Quotes

Contemporaneous statements from emails, briefings, and papers — selected for clarity, intent, or substance. 51 entries.

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• "FDA's analysis neglected to correct for masking, where signals for one vaccine are concealed by signals from other vaccines."

• "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."

• "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]."

• "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."

• "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."

• "Results from data mining are considered hypothesis generating and do not, by themselves, demonstrate causal associations."

• "I think that because of the FOIAs [Freedom of Information Act requests] we may have asked FDA to stop sending these weekly data mining outputs."

• "we discontinue the routine regular [weekly data mining] emails."

• "a more robust technique"

• "we have just learned that Dr. Szarfman is a co-author on a recently published paper based on COVID-19 vaccines and VAERS. We believe there are a number of issues with the paper and its findings, and we are discussing how to best respond."

• "[W]e are no longer routinely sending COVID data mining to CDC"

• "I was also hoping we would stop doing that at some point!"

• "especially in the capacity to unmask hidden signals"

• "Thanks. These are good."

• "'gold standard' for disproportionality analysis"

• "is roughly eight times more likely to occur with COVID-19 vaccines than with other vaccines."

• "signals for a vaccine of interest are hidden by the presence of other reported vaccines. This masking effect may in turn limit or delay our understanding of the risks associated with new and established vaccines."

• "create erroneous conflicts that feed in to anti-vaccination rhetoric"

• "Ana Szarfman[] has decided on her own to do vaccine analysis using VAERS as part of her work at FDA. She is, however, not doing this in collaboration with our CBER statisticians, and quite to the contrary, has been asked to cease and desist, because the strategy that she is using could create erroneous conflicts that feed in to anti-vaccination rhetoric."

• "[T]hanks for flagging this – we've made it clear to her that she should not be discussing or providing internal analyses externally, and needs to focus on her assigned work."

• "we have concerns about her communicating data mining findings using CBER VAERS data to CBER and non-CBER personnel."

• "[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]."

• "the background will only be for covid-19 vaccines, instead of for other vaccines. Therefore, masking covid-19 vaccine signals that are common with these vaccines, but not common across other types of vaccines."

• "RGPS is much, much better at unmasking signals than MGPS. It automatically identifies and corrects for confounders. This is an important function to have, given the pandemic situation."

• "[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"

• "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."

• "the 20-year-old MGPS model could potentially mask signals."

• "plan is actually to limit its distribution, largely for data security reasons."

• "she and Bill DuMouchel had found an increased risk of mortality following COVID-19 vaccination using data mining methods."

• "a method that automatically unmask[s] signals that remain hidden by other data mining methodologies, including MGPS [FDA's current data mining method abbreviated for Multi-item Gamma Poisson Shrinker]."

• "I am not astonished that [FDA's data mining system] was unable to detect these signals."

• "demonstrates the potential utility of a new signal detection methodology called RGPS that can address masking and confounding effects that cannot be properly controlled by conventional signaling methodologies."

• "Is [the Vaccine Adverse Event Reporting System ("VAERS")] signaling for myopericarditis?"

• "For the age groups 16-17 years and 18-24 years, yes."

• "This is a method that also strongly reduces confounding"

• "please hold off on creating and sending data mining reports and analyses using COVID-19 vaccine [adverse event] data."

• "Note that the ER05 signals of RPGS are higher than the EB05 signals of MGPS."

• "[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."

• "[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."

• "Note the safety signals for cardiac events with the Pfizer and Moderna vaccines, now in the news, that are better identified by RGPS than by MGPS."

• "Before we potentially reach out to Ana, we should meet internally – many considerations not suited to email..."

• "[t]he best person to ask would be Ana [Szarfman] as she has close ties with Bill DuMouchel."

• "[o]nly if you mix in more non-covid reports within each stratum can you get enough diversity to allow larger disproportionalities."

• "I don't pretend to understand it, but sounds like they are suggesting an analysis not stratified by year."

• "49 examples of extreme masking"

• "I know that she knows a lot more about data mining than I do!"

• "I know Ana [Szarfman] worked to develop the data mining system and this might be a special circumstance due to her knowledge and experience."

• "we aren't interested in additional data mining studies of COVID data outside of CBER's usual processes."

• "RGPS is the state of the art"

• "I know Ana [Szarfman] worked to develop the data mining system"

• "safety signals may remain hidden"