Declaring competing interests is a duty for doctors, scientists, and politicians
Too many doctors, scientists, and politicians have something to hide. When the truth is revealed, it can come hard at you, although rarely as spectacularly as the claims about government incompetence made by Dominic Cummings.1 You might be hiding a payment from a drug or device manufacturer, an offer of shares or future employment, or something less tangible, such as a desire for political power or revenge, religious superiority, or professional success. The first step in tackling competing interests is transparency about what is tangible—in other words, the money.
When people line their pockets in matters of patients’ and population health, the consequence is often that others pay by lining hospital beds and coffins. This is no lazy exaggeration or scare story: clinical and public health decisions distorted by financial conflicts do harm and do kill. Exhibit A: the pandemic response, from the UK to Japan.
Equally, conflicts of interest are a reality of working in public and private sectors. The requirement is not for purity but for transparency, as transparency is the bedrock for eliminating the influence of competing interests on decision making. Transparency is not a panacea but is essential for health systems that are serious about putting patients first and minimising harm.
This is why The BMJ is a prime mover in attempts by an all party parliamentary committee to create a central register of interests for UK doctors, to mirror systems already in place in other countries.23 The General Medical Council is an obvious custodian of such a register, although both the GMC and the government seem reluctant to commit themselves. In this they are at odds with patients, the public, and, increasingly, the profession.4
When individuals and organisations fail to commit to transparency, the worry is that they do indeed have something to hide. Lack of transparency is a scandal that rots from the head, such as when a country’s leaders refuse to hold an immediate inquiry into covid-19,5 try to suppress urgent public health data,6 persistently send mixed messages,7 and avoid collaboration with local bodies to tackle outbreaks.8
Similar scandals play out around the world, where the G20 countries pay lip service to vaccine equity while playing to the industry’s agenda910; the transparency of national vaccine policy committees in the US and UK is inadequate and their advice misleading11; corporate decision making leads to around 400 000 women being fitted with faulty implants12; data collected for health purposes are unavailable to patients but available for government or commercial use1314; and contracts awarded in primary care lack scrutiny.15
Transparency of data, for instance, allows better understanding of the balance between a vaccine’s safety and efficacy1617; why fewer non-covid hospital admissions were accompanied by more non-covid deaths18; when to implement and ease lockdowns19; which pandemic innovations to retain20; and how the pandemic affects women’s wellbeing and the provision of mental health services in primary care.2122
None of us should feel aggrieved at declaring competing interests as part of a clinical, scientific, or political role. It is our duty to patients and the public. The GMC must accept its responsibility to implement a central mandatory register of interests for the UK’s doctors, the key decision makers for a patient’s health. The government must extend that logic to population health by ensuring full transparency in the competing interests of policy makers, scientists, and politicians. Transparency is not a panacea, but fighting or delaying it—as Boris Johnson is doing with a covid-19 public inquiry—suggests something to hide and is as good as saying “mea culpa.”
Covid-19: How independent were the US and British vaccine advisory committees?
Experts who sit on national vaccine advisory panels are asked to disclose any industry ties and other conflicts of interest. Disclosure standards differ widely, often leaving the public in the dark
In the wake of lightning fast authorisations of covid-19 vaccines in the UK and the US, public health officials have worked hard to maintain confidence in these new products. British and American officials have emphasised the independence of the experts who authorise vaccines and those who issue advice on them. But an investigation by The BMJ has found that some of these experts have significant industry ties that government agencies do not always disclose.
We 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. It was not possible to repeat the exercise with the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), which licenses medicines and gave temporary authorisation for covid-19 vaccines, because the MHRA and its adviser, the Commission on Human Medicines, make almost none of their meetings or documents public.1
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. We also found examples where panellists disclosed to committees their grants, patents, and other industry relationships in their publications, but it seems that the committees did not find these matters worth making public, and they remained undisclosed until now.
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.”