HUMAN GROWTH HORMONE AND THE FDA BAN: PSYCHOLOGICAL IMPACT

Abstract

In April, 1985, the FDA banned the distribution of pituitary growth hormone (hGH) because of the possibility that it was contaminated by a “slow virus”. All parents of children receiving hGH were notified by mail of the ban and subsequently invited to attend 3 meetings during vhich the ban, hGH, bio-engineered growth hormone (hGH) and the risks were discussed by physicians and psychologists, Approximately 10 months after the ban, we interviewed 32 children (30 males, 2 females, mean age 13.8 ± 2.5 years) and at least one parent about tie psychological impact of it. The mean treatement with hGH for these children was 3.0 ± 2.5 years. All had started on hGH.Results: (1) Parents reported a shift from positive to negative feelings about their children's GH treatment. Children reported a similar but less pronounced shift. (2) All parents reported being well informed about the reason for the tea, but 19% of the children were uninformed by parental choice. (3) Parents and children frequently voiced concern about the possible risk of neurological disease from GH given prior to the ban. Parents also voiced concern about their children not being able to grow tall because GH was banned. Children, too voiced this concern, (4) Most parents stated a concern about the safety of hGH. (5) Despite fears about prior GH treatment and present bGH treatment, all chose bGH therapy.Conclusion: Statural growth is seen as more important than possible risk of therapy. Our policy of immediate, full disclosure with opportunity for interactive discussion was considered beneficial by the parents.