Research on a hormone pregnancy test that sparked an international debate on drug safety

Description of impact

For decades people affected by Primodos and their families have sought recognition, an apology and compensation because of birth defects linked to this hormone pregnancy test, dispensed from 1959-1978. Research at the University of Aberdeen into the effects of components of Primodos - norethisterone acetate and ethinyl estradiol - on vertebrate embryos, described in several Sky produced documentaries, led to Professor Vargesson providing expert opinion throughout government debate on drug safety. Scientific opinion based on the research was presented to the UK Government’s all-party parliamentary group of MPs, the German Government, the Medicines & Healthcare products Regulatory Agency and the European Medicine Agency. The research was at the centre of government discussions and parliamentary debate in questioning drug safety and helped contribute to an independent public inquiry in 2018 which concluded in July 2020 that systematic failures had let down the victims of Primodos. The inquiry called for survivors to receive a national apology, compensation and support, and advocated that existing regulations of patient and medicine safety should be overhauled.

Project summary and aims

Stakeholders / Beneficiaries

Policy makers, health workers, public

Themes

The underpinning research has given voice to the argument that the contribution of Primodos to deformities in babies born decades ago cannot be ruled out. From 2017 to 2020, evidence provided by Professor Vargesson on the causal effects of Primodos informed parliamentary debate leading to a major UK independent public inquiry into Primodos. Throughout, Vargesson presented scientific expert opinion based on the underpinning research to UK parliament; the UK Commission on Human Medicines (CHM) - Medicines & Healthcare products Regulatory Agency (MHRA); and the European Medicines Agency (EMA). He also advised German Parliament and their MPs on current scientific understanding based on his research.

Impact status	Impact Completed (Open)
Impact date	2013 → 2020
Category of impact	Policy