A systematic review on the effectiveness of a comparatively new group of drugs was submitted. The review had originally been for an independent body, so the submission was an abridged version. A reviewer pointed out that the review made no reference to a Cochrane review and the trials it cited, which had been published some four months before submission of the paper to the journal. The reviewer suggested that this was more than incompetence: he knew the authors were aware of the existence of the Cochrane review. He also questioned the role of the study’s advisory group which had supposedly “provided peer review and advice regarding the protocol, analysis, and interpretation.” He thought that the advisory group had not been involved throughout the project and had not peer reviewed the submitted manuscript. Another member of the advisory group seemed to confirm these suspicions. What should be done now?
Advice:
_ The Cochrane Database of Systematic Reviews is designed to be used by anyone. The paper was an incomplete systematic review so it should be rejected. _ Was the advisory group aware that the authors were not submitting a complete review? _ In effect, drug companies are often the advisory group. _ If the authors are asked to revise their paper, they should describe the role of the advisory group and refer to the previous Cochrane review. _ Their findings could conflict with the Cochrane review, which could itself, of course, be flawed, but the authors should include all relevant studies if asked to resubmit a revised version, and to detail why any flawed studies had been excluded. _ Write a frank letter to the authors asking how their review differed from the Cochrane review, and to explain the exact role of the advisory group. _ Transparency is required: ask the authors to declare any competing interests.
Follow up:
The case was referred to the journal’s ethics committee and the matter taken up with both the advisory group and the authors. The authors have not responded to all the editor’s concerns, and the ethics committee feels that it is not in a position to judge whether the authors had been deliberately dishonest. The role of the advisory group was found to be within the bounds of normal practice. Futher follow-up The journal’s ethics committee investigated the case thoroughly and compiled a report, concluding that the paper was muddled but that the authors had committed no outright research misconduct. The editor sent the report to the authors and requested that a copy be sent to the advisory group.
An author wrote us a letter for publication on the importance of doing research on a long established drug. He did not declare any competing interest, but we were later informed that he was conducting a trial of the drug funded by a pharmaceutical company. We approached him and asked him to declare his competing interest. Have we done the right thing? Should we do more than simply ask him to declare his competing interest and publish that declaration the journal?
Advice:
_ The author did not think he had a competing interest. _ It was agreed it was beneficial to publish statements of competing interest with the paper, letter, etc, otherwise authors might think this is an optional requirement.
Follow up:
A statement of declaration of competing interest was subsequently published which mentioned that this had been omitted because of naivety. The editor published a paper in 2001 on competing interests, highlighting journal policies on the issue.
A scientist wrote to a medical journal asking if it was interested in receiving an editorial from him. The editorial would criticise current HIV vaccine research. The scientist is the senior partner of a technology company, and he printed his company’s website in his communication to the journal. The home page of the website advertises a patented toxin, and the site claims that this toxin can “destroy free HIV virus” and that it “eliminates the need” for conventional anti-retroviral drug treatment. No evidence is cited for its clinical effectiveness. The journal naturally declined to publish his editorial, but does COPE think that this case has broader implications?
Advice:
Inform the Medicines Control Agency, as it is illegal to make therapeutic claims like this.
An article was published with three authors’ names. Not all of the authors’ signatures had been included on the original submission letter. A complaint was lodged by Y, who said that X had submitted the paper without either his or Z’s consent or knowledge, and that there were several specific errors and omissions. Y then submitted a statement for publication in the journal dissociating himself from the published article. The statement was copied with Y’s approval to the corresponding author, X, to give him the opportunity to respond. X responded and arranged for two colleagues, A and B, to submit statements about the research work in question. Y (the complainant) also submitted further information about the research work. This correspondence spawned a series of allegations, denials, explanations and counter-allegations. Although the journal feels it should publish Y’s dissociation from the article in the journal, would it be wise to publish this without anything from X? Additionally, if the editors are sure that X submitted the article without the approval of his supposed co-authors, should action be taken against him, such as barring him from publishing in the journal for a period of time?
Advice:
_ The corresponding author should have the right to reply. _ There had been a clear breach of publication ethics as not all the authors signed the original agreement on submission. _ It probably is not enough to publish a statement and the matter should be referred to the head of the institution for an investigation, after which the journal should publish the consequences. _ A representative from the other institution—that of author X’s—should also have the right of reply, and the editor would also need to comment on the issue. _ Institutions can hide behind confidentiality agreements and there is evidence that internal enquiries are not always useful. _ The heads of the institutions of all the authors should be informed and the journal should not make any public statement until the responses had been received.
Follow up:
A letter of dissociation from the author was published by the journal. The heads of the institutions were not contacted.
A paper on a controversial topic from three authors was published. All three authors completed forms to say that they did not have competing interests. This was stated at the end of the paper. A reader subsequently contacted the journal to say that she had clear evidence that one of the authors did have competing interests. He had, she said, been involved in legal cases and received substantial payments for his work. The article related to these legal cases. The author intends to write to the complainant and ask her permission to send her letter to the author. If he accepts that he did have a competing interest, then the journal will publish a statement saying so. Does COPE agree with this? Should anything more be done?
Advice:
_ The public has the right to know if there were conflicting interests and that if there was any doubt, it is better to disclose. _ Just because the material is in the public domain does not exonerate an author from declaring such interests.
Follow up:
The editor sent the complainant’s letter to the author in question after which a statement of competing interest was published in the journal.
An editorial was published on a particular subject in which the author’s competing interests were declared. He had given evidence on behalf of patients making a claim against a manufacturer. Three people then separately pointed out that we had already published a commentary on the same subject in which there had been no declaration of competing interest for the author. The three people all said that this author did have competing interests. A review of the documentation revealed a statement of competing interest from the author in his role as reviewer of the paper on which he subsequently produced a commentary. In his statement he said that he received funds from the pharmaceutical industry for speaking, researching, and advising—and for employing staff. He then, however, ticked the box to say he had no competing interest. He had not been asked to sign a separate statement of competing interest for the commentary, and so nothing appeared. He has now been asked to make a declaration of competing interest, which he has done. What lessons can the committee draw from this case, and should anything more be done?
Advice:
_ It is important that editorial staff are more vigilant in scrutinising competing interest forms. _ In this case enough has been done.
Follow up:
The competing interests of the authors were published on the journal’s website.