From the 1950s to the 1970s, a number of people in various parts of Japan complained of symptoms such as loss of vision and general numbness and pain, and the name SMON (Subacute Myelo-Optico-Neuropathy, or Subacute Spinal Optic Neuropathy) was coined from the initial letters of the symptoms. Initially, the cause of this condition was not identified, and it was suspected to be an “epidemic,” and victims suffered prejudice and discrimination.
Subsequent research identified the cause of the symptoms as a substance called quinoform, which was contained in the intestinal preparations at the time. The victim sued the pharmaceutical company that marketed the intestinal preparation and the government, and won an apology and compensation.
This trial led to the enactment of laws governing the safety of pharmaceuticals and paved the way for the prevention of drug-related harm. It is said that the final number of SMON victims exceeded 10,000.
| 1940 | Kinoform has been used in many countries since wartime |
| 1943 | Import of quinoform agent (Entero Vioform) begins. |
| 1945 | The war ends. All countries stop selling kinoform, but only Japan continues to market it. |
| 1955 | Damage occurred (circa 1955-1970) |
| 1969 | Ministry of Health and Welfare organizes “Sumon Research and Study Council”. |
| 1970 | Emergence of virus theory (Associate Professor Inoue, Kyoto University) and kinoform theory (Professor Tamura, University of Tokyo) The Ministry of Health and Welfare bans the use of quinoform at the Central Pharmaceutical Affairs Council |
| 1971 | Commencement of court proceedings against the government and pharmaceutical companies. |
| 1977 | District Court Decision (Plaintiffs prevailed) |
| 1979 | settlement |
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1. the outbreak of the SMON incident and the investigation of its causes
The powers were using quinoform, an ingredient of the kina plant, to make medicines to combat malaria and amoebic dysentery in their southern colonies. Although kinoform was designated as a deleterious drug in wartime Japan due to its neurotoxic properties, in 1939 the Ministry of Home Affairs lifted the designation of kinoform as a deleterious drug without explanation and began domestic production of kinoform preparations. After the end of World War II, Japan conducted a review of wartime pharmaceuticals, but not only was quinoform not restored to its deleterious drug designation, its application was expanded as a safe drug, and it was widely added to and sold in over-the-counter gastrointestinal products.
People who took this quino-form drug developed blurred vision, blindness, paralysis of the limbs, and trouble walking, and the name SMON was derived from the initial letters of these symptoms. Victims of SMON suffered from the progression of the disease and discrimination and prejudice.
Although the damage had been occurring since around 1955, it was called “Toda disease” because it occurred en masse in Toda City, Saitama Prefecture, where the rowing events for the Tokyo Olympics were scheduled to take place. The former Ministry of Health and Welfare organized a research group, but the budget was low and the research was dissolved with difficulty. Later, in 1969, a large number of smut victims occurred in some areas of Okayama Prefecture, and the former Ministry of Health and Welfare established a new research group at the request of the townspeople.
2. cause is identified and victims file a lawsuit
The excrement of SMON patients was green, and Professor Zenzo Tamura of the University of Tokyo proved that the causative agent was quinoform, which was contained in the gastrointestinal medicines of the time (quinoform theory). This was in 1970. At the same time, Associate Professor Inoue of Kyoto University proposed the theory that sumon was caused by a viral infection (virus theory). This was widely reported by newspapers and other media, and discrimination against patients intensified, with some patients even taking their own lives.
While research on SMON was underway, Professor Tadao Tsubaki of Niigata University, who was once involved in the discovery of Niigata Minamata disease, initiated an epidemiological investigation of the quinoform theory. One month after the epidemiological study, it was recognized that there was a correlation between the use of quinoform products and the incidence of SMON, and the sales of quinoform products were discontinued by the former Ministry of Health and Welfare.
3. connections among victims
Suffering from unexplained symptoms, the victims formed connections, petitioned, and exchanged ideas in various regions, and in 1969, the National SMON Association, made up of SMON victims’ associations from all over Japan, was established and began lobbying the government.
In 1969, after realizing that their symptoms were caused by the gastrointestinal drugs they were taking, the victims decided to file a lawsuit. In the first round of lawsuits, individual plaintiffs sued the pharmaceutical companies, the government, and the doctors and hospitals that administered the drugs, but the lawsuits gradually developed into nationwide class action lawsuits. Despite the division and creation of victims’ organizations due to differences in policy, a litigation structure was gradually developed and class actions spread nationwide. In solidarity with the anti-pollution movement, which was becoming a social issue at the same time, the victims appealed the damage to society.
As a result of the trial, which lasted about 10 years, all of the district courts ruled in favor of the plaintiffs, and the plaintiffs signed a “Letter of Confirmation” with the government and the pharmaceutical companies. The plaintiffs signed a “Letter of Confirmation” with the government and the pharmaceutical companies. The settlement acknowledged that the cause of SMON was a kinoform preparation and that the pharmaceutical companies were obligated to compensate the plaintiffs for their damages. Following the judgment, the government’s policy was to provide relief to patients through settlement.
4. relationship with pharmaceutical administration
At the same time, the Diet was discussing the “Pharmaceutical Affairs Law Amendment Bill” and the “Pharmaceutical Adverse Reactions Relief Fund Bill” (the so-called “Two Pharmaceutical Affairs Laws”). Both of these bills were related to the SMON lawsuit, with the Pharmaceutical Affairs Law Amendment Bill aiming to tighten the approval process for the manufacture of new drugs, and the Pharmaceutical Adverse Reactions Relief Fund Bill aiming to cover compensation for victims of drug-related injuries with contributions from pharmaceutical companies. The Pharmaceutical Affairs Law was passed in 1979, establishing the government’s responsibility for the safety of drugs and a system of relief for adverse drug reactions. In addition, permanent measures for SMON patients continue to be taken, including the search for the cause of the disease, the development of treatment methods, and the health care of patients.
References
- Jitsukawa, Yuta (ed.), 1990, Graphic Documents Sumon, Nippon Hyoronsha.