Ex-FDA officials, medical experts flog feds for politicizing COVID, misrepresenting evidence

"If the last administration did this, all experts would be outraged," tweeted University of California San Francisco medical professor Vinay Prasad.

Published: December 17, 2021 5:19pm

Updated: December 18, 2021 2:06pm

The federal agencies in charge of COVID-19 response are taking hits from former officials and high-profile medical professors for "sidelining experts," not conducting basic research, and mischaracterizing evidence related to vaccines and masks for young people.

The Biden administration is getting a pass for "extreme political pressure" that "appropriately" prompted outrage against its predecessor, two FDA alumni wrote in The Washington Post Thursday.

Former Office of Vaccines Research and Review Deputy Director Philip Krause and former acting Chief Scientist Luciana Borio protested three recent actions authorizing boosters for people as young as 16.

"Before last month, the standard practice was for the agencies to convene standing outside advisory committees, whose members inspect the relevant data, debate it and vote," they wrote. Earlier debates and votes suggest that "at least some experts would probably have voiced opposition," and the refusal to hear them out "could hurt the credibility of these agencies."

They criticized the FDA's "unpersuasive" explanation that authorizing boosters for 16- and 17-year-olds "does not raise questions that would benefit from additional discussion by committee members." 

Exigency is "the exact circumstance when expert discussion and interpretation of the data can make the biggest difference," the duo wrote.

An unidentified FDA spokesperson provided a statement to Just the News responding to the op-ed.

"As we said in our Nov. 19 press release, the FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older," it said. "Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one."

Krause left the FDA in apparent protest of the White House sidestepping the agency to promise booster shots across the board. He soon joined a public letter warning "there could be risks if boosters are widely introduced too soon, or too frequently," with implications for "vaccine acceptance." 

The White House is "acting seriously reckless," University of California San Francisco medical professor Vinay Prasad tweeted, echoing Krause's argument. "If the last administration did this, all experts would be outraged. Principles only matter when they are inconvenient."

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Johns Hopkins University medical professor Marty Makary, who agrees boosters can harm low-risk groups, blasted the feds for too much "speculation" and too little research on the Omicron variant, just their latest pandemic failure.

"In fact, most of our COVID findings have come from Israel and scientists abroad," he wrote in a New York Post op-ed Dec. 8 decrying "turtle-speed bureaucracy."

It's baffling that the National Institutes of Health or CDC has not "mobilize[d] any of their 7,000-plus scientists" to quickly answer how antibodies from vaccines and natural immunity respond to Omicron, said Makary, editor-in-chief of MedPage Today. There's not even a "real-time data dashboard" on Omicron cases.

"Perhaps [Anthony] Fauci could have done fewer media interviews and university lectures ... and instead personally overseen an NIH Omicron-antibody-binding experiment," he said. 

Makary blasted the CDC for consistently releasing "tardy and incomplete data, missing key information on risk stratification, the role of obesity and a breakdown of child deaths by comorbidity as we imposed blanket restrictions on 72 million children."

Also coming in for criticism: the FDA's monthslong "paralysis," as Makary put it, over how to respond to serious side effects reported from the Johnson & Johnson vaccine, and the CDC's belated recommendation to take mRNA vaccines instead.

"This is a decision that should have been made 8 months ago, which was needlessly delayed, benefiting the sponsor, and hurting people," said UCSF's Prasad, a columnist for Makary's publication. 

The hematologist challenged CDC Director Rochelle Walensky's statement that the reversal showed the agency's "commitment to provide real-time scientific information to the American public." Prasad cowrote a peer-reviewed paper published in August on the risks of J&J to women under 50.

Prasad also called out Walensky for making overbroad claims about vaccine safety, even though the feds have acknowledged higher-than-expected heart problems following mRNA vaccination in young people for months.

In a Dec. 10 interview with ABC News on early results from the vaccination of five million 5-11 year-olds, the CDC director said its "incredibly robust vaccine safety system" had not picked up "anything yet" regarding myocarditis reports.

The CDC's own data as of Dec. 10, Prasad noted, showed more than 3,200 reports in that age group to the Vaccine Adverse Event Reporting System, including 14 myocarditis reports, eight of which met the CDC's "working case definition." The damage from this "suboptimal" messaging "will last long after COVID19."

A writer who has repeatedly scrutinized evidence-thin COVID interventions in schools took square aim at Walensky's portrayal of evidence in a feature for The Atlantic.

The CDC director claimed several times in recent months that schools without mask mandates were 3.5 times as likely to experience COVID outbreaks as those with mask mandates. She was promoting a study of 1,000 Arizona public schools published by the agency's Morbidity and Mortality Weekly Report.

Several experts, including the lead author of the controversial Bangladeshi mask study, told David Zweig that the study was so flawed the CDC shouldn't promote it.

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Some of the schools had been open twice as long as others within the July 15-Aug. 30 study period. The measurement of "school-related outbreaks" didn't necessarily show in-school transmission, and one county excludes masked students from the definition of "close contacts," creating "detection bias."

Yale University economist Jason Abaluck of the Bangladeshi mask study said the Arizona study was "ridiculous" for not controlling for the vaccination status of staff or students, which could misattribute reduced spread to masks rather than vaccines.

The CDC and National Institute of Allergy and Infectious Diseases did not respond to queries about the criticisms.

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