Conflicts of Interest in Medicines Safety and Regulation

Abstract

Conflict of interest is a well known and growing controversy in many areas of healthcare, not least in medicines safety and regulation. The direction of these concerns seems to be both narrow and conservative: narrow in the sense of being dominated by financial interests, and conservative in excluding many experts from contribution to debate and decisions. A recent publication provoked my interest. It concerned the global donor agencies and, after the authors had delved into donors’ background dealings and their decision making, they came to the conclusion that sometimes donor investments, board member interests and lack of alignment with real public health needs represented conflicts that should be addressed. They also quoted some conflict of interest definitions. In US law, a conflict exists when there is ‘‘a real or seeming incompatibility between one’s private interests and one’s public or fiduciary duties’’. Wikipedia’s definition is also quoted as when ‘‘an individual or organisation is involved in multiple interests, one of which could possibly corrupt the motivation for an act in another’’. Furthermore, a WHO definition includes ‘‘y when a partner’s ability in one role is impaired by his or her obligations in another role or by the existence of competing interests. Such situations create a risk of a tendency (sic) towards bias in favour of one interest over another or that the individual would not fulfil his or her duties impartiallyy A conflict of interest may exist even if no unethical or improper act results from it. It can create an appearance of impropriety that can undermine confidence y’’ None of these definitions is confined to financial interest but the article by Stuckler et al. largely is! Money is perhaps the most tangible cause for biases, and the WHO definition captures a second – the organization that one represents. Certainly they are identifiable but I argue that they may not be the most important and will use pharmacovigilance as an example discipline. The late Professor Sir William Trethowan, a wise psychiatrist, taught us students that when first meeting any patient we should ask ourselves ‘do I like this person or not?’ He explained that our treatment of the patient may well be different depending on that insight. For those who may think this is trivial, I have seen many situations where doctors treating colleagues omit routines that are unpleasant to spare their friend discomfort, but to the ultimate detriment of that patient’s care. The opposite may also occur with patients one dislikes being treated perfunctorily. Such preconceptions and prejudices cannot always be discerned, but they are very powerful. They may cause us to leave out important references that oppose our work when writing a paper, or they may lead us to write a more negative review on a paper involving abortion, for example, if we are very much opposed to it. More in keeping with my introductory example, if we generally do not like an author, might not we, as reviewers or readers, be more negative to his/her work. The prejudice may only be amore general one, such as ‘nothing good was ever written in that university’, or indeed that ‘if it is from Yale or Oxford it must be good’ (that has certainly been the reasoning EDITORIAL Drug Saf 2011; 34 (8): 617-621 0114-5916/11/0008-0617/$49.95/0