TRANSPARENCY AND MEDICINE – A series examining issues from ethics to the evidence in evidence-based medicine, the influence of medical journals to the role of Big Pharma in our present and future health.
This week, the series focuses on issues of transparency affecting academic journals. Today, Robert Gross and Patricia Baskin from Neurology® explain measures the journals has put in place to combat the problem of ghost authorship.
Journal editors, with the help of peer reviewers (other experts in the field), aim to publish unbiased reports of valid research.
Most medical researchers, editors and reviewers try to remain as objective as possible by using standard controls and statistical methods. But everyone has other interests (financial, career, personal beliefs) that may bias the design of the study or the interpretation of its results.
Neurology®, along with numerous other journals, requires routine disclosures of potential “financial and other interests that might bias the work.” The journal publishes these conflicts of interest (CoI) statements alongside articles so readers can decide for themselves whether the likelihood of bias exists.
This system works as long as the authors of an article are accurately identified. But what constitutes authorship – often surprisingly to those not involved in research – is sometimes decided by opinion.
Ghosts and guests
At Neurology, we seek greater definition and transparency. When evaluating a study for bias, we are often concerned with the problem of “ghost authors” and “guest authors.”
We sometimes encounter research articles that are written by a medical writer working within the pharmaceutical industry or hired as a contract writer. These articles usually describe the outcomes of trials of new therapeutic agents and may therefore seek to influence prescribing practices of physicians, even if objectively reported.
Our journal files contain correspondence from pharmaceutical companies asking thought leaders in a field to “write” (for money) papers that a company has planned or written with professional writers – using the author’s name to lend professional credibility.
In these situations, the editors consider the invited author a “guest” author; those at the company who actually write the paper are considered “ghost” authors as they usually remain unnamed.
Pharmaceutical companies, whose activities have been highly publicised, are not the only transgressors muddying accuracy of authorship.
Academic research groups often include department chairs, laboratory supervisors, and those who obtained funding as authors on a paper, even though they may not have participated in a substantial way in the study.
Sometimes, everyone having any part in the study is included, creating a huge author list, and sometimes important people in a study are omitted for subjective reasons.
In the absence of definite authorship criteria, neither editors nor readers understand author roles or have any way to determine if biases exist.
Initial attempts
In 1985, the International Committee of Medical Journal Editors (ICMJE)established the first, well-defined authorship criteria, designed to standardise authorship and add public responsibility to an author’s role.
The criteria required that anyone named as an author meet all three of the following:
make substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data;
help draft the article or revise it critically for important intellectual content; and
give final approval of the version to be published.
The ICMJE stated that those not meeting these criteria, such as those participating in acquiring funding, collecting data, and general supervision, should be listed in the acknowledgments at the end of the article. Most medical journals now present these criteria in their instructions to authors and they are considered standard throughout the industry.
However, inadequacies in the ICMJE criteria abound.
Medical research has become more complicated, with specialists from many fields involved in large research studies. And because all three criteria need to be fulfilled, authors and editors routinely disregard the criteria completely.
No author group, for instance, will omit an author from the byline if that author conceived and designed the study (criterion 1) because she did not take part in the writing (criterion 2). And political pressures in institutions continues to result in adding chairs and other guest authors to the byline.
Author roles are often not defined. Sometimes, authors see their names on papers only after an article is published because no one asked for their approval – and sometimes their names were added by a colleague without permission in the hope that the paper would be more likely to be accepted.
Although publication planners, writers, and investigators in industry may plan and write entire studies, they can take advantage of these criteria to mask their participation by not signing off on the final version (thus not meeting criterion 3).
In the 1990s, the ICMJE encouraged editors to begin asking authors to explain their roles and to publish these roles in the journal for greater transparency. Some journals have added the contributorship model to their instructions, but most have not.
Refining standards
In 2007, Neurology tightened up its author criteria to address the insufficiencies that allowed guest authors to populate bylines and ghost authors to remain hidden.
We believe the articles we publish should reflect the conclusions of the expert authors who participated in either the research or the writing and that all authors should reveal all their contributions and make full disclosure of conflicts of interest (COI). This makes who did the research or writing, who contributed in other ways, who paid for the research and the writing, and who may profit from them transparent to the readers.
We changed our authorship criteria to include all the following as requirements:
design or conceptualisation of the study; or
analysis or interpretation of the data; or
drafting or revising the manuscript.
We also require all authors to acknowledge all versions of the paper. Those who do not qualify as authors are listed as co-investigators or contributors in an appendix or listed in the acknowledgements.
In addition, we require that any paid medical writer who wrote the first draft or responded to the reviewer comments be included in the byline and make full disclosure (eliminating the medical ghostwriters).
All authors must complete and sign authorship forms with roles and contributions and disclosure forms listing all sources of potential bias. Authorship contributions and disclosures are published in the journal.
Our authorship policy makes contributions more transparent, places more accountability on the individual authors for their contributions. It also ensures that conflict of interest disclosures are complete, and helps to eliminate both guest and ghost authorship.
Mainly, it promotes transparency so that readers, especially physicians, can decide for themselves whether bias exists. A recent excellent study in the British Medical Journal reported that guest and ghost authorship in articles submitted to a sample of top-tier medical journals have declined somewhat, but are still of concern.
In an accompanying editorial, we commented on the value of such data in improving standards. We recommend that other editors adopt policies similar to Neurology’s to help ensure that articles in medical journals can be trusted by the readers. We also suggest they continue to examine critically these and other proposed criteria so that the highest standards are sought and eventually achieved.
This is the sixth part of Transparency and Medicine. You can read other instalments by clicking the links below:
Part One: Power and duty: is the social contract in medicine still relevant?
Part Two: Big debts in small packages – the dangers of pens and post-it notes
Part Three: Show and tell: conflicts of interest undeclared for clinical guidelines
Part Four: Eminence or evidence? The ethics of using untested treatments
Part Five: Don’t show me the money: the dangers of non-financial conflicts
Part Seven: Clearing the air: why more retractions are good for science
Part Eight: Pharma’s influence over published clinical evidence
Part Nine: Insight into how pharma manipulates research evidence: a case study
Part Ten: Why data from published trials should be made public
Part Eleven: Open disclosure: why doctors should be honest about errors
Part Twelve: Reaching full and open disclosure for universities, medical schools and doctors
Part Thirteen: Ethics of accepting suppliers’ gifts in the business v medical world
Part Fourteen: Conflicts of interest in guideline development: the NHMRC responds
Part Fifteen: Consumer input in Medicines Australia’s code of conduct review