Towards transparency

Tina Kohnstam of Caudex Medical explains the importance of best practise standards.

Ten years ago, major concerns about the quality of clinical trial reporting threatened to damage the reputation of the pharmaceutical industry and industry-sponsored research. Issues included publication bias (the failure to publish negative data), 'ghost writing' and the relationship between the science and the commercial interests of sponsor companies. The publication of guidelines for Good Publication Practice (GPP) was the first attempt to redress this situation and establish best practice for reporting studies by the biopharmaceutical industry.

GPP has now been revised and updated (GPP2) and its provisions will have profound effects on the way that pharmaceutical companies work with external authors and investigators to communicate their data. It now covers all forms of communications - not just peer-reviewed publications - medical device and biotechnology companies as well as the pharmaceutical industry. The guiding principles of integrity, completeness, transparency, accountability and responsibility must be observed and be seen to be observed by the audience.

One outcome of GPP2 will be to finally lay to rest the issue of ghost writing. The role of authors has been clarified by endorsement of the ICMJE (International Committee of Medical Journal Editors) authorship criteria, accompanied by a requirement to acknowledge all other contributors. The acknowledgements will have to state not only who the contributors were, but also what they did. The exact nature of any support, financial or otherwise, will therefore be clear to all. A broad definition of conflict of interest is given and authors are advised to disclose any such conflicts regardless of the requirements of the journal or congress.

What will GPP2 mean in practice? Companies and their communication agencies need to review their current practices to ensure GPP2 compliance. Academic institutions are leading the way but the industry must also play its part. Authors must now assume a more central role than before, acknowledging their responsibility and accountability for communications bearing their name. Good working relationships will be critical to making sure that all parties collaborate in a balanced, transparent and open way.

Beyond publications, wider relationships and interactions with key experts are also changing. While it is necessary, and indeed desirable, that key experts retain their independence and their credibility, tighter regulations have reduced the frequency and level of interactions. Many feel that this is to the detriment of both parties. The pharmaceutical industry is a major source of funds for research and education, both of which are valued by physicians. Industry-sponsored activities provide opportunities for peer-to-peer dialogue between healthcare professionals that would probably not otherwise happen. Just as concerning is the potential negative impact on clinical trials and evidence-based medicine. Reduced interaction between key experts and the industry may lead to poorer study designs with less robust findings and missed opportunities for directing future research.

External advice and validation needs to be broad based. Patients are better informed than ever, but patient advocacy groups have indicated that there is still an overwhelming need for better educational materials, so why not work with them? Further, many patient groups believe that they are best served through the transparent interactions between key experts and the pharmaceutical industry. The overarching theme is that the industry must act and be seen to be acting in the interests of patient care; involving patients not only makes good business sense, it is logical and ethical as well.

Looking into the future, I believe that we will see wider recognition of the benefits of working with the pharmaceutical industry, but on a different footing. The separation of science and marketing will continue, and there will be renewed focus on working towards better patient outcomes. The emphasis on transparency, exemplified by GPP2, provides tangible evidence that the industry has cleaned up its act and left any unethical practice firmly in the past. A new era beckons.

Tina Kohnstam is the Global Medical Director at Caudex Medical, leading a team of specialist medical writers and editors in Caudex offices in Europe and the US. As a former physician, Tina is ideally placed to understand and guide the complex interactions between the industry and the medical profession.