Author:Jasmin Engelhart (University of Vienna)
Paper short abstract:
Knowledge production about drug safety increasingly takes place outside of clinics and labs. I examine how the role of patients as formal reporters of adverse drug reactions is enacted in parliamentary discussion, data processing at a drug regulation authority and in newspaper coverage.
Paper long abstract:
Drug regulation faces an increasing dilemma between the need for quick access to potentially life-saving medicines and the need for data on the efficacy and safety of new drugs. As a response to these challenges, the focus in drug testing is currently shifting from pre-marketing clinical trials to post-marketing pharmacovigilance measures.
In 2010, the EU passed a pharmacovigilance directive which ordered member states to create opportunities for patients to report experiences of adverse drug reactions directly to drug regulation authorities. Apart from concerns about expertise that have been voiced about this amendment, questions arise how this changes the meaning of drug safety and what implications it might have for public health.
As drug safety is increasingly produced in various public and political arenas, I will present findings from empirical research that focusses on three moments at which drug safety is 'made' in the Austrian context: in processing of adverse drug reaction reports at the national drug regulation authority, during parliamentary debate about new pharmacovigilance legislation and in newspaper coverage about this change of law.
I examine roles which are ascribed to patients in the production of knowledge about drug safety in these contexts: are they providers of vital information, sand in the drug regulation process, lay experts (Epstein, 1996)? I will show how drug safety and patient knowledge are enacted in multiple ways in different practices and deepen our understanding of how values are ascribed to patients' contributions to medical and regulatory science.
STS for pharmaceuticals and public health policy