Abstract
Before obtaining a marketing approval, the efficacy and safety profile of drugs is studied in specific populations and under well-controlled circumstances. After marketing approval, the drug is made available and used in ‘real world conditions’, which are known to deviate from the trial setting. During the drug life cycle (DLC),
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many factors influence drug uptake and use in the market place. In some undesirable circumstances, a drug sparks societal debate due to unexpected or unforeseen safety concerns. Without adequate intervention, these debates could always develop into a drug safety controversy.
The occurrence of drug safety controversies may have compromised public trust in the stakeholders of the pharmaceutical sector (i.e. the pharmaceutical industry, regulatory authorities and doctors). However, thorough analyses of controversies, and of the trust undermining process, are lacking. In this thesis, we present a series of empirical studies analyzing trust in the pharmaceutical sector. For this aim, DLCs were used to analyze one controversy: the increased suicidality risk during antidepressant (selective serotonin reuptake inhibitors-SSRI) treatment.
Prior to our analysis of this controversy, we identified two hurdles in relation to trust in the pharmaceutical sector: a definition of trust is lacking, and most arguments about an erosion of trust refer to evidence that has not been evaluated before. Based on an analysis of trust definitions in other disciplines, we provided a definition of trust that is of present value for the stakeholders of the pharmaceutical sector. With regard to the evidence for claims about distrust, a paucity of studies was observed and the methodologies are rather poor; insufficient to justify a claim of lack of trust. Nevertheless, the pharmaceutical industry and regulatory authorities enjoyed lower levels of public trust compared with doctors.
Subsequently, the SSRI and suicidality controversy was analyzed using DLCs. This model used different dimensions, such as publication patterns in scientific journals and newspapers, antidepressant use patterns (sales and prescription data), and event-related data. With the use of these dimensions, we observed that while scientific journals were predominantly positive about the efficacy and safety of SSRIs to treat depression, newspapers were drastically negative about SSRIs. The amount of bad news increased during the periods where regulatory agencies issued warnings banning the use of SSRIs in children (i.e., 2003-2004 and 2007-2008). Did bad news about antidepressants influence their use in the NL and UK? Changes in antidepressant consumption coincided with the periods of regulatory warnings. But, overall SSRI consumption did not decrease in both countries. Instead, SSRI use doubled from 2000 to 2010.
These contradictory trends raised questions about the role of trust during the controversy. After analyzing the role of trust, we observed that doctors played a mediating role between public distrust in the industry and authorities and the uncertain profile of SSRIs, disassociating patients from the controversy and the possible risks of an untreated condition.
In conclusion, multidimensional DLC analyses demonstrate to be useful instruments to study controversies and to clarify the role of stakeholders in these controversies.
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