HIV-tainted blood scandal (Japan)
Encyclopedia
, refers to an event in the 1980s when between one and two thousand haemophilia
patients in Japan contracted HIV
via tainted blood product
s. Controversy centers on the continued use of non-heat-treated blood products after the development of heat-treatments that prevent the spread of infection. Some high-ranking officials in the Ministry of Health and Welfare
, executives of the manufacture company and a leading doctor in the field of haemophilia study were charged for involuntary manslaughter.
caused by the Human Immunodeficiency Virus, HIV
. AIDS is currently considered incurable. The first reported cases of AIDS occurred in Los Angeles
in 1981. See full article at AIDS
.
It was not until 1985 that the first cases of AIDS were officially reported in Japan. As early as 1983, however, Japan's Ministry of Health and Welfare
was notified by Baxter Travenol Laboratories (BTL) that it was manufacturing a new blood product, licensed by the U.S.
Food and Drug Administration
(FDA), which was heat-treated to kill HIV
virus. BTL was interested in licensing this new product in Japan. Japanese Green Cross Corporation
(ミドリ十字), the main Japanese provider of blood products protested that this would constitute unfair competition, as it was "not prepared to make heat-treated agents itself". The Ministry of Health responded by ordering screening of untreated blood products, clinical trials of heat-treatments, and a campaign to increase domestic blood donations. Green Cross Corporation meanwhile distributed letters of "safety assurance of unheated blood products" to patients, many of whom suffered from haemophilia
.
and Tokyo
filed lawsuits against the Ministry of Health and Welfare and five Japanese drug companies. In 1994 two charges of attempted murder were filed against Dr. Abe Takeshi, who had headed the Health Ministry's AIDS research team in 1983; he was found not guilty in 2005. Abe resigned as vice-president of Teikyo University
.
In January 1996, Kan Naoto
was appointed Health Minister. He assembled a team to investigate the scandal, and within a month nine files of documents related to the scandal were uncovered, despite the Ministry of Health's claims that no such documents existed. As Minster, Kan promptly admitted the Ministry's legal responsibility and formally apologised to the plaintiff
s.
The reports uncovered by Kan's team revealed that, after the report about the possibility of contamination, untreated blood products were recalled by the Japanese importer. However, when the importer tried to present a report to the Ministry of Health, it was told that such a report was unnecessary. The Ministry claimed that there was a "lack of evidence pointing to links between infection with HIV and the use of unheated blood products." According to one official, "we could not make public a fact that could fan anxieties among patients" [J.E.N].
According to the files, the Ministry of Health had recommended, in 1983, that the import of untreated blood and blood products be banned, and that emergency imports of heat-treated products be allowed. A week later, however, this recommendation was withdrawn because it would "deal a blow" to Japan's marketers of untreated blood products [Updike].
In 1983 Japan imported 3.14 million litres of blood plasma
from the US to produce its own blood products, as well as 46 million units of prepared blood products. These imported blood products were said to pose no risk of HIV infection, and were used in Japan until 1986. Heat-treated products had been on sale since 1985, but there was neither a recall of remaining products nor a warning about the risks of using untreated products. As a result, untreated blood preparations stored at hospitals and in patients' home refrigerators were used up; there have been cases reported in which individuals were diagnosed with haemophilia for the first time between 1985 and 1986, began treatment, and were subsequently infected with HIV, even though it was known that HIV could be transmitted in untreated blood preparations, and treated products had become available and were in use at that time.
As early as 1984, several Japanese haemophiliacs were discovered to have been infected with HIV through the use of untreated blood preparations; this fact was concealed from the public. The patients themselves continued to receive "intentional propaganda" which downplayed the risks of contracting HIV from blood products, assured their safety, and promoted their use. Of some 4500 haemophiliacs in Japan, an estimated 2000 contracted HIV in the 1980s from untreated blood preparations [J.E.N].
Haemophilia
Haemophilia is a group of hereditary genetic disorders that impair the body's ability to control blood clotting or coagulation, which is used to stop bleeding when a blood vessel is broken. Haemophilia A is the most common form of the disorder, present in about 1 in 5,000–10,000 male births...
patients in Japan contracted HIV
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
via tainted blood product
Blood product
A blood product is any component of the blood which is collected from a donor for use in a blood transfusion. Whole blood is uncommonly used in transfusion medicine at present; most blood products consist of specific processed components such as red blood cells, blood plasma, or platelets.-Relation...
s. Controversy centers on the continued use of non-heat-treated blood products after the development of heat-treatments that prevent the spread of infection. Some high-ranking officials in the Ministry of Health and Welfare
Ministry of Health, Labour and Welfare (Japan)
The ' is a cabinet level ministry of the Japanese government. It is commonly known as Kōrō-shō in Japan. This ministry provides regulations on maximum residue limits for agricultural chemicals in foods, basic food and drug regulations, standards for foods, food additives, etc.It was formed with...
, executives of the manufacture company and a leading doctor in the field of haemophilia study were charged for involuntary manslaughter.
Background
Acquired Immune Deficiency Syndrome, or AIDS, is a communicable diseaseDisease
A disease is an abnormal condition affecting the body of an organism. It is often construed to be a medical condition associated with specific symptoms and signs. It may be caused by external factors, such as infectious disease, or it may be caused by internal dysfunctions, such as autoimmune...
caused by the Human Immunodeficiency Virus, HIV
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
. AIDS is currently considered incurable. The first reported cases of AIDS occurred in Los Angeles
Los Ángeles
Los Ángeles is the capital of the province of Biobío, in the commune of the same name, in Region VIII , in the center-south of Chile. It is located between the Laja and Biobío rivers. The population is 123,445 inhabitants...
in 1981. See full article at AIDS
AIDS
Acquired immune deficiency syndrome or acquired immunodeficiency syndrome is a disease of the human immune system caused by the human immunodeficiency virus...
.
It was not until 1985 that the first cases of AIDS were officially reported in Japan. As early as 1983, however, Japan's Ministry of Health and Welfare
Ministry of Health, Labour and Welfare (Japan)
The ' is a cabinet level ministry of the Japanese government. It is commonly known as Kōrō-shō in Japan. This ministry provides regulations on maximum residue limits for agricultural chemicals in foods, basic food and drug regulations, standards for foods, food additives, etc.It was formed with...
was notified by Baxter Travenol Laboratories (BTL) that it was manufacturing a new blood product, licensed by the U.S.
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA), which was heat-treated to kill HIV
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
virus. BTL was interested in licensing this new product in Japan. Japanese Green Cross Corporation
Green Cross (japan)
Green Cross Corporation was one of the premier pharmaceutical companies in Japan. The company merged into Yoshitomi Pharmaceutical Co., Ltd. on April 1, 1998, and renamed to Welfide Corporation on April 1, 2000. Finally Welfide Corp. and Mitsubishi-Tokyo Pharmaceutical Inc...
(ミドリ十字), the main Japanese provider of blood products protested that this would constitute unfair competition, as it was "not prepared to make heat-treated agents itself". The Ministry of Health responded by ordering screening of untreated blood products, clinical trials of heat-treatments, and a campaign to increase domestic blood donations. Green Cross Corporation meanwhile distributed letters of "safety assurance of unheated blood products" to patients, many of whom suffered from haemophilia
Haemophilia
Haemophilia is a group of hereditary genetic disorders that impair the body's ability to control blood clotting or coagulation, which is used to stop bleeding when a blood vessel is broken. Haemophilia A is the most common form of the disorder, present in about 1 in 5,000–10,000 male births...
.
AIDS spreading in Japan
The first HIV patient was reported in 1979, who was also a haemophilia patient and prescribed blood products by his doctor. Second example is a Japanese male artist who had lived abroad for some years. Some other example also reported in the early 1980s and these patients were haemophilia patients or had homosexual experiences. After the intense media coverage on a HIV-positive woman who had contracted the virus through heterosexual intercourses, the disease became well-known in Japan and the government ordered to study the dispute over the safety of blood products.Lawsuits
In May and October 1989, HIV-infected haemophiliacs in OsakaOsaka
is a city in the Kansai region of Japan's main island of Honshu, a designated city under the Local Autonomy Law, the capital city of Osaka Prefecture and also the biggest part of Keihanshin area, which is represented by three major cities of Japan, Kyoto, Osaka and Kobe...
and Tokyo
Tokyo
, ; officially , is one of the 47 prefectures of Japan. Tokyo is the capital of Japan, the center of the Greater Tokyo Area, and the largest metropolitan area of Japan. It is the seat of the Japanese government and the Imperial Palace, and the home of the Japanese Imperial Family...
filed lawsuits against the Ministry of Health and Welfare and five Japanese drug companies. In 1994 two charges of attempted murder were filed against Dr. Abe Takeshi, who had headed the Health Ministry's AIDS research team in 1983; he was found not guilty in 2005. Abe resigned as vice-president of Teikyo University
Teikyo University
is a private university headquartered in the Itabashi ward of Tokyo, Japan. It was established in 1931 as Teikyo Commercial High School by Lee. It became Teikyo University in 1966...
.
In January 1996, Kan Naoto
Naoto Kan
is a Japanese politician, and former Prime Minister of Japan. In June 2010, then-Finance Minister Kan was elected as the leader of the Democratic Party of Japan and designated Prime Minister by the Diet to succeed Yukio Hatoyama. On 26 August 2011, Kan announced his resignation...
was appointed Health Minister. He assembled a team to investigate the scandal, and within a month nine files of documents related to the scandal were uncovered, despite the Ministry of Health's claims that no such documents existed. As Minster, Kan promptly admitted the Ministry's legal responsibility and formally apologised to the plaintiff
Plaintiff
A plaintiff , also known as a claimant or complainant, is the term used in some jurisdictions for the party who initiates a lawsuit before a court...
s.
The reports uncovered by Kan's team revealed that, after the report about the possibility of contamination, untreated blood products were recalled by the Japanese importer. However, when the importer tried to present a report to the Ministry of Health, it was told that such a report was unnecessary. The Ministry claimed that there was a "lack of evidence pointing to links between infection with HIV and the use of unheated blood products." According to one official, "we could not make public a fact that could fan anxieties among patients" [J.E.N].
According to the files, the Ministry of Health had recommended, in 1983, that the import of untreated blood and blood products be banned, and that emergency imports of heat-treated products be allowed. A week later, however, this recommendation was withdrawn because it would "deal a blow" to Japan's marketers of untreated blood products [Updike].
In 1983 Japan imported 3.14 million litres of blood plasma
Blood plasma
Blood plasma is the straw-colored liquid component of blood in which the blood cells in whole blood are normally suspended. It makes up about 55% of the total blood volume. It is the intravascular fluid part of extracellular fluid...
from the US to produce its own blood products, as well as 46 million units of prepared blood products. These imported blood products were said to pose no risk of HIV infection, and were used in Japan until 1986. Heat-treated products had been on sale since 1985, but there was neither a recall of remaining products nor a warning about the risks of using untreated products. As a result, untreated blood preparations stored at hospitals and in patients' home refrigerators were used up; there have been cases reported in which individuals were diagnosed with haemophilia for the first time between 1985 and 1986, began treatment, and were subsequently infected with HIV, even though it was known that HIV could be transmitted in untreated blood preparations, and treated products had become available and were in use at that time.
As early as 1984, several Japanese haemophiliacs were discovered to have been infected with HIV through the use of untreated blood preparations; this fact was concealed from the public. The patients themselves continued to receive "intentional propaganda" which downplayed the risks of contracting HIV from blood products, assured their safety, and promoted their use. Of some 4500 haemophiliacs in Japan, an estimated 2000 contracted HIV in the 1980s from untreated blood preparations [J.E.N].
Charges
Matsushita Renzo, former head of the Ministry of Health and Welfare's Pharmaceutical Affairs Bureau, and two of his colleagues, were found guilty of professional negligence resulting in death. Matsushita was sentenced to two years in jail. A murder charge was also brought against him. Matsushita, who after retirement became president of Green Cross, is one of at least nine former Ministry of Health bureaucrats who have retired to executive positions in Japan's blood industry since the 1980s (see ama kudari).See also
- Ryuhei KawadaRyuhei Kawadais a Japanese activist, haemophiliac, and member of the House of Councillors.-HIV-tainted blood scandal in Japan:In the late 1980s, between one and two thousand Japanese patients with haemophilia contracted HIV via tainted blood products...
- Contaminated haemophilia blood productsContaminated haemophilia blood productsContaminated hemophilia blood products were a serious public health problem in the late 1970s through 1985. These products caused large numbers of haemophiliacs to become infected with HIV and hepatitis C...
- Infected blood scandal (France)Infected blood scandal (France)France's Infected blood scandal began in April 1991 when doctor and journalist Anne-Marie Casteret published an article in the weekly magazine the L'Événement du jeudi proving that the Centre National de Transfusion Sanguine knowingly distributed blood products contaminated with HIV to...
- Royal Commission of Inquiry on the Blood System in CanadaRoyal Commission of Inquiry on the Blood System in CanadaThe Royal Commission of Inquiry on the Blood System in Canada, more commonly referred to as the Krever Commission or Krever Inquiry, was a Royal commission headed by Mr Justice Horace Krever established by the Canadian Government in October 1993...
- Infected blood scandal (France)
- Tainted blood scandalTainted blood scandalThe terms tainted blood scandal, contaminated blood scandal, or infected blood scandal may be a reference to:*Contaminated haemophilia blood products...
Further reading
- "AIDS," in Encyclopædia Britannica Online
- Feldman, Eric A., and Ronald Bayer, eds, Blood Feuds: AIDS, Blood, and the Politics of Medical Disaster," New York: Oxford University Press, 1999.
- Ikeda, Eriko. Society and AIDS, in Japan Quarterly vol. 42. January–March 1995.
- "Japan Sent Back HIV-Tainted Blood Products to US in '83," in Japan Economic Newswire February 8, 1996.
- Updike, Edith Hill. "Anatomy of a Tragedy: An AIDS Scandal Shakes Up Japan, Inc.," in Business Week, March 11, 1996.