Summary of day two of the European Meeting of ISMPP: “Doing the right thing and doing things right” (Part 2)

Ryan Woodrow

Aspire Scientific

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

Ryan Woodrow concludes his summary of the 2013 European Meeting of the International Society for Medical Publication Professionals (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 second day of the meeting. A summary of the first day can be found here.

Publications for payors: what evidence do they really need?

The last decade has seen increased financial pressures on the healthcare environment. New technologies have become available that are associated with higher costs. However, the worldwide economic recession has left relatively less money to pay for it all. These budgetary challenges have resulted in Payors becoming ever more important. In this respect, the initial session of day two of the ISMPP European meeting provided an overview of the decision-making process for funding of medicines, and also discussed how to integrate payor evidence requirements into publication planning.

Who are payors and what information do they need?

Any stakeholder who makes decisions on the funding of a patient’s treatment, or who can stop a prescribing decision, is a payor (Figure 1).

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Figure 1: Who are payors?

“…pharmaceutical companies need to demonstrate value over and above just the efficacy and safety of a new technology in order for it to be prescribed.”

In today’s healthcare environment, pharmaceutical companies need to demonstrate value over and above just the efficacy and safety of a new technology in order for it to be prescribed. Consequently, reimbursement and market access are now considered by many to be as important as the licensing for a new product. However, the requirements of payors are critically different versus regulators. In this regard, Figure 2 shows the type of information that needs to be communicated to payors about a new technology.

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Figure 2. Information that needs to be communicated to payors about a new technology

 Payors and publications

Publications have an essential role in communicating information to payors. To help ensure that publications contain relevant information for payors, it is important that the right people are present in an industry publication team. Publication plans are optimised when they are integrated to include market access components.

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“To help ensure that publications contain relevant information for payors, it is important that the right people are present in an industry publication team.”

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Market access is based on a bed rock of good clinical data. Therefore, it is fundamentally critical that the underlying clinical data are good for a product, and well communicated, in order to gain reimbursement. Primary papers reporting data from pivotal trials are crucial to gain market access approval. However, there are also other publications that are important for payors:

• Treatment patterns, burden of disease, epidemiology and unmet needs.

• Pharmacoeconomics (utilities, mapping, cost of illness, and cost-effectiveness).

• QoL instrument validation.

• Summary of existing treatment practices.

• Studies showing use and performance of new drug in real life (e.g. dosing, adherence).

• Appropriateness and / or validity of endpoints / surrogate markers.

• Studies exploring the suitability or superiority of the new drug in additional subgroups of the patient population (subgroup and post-hoc analyses).

• Pharmacovigilance / safety surveillance.

• Treatment guidelines.

• Systematic reviews and meta-analyses.

In order to help authors write robust health economics papers, guidelines – called CHEERS – will be going live in March 2013. These guidelines will be simultaneously published across a number of health economic journals, including Pharmacoeconomics and Value in Health.

When choosing a journal with payors in mind, it is worth noting that impact factors are less important than timing (lead times) and appropriate audience. Clinical data can only make it into a systematic reviews and meta-analyses if they are published. Therefore, timely publication is key for payors.

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“…the findings and conclusions of medical research are frequently questioned by clinicians and other stakeholders…”

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Great expectations: extending the scope of publications

The keynote presenter at the European ISMPP meeting was Jonathan Montgomery, who is Professor of Health Care Law at the University of Southampton, Chair of the UK Health Research Authority and Chair of The Nuffield Council of Bioethics. Pr0fessor Montgomery summarised that the current major themes / issues relating to medical publications and research are as follows:

1. Trust

2. Integrity and openness

3. Value

Firstly, regarding trust, there remains a deep embedded mistrust of research, which is partly a legacy of the Tuskagee syphilis experiment –arguably “the most infamous biomedical research study in U.S. history”. This mistrust has been perpetuated over the past few decades by poor research, defamation litigation, “gagging clauses”, as well as by the media and influential parties such as Ben Goldacre.

Secondly, with respect to integrity and openness, there continues to be a culture of over-claiming findings from clinical research, problems regarding clinical trial registration and issues relating to the openness of results. In addition, reports of research misconduct remain. As a consequence, the findings and conclusions of medical research are frequently questioned by clinicians and other stakeholders. This problem is not helped by the currently limited opportunities for re-analysis of data by independent parties.

Thirdly, it was highlighted that authors and researchers are increasingly looking to add value to their results. There are a number of ways to do this:

• Making the publication results interactive, and incorporating a multichannel approach (video, podcasts etc).

• Extending the audiences, so that the research data is communicated appropriately to policy makers, and lay audiences – as well as clinicians.

• Making sure that these results are readily available to Cochrane and other groups for incorporation into meta-analyses to aid our accumulation of knowledge.

• Publishing negative results, as well as positive findings – thereby helping to ensure that others can learn from the reasons why.

Ultimately, to enhance how our industry is perceived, professionals involved in developing medical publications should consider how we can promote trust, enhance integrity, increase openness and add value.

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“…professionals involved in developing medical publications should consider how we can promote trust, enhance integrity, increase openness and add value.”

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Medical Writing support of industry-sponsored research: how bright (or not) is the future?

The final session at the ISMPP European meeting was focused on understanding the likely pressures that will be facing publication planners and medical writers over the next 5 years. The session was centred on three major issues:

• The terminology surrounding professional medical writers

• The declaration of physician payments, which was also discussed on the first day of the ISMPP European meeting

• Raising ethical benchmarks in publication planning.

Professional writers are NOT ghostwriters

Acknowledged professional writers are still often incorrectly referred to as “ghostwriters”. This confusion is in part driven by some journals and medical institutions, as well as the media. There is also a misunderstanding of what professional medical writers contribute. If these misunderstandings worsen, then there is the potential for increasing numbers of academics / investigators to refuse to work with medical writers.

To ensure that the situation improves, medical writers (e.g. through ISMPP and other bodies), journal editors (not just ICMJE) and / or institutions need to work together to:

• Develop clear authorship guidelines acceptable to all types of publications.

• Communicate the benefits that professional writers can bring (knowledge of guidelines, preventing non-publication due to lack of investigator interest, communication skills, etc.).

• Establish guidelines for the roles and involvement of other authors (preventing guest authorship).

In part, this topic will hopefully be examined in more detail in GPP-3 . It was mentioned that development of the GPP-3 guidelines would begin in the near future.

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“…too many people do not understand the positive contribution that publication professionals can make to quality and transparency.”

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Declaring physician payments

The US Physician Payment Sunshine Act and other global legislation will require reporting of payments, or transfers of value to healthcare professional / physicians. The major concerns about this issue are:

• If medical writing support is reportable, how we can work out the transfer of value in a fair and meaningful way?

• Will authors turn down medical writing help if reportable. If so, this could lead to publication delay, thereby resulting in the hold-up of important clinical information reaching practising healthcare professionals?

Since the ISMPP meeting occurred, the final rules surrounding the Sunshine Act have been announced by the Centers for Medicare &amp, Medicaid Services (CMS). Publication professionals will quickly need to understand how these rules impact on them.

Publication planning – advocacy and raising ethical benchmarks in 2013 and beyond

The future of the medical publication profession is at stake if we do not continue to raise ethical benchmarks and advocate the positives of what we do. At the current time, too many people do not understand the positive contribution that publication professionals can make to quality and transparency. This is largely the legacy of poor past publication practices, including the involvement of marketing teams and the lack of full involvement of authors.

Without advocacy, and if all parties do not raise ethical benchmarks, then additional onerous process requirements will most likely be enforced upon us that distract from our important task of communicating research. More importantly, there could be a failure of society to trust our science and how we communicate it

The European ISMPP meeting ended by discussing solutions to the issues we are facing in relation to advocacy and ethics:

• Publication professionals need to communicate about, and advocate for the positives of their role.

• Journal editors need to cooperate more and compete less, especially in providing clear guidance regarding authorship.

• Authors need to act responsibly and credibly.

• All sponsors (not just industry) need to report all their study findings promptly, completely and transparently.

• Stakeholders need to get the terminology right about authors and medical writers.

• Further evidence needs to be gained to support the benefits of medical writers.

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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?