Transparency and trust
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- Compston, J.E. Osteoporos Int (2010) 21: 711. doi:10.1007/s00198-010-1191-8
“Elaborate measures to ensure that people keep agreements and do not betray trust must, in the end, be backed by trust”.
A Question of Trust. Onora O’Neill. Cambridge University Press. The BBC Reith Lectures 2002
The relationship between industry and academia in medicine has come under close scrutiny during the past decade and has been subjected to increasing regulation. Few would argue that these changes were not long overdue; whilst this partnership is highly productive in advancing scientific and medical knowledge it is also open to abuse. The potential rewards of collaboration for both partners are considerable. For industry, the scientific credibility and profile of a product are enhanced by its association with key academic opinion leaders, who can also influence the acceptance and use of drugs in clinical practice. For clinicians and scientists, benefits include authorship on papers, sometimes published in high profile journals, and funding for research. In addition, there are substantial financial rewards to be gained from participation in clinical trials, advisory boards, consultancies and sponsored symposia.
A widely expressed concern is that conflicts of interest arising from industry/academic partnerships may compromise scientific objectivity and integrity. These concerns have been extensively aired by the media and have undermined public trust in clinical research and the medical profession. Although financial conflicts of interest have received the most attention, non-financial conflicts, for example those arising from personal beliefs and prejudices, close relationships and career advancement, are also relevant and are no less damaging.
A number of steps has already been taken by both sides of the partnership to manage conflicts of interest and to safeguard independence [1, 2, 3]. New requirements for manuscripts submitted to biomedical journals have been proposed, including full declaration of potential conflicts of interest (both financial and non-financial), defined criteria for authorship and a description of the contribution made by each author . In addition, editors may request that authors of a study funded by industry confirm full access to all data used in the study and acceptance of responsibility for the accuracy and integrity of those data. The obligation to register all clinical trials and to consider seriously publication of negative studies is stressed. Although these recommendations have not yet been universally adopted they provide an important step towards constructive management of conflicts of interest in medical publishing and protecting the credibility of biomedical research.
Policies to manage conflicts of interest in academic centres, teaching hospitals, research institutions and professional medical or scientific organizations have also been proposed [5, 6, 7]. Some measures have already been widely implemented, for example prohibition of acceptance of gifts from industry, removal of direct industry influence in medical education and in the development of clinical guidelines, and clearly defined institutional policies on conflicts of interest. Company funding for attendance of healthcare professionals at meetings has been substantially reduced and strict rules are in place for the permitted standards of travel and accommodation. Industry sponsored symposia are now almost exclusively conducted through intermediary continuing medical education (CME) organisations that are charged with ensuring high educational standards and avoidance of commercial bias and promotional content. More draconian proposals include a move towards a complete ban on industry funding for professional medical associations and on funding for satellite symposia at regional or national meetings. Stringent controls over research funding from industry have been recommended and include restricting the participation of individuals with conflicts of interest in research involving human subjects .
Managing conflicts of interest in members of committees that develop clinical guidelines and in officers and board members of professional organisations has also received attention [3, 7]. Recent proposals recommend that individuals with any financial tie to industry should be excluded from membership of committees that formulate practice guidelines or outcome measures. The concern that this strategy will limit the expertise available to such groups is acknowledged, with the minor concession that members with conflicts of interest might play a limited role in exceptional circumstances.
There is thus some divergence in the approach adopted by biomedical journals and professional associations, transparency being regarded as sufficient in the former whilst in the latter, the exclusion from some activities of individuals with any potential conflict appears to cast doubt on the value of transparency. The greater controls proposed for publication of papers in biomedical journals, particularly those reporting clinical trials are to be welcomed. Conversely, some of the more stringent policies outlined for professional medical associations are likely to be counterproductive for both education and research. Scientific meetings and CME programmes cost money and, particularly in the current economic climate, non-commercial sources of funding are severely limited. The majority of biomedical research is funded by industry and restriction of this source of income would have significant adverse effects on medical progress. The exclusion of individuals with conflicts of interest from committees and organizations weakens the expertise available and, by deterring some academics from collaborating with industry, might also reduce the expertise available to maintain the widely acknowledged benefits of these collaborations.
There is broad agreement that severance of the links between industry and the academic medical community would be highly damaging to scientific progress and counter-productive to the aim of improving patient care. Transparency identifies conflicts of interest but assessment of their influence requires judgement and trust. Management strategies for conflicts should embrace transparency; denial of any place for trust in the industry/academic partnership threatens the future of biomedical education and research.
The author acknowledges support from the Cambridge Biomedical Research Centre and National Institutes for Health Research (NIHR).
Conflicts of interest
The author has received consultancy, advisory board and/or speaking fees from Amgen, Crescent Diagnostics, Eli Lilly, Gilead, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Nycomed, Ono Pharmaceutical Co, Procter & Gamble, Sanofi Aventis, Servier, Roche and Wyeth. She has received research funding from Amgen, Nycomed, Osteotronix, Procter & Gamble and Servier.