Bioengineered human growth hormone (hGH) was released in the USA as an "orphan drug" intended for use in hypopituitary dwarfism. In fact it has been widely and increasingly used in healthy short-stature children and to improve performance in athletes. The National Institutes of Health also embarked upon controlled clinical trials with hGH in short-stature children and in children with Turner's syndrome, some of the latter received combined treatment with estrogen, others placebo. The situation has been challenged on the basis of the legal provisions applicable to "orphan drugs" but also in the light of the rules governing clinical trials. As a result, the experiments are to be subjected to independent review.