Around 1960, a succession of babies were born with malformations of the limbs and external ears. It is also estimated that many stillbirths occurred. The cause was a pharmaceutical drug called thalidomide (the name of its active ingredient), which was used at the time as a sedative and hypnotic. In Japan, it was also included in some gastrointestinal medications.When taken during the early stages of pregnancy, this drug interferes with fetal development and can also affect internal organs. Even after the dangers of thalidomide-containing medications had been warned against in Europe and elsewhere, these products continued to be sold in Japan, leading to an expansion of the damage.
Children affected by thalidomide underwent surgery during early childhood and worked hard to develop the skills needed to live independently, often through rigorous rehabilitation and training. In Japan, the affected children and their parents filed lawsuits against the government and pharmaceutical companies. The lawsuits were ultimately settled after the pharmaceutical companies and the government acknowledged their responsibility.The thalidomide tragedy prompted a major overhaul of Japan’s pharmaceutical regulatory system, including stricter standards for the application and review of new drugs and the establishment of a system for reporting adverse drug reactions.
Chronology
| 1957 | Sales of “Contergan”, a thalidomide-based drug, began in Germany (formerly West Germany) Dainippon Pharmaceutical receives manufacturing approval |
| 1958 | Sales of “Isomin“, a sedative and hypnotic containing thalidomide, began in Japan. |
| 1959 | Thalidomide-related birth defects began to occur. In Japan, affected births occurred between 1959 and 1969 |
| 1960 | Sales of “Proban M“, a gastrointestinal medication containing thalidomide, began in Japan. |
| 1961 | Dr. Lenz issued a warning, and thalidomide products were withdrawn from the market in Europe. Japan took no action, dismissing the Lenz warning as “lacking scientific basis” |
| 1962 | Media reports brought cases of thalidomide-related harm in Japan to public attention. The suspension of thalidomide sales and a product recall were announced |
| 1963 | Victims and their families filed lawsuits against the Japanese government and pharmaceutical companies. |
| 1974 | A settlement was reached between the victims and their families, and the government and pharmaceutical companies |
| 2008 | Thalidomide was approved in Japan for the treatment of multiple myeloma. |
| 2012 | Thalidomide was approved in Japan for the treatment of Hansen’s disease (leprosy). |
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1. Emergence of Thalidomide-Induced Suffering
Thalidomide preparations were developed in 1957 by Grünenthal in (then) West Germany and were subsequently marketed worldwide. Barely three months after the drug was launched in West Germany, Japanese pharmaceutical companies independently developed manufacturing methods, obtained approval, and began selling the drug as Isomin (a sedative) under the slogan “Distaval can be given with complete safety to pregnant women and nursing mothers without adverse effect on mother or child.” The drug was later incorporated into Proban-M (an antacid). Soon after marketing, reports mounted worldwide of babies born with limb malformations. In 1961, Dr. Widukind Lenz, a pediatrician at the University of Hamburg, warned of a causal link between maternal thalidomide intake and fetal malformations, prompting suspension and recall across Europe. In Japan, although the former Ministry of Health and Welfare (MHW) and pharmaceutical companies discussed the issue, sales continued on the strength of Grünenthal’s assurances that there was “no problem.” When Japanese media began reporting domestic cases of limb malformations, the MHW in 1962 ordered suspension and recall—roughly 9 months after West Germany. Continued sales and incomplete recall meant that the number of affected babies in Japan eventually reached 309.
2. Litigation and collaboration with scientists
Children harmed by thalidomide and their parents endured prejudice from medical staff and family members. Many children underwent repeated surgeries and strenuous rehabilitation; appearance-based stigma led to family strain—including divorce—and bullying at school. Despite their role in allowing sales to continue, neither the state nor manufacturers initially took action. Victims and supporters organized, and from 1963—beginning with a filing at Nagoya District Court—parents sued pharmaceutical companies and the state. The defendants categorically denied causality, prolonging the trials. Researchers and medical professionals joined the support network, assisting the lawsuits and public advocacy. In 1969, Prof. Sugiyama (School of Engineering, Osaka University) published “A Statistical Consideration of the So-Called Thalidomide Problem,” challenging Lenz’s warnings and later testifying for the defense; his claims were subsequently refuted on scientific grounds. While repeatedly refusing to accept responsibility, the state and companies floated settlement proposals. In 1974, they declared that they would “cease disputing causality and responsibility,” leading to settlement. Compensation was extended even to victims who had not sued, and, as a condition of settlement, welfare measures for victims were instituted. The foundation Ishizue was established as a support center for thalidomide victims and continues its activities today.
3. Implications for pharmaceutical regulation
The thalidomide litigation played a pioneering role in drug-induced suffering lawsuits and forced a re-examination of pharmaceutical regulation. In 1967, the Drug Affairs Bureau issued a notice, “Basic Policy on New Drug Manufacturing Approval,” tightening dossier requirements and restricting certain prescription drugs. However, the amendment of the Pharmaceutical Affairs Law itself would not occur until 1979, after the SMON litigation. Thalidomide has since been re-approved—under strict risk management—for multiple myeloma (2008) and for Hansen’s disease (2012). Its use is tightly controlled under the Thalidomide Education and Risk Management System (TERMS). The thalidomide tragedy is, therefore, not merely “past history”; continued vigilance, public education, and robust control systems for high-risk drugs remain essential to preventing new sufferings.
Reference
- The Pharmaceutical and Medical Device Regulatory Science Society of Japan (2012), 『知っておきたい薬害の教訓――再発防止を願う被害者からの声』YAKUJI NIPPO, (ISBN 4840812136).