In a revelatory set of secret recordings made public by the Informed Consent Action Network (ICAN), the U.S. Food and Drug Administration (FDA) finds itself at the center of controversy over its handling of reports on COVID-19 vaccine injuries. These recordings, which have been disseminated through ICAN’s “Real Peter Marks” website, cast a shadow on the FDA’s commitment to vaccine safety and transparency.
The recordings feature Dr. Patricia Lee, an ICU physician from San Francisco, recounting the tragic experience of a pregnant patient post-vaccination. Following the development of transverse myelitis and subsequent blindness, the patient passed away after complications from a C-section. Dr. Lee's efforts to report the incident via the Vaccine Adverse Event Reporting System (VAERS) seemingly went ignored by the FDA. "I filed VAERS reports with my own address, and I never heard anything back," Dr. Lee disclosed, emphasizing the FDA's apparent inattention to potential vaccine-related injuries.
Del Bigtree, CEO of ICAN and a vocal critic of the FDA’s response, accused the agency of "gaslighting" the public and failing to properly investigate severe vaccine-related injuries. He suggests that many patients with adverse reactions were dismissed with diagnoses like anxiety or other unrelated health conditions, instead of receiving proper medical attention.
A particularly alarming case that surfaced involves Maddie de Garay, a teenager who participated in a COVID-19 vaccine trial and became disabled after receiving the vaccine. Her family's attorney, Aaron Siri, criticized Pfizer for misreporting Maddie’s injury as "abdominal pain," accusing the FDA of complicity in obscuring the severity of the situation.
The controversy coincides with the recent resignation of Dr. Peter Marks from his role as director of the FDA’s Center for Biologics Evaluation and Research in late March. Marks was known for advocating rapid vaccine approval, but his approach to vaccine safety has drawn criticism. His resignation has unsettled the pharmaceutical industry, which had previously supported Marks for his promotion of COVID vaccines.
Marks' successor, epidemiologist Vinay Prasad, has been openly critical of Marks’ leadership and the undermining of vaccine approval standards. "He doesn’t feel that vaccine injuries should be taken seriously," Prasad declared, indicating internal disputes over vaccine safety within the FDA.
Wisconsin Senator Ron Johnson (R) has been a staunch advocate for acknowledging vaccine injuries and has confirmed his office’s inclusion of the secret recordings in an ongoing investigation into the FDA’s vaccine safety handling. Johnson is also calling for an end to the legal immunity granted to vaccine manufacturers and is demanding increased transparency from the FDA.
As the situation unfolds, ICAN and other advocacy groups are pressing the FDA for a thorough re-evaluation of COVID-19 vaccine safety. They are demanding public access to the CDC’s Vaccine Safety Datalink data and a more cautious approach to vaccine approvals. Calls for the removal of COVID vaccines from the market persist until long-term effects are comprehensively studied. To date, Pfizer and the FDA have yet to respond to the allegations, and the investigation into vaccine injuries continues.
