Introduction
Thalidomide is one drug that changed the way pharmaceutical companies develop and distribute new medicines. The drug, as Atoyebi et al. (2019) claimed, was initially developed by a German company, Grunenthal, as a tranquilizer but was banned due to its harmful consequences. It took less than a decade to establish the impact of thalidomide in children born to mothers who were taking thalidomide. Not only did thalidomide change the life of people, but it enforced strict regulations for approving new drugs that have remained in effect today.
History of Thalidomide
Thalidomide was discovered in 1953 by Ciba, a Swiss pharmaceutical company, to serve as a sedative drug. Upon determining that this drug did not contain the tranquilizing effect in the tested laboratory animals, the company canceled the research. Grunenthal, a German company, reexamined the compound and found that it could be used as a sleeping pill with no notable side effects. According to Atoyebi et al. (2019), combined with aspirin, thalidomide became a common pill and could treat several diseases, including cold, cough, nervousness, asthma, and calm children in pregnant women. In late 1957, the doctors recommended thalidomide as a pain reliever for pregnant women with morning sickness, which was soon adopted in more than forty-eight countries. By 1960, medical professionals reported numerous teratogenic effects in newborns from mothers using this drug worldwide (Atoyebi et al., 2019). Consequently, this drug was banned in 1962 globally, and the company was blamed for violating pharmacovigilance rights. This Act of distributing untested thalidomide to pregnant mothers enforced strict regulations for approving new vaccines and drugs that have remained in effect today.
Why Thalidomide was an Ethical Issue
From a historical perspective, several ethical violations revolve around the use of thalidomide. According to Atoyebi et al. (2019), the company distributed the drug to many parents illegally. It was distributed freely without testing for pregnancy before prescription and was given inadequate medical guidance. The patients were also fed with false information through booklets, adverts, and educational posters at the clinic. Secondly, there was little information about the production and distribution of the drug. Many doctors, nurses, and physicians issued the drug indiscriminately to patients with Hansen’s disease without informing women of childbearing age to avoid becoming pregnant. Furthermore, the medical team was not in mutual agreement with one another and overlooked the dangers of thalidomide. This gross form of ethical violation was seen in the deformities found in children of women who had taken thalidomide during pregnancy, posing shock, outrage, and public outcry.
The 1962 Kefauver-Harris Amendment Act
To address this public outcry, the public scrutinized methods and policies for drugs, and thalidomide made congress pass the 1962 Kefauver-Harris Amendments to the 1938 Food, Drug, and Cosmetic Act. Before this Act, there was no federal law requiring the medical professionals to maintain the records of drugs they have prescribed or follow up for their patients except for the original FDA, which only needed the product to be safe (Rucker & Young, 2021). The amended Act proved successful in controlling the safety and efficacy of drug distribution in the market. It required that any pharmaceutical company seeking to develop and publicize the drug must be approved by the FDA and provide a detailed outline of the clinical study information. Before the 1962 Act, if the FDA delayed approval of a drug application within six months, the drug would be approved automatically within the next six months. For instance, the amendment Act slowed the approval of drug applications. So, it empowered the FDA to regulate pharmaceutical companies.
References
Atoyebi, S. A., Rajoli, R. K., Adejuyigbe, E., Owen, A., Bolaji, O., Siccardi, M., & Olagunju, A. (2019). Using mechanistic physiologically-based pharmacokinetic models to assess prenatal drug exposure: thalidomide versus efavirenz as case studies. European Journal of Pharmaceutical Sciences, 140, 105068.
Moro, A., & Invernizzi, N. (2017). The thalidomide tragedy: the struggle for victims’ rights and improved pharmaceutical regulation. História, Ciências, Saúde-Manguinhos, 24(3), 603-622.
Morrison D. (2020). Poor balance, bilateral upper limb phocomelia, no previous exercise: a challenging combination for fall prevention in a middle-aged thalidomide survivor. BMJ case reports, 13(1), e231345. Web.
Rucker, J. J., & Young, A. H. (2021). Psilocybin: From Serendipity to Credibility?. Frontiers in Psychiatry, 12, 445.