Ethics in publishing: Conflict of interest

By David Woods (dwoods@rxcomms.com)

A recent article in the Journal of the American Medical Association (JAMA) concluded that women who stopped taking their antidepressant drugs during pregnancy were at greater risk of relapsing into depression.

But several newspaper and television reports latched onto the fact that most of the JAMA article’s 13 co-authors are consultants to pharmaceutical companies that produce antidepressant medications.

This kind of relationship between key medical specialists and the pharma industry isn’t new. The industry funds a significant number of medical research projects, as well as continuing medical education conferences and scientific publications.

In fact, the JAMA article was funded by the National Institutes of Health with no support from industry. And, as the study’s designer and the analyst and interpreter of its data pointed out: “[It] clearly and strongly suggested that… women who choose to discontinue antidepressant medication during the course of their pregnancy have a substantially greater risk of relapsing into a depression episode compared with those who choose to remain on their medication.”

Moreover, media focus on the perceived conflict of interest among the study’s authors has a negative public health impact and does a disservice to women, who may be confused by the conflicting messages.

That said, there remains an issue of complete transparency and rigor on the part of medical journals. JAMA’s editor said that the journal wasn’t aware of the relationship between some of the authors and the pharmaceutical industry. But it should have been. The International Committee of Medical Journal Editors (ICMJE), of which JAMA is a member, is explicit in the matter, requiring that putative journal authors disclose all potential conflicts; and moreover, to state explicitly that they have no such conflicts.

ICMJE specifically states that “conflict of interest exists when an author… reviewer, or editor has personal or financial relationships that inappropriately influence (bias) his or her actions.”

When you as a potential author submit a manuscript, you’re responsible not only for disclosing all financial and personal relationships but also for stating explicitly whether potential conflicts do or do not exist. The World Association of Medical Editors (WAME) offers a further definition of conflict of interest: “some fact known to a participant in the publication process that if revealed later would make a reasonable reader feel misled or deceived (or an author, editor or reviewer feel defensive).”

And editors must apply stringency by what the ICMJE calls “declining to consider papers unless the authors can attest that they had full access to the data and control over the decision to publish.”

In all of the fuss over the JAMA article, the point was not that it was a matter of duplicity but of laxity. Authors need to be more open about their affiliations, and editors more rigorous in making such connections known to readers. But in the final analysis, patients need to be served by findings they can trust.

No commercial or financial interests supported or influenced the content or contentions of this editorial.

Ethics in publishing: Authorship

While there is no universally agreed definition of authorship, several organisations, including the International Committee of Medical Journal Editors (ICMJE) and the World Association of Medical Editors (WAME), have taken a stab at defining what constitutes authorship.

ICMJE, for instance, recommends the following criteria:

• Authorship credit should be based upon substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; drafting the article or revising it critically for important intellectual content; and direct responsibility for the final approval of the version to be published.

• When a large, multicentre group has conducted the work, the group should identify the individuals who accept direct responsibility for the manuscript. The ICMJE notes that acquisition of funding, collection of data, or general supervision of the research group, alone, does not justify authorship; on the other hand, everyone designated as an author should qualify for authorship, and all those who qualify should be listed. The order of authorship on the byline should be a joint decision of the co-authors, who should be prepared to explain the order in which authors are listed.

WAME urges that all journals should publish guidance about what constitutes authorship; but while the association suggests awareness of the ICMJE guidelines, it waspishly suggests that these are the subject of some controversy, represent the views of editors rather than authors, and are widely disregarded even by authors publishing in ICMJE journals.

Authorship, says WAME, implies a significant intellectual contribution to the work, some role in writing the manuscript, and reviewing the final draft of the manuscript – but authorship roles can vary.

Who will be an author, and in what sequence, should be determined by the participants early in the research process, to avoid disputes and misunderstandings which can delay or prevent publication of a manuscript. For all manuscripts, the corresponding author should be required to provide information on the specific contributions each author has made to the article.

While all authors are responsible for the quality, accuracy, and ethics of the work, one author must be identified who will respond if questions arise or more information is needed and who will take responsibility for the work as a whole.

You can see that there’s a measure of agreement here – some of it based on common sense, some on covering all bases, and some on enlightened self-interest. The main points to look for, though, are responsibility, rigour, and transparency.