Chloroquine drug poisoning occurred in the 1950s when the antimalarial drug chloroquine was taken. Chloroquine was developed for short-term use, but its indication was gradually expanded in Japan to include nephritis, chronic rheumatoid arthritis, and bronchial asthma. As the drug was mass-marketed by pharmaceutical companies, serious side effects such as visual field constriction and retinopathy leading to blindness occurred among those who took the drug. It is estimated that 1,000 to 2,000 people have been affected by chloroquine because of the long-standing failure of the former Ministry of Health and Welfare and pharmaceutical companies to prevent side effects.
| 1934 | Synthesized by Bayer AG of Germany, effective against malaria, but development discontinued due to high toxicity. |
| 1943 | U.S. company used for short doses as a special treatment for malaria. |
| 1958 | Launched in Japan as a drug for nephritis, rheumatism, etc.; mass-marketed in 1961 as a special treatment for chronic nephritis |
| 1958 | Damage occurred (ca. 1958-1974) |
| 1971 | become a social problem |
| 1975 | Petition (primary) |
| 1980 | Petition (2nd) |
| 1982 | Prevailed (first round); no state liability found |
| 1987 | Prevailed (2nd round), no state liability found. |
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1. Chloroquine Development and Distribution in Japan
Chloroquine was synthesized by Bayer AG of Germany in 1934, but its development was discontinued due to its toxicity. In 1943, during World War II, a U.S. company used chloroquine in short doses as a special malaria treatment to replace quinine.
With the war over, countries would no longer need to treat malaria, but then, in 1958, Japanese companies began marketing chloroquine. At that time, chloroquine was marketed not for malaria, but initially as a drug for nephritis. Gradually, however, the indications were expanded to include chronic rheumatoid arthritis, bronchial asthma, and epilepsy, and in 1961, chloroquine began to be sold in large quantities as a specific treatment for chronic nephritis, and outbreaks of chloroquine retinopathy were reported.
2. Warning in the U.S. and Overlooked in Japan
After the war, chloroquine continued to be sold as a malaria drug in the United States. However, clinical trials had shown that chloroquine caused eye damage, so long-term administration was explicitly prohibited, and the Food and Drug Administration (FDA) instructed pharmaceutical companies to distribute warning letters about chloroquine’s harmful effects.
On the other hand, despite the fact that the possibility of eye damage from taking chloroquine had been pointed out in Japan, the former Ministry of Health and Welfare and pharmaceutical companies took no action. Some companies even advertised that chloroquine was suitable for long-term administration because of its low toxicity. Furthermore, in 1965, it was later revealed that a section chief of the former Ministry of Health and Welfare, who was taking chloroquine at the time, had stopped taking it himself after learning about the serious side effects of chloroquine in the United States, but took no action. Subsequently, it was not until 1969 that the former Ministry of Health and Welfare ordered chloroquine retinopathy to be listed on the label, and it was not until 1974 that chloroquine production was discontinued.
3. Prolonged trial
In 1971, one of the victims made a direct appeal to the then Minister of Health and Welfare about the damage and relief, which was widely covered by the mass media, and chloroquine damage became known as a social problem. In 1972, the “Association of Chloroquine Victims” was formed and began negotiations with four pharmaceutical companies. However, even after three and a half years of negotiations, no apology or adequate compensation was offered by the pharmaceutical companies.
To seek legal redress, the victims filed a lawsuit in 1975 against the government and pharmaceutical companies. Since few doctors were willing to cooperate in the trial, they decided to include medical institutions that were too uncooperative as defendants, but the number of defendants was so large that the lawsuit dragged on for a long time. During the course of the litigation, it was discovered that the papers that supported the efficacy of the drug in treating nephritis were not sufficiently scientific, and in 1976 chloroquine was ruled ineffective in treating nephritis.
In 1982, the victims won their case in the first instance, when the government, the pharmaceutical company, and the medical institution were found liable. However, an appeal by the defendant resulted in a reversal of the case against the government at the High Court of Appeals, and the Supreme Court also ruled against the government. The Supreme Court decision came in 1995, some 40 years after the chloroquine outbreak. Although the Supreme Court did not find the government liable, the plaintiff patients were awarded lifetime compensation in the range of 50 million yen, a rather high amount at the time. However, many years had passed before the verdict, and many victims died before the verdict was reached.
references
- Pharmaceuticals and Medical Devices Regulatory Science Foundation, 2012, “Drug Injury Lawsuits You Should Know: Aiming to Minimize Corporate Risks,” Pharmaceutical Affairs Daily, Inc.
- Japan Association for Public Publications, 2011, “Knowledge of Drug Hazards You Should Know–To Prevent Health Damage Caused by Drugs,” Jiho.