番茄社区

When it comes to authorizing COVID-19 vaccines, members of FDA's advisory committee and the U.K.'s counterpart often have undisclosed conflicts of interest.

Panelists for these advisory committees are only required to share conflicts of interest from the last 12 months, and when they do disclose these relationships, the committees do not always consider them significant enough to disclose to the public.

An investigation in by American journalist Paul Thacker, who is currently based in Spain, found examples where experts had disclosed potential conflicts -- such as publication ties, grant receipts, and patents -- to their respective committees. However, the article noted that according to the minutes of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the U.K.'s Joint Committee on Vaccination and Immunization (JCVI) meetings, most committee experts registered no conflicts of interest as of late-to-mid December 2020.

"[The panelists] seem to have all followed the rules they were provided," Thacker told 番茄社区 via email. "But that's the problem: the rules are not great."

Government bodies typically rely on experts who have no financial conflicts to report as of at least the last several years, Thacker wrote in his analysis. For example, the International Committee of Medical Journal Editors requires the disclosure of all conflicts of interest from the past 36 months.

Thacker said that the agencies should be asking for disclosures that go back at least 3 years.

"And there's no reason when someone is found to be conflicted to not find someone else without conflicts," Thacker told 番茄社区. "Both America and the U.K. have a plentiful supply of experts in biomedicine."

He said he believes that the investigation makes the case for standardized, universal disclosure rules even stronger, in order to create a more ethical approval process for products from government agencies.

Officially, only two members of the FDA's advisory committee reported having conflicts of interest during meetings in late 2020. But, when Thacker's analysis looked into each panelist on the disclosure website, he found more significant financial conflicts.

For example, Thacker noted, according to Open Payments, Arnold Monto, MD, of the University of Michigan School of Public Health in Ann Arbor, received more than $24,000 from drug companies in 2019. Monto was acting chair of the VRBPAC meetings that led to the emergency use authorizations of the Pfizer/BioNTech, Moderna, and Johnson & Johnson vaccines.

Another VRBPAC member, Myron Levine, MD, DTPH, of the University of Maryland School of Medicine, received approximately $30,000 -- mostly from consulting fees -- in the same year.

In response to an inquiry from Thacker, an FDA spokesperson said that all committee members are carefully screened for "potentially disqualifying interests or relationships and makes changes to committee meeting rosters as needed." But a recent analysis in the found that the FDA had issued six conflict-of-interest waivers for experts on the Oncologic Drugs Advisory Committee, who were advising on whether or not indications for a group of cancer drugs should be withdrawn after failed clinical trials.

Open Payments also showed that VRBPAC member Ofer Levy, MD, PhD, of Boston Children's Hospital, received about $5,000 in mostly travel expenses from GlaxoSmithKline (GSK) and that Levy had disclosed in a 2020 publication that he was a named inventor on several vaccine-related patents.

Levy explained in an email to Thacker, however, that GSK was not a sponsor for either of the COVID vaccine panels and that the pending patents had been revealed to the FDA in his disclosure information and they were "appropriately deemed by FDA as irrelevant to the subject matter being considered."

In the U.K., the JCVI's COVID-19 meeting chair, Wei Shen Lim, MD, of the Nottingham Biomedical Research Centre, had no registered conflicts of interest according to JCVI. But Thacker found that the same document also stated that Lim's institution "received unrestricted investigator-initiated research funding from Pfizer for a study in pneumonia in which Professor Lim is the chief investigator (non-vaccine related)," and that Lim himself had reported his grant from Pfizer in a preprint published not long before the JCVI meeting in December 2020.

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