Blind Trust

Many parents of children with serious health problems may wonder why new medicines are initially not approved for minors and, if their condition is rare, why at the same time there is such pressure to enter any young person under 18 into drug trials. So-called 'paediatric' pharmaceutical studies have become an international multi-billion business with many careers in academia, regulatory authorities and the pharmaceutical industry based on this work, yet much of this activity is founded on a series of flawed concepts that have led to immeasurable wastage of resources and serious, ongoing medical abuse. In this revelatory book, the former head of paediatric drug research at two major pharmaceutical companies provides a guide for parents and non-specialists interested in advancing the health of individual children and groups of children showing the key differences between clinically-directed and administratively-directed research, what will potentially benefit or harm children and how the law needs to change around the world so that true advances can be made.

Klaus Rose MD MS is a medical doctor who worked in the pharmaceutical industry for 20 years. He was an enthusiast for pharmaceutical studies in children and became global head of paediatric research first at Novartis and then Genentech/Roche before becoming an independent advisor on paediatric studies for drug approval in 2011. Through this work he came to understand a large proportion of 'investigations' in children were not only unnecessary and ethically questionable yet these problems are hidden behind the message of 'helping children' that is hard to challenge. His book for scientists and health professionals involved in drug trials - Considering the Patient in Pediatric Drug Development: How good intentions turned to harm - was published by Elsevier in 2020.