Wounds still open

The history of thalidomide and its victims

In the 1950s, thalidomide, manufactured by the German company Chemie Grünenthal, entered the market. Initially marketed for the treatment of respiratory infections, it was then patented as an anti-nausea and sedative drug in combination with other active ingredients. From that moment on, Chemie Grünenthal began an extensive marketing campaign, advertising the drug in authoritative scientific journals and distributing it widely to doctors. Sales skyrocketed, and thalidomide became the top-selling sedative in 46 countries.

Dr. Frances Oldham Kelsey, a pharmacologist and doctor who recently worked at the Food and Drug Administration (the body responsible for authorizing the marketing of drugs in the United States) was among the first to raise a shadow of suspicion about the safety of this drug, denying the authorization of the use of the drug in the USA. The researcher had realized the inconsistency of the experimental data provided for the approval of the clinical use of the drug and she had paid attention to some studies that hypothesized neuropathological effects of the drug.

Since 1960, studies have multiplied that demonstrated the link between the intake of thalidomide in pregnancy (administered to mitigate nausea in pregnancy) and congenital anomalies. The main side effects are in fact phocomelia or amelia (defective development or absence of limbs); to this is added the possibility of heart defects, renal and gastrointestinal malformations, deafness and mental retardation. In addition to these evident effects on surviving children, we must consider the high rate of abortions caused by taking the drug in the first months of pregnancy. At the end of 1961, thalidomide was withdrawn from the German market and - since then - the number of births with congenital anomalies decreased dramatically. Unfortunately, in some countries, due to lack of information and/or fraud, drug stocks were still sold for a few years, despite the announcements and withdrawals by the health authorities.

To make this story even more bitter is the fact that the first studies for the synthesis of this molecule were developed during the Nazism (1933-1945), originally as an antidote to nerve gas. Furthermore, among the ranks of the German company that marketed thalidomide, there were several individuals with backgrounds linked to the Third Reich, including some SS doctors.

In Italy the drug was withdrawn with a certain delay: however it took many years to have the recognition of the "thalidomide syndrome", to have adequate health care and to refine the laws on pharmacovigilance. Precisely to raise awareness on these topics, the V.I.TA. Association was born. (Vittime Italiane Thalidomide), which is monitoring the legislative procedures for the protection of Italian victims.

Science can bring great benefits, but only if accompanied by a vigilant conscience: acting according to personal interests, regardless of possible risks to individual human lives, only generates suffering.

Valentina Turinetto

NP Febbraio 2023