Ghostbusting
in medical research: latest guidelines reinforce the importance of ethics in
scientific publications
The
European Medical Writers Association, EMWA, welcomes the affirmation of the role
of medical writers in the updated guidelines on Good Publication Practice for
Pharmaceutical companies (GPP2) in the British Medical Journal.
The
guidelines reaffirm the legitimate role that professional medical writers can
play in the publication of medical research, and echo EMWA’s own comprehensive
guidelines on ethical publication practice. Both the EMWA and GPP2 guidelines
aim to stamp out the practice of “ghostwriting” – where a pharmaceutical company
pays a medical writer to write a paper without this arrangement being
disclosed.
Medical
writers are skilled communication professionals who can help ensure that
research is presented clearly and effectively, and to rigorous scientific
standards. Their role is to draft a concise scientific paper using the mass of
highly detailed results generated by clinical trials. EMWA and GPP guidelines
emphasise that this should always be done in close collaboration with the
researchers who are named as the paper’s authors.
The
coordinating role of the medical writer can speed up the publication process so
that research is presented more quickly. But it is the named scientific authors
who have control over – and responsibility for – the final published document.
EMWA guidelines stress that to ensure transparency, the role of the sponsoring
company in paying for medical writing should be clearly disclosed in the
paper.
Recent
research by EMWA (jointly with the American Medical Writers Association) has
shown that ghostwriting has become substantially less common over the last few
years, suggesting that the guidelines have been effective. GPP2 is the latest in
a series of initiatives designed to ensure that publication of clinical research
results by the pharmaceutical industry is done to the highest ethical standards.
The original GPP guidelines, published in 2003, were written by a group of
professional medical writers in response to criticisms that publications of
clinical research sponsored by pharmaceutical companies had a commercial bias,
at the expense of good science. Such criticisms were particularly likely when
“ghostwriters” were used.
EMWA and
the American Medical Writers Association have been at the forefront of
initiatives designed to improve ethical standards in medical publications. EMWA
published guidelines in 2005 which clarified the role of professional medical
writers based on clear ethical principles. EMWA hopes that the GPP2 guidelines
will help to ensure that ethical standards in medical publication continue to
improve.
Notes
to editors
The
European Medical Writers Association (www.emwa.org) is the
main professional organisation for medical writers in Europe. It has almost 1000
members, working in pharmaceutical companies, contract research organisations,
specialist medical writing companies, and as freelancers. It promotes good
practice in medical writing through its extensive training programme in all
aspects of medical writing, as well as being the official voice of medical
writers in Europe.
The EMWA
guidelines can be found at http://www.emwa.org/MembersDocs/GuidelinesCMRO.pdf
Details of
the research showing that ghost writing is becoming less common can be found at
http://www.emwa.org/JournalArticles/JA_V18_I2_Jacobs1.pdf
The latest
version of the GPP guidelines (GPP2) can be found at:
http://www.bmj.com/cgi/doi/10.1136/bmj.b4330
