Around the 1960s, babies were born with deformed limbs and external ears, and miscarriages and stillbirths due to internal organ damage occurred in rapid succession. The cause was a substance called thalidomide, which was contained in some stomach and sleeping pills at the time, and which, when taken in early pregnancy, interfered with the growth of the fetus. Even after worldwide warnings of the dangers of thalidomide preparations were issued, thalidomide preparations continued to be sold in Japan, causing widespread damage. Children of thalidomide drug victims underwent surgery immediately after birth and underwent rigorous independent training. There was also discrimination and bullying based on appearance. In Japan, the parents of the children filed lawsuits against the government and pharmaceutical companies, and the settlements led to a major revision of the Pharmaceutical Affairs Law.
| 1957 | Isomin begins sales in Germany Dainippon Pharmaceutical receives manufacturing approval. |
| 1958 | Started sales of “ISOMIN |
| 1960 | Started sales of “Provan M.” Damage occurred (around 1960s) |
| 1961 | Warning by Dr. Lenz, Recall in Europe. Japan ignores Lenz warning as “no scientific basis”. |
| 1962 | Manufacturing and sales of thalidomide discontinued and recalled in Japan due to a series of damages |
| 1963 | Commencement of court proceedings against the government and pharmaceutical companies. |
| 1974 | Settlement with the government and pharmaceutical companies |
| 2008 | Thalidomide Approved for Multiple Myeloma |
| 2012 | Thalidomide approved for treatment of leprosy |
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1. thalidomide drug incident
Thalidomide was developed by the former West German company Grünenthal in 1957 and subsequently marketed worldwide. Only three months after it was launched in West Germany, a Japanese pharmaceutical company developed and approved its own manufacturing process, and began marketing it as Isomin (a sleeping pill) with the claim that it was “a safe and harmless drug that pregnant women and children can take safely,” and later as Provan-M (a stomach medicine). It was also used for Provan M (stomach medicine).
In 1961, Dr. Lenz, a lecturer in pediatrics at the University of Hamburg, warned of a possible causal link between pregnant women taking thalidomide and malformations in their babies (the “Lenz Warning”), and all European All countries in Europe have stopped selling or recalled thalidomide products. Following the Lenz Warning, the former Ministry of Health and Welfare and pharmaceutical companies in Japan held discussions, but based on information from Grünenthal that there was no problem, thalidomide products continued to be marketed.
However, when the media reported that babies were being born with deformed limbs in Japan, the former Ministry of Health and Welfare suspended sales and recalled the thalidomide drug in 1962. This was about nine months after the recall in the former West Germany. Due to the continued sale of thalidomide products and the lack of a thorough recall, the number of babies who were victims of thalidomide products in Japan reached 309.
2. the trial and the cooperation of scientists
Babies and their parents affected by the thalidomide drug suffered prejudice from their doctors, family members, and others around them. They also underwent surgery to compensate for their limb disabilities and underwent rigorous training to become self-reliant. In addition, because of their appearance, they were regarded as “blood stains” in the family, leading to parental divorce issues and bullying at school.
However, the government and the pharmaceutical companies, which had continued to neglect the sale of thalidomide, did not take any action against the victims. In response, a group of victims of thalidomide and their supporters was organized, and around that time, some of the victims filed lawsuits against the pharmaceutical companies and the government, beginning with a lawsuit filed in the Nagoya District Court in 1963. The trial was protracted because the defendants, the government and the pharmaceutical companies, flatly denied any causal relationship between the thalidomide drug and the occurrence of the disability. In 1969, Professor Sugiyama of Osaka University’s Faculty of Engineering published “A Statistical Study of the So-Called Thalidomide Problem” in which he challenged the Lenz warning and took the stand against the defendant pharmaceutical companies. Although he took the stand against the pharmaceutical companies, the results of his study were academically rejected.
In 1974, the government and the pharmaceutical companies issued a statement that they would “stop making false accusations of causation and responsibility,” and reached a settlement with the plaintiffs. As a result, compensation was paid to victims who did not file suit, and as a condition of the settlement, measures for the welfare of the victims were implemented. As a result, the foundation “Ishizue” was established as a welfare center for victims of thalidomide drug production, and support activities for victims have been conducted to this day.
(3) Involvement with pharmaceutical administration
The thalidomide lawsuit played a pioneering role in drug lawsuits, and the judgment prompted a review of pharmaceutical administration. 1967 saw the issuance of a notice by the Director-General of the Pharmaceutical Affairs Bureau, “Basic Policy on the Approval of Pharmaceuticals for Manufacturing,” which tightened the scope of materials required for approval applications and banned ethical drugs. However, the Pharmaceutical Affairs Law itself was revised. However, the Pharmaceutical Affairs Law itself was not revised until 1979, after the drug-related SMON incident.
Thalidomide products were approved for multiple myeloma in 2008 and for leprosy in 2012, and their use is strictly controlled by the Thalidomide Education and Risk Management System (TERMS), so the thalidomide incident is not a thing of the past. Thalidomide is not an incident of the past. Thalidomide drug damage awareness and a management system for high-risk drugs are needed to prevent new damage.
References
- Foundation for Regulatory Science of Pharmaceuticals and Medical Devices, 2011, “Lessons Learned from Drug Injury: Voices from Victims Hoping to Prevent Recurrence,” Yakuji Nippo Publishing Co.