The history of thalidomide

Abstract

More than thirty years ago, i.e. in November 1961, I have become involved in the history of thalidomide, and up to the present day I have never lost contact with the problem. It is quite impossible to relate in one lecture (to present) the whole complicated story of the initial synthesis of the drug in 1954, of its marketing in 1957, its spread to many countries in Europe, Asia, Australia, America and Africa, and of the following epidemic of malformations of the limbs and of the ears, often accompanied by malformations of the internal organs. So I decided to restrict my account on the most essential aspects and to tell you more about my personal experience than about the extensive literature on the subject. Though the first child afflicted by thalidomide damage to the ears was born on December 25, 1956, it took about four and a half years before an Australian gynaecologist, Dr. McBride of Sydney, suspected that thalidomide was the cause of limb and bowel malformations in three children he had seen at Crown Street Women's Hospital. There are only conflicting reports unsubstantiated by documents on the reaction of his colleagues and the Australian representatives of Distillers Company, producers of the British product Distaval between June and December 16, 1961, when a short letter of McBride was published in the Lancet. Distillers Company in Liverpool had received the news from Australia on November 21, 1961, almost exactly at the same time as similar news from Germany.

Modelling and Clinical Trials in Paediatrics

“…Therapeutic catastrophes that followed the use of sulfanilamide in the 1930s and of thalidomide in the 1960s, [8] as well as numerous other examples of serious adverse effects observed in children and not in adults illustrate the particular susceptibility of children to adverse drug effects. [9] This risk is greater in children because of the lack of specific evaluation, [10] inappropriate use by parents and reconditioning of pharmaceutical forms developed for adults.…”

Modélisation et essais cliniques en pédiatrie

“…Les catastrophes thérapeutiques marquées par l'utilisation de la sulphanilamide dans les années 30 et de la thalidomide dans les années 60, [8] auxquelles s'ajoutent de nombreux autres exemples d'effets délétères observés chez l'enfant sans être prévisibles à partir de l'expérience adulte, illustrent la susceptibilité particulière des enfants aux effets indésirables des médicaments. [9] Ce risque est plus marqué en pédiatrie, en raison de l'absence d'évaluation spécifique, [10] du mésusage parental, et par le reconditionnement inadapté des formes pharmaceutiques adultes.…”

O conhecimento científico e tecnológico como evidência para políticas e atividades regulatórias em saúde

“…Medicamento utilizado no tratamento da hanseníase (Oliveira et al, 1999), foi também usado, há algumas décadas, no tratamento da náusea da gravidez. Foi necessária a ocorrência de milhares de casos graves de teratogenia, em muitos países, antes que os órgãos de saúde responsáveis pelo controle dos medicamentos suspendessem a indicação da sua utili-zação por mulheres grávidas (Botting, 2002). Fatos como estes, pela sua importância em termos da magnitude dos danos causados à saúde da população, ficaram na consciência coletiva e estão na base dos movimentos pelo desenvolvimento de mecanismos mais eficientes e que protejam a sociedade de forma ágil e efetiva, contra esses tipos de eventos indesejáveis.…”