Thalidomide Scandal 1 WHAT IS THALIDOMIDE? In the late 1950s and early 1960s, thalidomide was created and marketed as a sedative, sleep aid, and treatment for morning sickness in pregnant women. It was widely prescribed and marketed in multiple nations, including the United Kingdom, under different brand names. Thalidomide use during pregnancy, however, was later linked to serious birth defects and developmental abnormalities in foetuses. The most common and tragic thalidomide side effect was limb deformity, where newborns were born without or with shortened limbs. Thalidomide has come to be known as one of the most well-known cases of drug-induced harm as a result of this unfortunate outcome. 1.1 WHAT WERE THE REASONS BEHIND THE WIDESPREAD PRESCRIPTION OF THALIDOMIDE TO PREGNANT WOMEN? Pharmaceutical firms at the time actively promoted thalidomide as a beneficial and safe treatment for pregnant women. While its use for morning sickness proved to provide comfort for pregnant women experiencing nausea and vomiting, its sedative characteristics were seen as a solution for expectant mothers facing sleep difficulties or anxiety. Thalidomide was prescribed to women who were pregnant as a result of the marketing campaigns and the general belief that it was risk-free and had no negative effects. Unfortunately, when many infants were born with serious birth abnormalities, the deadly effects of thalidomide on foetuses in development became clear. 2 WHAT WERE THE BIRTH DEFECTS? Thalidomide mostly caused limb abnormalities known as phocomelia in infants born to women who used the medication while pregnant. Phocomelia describes missing or undeveloped limbs, frequently affecting the arms and legs. The malformation's severity ranged from partial limb reduction to total limb absence. Babies with severe phocomelia were born with very short or flipper-like limbs and legs that were joined to the trunk directly, resembling a seal's flippers. The limbs could be shorter or exhibit varying degrees of malformation, such as missing bones, fused joints, or deformed digits, in milder cases. Thalidomide was linked to additional developmental problems in addition to limb deformities. These included defects in the heart, gastrointestinal tract, eyes, hearing, and internal organs. Some newborns were born with facial abnormalities like cleft lip and palate. Because they happened during a crucial stage of foetal development when limbs and major organ systems were developing, the effects of thalidomide were more severe. At the time, it was uncertain how the drug particularly caused these irregularities and what its mechanism was. 3 POST-BIRTH THALIDOMIDE BABIES The Thalidomide catastrophe claimed many lives and left the affected children and family members in severe pain. The level of mercy kills, or euthanasia related to Thalidomide is unfortunately difficult to quantify, as is the number of children who died in hospitals at the period. There is a dearth of official statistics on these particular topics, and the precise numbers may change as a result of underreporting, different documentation standards, and time. Medical practises and ethical standards for the care of newborns with severe conditions differed over that time. Infants with severe deformities and life-threatening conditions may have occasionally been subjected to what were seen to be merciful actions, such as the discontinuation of life-supporting treatment or, in rare cases, euthanasia. 4 THALIDOMIDE INTRODUCED – 1950S. Thalidomide was first made available as a medicine in the late 1950s that had a sedative and antinausea effects. It was created in Stolberg, close to Aachen, at German pharmaceutical company Chemie Grünenthal GmbH. In Germany, the medication was first sold under the brand name "Contergan" with the intention of treating morning sickness, anxiety, and insomnia in pregnant women. Its sedative qualities made it appealing as a sleep aid, and its extensive use among pregnant mothers was a result of its alleged ability to reduce morning sickness. Due to rich marketing operations that presented thalidomide as a reliable drug, it swiftly became wellknown. Following that, it was released in a number of nations, including the UK, where it was promoted as "Distaval." But in the early 1960s, information started to circulate connecting Thalidomide to serious birth abnormalities. Serious questions about the drug's safety were raised by instances of infants being born with phocomelia and other limb anomalies, as well as internal organ defects. Thalidomide was taken off the market in numerous nations once its teratogenic (producing birth abnormalities) effects were discovered. The incident highlighted the requirement for more stringent testing methods and tougher drug laws to guarantee the safety of drugs, especially those intended for use during pregnancy. Investigations and lawsuits followed the Thalidomide catastrophe. Affected people and their families’ filed lawsuits against Chemie Grünenthal and requested compensation. As a result of the disaster, regulatory organisations were created, and testing requirements were tightened in order to stop similar tragedies from happening in the future.