Affiliations: [a] Physician-Epidemiologist, Utrecht, The Netherlands | [b] Professor of Psychiatry, Hergest Unit, Bangor, Wales, UK
Correspondence:
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Address for correspondence: Dick Bijl, Physician-Epidemiologist, Vredenburgplein 40, 3511 WH, Utrecht, The Netherlands. E-mail: [email protected]
Abstract: Recently a drug trial in the Netherlands in which the efficacy of oral sildenafil was compared to placebo in women bearing children with fetal growth restriction was stopped early because of very harmful side effects to the babies. There were quite some unwanted and unscientific aspects related to this study and the manner in which the side effects were communicated to the patients and the community. These have not gained the attention they ought to have. We therefore made an analysis of the basic problems which aims to prevent that the trust in medical research will be weakened.
Keywords: Sildenafil, cardiovascular side effects, Ethical Commissions, fetal growth retardation, STRIDER, inadequate patient information, death of patients
