I’ve been to two meetings recently on the general theme of access in biomedical publishing. One was an in-house meeting to share some thoughts and learning points on open access (OA) publishing and the other a Medcomms Networking meeting to hear Guardian columnist Ben Goldacre’s views on how clinical trials results are published. That meeting has prompted a discussion thread on The Publication Plan’s LinkedIn page that has been running ever since and which seems to have pulled those two ideas together.
Open access publishing, particularly in the biomedical sector, is undergoing steady growth.1 Beyond the laudable concept of allowing everyone (including patients) to read and study the research, the ‘online only’ nature of OA publishing has other benefits, not least the facility to publish (sometimes extensive) data tables for which there would never be room in a print journal and the potential for more rapid publication. The editorial boards of OA journals also seem to be more open in their approach to content, needing primarily to satisfy themselves that studies are scientifically robust rather than making an additional judgement call on whether the work would be of interest to their subscribers.
The expansion in OA publishing has pretty much coincided with increasing requirements for the pharmaceutical industry to be more open and transparent about its funding and reporting of clinical trials including its relationships with trial investigators who author papers and the medical communications and medical education agencies who provide medical writing and other support for the preparation of manuscripts in which trial results are reported. This followed the disclosure in a number of class actions involving patients who had suffered drug-related adverse events that data about the drug’s safety and efficacy had not been fully reported in papers that had not been written by the study investigators but by un-named and unacknowledged medical writers (ghost writers) working for med comms agencies and paid for by pharma companies.
These requirements, which largely have been driven by the International Committee of Medical Journal Editors (ICMJE) in its Uniform Requirements for Manuscripts Submitted to Biomedical Journals, and the International Society for Medical Publication Professionals (ISMPP) – authors of Good Publication Practice, aim to make it possible for editorial staff, reviewers and readers to know when trials have been funded by pharmaceutical companies and to scrutinise the reporting of trial results against the study protocol to make it easier to see if data are being withheld or misused. They also require the involvement of medical writers to be disclosed along with the source of funding for this involvement. Authors must declare how much involvement they have had in preparing the manuscript, any financial arrangements with pharmaceutical companies, and their willingness to take responsibility for the content of the paper.
Dr Goldacre, whose passion is evidence-based medicine, charges that, even now, too many clinical trial reports distort the evidence-base for drug safety and efficacy and that medical communications companies and the medical writers that work for them are complicit in this distortion. See his website for some specific examples. You might imagine that this was not easy for a group of medical writers to hear – perhaps particularly so because Dr Goldacre is not a typical pharma industry ‘basher’. He readily acknowledges the role of drugs in healthcare (‘no medicine without medicines’) but wants doctors and healthcare funders to have access to all the trial data. He singled out the dearth of reports of negative findings (ie where the test drug fails to demonstrate superiority over other drugs or placebo) as a particular source of bias. I think that this point was generally accepted by people at the meeting – certainly from the point of view of transparency. Where opinions diverged was on whether it could be achieved.
Going forward, pharmaceutical companies will be posting all raw clinical trials data on the clinical trials.gov and EudraCT websites. But in terms of providing useful information to physicians, if this is the only way that negative data get published, is that either sufficient or appropriate?
The usual answer to the question ‘Why don’t negative results get published?’ is that journals won’t accept papers that don’t advance the understanding of medicine. But I don’t know how many people are trying to ‘push the envelope’ and convince journals that understanding might be advanced by publishing negative results in some circumstances. A published study report would allow some context to be added to the results and some reasoned speculation about why the study hypothesis wasn’t proved, which might open up avenues to further research (I, of course, as a medical writer, should declare a vested interest at this point).
Going back to where we came in, in OA journals we have a broader forum for publication. If even a negative study meets the requirement for robustness, there is perhaps a greater chance of it being accepted. Moreover, where allowed by the journal, readers may have the opportunity to comment on and ‘discuss’ the paper online, and in real time, adding to the scientific interest in the paper. In theory at least though, OA journals should not be the only option open to teams wishing to publish negative results. The ICMJE’s position statement on publishing negative studies says that: ‘Editors should seriously consider for publication any carefully done study of an important question, relevant to their readers, whether the results for the primary or any additional outcome are statistically significant. Failure to submit or publish findings because of lack of statistical significance is an important cause of publication bias’.2
At the current time, the pharmaceutical industry has much to do regain the confidence of the people who use its products. Granting access to data for all studies, in tandem with complete disclosure of the nature of its relationships with the study investigators and the people who write up the study, may go some way to achieving this aim.
To find out more about me and my medical writing work, please visit my website at www.freelancemedicalwriting.co.uk .
1. Laakso M et al. PLoS One 2011;6:e20961.
International Society of Medical Publication Professionals www.ismpp.org
International Committee of Medical Journal Editors www.icmje.org
European Medical Writers Association www.emwa.org
MedComms Networking www.medcommsnetworking.co.uk (for links to the LinkedIn page of The Publications Plan)
Ben Goldacre www.badscience.net