EDITORIAL
Annals Policy on Deceptive Disclosure of Conflicts of Interest
A
s a new Editor of a medical journal, one enters with fairly clear concepts of what one would like to achieve. My own list included the types of papers I wanted to publish and the level of quality I wanted to achieve. Further down the list were things like features I would like to try out, to broaden the reach of the journal. My own list did not even include dealing with deception on the part of authors when it comes to disclosing conflicts of interest (COI) in their manuscript. I thought that this issue would have been handled by the use of COI forms from the International Committee of Medical Journal Editors (ICMJE). Since assembling the new editorial team we have repeatedly encountered articles where the authors either were deceptive in the way in which they filled out the COI forms or in the way that they described the relationships in the section of their paper devoted to this, which is supposed to summarize the COI information. This issue has arisen repeatedly from reviewers and editors, despite the fact that we have not explored for potential lapses in COI disclosure systematically. The frequency with which we have uncovered these issues is alarming, and suggests that there is something wrong with our current COI policies, certainly at the level of this journal, very likely at most other medical journals, and quite probably across our entire medical research enterprise. Let me start by framing the purpose of COI disclosures, at least for Annals. The readers of a research paper or review published in Annals have the right to know whether the opinion of the authors may have been influenced by financial or personal interests in the results of the research. We all realize that it is necessary for scientists and clinicians who discover new methods for diagnosis or treatment to collaborate with industry to make the fruits of their work available to the wider medical community. We also understand that these investigators and their institutions deserve fair compensation for licensing these products. However, there is also no doubt that readers of the work of such investigators must be aware that such potential biases exist, if they are to reasonably interpret the reports. To permit this, these relationships must be clearly, explicitly, and fully stated in the COI Disclosure Statement that is part of each published manuscript. To pro-
vide detail that supports that statement, the ICMJE created a form, the purpose of which is to bring to light any issues that should be highlighted in that published Disclosure Statement. This form is not a substitute for an explicit summary of COI in the Disclosure Statement in the body of the published paper. All of the conflicts that come out in the ICMJE COI form should also be included in the manuscript, in that brief statement. In fact, any additional potential conflicts of which the authors are aware but which may not be covered by the ICMJE form (such as personal relationships with individuals who may have financial interests in the work) should be included as well. Please note that I do not wish to imply that an author who has a financial interest in the work is “compromised.” As long as he or she fully discloses the relationships, I think that it is the reader’s responsibility to determine what role that may play in the work, and the author has fully discharged his or her responsibility. I am instead concerned with the investigator who undermines his or her own work by not fully disclosing these relationships. If the investigator truly believes that the work has not been influenced in any way by the financial relationships of the investigators (as most do), then he or she should have no reason to avoid disclosing fully the extent of that relationship. It is the papers that are submitted where the authors have not disclosed their relationships fully in the ICMJE COI form, or worse, have not spelled out the relationships clearly in the COI Disclosure Statement in the manuscript, that are, in my opinion, compromised. This problem is, unfortunately, distressingly common both at the level of incomplete disclosure in the ICMJE form and in the text of the paper. We have, for example, had authors who were on the Scientific Advisory Board of a company (information that was clearly described in the company website), not declare that information in their ICMJE COI form. Others have indicated that they had patented a discovery and that the patent belonged to their employer institution, without mentioning that the employer had licensed the patent to a drug company. The name of that company appeared as making grants or other payments to the authors of the paper, but unless one knew that it also had licensed the intellectual property described in the manuscript, there was no way for a reader to make the association.
C 2014 American Neurological Association V 149
ANNALS
of Neurology
However, the greatest problems have come with authors translating the information from their own COI forms to the COI Disclosure Statement of their manuscript. A paid member of a Scientific Advisory Board who had stock holdings in the company, for example, was described in one recent manuscript as having “no conflict of interest,” and when that was challenged by a reviewer, wanted to change this to admitting to be “a technical advisor” to the company. Other descriptions have failed to mention that authors were stockholders in the company that was trying to develop the drug that was the subject of the paper; or have disclosed that authors consulted for or held stock in a list of companies, without mentioning that one of those companies held the license on the drug. In order to address this problem, as of this issue, Annals will expect not only that each investigator fully disclose his or her COI on the ICMJE form, but also that the information that is relevant to that manuscript be summarized accurately and fully for the reader in the COI Disclosure section of each manuscript. Let me be clear about what we expect. We want the authors to outline for the readers any personal or financial interest they may hold in the work that is being described in the manuscript. A long list of relationships with irrelevant drug companies need not be in the manuscript; in fact this clouds the issue. But the fact that an author holds a patent on a drug that has been licensed to a drug company that supports the work, or some of the other authors, is important (even if the author who holds the patent is not receiving payment directly). Even the
150
appearance of COI, which the author may think is inconsequential, should still be disclosed in the manuscript. The Editors of Annals should not have to become the “disclosure police” to insure that this policy is upheld. We have to trust our authors, as we do for all other aspects of their scientific work. However, lack of full disclosure of COI should be considered a serious offense, like any other form of scientific misconduct, and it should be treated accordingly. For that reason, lack of full disclosure will no longer be considered a minor issue, to be dealt with in revision, if the reviewer happens to discover this impropriety. It will be immediate grounds for the paper being rejected, and in the case of particularly blatant or repeated offenders, the case will be referred to our Associate Editor conference for consideration of further sanctions, including not permitting submission of future manuscripts to Annals or a letter to the employer of the authors indicating the nature of the offense. This policy could be viewed as harsh, but from the pervasiveness of the problem in just my first nine months as the Editor-in-chief, it is necessary. Deceptive lack of full COI disclosure is a form of scientific misconduct, and Annals of Neurology will treat it as such in the future. Clifford B. Saper, MD, PhD Editor-in-chief
DOI: 10.1002/ana.24234
Volume 76, No. 2
Annals Policy on Deceptive Disclosure of Conflicts of Interest
A
s a new Editor of a medical journal, one enters with fairly clear concepts of what one would like to achieve. My own list included the types of papers I wanted to publish and the level of quality I wanted to achieve. Further down the list were things like features I would like to try out, to broaden the reach of the journal. My own list did not even include dealing with deception on the part of authors when it comes to disclosing conflicts of interest (COI) in their manuscript. I thought that this issue would have been handled by the use of COI forms from the International Committee of Medical Journal Editors (ICMJE). Since assembling the new editorial team we have repeatedly encountered articles where the authors either were deceptive in the way in which they filled out the COI forms or in the way that they described the relationships in the section of their paper devoted to this, which is supposed to summarize the COI information. This issue has arisen repeatedly from reviewers and editors, despite the fact that we have not explored for potential lapses in COI disclosure systematically. The frequency with which we have uncovered these issues is alarming, and suggests that there is something wrong with our current COI policies, certainly at the level of this journal, very likely at most other medical journals, and quite probably across our entire medical research enterprise. Let me start by framing the purpose of COI disclosures, at least for Annals. The readers of a research paper or review published in Annals have the right to know whether the opinion of the authors may have been influenced by financial or personal interests in the results of the research. We all realize that it is necessary for scientists and clinicians who discover new methods for diagnosis or treatment to collaborate with industry to make the fruits of their work available to the wider medical community. We also understand that these investigators and their institutions deserve fair compensation for licensing these products. However, there is also no doubt that readers of the work of such investigators must be aware that such potential biases exist, if they are to reasonably interpret the reports. To permit this, these relationships must be clearly, explicitly, and fully stated in the COI Disclosure Statement that is part of each published manuscript. To pro-
vide detail that supports that statement, the ICMJE created a form, the purpose of which is to bring to light any issues that should be highlighted in that published Disclosure Statement. This form is not a substitute for an explicit summary of COI in the Disclosure Statement in the body of the published paper. All of the conflicts that come out in the ICMJE COI form should also be included in the manuscript, in that brief statement. In fact, any additional potential conflicts of which the authors are aware but which may not be covered by the ICMJE form (such as personal relationships with individuals who may have financial interests in the work) should be included as well. Please note that I do not wish to imply that an author who has a financial interest in the work is “compromised.” As long as he or she fully discloses the relationships, I think that it is the reader’s responsibility to determine what role that may play in the work, and the author has fully discharged his or her responsibility. I am instead concerned with the investigator who undermines his or her own work by not fully disclosing these relationships. If the investigator truly believes that the work has not been influenced in any way by the financial relationships of the investigators (as most do), then he or she should have no reason to avoid disclosing fully the extent of that relationship. It is the papers that are submitted where the authors have not disclosed their relationships fully in the ICMJE COI form, or worse, have not spelled out the relationships clearly in the COI Disclosure Statement in the manuscript, that are, in my opinion, compromised. This problem is, unfortunately, distressingly common both at the level of incomplete disclosure in the ICMJE form and in the text of the paper. We have, for example, had authors who were on the Scientific Advisory Board of a company (information that was clearly described in the company website), not declare that information in their ICMJE COI form. Others have indicated that they had patented a discovery and that the patent belonged to their employer institution, without mentioning that the employer had licensed the patent to a drug company. The name of that company appeared as making grants or other payments to the authors of the paper, but unless one knew that it also had licensed the intellectual property described in the manuscript, there was no way for a reader to make the association.
C 2014 American Neurological Association V 149
ANNALS
of Neurology
However, the greatest problems have come with authors translating the information from their own COI forms to the COI Disclosure Statement of their manuscript. A paid member of a Scientific Advisory Board who had stock holdings in the company, for example, was described in one recent manuscript as having “no conflict of interest,” and when that was challenged by a reviewer, wanted to change this to admitting to be “a technical advisor” to the company. Other descriptions have failed to mention that authors were stockholders in the company that was trying to develop the drug that was the subject of the paper; or have disclosed that authors consulted for or held stock in a list of companies, without mentioning that one of those companies held the license on the drug. In order to address this problem, as of this issue, Annals will expect not only that each investigator fully disclose his or her COI on the ICMJE form, but also that the information that is relevant to that manuscript be summarized accurately and fully for the reader in the COI Disclosure section of each manuscript. Let me be clear about what we expect. We want the authors to outline for the readers any personal or financial interest they may hold in the work that is being described in the manuscript. A long list of relationships with irrelevant drug companies need not be in the manuscript; in fact this clouds the issue. But the fact that an author holds a patent on a drug that has been licensed to a drug company that supports the work, or some of the other authors, is important (even if the author who holds the patent is not receiving payment directly). Even the
150
appearance of COI, which the author may think is inconsequential, should still be disclosed in the manuscript. The Editors of Annals should not have to become the “disclosure police” to insure that this policy is upheld. We have to trust our authors, as we do for all other aspects of their scientific work. However, lack of full disclosure of COI should be considered a serious offense, like any other form of scientific misconduct, and it should be treated accordingly. For that reason, lack of full disclosure will no longer be considered a minor issue, to be dealt with in revision, if the reviewer happens to discover this impropriety. It will be immediate grounds for the paper being rejected, and in the case of particularly blatant or repeated offenders, the case will be referred to our Associate Editor conference for consideration of further sanctions, including not permitting submission of future manuscripts to Annals or a letter to the employer of the authors indicating the nature of the offense. This policy could be viewed as harsh, but from the pervasiveness of the problem in just my first nine months as the Editor-in-chief, it is necessary. Deceptive lack of full COI disclosure is a form of scientific misconduct, and Annals of Neurology will treat it as such in the future. Clifford B. Saper, MD, PhD Editor-in-chief
DOI: 10.1002/ana.24234
Volume 76, No. 2
