Investigation finds disclosure standards differ widely, often leaving the public in the dark
Experts who sit on national vaccine advisory panels are asked to disclose any industry ties and other conflicts of interest. But an investigation published by The BMJ today finds that disclosure standards differ widely, often leaving the public in the dark.
Investigative journalist Paul D Thacker looked at experts sitting on the covid-19 authorisation committees at the US Food and Drug Administration (FDA), as well as those on the UK's Joint Committee on Vaccination and Immunisation (JCVI), which advises the government on vaccines.
Both the FDA and the UK government require panellists to disclose conflicts only from the previous 12 months, "which can miss significant financial payments that occurred in recent years," he notes.
He found that most experts on the FDA and JCVI committees registered no conflicts of interest. For example, from the JCVI's December meeting on 22 December 2020, the minutes report that 18 of 19 members had "no registered conflicts of interest," a pattern repeated in its eight other minuted meetings.
And among FDA experts who were not industry or consumer representatives, the agency reported that 20 of 21 voting members had no conflicts at the 10 December advisory committee, as well as the same or a similar proportion at other covid vaccine meetings.
Thacker also finds that in some cases an expert has made a disclosure - for example, receiving a study grant or honorarium from a vaccine manufacturer - but the committee has not deemed it a conflict.
A spokesperson for Public Health England told The BMJ that for a single issue meeting of the JCVI such as for covid-19, conflicts of interest must be reported "only if they relate directly to that matter, rather than more widely."
Transparency problems increase with the UK's MHRA, which authorises vaccines after seeking advice from the Commission on Human Medicines, an independent expert scientific advisory body to government ministers, adds Thacker, saying: "The commission does not make its advice public, publishes a scant record of meeting minutes, and has not disclosed its members' declarations of financial interest since 2018."
In the US, outside experts advise the FDA on whether to approve or authorise products. Thacker notes that only two members were reported to have conflicts of interest among several covid authorisation panels that met in late 2020. But The BMJ found panellists who had significant financial matters by looking at the Open Payments disclosure website and examining panellists' published papers.
For example, Open Payments reported that Arnold Monto, professor at the University of Michigan School of Public Health and acting chair for the FDA's covid vaccine authorisation meetings, had received over $24,000 in payments from drug companies in 2019.
Adriane Fugh-Berman, professor of pharmacology and physiology at Georgetown University in Washington, DC says that these results reveal how confusing disclosure is and that common rules are needed.
Few people realise that there's no common standard for what must be disclosed and how far back, she explains, nor that disclosure is a two step process. Experts disclose interests to an entity - such as a journal, university, or government agency - which then decides what to disclose to the public. "There needs to be standardisation of what should be disclosed and how it should be disclosed," she says.
Joel Lexchin of York University in Toronto, who publishes research on conflicts of interest, suggests that government agencies should publish everything that experts disclose to them, instead of picking and choosing what to make public.
He agrees that a standardised, universal disclosure form would make compliance easier for people and help avoid confusion about which financial matters should be disclosed and what the institutions should make public. "People can legitimately follow whatever rules they encounter, but important things may still get left out," he explains.
The BMJ's investigation also uncovered close ties between a leading medical journal and the FDA's authorisation process.
The editor in chief of the New England Journal of Medicine (NEJM), Eric Rubin, sat on the authorisation panels for and voted to recommend authorising the Pfizer, Moderna, and Johnson & Johnson covid-19 vaccines.
Pfizer and Moderna subsequently published their clinical trials in NEJM. Yet Rubin declared no conflicts of interest to all three vaccine panels.
Asked by The BMJ whether he recused himself from the decisions on the NEJM submissions, he said: "Overall, we consider the deep involvement of editors in the medical and research communities to be a strength, not a problem."
