Only full access to trial data will show signs of ghostwriting, meeting hearsBMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d2925 (Published 10 May 2011) Cite this as: BMJ 2011;342:d2925
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Submitted on behalf of the ISMPP Board of Trustees:
This article raises two distinct issues - selective reporting of
trial data and ghostwriting, both of which are of concern to the
International Society for Medical Publication Professionals (ISMPP), a non
-profit organization that advocates for and educates on best practices,
professional ethics, and transparency in medical publishing.
The ISMPP Board of Trustees is pleased to see these challenges
brought forward, shares in the concerns raised, and welcomes opportunities
to collaborate on best practices that result in full disclosure of study
results and transparency in the publication of trial data. While
fundamentally separate issues, trial reporting and full disclosure of
authorship clearly share the common ground of good professional ethics in
Transparency in Trial Reporting. As with all clinical trials, those
that are sponsored by pharmaceutical companies must fulfil the
requirements of government-appointed regulatory bodies in publicly posting
key details on www.clinicaltrials.gov, EudraCT or other national clinical
trial registries. The US government and European Union have passed
legislation to ensure that all clinical study results are made publicly
available, regardless of the results of the study. Clearly, there have
been past instances of inadequate transparency, which have prompted ISMPP
and other professional organizations such as the American and European
Medical Writers Associations (AMWA and EMWA) to develop additional
guidance aimed to improve the standard of research reporting (e.g.,
GPP2 ). Indeed, ISMPP's Code of Ethics  requires accuracy,
completeness, fair balance in medical publishing and considers commercial
product promotion inappropriate.
ISMPP continues to support appropriate access to trial protocols and
data in order to ensure scientific integrity. We believe strongly that in
addition to trial reporting, translation and context via peer-reviewed
scientific publications are critical for truly providing meaningful
education that allows for optimum patient care.
Transparency in Authorship. Professional medical writers have a
valuable role in supporting the publication of scientific publications.
By definition, they facilitate the development of a manuscript by
eliciting the direction of byline authors and developing publication
components (e.g., text, figures, tables, etc.) on the basis of author
direction. Professional medical writers are then appropriately
acknowledged for their role in the development of the publication or
recognized as byline authors if they fulfil the authorship criteria of the
publishing journal. ISMPP supports the position of the Workshop attendees
that when byline authors have not directed publication development or when
contributors have not been properly acknowledged or appropriately listed
as authors, this is ghostwriting. ISMPP does not support ghostwriting. We
do, however, advocate for clarity and consensus on the definition of
authorship and the responsibilities thereof.
ISMPP applauds the efforts of the various organizations and
regulators who share the common vision of ensuring integrity in scientific
exchange. We are eager to partner with other societies and organizations
that seek best information for physicians through fulfilling the parallel
goals of transparency and good professional ethics in medical publishing.
1. Graf C, Battisti WP, Bridges D, et al. for the International
Society of Medical Publication Professionals. Good publication practice
for communicating company sponsored medical research: the GPP2 guidelines.
2. ISMPP Code of Ethics. 2010.
http://www.ismpp.org/ISMPP%20CODE%20OF%20ETHICS%2011_10.PDF last accessed
20 May 2011
Competing interests: I am an employee of the International Society for Medical Publication Professionals, Inc. (ISMPP)
Silversides's article does not seem to be completely clear on what is
the main problem to be addressed. Both ghostwriting and selective
reporting are mentioned, which are separate issues (although no doubt some
ghostwriters are also responsible for selective reporting).
Many guidelines have been published that make it clear that
ghostwriting is unacceptable, and although the prevalence of ghostwriting
is decreasing , it still exists. What can be done to enforce the
guidelines? In practice, very little can be done unless journal editors
themselves take an interest in enforcement. If a journal does not care
whether it publishes ghostwritten articles, then the chance of anyone
using a ghostwriter being discovered is slim. I and some other medical
writers have published a checklist specifically designed to help medical
journals ask questions aimed at ensuring that any medical writing
assistance is transparent and ethical . Sadly, few if any journals have
taken it up. Until they do (or implement similar measures), ghostwriting
is likely to persist.
The problem of selective reporting is also an important one, but I am
puzzled about why Silversides implies this is mainly an industry problem.
A recent study published in a high-profile journal  found that
reporting of primary outcomes that was inconsistent with pre-specified
primary outcomes was significantly less likely in industry funded studies.
Access to protocols would certainly help to reduce the problem of
selective reporting, from both industry and independent authors. But
again, this will only happen if journal editors require it to happen.
Those of us in the medical writing world who care about publication
ethics can and do advise our clients about ethical publication practices.
However, if some authors choose to work with less ethical writers instead,
there is little we can do. Journal editors, however, could do considerably
more about it if they had the appetite to do so.
1. Jacobs A, Hamilton CW. Decreased evidence of ghostwriting in a
2008 vs 2005 survey of medical writers. The Write Stuff (Journal of the
European Medical Writers Association) 2009;18:118-123
2. G?tzsche PC, Kassirer JP, Woolley KL, Wager E, Jacobs A, Gertel A,
Hamilton C. What Should Be Done To Tackle Ghostwriting in the Medical
Literature? PLoS Medicine Vol. 6, No. 2, e23
3. Bourgeois FT, Murthy S, Mandl KD. Outcome reporting among drug
trials registered in ClinicalTrials.Gov. Ann Intern Med2010;153:158-166
Competing interests: My company provides professional medical writing services to both pharmaceutical companies and independent researchers, but much more often to the former.
If we really want to tackle misconduct in the published literature,
do you think it would be helpful to base corrective strategies on
As published recently in CMRO (internationally, peer-reviewed journal
ranked in the top 20% of general medical journals), our analysis of papers
retracted for misconduct showed that the odds of misconduct vs mistake
were significantly higher when the original paper had a single author, had
an author who had already had a paper retracted, and had a first author
who came from a lower-income country. Let's focus our educational efforts
on these evidence-based factors, which most people seem to accept as being
The other two key results from our research challenge popular
perceptions. We found that the odds of misconduct were significantly
LOWER if a paper had declared medical writer involvement or declared
industry sponsorship. This evidence requires us to understand why a
declared professional medical writer (different breed entirely from
unethical ghostwriters!) and why declared industry sponsorship can reduce
the odds of having a paper retracted for misconduct.
I encourage readers interested in this topic to read the full paper
in CMRO and then comment.
Anyone can repeat our study and the data were analysed by an
independent academic statistician.
Isn't it time we started to base our educational efforts on a
systematic analysis of the evidence on misconduct?
Isn't it time for more journalists and editors started to understand
the difference between ghostwriters and professional medical writers?
Ghostwriters are the enemy of ethical publication practices; professional
medical writers can be the enablers.
Competing interests: I am actively involved in not-for-profit associations that educate members on ethical publication practices. I am paid to provide ethical medical writing training courses and services for not-for-profit and for-profit clients.
I support greater transparency for all (not just commercially
sponsored) research. Initiatives such as trial registration, publishing
protocols, improving disclosures and enforcing reporting guidelines should
be encouraged. There is still much to do in these areas, but the obvious
next step is data sharing and I agree we should be working towards this.
However, as a former medical writer and sometime trainer of writers I
don't like all the problems of lack of transparency being lumped together
as a 'ghost writing' problem. When done correctly and responsibly, the
involvement of professional writers can raise the standard of reporting.
Of course the writers and their funding sources must be acknowledged. But
please don't lay all the blame at the writers' door.
As well as training writers, I run courses for doctors and other
healthcare professionals and I invariably find that the professional
writers are far better informed about reporting guidelines (eg CONSORT)
and ethical requirements. I would like to see writers becoming part of the
solution (as many are keen to be) not simply viewed as the problem which
is an over-simplification. Please don't forget that writers have worked to
develop guidelines such as GPP (BMJ 339:b4330) which have helped to raise
standards (as one speaker apparently reported).
Competing interests: I have worked, in ths past, as a medical writer (as an employee and contractor) for several pharmacuetical companies. I was involved in developing Good Publication Practice for pharmaceutical companies and European Medical Writers Association guidelines. I sometimes run training courses for drug companies on medical writing and publication ethics. I have advised various drug and communication companies on their publication policies and practices.