The so-called ‘Thalidomide Tragedy” represented the start of strict drug controls through rigorous clinical studies, prior to its commercialization.
From 1957 until its withdrawal in 1963, Thalidomide, which had hardly shown any side effects, was prescribed to women pregnant women to calm the nausea that usually occurs during the first months of pregnancy. The medicine, marketed by the German pharmaceutical Grünenthal GmbH, turned out to be the cause of thousands of babies being born affected by phocomelia (malformations and absence of limbs or very short limbs).
The connection between Thalidomide and these deformities was not immediately established and as a consequence, in the late 1950s and early 1960s, more than 10.000 children in 46 countries were born with deformities.
The Thalidomide Tragedy highlighted the importance of establishing rigorous protocols for the control of drugs before being marketed. With this objective, regulatory agencies and bodies were created throughout the world and strict rules were introduced in the conduct of clinical trials as the best way to avoid these types of consequences.
Although the history of humanity has always been based on experimentation and ‘trial/error’, we can locate the first clinical trial conducted by a doctor in the s. XVIII, against scurvy, one of the serious problems suffered by the Royal Navy, against which surgeon James Lind decided to experiment by treating a group of affected sailors.
Since then, innumerable tests, experiments, and even tragic events such as the Thalidomide case, which have contributed to the establishment of robust clinical trials, currently considered the best way to assess the safety and efficacy of a drug or a medical device.