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Authors Not Declaring Conflicts of Interest

March 12, 2007 to March 13, 2007

How would you manage this situation? A pair of research and clinical professionals have written for our medical magazine once before. This time the article is about a specific piece of equipment that is the only type available in Australia. They have been commissioned by our Ed. Board, as they are up to date in this area.

They send an email back in reply to our question: "We have no conflict of interest regarding our article."  Later, just before publication, a Board member wants to know if they have declared conflict of interest regarding this particular equipment and their article. When asked again 6 weeks later, they come out with a whole string of conflicts, from frank remuneration for lectures about this topic to grants from drug companies for the research they were doing that was mentioned in the article! Luckily we could put this later declaration into print just in time for publication.

I am not inclined to use these two again. We are having our annual meeting soon and I would appreciate others' opinions—I think the Board might give them a second chance—they are busy, etc, and doing important research that needs to be aired intermittently. Am I on firm ground if I disagree?

Vivienne Miller
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I think the typical handling of conflict of interest declarations misses the point entirely. We seem to think that as long as the authors disclose their biases, that this somehow sanitizes the content, or that readers will then be able to take the authors’ financial relationships into consideration when reading the article. This is naïve and misguided. Biased information is biased information. Would you rather read a review article about the appropriate use of a new drug or device written by someone with ties to the manufacturer, or by an independent expert?

Conflicts seem to be the norm in research, and although such studies are subject to bias, hopefully the scientific process minimizes their effect. But especially with review articles, I think that simply noting the authors’ close financial ties to the topic does not provide enough safeguards. That’s why our journal, which primarily publishes clinical review articles, does not consider manuscripts written by authors with conflicts related to the topic. As far as I know, American Family Physician is the only journal with this published policy. The New England Journal of Medicine used to have a similar policy for its review articles and editorials, but abandoned it when they felt they could not find enough experts without ties to industry—a sad commentary indeed.

Jay Siwek
Editor, American Family Physician
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I agree, but in this case the authors were really the only people in Australia who could write the article in as much detail as was needed (we are not yet using international authors). There is an ethical issue that is presumed (ie, as this is the only product of its type and the authors the only professionals with expertise in it, that their article will declare this bias and the written facts are true). This ethical issue, as far as I am concerned, was not respected.

Vivienne Miller
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I came across a very similar case at another journal recently. The author initially declared no competing interests then, after the article had gone to press, suddenly listed a whole string of clearly relevant financial interests.

In this case, the journal decided to print a correction. I'm not sure if they would use this author again, but I guess they might be wary. The person was quite senior and so certainly should have known better.

I do hope this 'delayed' submission of competing interests is not a new ploy by authors who believe their article will get a more favourable reception if they claim to have no conflict of interests, and that maybe the journal won't bother to list their interests if they submit them really late. I guess all editors can do is query ANYBODY who claims to have no competing interests.

Liz Wager
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To make things as efficient as possible in the editorial office by avoiding the need to do background checking or enter into correspondence with authors, perhaps a Competing Interests form could be designed that asks authors to "Please list your competing interests here" and then offers a menu of items to tick (such as Speaking fees, Product development consultancy, Stock, Paid travel expenses, etc.).

The form would not even contain an option for "None," but since the nature of the relations between authors and sponsors evolves continuously, it would contain an item for "Other (please explain briefly)."

There may be no need for a separate form if a section on this information can be added to whatever existing paperwork the journal currently requests from authors.

Those (increasingly rare, apparently) authors who have no competing interests would need to ask the editorial office what to do—which would probably be to write out a brief ad hoc explanation of their situation. Needing to ask the editor and put it into writing makes it less likely people would invent false claims of having no competing interests (or later say they were confused by the paperwork, or forgot to do it, or lost it, or whatever). Asking authors to submit their Competing Interests information at the time of manuscript submittal might save time, avoid delays (because there would be no more sudden changes in the information provided), and avoid the need for corrections to be published later on.

To motivate authors and sponsors to overcome their reticence about "admitting to" conflicting interests, editors could say plainly that the idea is not to raise questions about these (legitimate, and almost inevitable) relationships, but simply to provide clear information on these relationships so that researchers, evaluators, policy-makers, ethicists, and other readers don't need to imagine the worst. The "stigma" attached to competing interests will need to be removed to encourage researchers and medical affairs staff at the sponsors' firms to be open about them.

Being dishonest and then being caught and denounced publicly seems a much less desirable outcome for authors and their sponsors than being honest in the first instance.

Karen
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We learned the hard way that you must use a check-off form listing various kinds of potential conflicts of interest and must include a check off for "none". We now use a form modeled after JAMA's. We will not review a manuscript that discusses any product or organization until we have such a signed form from all authors. We've wasted our time and our reviewers' time by not having the forms in hand, only to discover that the paper was ghostwritten by someone hired by a pharmaceutical company, not the author. The form will expose things like "a grant for manuscript preparation" that didn't go to the author directly but to the ghostwriter—that's if the author is honest (not always the case).

Diana J. Mason
Editor-in-Chief, American Journal of Nursing
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We had a similar situation. After a letter about antibiotic therapy for pneumonia was printed, an alert reader asked why we hadn't disclosed the numerous ties to industry that the authors of the letter had. A Google search disclosed many relevant relationships, all undisclosed, despite two prompts to disclose relevant relationships. We printed the following notification http://www.aafp.org/afp/20070215/letters.html

[By the way, we've found that Google is a great way to check for potentially undisclosed conflicts]

"Editor's Note: Importance of Revealing Any Author Conflicts of Interest

The November 1, 2006, issue of American Family Physician contained a letter titled "Medication Options for the Treatment of CAP." Each of the authors of this letter was instructed at the time of submission and asked again at the time of acceptance to disclose any potential conflicts of interest, including financial relationships with the manufacturers of the medications that they discussed. At the time of publication, none of the authors had disclosed any potential conflicts of interest. When numerous financial relationships were later discovered to exist, the authors responded that they had not realized that it was necessary to disclose these relationships. The editors of American Family Physician feel that it is important for our readers to be aware that the following relationships existed at the time of the letter's publication:

Lionel A. Mandell, M.D., has received research funding from Bayer Corp., Chiron Corp., Ortho-McNeil Pharmaceutical Corp., Oscient Pharmaceuticals, and Pfizer Pharmaceuticals, Inc.; has served as a paid consultant to Bayer, Cempra Pharmaceuticals, Novexel, Oscient, Ortho-McNeil, Pfizer, Sanofi-Aventis, Targanta Therapeutics, and Wyeth Laboratories; and is on the speaker's bureaus for Bayer, Ortho-McNeil, Oscient, Pfizer, and Sanofi-Aventis.

Thomas M. File, Jr., M.D., has received research funding from Binax, Ortho-McNeil, Oscient, Pfizer, and Sanofi-Aventis; has served as a paid consultant to Bayer, GlaxoSmithKline, Merck & Co., Ortho-McNeil, Oscient, Pfizer, Sanofi-Aventis, Schering-Plough Pharmaceuticals, and Wyeth; and is on the speaker's bureaus for Abbott, GlaxoSmithKline, Merck, Ortho-McNeil, Oscient, Pfizer, Sanofi-Aventis, Schering Plough, and Wyeth.

Paul B. Iannini, M.D., has served as a paid consultant, received honoraria from, and is on the speaker's bureaus for Oscient, Sanofi-Aventis, and Schering-Plough."

Kenny Lin
Assistant Editor, American Family Physician

Jay Siwek
Editor, American Family Physician
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The solutions suggested by Karen are well said. Editors should also take time to find ways to educate authors about the role that the declaration of any competing interests serves. For a long time, I thought that such a declaration would stand in my way to publication. In fact, it has not but I have learnt this with time and from editors.

Adamson Muula
Malawi Medical Journal

 

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