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Wednesday, Dec. 5, 2007

LATE SETTLEMENT LITTLE SOLACE

Hepatitis disaster another warning ignored


Staff writer

Ikuko Kuno gave birth to her first son at a maternity hospital in Ise, Mie Prefecture, in May 1988. The only thing different from when she gave birth to her daughter in 1986 was that the obstetrician gave her a blood-clotting agent to stop her hemorrhaging.

News photo
Ikuko Kuno, one of the plaintiffs in a lawsuit against the government and drugmakers over mass hepatitis C infections via tainted blood products, is interviewed last month in her home. SATOKO KAWASAKI PHOTO

Soon after she was discharged from the hospital, she began tiring and displaying signs of jaundice. A month later, she was diagnosed with hepatitis C and immediately hospitalized.

At that time, Kuno, a dental hygienist who now lives in Chiba Prefecture, knew that contracting the virus runs the risk of developing cirrhosis and then liver cancer. What she did not know was that she was among thousands of victims of a drug-induced medical disaster that experts say could have been prevented if regulators had heeded international warnings and acted sooner.

Last year, she joined a Tokyo-based lawsuit over the infections, targeting Mitsubishi Tanabe Pharma Corp., its subsidiary, Benesis Corp., and Nihon Pharmaceutical Co. — the firms that made and sold the tainted coagulants — and the government, which approved the products from 1964 to 1976.

Now Kuno and 200 other plaintiffs — mainly women — who have filed similar suits with five district courts are waiting for the Osaka High Court to draw up a basic settlement proposal — due out Friday — in hopes it will help ease their suffering and end their legal battles.

"I want the government and the companies to apologize for causing the disaster. I would not have contracted the disease if the government had taken action to stop the use of fibrinogen earlier," Kuno said.

Fibrinogen is one of the blood-clotting agents that caused the infections and was more widely used than the other two — christmassin and PPSB-Nichiyaku.

"I want (the defendants to provide) relief measures to all patients. The plaintiffs represent the tip of the iceberg. There are so many patients who cannot join the suits" because their medical records have been lost after their doctors destroyed them or retired, she said.

According to a 2002 estimate by the maker of fibrinogen, some 280,000 people were administered with the drug between 1980 and December 2001. About 10,000 of them contracted hepatitis C. There are no corresponding figures available for the other two products.

Kiyohiko Katahira, a professor of social welfare at Toyo University in Tokyo, said victims could number some 30,000 if patients who were given fibrinogen and the factor IX coagulants, including christmassin and PPSB-Nichiyaku, before 1980 are included. This would make it the largest drug-induced disaster in Japan's history.

Fibrinogen was manufactured by Green Cross Corp., now part of Mitsubishi Tanabe and Benesis, and approved by the government in 1964.

The U.S. Food and Drug Administration canceled its approval of fibrinogen in 1977 because it suspected the coagulant — made from donated blood — might have been tainted with hepatitis viruses.

Japanese authorities, however, did not take any action to halt the use of the coagulant, which was widely used to stop hemorrhaging during childbirth and surgery, until the late 1980s, when the hepatitis risk was recognized and the drugmaker began recalling the products.

Hepatitis C patients have suffered for decades.

The first adversity Kuno faced was the public misconception about the disease. When she was looking for a job in 1988, a dental clinic employee told her she could not be hired because her virus could possibly be transmitted.

She said she was shocked that someone involved in the medical profession knew so little about the virus or would use such callous words.

Hepatitis C can be transmitted via transfusion of tainted blood, use of tainted blood-clotting agents or tainted needles. The virus is not transmitted by ordinary human-to-human contact.

The medical treatment Kuno had to endure was also unpleasant. She was given interferon injections for five months in 1992 after she was diagnosed with chronic hepatitis. The treatment caused fever and hair loss, and the cost to receive interferon several times a week — several thousand yen per injection — hit her family's pocketbook.

In October, Yasuo Fukuda became the first prime minister to admit the government bears a responsibility for the mass hepatitis C infections — after four district courts in separate rulings between June 2006 and last March held the government and the three companies liable.

There is, however, no guarantee the Osaka High Court will offer a settlement plan that meets the plaintiffs' demands for an official apology, financial redress, permanent steps to help everyone infected, including those not involved in the lawsuits, proper medical treatment and an end to the social discrimination they face.

The virus, its symptoms, sufferers, and facts

What is hepatitis C and what are its symptoms?

Hepatitis C is a virus that weakens the liver. It was identified in 1988. It can develop into cirrhosis and liver cancer over decades if proper medical treatment is not administered.

Symptoms include fatigue, poor appetite and nausea, but they can be so mild that carriers may be unaware of their infection until they develop chronic hepatitis C or cirrhosis.

How many hepatitis C patients are there in Japan?

More than 1.5 million people are believed to have contracted the virus, according to the Health, Labor and Welfare Ministry.

How was the virus contracted?

In many cases, people undergoing treatment for unrelated ailments were infected by receiving transfusions of tainted blood or treated with contaminated blood-clotting agents such as fibrinogen, christmassin and PPSB-Nichiyaku.

Fibrinogen and christmassin were manufactured by the now-defunct Green Cross Corp., and PPSB-Nichiyaku was produced by Nihon Pharmaceutical Co. Such coagulants had been made from blood donated by thousands of people, including some infected with hepatitis C. Christmassin and PPSB-Nichiyaku output was halted by the late 1980s.

In 1992, a sophisticated examination system to screen blood for the virus was introduced in Japan, thereby reducing the infection risk from clotting agents.

How can the virus be transmitted?

The virus cannot be transmitted through ordinary social contact, including shaking hands and bathing together. Infection through sexual intercourse is rare and the risk of mother-infant transmission is low.

But public misperceptions mean hepatitis C patients still face discrimination in the workplace and at medical institutions.

Is there an effective medical treatment?

Interferon, an antibody protein that prevents the virus from increasing, can eliminate hepatitis C. The symptoms disappear in roughly 60 percent of interferon recipients.

But interferon causes serious side effects, including fever and hair loss, and costs about ¥800,000 a year. The length and frequency of the treatment varies by individual.

Beginning in 2008, the government plans to subsidize hepatitis patients who need to take interferon.

Can people be tested to determine if they are infected?

Most local governments offer free examinations at public health offices.

Recent media reports indicate the government wants to limit its compensation to hepatitis C patients who were infected from tainted coagulants during a set period based on a Tokyo District Court ruling last March.

The court ruled the government is liable for the infections that took place between April 1987, when an obstetrician in Misawa, Aomori Prefecture, reported to the health ministry that eight mothers given unheated fibrinogen were infected with hepatitis C, and June 1988, when the ministry finally ordered Green Cross to withdraw coagulants it had already sold — although the agent continued to be used in some cases.

The three other courts expanded the government's liability, ordering it to pay damages for infections that took place over a longer period of time.

Ryuhei Kawada, an Upper House member and hemophiliac who was infected with HIV and hepatitis C in the mid-1980s through tainted coagulants, said the health ministry has not learned anything from the HIV/AIDS fiasco of the 1990s. Here again, the U.S. had issued HIV-risk warnings about unheated blood products several years before the Japanese government and profit-hungry drug firms acted.

Kawada and other hemophiliac plaintiffs who filed lawsuits since 1989 won an out-of-court settlement with the government and drugmakers in 1996 that provided relief measures to some 2,000 hemophiliacs who contracted HIV through tainted coagulants. Green Cross was also the source of the blood-clotting agent that caused the mass HIV infections.

"The ministry has neglected the (hepatitis C) problem even though it had information" about the risk of infection, and the drugmakers have been insincere to the patients, he said.

Kawada said that although the settlement provided relief for all the HIV-infected hemophiliacs, it left unresolved key questions about how and why the mass infections occurred and to what extent the government was to blame.

Katahira of Toyo University said the collusive relationship among the government, drugmakers, academia, doctors and pharmacists has caused repeated drug-induced disasters in Japan.

"It was the government's fault that it approved fibrinogen (in 1964) and factor IX coagulants (in 1972) without sufficient examination of their safety. It was a violation of the Pharmaceutical Affairs Law," which bans manufacturing and selling contaminated drugs, said Katahira, who has studied Japan's drug-induced debacles for decades.

Katahira charges that tainted blood products were approved in the first place because of the systemic collusion, including "amakudari" (descent from heaven) — the practice in which retired bureaucrats land lucrative jobs with companies they once oversaw. In this case they went from the health ministry to drugmakers.

Bureaucrats at the ministry who authorize drugs side with the makers' safety claims when they examine the products, he says.

To prevent drug-related disasters, Katahira said it is necessary to ban amakudari and other collusion and create a system that can detect problems at an early stage and monitor how the safety of drugs is determined.

Kuno's hepatitis symptoms disappeared two years ago, but she gets a medical checkup every three months due to fear of a relapse.

"I previously felt drug-induced disasters were (someone else's) problem. After I was infected, the problem weighed heavily on me psychologically," she said. "I think health ministry bureaucrats (also) view the problem as somebody else's, and do not understand the suffering of the patients."



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