Demanding those with conflicts be removed from vaccine monitoring boards

The boards overseeing the COVID-19 vaccine clinical trials (known as Data and Safety Monitoring Boards (DSMBs) are supposed to be independent.  The Informed Consent Action Network’s (ICAN) investigation revealed shocking conflicts of interest with pharmaceutical companies. ICAN, through its attorneys, has therefore filed a formal demand to remove these individuals from these boards.

As explained by pro-vaccine bioethicist, Art Caplan, regarding DSMBs: “They’re very powerful. They’re key guardians of science and safety and are as important if not more important than the FDA.”

There are four COVID-19 experimental vaccines currently in Phase III clinical trials in the United States.  The clinical trials for three of these – to be sold by AstraZeneca, Moderna, and Johnson & Johnson – are overseen by a DSMB created by Dr. Fauci’s National Institute of Allergy and Infectious Diseases (the NIAID DSMB).  The clinical trial for Pfizer’s vaccine is overseen by a different DSMB (the Pfizer DSMB).  

The members of these DSMBs are selected in secret; they meet in secret, and their identities are supposed to remain a secret.  This veil of secrecy has sustained with the exception of two members – the chairperson of the NIAID DSMB, Dr. Richard Whitley, was mistakenly revealed by his university in an announcement since scrubbed from its website.  One of the members of the Pfizer DSMB, Dr. Kathryn Edwards, was mistakenly revealed by CBS.

Selecting these two individuals could only occur by turning a blind eye to their troubling and blatant conflicts with pharmaceutical companies.  For example, ICAN’s investigation revealed that one or both of these two doctors have been consultants for Gilead Science, AstraZeneca, GlaxoSmithKline, Merck, Sanofi, Sequirus, La Roche, Allergan, Moderna, and Novartis; advisors to Merck, Bionet, GSK, and Pfizer; paid speakers for Connaught, Lederle-Praxis, Wyeth Lederle, Glaxo, and Novartis; paid millions of dollars from these companies; and, on the tab of these companies, wined-and-dined hundreds of meals and took dozens of trips to exotic destinations.  They have had duties to these companies as consultants and advisors, have been personally financially supported by them, and have been their mouthpieces to the public.  

Dr. Fauci, Secretary Azar, and other public health officials constantly assure that DSMB members are independent of pharmaceutical companies.  For example, Dr. Fauci recently told the public that: “[P]eople need to understand that an independent body, the Data and Safety Monitoring Board, is beholden to no one, not to the president, not to the vaccine companies, not to the FDA. Not to me.”  

Only those wearing blinders could label Dr. Whitley and Dr. Edwards as “independent.”  To lead the “independent” DSMB, Dr. Fauci could select from a sea of potential scientists, many of whom do not consult for pharmaceutical companies, were never on pharmaceutical company speakers’ bureaus, and who have enjoyed luxurious perks on the pharmaceutical tab. Dr. Fauci makes a mockery of the term “independent”.

ICAN, through its attorneys, headed by Aaron Siri, sent a demand letter to the Director of HHS, Director of NIAID, Director of the FDA’s CBER, the White House Coronavirus Task Force, and POTUS.  This letter describes in detail: the conflicts of interest that Dr. Whitley and Dr. Edwards have with pharmaceutical companies; the litany of lies from Dr. Fauci and other public health officials regarding the supposed independence of the DSMBs; and demands that they “remove any member of the NIAID DSMB, including Dr. Whitley, who has ever been a consultant, has been on a speakers’ bureau, or has had meals or travel paid for by any pharmaceutical company.”
Read the full demand letter here

Information obtained from

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