Japan's Hep C Crisis
First ruling near in suit over drug-caused hepatitis C debacle
By YOHEI SEKIand JUN NAGATA
OSAKA (Kyodo) Life changed drastically for Osaka resident Etsuko Morigami in 1987 when she was diagnosed with cirrhosis of the liver, some 13 years after being infected with hepatitis C through a tainted blood-clotting agent given to her while she was giving birth.
Morigami was treated with a blood-clotting product to stop her bleeding when she had her first son, Minoru, now 32.
After contracting cirrhosis, she developed diabetes and kidney damage. Insulin injections three times a day were a must.
"I often went out with my family and I was really in good shape," Morigami, 56, said of the time before the symptoms became severe, looking at the more than 10 kinds of drugs on a table beside her.
Considering her condition, treatment of hepatitis C with interferon, which eliminates the virus but whose side effects are severe, was halted. She developed liver cancer, and a long tube was inserted into her side to kill cancer cells with ethanol.
But she had relapses, with the intervals becoming shorter and shorter. Eventually she had no other option than a partial liver transplant, and Minoru was the donor.
"As you were infected when I was born, I will repay my debt to you," he told her.
Morigami underwent the transplant last June. To prevent rejection, she took an immuno-suppression drug, and to avoid infectious diseases she could not leave home, except to go to the hospital.
But her new liver gradually deteriorated, and the interferon treatments were resumed in February, now that there are more drugs available to control its side effects. Although she has also been diagnosed with lung cancer, it is inoperable.
"There is a time bomb inside you. If it explodes, you will blow up," a group of lawyers said in a statement aimed at trying to explain the plight of patients, many of them unwittingly infected with hepatitis C.
Although initial symptoms may not be critical, the hepatitis will eventually lead to cirrhosis and liver cancer.
"Swift measures should be taken before it is too late," said Morigami, one of the plaintiffs in a damages lawsuit against the government and Mitsubishi Pharma Corp.
Mitsubishi Pharma is the successor of Green Cross Corp., the firm that produced the blood product that caused her hepatitis C infection. The blood product was marketed under the brand name Fibrinogen-BBank.
The Osaka District Court will rule on the suit Wednesday in the first legal judgment involving tainted blood products leading to hepatitis C infections.
Besides the physical effects of hepatitis C, patients face discrimination often born out of ignorance and fear.
At a gathering in Tokyo's political center of Nagata-cho in late May, plaintiffs complained of discrimination and prejudice against them by employers and other sectors of society.
"I may not be employed if I tell (my employer) I am suffering from hepatitis C," a man in his 20s, one of the plaintiffs in a lawsuit filed with the Tokyo District Court, said.
A woman said, "I am hiding my disease because I fear that my children's friends' parents may tell them not to play with my kids."
Hepatitis C is caused mostly by direct infection of the blood and is not transmitted by ordinary social contact, but at the gathering many patients complained of the agony of not being able to tell people they have the disease.
Some reported having been refused dental treatment, and one woman was fired from her job in a company cafeteria. Management told her the disease was infectious.
Since the end of World War II, Japan has suffered several drug-induced disasters, including the childbirth deformities caused by thalidomide in the 1950s and '60s, SMON (a disease similar to polio), another disease caused by defective chloroquine in the 1950s, and the HIV/AIDS outbreak caused by contaminated blood products -- also marketed by Green Cross -- in the 1980s.
"The suffering can be said to be on a historically large scale, but the real situation is not well-known in society," said Kiyohiko Katahira, a professor of health and welfare at Toyo University.
Regarded as the largest of these drug-induced diseases is SMON, caused by the antiflatulence drug chinoform in the 1950s and 1960s, which affected some 10,000 people.
According to Mitsubishi Pharma, the number of patients since 1980 infected with hepatitis C as a result of taking the tainted blood product based on the naturally occurring protein fibrinogen is estimated at 10,000.
But as the product had been sold since its approval by the government in 1964, Katahira said, "The number of victims will be about 30,000 if the average annual number of victims before 1979 is assumed to be the same," making it much larger than the SMON disaster.
There is more than one similarity between this case and the HIV/AIDS fiasco, in which a doctor and a high-ranking official at the old Health and Welfare Ministry were prosecuted for allowing tainted products to stay on the market after being officially warned of their dangers. Victims in both cases have been plagued by discrimination and prejudice, and are waging lawsuits without revealing their real names.
In the case of hepatitis C, only 10 of the 96 plaintiffs across the country have made their real names public.
There are also many other victims who cannot become plaintiffs even if they wanted to, because their medical records have been lost and their link to tainted blood products cannot be proved.
Fibrinogen is a globulin in the blood that aids coagulation, and products containing it were widely used by obstetricians, gynecologists and surgeons. But the U.S. government canceled its approval for such blood products in 1977 because there was a danger that the products, made from donated blood, could be infected.
Despite that, 50,000 to 70,000 packages of the Green Cross product were sold annually between 1980 and 1986. When an epidemic of liver inflammation-infection cases erupted in Aomori Prefecture in 1987 and similar reports continued, Green Cross began to recall the product.
Although the government began to study ways to strengthen the medical examination and treatment system, Norio Hayashi, a professor at the graduate school of Osaka University, said the system is not satisfactory. "Hepatitis C patients are estimated to number 1.5 million in Japan, but there are only some 3,000 liver-specialist doctors," he said.
By YOHEI SEKIand JUN NAGATA
OSAKA (Kyodo) Life changed drastically for Osaka resident Etsuko Morigami in 1987 when she was diagnosed with cirrhosis of the liver, some 13 years after being infected with hepatitis C through a tainted blood-clotting agent given to her while she was giving birth.
Morigami was treated with a blood-clotting product to stop her bleeding when she had her first son, Minoru, now 32.
After contracting cirrhosis, she developed diabetes and kidney damage. Insulin injections three times a day were a must.
"I often went out with my family and I was really in good shape," Morigami, 56, said of the time before the symptoms became severe, looking at the more than 10 kinds of drugs on a table beside her.
Considering her condition, treatment of hepatitis C with interferon, which eliminates the virus but whose side effects are severe, was halted. She developed liver cancer, and a long tube was inserted into her side to kill cancer cells with ethanol.
But she had relapses, with the intervals becoming shorter and shorter. Eventually she had no other option than a partial liver transplant, and Minoru was the donor.
"As you were infected when I was born, I will repay my debt to you," he told her.
Morigami underwent the transplant last June. To prevent rejection, she took an immuno-suppression drug, and to avoid infectious diseases she could not leave home, except to go to the hospital.
But her new liver gradually deteriorated, and the interferon treatments were resumed in February, now that there are more drugs available to control its side effects. Although she has also been diagnosed with lung cancer, it is inoperable.
"There is a time bomb inside you. If it explodes, you will blow up," a group of lawyers said in a statement aimed at trying to explain the plight of patients, many of them unwittingly infected with hepatitis C.
Although initial symptoms may not be critical, the hepatitis will eventually lead to cirrhosis and liver cancer.
"Swift measures should be taken before it is too late," said Morigami, one of the plaintiffs in a damages lawsuit against the government and Mitsubishi Pharma Corp.
Mitsubishi Pharma is the successor of Green Cross Corp., the firm that produced the blood product that caused her hepatitis C infection. The blood product was marketed under the brand name Fibrinogen-BBank.
The Osaka District Court will rule on the suit Wednesday in the first legal judgment involving tainted blood products leading to hepatitis C infections.
Besides the physical effects of hepatitis C, patients face discrimination often born out of ignorance and fear.
At a gathering in Tokyo's political center of Nagata-cho in late May, plaintiffs complained of discrimination and prejudice against them by employers and other sectors of society.
"I may not be employed if I tell (my employer) I am suffering from hepatitis C," a man in his 20s, one of the plaintiffs in a lawsuit filed with the Tokyo District Court, said.
A woman said, "I am hiding my disease because I fear that my children's friends' parents may tell them not to play with my kids."
Hepatitis C is caused mostly by direct infection of the blood and is not transmitted by ordinary social contact, but at the gathering many patients complained of the agony of not being able to tell people they have the disease.
Some reported having been refused dental treatment, and one woman was fired from her job in a company cafeteria. Management told her the disease was infectious.
Since the end of World War II, Japan has suffered several drug-induced disasters, including the childbirth deformities caused by thalidomide in the 1950s and '60s, SMON (a disease similar to polio), another disease caused by defective chloroquine in the 1950s, and the HIV/AIDS outbreak caused by contaminated blood products -- also marketed by Green Cross -- in the 1980s.
"The suffering can be said to be on a historically large scale, but the real situation is not well-known in society," said Kiyohiko Katahira, a professor of health and welfare at Toyo University.
Regarded as the largest of these drug-induced diseases is SMON, caused by the antiflatulence drug chinoform in the 1950s and 1960s, which affected some 10,000 people.
According to Mitsubishi Pharma, the number of patients since 1980 infected with hepatitis C as a result of taking the tainted blood product based on the naturally occurring protein fibrinogen is estimated at 10,000.
But as the product had been sold since its approval by the government in 1964, Katahira said, "The number of victims will be about 30,000 if the average annual number of victims before 1979 is assumed to be the same," making it much larger than the SMON disaster.
There is more than one similarity between this case and the HIV/AIDS fiasco, in which a doctor and a high-ranking official at the old Health and Welfare Ministry were prosecuted for allowing tainted products to stay on the market after being officially warned of their dangers. Victims in both cases have been plagued by discrimination and prejudice, and are waging lawsuits without revealing their real names.
In the case of hepatitis C, only 10 of the 96 plaintiffs across the country have made their real names public.
There are also many other victims who cannot become plaintiffs even if they wanted to, because their medical records have been lost and their link to tainted blood products cannot be proved.
Fibrinogen is a globulin in the blood that aids coagulation, and products containing it were widely used by obstetricians, gynecologists and surgeons. But the U.S. government canceled its approval for such blood products in 1977 because there was a danger that the products, made from donated blood, could be infected.
Despite that, 50,000 to 70,000 packages of the Green Cross product were sold annually between 1980 and 1986. When an epidemic of liver inflammation-infection cases erupted in Aomori Prefecture in 1987 and similar reports continued, Green Cross began to recall the product.
Although the government began to study ways to strengthen the medical examination and treatment system, Norio Hayashi, a professor at the graduate school of Osaka University, said the system is not satisfactory. "Hepatitis C patients are estimated to number 1.5 million in Japan, but there are only some 3,000 liver-specialist doctors," he said.
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