Deception and Fraud in the Justification of "Pediatric Drug Development": A Challenge at the Interface of Medicine and Law.

Abstract

United States and European Union laws demand separate clinical studies in children as a condition for drugs' marketing approval. Justified by carefully framed pseudo-scientific wordings, more so the European Medicines Agency than the United States Food and Drug Administration, "Pediatric Drug Development" is probably the largest abuse in medical research in history. Preterm newborns are immature and vulnerable, but they grow. Adolescents are bodily no longer children. Younger children are not another species. Instead of reasonable dose-finding, most "pediatric" studies replicate at best what is known already; others withhold effective treatment and/or harm by substandard comparison, triggering "pediatric" drug labels and "pediatric" careers. Researching deception and fraud focuses currently on individuals. The mechanisms by which lawmakers and the public were and are deceived need elucidation in our increasingly complex society, including new types of conflicts of interest. Candidly addressing deception and fraud at the interface of medicine and law will help to unmask pseudoscience.