Over 1 billion people practice open defecation. (Image credit: Rémi Kaupp; wikimedia commons)

Diarrhea, abdominal pain, malaise, anemia, and delayed child development: these are the debilitating effects of one group of diseases, the soil-transmitted helminths (worms). As indicated by the name, these diseases are transmitted via contaminated soil; as such, good sanitation has a key role in prevention. However, because sanitation systems vary greatly, their impact is difficult to study. Now, a PLoS Medicine systematic review and meta-analysis (a reanalysis of data from already published studies), by Ziegelbauer and coauthors, quantifies the benefits of sanitation: for all three of the STHs, when sanitation was both available and regularly used, the odds of getting a worm disease was cut in half.

One billion of the world’s people experience a diminished ability to work, learn, and thrive as a result of infection by these parasites  – roundworm, whipworm, and hookworm. The resulting losses in quality of life and productivity can trap people in a cycle of poverty and stigma and diminish their ability to care for themselves and their families.

Currently, the primary approach to the problem is repeat drug treatment. As important as drugs are, though, they also have limitations: reinfection in endemic areas; possible reduced efficacy and development of resistance; and supply, delivery, and compliance problems. Drug administration can go only so far, and currently many programmatic goals are not being met. For the STHs, many authors argue that integrated control is the only hope for lasting improvement (see Further Reading).

Integrated control of infectious diseases involves not only drug treatment to knock down the illness itself, but preventive measures such as education of at-risk communities, surveillance and research, strong healthcare systems, vector control, safe water supplies, good hygiene practices, and adequate sanitation systems.

Thus, Ziegelbauer and coauthors urge, drug treatment should be only part of efforts toward STH control; sanitation should also be emphasized. And the authors point out something that drug treatment does not do: “Implementation of sanitation facilities and integrated control approaches go far beyond the prevention and control of intestinal helminths; they impact other neglected tropical diseases, such as schistosomiasis, trachoma, and diarrhea…and can even help promote social and educational advances for women and girls…”

Policy and funding support for integrated control that includes good sanitation should be a focus as the world fast approaches the deadline for the Millennium Development Goals with disappointing progress toward #7C (to “Halve, by 2015, the proportion of the population without sustainable access to safe drinking water and basic sanitation.”).

Further Reading

Hotez PJ (2008) Hookworm and poverty. In: Reducing the Impact of Poverty on Health and Human Development: Scientific Approaches. Ann NY Acad Sci 1136: 38–44.

The 2010 PLoS Water and Sanitation collection

WHO: Water Sanitation and Health

WHO / UNICEF Joint Monitoring Programme (JMP) for Water Supply and Sanitation

Ziegelbauer K, Speich B, Mäusezahl D, Bos R, Keiser J, et al. (2012) Effect of Sanitation on Soil-Transmitted Helminth Infection: Systematic Review and Meta-Analysis. PLoS Med 9(1): e1001162. doi:10.1371/journal.pmed.1001162

A cluster trial has been defined as a trial in which “the study, randomize[s] interventions to groups of patients (e.g., families, medical practices) rather than to individual patients”.

The group coordinating this consultation has developed a set of wiki pages, and has published a series of papers in the open-access journal Trials outlining what the issues are (each of the papers is accessible via the group’s wiki site above, as well as the journal website itself).

The consultation is dividing its efforts into defining and discussing each of six key ethical problems, each of which affects cluster trials in unique ways.

“Firstly, who is the research subject in a cluster trial? Secondly, when, and from whom, is informed consent needed in a cluster trial? Thirdly, does clinical equipoise apply in cluster trials? Fourthly, how should benefits and harms be assessed in cluster trials? Fifthly, do gatekeepers have a role to play in protecting the interests of those affected by cluster trials? Finally, what are the issues for cluster trials in vulnerable populations?”

These are important issues, as convincingly set out in the conference and in the introductory papers. Data presented in the webcast showed that a sizeable proportion (up to 30%) of published reports of cluster trials do not provide information on the ethical oversight, or consent procedures for the study. The chairs of research ethics boards consider the issues raised to be important, but do not apply protections consistently, and there’s a risk of both over- and under-regulating participants in cluster trials. For example, if ethics committees require consent from everyone affected in the randomized communities, for some types of cluster trials this may make the study unfeasible or consent meaningless (eg if interventions are applied at a community level, exposing everyone in a particular setting to the intervention, it may be completely unfeasible to avoid exposing individuals to the intervention even if they decline consent). The series of papers give some great real life examples highlighting what the problems and questions are.

So, what are the solutions on the table? The consultation sets out possible definitions for the research “subject” (or perhaps, more accurately, the research participant) in cluster trials. Specifically, this definition proposes:

“A research subject is an individual whose interests may be compromised as a result of interventions in a research study”

This definition would include individuals who are directly intervened upon by investigators for research purposes; individuals who are intervened upon by manipulation of their environment by investigators for research purposes; individuals who interact with investigators for the collection of data; and individuals from whom investigators obtain identifiable private information for the purpose of collecting data.

The guidelines under development also distinguish, as previous work has done, between different types of cluster trials, and this helps define at what level, and which individuals should be protected as research participants. Three types of cluster trials are defined – “cluster-cluster” trials (interventions are applied to entire clusters and not to individuals); “physician-cluster” trials (interventions are intended to affect the process of care offered by physicians, and thus their patients are indirectly affected); and “individual-cluster” trials (in which groups of individuals are randomized, but interventions are applied to individuals within those groups). Defining these different types makes it easier to work out whose interests need to be protected in the trial, and how. It’s also clear that editors need to do a much better job of encouraging authors to explain how they viewed the ethical implications of their cluster study, and at what level they applied specific protections such as consent, and why.

The guidelines group is still keen to hear from interested parties and you can post your discussion questions via the wiki pages – so if these issues are important to you, read the papers and get involved with the group. A summary of the webcast will also be posted on the site.

Recent cluster trials published in PLoS Medicine include:

Roca A, Hill PC, Townend J, Egere U, Antonio M, et al. (2011) Effects of Community-Wide Vaccination with PCV-7 on Pneumococcal Nasopharyngeal Carriage in The Gambia: A Cluster-Randomized Trial. PLoS Med 8(10): e1001107.

Cuevas LE, Yassin MA, Al-Sonboli N, Lawson L, Arbide I, et al. (2011) A Multi-Country Non-Inferiority Cluster Randomized Trial of Frontloaded Smear Microscopy for the Diagnosis of Pulmonary Tuberculosis. PLoS Med 8(7): e1000443.

Kangwana BP, Kedenge SV, Noor AM, Alegana VA, Nyandigisi AJ, et al. (2011) The Impact of Retail-Sector Delivery of Artemether–Lumefantrine on Malaria Treatment of Children under Five in Kenya: A Cluster Randomized Controlled Trial. PLoS Med 8(5): e1000437.

Luoto R, Kinnunen TI, Aittasalo M, Kolu P, Raitanen J, et al. (2011) Primary Prevention of Gestational Diabetes Mellitus and Large-for-Gestational-Age Newborns by Lifestyle Counseling: A Cluster-Randomized Controlled Trial. PLoS Med 8(5): e1001036.

My 2010 competing interests are on the PLoS Medicine site.

“Peer review in scholarly publishing, in one form or another, is crucial to the reputation and reliability of scientific research… However, despite the many criticisms and the little solid evidence on its efficacy, editorial peer review is considered by many as important and not something that can be dispensed with”.

So I was pleased to see a recent study reported in BMJ which takes a rigorous approach to evaluating the impact of one particular component of peer review. This study aimed to find out whether the use of reporting guidelines in peer review can improve the quality of published papers.

The researchers use this definition of a reporting guideline:

“statements that provide advice on how to report research methods and findings… they specify a minimum set of items required for a clear and transparent account of what was done and what was found in a research study, reflecting in particular issues that might have introduced bias into the research”

The study used a randomized design, in which 92 papers under evaluation at the journal Medicina Clinica were randomized to intervention or control arms. For “intervention” papers, the authors received an additional, reporting-guideline driven evaluation from a senior statistician (on top of regular peer reviewers). For “control” papers, authors received just the regular reviews. An interesting feature of the trial design was that all papers received the additional, reporting-guideline led review, but this was only sent to authors in the intervention (and not the control) arm; randomization was actually done after the reporting guideline review was completed. By doing this, the investigators were able to collect detailed baseline data on study quality, and to ensure the person doing the guideline-led review could not be biased with respect to group assignment. The instrument used to rate study quality was the scale developed by Goodman and colleagues.

What did the study show? Well, it’s a little bit hard to tell, and the evidence does not look desperately strong. In the study four papers in the “control” arm had to go through a reporting guideline-led additional review, because the editors were worried about protocol deviations in the studies reported in the papers. So these 4 papers crossed over from one arm to another. The investigators then analyse their data both intention to treat (handling the 4 crossover studies in their randomized group) and as-treated (handling the 4 crossover studies in the reporting-guideline led review group). The intention to treat analysis gives you an effect estimate for improvement of 0.25 (95% CI -0.05 to 0.54) (comparing intervention vs control arm) on the Goodman scale. The “as-treated” comparison is better, 0.33 (95% CI 0.03 to 0.63) – so if you are keen on per-protocol analyses you might conclude from this that reporting guidelines improve study quality (a bit) more than not using them… A cynic might say the study is just a bit underpowered, and if there is an effect, it’s fairly small. Of course, there does also seem to be evidence that papers in both study arms improve during peer review, although this wasn’t an objective of the project.

So what can you conclude? Firstly that it is tough to deliver properly designed studies such as this, which aim to concretely investigate the benefit (or otherwise) conferred by specific facets of peer review. The study did not definitively answer its question as to the benefit provided by use of reporting guidelines but will help others design similar studies in the future. And finally, editors and journals still operate with a huge set of “reasonability” assumptions about what works and what doesn’t, but we lack strong evidence informing a huge amount of what we do.

My competing interests are declared here. In addition, since that page was updated I have received reimbursement for local travel expenses to contribute to seminars organised by the EQUATOR group (an initiative aimed at promoting the quality and transparency of health research – and which collects together reporting guidelines). I have also contributed to the development of a number of reporting guidelines, some of which also had the involvement of some of the authors of the BMJ paper discussed in this blog.

In a blog posted on January 25, 2011 I proposed that ministers of health in developing countries must strive to strengthen health research in their countries by addressing several key questions, which will be the focus of the World Health Report 2012:

How should research priorities be set? What human and institutional capacities are needed? How to ensure ethical and good behaviour? How to promote transparency and accountability? How should knowledge be translated into action? What is the best way to coordinate research among the many performing it, and when so many health challenges involve sectors beyond health?

In the past 10 months we have run these ideas past a series of interested party consultations in order to gauge the validity of the focus and scope of the Report. While the central theme remains solidly relevant and important, two additional areas have been included to broaden the appeal, and potential value, of the Report.

First, there is a perception that the target audience should broaden. At the end of the day there are fewer than 200 ministers of health in the whole world and perhaps the Report should be aiming at a broader group of national health (and health research) policymakers. In many developing countries, where ministers of health are often short-lived political appointees, targeting the Report at decision- and policy-makers in executive, operational, leadership and managerial positions would seem to be a sensible approach. Importantly, this broader outreach should go beyond ministries of health as research funding is often controlled by other, more powerful ministries such as science & technology, finance and education.

Second, and while continuing to advocate for the importance of research in diagnosing the problem, deciding on appropriate interventions and relevant scale-up strategies, it was felt that we also needed to convey some excitement about science and research. We will therefore aim to show how research can contribute new insights by including some examples of emerging research issues with potential impacts on health including innovative technologies (e.g. advances in genomics, personalized medicine, stem cell therapy, etc), zoonotic diseases, climate change, agriculture and health.

These two additional dimensions underscore the subtle but important shift from ‘No Health Without Research’ to ‘Research for Health’ thus acknowledging that health, and the role of research, has become very multi-dimensional and inter-sectoral in nature and a broader, more inclusive approach is thus necessary.

The World Health Organization is continuing its collaboration with PLoS Medicine to develop the Collection announced previously elaborating on the themes driving the Report. The PLoS Medicine / WHO Collection will help capture the richness and diversity of country experiences in how to strengthen health research systems. A collection in an open access platform will allow all researchers, rich and poor alike, to contribute equally to the global pool of knowledge. The sharing of such experiences will complement and reinforce the practical advice contained in the World Health Report.

In relation to the expanded themes of the Report outlined above, submissions relating to research describing experiences with decision- and policy-makers within ministries of health and inter-sectoral policy development would be especially welcome. In addition papers on the implications of new technologies as it affects health care delivery and other, inter-sectoral aspects with potential impacts on health in developing countries (e.g. climate change, agriculture, trade, food security, etc) would also be welcome.

The WHO-PLoS Collection will bring together content from across the PLoS journals. Prospective authors wishing to submit articles for the WHO-PLoS Collection should submit initially to PLoS Medicine, and submissions will then be directed as appropriate to the most relevant PLoS journal, where they will be evaluated as per the journal’s usual policies, scope and standards.

To find out more about the WHO/PLoS Collection and how it will inform the World Health Report 2012, go to the collection site. Prospective authors should submit directly to PLoS Medicine via the online submission site or contact the editors on whr2012@plos.org.  We recommend that authors wishing to submit work to PLoS journals for potential consideration in the WHO/PLoS collection should submit their articles within the next two months (ie by the end of January 2012) to stand a good chance of their findings informing the eventual Collection and Report.

Competing Interests: Tikki Pang is with the World Health Organization’s Innovation, Information, Evidence and Research cluster and is the focal point for the development of the World Health Report 2012.

Today we launched a new submission and peer-review system for PLoS Medicine. The system is called PLoS Editorial Manager and it puts us on the same software that PLoS ONE migrated to a few weeks ago. PLoS Biology also moved today and the other PLoS titles will migrate to the new platform next week.

New submissions will be directed to PLoS Editorial Manager.  If you are a PLoS Medicine author who has  a manuscript currently under consideration then your manuscript will continue to be processed in the old system for a period of time.

Read  more about the PLoS journals’ migration to this new submission site and some of the benefits we hope it will bring.

Please feel free to get in touch with us at plosmedicine@plos.org if you have any questions about the new system or if you want to provide your feedback as an author, reviewer or academic editor using the new system.

Although the study is very small, and the lack of response was due to a number of differing issues including incorrect email addresses for two authors, nevertheless, the study raises important questions about whether authors really understand what journals’ policies on requiring data sharing means, whether they are willing to abide by such policies, and what journals can do to enforce such policies.

Our policies state

“Data Availability

Open access applies to both the scientific literature and the data used to establish that literature. Publication is contingent on making data integral to a manuscript freely available without restriction, provided that appropriate attribution is given and that suitable mechanisms exist for sharing the data used in a manuscript and that in the case of clinical information patient confidentiality is not compromised.

1. Data for which public repositories have been established that are in general use should be deposited before publication, and the appropriate accession numbers or digital object identifiers published with the paper.
2. If an appropriate repository does not exist, data should be provided as supporting information with the published paper. If this is not practical, data should be made freely available upon reasonable request.
3. The conclusions of a study must not be dependent solely on the analysis of proprietary data. If proprietary data were used to reach a conclusion, and the authors are unwilling or unable to make these data public, then the paper must include an analysis of public data that validates the conclusions so that others can reproduce the analysis and build on the findings.

Note that any restrictions on the availability or on the use of datasets might be judged to diminish the significance of a paper and will therefore influence the decision about whether a paper should be published. These policies have been developed in accordance with the principles established in Sharing Publication-Related Data and Materials (National Academies Press, 2003).”

We do not know who the authors contacted by Vickers and Savage were. During the review process of the Vickers paper at PLoS we offered to ourselves contact these authors, but the investigators declined. It is possible (though not an excuse) that the authors contacted by Vickers and Savage did not take the request as seriously as they should—indeed, as the investigators noted in the PLoS ONE paper “Our method of requesting data sets was intentionally left vague as we were interested as much in the investigators responses as acquiring the actual data set; perhaps a more detailed request would have garnered more positive responses.”

We would hope that the investigators’ conclusion that “our findings suggest that explicit journal policies requiring data sharing do not lead to authors making their data sets available to independent investigators” would not prove to be generally true.  However, even if these authors are not representative more generally of PLoS authors, the findings remain troubling. We take the issue of data sharing very seriously—if we are made aware of failure to comply with our policy of data sharing will gladly contact authors ourselves. On occasion, as in one recent case, a reason for non-compliance may become apparent, i.e., that supplying data would have compromised patient confidentiality. In other cases where we have contacted authors, they have quickly complied.

We will be looking at the language on our instructions and ensuing authors are aware of it at submission. The scientific world expects authors to be able to stand by their results; a critical part of this is making the data available if others need it. Non compliance for trivial reasons is not acceptable. At PLoS Medicine should an author fail to comply we would consider it appropriate to post a note on the online paper to that effect. In disagreements involving requests for data, we may also refer the requestor to officials at the author’s institution, or vice versa.

As part of our ongoing article-level metrics program, we’re delighted to announce that all seven PLoS journals will now provide online usage data for published articles, going back to their date of original publication. With this addition, the suite of metrics on PLoS articles now includes measures of: online usage; citations from the scholarly literature; social bookmarks; blog coverage; and the Comments, Notes and ‘Star’ ratings that have been made on the article.

As discussed recently, we at PLoS feel that there is much to be gained from assessing research articles on their own merits rather than on the basis of the journal (and its impact factor) where the work happens to be published. Until recently, however, readers have simply not had suitable tools to give them any indication of the quality (or ‘impact’) of an individual article. With the advent of online publishing and a burgeoning array of third parties providing information on scholarly articles, it has finally become feasible to provide meaningful article-level metrics and indicators for readers.

PLoS has therefore embarked on a program to aggregate a range of available data about an article and place that data on the article itself. The data are found on the new tab called ‘Metrics’, available on all articles. A reader can now scan the various metrics to determine the extent to which the article has been viewed, cited, covered in the media and so forth. With the addition of usage data to the article-level metrics we have taken another step towards providing the community with valuable data that can be used and analyzed.

In order to make article-level metrics as open and useful as possible, we are providing our entire dataset as a downloadable spreadsheet and we encourage interested researchers to download the data and perform their own analyses. We will be updating this spreadsheet periodically, but on launch the data it contains are correct up to July 31st, 2009. Future developments in our article-level metrics program will include the provision of more data for each metric (whenever we can locate high quality sources) and new indicators as they arise, as well as the development of more sophisticated display and analysis tools on the site itself.

We believe that article-level metrics represent an important development for scholarly publishing. While some publishers are providing limited data, we are not aware of any publisher that has gone as far as PLoS in providing such a broad range of indicators and metrics, and in making the data openly available. We invite you to visit our journal sites and seek out the Metrics tab for each article.

It’s also important to emphasize that online usage should not be seen as an absolute indicator of quality for any given article, and such data must be interpreted with caution. To provide additional context and to aid interpretation, we have provided a series of summary tables indicating the average usage of categories of article (grouped by age, journal and topic area). Users will also notice that a number of articles do not have any usage data, because of problems with the log files. We are working hard to add data for these articles, and we also encourage readers to let us know if they find any anomalies or have any questions about the data.

More information about our article-level metrics program can be found in our FAQ, this explanatory website as well as in this page of descriptive text for each journal (e.g for PLoS Biology and PLoS ONE). We look forward to your feedback, and to further developments in article-level metrics.

Mark Patterson, Director of Publishing

Media and other enquiries to Liz Allen, Director of Marketing, Tel (001) 415 624 1218

The committee was set up to focus on specific areas where there was particular potential for collaboration between Chinese and UK researchers – including three fields chosen for special attention – stem cells; clinical trials relating to emerging infections; and Traditional Chinese Medicine.

The report highlights that the system of ethical review (involving Institutional Review Boards) differs somewhat between the UK and PRC, with little national-level oversight of IRB function in PRC. In addition, the committee found that “Chinese guidelines are notably less specific than international guidelines in ensuring the independence of IRBs from the institutions they are scrutinising”, and frequently lacked members independent of the research centre.

Regulation of stem cell research and therapeutic applications is also an area where collaborating researchers should be aware of important differences in oversight.

The report sets out specific recommendations for UK and Chinese researchers who engage in research collaboration.

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

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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.