Woolley, Karen L.

University of Queensland eSpace

 PAGE 1
If your journal receives a manuscript where 
assistance from a professional medical writer 
has been declared, do you:
a. Decline to review the manuscript as 
your journal bans manuscripts that have 
been prepared with medical writing 
assistance?
b. Become concerned about the 
credibility of the manuscript, fearful that 
the manuscript may not be presenting the 
data in a fair and objective manner?
c. Anticipate that at least somebody has 
read your ‘Instructions to Authors’ and that 
the manuscript would have been prepared 
in an ethical manner, will meet your 
submission requirements, be easy for your 
voluntary peer-reviewers to read and 
understand, and be quick for your staff to 
edit?
I have encountered answers a, b, and c 
during the last ten years in my organization, 
where our PhD-qualified medical writers have 
assisted more than 1,000 authors from around 
the world.  I believe (as you might expect) 
answer c should be the most appropriate 
response.   
In this brief article, my aim is to convince 
you that involving professional medical writers 
in manuscripts should be a blessing, not a 
curse.  To achieve this aim, I will need to: 
(1) differentiate professional medical 
writers from ghostwriters; 
(2) reinforce the legitimate role of 
professional medical writers; and 
(3) direct you to a practical tool that will 
allow you to evaluate whether authors have 
used medical writing assistance appropriately.
Professional Medical Writers Are a 
Blessing (Ghostwriters Are a Curse)
Whether medical writing assistance is a 
blessing or a curse for your journal depends on 
whether the assistance has been provided by a 
professional medical writer or a ghostwriter.  
The two are not the same1.  Whereas 
professional medical writers are aware of, and 
abide by, guidelines for ethical medical writing 
practices, ghostwriters are not aware of these 
guidelines or deliberately choose to ignore 
them2.  Professional medical writers declare 
their involvement and funding source, and 
ensure authors control content3.  In contrast, 
COLUMN:  Ethical Questions To Ponder
Involvement of Professional Medical Writers 
in Manuscripts - A Blessing or a Curse?
by Karen L. Woolley, PhD
CEO, ProScribe Medical Communications, Australia
Associate Professor, University of Queensland, Australia
Associate Professor, University of the Sunshine Coast Australia
kw@proscribe.com.au 
1 Woolley KL (2005) Letter to the Editor. AMWA Journal 
20(4): 184.
2 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): e23.
3 Woolley KL (2006) Goodbye Ghostwriters! How to work 
ethically and efficiently with professional medical writers. 
Chest 130(3): 921-923.
December 2009 / January 2010 PAGE 2
COLUMN:  Ethical Questions To Ponder
Professional Medical Writers           continued
ghostwriters hide their involvement and 
funding source, and may try to control 
content3.  Ghostwriting is an unethical 
practice and should be eradicated2.   
The good news for editorial staff is there 
are signs professional medical writers may be 
winning the war against ghostwriters.  
Professional medical writing associations in 
North America (American Medical Writers 
Association; www.amwa.org), Europe 
(European Medical Writers Association; 
www.emwa.org), and the Asia-Pacific region 
(ARCS; www.arcs.com.au) have a vested 
interest in ridding ghostwriters from the 
medical writing profession.  These associations 
reinforce ethical medical writing practices 
through their position statements, 
membership criteria, and continuing 
professional education programs.  Reassuringly, 
surveys of medical writers in 2005 and 2008 
indicate more medical writers are becoming 
familiar with guidelines for ethical medical 
writing practices and more medical writers are 
declaring their involvement4.  Be under no 
illusion…there is still much work to be done, 
but these results suggest the prevalence of 
declared medical writing assistance may 
increase; currently, approximately 6% of 
publications in high-ranking, international, 
peer-reviewed journals have declared medical 
writing assistance5.  In the future, editorial 
staff are likely to become increasingly exposed 
to declared medical writing assistance – they 
will need to decide whether such assistance is 
legitimate.
Legitimate Role for Professional Medical 
Writers
Academics and journal editors from 
around the world have reinforced that 
professional medical writers can have a 
legitimate role in helping authors prepare 
manuscripts, providing appropriate disclosures 
are made2,6.  There is the belief, although 
limited empirical evidence, that professional 
medical writers can help authors prepare high 
quality manuscripts in a timely manner7,8.  
Professional medical writers may also help 
authors edit previously rejected manuscripts to 
enhance the probability of publication 
success9.  Authors tend to seek professional 
medical writing assistance when they are 
limited by time, language, or manuscript 
preparation experience3.  Rather than be 
frowned upon, such assistance may help 
address the ethical and scientific problems of 
nonpublication, given that almost half of the 
4  Jacobs A, Hamilton C (2009) Decreased evidence of 
ghostwriting in a 2008 vs 2005 survey of medical writers. The 
Write Stuff 18(2):118-123.
5  Woolley KL, Ely JA, Woolley MJ, Findlay L, Lynch FA et al 
(2006) Declaration of medical writing assistance in 
international peer-reviewed publications. JAMA 296(8):
932-934.
6  Hirsch LJ (2009) Conflicts of interest, authorship, and 
disclosures in industry-related scientific publications: the tort 
bar and editorial oversight of medical journals. Mayo Clinic 
Proc 84(9): 811-821.
7  Phillips SG (2009) Authorship and writing practices in the 
health care industry. AMWA Journal 24(1): 4-8.
8  Woolley KL, Ely J, Woolley MJ, Lynch F, McDonald J et al 
(2005) Declaration of Medical Writing Assistance in 
International, Peer-Reviewed Publications and Effect of 
Pharmaceutical Sponsorship. Abstract presented at the 5th 
International Congress on Peer Review and Biomedical 
Publication. Available: http://www.ama-assn.org/public/peer/
program.html. Accessed 1 September 2009.
9  Woolley KL, Barron JP (2009) Handling manuscript 
rejection: insights from evidence and experience. Chest 135(2): 
573-577.
December 2009 / January 2010 PAGE 3
COLUMN:  Ethical Questions To Ponder
Professional Medical Writers                 continued
medical research results presented at 
conferences are never published in full10.  
Professional medical writers may also have 
a legitimate role in minimizing the risk of 
misconduct.  This statement may be surprising 
to some, particularly those who confuse 
professional medical writers with ghostwriters.  
However, evidence from the largest study 
conducted to date on retracted publications 
shows publications with declared medical 
writer involvement have rarely had to be 
retracted from the literature due to 
misconduct11.  The same cannot be said of 
publications without declared medical writing 
assistance.  In practical terms, this research 
suggests that if editors do receive manuscripts 
with declared medical writing assistance, they 
are unlikely to have to go through the 
emotional and financial minefield of issuing a 
retraction for misconduct.
Although some journal editors may 
contemplate banning any manuscripts with 
medical writing assistance, this strategy, when 
implemented, has been short-lived12 and has 
not been embraced by many other editors.  
Indeed, this strategy may exacerbate the 
problem of nonpublication and cause more 
work for editorial staff if they have to manage 
an increasing number of poorly written 
manuscripts that do not comply with journal 
requirements.  This latter prospect is unlikely 
to be welcomed by busy editorial staff13.
Evaluating the Appropriateness of 
Medical Writing Assistance
If you accept that professional medical 
writers can have a legitimate role in preparing 
manuscripts and you receive a manuscript with 
declared medical writing assistance, then you 
will no doubt want to know whether the 
authors have used medical writing assistance 
appropriately.  This is where a practical tool 
could help you.  With input from journal 
editors and professional medical writers from 
around the world, my colleagues and I 
developed a five-question, structured 
instructional checklist; authors complete this 
checklist to show they have used medical 
writing assistance appropriately (Table 1)2. This 
checklist is freely available and can be 
downloaded from the PLoS Medicine 
(www.plosmedicine.org) or the EQUATOR 
network (www.equator-network.org) websites.  
Journal editors are encouraged to require 
authors who use medical writing assistance to 
complete and submit this checklist with their 
manuscript.
The first question in the checklist, which 
prompts authors to ensure medical writer 
involvement is appropriately acknowledged, 
could help raise awareness of authorship 
criteria and reduce poor authorship 
attribution practices.  The second question 
reinforces the need for transparency and 
10  Scherer RW, Langenberg P, von Elm E (2007) Full 
publication of results initially presented in abstracts. Cochrane 
Database Syst Rev: MR000005.
11  Woolley KL, Woolley MJ, Lew R, Bramich N,  Ely J et al 
(2009) Round Up the Usual Suspects?  Involvement of Medical 
Writers and the Pharmaceutical Industry in Retracted 
Publications. Abstract presented at the 6th International 
Congress on Peer Review and Biomedical Publication. 
Available: http://www.ama-assn.org/public/peer/
program_2009.pdf. Accessed 1 September 2009.
12  Mayer DK, Mahon SM, Eaby B (2009) Writing for hire: 
advice for authors (and readers). Clin J Oncol Nurs 13(2): 131-132.
13  Salkin I (2009) Editing a biomedical journal: a personal view. 
Editorial Office News January 2(1): 5-10.
December 2009 / January 2010 PAGE 4
COLUMN:  Ethical Questions To Ponder
Professional Medical Writers                continued
disclosure in relation to the source of funding 
for medical writing services.  The third and 
fourth questions focus on author control over 
the manuscript.  The third question reinforces 
that the author(s) should make the final 
decision about the main points communicated 
in the manuscript.  The fourth question 
reinforces that the author(s) should make the 
final decision about the outcomes and data to 
include in the manuscript.  This question also 
reinforces to authors that they should not hide 
relevant, non-supportive data.  Confirmation 
of author control over the main points, 
outcomes, and data should provide a level of 
reassurance to editorial staff and reviewers 
and, ultimately, to readers.  The fifth question, 
which requires the authors to confirm ethical 
medical writing practices were followed during 
the manuscript preparation process, provides 
the checklist with some ‘teeth’.  This question 
alerts authors and medical writers that the 
journal editor may probe into the medical 
writing practices used.  Even if a journal’s 
limited resources mean the risk of an audit is 
low, this question reinforces to authors and 
writers that ethical medical writing guidelines 
are readily available and they should be 
followed.  
 In conclusion, the involvement of 
professional medical writers in manuscripts 
can be a blessing, not a curse.  Professional 
medical writers, but not ghostwriters, can have 
a legitimate role in helping authors prepare 
manuscripts.  Editorial staff now have free 
access to a practical tool that can help them 
evaluate whether authors have used such 
assistance appropriately.   
 
 
Table 1. Checklist for Authors Using Medical Writers: A Practical Tool to Discourage 
Ghostwriting*
Professional medical writers can be legitimate contributors to manuscripts, but ghostwriting is 
dishonest and unacceptable.  
Authors: If a medical writer contributed to the preparation of your manuscript, you must 
answer the questions below. 
Question Answer
No Yes
1 (a) Did the medical writer meet the three criteria for authorship, as 
specified by the International Committee of Medical Journal Editors? 
(b) If not, has the writer been identified in the acknowledgments or as 
directed by the journal? 
December 2009 / January 2010 PAGE 5
COLUMN:  Ethical Questions To Ponder
Professional Medical Writers                      continued
Table 1. continued
Question Answer
No Yes
2 Has the source of funding for the medical writer’s services been 
identified in the acknowledgments or as directed by the journal? 
3 Did the author(s) make the final decision on the main points to be 
communicated in the manuscript, particularly in the conclusion?
4 Did the author(s) make the final decision on the primary and 
secondary outcomes and relevant data to be reported in the 
manuscript?
5 If requested by the journal, can the medical writer provide evidence 
that the manuscript was prepared in accordance with international 
guidelines for ethical medical writing (e.g., Uniform Requirements for 
Manuscripts Submitted to Biomedical Journals; Good Publication 
Practice for Pharmaceutical Companies; Position Statements from the 
European or American Medical Writers Associations, or the 
International Society for Medical Publication Professionals)?
* This checklist was first published in PLoS Medicine2 and is available for use under the Creative Commons 
Attribution License.
Have You Fallen Behind?
If you’ve gotten behind in checking the weekly news items on the ISMTE home page, you 
can catch up by going to the ISMTE Resources page at http://ismte.org/resources.html.  
Scroll down to ‘News from the world of publishing’ and click on the ‘archive’ link.


Involvement of professional medical writers in manuscripts – A blessing or a curse?

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Involvement of professional medical writers in manuscripts – A blessing or a curse?

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