The drug known as thalidomide was developed and manufactured by the German pharmaceutical company Chemie Grünenthal (now Grünenthal GmbH). The drug was initially marketed as a sleep-inducing agent, sedative and anti-nausea medicine for pregnant women, and was first marketed under the brand name Contergan in West Germany on 1 October 1957. Grünenthal immediately licensed thalidomide for sale worldwide. The first serious event associated with thalidomide use even preceded marketing, with the birth in West Germany of the first affected baby, the son of a Grünenthal employee, on 25 December 1956.

In April 1958, a licence was approved for the distribution of thalidomide throughout the United Kingdom and the Commonwealth of Nations, including Australia, by Distillers Company Biochemicals Limited (now Diageo) under the brand name Distaval. The sedative was promoted as a ‘miracle drug’ to treat a range of conditions, including headaches, insomnia and morning sickness in pregnant women. The advertisements highlighted the safety of the drug with phrases such as ‘non-toxic’ and ‘no known toxicity’. According to research by legal advocates for Australian thalidomide survivors, during 1958 alone, Grünenthal placed fifty advertisements for thalidomide in medical journals and sent more than 200,000 letters to doctors, as well as mailings to 50,000 doctors and pharmacists, making it the best-selling sleeping pill in its home country by the early 1960s. In 1959, Chemie Grünenthal dismissed a warning by Dr. Ralf Voss, a German neurologist from Düsseldorf, that ‘thalidomide damages the central nervous system’. During 1960, the company also received numerous reports about the toxic effect of thalidomide on the nervous system. However, company officials stepped up their campaign to maintain revenues: their brochures extolled the virtues of thalidomide and promoted its use among pregnant women: these promotional materials stated that it could be ‘safely administered to pregnant women and nursing mothers without any adverse effects to mother and child’ and that it was ‘extraordinarily safe’, ‘completely harmless to infants’ and ‘safe even during a long period of use’.

In June 1960, the sale of thalidomide began in Australia, although in the same year Dr Francis Kelsey, a reviewer for the US Food and Drug Administration, initiated an investigation into the paucity of supporting clinical evidence that ultimately blocked the distribution of thalidomide in that country (for her efforts to prevent the marketing of thalidomide and thus avert a major tragedy in the United States, Dr Kelsey received the 1962 President John F. Kennedy Distinguished Federal Civilian Service Award). In 1961, the German paediatrician Hans Rudolf Wiedemann drew attention to thirteen affected children who had been referred to him over a period of ten months. They had a number of associated malformations, including congenital heart disease, which led him to point to an epidemic. In the same year, German paediatrician Widukind Lenz and Australian obstetrician William McBride simultaneously but independently linked congenital malformations to thalidomide use. On 27 November, Chemie Grünenthal reluctantly withdrew thalidomide from the West German market. On 2 December, Distillers Company Biochemicals Ltd did the same for the British and Australian markets. On 16 December, a letter from Dr William McBride was published in The Lancet, publicly establishing for the first time a link between thalidomide and birth defects. McBride had notified the distributor in Australia of his findings in April, and the Crown Street Hospital for Women in Sydney in May.

Despite this background and the fact that the Australian Ministry of Health was informed of the dangers of thalidomide in late 1961, government agencies did not act immediately to destroy supplies or ban the use of the drug. According to the Australian Senate Community Affairs and References Committee’s March 2019 Final Report ‘When it became clear in November 1961 that thalidomide was linked to birth defects and Distillers withdrew the drug from sale, neither state governments nor the Australian government took prompt action to ban the importation of thalidomide or prohibit its sale. Unlike in other countries, no effort was made to recall and destroy the product found in doctors’ clinics or pharmacies’. The Australian government finally banned the sale of thalidomide on 9 August 1962.

Research into the consequences of thalidomide use by pregnant women has shown that these include birth defects such as ‘shortened or missing limbs, blindness, deafness or malformed internal organs’ for their children, according to the Australian Department of Health. The drug was never clinically tested on pregnant women before it was approved. Otto Ambros and Heinrich Mückter, employees of Chemie Grünenthal credited as inventors of thalidomide in 1953, were later shown to have been involved under the supervision of Joseph Mengele in experiments on female prisoners of war, administering a preparation of the same chemical formula as thalidomide at the Auschwitz extermination camp during 1944. Ambros had been Hitler’s adviser on chemical warfare. Convicted at Nuremberg in 1948 of mass murder and enslavement, he was sentenced to eight years in prison. Four years later he was released from prison to assist in Cold War research, which he did by working for J. Peter Grace, Dow Chemical and the US Army Chemical Corps. Ambros was a member of the board of directors and chairman of the Grünenthal advisory board at the time of the development of thalidomide. For his part, Mückter conducted chemical experiments on people in the Auschwitz and Buchenwald concentration and extermination camps. Responsible for the deaths of hundreds of prisoners, after the war Mückter was finally offered the opportunity to continue his work at Chemie Grünenthal. As the company’s Chief Scientist and Head of Research, he was credited with the development of thalidomide and the responsibility for its marketing and promotion.

According to the Thalidomide Group of Australia, a civil society organization that brings together survivors and their families, “It is estimated that more than 10,000 children worldwide have been born with birth defects due to thalidomide use, with 40% of them dying within a year. Thalidomide survivors are still living with the consequences of the drug today”. The thalidomide crisis led to increased medical oversight worldwide, including the creation of the Australian Therapeutic Goods Administration, and made the drug one of the most important cases of the 20th century in terms of mobilizing health legislation by marking the starting point for the implementation of drug safety and pharmacovigilance concepts. It also triggered ethical debates about the behavior of the pharmaceutical industry and the living conditions and rights of people with drug-induced disabilities. The actions of civil society in Australia and in other countries worldwide with thalidomide victims among their citizens promoted social debate in several areas, such as conflicts of interest in healthcare and the practices of some companies related to research involving human beings as subjects of experimentation. In this way, they contributed to the emergence and consolidation of bioethics in the field of scientific research in general and medical research in particular.