The Ethics Committee recently reviewed a case which has attracted a good deal of marketing attention, and may also be of interest to readers because it demonstrates how even a well-known journal in an affluent country can be very out of step with current best ethical publication practice. Our discussion is anonymous, as usual, although subsequent press reports identify the parties involved.
The case was submitted by a nonprofit organization established in 1986 to conduct research on the clinical, economic, and social implications of new and emerging health care technologies. Their research is directed toward the formulation and implementation of local and national health care policies, and they have been designated as a WHO Collaborating Center for Health Technology Assessment.
This organization wrote an editorial commentary on the subject of whether government insurance coverage of a particular expensive patented medication was cost effective and whether this medication had met a high standard of evidence for its effectiveness. This manuscript took the position that such a standard had not been met, and that existing evidence did not justify its coverage under this plan.
The organization submitted this manuscript to a well established and prestigious peer reviewed journal specializing in this area of medicine. After peer review, the authors of the manuscript received the following letter from the editor of the journal:
"Dear Dr. X:
I have now heard back from a third reviewer of your editorial, who also recommended that it be published.
As all three of the reviewers who recommended that your editorial be published were (specialists on this topic) (some rather prominent), I think that you are underestimating the underlying sentiments within the (specialist) community.
As you accurately surmised, the publication of your editorial would, in fact, not be accepted in some quarters... and apparently went beyond what our marketing department is willing to accommodate.
Please know that I gave it my best shot, as I firmly believe that contrary points of view should always be provided a forum, especially in a medicalenvironment, and especially after those points of view survive the peer review process.
I truly am sorry.
The author wanted to know if this was considered unethical and/or was normal or acceptable journal practice.
Committee Comment on the Case
The committee unanimously condemned this occurrence and the journal's complete absence of a policy governing editorial independence. The WAME Policy on Editorial Independence
, posted in 2000, states the following (excerpts):
Editors-in-chief should have full authority over the editorial content of the journal, generally referred to as "editorial independence." Owners should not interfere in the evaluation, selection, or editing of individual articles, either directly or by creating an environment in which editorial decisions are strongly influenced.
Editorial decisions should be based mainly on the validity of the work and its importance to readers, not the commercial success of the journal. Editors should be free to express critical but responsible views about all aspects of medicine without fear of retribution, even if these views might conflict with the commercial goals of the publisher. To maintain this position, editors should seek input from a broad array of advisors, such as reviewers, editorial staff, an editorial board, and readers.
Editors-in-chief should establish procedures that guard against the influence of commercial and personal self-interest on editorial decisions.
The case is remarkable for the fact that a major journal would neglect to have a formal policy on this matter at all, that the editor himself was unaware of international standards of publication ethics, and that he clearly regarded himself as helpless under the circumstances (and seems to have accepted that status). (Some editors might have considered this grounds for resignation or challenging the publisher directly).
Review of the Web site of this journal identified no explicit policy on this matter at all, nor any awareness that they should have such a policy. We can only assume that the distinguished editorial board was unaware of the actual policy (that marketing could over-rule the editor), and saw no need to explicitly discuss or describe their policy on this matter. This is, unfortunately, probably more the rule than the exception among scientific journals.
Specific discussion of pharmaceutical company guidelines appears in the committee member comments at the end of this summary.
Committee's Advice to Author
WAME policy, along with similar language in the ICJME standards
, was pointed out to the author, and various methods suggested how he might protest this event. These included raising the issue with the editorial board and publisher and pointing out the potential conflict of interest, in particular since this issue was up for regulatory review by a governmental body and its manufacturer was an advertiser. Other committee member comments follow below (at the end of this summary).
The author was appreciative of the advice and protested to the journal, which first confirmed the decision and then, as pressure from the editorial board grew, retracted its decision and offered to publish the original article, which the author declined. The author subsequently went public with his concerns, leading to a story in BMJ
and the Washington Post
(Feb 7, 2004).
The principle that the owner/publisher of a journal, and its editors, have different and separate responsibilities and interests is a crucial one, and a structure is recommended in WAME policy that keeps these separate and recognizes that editors must have the last word in deciding what will or will not be published in the journal. In the past, editors of some of the world's leading medical journals have stood up, and lost their jobs, for these principles. Remarkably, there are many journals that not only have no explicit policy that they conform with WAME or ICJME standards, but also do not seem to be aware of that fact or bothered by its omission.
Committee Member Additional Comments
(Note in particular comments on pharmaceutical policy towards the end)
The current publication system gives the authors few choices. The possible options could be:
Write to the journal owners (publishers)—but they are unlikely to be of help since the marketing department possibly represents their views.
Write to a few prominent members of the Editorial Board and ask them to intervene to ensure editorial freedom. If several Editorial Board members take a tough stance and threaten to resign, the marketing department, the publisher, and the editor may be forced to reconsider their decision. Even if the authors may no longer wish to publish the paper in this particular journal, I think they should let at least some of the board members know about the issue—most likely none of them other than the editor are aware of it. Of course, they must send a copy of the letter to the editor too.
Write to the governmental regulatory agency that will be reviewing the reimbursement issue with copies of their manuscript and the correspondence. This may ensure that the agency is aware of the issues raised by them and that marketing presures are on, and that they need to tread with care. They may considering informing the editor beforehand of this course of action.
I believe that none of these may ensure publication of their paper. However, informing the board members may lead to improvements in editorial independence at the journal in the future and informing the regulatory agency may lead to their point of view being incorporated in the proposed policy.
This referral once again raises the issue of regulation of editors and publishers; possible solutions are (a) ombudsmen for journals, and (b) a regulatory agency for regulating editors (e.g. COPE could take up such a role).
In this particular journal, the editorial and business functions seem to be integrated to an unacceptable extent.
What can the author do?
Get the final opinion of the WAME ethics committee and send it to the editor of the journal asking him to reconsider the decision in the light of the opinion of the WAME ethics committee.
Approach COPE for another opinion and pass it on to the editor of the journal.
If nothing happens, consider posting a non-anonymised version on the WAME listserve to let a wider audience know.
I find this case extraordinary and alarming although, in some ways, the candour of the Editor is creditable. It seems clear that this Editor does not enjoy the editorial freedom recommended by WAME and adopted by the ICMJE. The journal's action only becomes unethical, however, if its stated aim is to promote discussion, disseminate information freely, publish the best material it receives, etc.—but I wouldn't be surprised if it does state this somewhere, or at least imply it. We don't criticize a daily newspaper because it adopts a particular party line and doesn't accept unsolicited articles, but we expect peer-reviewed medical journals to play by different rules.
I suggest the authors should resubmit to another journal as soon as possible but, in the meantime, should write a letter of protest to the journal's owner/publisher expressing their concern that the journal does not operate under the usual standards of editorial freedom and clearly lets commercial considerations override editorial decisions.
If the journal advocates that authors should follow the ICMJE Uniform Requirements, the authors might also ask why the journal does not follow them itself.
The editorial actions in this case clearly reflect an absence of "editorial freedom." It would be important to know what the journal policy is with reagrd to editorial freedom. Does it's Information for Authors state that the editor has final say on all publication decisions? Does the journal say that it follows the ICMJE recommendations? Although the Uniform Requirements doesn't specifically say "the marketing department shall not make publication decisions," the sections of the URMs on editorial freedom clearly imply that such behavior would be problematic (see exerpt from URMs below). If the journal clearly states its policy is that the marketing department must approve all papers, then there is no ethical issue with the decision. Although many would find this policy problematic, authors should have been aware of it before they submitted their work to the journal.
The most surprising aspect of this case is how open the editor was about the reason for rejecting the manuscript. This makes me wonder whether the journal does not have a policy that places a firewall between journal editors and journal owners or this particular editor is too naive to realize that journal owners have violated his or her freedom.
Another thing to consider is what the journal says about the confidentiality of submitted papers. Authors expect that the editors and external reviewers will see their papers and handle the content in a confidential manner. Can they expect the same of marketing staff?
If they haven't already done so, the authors must review the written policy of the journal with respect to final editorial decision-making. If the journal does not have a policy of editorial freedom, they can't really do more than avoid submitting their work to this journal and making their colleagues aware of the lack of editorial freedom at this particular journal. However, if the journal policy implies that the editor has final say or defers to the ICMJE statement, then the authors need to write the editor and publisher about this incident and should send copies of the letter to the funding institution (WHO?) and the chief officers (deans, presidents, CEOs) of all institutions that participated in the work.
In follow up e-mails, I have learned that the journal does not say anything in its written policy that claims editorial freedom and does not say that it follows ICMJE (or any other) recommendations. I still think the authors should write to the parties I mentioned in my last e-mail, expressing their concern about the manner that this journal makes decisions and point out that the journal's behavior is not in line with some existing recommendations/policies. However, the journal does not appear to have breached its own policy on editorial freedom (it has none). Caveat emptor...authors shouldn't assume that all journals respect editorial freedom.
I note the Journal is described as being well-established, prestigious, and peer-reviewed. Most likely, the Journal has an excellent editorial board consisting of members who loan their names and their reputations to the Journal. Therefore, I suggest the author write a letter of protest to the editorial board. I imagine these members will be alarmed by this situation and will ask for clarification and an acceptable resolution. Hopefully, those overruling the editor will be fully aware that the Journal's prestigious reputation is, in some part, related to the editorial board and its willingness of members to serve on it.
Sensustrictu there's no code covering all the industry, however (as I'm sure you're well aware) the latest revision of the Declaration of Helsinki http://www.wma.net/e/policy/pdf/17c.pdf (which presumably applies to all doctors working either with or for companies) states:
"In publication of the results of research, the investigators are obliged to preserve the accuracy of the results. Negative as well as positive results should be published or otherwise publicly available."
"We commit to timely communication of meaningful results of controlled clinical trials of marketed products or investigational products that are approved for marketing, regardless of outcome. Communication includes publication of a paper in a peer-reviewed medical journal, abstract submission with a poster or oral presentation at a scientific meeting, or making results public by some other means."
"Companies should endeavour to publish the results from all of their clinical trials of marketed products."
In other words, once the drug is approved, then the PhRMA guidelines and GPP encourage publication of all trials. So if the drug has already been approved for marketing (anywhere, not just in the US), I suggest these guidelines are applicable.
None of these, however, says anything about publishing other types of information, such as safety data obtained through routine surveillance or case reports, although, in most countries, companies have to report this sort of thing to the regulatory authorities in periodic safety updates. In most places this information remains confidential unless that country has strong freedom of information laws.
Even if we assume the PhRMA guidelines apply, since the product is marketed—although, to be honest, these are not particularly widely known or followed, but there's a good chance that the company is a member of PhRMA—the question might hinge on whether an economic study/model constituted a clinical trial. If the evidence is based purely on modelling one could argue that no patients are involved, and this isn't clinical research, so the declaration of Helsinki wouldn't apply either.
I am also in agreement with the comments made. I would add however that many authors and most readers do not read the written policy of journals regarding control of the editorial content even where they exist. I believe therefore that they would be surprised to know that the marketing department was controlling the editorial content of a prestigious peer-reviewed journal. I suggest that the author should also bring this matter to the attention of the relevant academic and professional societies and institutions involved in this area besides the editorial board and other parties mentioned in the previous messages.
The question that bothers me is that a journal which has been in existence for 30 years, has a fairly large circulation and is included in Pubmed does not seem to conform to any set guidelines—icmje, wame, cse, etc. Interestingly the NLM fact sheet suggests that among other criteria the NLM assesses "Quality of editorial work" which includes "statements adhering to ethical guidelines" while evaluating journals for inclusion in Pubmed. This brings me to the larger question of "implementation" of certain standards in journal publishing—can a journal not state adherence to any of the published and widely known statements on ethical standards and still continue to be in PubMed? It seems that it does happen in the case of this particular journal and there may be others.