The FDA knew the COVID shots would kill and maim countless Americans. They kept injecting anyway. One government employee tried to sound the alarm about “49 examples” of deadly side effects that conventional safety analyses weren’t detecting. She was shut down. Her name was Dr. Ana Szarfman. On March 1, 2021, less than three months after the rollout of the COVID-19 injections, Dr. Ana Szarfman, an employee at CDER and safety data mining developer, warned that the FDA’s existing system could hide vaccine safety signals due to a flaw called “masking.” She proposed a newer method developed by statistician Dr. William DuMouchel that corrected for this issue and, when applied, detected “49 examples of extreme masking” that the standard system did not. These “49 examples of extreme masking” include not “minor” but serious adverse events: • Bell’s palsy • Cardiac failure • Acute left ventricular failure • Agonal rhythm (severe end-of-life arrhythmia) • Pulmonary infarction • Cerebral artery occlusion • Aortic stenosis • Sudden cardiac death • Hypertensive emergency • Basal ganglia stroke When Dr. Szarfman proposed a new method, she was told to “hold off on creating and sending data mining reports and analyses.” Later, they “made it clear” that she “needs to focus on her assigned work” and “should not be discussing or providing internal analyses externally.” As Dr. Szarfman puts it, her work became a “pest” for raising concerns about safety signal masking. In September 2021, Dr. Peter Marks, the FDA's top vaccine official, decided that Dr. Szarfman’s COVID vaccine data-mining days were over. He informed Dr. Patrizia Cavazzoni, the then director of CDER, that Dr. Szarfman “has been asked to cease and desist conducting her data analysis.” Dr. Marks complained that Dr. Szarfman’s work had become “a major distraction” and that her efforts could “create erroneous conflicts that feed into anti-vaccination rhetoric.” Dr. Szarfman went on to retire from the FDA in 2025 after more than 35 years of service. She raised concerns about safety signal masking. The FDA essentially told her to shut up. Because in their eyes, “49 examples of extreme masking” could create “erroneous conflicts” and fuel “vaccine hesitancy.” Unfortunately, this is not a one-off instance. It’s part of a much deeper problem: the gap between what’s known internally and what’s allowed to reach the public. 🧵
