Ghost Writing for Industry

[This listserve has been edited to remove identifying details in the case but retain the essential points for educational purposes.]

Dear WAME members,
I edit a general medical journal. We received a manuscript reviewing _____ . We sent it out for peer review and one of the reviewers responded that

"This paper was written by a medical education company (Y) for X, apparently as part of a campaign meant to pave the way for acceptance of ___."

We require a conflict of interest statement from each author of each manuscript before sending the manuscript out for review, and this author did not list X as a conflict of interest. However, I understand that no money changed hands: the "reward" for writing this paper for X (which provided all of the research in a format that could be cut and pasted into the article) is having an easily published article. The article itself stated that "Editorial assistance from Y, was made possible via educational funding from X." Clearly, this is a misrepresentation of the financial relationship between X, the intermediary Y, and the author. The author of the original draft and the person(s) who did the obviously biased literature review is/are not listed as authors.

The reviewer included with the review a copy of the original offer made to the reviewer by Y that included the draft manuscript (complete with title page) and the following header:

[Title]
[Contact for Y]
Client company: X
Project number: [withheld]
Target journal: To be decided
Target audience: Pharmacists, nurses, general practitioners
Aim of article: To outline ______.
Number of references: 65
Word count: Approx. 3000 (excluding abstract and references)
Number of tables: 1
Number of figures: 0
Current status: First draft
[Date]

Comparing the material sent by Y and the submitted manuscript shows some minor editing by the submitting "author," but a lot of it is word-for-word the same between the two documents.

I am writing this for two reasons. First, I wanted to alert WAME members that pharmaceutical companies do this, although I suspect that most of you know that. Second, I would like to know if your journals have specific policies about accepting articles commissioned by drug or device companies to create a "literature" that supports arguments for their products by ghost writing the articles for other "authors" to submit to a journal. Although it is clear to me that this is unethical behavior on the part of X and Y, it is less clear to me how a journal can protect itself from publishing such articles. We were very fortunate to have the article reviewed by an expert in the field who had previously turned down Y's request to edit and submit this article for them.

I would be interested in whether WAME editors have had similar experiences, how they have handled them (we obviously rejected the article but are also contacting the author to discuss the inappropriateness of this approach to publishing "science"), and how they have avoided being victimized in this way.

Bill Tierney
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Bill, this is terrible, and unusually clear-cut in its terribleness. I wonder if WAME should step out of its usual strategies and determine whether this sort of behavior is legally actionable and/or should become explicitly illegal. I know we usually don't like lawyers fishing about in journal business, but that's typically because we're trying to preserve scientific integrity and journalistic autonomy, and that's sure what this kind of case is about. What if we'd partner with some of the publishers by filing a case about these (or similar) behaviors? White papers don't seem to have stopped this embarrassing and patient-compromising activity.

Erica Frank
Vice Chair, Division Chief, and Associate Professor Director, Preventive Medicine Residency Program
Education Coordinator, WHO Health InterNetwork
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I agree with Erica that WAME should consider carefully some ACTION against this practice. Lawsuits are one thing—which may be difficult because of WAME's (lack of) financial resources, to say nothing of the global nature of the organization. I wonder whether a more direct approach is to make it a policy to contact the medical school/organization of the author and pass on the information gathered. I am well aware of the ethical issues involved in such an approach. WAME's Executive Committee/Council may want to decide which committee (Ethics/Policy, both, other?) should consider this issue. The most important thing is to go beyond discussing this among ourselves and issue some sort of statement, hopefully outlining actions that we encourage editors to take when faced with an occurrence like this.

Suzanne Fletcher
Professor of Ambulatory Care and Prevention, Harvard Medical School
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Fortunately I am editor of a journal, Injury Prevention, that does not have this problem. Unfortunately, as Director of Clinical Research at our Research Institute, I am responsible for the scientific review of studies before sending them to our Ethics Board for approval. Both at our end and at Ethics, this issue has been a concern. We agree it is an entirely unacceptable practice and I see no easy solution. Two thoughts: certainly, unless your lawyers advise otherwise, an editorial naming the company should be considered; second, the acknowledgment re 'editorial assistance' phrase may be a tip off and perhaps when such papers arrive this 'support' should be explored further before it is decided what to do. The problem, of course, is that not all such papers state this and if you reject the paper, it will go to another, less diligent journal.

Ivan Barry Pless
Editor, Injury Prevention
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This issue has two key aspects:

1. Bad science and biased work are not just the domain of the pharmaceutical industry. This is something seen coming as well from medical practitioners, researchers and academics. The poor quality and obvious bias of a manuscript should be picked up by the expert editors and reviewers who are assigned to review submissions (and apparently it worked well in this case...as the reviewer points out, the paper was mediocre, was full of errors, and obviously not written by an expert ). That should be the number one focus upon which efforts are made to prevent this type of work being published.

2. Honesty in declaring relationships and roles in publishing is trickier and again, commercial interests aren't the only ones that lead authors to misrepresent themselves and their work. There are a lot of potential authors out there who do not know or understand how scientific publishing works or even that there are rules to follow (hard to believe but I meet them on a routine basis) and they need to be educated, again and again. Very few know of the existence of Uniform Requirements, let alone read them (despite most journals citing them in their author instructions), and even fewer have heard of WAME and its ethics statement. I've come to believe that only by making the rules crystal clear, and each journal being rigorous in demanding full (signed) disclosure can this behavior be kept down. The consequences of misrepresenting contributions and authorship should also be made clear. Sometimes the only way some contributors can be convinced to comply is by exaggerating the public disgrace and potential blacklisting they might face otherwise. Yes, pharma industry is among this group but physicians and academics of various levels of repute are too.

If the editors of WAME want to play a positive role here, it should be in clarifying in their instructions to authors concerning what constitutes full disclosure, what is appropriate and inappropriate authorship, and what will be the consequences of failure to make full disclosure, etc. I KNOW it's all been done before, but it is an area where there is continual misunderstanding and ignorance and ongoing efforts are necessary.

Finally, I don't consider the person who submitted the "egregious" manuscript described by Bill Tierney to be a victim. He/she acted with the full knowledge that they did not prepare the manuscript, and either was not an expert in the field (so should not be publishing in it) or did not bother to verify the content of the manuscript (even more culpability).

Donna
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You seem to be saying, in your first point, that all we need is for all reviewers to be as diligent as the one who pointed out the problems with this submission. But in fact that particular reviewer was more than just diligent. She was also privy to information that presumably other potential reviewers would not be, as she was also invited to write this piece. Do you really consider it anything other than a fortuitous draw that such a reviewer was selected? Or, rather, do you think that there are ways to ensure that if such problems exist, then reviewers can always find them? This does not seem very feasible. Certainly you are correct that the best possible reviewers should be selected, but in recognizing that many biases and problems cannot be detected from the submission itself, perhaps other deterrents are needed.

Vance
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We don't accept reviews written by ghost writers for commercial companies. The tricky part is knowing when you have one of these beasts in your hands. Often, the ghost-writing company submits the article in the author's name, making it easy to contact the author to find out what role he or she played in writing the review (sometimes, it's a sponsored review but the author claims full responsibility for the review and just used the ghost writing company to do the manuscript preparation and submission). Sometimes, the topic helps to give away the game (a review of a particular class of drugs) even when the author doesn't acknowledge sponsorship.

We also steer clear of reviews that are sponsored by a commercial entity, even when no ghost writer is involved.

In both of these cases, requiring the author to attest to his/her role and the sponsors role is the best way to avoid being taken in by the author/sponsor/ghost writer. Absent the attestation, send the article back and ask the author to complete the attestation.

Hal Sox
Editor, Annals of Internal Medicine
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Regarding Bill Tierney's posting, another option is to go to the lay press with this story. Peer review and other ethical and procedural standards will never completely eliminate the publication of ghostwritten, shill papers. However, should public opinion congeal around the idea that such behavior is unacceptable corporate policy might change so that pharma regulates itself in an effort to avoid embarrassment.

Does anyone see a problem with this approach?

David Schriger, MD MPH
Special Projects Editor, Annals of Emergency Medicine
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Because of the difficulty detecting these situations (it was luck in our case), it would be useful to have a broader response from WAME to this type of unethical behavior from the pharmaceutical industry and authors.

Martha Gerrity
Co-Editor-in-Chief, Journal of General Internal Medicine
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Some excellent points have been made by others about this none-too-rare practice. Let me point out that WAME has a detailed set of recommendations on Publication Ethics Policies for Medical Journals (http://www.wame.org/pubethicrecom.htm#top), which suggest formal policies that each journal should have in place to prevent unethical practices. We would hope this discussion leads journal editors to review the WAME recommendations and revise their policies accordingly.

The section on authorship is pertinent; part of the problem identified in this case could be reduced by requiring the corresponding author of any manuscript to identify anyone who contributed to the manuscript as an author. The WAME policy language on this is as follows:

"For all manuscripts, the corresponding author should be required to provide information on the specific contributions each author has made to the article. (Alternatively, since authors may differ on the nature and magnitude of contributions, each author may be asked to describe their own.) All authors are responsible for the quality, accuracy, and ethics of the work, but one author must be identified who will reply if questions arise or more information is needed, and who will take responsibility for the work as a whole. This description of author contributions should be printed with the article. The authors are responsible for creating all components of the manuscript. If writers are provided by the sponsoring or funding institution or corporation to draft or revise the article, the name of the writer and their sponsoring organization must be provided. Their names and contributions will be provided with the acknowledgments. Journals should discourage "honorary" authorship (when authorship is granted as a favor to someone powerful or prestigious who would not have qualified for it otherwise) and should also try to ensure that all those who qualify as authors are listed."

The discussion of this case mentions legal action by WAME or others. There is little possibility of legal recourse by journals or editorial associations in these cases; it would be prohibitively expensive and most of these organizations have neither the resources or the experience to carry out investigations. Generally only educational or research institutions, or governmental oversight bodies, have such resources and authority. However, WAME also believes editors have an obligation to follow up on possible unethical activities and WAME policy recommends a series of possible corrective steps, which should be chosen based on the level of ethical violation and the quality of the evidence. A few possible steps are listed below:

"Journals have an obligation to readers and patients to ensure that their published research is both accurate and adheres to the highest ethical standard. Therefore, if the inquiry concludes there is a reasonable possibility of misconduct, responses should be undertaken, chosen in accordance with the apparent magnitude of the misconduct. Responses may be applied separately or combined, and their implementation should depend on the circumstances of the case as well as the responses of the participating parties and institutions. The following options are ranked in approximate order of severity:

• A letter of explanation (and education) sent only to the person against whom the complaint is made, where there appears to be a genuine and innocent misunderstanding of principles or procedure.
• A letter of reprimand to the same party, warning of the consequences of future such instances, where the misunderstanding appears to be not entirely innocent.
• A formal letter referring the concerns to the relevant head of educational institution and/or funding body, with all the commentary and evidence collected by the journal. This will occur when it is believed that genuine misconduct is likely to have occurred, and its goal will be to submit the case for consideration of formal review and judgment by organizations better suited to that task than a peer review journal.
• A formal letter as above, including a written request to the supervising institution that a investigation be carried out and the findings of that inquiry reported in writing to the journal.
• Publication of a notice of redundant or duplicate publication or plagiarism, if appropriate (and unequivocally documented). Such publication will not require approval of authors, and should be reported to their institution.
• Formal withdrawal or retraction of the paper from the scientific literature, published in the journal, informing readers and the indexing authorities (National Library of Medicine, etc), if there is a formal finding of misconduct by an institution. Such publication will not require approval of authors, should be reported to their institution, and should be readily visible and identifiable in the journal. It should also meet other requirements established by the International Committee of Journal Editors (http://www.icmje.org/#correct, accessed 12/2/03). It is recommended that editors inform readers and authors of their reservation of the right to publish a retraction if it meets these conditions, thereby helping decrease arguments with authors. "

Michael Callaham
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Dear Bill, What an amazingly florid case. I agree with Suzanne that there are actions that journals can and should take, and a role for WAME in developing a policy on handling misconduct. It is obviously right to have asked the author for an explanation. Once you get this, or if you receive none, the next steps I think would be: to contact his or her institution or regulatory body to make them aware of the situation, ask them to investigate, and let you know the outcome of their investigation; and to contact the pharma company to make them aware that they have been rumbled and to ask them to comment. This would be in line with the COPE code of conduct for editors (see http://www.publicationethics.org.uk).

An editorial would be an great way to raise awareness of this among authors and reviewers and to show the pharmaceutical industry that journals will not take this lying down. This could be done referencing this case specifically if the lawyers will allow—you do after all have what sounds like irrefutable evidence, or with the case anonymised.

Fiona Godlee
Head of BMJ Knowledge
Executive Editor, Clinical Evidence
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Another possibility (which I think somebody already thought of for a different case, but my memory is fuzzy here) is to at least tell WAME the specifics so that another journal is not duped. This would violate confidentiality, but the argument could be made that the implicit contract that mandates confidentiality on the part of journals becomes null and void when authors violate this implicit contract, for example by misrepresenting the facts. So if a given journal becomes aware of this by chance, and suspects that other journals would likely not catch the problem, is it more ethical to keep silent or to spread the good word?

Vance
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Thank you for your customarily clarifying response, Michael. The remaining problem, to me, is that these WAME recommendations are necessary and right, but perhaps not completely accomplishing their mission. I think that these practices/practitioners need to be "outed" and stopped. I don't know if it's by publicity (as others mentioned), or by lawyers (for resources, I had suggested that this be done in conjunction with publishers), or by some other means. But this practice is embarrassing at best, and I think we should consider being pushier.

Erica
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Vance, I was trying to make the point that there are 2 key issues that should be sorted out to diffuse the emotional content of this situation and address the real culprits, incomplete disclosure and bad science. The mode of discovery in this instance was serendipitous, but it shouldn't create paranoia of vast conspiracies to defraud journals. Yes, it was a horrific story, and yes it does happen from time to time that people will be ignorant of, or purposely try to bypass accepted publishing practice. But what I am hearing is a lot of antagonism to the pharma industry instead of taking a global view and dealing with the issues. Such an emotional response leads to incorrect generalizations and does not address the problem.

As Michael Callaham expressed so well, there are already tools in place to prevent poor science, biased science, manipulated science, from being published and to deal with mischief and fraud. We have editorial discretion, peer review, guidelines and ethics policies, author's instructions, and several forms of recourse once fraud or gross error has been discovered. Rather than being self-righteously indignant or continuously worried about fraud, we should continue to educate authors so they know what is acceptable, ensure each author confirms their participation in a work, not accept manuscripts without that, ensure reviewer expertise, and follow through with consequences if unacceptable practices are revealed. I think a lot more work can be done in this area.

This won't guarantee that all bad practice is stopped, but it will help create an environment where it is less likely and less acceptable.

Donna
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Thank you for clarifying Donna, and I agree completely with everything that you said, but I don't agree with that which you didn't say, but may have implied. Specifically, you did not explicitly state that these mechanisms we already have in place are enough, but you seem to be suggesting that. I do not see how efforts to improve safeguards can be construed as criticism of the existing safeguards, and certainly it was not my intent to criticize what is already being done. However, I will share another little episode with you (and WAME), and then ask you if you think the current system handled it well, or even well enough.

I reviewed a manuscript submitted to Journal A. This was a randomized trial, except that it wasn't. You see, while the title and abstract stated clearly that it was a randomized trial, scrutiny of the methods revealed that in fact a deterministic allocation scheme had been used. Innocent mistake, right? So I pointed this out, and the manuscript was rejected by Journal A, either because of this error or despite the error, but this is immaterial. What is material is that the story does not end here. A few years later I came across the same manuscript, only now it was published in Journal B. The title and abstract still called the trial randomized, only now the text that would have allowed the careful reader to discern that it was in fact not randomized had been removed. To the best of my knowledge, the field is still in ignorance of this breach.

How much damage has occurred due to the transgression? Of course it is impossible for me to say, but here is a scenario. The study which would have had less impact now had more, and to that extent influenced medical decisions beyond what it should have, potentially changing what these decisions would have been in the counterfactual case. It is not hard to see that harm could have been caused. And there would have been a very easy solution to avoid this harm. Editors could be spared from being misled by a warning system. If Journal A had been allowed to write to WAME something along the lines of "We reviewed this manuscript (with specific details provided), the study was not randomized, if it comes your way then please treat it as such", then it is unlikely that Journal B would have published it as it was published, and we would have been that much closer to the truth.

Back to your point about antagonism to the pharmaceutical industry. I cannot speak for anyone else, but I used to work in that industry, and still have friends that do, so it was not my intention to paint it with a broad brush. My antagonism is instead directed toward those who seek to mislead, whether for profit or for tenure or for citations or for influence. Is this antagonism misplaced?

Vance
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Donna: I appreciate your reasoned reaction to this situation. There are two issues (bias and authorship), neither new, neither newsworthy at this point, neither the sole province of industry, and neither easily regulated out of existence.

As a medical writer who has thought about this issue for some time, I think that the primary unholy alliance is that between pharmaceutical marketing departments and medical communications companies. Marketing people are not trained in science and seem to use it only when it suits their purposes. Communications companies will do whatever it takes to make their clients happy.

Although I'm sure what intervention is appropriate, I'm convinced that the marketing departments should be the initial target of it. Medical communications companies will do what marketing departments tell them to do, although I know of several cases in which the suggestions came from the communications companies.

Other than educating marketing departments about science and its ethical publication, I'm not sure what else can be done. It might be a fruitful area for thought, however.

Tom
Tom Lang Communications and Training
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If you're hearing a lot of antagonism to the pharma industry, Donna, it's probably because there's a lot of antagonism out here. For over a decade I have worked with some in pharma in a completely fruitless effort to get the industry to take seriously the call issued in 1998 BMJ editorial by Richard Sykes, then CEO of GlaxoWellcome, to behave more transparently (Being a modern pharmaceutical company. BMJ. 1998;317:1172-1180), and to sign up to Good Publication Practices (see: http://www.gpp-guidelines.org); but the long and the short of it is that, in spite of the recent declaration that it intends to voluntarily behave better in future, big pharma continues to think that it can get away with distorting the public record by biased under-reporting of clinical research. Maybe it can, but industry now has to deal with the reality that many of us out here simply don't trust it to protect the interests of patients, let alone the people who pay for their products. I predict it will take a long time and evidence of a genuine change of heart for the industry to dig itself out of the hole it has made for itself. And I don't hold out much hope for that in a world that has become as acquisitive as our world has become.

Iain Chalmers
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I understand the frustration, Iain, and I know there is reason to be especially wary of all research that has commercial interests behind it. But it's necessary to separate out the distrust and generally negative reaction against pharma from the issue at hand if we want to achieve anything positive. Pharma isn't one body behaving as a whole, but a great number of individuals with competing and conflicting interests and a variety of backgrounds and experience. In my experience, given sufficient knowledge of publishing do's and don'ts , and sufficient incentives (both positive and negative consequences) to operate within the boundaries, good publishing practices can prevail even from pharma. I don't think I'm being too idealistic; we will always require journal vigilance and effective negative consequences for serious infractions.

Donna
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I am reminded of the letter to the editor of the NEJM after Marcia Angel wrote her editorial entitled: "Is American medicine for sale". The letter said "it was not for sale, the current owners were quite happy with it." Almost all research has commercial interests or ramifications, directly or indirectly; the key issue is one of transparency.

David Riley
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Transparency is only part of the issue—it does not address the question of marketing departments of drug companies designing studies. That's why we so don't see enough well-designed, adequately powered studies comparing competing drugs that measure patient-oriented outcomes.

Mark H. Ebell
Deputy Editor, American Family Physician
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If any editors are considering an editorial on the subjects raised by this discussion (as suggested by Fiona Godlee) could I make a plea that, as well as the WAME guidelines, they also bear in mind the Good Publication Practice guidelines for pharma companies which were published a couple of years ago (details at http://www.gpp-guidelines.org).

They might also be interested in a further set of guidelines recently endorsed by the European Medical Writers Association and currently in press (these should be published very soon—check http://www.cmrojournal.com for details).

I admit to a strong personal interest, being an author of both these guidelines, but I hope that editors might follow the lead of the BMJ and BioMedCentral journals by referring to these guidelines in their instructions to contributors.

I suggest that authors of submissions that have anything to do with a commercial company should be asked if the submission was prepared in accordance with GPP and, if a professional writer was involved, whether the EMWA guidelines were followed.

I realise it is only a small step, and good guidelines can't change the world overnight, but I believe the CONSORT guidelines have had a considerable impact on the quality of trial reporting, so it's not impossible that educating contributors (and sponsors), and asking them to follow these guidelines might, at least, lead to some improvements.

References
Jacobs A, Wager E. EMWA guidelines on the role of medical writers in developing peer-reviewed publications. Curr Med Res Opin. 2005;21:in press

Wager E, et al. Good Publication Practice for pharmaceutical companies. Curr Med Res Opin. 2003;19:149-54

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Aside from the numerous other reasons that this practice is unsavory, it may in some instances (in the US) be a mechanism for industry to get around the FDA rules that prohibit advertisement of drugs for non-approved, off label uses. While the companies can't run conventional ads for off-label uses, they can get some big name to put his or her name on a review that supports a non-approved use of a drug. This is just another form of advertisement and may violate FDA regulations...at least in principal.

Christine Laine
Senior Deputy Editor, Annals of Internal Medicine
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No one seems to have picked up on this suggestion. Ray Moynihan is an Australian investigative journalist now working in Washington who has written extensively on the influence of the pharmaceutical industry on prescribing, "medicalisation" of the ordinary problems of life etc. He often writes for the BMJ. He is writing a book and am sure would find this material of great interest.

More generally, is there any WAME policy about the post to this list being only for the eyes of those on the list. From time to time I forward particularly interesting ones to colleagues, but am unsure of the etiquette of this.

Simon Chapman
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Listserve discussions are periodically compiled, lightly edited to remove salutations and correct spelling, and posted on the WAME Web site at http://wame.org/listservdis.htm. If anyone participating in the listserve discussion does not wish to have their response posted, please include that in the text of the response.

Margaret Winker
Secretary, WAME
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I know Ray Moynihan and know that he would be interested in this issue. If Bill and I go to the lay press, it would be useful to have some type of condemnation of this behavior from a group like WAME. Unfortunately, these companies are preying on faculty who need publications for P&T or other reasons. They are not offered money which is a more obvious conflict of interest situation. Given that it is sometimes difficult to identify these "ghost written" manuscripts, Bill and I would consider going to the lay press if we thought we could have an impact on this behavior by pharmaceutical companies. What do WAME members think about this strategy?

Unfortunately, the author in this instance did not see a problem with taking a draft of a manuscript from an educational company that received an "unrestricted educational grant" from X and then doing "extensive" edits prior to submitting it as their own manuscript. I am not sure I would call the edits extensive. In addition, the cover letters and statements of authorship are carefully crafted to look OK. I suspect the "authors" get some help with this too.

Martha Gerrity
Co-Editor-in-Chief, Journal of General Internal Medicine
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I sincerely believe that the problem you are raising is a very important one. Unluckily this is an unequal competition: our opponents are a highly intellectual and well-sponsored group, whereas we editors are hard working people with limited means. I dare to propose one solution: WAME should try to get a wealthy sponsor, not involved with the pharmaceutical industry.

Aleksej
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I don't disagree with Liz, although in the case I originally described that started this discussion there was a direct attempt by the author and coauthor(s) from the "communications" company to mislead by saying that the author received only "editorial assistance" from the communications company and the drug company only provided "educational funding." Both are direct lies. I have no idea how newsworthy this is—perhaps someone like Ray Moynihan would have an opinion.

I also agree with Liz's comments about the CONSORT guidelines. Since, in my experience, these attempts to affect the literature often take the form of reviews, the CONSORT guidelines (established for reporting randomized trials) are not relevant. However, there are similar formats for systematic reviews and meta-analyses that our journal strongly urges authors to follow. (See the recommendations of the Meta-analysis Of Observational Studies in Epidemiology [MOOSE] group whose guidelines have been published in JAMA [2000;283:2008-2012] and on the Internet [http://www.consort-statement.org/MOOSE.pdf].) Although these guidelines don't discuss funding of the review (but should), following them should result in a less biased review, and any such bias would be more obvious.

Bill
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I do not share Liz's trust in human nature. Asking authors to indicate which tasks they performed and requiring pharma companies to follow guidelines is a way to bring good practice to the attention of the innocent but will have little influence on hard bitten marketing folk. Rogues are not known for their propensity to follow guidelines. Asking which authors performed which tasks results in reality in gift authors being "allocated" tasks to bring them within the Uniform Requirements. Such things cannot be policed. To be really effective pressure needs to come from elsewhere. Those who are cheating the system need to be hit where it hurts and exposure is one place where it might hurt. Perhaps the articles Liz mentioned as virtually having had no effect—although I believe they have had- have not done so because there have not been enough of them. Whether this incidence is newsworthy is something the lay press can decide and the more that is reported the more seriously such transgression might be taken by industry as a whole.

Compulsory registration of clinical trials would certainly also help. But the ultimate hope is that competition BETWEEN pharma companies themselves will resolve the problem because this is something the marketing departments understand. An article that in effect recommends a product surely has a competitor product that is being disadvantaged thereby. This is where editors can really do something by having an open mind to pharma-contributed letters to the editor pointing out bias reporting. My experience is that these can be difficult to get published, ironically because they come from the pharma industry.

One final reality is that pharma support is much sought after—like the goose that laid the golden egg—for research, advertising, congresses etc. And editors often have connections that stand to benefit from such support. Yes, I know what the Uniform Requirements have to say about this.

Elise Langdon-Neuner
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Bill makes some excellent points.

I agree that 'editorial assistance' is misleading (and perhaps intentionally so). Journal editors need to be alert to this type of wording.

The new EMWA guidelines state:

The involvement of medical writers and their source of funding should be acknowledged. Identifying the writer, either as an author or contributor or in the acknowledgements section helps readers, reviewers, and journal editors to understand how the manuscript was developed, and recognises the writer's involvement. Identifying the writer's funding source ensures transparency and makes readers aware of any potential conflicts of interest. Medical writers should therefore ensure that the relevant journal's or meeting's requirements for financial disclosure, or other statements of competing interest, are met.

If writers are not listed among the authors or contributors, it is important that their role be acknowledged explicitly. Vague acknowledgements of the medical writer's role, such as 'providing editorial assistance' should be avoided as they are open to a wide variety of interpretations. We suggest wording such as 'We thank Dr Jane Doe who provided medical writing services on behalf of XYZ Pharmaceuticals Ltd.'

Now I think I've mentioned these forthcoming guidelines (Current Medical Research & Opinion (2005) Vol 21(2) doi:10.1185/030079905X25578) quite often enough, so I promise not to bore WAME members with them on this 'string' again!

Liz
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The BMJ is beginning to ask authors of review articles and editorials such questions in addition to our usual questions about competing interests and contributors. Here's an extract from an email I sent recently to someone who offered us a review article:

"Thanks very much for offering us this review article. We'd be pleased to consider this, particularly if it's clearly evidence based. This is a highly controversial area with many commercial interests and, therefore, one promoted by many biased publications. I do hope you'll forgive me, therefore, for asking you some questions that, increasingly, we ask at this stage:

1. has anyone (particularly a pharmaceutical or public relations company) prompted or paid you to write this article?
2. would you write the article yourself, or would it be written mainly by a professional medical writer?
3. would the BMJ article be original, or would it be similar to review articles submitted elsewhere, perhaps to more specialist journals?

Even if the answer to all these questions was yes, this wouldn't necessarily mean we would reject the proposal. We appreciate that companies can commission some excellent evidence based work and that professional writers can present that evidence in a particularly readable and clear way that benefits readers and learners. We would, however, expect such companies' and professional writers' contributions to be mentioned at the end of the article. And we would want to know that the BMJ article didn't overlap by more than 15% with any similar publication written by the same authors elsewhere.

I'd be very grateful if you would email me back with your answers. Once again, I do hope you and your coauthor won't be offended by these questions: they're a sign of the times, and an example of the BMJ's policy of transparency rather than censorship."

Lastly, for research papers we ask for an additional statement describing the role of the funding body as explained at http://bmj.bmjjournals.com/advice/article_submission.shtml

"Authors must describe the role of the study sponsor(s), if any, in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the paper for publication. If the authors' work was independent of the funders (the funding source had no involvement), the authors should so state."

Trish Groves
Senior Assistant Editor, BMJ
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Because our journal, American Family Physician, primarily publishes review articles, the issue of sponsored manuscripts (ghost written or otherwise), has been a concern of ours for decades. Our published policy on this issue is that we do not consider papers that are sponsored directly or indirectly by a pharmaceutical company, public relations firm or other commercial entity, or written by an author with a close financial interest in a company that makes a product discussed in the manuscript or a competing product. We ask all authors to state that they do not have such an association in our Authors Statement that is submitted with all manuscripts:
http://www.aafp.org/PreBuilt/afp_authors_form.pdf

Even so, we regularly receive manuscripts that have every conceivable variation of sponsorship, some very subtle (such as national panels of experts that are fronted by drug companies to "increase awareness" about a given clinical condition, drug, or class of drugs). As is well known, the ATP III panel, which endorsed more aggressive targets for cholesterol levels, was criticized because almost all of its members had close ties to statin makers.
http://www.findarticles.com/p/articles/mi_m0815/is_8_29/ai_n6160540

Medical editors need to be on the lookout for every variation of attempts at pharmaceutical marketing disguised as medical education.

Jay Siwek
Editor, American Family Physician
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Your suggested wording for acknowledging the medical writer is nice; however, I wish it were that easy for Dr (or more likely Ms) Doe, the writer. In my experience medical writers who work for communications companies are forbidden by their employers from being identified in their work, even in the acknowledgments. When they would cold-call me at my former journal to suggest a review article, and I said "but of course the person who wrote the main draft would have to be named somewhere" they sounded downcast because 1) now they couldn't submit the article and 2) their company's no-names policy was the reason. A medical ghost writer may not be a ghost by suicide; many would be thrilled to see their names in print. Some communications companies forbid this to assure their pharma clients of authoritative-sounding articles. Another reason is to protect the egos of the named "authors" who may not want to share published credit, or have to explain the sharing thereof to their colleagues and superiors.

In any event, I agree with the suggestions of Drs Groves and Siwek of ways to try to protect one's journal from this. Unfortunately the honor system is involved in any such policies. Those who have honor will abide by reasonable guidelines. Those without honor will still exist even in the best of all possible worlds.

Judy M. Dyrud
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One way that we avoid this problem is our policy of not discussing potential manuscripts with communications companies, but only bona fide authors.

Jay Siwek
Editor, American Family Physician
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This is very troubling and the nature of this response illustrates the problem well. Of course it is not just the communications companies who are the bad guys; more often, it is the pharmas. As an editor, apart from all the other issues, I labour under the illusion that people gain reputations as good scientists if they communicate well. If a paper is well written and scientifically meritorious, I am more likely to use the author as reviewer rather than one that is badly written. But if the reason it is well written is because it has been ghost written, and there is no way to know this, it is wrong, misleading, etc. etc. Indeed, the problem is those without honour (however we choose to spell it) and you can guess who is at the top of my dishonourable list.

Barry Pless
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What a lively debate and response that this issue has generated. I'm wondering if this is the sort of stuff that Michael Moore will raise in his new documentary "Sicko" (as reported by The Guardian). Is there a Flint Medical Journal?

As for Jay's suggestion of not discussing papers with the industry, my impression is that papers are submitted in a way in which the journals usually remain unaware of what is going behind the scenes. Ghost writing is a very profitable business that involves huge marketing corporations; some nearly as big as the pharmaceutical companies that hire them. The whole business is marketed in subtle ways; those who end up doing this will be approach by the nicest people in such subtle ways that when they make them feel like if they were dealing with Mother Theresa. The whole business is so cleverly managed that responsibility is diluted to the point that none of the involved parties will end up feeling they did any wrongdoing—I guess this approach of diluting responsibility is rather common amongst corporations work nowadays.

L.G. Cuervo
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This may be interest to WAME members:

Politics & Society
NIH Announces New Ethics Rules
by Joe Palca

All Things Considered, February 1, 2005 · The National Institutes of Health announces reforms to its conflict of interest guidelines. The new rules require NIH scientists to sever ties with pharmaceutical or biotech companies, hospitals or health insurers.

http://www.npr.org/templates/story/story.php?storyId=4474439

The audio clip is 4:01 minutes.

Here are the stories in the Los Angeles Times referred to in the NPR piece:

NIH Seeks 'Higher Standard'
February 2, 2005
By David Willman/Times Staff Writer
BETHESDA, Md—The director of the National Institutes of Health, Dr Elias A. Zerhouni, said that rules he announced Tuesday banning all staff scientists from taking drug-company fees would help the federal research agency set the highest ethical...
http://www.latimes.com/news/nationworld/nation/la-na-nih2feb02,1,5273080.story

NIH to Ban Deals With Drug Firms
February 1, 2005
By David Willman/Times Staff Writer
WASHINGTON—Under a far-reaching reform to be announced today, all staff scientists at the National Institutes of Health will be banned from accepting any consulting fees or other income from drug companies, and the employees must also divest...
http://www.latimes.com/news/printedition/la-na-nih1feb01,1,1055629.story

NIH Seeks Outside Inquiry of Scientist
January 28, 2005
By David Willman/Times Staff Writer
WASHINGTON—Ethics specialists at the National Institutes of Health have requested an outside investigation of an Alzheimer's disease researcher who accepted more than $500 000 from a drug company without seeking permission or reporting the income...
http://www.latimes.com/news/nationworld/nation/la-na-nih28jan28,1,3197774.story

Alice Landwehr
Managing Editor, The Journal of Pediatrics
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