The Role Of Professional Writers

Posted by: American Medical Writers Association’s (AMWA) Jim Cozzarin, MaryAnn Foote, Adam Jacobs, Mary Royer, and Barbara Snyder.

Medical writing has been the subject of numerous editorials.  Recently, two journals decided that they will no longer accept manuscripts prepared with the help of a medical writer.  This decision is both startling and drastic, and may have untoward consequences.  At least 1 journal, however, has endorsed the use of medical writers...

As professional writers, we acknowledge that some writers, agencies, and/or biopharmaceutical companies have “shopped around” for suitable key opinion leaders to serve as lead authors for manuscripts written by a professional writer.  We, along with the American Medical Writers Association and European Medical Writers Association, strongly disapprove of this practice, which is ‘ghostwriting’.  We know of no evidence that this practice is the norm.  We suspect that ghostwritten papers gain a high profile because journalists consider them highly newsworthy, not because they are common.

AMWA (www.amwa.org) and EMWA (www.emwa.org) have published guidelines concerning the way medical writers should interact with researchers to write manuscripts for publication.  We believe that medical writers are valuable to the writing process and can facilitate and speed the publication of important scientific information. 

Professional writers ensure that the literature cited is current; the study and statistical methods are complete, appropriate, and adequately detailed; and the author’s interpretation of the study findings is clearly and concisely communicated.  Because of their contributions, manuscripts may be reviewed more easily by peer reviewers with fewer queries to be answered before final acceptance. 

Medical writers have an important role in conveying valuable information to physicians and others in both a clearly communicated and a timely manner.  We do not consider ourselves to be ‘ghostwriters’ and do not promulgate the term.  For those who do see us as such, we would welcome an open and fair dialog so that we can explain our value.

Comments

[Tom Lang]

We must distinguish between "ghostwriting," in which a professional medical writer assists in presenting the content of a named author, and "ghostauthorship," in which the content developed by one person is attributed to another. Ghostwriting is necessary and desirable: medical writing is a speciality that is not easily mastered, especially by those whose primary interests are medicine or research. Ghostauthorship is unethical and is, in my mind, the correct term for the example in the above posting. The prevalence of ghostauthored articles is unknown, but it is high enough to arouse concern among professional societies. I disagree that it is rare enough to be noticed ony because it is newsworthy.

[Michael S. Altus, PhD, ELS]

One reason that the prevalence of ghostauthored articles is unknown is, obviously, that those responsible for these articles try to keep it hidden and won’t discuss it. For example, an article in the May 8, 2006, issue of Forbes, entitled “The Lure of Off-Label” http://www.forbes.com/business/forbes/2006/0508/094sidebar.html, told of Johnson & Johnson’s Scios division’s being under federal investigation for the marketing and promotion of its heart drug, Natrecor. Scios sponsored the publication of a journal supplement in which the articles, according to J&J, were developed by independent experts.

One of these experts declined the supplement publisher’s offer to ghostauthor the article for him. J&J wouldn’t answer whether ghostauthors were involved. J&J’s keeping mum about ghostauthoring contrasts, sadly, with its taking responsibility for the public interest when people died after ingesting cyanide-laced Tylenol (see The Tylenol Crisis: How Effective Public Relations Saved Johnson & Johnson: http://www.personal.psu.edu/users/w/x/wxk116/tylenol/crisis.html.

Another reason for the difficulty in determining the prevalence is that to find a fever, you must take a temperature. Woolley et al. (Declaration of medical writing assistance in international peer-reviewed publications. JAMA. 2006;296:932-934) quantified the percentage of 1000 articles reporting medical writing assistance that were published between November 2004 and January 2005 in 10 international, peer-reviewed, high-ranking journals. Medical writing assistance was reported in only 60 (6%). Of interest is that only two of the ten journals specifically advised authors to acknowledge writing assistance.

Although AMWA strongly disapproves of ghostauthorship, AMWA guidelines are only voluntary and therefore only of questionable usefulness in decreasing the prevalence of ghostauthored articles. Members, sponsors, and advertisers are not required to adhere to them, and they face no AMWA consequences for violating them. Furthermore, a pilot survey of AMWA members who provide freelance writing assistance found that fewer than 60% of the 73 respondents indicated that they followed AMWA guidelines and encouraged authors and other contributors to do so (Hamilton et al. Comments on "The corporate author". J Gen Intern Med. 2005;20:972).

I am a freelance medical writer and editor whose concerns about ghostwriting and ghostauthoring are expressed in a series, “Ghostwriting, medical writers, and ethics”. The posts are publicly available on the Council of Science Editors (CSE) Forum: http://www.councilscienceeditors.org/services/bboard1/

[Michael S. Altus, PhD, ELS]

A research article published early during 2007 provides evidence that that “this practice”—ghostauthoring—“is the norm.”

The article’s citation is as follows:
Gøtzsche PC, Hróbjartsson A, Johansen HK, Haahr MT, Altman DG,Chan A-W. 2007.
Ghost authorship in industry-initiated randomised trials.
PLoS Med 4(1): e19 doi:10.1371/journal.pmed.0040019
(Freely and publicly available at:
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pmed.0040019

Here's a summary from the article itself and from the helpful editor's summary included in it:

Ghost authors are people who were involved in some way in the research study, or writing the paper, but who have been left off the final author list. This might happen because the study "looks" more credible if the true authors (for example, company employees or freelance medical writers) are not revealed. The researchers sought to find out if authors of research protocols were also named as authors of published reports. To do so, they used a variation of ICMJE criteria to compare the authors of industry-funded protocols in Danish registries with the authors of and acknowledgments in published reports. Of 44 identified trials, 31 (75%) had evidence of ghost authorship. This means in these 31 trials, people were identified as having written the protocol, or having been involved in doing statistical analyses or writing the manuscript, did not end up named as authors. Gøtzsche et al. concluded that ghost authorship in industry-initiated randomized trials is very common, and they believe that this practice serves commercial purposes.

The article by Gøtzsche et al. was accompanied by a commentary from communications consultant Elizabeth Wager:
Wager E. 2007. Authors, Ghosts, Damned Lies, and Statisticians. PLoS Med 4(1): e34 doi:10.1371/journal.pmed.0040034
(Freely and publicly available at:

http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0040034

This commentary concluded, “perhaps we should now admit that there are four types of lie: lies, damned lies, statistics, and the authorship lists of scientific papers, and that statisticians may be able to help prevent both the third and fourth types.”

Will the AMWA leaders “now admit” to this?

Gøtzsche et al. join Wooley et al. (Declaration of medical writing assistance in international peer-reviewed publications. JAMA.2006;296:932-933) in using a quantitative approach to study the problem of ghostauthorship. These two groups are to be congratulated for applying quantitative approaches to useful effect.

Michael S. Altus, PhD, ELS
Intensive Care Communications, Inc.®
Biomedical Writing and Editing
Baltimore MD; MichBALT@aol.com