Medical Ghostwriting: When an “Author” Is Not Necessarily an “Author”

In an effort to ban the practice of medical ghostwriting, the following is a draft of a letter I have written for the editors of the major medical journals. Real medical editors are free to use it if they wish.

Ghostwriting Will No Longer Be Tolerated in the Medical Literature

The practice of ghostwriting has led some researchers to declare that many medical journal articles are little more than infomercials. And when the very first section of a paper is not accurate, who can blame them? Three-Card Monte is a scam in which a card shark uses a sleight of hand to stump the naïve mark into misidentifying the money card. Ghostwriting, which is especially prominent in the psychiatry literature, is a scam in which pharmaceutical companies use an academic sleight of hand to stump the naïve reader into misidentifying the author of a scientific paper. In the rest of the academic world, the use of ghostwriters is considered academic dishonesty (See Leo and Lacasse, 2010 Chronicle of Higher Education.) It is time for us, the editors of the major medical journals, to take back control of our journals and use the same standards of authorship found in the humanities and social sciences. Individuals who deserve to be named as authors should be listed on the byline and not thanked in the acknowledgement section.

When Should a Paper Be Considered Ghostwritten?

We have noticed that over the years when charges of ghostwriting appear about a medical paper, there are all sorts of endlessly creative reasons given why the paper should not be considered ghostwritten. The defenses include such notions as: the paper was accurate, the “named” authors signed off on the paper, the paper was peer-reviewed, the person who wrote the first draft is thanked in the acknowledgement section, that the “named” authors are good scientists, that higher powers have determined that the paper is accurate, and the list goes on. These defenses are not just espoused by companies but are often put forth, unfortunately, by university administrators. It seems slightly paternalistic to tell our readers that they shouldn’t bother themselves with concerns about who actually wrote the paper. Because of its secretive nature, no one knows the true extent of ghostwriting in the medical literature, but we do know that virtually every single blockbuster medication has been tainted by charges of ghostwritten clinical trials.

The Purpose of the Acknowledgement Section

Traditionally, the acknowledgement section of a paper is reserved for people who do not rise to the level of the byline — laboratory assistants or copyeditors, for instance. But, unfortunately, pharmaceutical companies have used this as a loophole to get around hiding the true authors of papers. Medical researcher Peter C. Gøtzsche and colleagues note that such acknowledgements are a euphemism for “XX from Company YY wrote the paper.” The reasons for moving the real author from the byline to the acknowledgement section are obvious: “Editorial assistants” are not listed in PubMed, are not listed in the abstract, are not cited, and are not contacted by the media to talk about the importance of a study.

We are aware that several professional organizations of medical writers such as the European Medical Writers Association (EMWA)¹ and the American Medical Writers Association (AMWA)² endorse the practice of thanking medical writers for providing “editorial assistance” in the acknowledgement section of the paper instead of listing them on the authorship byline. In the EMWA’s words: “The role of medical writers must be transparent, which normally means a mention in the acknowledgements section.” But these groups are not one of our constituents. We are beholden to our readers, and not to medical writers employed by pharmaceutical companies. Quite frankly, what medical writers believe about ghostwriting does not matter to us. We are in charge of our journals and we develop the rules, and if medical writers want to publish in our journals then they need to follow our rules. If they do not like our rules then they are free to go somewhere else.

An example of ghostwriters attempting to change the definitions of ghostwriting: A 2014 systematic review of ghostwriting written by several medical writers starts off with this definition of ghostwriting: “Ghostwriting occurs when paid or unpaid writing contributions to a manuscript that do not meet authorship criteria are not disclosed in the acknowledgements.”³ The authors then go on to denigrate the bulk of the existing literature on ghostwriting because it used the traditional definition of ghostwriting, and not the medical writers’ version. Medical writers who try to change the standard definition of ghostwriting or to change journal rules with blogs, letters to the editor, systematic reviews, or papers are certainly free to do so, but they will not sway us in our efforts to clean up the medical literature.

In a report on ghostwriting from the Senate Committee on Finance, Senator Charles Grassley aptly summarized the reason behind the evasion: “Despite its acknowledgement of medical writers for ‘editorial assistance,’ the role of pharmaceutical companies in medical publications remains veiled or undisclosed.” Ascertaining whether a paper has ghost authors is addressed by the simple question: Was there a writer who contributed significantly to the paper, who was not listed as an author? If the answer is yes, the paper was ghostwritten. As an example, the editors of JAMA defined a paper as ghostwritten when, “An individual who was not listed as an author made contributions that merited authorship,” or “An unnamed individual participated in writing the article.”

ICMJE’s Criteria for Who Is Considered a Writer

In 2009, The International Committee of Medical Journal Editors (ICMJE), a group of medical editors who have developed policies related to the medical publishing process, proposed three criteria for determining who should be given a byline as author on scientific papers.⁴ These criteria are “(1) substantive contributions to conception and design, acquisition of data, or analysis and interpretation of data; (2) drafting the article or revising it critically for important intellectual content; and (3) final approval of the version to be published.” While these are now the traditional, oft-cited criteria for authorship, they do not address the contemporary concern of ghostwriting.

Consider this hypothetical situation: An industry-funded medical writer authors a paper in conjunction with academic researchers. The medical writer composes the first draft of the paper and makes many substantive edits, eventually writing 99% of the paper. Before the absolute “final” version is reached, the medical writer turns it over to the academic researchers and never approves the final version, and now the medical writer who did all the work is “acknowledged” for editorial assistance. Although the byline is not an accurate representation of who contributed to the article, the paper meets the ICMJE guidelines. Several groups, including some medical writers, have pointed out that this is a loophole in the ICMJE guidelines (Matheson, 2011, and Leo and Lacasse 2011). Matheson refers to this as the “Triple Lock” and points out that it downplays the importance of planning and writing texts. ICMJE needs to clarify their definitions of authorship and who should be listed on the byline so that ghostwriting is prohibited.

Our declaration that all those who deserve to be named as authors should be listed on the byline will bring us back in alignment with the rest of the academic world and even the media. It would be hard to imagine Newsweek knowingly publishing an article drafted by a Toyota employee that recommends buying Toyotas but that lists a University Professor as the named author. Newsweek’s readers would hardly stand for this behavior. Why should a doctor evaluating the results of a clinical trial stand for it?

There is nothing inherently wrong with using medical writers in the publication process, as long as they are given credit on the byline for their work. Furthermore, as editors, we are fully aware that there are numerous complex issues generated by the interplay of university researchers and pharmaceutical companies, and that calling an author an author will not solve all of these problems. However, on the other hand, if our readers cannot count on us to take such an obvious straightforward approach to ghostwriting, then why should they trust us to handle the more complex problems? Calling an author an author is a baby step.