I. Executive Summary
Documents produced by the Department of Health and Human Services (“HHS”) to the Permanent Subcommittee on Investigations (“PSI” or “the Subcommittee”) show that beginning in early 2021, Dr. Ana Szarfman, who at the time was a senior medical officer and safety datamining developer at the Food and Drug Administration (“FDA”), used an updated data analysis technique that identified dozens of statistically significant safety signals for adverse events associated with the COVID-19 vaccines.1 She immediately shared her findings with other FDA officials, including officials responsible for COVID-19 vaccine safety surveillance, but they largely ignored her and eventually told her to stop her data analyses.
Specifically, on March 26, 2021, Dr. Szarfman, who worked in the FDA’s Center for Drug Evaluation and Research (“CDER”), shared a data mining analysis of COVID-19 vaccine adverse events using a newer methodology that reduced masking.2 Masking is a known data limitation with FDA’s current data mining method that can inhibit the detection of safety signals for adverse events.3 Dr. Szarfman’s analysis—which was done in collaboration with Dr. William DuMouchel, the then-Chief Statistician at Oracle and inventor of the data mining algorithm that supported FDA’s current data mining system—found “49 examples of extreme masking” with over twenty of those examples of adverse events now showing a statistically significant safety signal when adjusted for masking.4 In other words, by using a methodology that accounted for the masking limitation, Dr. Szarfman and Dr. DuMouchel uncovered approximately 25 statistically significant safety signals for adverse events associated with the COVID-19 vaccines that were not previously detected by FDA’s current methodology, including sudden cardiac death, Bell’s palsy, and pulmonary infarction.5
Dr. Szarfman shared similar findings with other senior officials at the FDA in this instance and at least three other times in April 2021, May 2021, and July 2021 when her and Dr. DuMouchel’s analyses yielded even more statistically significant safety signals with higher values for adverse events, including acute myocardial infarction associated with the Moderna and Pfizer-BioNTech (“Pfizer”) COVID-19 vaccines, non-site specific embolism and thrombosis associated with the Janssen (“Johnson & Johnson”) and Pfizer vaccines, dementia associated with the Pfizer vaccine, and “Death and sudden death” associated with the Moderna and Pfizer vaccines.6
However, rather than warn the public or hold distribution of the vaccines for further investigation, records appear to indicate that Biden health officials ignored the statistically significant safety signals uncovered through the new methodology and were more concerned about Dr. Szarfman’s efforts rather than her troubling findings. In April 2021, after Dr. Szarfman emailed a data mining analysis apparently underscoring the limitations of FDA’s current system, one senior FDA official wrote to his colleagues, “[b]efore we potentially reach out to Ana, we should meet internally – many considerations not suited to email…”7
By May 2021, senior officials in the FDA’s Center for Biologics Evaluation and Research(“CBER” – the unit responsible for COVID-19 vaccine safety surveillance), including Drs.David Menschik, Narayan Nair, and Craig Zinderman drafted an email to Dr. Szarfman, that Dr.Zinderman eventually transmitted to her, directing Dr. Szarfman to “hold off on creating andsending data mining reports and analyses.”8 Dr. Peter Marks, a staunch supporter of the COVID-19 vaccines who at the time led CBER, eventually warned Dr. Patrizia Cavazzoni, the then-Director of CDER, that Dr. Szarfman’s data mining could “create erroneous conflicts that feed in to anti-vaccination rhetoric.”9
Although senior officials at FDA instructed Dr. Szarfman to “hold off” on generating and distributing her and Dr. DuMouchel’s analyses, she continued.10 Dr. Szarfman tried to convince other colleagues that the data mining method she was sharing was more effective than the method FDA was using. She wrote to FDA officials in early May 2021 that her and Dr. DuMouchel’smethod “strongly reduces confounding” and that the safety signals in this method are much higher than the signals detected in FDA’s method, particularly for acute myocardial infarction.11
As highlighted in Chairman Johnson’s report on myocarditis and the COVID-19 vaccines, on May 24, 2021, draft notes from a meeting involving federal health officials contained the question, “Is [the Vaccine Adverse Event Reporting System (“VAERS”)] signaling for myopericarditis?”12 The answer stated: “For the age groups 16-17 years and 18-24 years,yes.”13 Despite this unambiguous acknowledgement of the myopericarditis signal, Biden health officials continued to fail to immediately warn the public about the risks of cardiac events associated with the COVID-19 vaccines.14
In early June 2021, Dr. Szarfman emailed an FDA colleague about ongoing discussionsbetween the FDA and the Centers for Disease Control and Prevention (“CDC”) about COVID-19vaccines and “myocardial events and the lack of signals in VAERS and other data resources.”15
She enclosed Dr. DuMouchel’s data mining analysis from a month earlier showing higher statistically significant safety signals for acute myocardial infarction and noted that she and Dr.DuMouchel “also detected clear signals for other similar events.”16 Dr. Szarfman wrote, “I amnot astonished that [FDA’s data mining system] was unable to detect these signals.”17
In July 2021, Dr. Szarfman warned FDA officials that her and Dr. DuMouchel’s data mining method detected “an increased mortality signal with the COVID-19 vaccines,” reminding her colleagues that she and Dr. DuMouchel use “a method that automatically unmask[s] signals that remain hidden by other data mining methodologies, including by MGPS [FDA’s current data mining method abbreviated for Multi-item Gamma Poisson Shrinker].”18 Again, in September2021, Dr. Szarfman urged senior FDA officials to utilize her and Dr. DuMouchel’s data mining method underscoring that this method is “much better at unmasking signals than MGPS. It tautomatically identifies and corrects for confounders. This is an important function to have,given the pandemic situation.”19
Records indicate that FDA did not make any adjustments to its data mining methodology as recommended by Dr. Szarfman. However, Dr. Szarfman continued to advocate for the newer methodology, eventually co-authoring a June 2022 paper with Dr. DuMouchel and others published in the journal Drug Safety, which discussed their data mining technique and stated tha masking “is roughly eight times more likely to occur with COVID-19 vaccines than with other vaccines.”20 In July 2022, Dr. Szarfman emailed this article to then-FDA Commissioner Dr.Robert Califf noting that her paper describes advances in data mining methodology “especially in the capacity to unmask hidden signals[.]”21 Upon receipt of this and another article, Dr. Califf simply replied, “Thanks. These are good.”22 Documents reviewed to date do not indicate whether Dr. Califf took any action based on his review of Dr. Szarfman’s article.
Other FDA officials were not so thrilled with Dr. Szarfman’s publication. In August 2022, Dr. Richard Forshee, the then-Deputy Director of CBER’s Office of Biostatistics and Pharmacovigilance, wrote to Dr. Marks, “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.”23
It remains unclear based on the records received to date whether FDA officials confronted Dr.Szarfman about her paper.
No comments:
Post a Comment