As explained in a previous update, the boards overseeing the COVID-19 vaccine clinical trials are supposed to be independent of pharmaceutical companies. ICAN’s intensive investigation into these boards has revealed conflicts of interest with pharmaceutical companies that are shocking to the conscience. ICAN, through its attorneys, has therefore filed a formal demand to remove these individuals from these boards.
The FDA has now responded in a letter that fails to address any of these shocking conflicts and does not indicate it will take any action to rid these boards of pharmaceutical foot-soldiers. This response is a shocking indictment of the conflict-ridden judgment that will be relied upon to assess the safety and efficacy of any COVID-19 vaccine.
The boards overseeing the COVID-19 vaccine trials are known as Data and Safety Monitoring Boards (DSMBs). As explained by pro-vaccine bioethicist, Art Caplan, regarding these 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 potential COVID-19 vaccines that are currently in Phase III clinical trials in the United States. The clinical trials for three of these experimental vaccines – the ones to be sold by AstraZeneca, Moderna, and Johnson & Johnson – are being 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 experimental vaccine is being overseen by a different DSMB (the Pfizer DSMB).
The members of these DSMBs were selected in secret. They meet in secret. Their identities are supposed to remain a secret. This veil of secrecy has held with the exception of two members. The identity of the chairperson of the NIAID DSMB, Dr. Richard Whitley, was mistakenly revealed by his university in an announcement that has been scrubbed from its website. As for the Pfizer DSMB, made up of five individuals, one of its members, Dr. Kathryn Edwards, was apparently mistakenly revealed in a CBS article.
Selecting these individuals could only occur by turning a blind eye to their extremely troubling and blatant conflicts with pharmaceutical companies. For example, ICAN’s investigation has revealed that one or both of these doctors have been, among other things, 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 to hundreds of meals and taken dozens of trips to exotic destinations. Meaning, 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.
Nonetheless, the American public is constantly assured by Dr. Fauci, Secretary Azar, and other public health officials that the 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 give Dr. Whitley and Dr. Edwards the label “independent.” To head the “independent” DSMB, Dr. Fauci could have selected from a sea of potential scientists, many of whom have never consulted for a pharmaceutical company, were never on a pharmaceutical company speakers’ bureau, and have not had hundreds of meals and dozens of exotic trips paid for by pharmaceutical companies. Instead he chose Dr. Whitely as its head. Dr. Fauci makes a mockery of the term “independent” and calls into serious question his judgment and objectivity.
ICAN, through its attorneys, headed by Aaron Siri, therefore 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 lays out in detail: the conflicts of interest that Dr. Whitley and Dr. Edwards have with pharmaceutical companies; the litany of lies told by 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.”
The Director of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks, has now responded in a letter that fails to address any of these conflicts, conceding the existence of these conflicts. It also fails to provide any vow that the FDA will replace these individuals with those that are actually independent of pharmaceutical companies. This response should send shivers down the spine of anyone considering the process by which the safety and efficacy of any COVID-19 vaccine will be evaluated.