Making Research Data Available: An Ethical Imperative Demonstrated by the SSRI Debacle

The last decade has seen enormous expansion in the use of psychotropic medications to treat behavioral and emotional disorders in children and adolescents. Because much prescription of these agents is off-label, serious attempts are being made to encourage pharmacological research in children. Without examining the data upon which government recommendations are based, what are physicians and their patients expected to do? Many individuals appear to respond favorably to these drugs and most youths taking them do not develop suicidal thoughts. Is the FDA qualified to make such treatment decisions? How valuable is a warning without the data upon which it is based? This article concludes no clinical trial is finished until the data are made available. Just as there is an ethical mandate to study drugs in children, there is an equal mandate to make the data from those trials available and to do so expeditiously. Nothing less should be tolerated.