Medical communications – The new era starts now

By Tina Kohnstam, Global Medical Director, Caudex Medical Ltd

It is a source of great frustration to medical communications agencies that ghost writing is still widely perceived to be a major part of their business practice. In fact, leading agencies have long had policies in place to ensure that ghost writing does not operate in their company. Instead, medical communications agencies offer the knowledge and expertise to help pharmaceutical clients communicate the data on their products in the best way possible - to the right audiences, and in a timely and ethical manner that is fully compliant with all relevant codes of practice. Indeed, recent experience in the USA has shown that it is not enough to comply with current rules and regulations; we must also ensure that we think about how our actions might appear in the context of a later review by outside observers. In the current environment, medical communications must be transparent and should always keep in mind the ultimate objective: improved patient outcomes.

Good Publication Practice

Ghost writing has been defined as 'the failure to designate an individual (as an author) who has made a substantial contribution to the research or writing of a manuscript'¹. Less well known is its counterpart, guest authorship - 'the designation of an individual who does not meet authorship criteria as an author'¹. Both practices have been condemned: the World Association of Medical Editors (WAME) describes ghost writing as 'dishonest and unacceptable'². The main objections focus on the issue of integrity - the author's responsibility for papers published in their name - and the opportunities for the introduction of bias (e.g. suppression of negative data) if authors have allowed others to write papers on their behalf.

Several high profile organisations have introduced recommendations to counter ghost writing and consign it to history. Most notable among these are the stringent recommendations published in the Journal of the American Medical Association in 2008³ and the revised guidelines for Good Publication Practice (GPP2)⁴. The level of interest in GPP2 suggests that most pharmaceutical companies are aware of its development and the need for compliance, but in many cases this will require major revisions to their processes. There may be a difficult period ahead while companies try to comply with guidelines that did not exist at the time they set up contractual arrangements with study investigators.

Working with external experts

GPP2 demands full involvement from authors in publication development from an early stage. This creates enhanced opportunities for pharmaceutical companies to build effective working relationships with Key External Experts (KEEs) who are opinion leaders in their medical field. Such relationships are increasingly recognised as beneficial to both parties. The industry benefits when KEEs play a role in product development, regulation, and education. KEEs also value their interactions with the industry as it enables them to contribute to development of new drugs at an early stage and participate in industry-sponsored meetings that provide opportunities for peer-to-peer dialogue that might otherwise not happen. However, KEEs who are perceived to be too promotional rapidly lose respect and credibility, damaging their own careers and detracting from their support of new agents.

The guiding principle when working with KEEs should be that interactions are ethical and transparent. It is all too easy to forget that KEEs also have extensive clinical and teaching responsibilities and industry contacts must be kept at a manageable level. This can be difficult when an individual KEE is involved in a series of different activities with multiple points of contact. Centralised management can coordinate interactions and avoid exhausting the goodwill of KEEs.

Multi-disciplinary communications

Looking to the future, we expect to see other, more fundamental, shifts in the pharmaceutical industry that will have a profound impact on the way companies communicate with customers. The 'old' model of marketing and promotion will become increasingly irrelevant as we move towards a much greater focus on the science and the needs of customers, both international and local. This means that pharmaceutical companies will have to engage stakeholders in a two-way dialogue, responding to their needs in ways that have not been seen before. In this new environment, broadcasting the product's attributes and benefits to whoever might be listening will no longer suffice. It will be replaced by multi-channel communications, designed to ensure mutually beneficial relationships.

Evidence-based medicine now forms the basis of clinical decision-making and the industry has to support that by highlighting the scientific rationale for treatment. At the same time, the customer base is changing to include patients and payors. They will need communications tailored to their needs every bit as much as the scientific publications for healthcare professionals. The new multi-disciplinary audience will demand much, but working for the benefit of patients - and being seen to do so - will ensure that the pharmaceutical industry leaves behind any questions about dubious ethical practices and enters a new age of corporate responsibility.

The agency's role

Increasing separation of science and marketing and an ever tighter regulatory environment make medical communications a progressively more specialised discipline requiring specialist expertise and skills. Medical communications agencies can play a central role in helping pharmaceutical companies stay abreast of developments and adjust to the changing environment. As well as providing a specialist consultancy, they can offer services and knowledge that pharmaceutical companies would find difficult to supply internally.

Throughout 2009, Caudex Medical has remained close to the development of the GPP2 guidelines and has designed new processes and procedures to ensure compliance in advance of their publication. As well as training our own staff on the guidelines, we have designed a training workshop to help clients align their processes during the critical early phase of implementation. Mindful of the need for transparency in other areas such as relationships with KEEs, we have built a customised management tool, the KorE Exchange™, which will provide a full record of interactions for auditing purposes as well as helping companies to manage their interactions more effectively and efficiently.

Medical communications is still a young industry but it has developed rapidly into a highly specialised area that can counsel and advise pharmaceutical companies on comprehensive, ethical, and effective communication, ensuring that the needs of all relevant stakeholders are met and that the right vehicles are used for each audience sector.

References:

1. Rennie D, Flanagin A. JAMA, 1994;271:469-71.
2. WAME Policy Statement, 2005. Available at http://www.wame.org/resources/policies#ghost
3. DeAngelis CD, Fontanarosa PB. JAMA, 2008;299:1833-5.
4. Graf C, Battisti WP, Bridges D, et al. BMJ, 2009;339:b4330.