David Menschik, MD, MPH
Associate Director for Surveillance Informatics, Division of Pharmacovigilance, FDA CBER OBPV
Distributed FDA's weekly COVID-19 vaccine data mining reports and helped draft the May 2021 email directing Dr. Szarfman to hold off on her analyses.
Timeline appearances (22)
- analysis
Menschik and Baer exchange about classic data mining references written by Szarfman and DuMouchel.
- 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
Menschik circulates safety signal list and a draft presentation on MGPS limitations to FDA and CDC 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
Zinderman directs Szarfman to hold off on creating COVID-19 vaccine data mining reports and analyses.
- internal
Menschik informs CDC officials that FDA will limit distribution of its data mining reports for data security reasons.
- 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
Menschik tells Szarfman that VAERS data mining is CBER's responsibility and discussions must stay in chain of command.
- publication
Menschik shares draft article language with CDC's Su that echoes Szarfman's masking concerns without crediting her.
- 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
CDC officials discuss the end of weekly FDA reports; one notes CDC may have asked FDA to stop because of FOIAs.
- 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.
- 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 (10)
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"I was also hoping we would stop doing that at some point!"
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"Before we potentially reach out to Ana, we should meet internally – many considerations not suited to email..."
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"[I]f the comparison group is enriched with so many mRNA COVID-vaccine reports, tha[n] it becomes very difficult to exceed the EB05>2 alert threshold for an adverse event that may be associated with mRNA vaccines – thus data mining has blind spots"
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"can be muted by COVID-19 vaccine reports contributing substantially to the comparator group, particularly if both mRNA COVID-19 vaccines are associated with the same adverse event."
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"plan is actually to limit its distribution, largely for data security reasons."
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"[W]e are no longer routinely sending COVID data mining to CDC"
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"[a]ny further discussion on VAERS data mining methods/findings outside my chain of command will have to be offline and in general terms, as well as without reference to any specific VAERS [adverse events]."
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"in general the [RGPS model] appears way more sensitive in that its scores are generally higher than corresponding [MGPS model] scores when sampling different [adverse events]."
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"For the age groups 16-17 years and 18-24 years, yes."
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"Is [the Vaccine Adverse Event Reporting System ("VAERS")] signaling for myopericarditis?"