The parts I found most intriguing were their examples of how academic medicine is complicit. We all know that in the “publish or perish” environment of medical academia publications are currency, which must help explain why many academic guest authors receive no monetary payment at all for their unethical and dishonest collusion with pharma that allows them to take (academic) credit for papers they didn’t write.

But don’t institutions expect their faculty and members to publish ethically and in the best interest of patients?

Apparently not. One particular example cited by Leo and colleagues, involving the widely-prescribed Paxil (paroxetine; an SSRI antidepressant), jumped out at me: they describe allegations that an American Psychiatric Press (APP) textbook called “Recognition and Treatment of Psychiatric Disorders,” ostensibly authored by leading psychiatrists Charles Nemeroff and Alan Schatzberg, was actually ghostwritten by writers employed by the manufacturer of Paxil, GlaxoSmithKline, who paid the writing firm US$120,000.  An earlier draft of the text written by the paid medical writers is on the website of the US-based Project on Government Oversight.

What’s astonishing is not that the institutions and publishers deny the involvement of GSK-paid ghostwriters (they don’t), but that they accept and justify the ghostwriting because the authors “signed off on the final copy.” Leo and colleagues quote James Scully, Medical Director for the American Psychiatric Association: “The book was reviewed for any potential bias (among other things) by eight independent reviewers, and there was no undue influence on the content from industry or any other outside source.” The psychiatrist Daniel Carlat, in his New York Times blog last year, on the other hand, called the textbook “an advertisement for Paxil.”

That medical academia finds these types of arrangements acceptable is, I think, at the heart of the problem of ghostwriting. And for anyone who has been a student or trainee in medical academia─subject to strict codes of conduct prohibiting plagiarism etc.─this apparent double-standard will strike as more than a little ironic. Clearly we need to address this double-standard. I love the analogy Leo and colleagues draw, so I quote from their article directly:

A college professor determines one of his graduate students handed in a paper largely written by someone else. After being confronted, the student acknowledges that indeed someone else wrote the paper. The student then says, “I approved the final copy, and had eight classmates look over the paper and they all vouch for its unbiased conclusions.”

Ghostwriting is not only an unethical practice, but it may also constitute legal fraud, according to an article by University of Toronto law professors Simon Stern and Trudo Lemmens, published this week in PLoS Medicine. As such, they argue that medical academics who serve as “guest authors” could be held legally liable.

It’s irrelevant whether publications with academic guest authors are factually accurate, Stern and Lemmens say. What’s important is the false gravitas given to claims of safety and effectiveness through the use of academic authors when these claims–contained in articles ghostwritten by industry but guest authored by academics–are used as scientific evidence in the courtroom. So not only does the dishonest and manipulative practice of ghostwriting undermine the integrity of medical research and patient care (as many previous PLoS Medicine articles have argued), but now we can see how a guest author’s claim for credit of an article written by someone else constitutes legal fraud.

The legal repercussions for the company that sponsored the research reports could be severe.  Stern and Lemmens say that patients and others could file class action suits based on the Racketeer Influenced and Corrupt Organizations (RICO) Act, as well as make claims of ‘‘fraud on the court’’ against a pharmaceutical company that has used ghostwritten articles in litigation.

Even though industry personnel write these ghostwritten medical and scientific articles, the academic authors serving as guest authors still receive substantial professional credit for their work.  And so, Stern and Lemmens take a hard line, saying that the legal remedy is to charge academics who lend their names with professional and academic misconduct and fraud.

Photo via Flickr / Truthout.org

I’d like to throw one more idea into the mix. Authorship has become such a prized commodity, being as it were the currency of scientific and medical worth, that the flip side of ghost authorship – guest authorship – has become something that some academics gladly consider. “Guest” authors may be added to a manuscript to. for instance, thank them for helping to obtain funding. “Ghost” authors on the other hand are not named but may have in fact written the whole article.

Until the publish or perish culture is seriously addressed by academic institutions, some academics will continue to feel pressured to get just one more publication. We need to find new ways to enable academics to be credited for all their contributions rather than an undue weight being placed on publication and “authorship”.

Meanwhile earlier this month DIDA added 15 new documents to the archive. According to Kim Klausner, the Tobacco Digital Library Manager at University of California, San Francisco, who manages the DIDA archive, these documents include “Depositions from Karen Mittleman, the DesignWrite staffer who worked on Wyeth’s publication plan for Premarin products.  She responds to questions about how academic authors, her medical communications company and the drug manufacturer implemented its plan.”

We’re pleased to announce the addition to the Drug Industry Document Archive (DIDA) of the Wyeth ghostwriting documents unsealed by a Federal judge last month at the request of PLoS Medicine, represented by Public Justice, and the New York Times.

As you are probably aware, the documents illustrate how Wyeth Pharmaceuticals contracted with DesignWrite, a medical communications company, to write articles for top-tier medical journals with the intention of bolstering the sales of the Premarin family of hormone replacement products.  After the articles were written, DesignWrite solicited prominent health professionals to appear as “authors.”

The documents are full-text searchable and limited metadata, such as names of people and organizations mentioned, has been created for most documents to aid searching. The documents can be found by entering “ddu:2009*” without the quotation marks in the query box on DIDA’s home page (http://dida.library.ucsf.edu).

I have selected a few of the 1,120 documents that, taken together, show how the integrity of the scientific process was compromised.

A summary of DesignWrite’s work: a “comprehensive publication program for Premarin… [which] includes peer-reviewed journal articles, editorials, letters to the editor, sales training backgrounders, and critiques of the current literature, all designed to support the [company’s] marketing efforts.”

An August 2000 contract between DesignWrite and Stephen Gutkin, President and founder of Rete Biomedical Communications, to write 8- to 10-page manuscript on “Can a Healthy Endothelium Influence the Cardiovascular Effects of HRT?”

A September 12 letter (page 4 of the document) to Gutkin paying him for completing the outline.

A DesignWrite document (page 2 of the document) from September 27 indicates that Professor Kwang Kon Koh has been approached to “author” the paper but “needs to be confirmed.”

An October 13 letter (page 3 of document) from DesignWrite Medical Editor to Gutkin about revisions to the manuscript: “Anything that doesn’t bolster the main message that early intervention with estrogen in order to maintain a healthy endothelium in postmenopausal women can go.”  The Editor accepts that the academic “author’s” “own additions will probably have to stay [in the article] no matter what.”

A letter (page 2 of document) from DesignWrite to Gutkin asking for further revisions to the manuscript in January, 2001.

In April, Koh suggests in an email that DesignWrite staffer Karen Mittleman be listed as co-author of the paper.  (This document should be read from page 4 to page 1.)

The paper is published in the International Journal of Cardiology in 2003.  Mittleman’s “editorial assistance” is acknowledged.  Stephen Gutkin’s name is nowhere to be found.

If you have any questions (or comments) about DIDA, please comment here and we’ll forward any specific requests to Kim Klausner.

As reported in the New York Times and highlighted by Jim Edwards in BNET Pharma,  the FY 2004 marketing plan for Forest Labs’ antidepressant Lexapro included $100,000 for “Bylined Articles”:

Bylined articles will allow us to fold Lexapro messages into articles on depression, anxiety, and co-morbidity developed by (or ghostwritten for) thought leaders.  We will identify a Lexapro thoughtleader to place 1-3 bylined articles in trade journals, consumer publications and on the Internet.  Estimated costs include article development, revisions and honoraria for the authors. Examples of topics include co-morbidity of depression and anxiety and selectivity.

The plan, made public by the US Senate’s  Special Committee on Aging, appeared to recognize that the editorial process might at times  interfere with the marketing message, and accordingly estimated expenses of $200,000 for “Paid Media Outreach”:

In addition to the traditional editorial media outreach, there are also opportunities in which we can increase control over the final product by paying for the placement.  These opportunities, which will supplement our core activities, may include Lexapro message placement in radio programs (e.g., American Health Radio) or other “advertorial” venues.  Expenses may include spokesperson honoraria, production costs, logistics, and script writing.

Earlier this year, Lexapro was featured in news stories about a lawsuit by federal prosecutors around promotion of the drug for  prescription to children (allegedly involving payments to physicians), and also about the flap that ensued after a researcher pointed out that the author of a Lexapro clinical trial published in JAMA had failed to disclose that he had a financial relationsip with Forest Labs.

Barbara Sherwin, a McGill University psychology professor widely considered an expert on hormones, was the sole author of a 2000 JAGS article arguing that estrogen was beneficial for memory loss in older patients, as well as for reducing the risk of cardiovascular disease, osteoporosis,  colorectal cancer, and all-cause mortality in postmenopausal women. But an investigation of the ghostwriting documents by Toronto Star reporter Stuart Laidlaw shows that the article was actually written by DesignWrite, the medical writing company hired by Wyeth to promote its products.  Dr. Sherwin was faxed the article 18 months prior to its publication, with a request from DesignWrite to “review the enclosed outline,” says Mr. Laidlaw’s article.

Mr. Laidlaw broke the story in Saturday’s newspaper with a headline “Canadian named in HRT scandal.”  Reports by the Montreal Gazette, the Chronicle of Higher Education, and the news wire United Press International followed. His earlier report, “Ghostwriting is bad medicine” appeared last week.  An article in today’s Gazette says that ghostwriting is common.

McGill University, Canada’s second largest university, is now investigating the allegations against Dr. Sherwin.

Mr. Laidlaw said yesterday that he feels the practice of Wyeth to have international reach in its ghostwriting campaign for Prempro means that the PLoS Medicine documents can and should be mined by journalists and researchers for local content.

Recently, 1,500 documents detailing the practice of ghostwriting in relation to the marketing of hormone replacement therapy and other drugs were released into the public domain as a result of a court case intervention by PLoS Medicine and The New York Times. To make the released documents publicly available without delay, PLoS has created the Wyeth Ghostwriting Archive.

We have also passed these documents to the Drug Industry Document Archive at UCSF who will be sorting and posting them on their site. Other postings by Adriane Fugh Berman (see here and here) and by Andrew Hyde on this blog have discussed these documents. We  hope by making them freely available that they will be scrutinised in detail. Our press release on the documents is available here.

LINK TO THE FULL SET OF GHOSTWRITING DOCUMENTS: http://www.plosmedicine.org/static/ghostwriting.action

*************************************

Ghostwriting: The Dirty Little Secret of Medical Publishing That Just Got Bigger

The PLoS Medicine Editors

E-mail: medicine_editors@plos.org

The PLoS Medicine Editors are Virginia Barbour, Jocalyn Clark, Susan Jones, Larry Peiperl, Emma Veitch, and Gavin Yamey.

Provenance: Written by editorial staff; not externally peer reviewed

If you are an editor, author, reviewer, or reader of medical journals, or if you depend on your doctor or health care provider getting unbiased information from medical journals, then the 1,500 documents now hosted  on the PLoS Medicine Web site should make you very concerned and angry [1]. Because, quite simply, the story told in these documents amounts to one of the most compelling expositions ever seen of the systematic manipulation and abuse of scholarly publishing by the pharmaceutical industry and its commercial partners in their attempt to influence the health care decisions of physicians and the general public.

Here’s just one sample thread [2] that gives an idea of the topsy-turvy world invented by the pharmaceutical and medical writing companies involved. While readers expect and assume that the named academic authors on a paper carried out the piece of work and then wrote up their article or review informed by their professional qualifications and expertise, instead we see a prime example of “ghostwriting”: a writing company was commissioned to produce a manuscript on a piece of research to fit the drug company’s needs and then a person was identified to be the “author”:

An email from a writer employed by the medical writing company, DesignWrite, to employees of Wyeth, the company that performed the study,  and  Parthenon (another medical writing company) on November 10, 2003 concerning manuscripts on Totelle (a brand of hormone replacement therapy manufactured by Wyeth) tells the story concisely. [our emphasis added] “Thanks to all who have reviewed and approved the manuscripts… I have received no word on authors for the Totelle 2mg bone manuscript P3(2), and need input on this matter before this manuscript can move forward” .

PLoS Medicine became involved in this particular ghostwriting story when we intervened in an ongoing court case in which women were suing Wyeth, the manufacturers of Prempro, a hormone replacement therapy. During the discovery process for this case, one of the lawyers representing injured women in the litigation, Jim Szaller of Cleveland, Ohio, became aware of many documents that laid out in detail the company’s (mostly successful) attempts to publish papers written by unacknowledged professional medical writers in which the message, tone, and content had been determined by the company but the paper was subsequently nominally “authored” by respected academics—in sum a coordinated and carefully monitored campaign of ghostwriting. Our interest was not in the specific drugs, but in the issue of ghostwriting itself, a topic we have long been interested in and published on [3–6] The intervention, presented by lawyers from public interest law firm Public Justice (http://www.publicjustice.net), and a similar one from the New York Times, was successful. On July 24, 2009, US District Judge William R. Wilson, Jr., in Little Rock, Arkansas, granted the Motions of the Interveners, and the similar Motion of the lawyers representing the women, to make the discovery materials public as of July 31.

This is not the place to review everything written on this topic. Others have written about ghostwriting campaigns concerning single drugs that have led to catastrophic health effects [7], and how even research papers and clinical trials are affected by ghost authors [7,8]. What’s clear is that ghostwriting can no longer be considered one of the “dirty little secrets” of medical publishing that nothing can be done about. While editors, medical schools, and universities have turned a blind eye to, or at the least failed to tackle head-on the pervasive presence of ghostwriting, drug companies and medical education and communication companies have built a vast and profitable ghostwriting industry. Recruitment of academic “authors” appears, within some academic circles, to have come to be considered acceptable, and marketing campaigns are no longer orchestrated around paid display advertisements but instead center on “evidence” provided by seemingly respectable academic review articles, original research articles, and even reports of clinical trials. What, a cynical reader might ask, can I truly trust as being unbiased? The answer is that, sadly, for some or even many journal articles, we just don’t know.

So what can be done? The documents that have been made available are a substantial step forward in advancing knowledge of this practice and explaining the mechanics of how ghostwriting campaigns are organized, and will add to the evidence base. By making them easily and openly accessible we hope that others will quickly delve into the documents and analyze them in detail (we have yet not done so in the interest of speed in making them publicly available). But we also hope that the papers not only will become the subject of academic scrutiny but will help to guide the way to identifying reforms that will eventually stamp ghostwriting out.  In an environment in which drug companies are beholden to their shareholders, and the drive for profit takes center stage, it is naïve to think that companies will put their own houses in order.

Over the past several years some journals and editors’ organizations [9,10], and even some individual medical writers [11], have pursued what might be called a war of attrition against the practice by requiring contributorship statements for authors and publishing them, insisting on the naming of all who were involved in writing, requiring detailed competing interest statements, and detailing and publishing the provenance of non-research articles. Editors’ bodies such as the International Committee of Medical Journal Editors (ICMJE) expressly define criteria for authorship in biomedical publications [12], and the World Association of Medical Editors (WAME) developed a specific policy on ghostwriting [10] initiated by commercial companies that calls the practice dishonest, unacceptable, and sanctionable. But it seems that these tactics are simply not enough to prevent ghostwriting, and are being sidestepped by those involved. Although medical writers can and do have a legitimate place in assisting in the preparation of manuscripts (and, of course, academics and pharmaceutical companies can have legitimate and appropriate relations, and not all papers in this archive will have been written by ghost authors), attempting to hide the presence of ghostwriters or the involvement of writers beyond technical support, such as copyediting, is unacceptable. We’d argue, therefore, that all involved must adopt a much tougher approach of complete nontolerance to practices that aim to conceal authors or where the involvement of medical writers goes beyond technical support.

What might this mean in practice for journals? Primarily, it would mean a sea change in the thinking and behavior of editors, who should create—and be prepared to enforce—journal policies clarifying that involvement with ghostwriting is a serious and punishable breach of publication ethics. Of course, prevention is key: possible measures could include requiring statements upon submission from academic authors about involvements by any company whose products are mentioned (positively or negatively, directly or indirectly) in the commissioning of a third party to provide editorial assistance, manuscript preparation, or submission of the paper.

But journal polices should also include enforceable sanctions. For example, if nothing is declared on submission but inappropriate involvement of a medical writer subsequently comes to light, any papers where this breach is substantiated should be immediately retracted and those authors found to have not declared such interest should be banned from any subsequent publication in the journal and their misconduct reported to their institutions.

In the case of the documents deposited here, a good start, and a signal of the seriousness of journals’ intent, would be the formal retraction of all the papers mentioned in which ghostwriting has been conclusively shown. Institutions whose academics are shown to be involved should investigate as a matter of urgency.

It’s time to get serious about tackling ghostwriting. As has been shown in the documents released after the Vioxx scandal [7], this practice can result in lasting injury and even deaths as a result of prescribers and patients being misinformed about risks. Without action, the practice will undoubtedly continue. How did we get to the point that falsifying the medical literature is acceptable? How did an industry whose products have contributed to astounding advances in global health over the past several decades come to accept such practices as the norm? Whatever the reasons, as the pipeline for new drugs dries up and companies increasingly scramble for an ever-diminishing proportion of the market in “me-too” drugs, the medical publishing and pharmaceutical industries and the medical academic community have become locked into a cycle of mutual dependency, in which truth and a lack of bias have come to be seen as optional extras. Medical journal editors need to decide whether they want to roll over and just join the marketing departments of pharmaceutical companies. Authors who put their names to such papers need to consider whether doing so is more important than having a medical literature that can be believed in. Politicians need to consider the harm done by an environment that incites companies into insane races for profit rather than for medical need. And companies need to consider whether the arms race they have started will in the end benefit anyone. After all, even drug company employees get sick; do they trust ghost authors?

References

1. http://www.plosmedicine.org/static/ghostwriting.action

2. Lea A (2003) Totelle manuscripts sign-off and review [E-mail]. Available : http://www.plos.org/ghostwriting/Exhibits2/CONSG204-014513.TIF. Accessed 19 August 2009.

3. The PLoS Medicine Editors (2009) An unbiased scientific record should be everyone’s agenda. PLoS Med 6(2): e1000038. doi:10.1371/journal.pmed.1000038

4. Sismondo S (2007) Ghost Management: How much of the medical literature is shaped behind the scenes by the pharmaceutical industry?, PLoS Med 4(9): e286. doi: 10.1371/journal.pmed.0040286

5. Gøtzsche PC, Kassirer JP, Woolley KL, Wager E, Jacobs A, et al. (2009) What should be done to tackle ghostwriting in the medical literature? PLoS Med 6(2): e1000023. doi:10.1371/journal.pmed.1000023

6. Wager E (2007) Authors, ghosts, damned lies, and statisticians. PLoS Med 4(1): e34. doi:10.1371/journal.pmed.0040034

7. Ross JS, Hill KP, Egilman DS, Krumholz HM (2008) Guest authorship and ghostwriting in publications related to rofecoxib. A case study of industry documents from rofecoxib litigation. JAMA 299: 1800-1812.

8. Gøtzsche PC, Hróbjartsson A, Johansen HK, Haahr MT, Altman DG, et al. (2007) Ghost Authorship in Industry-Initiated Randomised Trials. PLoS Med 4(1): e19. doi:10.1371/journal.pmed.0040019

9. DeAngelis CD, Fontanarosa PB (2008)Impugning the integrity of medical science the adverse effects of industry influence. JAMA 299: 1833-1835.

10. WAME (2005) Ghost writing initiated by commercial companies. Available: http://www.wame.org/resources/policies#ghost. Accessed 19 August 2009.

11. Wager E, Field EA, Grossman L (2003) Good publication practice for pharmaceutical companies. Curr Med Res Opin 19: 149-154. Available: http://basic1.easily.co.uk/03100E/00605D/GPP.pdf. Accessed 19 August 2009.

12. ICMJE (2008) Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication: Byline authors. Available : http://www.icmje.org/#author. Accessed 19 August 2009.

Arrangements are underway for posting the ghostwriting documents disclosed through the intervention of PLoS Medicine and the New York Times. While you look forward to exploring the parallel universe of ghostwriters, guest authors, and ghost handlers, PLoS Medicine will release selected documents on this blog.

Our story to date: Wyeth-Ayerst (“the client”) paid DesignWrite, a medical education and communication company (MEC), to write and submit papers to medical journals as part of promotional efforts for Premarin- (conjugated equine estrogens) – and Prempro, which adds medroxyprogeterone acetate to CEE.

Excerpts from our first release, a MEDICAL EDUCATION AND COMMUNICATIONS PLAN FOR THE PREMARIN PRODUCT LINE prepared by DesignWrite for Wyeth-Ayerst (now Wyeth) in 1996.

The first step is to choose the target journal best suited to the manuscript’s content. …We will then analyze the data and write the manuscript, recruit a suitable well-recognized expert to lend his/her name as author of the document, and secure his/her approval of its content. After the client has reviewed and released the manuscript for submission, DesignWrite will see it through the necessary production stages — creating camera-ready figures and tables and the text according to the journal guidelines — and submit the package (manuscript, art, cover letter, and any required forms and checklists) to the appropriate journal editor… Any revisions requested by the journal will be handled by DesignWrite in conjunction with the client and the author. Should the journal reject the manuscript, DesignWrite will restyle it for submission to another journal within 10 working days.”     (1)

From receipt of the internal summary report for a given study, a time frame of one to two months is estimated for manuscript development. The time frame between submission of the draft and the client approval is subject to the client’s internal review. Subsequent revisions, based on client, author, or reviewer comments, are typically addressed in two to three weeks. A period of six to sixteen months is projected for actual publication once the manuscript has been accepted by the journal. The latter time frame is solely a function of individual journal policies.

The following is a typical work flow plan for developing a manuscript for submission to a peer-reviewed journal:

Client provides data report………. TBD
DesignWrite prepares outline………. 2 weeks
Client internal review………. 2 weeks
DesignWrite prepares first draft………. 4-8 weeks
Client internal review………. 2 weeks
DesignWrite addresses consolidated
client comments (second draft)………. 2-3 weeks
Second draft reviewed by selected author………. 2 weeks
DesignWrite incorporates author comments
(third draft)………. 2 weeks
DesignWrite assists in journal submission………. 2 weeks
Journal provides peer-reviewer comments………. TBD
DesignWrite addresses comments; resubmits………. 2 weeks
Journal acceptance and publication………. TBD

Manuscripts are submitted to peer-reviewed journals directed at the target audiences. Where appropriate, articles dealing with pharmacologic aspects of the drugs will be placed in journals with a pharmacology orientation. These articles could combine updates on study results as well as information comparing the product with other selected therapeutic agents. In addition, they could address trends in treatment and topical issues in patient management.

Journal Supplements

Selected data derived from individual studies could be published together as supplements to target journals within a particular therapeutic specialty. Should the client wish to pursue this publication option, the following guidelines are applicable. A turnaround time of six months is generally adhered to for producing the supplement. This includes all editorial components, including interactions with invited authors, and the target journal. Timing of the publication is ultimately predicated by the individual journal’s supplement schedule. Journal supplements could be published before product launch and be targeted to specific audiences.

Scientific Poster Presentations

At selected medical meetings, lead investigators are able to present the results of their in vitro, preclinical, or clinical studies in an academic atmosphere that many meeting attendees consider desirable. DesignWrite is quite experienced and successful in working with these investigators to ensure that their results are presented in a clear, professional, and impactful manner. Such presentations often represent merely abstracts of studies while others are more thorough. In either event, DesignWrite feels strongly that such poster presentations represent a significant manner of presenting scientific information to target audiences, particularly in preparation for the launch of a product and even postlaunch.

Budget

Preclinical manuscript………. $10,000
Clinical manuscript…………… $16,000
Review article………………….. $20,000
Poster presentation…………… $6,000
Journal supplement………….. $175,000                                                   (2)

Want more? Click here, for the entire 50 page MEDICAL EDUCATION AND COMMUNICATIONS PLAN FOR THE PREMARIN PRODUCT LINE. Proposal for Jeff Solomon, Senior Product Manager, ERT/HRT, Wyeth-Ayerst Laboratories. Submitted by DesignWrite, Inc. Aug 12, 1996

References:

1.DESIGN151927. The explanation is in an e-mail dated March 24, 1999 from Rosie Lynch of DesignWrite to Alice Conti of Wyeth Marketing.

2. DW065764. Medical Education and Communications Plan for the Premarin Product Line. Proposal for Jeff Solomon, Senior Product Manager, ERT/HRT,Wyeth-Ayerst Laboratories. Submitted by DesignWrite,Inc. August 12, 1996 (3) (See DW 065773, DW 065774 DW 065775 within this document).

Competing interest statement: Adriane Fugh-Berman has been a paid expert witness on behalf of plaintiffs in the multidistrict litigation against hormone manufacturers referred to in this blog.

Image: Peter Gotzsche

To learn more about ghostwriting in medical literature, you might be interested in this February 2009 debate published in PLoS Medicine which discussed ghostwriting, strategies for handling it, and the importance of transparency for authors, editors and journals. All contributors to the debate agreed that a transparent declaration of author contributions is an essential element of a published article, but they provided different perspectives. Peter Gøtzsche argued that ghostwriting is “scientific misconduct” because it prevents proper accountability of the role of authors and study sponsors in the publication process – he cited a recent example of ghostwriting involving the anti-inflammatory drug rofecoxib (Vioxx) and the Journal of the American Medical Association (JAMA), and made ten suggestions for journals and editors to reduce misappropriated authorship.

Whilst agreeing that ghostwriting “debases the fundamental tenets of the medical profession”, Jerome Kassirer provided a different viewpoint, arguing that ghostwriting can be difficult to define and that there is a lack of uniformity among journals – the “gatekeepers” of scientific literature – regarding authorship criteria. He said that more evidence is needed of its existence and that excessive regulation should be avoided.

The third perspective on ghostwriting came from an international group of professional medical writers who argued that as long as their contribution to publication was explicitly disclosed, “the communication expertise and health care knowledge” of professional medical writers could help researchers publish and disseminate their research. They proposed a checklist for authors to help facilitate the disclosure of writing assistance.

The need to increase awareness of ghostwriting, and develop robust journal policies regarding the practice, is one of five proposals set out in this PLoS Medicine editorial to reduce bias in the scientific literature.

What does PLoS Medicine do to encourage transparent authorship?

As stated in our Guidelines for Authors, PLoS Medicine requires that the involvement of any professional medical writer is declared and we encourage authors to consult the European Medical Writers’ Association Guidelines on the role of medical writers. Before a decision to publish an article submitted to the journal is made, each author has to state the specific contributions they have made to the study or writing of the manuscript and each author has to declare that it is appropriate for them to be named as an author under ICMJE criteria. We also ask each author to make a declaration of competing interests – which can be financial, or non-financial (such as personal or professional relationships, or political or religious views when relevant)

We warn corresponding authors that a paper may be held up during the review process if these statements are not received from each individual author. All of these authorship statements and declarations of competing interests relating to a paper are published with the article. You can also find the annual declaration of competing interests of the PLoS Medicine Editors online.

Upcoming posts on the unsealed Wyeth documents are coming soon – and you can keep up to date with this and other topical medical issues by signing up for the Speaking of Medicine eNewsletter.