Drug-induced suffering
Pharmaceutical Affairs Administration and Developments in Japan
ChloroquineBayer of Germany synthesized chloroquine (1934), and U.S. companies used chloroquine as a specific treatment for malaria (1943).
1935
SMONMajor powers used quinoline for malaria treatment; quinoline was included in the Japanese Pharmacopoeia (1939)
End of the War (1945)
1955
Thalidomide Drug HarmLaunch of “Isomin” sales in Japan (1958)
ChloroquineJapanese companies expand the efficacy of chloroquine to include nephritis, chronic rheumatoid arthritis, bronchial asthma, and epilepsy (1958)
Thalidomide Drug HarmDr. Renz’s warning, recall in Europe (1961), recall in Japan (1962), initiation of lawsuits against the country and pharmaceutical companies (1963)
Enforcement of the Pharmaceutical Affairs Law (1961)
National Health Insurance System Begins (1961)
ChloroquineFDA orders pharmaceutical companies to distribute warning letters regarding the harmful effects of chloroquine (1962)
SMONOutbreak of “Toda Disease” in Olympic Rowing Venue Area; Research Team on “Cerebrospinal Inflammation with Abdominal Symptoms” Established (1964)
Drug-induced hepatitisApproval of “Fibrinogen” (1964)
Tokyo Olympics (1964)
U.S. Ambassador to Japan Edwin O. Reischauer attacked by thugs, contracted hepatitis C from transfusion blood (1964)
Following the Reischauer Incident, the Cabinet decided to establish a system securing blood for transfusions through voluntary donations rather than paid blood sales (1964).
1965
Following the thalidomide incident, the “Basic Policy on Pharmaceutical Manufacturing Guidelines” notification (1967) was issued to supplement deficiencies in the Pharmaceutical Affairs Law through administrative guidance.
ChloroquineMinistry of Health and Welfare Instructs Inclusion of Chloroquine Retinopathy in Package Insert (1969)
SMONThe Ministry of Health and Welfare established the “SMON Research Council” (1969); the “National SMON Association” was founded (1969).
Harm from Induced Labor DrugsAbuse of labor induction by physicians becomes a problem (1970s–1980s)
SMONThe S-mon virus theory (Associate Professor Inoue, Kyoto University) and the chloroquine theory (Professor Tamura, University of Tokyo) emerge. The Ministry of Health and Welfare bans chloroquine use (1970). Lawsuits against the government and pharmaceutical companies commence (1971). Settlements begin in various regions (1979).
Drug-induced Jacob’s diseaseApproval of “Laiodura” (1973)
Muscle contractureNotice from the Japan Medical Association on Countermeasures Against Muscle Shortening Syndrome (1974), Apology Statement from the Japan Pediatric Society (1976)
Thalidomide Drug HarmSettlement with the State and Pharmaceutical Companies (1974)
1975
ChloroquineFiled lawsuits against the government and pharmaceutical companies (1975), Chloroquine removed from the Japanese Pharmacopoeia (1976)
Amendments to the Pharmaceutical Affairs Law (Reevaluation and Reexamination System, Adverse Reaction Reporting Obligation, Emergency Orders, Recall Orders)
Pharmaceutical Side Effects Victims Relief Fund Act (1979)
Pharmaceutical Side Effects Victims Relief Fund Act (1979)
Drug-induced AIDSApproval of Non-Heat-Treated Factor Preparations (1982)
An unknown immune disorder is named “AIDS” in the United States (1982)
1985
Japan’s first HIV patient is identified (1985)
Drug-induced hepatitisThe Ministry of Health and Welfare issued a non-binding directive to pharmaceutical companies to restrict the indications for fibrinogen (1987)
Drug-induced Jacob’s diseaseBanned in the United States (1987)
First HIV-Positive Woman in Japan Sparks “AIDS Panic” (1987)
Drug-induced AIDS“Resolution on Early Relief for AIDS Virus Infection Victims from Blood Products” passed (1988); lawsuits filed against the government and pharmaceutical companies in Tokyo and Osaka District Courts (1989)
Harm from Induced Labor DrugsThe Association for Considering Damage Caused by Labor Induction Drugs was established (1988)
MMRRegularization of MMR Vaccination (April 1989)
MMRSurvey report by the Maebashi City Medical Association (June 1989), Three victim families sued the national government and pharmaceutical companies (1993), Suspension of MMR vaccinations for the time being (1993)
Muscle contractureSettlement with Medical Institutions and Pharmaceutical Companies (1990s)
Harm from Induced Labor DrugsThe “Association for Considering the Harm Caused by Labor Induction Drugs” requested the Ministry of Health and Welfare to revise the package inserts, and the government responded (1992).
1995
ChloroquineSupreme Court Decision (1995)
Drug-induced AIDSSettlement with the government and pharmaceutical companies (1996); Representative of the AIDS research team, three successive presidents of the pharmaceutical company, and the Director of the Biological Products Division at the Ministry of Health and Welfare were arrested in succession (1996).
Drug-induced Jacob’s diseaseLawsuits filed against the government and pharmaceutical companies in Otsu and Tokyo District Courts (1996, 1997); Notice prohibiting the use of Lyodura (1997)
Amendment to the Pharmaceutical Affairs Law (Mandatory Reporting of Infectious Diseases, Mandatory Non-Clinical and Clinical Trial Standards) (1996)
Drug-induced hepatitisThe Ministry of Health restricted the indications for fibrinogen (1998)
A monument vowing to eradicate drug-related harm was erected within the Ministry of Health, Labour and Welfare (1999)
Enforcement of the New Infectious Diseases Control Law (1999)
Mad Cow Disease Outbreak in Japan (2001)
Iressa Drug-Induced HarmIressa Approval (2002)
Drug-induced hepatitisLawsuits filed in district courts (2002), Judgments recognizing the liability of the government and pharmaceutical companies (2006–2007), Basic Act on Hepatitis Countermeasures passed by the Diet (2009)
Drug-induced Jacob’s diseaseSettlement with the State and Pharmaceutical Companies (2002)
Amendments to the Pharmaceutical Affairs Law, the Blood Law, and the Comprehensive Organization Law (Regular Reporting of Infectious Diseases, Safety Measures for Biological Products, Relief for Victims of Infectious Diseases) (2002)
Establishment of PMDA (2004)
Compensation System for Injuries Caused by Biological Products (2004)
2005
Iressa Drug-Induced HarmClinical trial results indicating Iressa has no life-prolonging effect were announced, leading to a ban on its use for new patients in the U.S. (2005). Lawsuits against the government and pharmaceutical companies commenced in Tokyo and Osaka District Courts (2005).
Amendment to the Pharmaceutical Affairs Law (Sales System for Over-the-Counter Drugs Based on Risk) (2006)
Thalidomide Drug HarmThalidomide approved as a drug for multiple myeloma (2008) and leprosy (2012)
HPV Vaccine Drug HarmMunicipal public funding began (2010)
Final Recommendations of the Study Group on Pharmaceutical Administration for Verifying Drug-Induced Hepatitis and Preventing Recurrence (2010)
Iressa Drug-Induced HarmAstraZeneca withdrew its application for approval of Iressa in the United States (2011), limited health insurance coverage for Iressa in Japan to patients with specific genetic mutations (2011), faced rulings and appeals in Tokyo and Osaka District Courts (2011), and saw the Supreme Court dismiss the appeal against the government, resulting in the plaintiff’s defeat (2013).
Inclusion in the Routine Immunization Schedule under the Vaccination Law (2013)
HPV Vaccine Drug HarmNational Association of Cervical Cancer Vaccine Victims established (2013) Inclusion in the National Immunization Program under the Vaccination Law, followed by a temporary suspension of active vaccination recommendations three months later (2013) Initiated lawsuits against the government and pharmaceutical companies (2016)
2015
HPV Vaccine Drug HarmResumption of HPV Vaccine Recommendation (2022)