Secret recordings with ousted FDA vaccines chief suggest disinterest in documenting vax injury

The Food and Drug Administration's top vaccine official until late-March met online several times with a COVID-19 vaccine injury group's leader, who, opposing the vaccines in part, begged him to no avail to take severe adverse events such as paresthesia as a precursor to neuropathy seriously and to urge doctors to treat them as such rather than write them off as "anxiety," secret recordings suggest.

The Informed Consent Action Network (ICAN) released the videos, compiled on "The Real Peter Marks" website, with other documentary evidence from Marks' leadership of the COVID response starting with Operation Warp Speed, at the National Press Club in Washington on Tuesday.

They also include a virtual meeting between San Francisco intensive care unit doctor Patricia Lee, Marks and other FDA officials, who asked no questions after Lee said a patient's severe complications from vaccination at 22 weeks' pregnancy and related death prompted a "nervous breakdown" among nurses on her shift, requiring a psychiatrist's overnight visit.

ICAN CEO Del Bigtree shared pieces of Lee's Oct. 22, 2021, conversation with FDA officials, who allegedly ignored her pleas for vaccine-injured patients until she brought "legal pressure," on his show two weeks earlier with ICAN lawyer Aaron Siri and REACT19 founder Brianne Dressen, whose neurological injuries from the AstraZeneca vaccine trial were confirmed by the NIH. 

Organized as an animated vertical timeline that loads as it scrolls, the Marks website loaded slowly during Just the News' review Wednesday. "They are receiving a ton of traffic and working on it," a spokesperson said in the early afternoon.

The website contains Dressen's seven virtual meetings with officials from Aug. 23, 2021 to Dec. 14, 2022, some of which also loaded slowly Wednesday. In the second meeting, a month after President Biden's large-employer COVID vaccine mandate, she is lying down on a couch during the recordings.

The office of Sen. Ron Johnson, R-Wis., who chairs the Permanent Subcommittee on Investigations, has fought for recognition of COVID vaccine injuries and seeks the end of legal immunity for manufacturers, told Just the News he was aware of the recordings and "they will be part of the investigatory record."

ICAN and REACT19 hope the recordings and timeline prompt the FDA to evaluate licensed vaccines "continuously," make the Centers for Disease Control and Prevention's Vaccine Safety Datalink public and, for Bigtree specifically, stop recommending COVID vaccines without pulling them from the market.

An FDA official like Marks should not be "jumping up and down with pom poms" for vaccines during their Phase II trials, Bigtree said.

Marks' disputed resignation in March as director of the Center for Biologics Evaluation and Research sent panic through the pharmaceutical industry, which loved Marks for his uncritical promotion of COVID vaccines even before full licensure through his jazzy but conclusory "Just a Minute" videos, which make various claims about their safety and effectiveness.

One of his most vocal critics, University of California San Francisco epidemiologist Vinay Prasad, is taking over Marks' job, FDA Commissioner Marty Makary announced Tuesday. The S&P Biotech ETF fell more than 6% following news of Prasad's appointment, STAT News reported, suggesting the industry sees him as a threat to the bottom line.

Prasad dinged Marks three years ago for promising congressional Democrats to lower COVID vaccine approval standards to ensure that kids can get jabbed, and called him "one of the most dangerous, pro-pharma regulators of the 21st century" when Marks departed.

A week before the departure, which Marks implied was out of principle but media claimed was forced, Prasad noted that Marks sidelined Office of Vaccines Research Research and Review leaders in 2021 for resisting rushed full approval of COVID vaccines and overturned agency reviewers by approving gene therapy that Prasad said "seems to be killing kids."

He said the FDA could replace Marks with "a bobblehead doll that just stamps approval" and get the same results for less money.

Tuesday's press conference included public videos such as Sen. Johnson's COVID vaccine injury hearing with Maddie de Garay, whose parents let her join a clinical trial that disabled and left her feeling like "my heart is being ripped out through my neck," in Maddie's words, according to her mother, who sobbed, "Why aren't they researching her to figure out why this happened?" 

Pfizer violated its legal obligation to report that de Garay had to go on a feeding tube and use a wheelchair following the jab, simply listing "abdominal pain," the family's lawyer Siri alleged. "The FDA did nothing, just brushed it under the rug, at Peter Marks' direction" because the principal investigator said "he doesn't feel" her injury is related to the jab, Siri added.

Pfizer and the FDA did not respond to queries for their response to the allegations.

Another video showed Tiffany Dover, a nurse at CHI Memorial Hospital, in Tennessee, collapsing during her own Dec. 17, 2020, press conference minutes after taking the vaccine. NBC News wrote off the narrative of her immediate injury as a "conspiracy theory." 

She told the news outlet in its roughly-worded 3,200-word story in 2023: "Yes, I did pass out. This could be a side effect. You can pass out from receiving a vaccine, but that’s OK because it can also save your life. So it’s worth it.”

Vaccination locations "started delaying people 45 minutes" after inoculation so those who received a shot wouldn't have an emergency driving home, which is why reporting post-vaccination car accidents in the Vaccine Adverse Event Reporting System is legitimate, ICAN's Bigtree said.

The secretly recorded videos, which can be downloaded by viewers but not embedded, contrast with what was "told in public versus what was known behind the scenes" to regulators and shows them "gaslighting and really obfuscating," Bigtree said.

One virtual meeting shows Marks saying the worst complication the agency had seen was "mild" heart inflammation in 1 in 5,000 males under 30, only requiring ibuprofen, with only 2% requiring "significant medical intervention." He said "it's very hard to find cases of deaths that are directly related" and the idea that "thousands" of people are dying is "incredible BS."

Marks should look at the 38,000 directly related deaths in VAERS, which research has found suffers from under-reporting of vaccine injuries, according to Bigtree.

In Dressen's Oct. 4, 2021 virtual meeting, she said people showing up to emergency rooms and clinics with vaccine injuries couldn't get them acknowledged as such, so whatever treatment they received was based on misdiagnosis. NIH must tell the medical community that early intervention could mitigate neurological complications, she said.

REACT19, her group, found 36,000 VAERS reports for neurological complications but an "incredibly small number" received followup from the feds, Dressen told the press conference. Subsequently filed VAERS reports for new complications are not public, she said. 

They kept going back to Marks to tell him "you can't find what you're not looking for" – severe adverse events in "young healthy people," Dressen said.

In one video, Dressen says an ER diagnosed a woman with anxiety who "very clearly" had multisystem inflammatory syndrome but refused to test her, sending her to another ER that ran labs and correctly diagnosed the MIS. 

She asked NIH to tell doctors "it's OK to evaluate a patient" if they suspect vaccine injury, which is "almost a dirty word" for doctors who fear their licenses are at risk from medical board investigations if they take vaccine injury seriously.

"Why aren't they treating what's in front of them?" Marks responded. An "injured critical care physician" speaking through an artificial intelligence-generated voice told him the treatment may be wrong if the injury isn't correctly attributed to a vaccine.

San Francisco doctor Lee's virtual meeting with Marks and other officials, which Siri said he arranged after the FDA refused her offer to meet directly, may be the most revealing. 

She kept getting previously healthy patients whose injuries showed a "very distinct temporal relationship" to vaccination and "atypical disease progression," and filed VAERS reports with her own mailing address but never heard back, Lee told officials.

The doctor said her 36-year-old pregnant patient developed transverse myelitis, went blind and had a tracheotomy. Lee resuscitated the patient after she went into "hemorrhaging shock" following a Caesaran delivery. The patient declined, and a month later died minutes after her family took her off life support. 

None of the officials had questions for Lee when asked.