Summary of day one of the European Meeting of ISMPP: “Doing the right thing and doing things right” (Part 1)

Ryan Woodrow

Aspire Scientific

In our medical communications themed month we hear from Ryan Woodrow of Aspire Scientific, who provides an overview of day one of the European Meeting of ISMPP.

It is essential that medical publication professionals follow guidelines and best practice to ensure that the industry’s reputation for ‘doing the right thing’ continues to improve. As well as reminding participants of best practices, the 2013 European Meeting of the International Society for Medical Publication Professionals (ISMPP) was focused on providing attendees with practical solutions to help ensure that we are ‘doing things right’.

This report focuses on the first day of the meeting. A summary of the second day will be provided next week.

2012 global insights and trends

The initial session of the meeting reviewed major issues from 2012, and summarised how these will impact on medical publication professionals in 2013.

Increased drive for clinical trial transparency

In 2012, the call for increased clinical trial transparency was driven forward to a great extent by the publication of Dr Ben Goldacre’s book, Bad Pharma, which generated a sizable amount of press on this important topic. The media surrounding the book, as well as press surrounding the non-disclosure of Tamiflu data, may have contributed to a pivotal workshop being held on this topic by the European Medicines Agency (EMA) on November 22. At this meeting, the EMA voiced their commitment to make all clinical trial data accessible. However, there is still debate about how full data transparency will be achieved, being mindful of the need to protect patient confidentiality and industry’s intellectual property rightst. To move this issue forward, smaller advisory groups have been drawn up by the EMA. The Agency plans to take final advice from each advisory group by 30 April 2013, with a view to publishing a final policy on 30 November 2013, which would come into effect on 1 January 2014.

The seemingly irreversible path to increased transparency of clinical trial data was also echoed in 2012 by a number of other important parties:

• The BMJ announced that, from January 2013, publications based on clinical trial data would only be published in the journal if the authors are committed to full transparency.

• GlaxoSmithKline stated that it will make detailed anonymised patient-level data from their clinical trials available to qualified researchers.

• United Kingdom (UK) members of parliament, and the UK prime minister also backed more complete transparency of clinical trial data.

Uncertainty surrounding the Sunshine Act

Much discussion took place in 2012 regarding the United States (US) Physician Payment Sunshine Act, which will require manufacturers to track and publicly report payments or other transfers of value to physicians and teaching hospitals. This act reflects the ever-increasing trend toward requirements of greater transparency in industry-physician interactions.

The question for publication professionals is whether medical writing support for publications will be seen as a transfer of value, and if so, how do we determine the financial worth of that transfer of value to authors? It was stated at the ISMPP meeting that there are still many unknowns regarding the impact of the Sunshine Act. Reassuringly, ISMPP have established the Sunshine Act Task Force to follow the issues.

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“In 2012, the call for increased clinical trial transparency was driven forward to a great extent by the publication of Dr Ben Goldacre’s book, Bad Pharma…”

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Legal remedies for “ghostwriting”

During the course of 2012, two articles were published in PLOS Medicine relating to the potential legal implications of “ghostwriting”, whereby a medical writer provides assistance in the development of a publication, but is not appropriately acknowledged.

The first article argued that a guest author’s claim for credit of an article written by someone else constitutes legal fraud. The argumentation is that journal subscribers read articles in good faith, believing that they are independently written by the authors stated. However, when an article is ghost written, the readers are misled. Consequently, the parties involved could be legally pursued.

The second article went on to state that when an injured patient’s physician directly or indirectly relies upon a journal article containing false or manipulated safety and efficacy data, the contributors to the article could potentially be held legally liable for patient injuries.

Despite these articles, it not yet clear if legal action has been taken against any company or individual.

Open access: the “academic spring”

There has been a dramatic increase in open access since 2005, particularly in biomedicine (Figure 1).

Open-access-across-major-scientific-disciplines

Figure 1: Open access across major scientific disciplines (Laakso and Björk 2012).

However, despite this increase in open access articles, 2012 saw a considerable mood change amongst academics and politicians against publishers. The movement against publishers began with an article in The Guardian, called “Academic publishers make Murdoch look like a socialist”. This article led to a petition, with over 10,000 signatories stating that they would boycott publishing in Elsevier journals, and from peer reviewing for the publisher.

Other significant parties also got involved with the movement for increased open access in 2012, including Harvard University, the Wellcome Trust and the UK government. Perhaps most significantly, pressure led a petition demanding that all US government-sponsored research should be published only in open access articles. The petition gained over 60,000 signatories, and will be looked at by the US government in the future.

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“The seemingly irreversible path to increased transparency of clinical trial data was also echoed in 2012 by a number of other important parties…”

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As a likely consequence of the bad press surrounding traditional publishers, two novel journals were launched in 2012: Peer J and eLIFE. PeerJ provides a different open access model, called “The lifetime model”, in which publication fees are not levied at the article level, but instead at the author level. eLIFE is an independent collaboration between the Howard Hughes Medical Institute, the Max Planck Society, and the Wellcome Trust that is driven by researchers, not publishers.

Overall, it is clear that the open access movement is not going to go away and that further impact is likely to be seen in 2013.

Compliance in practice: publication planning and execution

The second session of the 2013 European ISMPP meeting was focused on exploring what controls are in place to support best practice in publication practice in the absence of mandatory regulation.

Full and transparent publishing of clinical data

A publication is a permanent, and sometimes the only permanent, record of scientific research. It can be used by systematic reviews, can lead to further research, can inform health practice and clinical practice, and also has multiple other purposes. Therefore, publications need to be fit for purpose, and provide sufficient information so that the research is replicable and so that the reader has a clear understanding of what was done. The goal should be transparency and to ensure that readers are not misled.

Unfortunately, however, poor reporting commonly occurs (Figure 2).

Examples-poor-reporting

Figure 2: Examples of poor reporting.

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“…there are still many unknowns regarding the impact of the Sunshine Act.”

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As a consequence of this poor reporting, the evidence base is reduced and distorted. Medical publication professionals can play a key role in helping to improve reporting of data by:

• Ensuring that reporting guidelines, such as CONSORT and others are followed. Current evidence suggests that adherence with these guidelines is low.

• Being aware of ethical / moral responsibility of publishing results honestly and transparently.

• Being aware of how articles will be used, and considering the needs of the reader.

• Using the author toolkit provided by the Medical Publishing Insights and Practices Initiative (MPIP), as well as reading the 2012 recommendations from MPIP about how to close the credibility gap in the reporting of industry-sponsored research.

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“As a likely consequence of the bad press surrounding traditional publishers, two novel journals were launched in 2012…”

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Working with editors: consideration for medical publication professionals

When submitting to journals, authors and publication professionals should be mindful of the following issues that can cause annoyance to editors:

1. Over word-smithing. Particularly in top-tier journals, papers will be edited. Therefore authors need not argue around the placement of every comma.

2. Spin. Journals are the guardians of the scientific literature whose duty it is to ensure that data are reported in a non-biased way. Consequently any spin in a paper is an annoyance that can lead to rejection.

3. Manipulation of data. Papers should report data in line with the protocol and statistical analysis plan.

4. Informed corresponding authors. Lead authors should know the full picture about the study they are involved in. They should have complete access to the full data set and understand the paper and study sufficiently.

5. Acknowledging data safety monitoring boards (DSMBs). DSMB members should be listed in the acknowledgements of publications. They are an important group who take responsibility for trials, particularly in terms of stopping them (or not stopping them) for safety events. Therefore they should be publicly accountable.

6. Publication vetos and timelines. If authors wish the publication of their article to coincide with a congress presentation or press release, then they should give the journal as much notice as possible.

Consideration of these issues may help to ensure that papers are considered more favourably and expeditiously.

Read more in Ryan’s article about Day 2 of the 2013 European Meeting of ISMPP here

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About the author:

Ryan Woodrow is a medical writer with 15 years of experience in developing and implementing medical communication plans for the pharma industry. Ryan started his professional career within the medical information departments at Zeneca (now AstraZeneca) and Roche, where he was required to provide information to internal teams or to healthcare professionals on a number of drugs in written and oral format. Ten years ago, Ryan felt it was time for a new adventure and began looking for a career offering plenty of variety, but which gave him the opportunity to do more of the thing that he enjoyed doing most: medical writing, and he has not looked back. Ryan now co-runs Aspire Scientific, a medical writing agency that serves medical communications companies, and he is a Certified Medical Publication Professional (CMPP). As well as writing and consulting, Ryan is actively engaged with assisting in the organisation of educational and networking events, and he is also a member of the organisation committee for the ISMPP European meetings. Ryan can be contacted by email (ryan.woodrow@aspire-scientific.com) or on Twitter (@aspiresci).

What did you take away from the European Meeting of ISMPP?