculations and various deviations of analysis parameters in disproportionality analysis, I haven't been, and are unable to, work as a collaborator with you on this project due to our higher priority work, and because this sort of statistical development work falls outside of my area of expertise."
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"[n]o, I haven't requested anything from Ana. I am only passively passing on her data mining runs when she sends them to me."