What independence did the U.S. and UK vaccine advisory committees have?


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Experts who are part of national advisory panels on vaccines are asked to reveal industry links and other conflicts of interest. But an investigation published by The BMJ today he finds that disclosure rules differ widely, often leaving the public in the dark.

Investigative journalist Paul D Thacker examined the experts on the covid-19 authorization committees of the U.S. Food and Drug Administration (FDA), as well as those on the Joint Vaccination and Vaccination Committee (JCVI) of the United Kingdom, which advises the government on vaccines. .

Both the FDA and the UK government require group members to disclose disputes only from the previous twelve months, “which may lose significant financial payments that have occurred in recent years,” he notes.

He found that most experts on the FDA and JCVI committees registered no . For example, since the December meeting of the JCVI on December 22, 2020, the minutes report that 18 of 19 members had “no registered conflict of interest,” a pattern that was repeated in its other eight minute meetings.

And among FDA experts who were not industry or consumer representatives, the agency reported that 20 of the 21 voting members had no disputes on the Dec. 10 advisory committee, as well as the same or a similar proportion in others. covide vaccine meetings.

Thacker also finds that in some cases one has made a disclosure — for example, receiving a scholarship or a fee from a vaccine manufacturer — but the committee has not considered it. .

A Public Health England spokesman said The BMJ that for a single JCVI issue meeting, as for covid-19, conflicts of interest should be reported “only if they are directly related to this issue, rather than having them more broadly “.

Transparency issues are mounting with the UK MHRA, which authorizes vaccines after seeking advice from the Commission on Human Medicines, an independent scientific expert body advising government ministers, Thacker adds: from the minutes of the meeting and it has not disclosed its members ’financial statements of interest since 2018.”

In the United States, external experts advise the FDA whether to approve or authorize products. Thacker notes that only two members were reported to have conflicts of interest between various coveted authorization panels that met in late 2020. But The BMJ they found group members who had important financial matters by consulting the open payments disclosure website and examining the published work of the group members.

For example, Open Payments reported that Arnold Monto, a professor at the University of Michigan School of Public Health and acting chair of the FDA’s coveted vaccine authorization meetings, had received more than $ 24,000 in payments from pharmaceutical companies in 2019.

Adriane Fugh-Berman, a professor of pharmacology and physiology at Georgetown University in Washington, DC, says these results reveal the confusion of disclosure and that common rules are needed.

Few people realize that there is no common rule about what needs to be revealed and about what distance, she explains, or that disclosure is a two-step process. Experts reveal interests to an entity, such as a magazine, university, or government agency, that decides what it wants to disclose to the public. “There needs to be a normalization of what needs to be disclosed and how it needs to be disclosed,” he says.

Joel Lexchin, of York University in Toronto, who publishes research on conflicts of interest, suggests that government agencies should publish everything the experts reveal to them, rather than choosing and choosing what to make public.

He agreed that a universal, standardized disclosure form would facilitate compliance by individuals and help avoid confusion about what financial issues should be disclosed and what institutions should make public. “People can legitimately follow any rule they find, but important things can be left out,” he explains.

The BMJThe research also uncovered close links between a leading medical journal and the FDA approval process.

New England Journal of Medicine (NEJM) editor-in-chief Eric Rubin sat on the authorization panels and voted to recommend the authorization of the Pfizer, Moderna and Johnson & Johnson covid-19 vaccines.

Pfizer and Moderna subsequently published their clinical trials in NEJM. However, Rubin did not declare any conflict of interest to all three panels.

Asked by The BMJ Whether he withdrew from decisions on NEJM submissions, he said, “Overall, we see the deep involvement of publishers in the medical and research communities as a strong point, not a problem.”

Conflicts of interest between COVID-19 advisers to the UK government are not transparent

More information:
Feature: Covid-19: What independence did the U.S. and UK vaccine advisory committees have? The BMJ DOI: 10.1136 / bmj.n1283 , www.bmj.com/content/373/bmj.n1283

Citation: What was the independence of the U.S. and UK vaccine advisory committees? (2021, May 26), retrieved May 26, 2021 from https://medicalxpress.com/news/2021-05-independent-british-vaccine-advisory-committee.html

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