Ex-FDA officials, medical experts flog feds for politicizing COVID, misrepresenting evidence
JUST THE NEWS | By Greg Piper | December 17, 2021
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.
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.”
FDA vaccine deputy director who resigned over WH pressure on boosters is writing op eds critical of pushing boosters for teens without Ad Com.
— Vinay Prasad, MD MPH 🎙️📷 (@VPrasadMDMPH) December 17, 2021
WH is acting seriously reckless. If the last administration did this, all experts would be outraged. https://t.co/JRTsDUzHij
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 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.
EXPERTS: the CDC study on masks was “so unreliable that it probably should not have been entered into the public discourse”
— David Zweig (@davidzweig) December 16, 2021
A multi-month investigation into a flawed study, and a public health agency's lack of transparency
My latest, for @TheAtlantic https://t.co/1aK7ROOzIe
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, FDA and National Institute of Allergy and Infectious Diseases did not respond to queries about the criticisms.
