According to the ICAN report, the doctors were part of the data and safety monitoring boards (DMSBs) for phase 3 trials for multiple COVID-19 vaccine candidates. This places them in a role that's as important as that of the Food and Drug Administration, the chief regulator for COVID-19 drugs and vaccines.
The identities of DSMB members are also kept anonymous to ensure integrity and impartiality. This means that companies select their members -- and meet with them -- in secret.
In the U.S., two DSMBs are currently overseeing phase 3 trials for the four vaccine candidates for COVID-19: the National Institute of Allergy and Infectious Diseases, which oversees the trials for AstraZeneca, Johnson & Johnson and Moderna, and Pfizer DSMB, which supervises the trials for the vaccine candidate developed by Pfizer and BioNTech.
To note, reports have identified doctors who are part of the DSMB: Dr. Richard Whitley, a pediatric disease expert at the University of Alabama at Birmingham, serves as the head of the NIAID DSMB, according to a Kaiser Health News report; meanwhile, a CBS article identified Dr. Kathryn Edwards as a member of Pfizer's five-person DSMB.
Ironically, the article identifying Whitley said: “Shielding the identities of [people] on the board is meant to insulate them from pressure by the company sponsoring the trial, government officials or the public.”
Health authorities have emphasized that DSMBs supervising vaccine trials are independent of pharmaceutical companies. NIAID Director Dr. Anthony Fauci told Today, Explained host Sean Rameswaram during a Sept. 24 podcast: “People need to understand that … the [DSMB] is beholden to no one, not to the president, not to the vaccine companies, not to the FDA, not to me.”
Fauci added that the DSMB is composed of independent health and science professionals that have exclusive access to data on vaccine trials. However, further scrutiny by ICAN revealed that the two doctors on the NIAID and Pfizer DSMBs are not as impartial as they appear.
ICAN's investigation revealed that both Whitley and Edwards have been consultants, advisers and paid speakers for various pharmaceutical giants. These include GlaxoSmithKline, Merck, Novartis, Sanofi, Moderna, AstraZeneca and Pfizer – the last three companies having their own coronavirus vaccine candidates. The doctors also received millions of dollars in cash from these drugmakers, aside from meals and trips on these companies' tabs. Whitley and Edwards' connection with these companies contradict Fauci’s statement that DSMBs are “not beholden” to anyone.
Given this clear conflict of interest, ICAN sent a formal letter addressed to Fauci, Department of Health and Human Services Secretary Alex Azar, FDA Center for Biologics Evaluation and Research Director Peter Marks and White House Coronavirus Task Force adviser Scott Atlas – with a copy furnished for President Donald Trump. The letter, prepared by ICAN attorney Aaron Siri, urged Fauci to remove “any member of the NIAID DSMB ... who has ever been a consultant, on a speaker's bureau, or has had meals or travel paid for by any pharmaceutical company” – including Whitley.
An impartial DSMB plays a key role in ensuring that any approved vaccine will be safe to use, especially that the development of a coronavirus vaccine is being fast-tracked under the Trump administration’s Operation Warp Speed. (Related: The rule of law is dead: There will be no legal recourse for anyone injured by new COVID-19 vaccines.)
Two vaccines overseen by the NIAID DSMB, where Whitley is part of, have encountered issues. Trials for AstraZeneca’s COVID-19 vaccine candidate have been temporarily halted after two volunteers experienced spinal inflammation. Johnson & Johnson also suspended trials for its vaccine after a participant developed an “unexplained illness.”