Covid-19: How independent were the US and British vaccine advisory committees?

No conflicts registered

Most experts on the FDA and JCVI committees registered no conflicts of interest. 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. 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.

Adriane Fugh-Berman, professor of pharmacology and physiology at Georgetown University in Washington, DC, is not surprised at this low level of declarations. “Twelve months is too short. It’s not going to give you a complete picture,” she says. She adds that it’s preferable for government bodies to rely on experts who have had no financial ties for several years previously. The International Committee of Medical Journal Editors, for example, calls for disclosure of relationships going back 36 months.

In some cases, an expert has made a disclosure but the committee has not deemed it a conflict. For example, in the case of the UK’s JCVI, the chair of the covid-19 meeting is Wei Shen Lim, a professor at the Nottingham Biomedical Research Centre, who JCVI says has “no registered conflicts of interest.” The same document, however, further states that Lim’s “institution has 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 in a preprint published only months before the JCVI’s December meeting, Lim reported this Pfizer grant.

Similar matters exist with Adam Finn, professor at Bristol University, UK, as the JCVI reports him as having “no personal payments from manufacturers of vaccines” but adds that he is a local principal investigator for the Oxford-AstraZeneca covid vaccine. In disclosures for the New England Journal of Medicine in 2020 and in a disclosure the same year to The BMJ, Finn reported a study grant from GlaxoSmithKline (GSK). And in 2019 he published a study disclosing that his institution received funding from various drug companies and that he was president of a medical society whose annual meeting received sponsorship from vaccine manufacturers.2

For Maarten Postma of the University of Groningen in the Netherlands, the matter is rather complex. The JCVI reports no conflicts for his work on the covid-19 guidance, while he discloses board membership for two scientific consultancies on his website. And in a 2018 paper published in JAMA Oncology Postma disclosed grants and honorariums from more than a dozen drug companies, including AstraZeneca, Pfizer, and GSK. He also disclosed grants and personal fees from various pharmaceutical industries and financial support from the flu vaccine company Seqirus in studies he had published in recent months.34

“I declare my conflicts of interest to JCVI in the field of vaccines,” wrote Postma in an email to The BMJ. “They are indeed aware of those in the field of vaccines. Outside vaccines, I am happy to declare, but I think we decided we felt these are not relevant.” He also emailed The BMJ a list of his conflicts that JCVI reported for the main JCVI meeting, which was more expansive than what it reported for Postma for the covid meeting.

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. 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.

Seeking the full picture

In the US, outside experts advise the FDA on whether to approve or authorise products. 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 (£16 970; €19 650) in payments from drug companies in 2019. That same year, Open Payments reports that Myron Levine, a panellist from the University of Maryland School of Medicine, received about $30 000, mostly in consulting fees.

In 2019, Open Payments reports, Robert Schooley of the University of California at San Diego received over $25 000 in payments. It also reports that Ofer Levy at Boston Children’s Hospital received $5500 in mostly travel expenses from GSK. And in a 2020 publication Levy disclosed that he was a named inventor on several patent applications related to vaccine adjuvants.

Ofer explained in an email that GSK was not a sponsor for either of the covid vaccine panels. He added that the pending adjuvant patents “were revealed to FDA in my disclosures and these were appropriately deemed by FDA as irrelevant to the subject matter being considered.”

In another email an FDA spokesperson explained that all potential candidates were required to report detailed financial matters to evaluate possible conflicts of interest. The email advised, “To protect the credibility and integrity of advisory committee advice, the FDA routinely screens members of all advisory committees carefully for potentially disqualifying interests or relationships and makes changes to committee meeting rosters as needed.”

However, a recent analysis by the Pink Sheet, an industry newsletter, found that the FDA had issued six conflict of interest waivers for experts who advised the agency on whether three oncology drugs should be withdrawn after failed clinical outcome studies.5 And a 2006 study published in JAMA found that conflict of interest disclosures were common at FDA advisory meetings but that they seldom resulted in recusals.6

The BMJ reviewed a blank copy of the FDA’s disclosure form and found that, as in the case of the JCVI’s disclosure policy, the FDA requires advisory members to disclose matters going back only 12 months.

Fugh-Berman 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.

Fugh-Berman adds that she’s sometimes disclosed her own conflicts to editors when writing op-eds for newspapers, for example, and the outlets didn’t make them public. She says, “There needs to be standardisation of what should be disclosed and how it should be disclosed.”

Joel Lexchin of York University in Toronto, who publishes research on conflicts of interest, says, “Twelve months is really quite short. I think that’s not acceptable.” He also suggests that government agencies should publish everything that experts disclose to them, instead of picking and choosing what to make public. “The best policy is disclose everything,” he says. “Second best, pretty far down, is to have clear rules about why certain things don’t need to be disclosed.”

Schooley explains that the various time windows required by different disclosure policies can make it appear that an academic has reported financial interests in one case but not in another. More consistent disclosure policies are needed, he says—and universities, agencies, and journals should come together to normalise standards.

“If all of this were harmonised, it would improve transparency and reduce the time required for all involved,” he wrote to The BMJ. “In the meantime, we can try to answer each request as best we can based on how we interpret each query.”

Lexchin 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. As he explains, “People can legitimately follow whatever rules they encounter, but important things may get still get left out.”