What do Stakeholders Think about Pharmacovigilance?

Abstract

Sylvie Fainzang, a medical anthropologist, has written on ‘‘Discourse on Safe Drug Use: Symbolic Logics and Ethical Aspects’’ in this edition of Drug Safety. To many, this article will seem very different in structure, method and content compared with usual Drug Safety material. The article is based on a presentationmade at the 2009 International Society of Pharmacovigilance (ISoP) meeting and it caused controversy. In discussions with colleagues following the presentation, some found it interesting and thought provoking, others thought it was ‘unscientific’. Although anthropology has used some of the broadly positivist thinking that we use in medical science, there is in social anthropology much use of ethnography. Ethnography uses techniques such as direct observation, individual and group interviews, and others that resemble focus group analysis conducted by interviewing, directly or by questionnaire, a number of selected people on a particular matter of interest. The result of this is a reasoned analysis of the interviewees’ responses and the investigator’s interpretation of them, and the validity of this approach is argued within Dr Fainzang’s article. The aim is to develop a hypothesis about how humans behave, and how their beliefs shape their behaviour. Understanding the logic of these beliefs within their own social context can illuminate some behaviour that might otherwise be derided as noncompliant or irrational. In this instance, Fainzang looks at patient behaviours around drug use, and some factors that influence them; the interaction between doctors and patients in discussing drug risks; and the pharmaceutical industry’s stance over selfmedication and risks. Fainzang opens by arguing that patients are an active part of the pharmacovigilance team, not only passive recipients, whether or not the professionals on the team accept them as such; theymake choices based on their own perceptions of drug safety, which may result in them refusing to buy or to take drugs they regard as too risky. Fainzang argues that patients’ views about safety are inextricably related to their background knowledge and beliefs. Their perceptions are real to them and influence how they behave andwhat they say, and in turn this influences clinical trials and case reports. The focus of Fainzang’s patient study explores the influence of religious-cultural origins on attitudes to drug therapy and outcomes. Her study group is small and the assessments are qualitative, so this information in pharmacovigilance terms represents a fascinating signal that can open the door to further similar studies or to alternative approaches. To pick one example, she points out the prime importance of memory to Jewish individuals and the fear they expressed that psychotropic drugs might impair memory. This realization might result in comparative studies of drug use and individual case harm reports (ICHRs). Fainzang’s commentary on the discourse between doctors and patients and her reflections on aspects of the discourse between the industry and the public are based on information we may already know. Indeed, her assertion that some doctors adumbrate or prevaricate around adverse reactions to drugs is well recognized. More important are her comments around the effects of such practices. These demonstrate and perpetuate a mutual lack of trust between the two EDITORIAL Drug Saf 2010; 33 (8): 619-621 0114-5916/10/0008-0619/$49.95/0