Narayan Nair, MD
Division Director, Division of Pharmacovigilance, FDA CBER OBPV
Suggested in 2022 that FDA discontinue routine distribution of weekly COVID-19 data mining reports to CDC and acknowledged in 2023 that FDA was aware of the masking limitation during the pandemic.
Timeline appearances (10)
- analysis
Szarfman organizes a virtual meeting on a new safety data mining methodology designed by DuMouchel.
- internal
Zinderman directs Szarfman to hold off on creating COVID-19 vaccine data mining reports and analyses.
- internal
Anderson asks Marks that Szarfman refrain from using FDA email or communicating findings using CBER VAERS data.
- internal
Zinderman sends what records suggest is FDA's final weekly COVID-19 vaccine data mining report.
- internal
Menschik confirms FDA is no longer routinely sending COVID-19 vaccine data mining to CDC.
- internal
Nair tells colleagues he suggested CDC discontinue the routine weekly data mining emails.
- internal
Menschik argues against sharing FDA data mining output with CDC, citing concerns about misuse and over-reliance.
- internal
Nair responds to CDC framing data mining as hypothesis-generating and not, by itself, evidence of causation.
- analysis
Nair tells Harvard's Maro that FDA was aware of the masking limitation before and during the pandemic.
- internal
FDA officials discuss the masking effect three years after Szarfman raised it; Baer points to her published paper.
Quotes (4)
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"We were aware of this limitation before and during the pandemic. There are many data mining tools and there was some discussion about utilizing a novel tool to adjust for this. However, we thought it would be problematic to use a brand new, possibly unvalidated tool in the context of an EUA."
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"we discontinue the routine regular [weekly data mining] emails."
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"I know in the past we have discussed one of the possible limitations of data mining currently is the vast number of VAERS reports from the COVID vaccines may limit our ability to detect statistical alerts because disproportionality scores may be driven towards the null."
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"Results from data mining are considered hypothesis generating and do not, by themselves, demonstrate causal associations."