ISMPP EU 2014: 5 things you need to know
Missed ISMPP Europe this January? See our bitesize summary of the key take home topics discussed during the meeting including the future of the Sunshine Act and digital publications…
Controversy reigned at the recent 2014 European Meeting of ISMPP, as seasoned attendees and growing numbers of newcomers (over one-third) discussed A New Era in Global Publications. Here are the top 5 things you need to know.
1. Transparency: an unstoppable trend
The current hottest topic among the medical publication community is the imminent reporting deadline (31 March 2014) of the Physician Payments Sunshine Act. The key question is, does publications support from pharma constitute a transfer of value to the authors and, if so, how much? Specific guidance from the Centers for Medicare and Medicaid Services (CMS) has been lacking, so companies have been left to determine for themselves what the transfer of value might be. Unsurprisingly, interpretation varies widely.
AstraZeneca and Pfizer presented their cost-reporting models, both broadly based on the ISMPP guidance of assigning fair market value to each publication and dividing by the number of authors, an approach which confuses value to the author with cost to the sponsoring company. Meanwhile Shire simply announced that it did not consider publication support to constitute a transfer of value to the authors (the value being to Shire itself), and as such would not be reporting it. We await with interest the response of the CMS to the reported data.
The AllTrials campaign calls for all studies past and present to be registered, and the full methods and results reported, which has significant practical implications for pharma in terms of patient confidentiality and the risk of misleading analyses. GSK is at the forefront of data transparency, and outlined its approach to ensuring data are available to everyone while maintaining patient anonymity via the use of ‘independent data custodians’.
“GSK is at the forefront of data transparency, and outlined its approach to ensuring data are available to everyone while maintaining patient anonymity via the use of ‘independent data custodians’.”
The excellent keynote presentation entitled The Good, the Bad and the Ugly was from John Clare, of LionsDen Communications, one of the few individuals prepared to face Ben Goldacre in public debate. He challenged the audience to recognise that the poor public perception of pharma is a direct result of inappropriate behaviour in the past. He further highlighted the need for pharma to engage in discussion and boost transparency in order to regain public trust, and to emphasise the positive influence that pharma has in furthering medicine.
2. Asia-Pacific: increasingly important and challenging
Most think only of China when they think of the Asia-Pacific region, which is hardly surprising given the recent healthcare reform policies that have opened up new opportunities for the pharmaceutical industry in that country. However, the culture in the region is very different, and there are several high-profile examples of pharmaceutical companies failing to steer a safe course through local business practice and Western compliance standards. The strict hierarchical structure of organisations is proving a barrier to rapid progress which can be extremely frustrating for those used to Western styles of business.
The Asia-Pacific region includes countries with widely different cultures and evaluating systems, and as the importance of medical publications grows in this region, we must learn to work within each of these cultures and also engaging with the critical need to have an understanding of the local practice. Importantly, processes are adapting, although change is slow and complicated, with increased value being placed on publication and education of doctors.
3. Digital publications are evolving
Discussion at the digital publications panel at ISMPP centred around enhanced content available from online journals. Additional content ranges from slides and podcasts to videos and any combination thereof. Its impact could be tremendous but practical challenges remain. Will all this enhanced content be peer reviewed? Who will retain copyright? Unfortunately there is no consensus as eventually this will come down to individual journals. The demand from healthcare professionals is strong, with an emphasis on portable, simple summaries which do not ‘dumb down’ the publication.
“The demand from healthcare professionals is strong, with an emphasis on portable, simple summaries which do not ‘dumb down’ the publication.”
4. Different products; different approaches
A series of workshops on Devices and Diagnostics, Consumer Health Products and Biosimilars highlighted the unique aspects of these growing areas of healthcare. A clear understanding of the regulations is crucial for each of these areas, particularly as they often vary not only from region to region but also in interpretation across organisations including among publishers and editors.
For devices and diagnostics, the key question is often when to publish considering that the development process is iterative. In consumer health, defining who your audiences are is critical for deciding the content of publications. For biosimilars, knowing what to publish is the issue as the demands for registration are unique. For example, data need not demonstrate efficacy outright but instead only equivalence to the innovative product. This leads to different publication needs which are often poorly understood by healthcare professionals.
5. Ensure relevance for different audiences
The communications needs of payers, nurses and primary care physicians (PCPs) were discussed in a second series of workshops. The theme across all these workshops was to ensure relevance to the local practice. For PCPs and nurses in particular, we heard that decision tools are essential, for example in the form of guides or case studies. For PCPs the information needs to be accessible during a consultation and needs to educate around the disease state as well as the particular treatment options. We heard from physicians that they have increasingly less time to assimilate new information and so an upfront summary is essential. To them, a poorly written publication is a wasted one.
Payers are a heterogenous group, and it is important to identify the specific needs of the type of payer you are addressing, for example whether they are a regional committee or a pharmacist on a hospital formulary. The impact of a therapy on resource use is important for all payer groups, and data must be transparent. These are the core truths that are the foundation of tailored yet consistent communications to diverse payer audiences.
About the authors
Judy Brownsword (PhD, CMPP) is Director of Scientfic Services at Adelphi Communciations. During her 14 years of working for the pharmaceutical industry, she has developed a keen interest in evolving trends in medical communications, with particular focus on the changing regulatory environment and the new opportunities offered by technological advances.
Lotte Rietveld is a Business Development Manager at Adelphi Communications. She is passionate about recognising the value of pharma and working with the industry to develop solutions to these emerging challenges. Paramount is ensuring that healthcare professionals are supported in their abilities to make the best treatment decisions for their patients via effective communications and compelling educational initiatives.
For further information on current issues in publication planning, contact Judy Brownsword (+44  1625 577358 or email@example.com) or Lotte Rietveld (+44  1625 577376 or firstname.lastname@example.org)
Closing thought: What topic did you find to be of most interest at ISMPP 2014?