Policies of five medical journals on authors declaring financial competing interests

The constraints of a "short report" meant that we could not include all the findings of our study. This "Web Extra" outlines the written policies of each journal. It also includes information about how these policies are put into practice, which was relayed to Amina Hussain verbally during interviews with editors.

Annals of Internal Medicine

Written policy: Under the heading "Dual Commitment" contained in the document "Information for Authors," the journal’s current policy for individual authors states: "In the cover letter…authors must disclose any financial interests, direct or indirect (dual commitment), that might affect the conduct or reporting of the work they have submitted. If the authors are uncertain about what might be considered a dual commitment, they should err on the side of full disclosure. Information about dual commitment may be made available to reviewers. If, in the Editors’ judgement, a dual commitment represents a potential conflict of interest, information concerning the relationship may be published at the Editors’ discretion; authors will be informed of the decision before publication." ⁽¹⁾

More specifically, the policy with respect to original research projects reads: "Sources of outside support for research, including funding equipment, and drugs, must be named in the cover letter. The role(s) of the funding organisation, if any, in the collection of data, its analysis and interpretation, and in the right to approve or disapprove publication of the finished manuscript must be described in the Methods section of the text."

In addition, each author is required to submit a completed and signed "Authors’ Form" acknowledging that: "Financial interests, direct or indirect, that exist or may be perceived to exist for individual authors in connection with the content of this paper have been disclosed to Annals in the cover letter. Sources of outside support of the project are named in the cover letter, and the role of funding organisations, if any, in the conduct of the study is described in the Methods section of the manuscript."

Authors of letters must also submit a covering letter acknowledging and providing details "as appropriate, on potential individual author dual commitment."

The "Information for Authors" document does not describe the policy on editorials. This is because these articles are commissioned, not submitted spontaneously. The invitation letter to potential editors is explicit about requiring them to state whether or not they have any conflict of interest or dual commitment.

Interview with editor: The editor, Frank Davidoff, explained that the current version of the policy (1999) had been in place for about three years, and had changed in two important ways from previous versions. Firstly, he said that authors had to differentiate between industry support of a project and industry ties of an individual investigator. This change was introduced because the source of project funding was always viewed by Annals of Internal Medicine as a potential source of bias, not dissimilar to other biases found in methodological research. So, information regarding the potential bias of the funding source was contained in the "Methods" section of original research articles in the journal, and not as a footnote statement at the end as in other journals. (In this study we did not regard statements on funding source as synonymous with statements on competing interests. Therefore, we did not include them in the counting unless they were backed up by additional statements on individual authors’ competing interests.)

Secondly, Davidoff explained that the journal discriminates between conflicts of interest and dual commitments to differentiate between "individual industry" links that were not likely to bias studies in a meaningful way (and therefore merely termed "dual commitment") and those that were (and hence termed "conflict of interest"). This was an attempt to recognise the enormous variability of these links.

BMJ

Written policy: The journal’s current policy for authors follows a description of when a competing interest might be said to exist: "We, the editors of the BMJ, believe that to make the best decision on how to deal with a paper we should know about any such competing interest that authors may have. We are not aiming at eradicating competing interests—they are almost inevitable. We will not reject papers simply because you have a competing interest, but we will make a declaration on whether or not you have competing interests.

"We used to ask authors about any competing interests, but we have decided to restrict our request to financial interests. This is largely a tactical move. We hope that it will increase the number of authors who disclose competing interests. Our experience, supported by some research data, was that authors often did not disclose them." ⁽²⁾

The BMJ adopted the recommendations outlined in Stelfox's study, which requires that authors answer a series of short questions: ⁽³⁾

"1. Have you in the past five years accepted the following from an organisation that may in any way gain or lose financially from the results of your study or the conclusions of your review, editorial, or letter:

• Reimbursement for attending a symposium?
• A fee for speaking?
• A fee for organising education?
• Funds for research?
• Funds for a member of staff?
• Fees for consulting?

2. Have you in the past five years been employed by an organisation that may in any way gain or lose financially from the results of your study or the conclusions of your review, editorial, or letter?

3. Do you hold any stocks or shares in any organisation that may in any way gain or lose financially from the results of your study or the conclusions of your review, editorial, or letter?

4. Do you have any other competing financial interests? If so, please specify."

If authors do have competing interests they are asked to draft a statement that might be published with their article. If authors have none, then the statement "Competing interests: none declared" appears.

The option of disclosing other types of competing interest is also afforded, stating: "We are restricting ourselves to asking directly about competing financial interests, but you might want to disclose another sort of competing interest that would embarrass you if it became generally known after publication." This is followed by a list of examples. Reference is then made to an article that authors are requested to read in order to learn more about the thinking behind the policy. ⁽⁴⁾ Finally, each author of a manuscript is directed to add his or her signature to the document.

Interview with editor: The editor, Richard Smith, explained that implementation of the journal’s current policy began after he wrote an editorial entitled "Beyond Conflicts of Interest" in 1998. ⁽⁴⁾ Before this, authors of original research articles were not required to answer the short questions that they are now, before signing the declaration form. Consequently, he believed that many people had felt able to sign, attesting that they had no conflict of interest when, he suspects, many of them probably did. He thought that there were two reasons why authors signed: firstly, people felt it "naughty" to have a conflict, and, secondly, they didn’t think a conflict had influenced them even if they had one. His own thoughts were that it was not naughty to have a conflict of interest, but it was naughty not to disclose it. He also thought it was naive of authors to think that they had not been influenced by their competing interests because people did not have that much insight into their biases and motivations. He emphasised that the whole point about a potential competing interest is that it might possibly have operated, and that it was difficult to know with certainty whether it had, or not.

Smith thought it may be useful to reiterate, in the competing interest statement, that the source of funding was a potential conflict. He cited a typical example of pharmaceutical companies who fund studies and also make the drugs, or competing drugs, used in those studies. Even though there is always a separate statement made in the BMJ on the funding source, sometimes the competing interest statement appearing alongside still reads "none declared." Some authors may assume that in declaring their funding source, they have made implicit a competing interest and see no need for mentioning it when completing the actual "competing interests" declaration form.

The policy is currently not applied systematically to all authors of letters. But increasingly, as letters arrive as "rapid responses" to the BMJ’s website, the intention is to implement the policy on the electronic version. He said that, in fact, the BMJ is looking to extend the policy throughout the journal, and to apply it to reviewers, who make decisions on whether a paper should be published. Another area for consideration is deciding when, and if, the competing interests of reviewers should be revealed to the authors of the articles they review.

JAMA

Written policy: The journal’s current policy (1999) requires that authors must read and sign a statement on financial disclosure, pertaining to competing interests, which reads: "I certify that all my affiliations with or financial involvement (e.g., employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, royalties) with any organisation or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript are completely disclosed below or in an attachment." ⁽⁵⁾

These are requirements for authors of all types of manuscripts submitted, including editorials, original research papers, and letters.

Interview with editor: One of the deputy editors, Drummond Rennie, said that the current policy on financial competing interests and all requirements for authors was contained in JAMA’s "Instructions for Authors" document, and that nobody could send in a paper unless they had signed that form. It is made clear that if the form is not signed then the paper will not be considered further. In practice, the editors tended towards telling readers whatever was disclosed to them, rather than assume the role of judge in deciding what should and should not be disclosed—he felt this was too paternalistic. In the 16 years he has worked at JAMA, it has always been a requirement for authors of original research to sign something attesting to financial interests. These requirements extend to all areas of the journal, including book reviews. There has been some fine tuning of the wording contained in the guidelines over the years. For example, a subtle change from "any affiliations" (in 1996) to "all my affiliations" (in 1999) was made to convey the message that associations in the past were also relevant. The modification was prompted by enquiries from a newspaper regarding the previous financial affiliations of an author of a JAMA editorial who had not declared a conflict. The author was challenged and it later came to light that he did indeed have a conflict because of his previous financial involvement with an organisation concerned with the subject matter of his article. In his defence, the author had pointed out that the association had been five years ago, and was not ongoing at the time he wrote the editorial. Also, people often made mistakes, or even lied, but editors should act on whatever suspicions they had.

Lancet

Written policy: Current policy states: "The conflict-of-interest test is a simple one, and it applies to all contributions to The Lancet, letters, reviews, and commentaries included. Is there anything - e.g. a shareholding in or receipt of a grant or consultancy fees from a pharmaceutical company or a contract from a medical devices manufacturer - that would embarrass you if it were to emerge after publication and you had not declared it? The Editor needs to be informed and will discuss with you whether or not disclosure in the journal is necessary. The covering letter is the appropriate place for such disclosure. All sources of funding must be disclosed, as an acknowledgement in the text." ⁽⁶⁾

In guiding authors, the Lancet states that it will not publish articles unless it has the signatures of all the authors, and recommends that this be done at the time of submission. It proposes a suggested format for papers on original research, and contains the following: "…I declare that I have no conflict of interest in connection with this paper, other than any noted in the covering letter to the editor." It also suggests that a similar format can be used for other types of submission. In the covering letter, authors are asked to: "…state precisely what each author has contributed and what conflicts of interest there are."

The first editorial of each issue of the Lancet is written in-house and no individual’s name appears, making it impossible to know whether authors have competing interests. Subsequent editorials in the same issue are written and signed by individual authors, making it possible to disclose competing interests.

Interview with editor: The editor, Richard Horton, reiterated that the message the journal wanted to convey to authors was that they should disclose something if they are likely to be embarrassed by it, especially if it were to emerge after publication and they had not declared it. In the policy it was insisted that all authors of original research sign a piece of paper verifying this. For letters, too, authors were asked to supply declarations of interest. However, in practice, if this was not supplied initially then it was not necessarily requested again—unless there was suspicion that a competing interest might be operating, for example in some letters relating to pharmaceutical products. He said, in essence, that the current policy had been in place since just before he became Editor in 1995 and, although in principle it had remained largely unchanged, the way it was applied in-house had altered subtly. He cited Stelfox’s study as a landmark report that proved, if ever proof was needed, the importance of reinforcing the message that potential conflicts of interest need to be dealt with more assiduously now than they may have been in the past. ⁽³⁾

Horton thought that applying more rules and regulations, prompted by a presumption of suspicion, was not necessarily a solution to a problem. An alternate response, exploring the underlying causes, might be more useful, particularly questioning how society has reached the position whereby industry is having a pervasive, adverse influence on the agenda of medicine.

He acknowledged the tactics of some other journals that required authors to sign more detailed forms testifying that they don’t have a conflict when they say they haven’t. He realised that such tactics probably forced people to think about the issue more carefully, and that it was the next level up from what the Lancet calls for. But Horton had three reasons why he did not anticipate implementing this procedure. Essentially, he advocated the promotion of trust above suspicion, he felt the procedure was too bureaucratic, and that it emphasised financial interests without really highlighting other, potentially more significant, ones. He particularly considered academic competition to have a strong influence on an author’s decision to submit an article for potential publication. Although he thought it very important to ask about financial conflicts and to deal with them seriously if disclosed, he was still wary of the disclosure, alone, argument (i.e. the inference that simply disclosing a potential financial competing interest in some way "absolves" the drug industry of its adverse influence on medicine) because he believed it lulled people into a false sense of security and stopped them questioning the much more fundamental issue of how the position of industry adversely influencing medicine had been reached in the first place.

New England Journal of Medicine

Written policy: The journal’s current policy states: "Authors of research articles should disclose at the time of submission any financial arrangement they may have with a company whose product figures prominently in the submitted manuscript or with a company making a competing product. Such information will be held in confidence while the paper is under review and will not influence the editorial decision, but if the article is accepted for publication, the editors will usually discuss with the authors the manner in which such information is to be communicated to the reader.

"Because the essence of reviews and editorials is selection and interpretation of the literature, the Journal expects that authors of such articles will not have any financial interest in a company (or its competitor) that makes a product discussed in the article." ⁽⁷⁾

To guide prospective editorialists, the journal sends them a letter containing the statement: "Because editorials involve interpretation and opinion, we require that authors be free of financial associations (including equity interest, consultancies, or major research support) with a company that stands to gain from the use of a product (or its competitor) discussed in the editorial. If there are any questions about this policy, please phone us. Otherwise, please sign the attached form attesting that you have no such associations." Whether research support is major or not is decided on a case by case basis. Minor support does not preclude authorship but is disclosed to readers at the time of publication.

Interview with editor: The deputy editor, Bob Utiger, explained that the current policy stipulates that authors of editorials and review articles should not have any current ties with industry—a situation, it is hoped, that would continue until the article is published. It was acceptable, however, to have had ties in the past. This did not apply to authors of original research, where the policy has always been simply disclosure. He said that for about three years now, all authors of an editorial have been asked to sign a form attesting that they have no such relations, but that authors of original research papers were not required to do this. It has also been routine procedure for the past three years to ask about conflicts of interest whenever a letter to the editor was accepted. If no statement was supplied, or if the situation was unclear, the author(s) would be asked again.

Recently, a firmer position had been adopted on what was considered to be an acceptable time to have elapsed since a major financial association between a potential editorialist and a company that might feature in the editorial had taken place. Although the details had yet to be published, he conveyed that the journal was thinking in terms of a two year period.

In common with some other editors, Utiger also said that one of the main reasons for requesting that potential authors of editorials signed a form was to make them think about the issue of competing interests more carefully. He thought that there were times when authors genuinely had not remembered something, but having seen the form they were prompted to disclose it. He remembered instances in the past when authors had not been asked about conflicts of interest when, in retrospect, they should have been, as it later became evident that conflicts had existed and therefore could have influenced what was written. It was events like these that provoked a change to the current policy.

Interestingly, he was curious to see how, if at all, the proportions of declarations in original research papers had changed over the years. In particular, he wondered if more papers were funded by drug companies now and fewer were funded by the National Institutes of Health (in the USA) compared to five years ago, implying that one might expect this to have an obvious knock-on effect in the number of disclosures being published along with original research articles.

1. Annals of Internal Medicine. Information for Authors. www.annals.org/shared/author_info.html (accessed 10 May 2001).
2. BMJ. Competing interests. www.bmj.com/advice/5.html (accessed 10 May 2001).
3. Stelfox HT, Chua G, O’Rourke K, Detsky AS. Conflict of interest in the debate over calcium channel antagonists. N Engl J Med 1998;338:101-5.
4. Smith R. Beyond conflict of interest. BMJ 1998;317:291-2.
5. Journal of the American Medical Association. Authorship criteria and responsibility, financial disclosure, copyright transfer, and acknowledgement. jama.ama-assn.org/info/auinst.html#Authorship (accessed 10 May 2001).
6. Lancet. Writing for The Lancet. www.thelancet.com/newlancet/any/author/uniform1.html (accessed 10 May 2001).
7. The New England Journal of Medicine. Conflict of interest. www.nejm.org/general/text/InfoAuth.htm#Conflict (accessed 10 May 2001).