What conflict of interest?

Under full glare of the media spotlight in February this year, the editor of The Lancet, Richard Horton, partially retracted an article published 6 years before.2,3 This act was triggered by allegations of research misconduct in the study, taken to The Lancet by a Sunday Times journalist.4 The Lancet’s investigations5 and the events that ensued involved the article’s authors (doctors at London’s Royal Free and University College Medical School), the institution’s ethics committee, the General Medical Council, the British Parliament, and even the Prime Minister, Tony Blair.

Why the fuss? In 1998, this research report implied a link between autism, bowel disease and the combined measles– mumps–rubella (MMR) vaccine.3 A storm of controversy erupted, and MMR vaccination rates in England fell from 92% of children reaching the age of two in 1996/97 to 82% in 2002/03.6 Confirmed cases of measles rose from 112 in 1996 to 442 in 2003. When the allegations of misconduct were probed this year, it was found that, at the time the article was submitted and published, its lead author and senior investigator, Dr Andrew Wakefield, had not disclosed that he had been commissioned by the Legal Aid Board (for the sum of £55,000) to determine if there was evidence to support legal action by parents of children allegedly harmed by the MMR vaccine. Some of these children were also in Wakefield’s Lancet study. This led to a partial retraction of the article by 10 of its original 13 authors, but not by Wakefield.7 Richard Horton remarked, “If we had known the conflict of interest Dr Wakefield had in this work I think that would have strongly affected the peer reviewers about [its] credibility . . . in my judgement, it would have been rejected”.2

The Medical Journal of Australia has not had such sensational experiences (yet!). Conflict of interest in publication was first raised in a position statement by the International Committee of Medical Journal Editors, published in 1993.8 Our first conflict of interest statement appeared in the late 1990s, but declaring conflict of interest was deemed by many then to be optional — an exercise in political correctness.

So, except in extreme situations, does conflict of interest really matter? Unfortunately it does. It is a principle long enshrined in the conduct of scientific research.9 Moreover, we can no longer ignore the growing body of evidence that conflict of interest can bias research outcomes. Systematic reviews have shown that results of sponsored studies are more likely to favour the sponsor when it is a pharmaceutical company,10 and industry-sponsored studies are not only associated with pro-industry conclusions, but with restrictions on publication and data sharing.11 As more research is funded by non-academic sources, we cannot ignore the potential for bias to affect its outcomes.12 Neither can we ignore an increasingly educated, involved 21st-century Western society that is calling for greater accountability in health research.

• “Financial or personal relationships that inappropriately influence (bias) . . . actions [of an author (or the author’s institution), reviewer, or editor] . . . The potential for conflict of interest can exist whether or not an individual believes that the relationship affects his or her scientific judgment”.13

• Anything, be it personal, financial, academic, religious, or political, “which, when revealed later, would make a reasonable reader feel misled or deceived”.1