Drug-induced AIDS is a human immunodeficiency virus (HIV) infection that occurred in the 1980s, mainly among hemophilia patients who used unheated blood products (a disease in which the clotting factor that stops bleeding is in short supply from birth). At the time, the blood used to make blood products was not treated to make it less infectious, and HIV contamination was the cause. In 1989, a lawsuit was filed against the government and the pharmaceutical company, which was settled in 1996.
| 1970’s | Approval of unheated formulations (late 1970s) |
| 1980’s | Damage occurred (mainly circa 1982-1985) |
| 1983 and 1984 | Approval of heated formulations in the U.S. |
| 1985 | Japan’s First HIV-Positive Patient Found Marketing approval for heated formulation in Japan |
| 1988 | House of Representatives Committee on Social and Labor Affairs passes “On Early Relief for Persons Infected with the AIDS Virus through Blood Products |
| 1989 | Tokyo/Osaka HIV lawsuits filed by plaintiffs and defense lawyers |
| 1996 | Settlement with the government and pharmaceutical companies (1996) |
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1. the advent of unheated preparations and HIV infection
Hemophilia is a disease in which a person is born with a partial deficiency of a clotting factor (a factor that stops bleeding) in the blood, making it difficult to stop bleeding. In order to stop bleeding, this clotting factor must be replaced. Before the advent of blood products, the disease was so serious that it was said “you will not live to adulthood,” and blood transfusions had to be performed in hospitals after bleeding. Until the bleeding stopped, even minor bleeding was experienced as “hellish pain.
In the 1970s, however, the quality of life for hemophiliacs was greatly improved with the introduction of unheated concentrated blood coagulation factor products (unheated products). It also became possible to supplement blood coagulation factor products at home on a regular basis without having to go to the hospital.
However, this unheated preparation was made from blood obtained by purchasing blood overseas. For this reason, the blood purchased by Japan was contaminated with HIV, the cause of AIDS (acquired immunodeficiency syndrome), which had been spreading mainly in the United States since the early 1980s. Because the blood products were not heat-treated to inactivate the virus during the manufacturing process, many hemophiliacs who used the blood products became infected with HIV. In 1985, heated blood products were approved in Japan to prevent hepatitis and other infections, but the number of hemophiliacs infected with HIV continued to increase because of the continued use of unheated products. infected with HIV, and 418 of them developed AIDS.
2. the fight of hemophiliacs
In the 1980s, AIDS was viewed as a “deadly disease,” and in 1987, the “AIDS panic” was triggered by the media coverage of women infected with HIV. They also suffered from a lack of proper notification of their infection. In addition, because no effective treatment had been developed at the time, many hemophiliacs were left with no choice but to develop AIDS and die. In 1988, the House of Representatives Committee on Social and Labor Affairs passed a bill “Concerning Early Relief for Persons Infected with the AIDS Virus through Blood Products,” and in December of the same year, the AIDS Prevention Law was enacted. However, due to the low amount of public funds and the desire to seek “compensation” rather than “relief,” Noriyasu Akase and Yoshiaki Ishida, both infected persons, filed lawsuits against the government and pharmaceutical companies in 1989. Many of the HIV-infected hemophiliacs were children and young people, and young people who joined them staged a demonstration in front of the former Ministry of Health and Welfare, This became a major social phenomenon.
In 1995, a court recommended a settlement, and when the settlement was reached in 1996, the government and the pharmaceutical companies were found liable, and the then Minister of Health and Welfare apologized to the plaintiffs in the AIDS lawsuit and their supporters. In a criminal case, the three presidents of the pharmaceutical companies that sold the unheated drug were convicted for “putting business profits before human life,” as well as an administrative official of the former Ministry of Health and Welfare who failed to take the necessary administrative action. The head of the AIDS research team who made the decision to continue using the unheated drug was also indicted, but was acquitted at the first trial, and his appeal was later dismissed due to his death.
3. post-judgment activities
In 1996, the former Ministry of Health and Welfare established the “Study Group on Blood Administration” in order to apply the lessons learned from the drug-related AIDS case to blood administration. The Pharmaceutical Affairs Law was revised to reflect the results of the study group’s deliberations and to ensure the safety of biologically-derived products, including blood products.
Following the verdict, protease inhibitors developed in the U.S. were approved as drugs against HIV, and with the establishment of multidrug therapy, AIDS went from being an incurable disease to a chronic disease. The preamble of the “New Law on Infectious Diseases” enacted in 1998 by integrating the “Law for the Prevention of AIDS,” the “Law for the Prevention of STDs,” and the “Law for the Prevention of Infectious Diseases” states, “In Japan, there has been unjust discrimination and prejudice against patients with infectious diseases, including leprosy and acquired immune deficiency syndrome. に対するいわれのない差別や偏見が存在したという事実を重く受け止め、これを教訓として今後に生かすことが必要である」と記されています。
References
- Foundation for Pharmaceuticals and Medical Devices Regulatory Science, 2012, “Lessons Learned from Drug Injury: Voices from Victims Hoping for the Prevention of Recurrence,” Yakuji Nippo Co.
- Japan Association for Public Publications, 2011, “Knowledge of Drug Hazards You Should Know–To Prevent Health Damage Caused by Drugs,” Jiho.
- Yamada, Tomiaki, 2011, Fieldwork Aporia: Ethnomethodology and Life Stories, Serika Shobo.