Thalidomide: Scare of the Sixties.

Thalidomide: Scare of the Sixties

It was in 1954, in West Germany, that Wilhelm Kunnz first synthesised a drug, which in decades to come, would have a detrimental effect on the lives of an estimated 10,000 new-born babies.[1]

Despite being initially marketed as an antihistamine, by 1956, it had been presented to the mass market as a highly effective sedative, by the German pharmaceutical manufacturer Chemie Grunenthal. Such a market certainly had a global reach and before long, this same drug was easily accessible in 46 countries, though was marketed under 51 different brand names. With incredible successes due to its ‘prompt action, lack of hangover effects and apparent safety’, the drug, commonly regarded as Thalidomide, quickly became one of the three most sought after drugs throughout Europe.[2] Available on demand, Thalidomide was frequently prescribed by physicians to pregnant women as an anti-sickness medication, in an attempt to minimise the impact of morning sickness.[3]

In 1958 Distillers Biochemicals LTD commenced the manufacture and distribution of Thalidomide throughout the United Kingdom. Following their entrance into the pharmaceutical market, they successfully launched a campaign advertising Thalidomide as a replacement for ‘barbiturates’, a drug previously held accountable for numerous fatalities.[4] Before long, Thalidomide was advertised to physicians across the globe, with sales rising exponentially. 

However, this façade of success was incredibly short lived. On a timeline parallel to the surge in sales, a tragedy had taken hold on the world’s population.

In 1960, The Food and Drug Administration [FDA] received an application for Thalidomide to be distributed throughout the United States. Following investigation, the case was swiftly rejected by Frances Kelsey, who had uncovered a range of damaging implications catalysed by its use. This decision was reinforced by physicians after countless reports emerged detailing thousands of babies born with life threatening birth defects.[5] These deformities were predominantly present in the limbs of infants, where proximal sections of limbs had failed to develop. Not only were these birth defects extremely debilitating, but in a handful of cases, children were even found to have suffered neuropathic impairment.[6]

Physicians were left completely perplexed as to the catalyst of the deformities after investigations evidenced that they were not caused by hereditary illnesses. However, in 1961, Widukind Lenz drew significant connections between the use of Thalidomide during pregnancy and the resulting neurotoxic defects.[7]

With circumstantial evidence accumulating from every corner of the globe, Distillers Co, saw no choice but to halt operations and did so, on 3^rd December 1961.[8]

The scale of the disaster was unfathomable. Not only had the tragedy shattered the confidence of the general public, but the unfolding epidemic emphasised the absolute failure of sufficient preclinical testing, unnecessarily risking the lives of the population. Following this realisation, drug regulation and preclinical testing rapidly became the subject of public attention throughout the UK and the US. The Thalidomide tragedy not only marked a watershed moment in the history of drug regulation but acted as a catalyst for drastic improvements to be made to the pharmaceutical industry.[9]

Such improvements came in the form of legislations, including critical changes to the Food, Drug and Cosmetics Act 1962. Not only did these changes investigate the effectiveness and safety of new preliminary drugs, but they challenged the efficacy of their use.[10] By 2003, throughout the US, Thalidomide became the subject of law 10.651. It was an unprecedented change and to this day, it remains the only drug in the US to have its own dedicated law. [11]

Currently regarded as a ‘potentially life-saving drug’, Thalidomide continues to be used in modern medicine to treat a range of conditions, including leprosy. However, it is only used under strict adherence to the legislations previously set out, to avoid yet another disaster.[12]

---

[1] Timmermans, Stefan, and Valerie Leiter. "The Redemption of Thalidomide: Standardizing the Risk of Birth Defects." Social Studies of Science 30, no. 1 (2000): 41-71. Accessed March 17, 2020. www.jstor.org/stable/285769.

[2] Timmermans, Stefan, and Valerie Leiter. "The Redemption of Thalidomide: Standardizing the Risk of Birth Defects." Social Studies of Science 30, no. 1 (2000): 41-71. Accessed March 17, 2020. www.jstor.org/stable/285769.

[3] Timmermans, Stefan, and Valerie Leiter. "The Redemption of Thalidomide: Standardizing the Risk of Birth Defects." Social Studies of Science 30, no. 1 (2000): 41-71. Accessed March 17, 2020. www.jstor.org/stable/285769.

[4] MORO, Adriana; INVERNIZZI, Noela. The thalidomide tragedy: the struggle
for victims’ rights and improved pharmaceutical regulation. História, Ciências, Saúde – Manguinhos, Rio de Janeiro, v.24, n.3, jul.-set. 2017. Available at: http://www.scielo.br/hcsm.

[5] Timmermans, Stefan, and Valerie Leiter. "The Redemption of Thalidomide: Standardizing the Risk of Birth Defects." Social Studies of Science 30, no. 1 (2000): 41-71. Accessed March 17, 2020. www.jstor.org/stable/285769.

[6] Taussig, Helen B. "The Thalidomide Syndrome." Scientific American 207, no. 2 (1962): 29-35. Accessed March 17, 2020. www.jstor.org/stable/24936633.

[7] Taussig, Helen B. "The Thalidomide Syndrome." Scientific American 207, no. 2 (1962): 29-35. Accessed March 17, 2020. www.jstor.org/stable/24936633.

[8] Venkataramiah, E. S. "THE SUNDAY TIMES' THALIDOMIDE CASE." Journal of the Indian Law Institute 30, no. 2 (1988): 129-37. Accessed March 18, 2020. www.jstor.org/stable/43951160.

[9] Timmermans, Stefan, and Valerie Leiter. "The Redemption of Thalidomide: Standardizing the Risk of Birth Defects." Social Studies of Science 30, no. 1 (2000): 41-71. Accessed March 17, 2020. www.jstor.org/stable/285769.

[10] Timmermans, Stefan, and Valerie Leiter. "The Redemption of Thalidomide: Standardizing the Risk of Birth Defects." Social Studies of Science 30, no. 1 (2000): 41-71. Accessed March 17, 2020. www.jstor.org/stable/285769.

[11] MORO, Adriana; INVERNIZZI, Noela. The thalidomide tragedy: the struggle
for victims’ rights and improved pharmaceutical regulation. História, Ciências, Saúde – Manguinhos, Rio de Janeiro, v.24, n.3, jul.-set. 2017. Available at: http://www.scielo.br/hcsm.

[12] Timmermans, Stefan, and Valerie Leiter. "The Redemption of Thalidomide: Standardizing the Risk of Birth Defects." Social Studies of Science 30, no. 1 (2000): 41-71. Accessed March 17, 2020. www.jstor.org/stable/285769.