SGLT2 Inhibitors are Blockbusters in Adults - But Not Studied in Children with Kidney Disease due to Industry Conflicts of Commercial Interest: A Call for Help To Regulators

Abstract

This article reviews the circumstances why and how the pharmaceutical industry is avoiding the pediatric investigation plans for their block-buster drugs in chronic kidney diseases. The "why" is easy to answer because it is just about economic reasons. This is much to the disadvantage of sick children, who are thus deprived of the opportunity for evidence-based therapy. Just as in the time prior to the pediatric trial regulation, pediatricians remain in a legal gray zone of off-label use and expose themselves to the risk of lawsuits. The article is intended to start a discussion on how regulatory authorities could support the development of better treatment recommendations for children with kidney disease for drugs that are not promoted by the industry. This could be by working more closely with patient representatives and academia, by supporting the planning phase of investigator-initiated trials, or by scientific advice on cumulative real world and randomized controlled trial data on specific medications or substance groups.