Hepatitis C(rime)

by Ian Priestley

In December 2009, along with a bill promising to support victims, the Japanese government released a statement recognising their liability in the infections of thousands with Hepatitis C. It was the latest instalment in a long running campaign fought by sufferers.

Hepatitis C is a blood-borne disease that may lead to cirrhosis of the liver. At the moment there is no failsafe cure, though interferon treatment is successful in some cases. As the virus is passed through blood, in a lot of countries the main mode of transmission is via hypodermic needles used by illegal drug users. In Japan there is a tiny population of injecting drug users so the virus has mainly been spread through medical channels approved by the government. In the post-war period, inoculations were often given with the same needle. Blood used in transfusions was also a likely source of infection as this remained unchecked for viruses until the 1960s.

There is nothing particularly unique to Japan in this. Many countries have unwittingly allowed blood-borne viruses to spread through a lack of regulation. This was mostly due to insufficient knowledge. Hepatitis viruses are particularly complex and there are different strains—some we are just discovering now.

The legal battle that led to the December 2009 ruling, however, made it clear that in Japan many infections could have been prevented.

From 1964 to 1988, women were routinely given blood-clotting agents, most notably fibrinogen, to stop them from hemorrhaging during childbirth. These blood-clotting agents, which used samples of donated blood, were later proved to contain the hepatitis C virus. It is thought that around 10,000 people contracted the disease through fibrinogen alone. It remains unclear, however, how many were contaminated with similar products, making it one of the worst pharmaceutical disasters in Japan’s history. The infections could have been stopped because there were clear warnings about fibrinogen’s danger, which, for various reasons, were ignored.

Although the hepatitis C virus wasn’t officially named until the late 80s, there were other known blood-borne forms such as hepatitis B and so-called non-A non-B (later hepatitis C).

In the US, the Food and Drug Administration (FDA) withdrew its approval of fibrinogen because a number of fibrinogen-transmitted hepatitis cases had been reported. Fibrinogen was banned in the US in 1977.

In Japan, the Green Cross Corp (now part of the Mitsubishi Tanabe and Benesis group) had been manufacturing fibrinogen from imported plasma since the Japanese government approved its use in 1964. When fibrinogen was banned in the US, naturally, Green Cross became aware of this, but it was under no obligation by law to inform the Ministry of Health and Welfare. It did nothing and continued to produce and sell fibrinogen despite doubts over its safety.

The Ministry of Health and Welfare has claimed that it didn’t know about the US withdrawal of approval because it had no system in place for gathering information from abroad—a claim which strains credibility. A report issued years later by the Investigation Commitees for Re-evaluation of Human Blood Products showed that approval for use in Japan was actually based on a study of only 60 patients. Japanese obstetricians went on routinely using the blood-clotting agent until 1988, after a doctor in Aomori reported that a group of mothers had contracted hepatitis C after its use.

Given the risks, the only possible case to make for the continued use of fibrinogen without further tests since the time of the American ban would be that the benefits outweighed the dangers. But this was not the case. Another reason cited for the withdrawal of the license in America was that the FDA doubted fibrinogen’s effectiveness. This doubt would prove justified. The widely accepted view now is that there are no benefits of fibrinogen to obstetric practices. If there were no benefits in the use of fibrinogen to patients, there were benefits to other parties.

The financial benefits to Green Cross Corp in continuing to produce fibrinogen are obvious. There were advantages for government ministers too, who had little to gain and a lot to lose by turning the screw on a major pharmaceutical company. The well-known practice of amakudari (descent from heaven) meant that lucrative retirement positions were lined up for health ministers in companies like Green Cross, so criticizing the actions of such companies would not have been in their interest.

While doctors themselves cannot really be accused of directly benefiting from the use of fibrinogen, they did little to question the practice. This may have been due in part to limited information. In medical texts dealing with obstetrics there were few mentions of the dangers of fibrinogen; on the contrary, it was recommended by ‘experts’ within the field. The lack of an inter-disciplinary approach in the Japanese academic/medical world may have meant that information from other areas such as virology, which could have highlighted the dangers, was not considered fully. According to Yasunaga Hideo of Tokyo University’s Department of Planning and Information Management, however, “Everyone who had a Japanese doctors license knew of the presence of non-A non-B hepatitis and the possibility of infection, even in the 1980s.” Despite this, most seemed happy to follow standard practice and use fibrinogen liberally. There was no real debate or calls for research into its effectiveness or its risk.

The December 2009 bill and admission of liability by the government didn’t come easily. An earlier court ruling had limited government responsibility to the period between the Aomori doctor’s discovery of the problem (April 1987) and when the government finally ordered Green Cross to withdraw the product (June 1988). That this case got as far as it did is due to an unlikely campaign waged by a group of (mainly) female hepatitis C sufferers, who asked questions in a way those in government and the medical profession had failed to.

There are different reasons for the disaster: collusion, self-interest, passive acceptance of authority, and poor dissemination of information all played a part. Add to that an inability to learn from mistakes—this wasn’t the first case of its kind. The current prime minister, Naoto Kan, is famous for exposing a Health Ministry cover-up involving contaminated blood, HIV, and (surprise, surprise) Green Cross. In both cases, the government and the company first responded by denying responsibility and trying to limit compensation.

Given the attention the hepatitis C case received, it may be a while
before the next major pharmaceutical disaster occurs, but unless this
time more energy is spent dealing with the actual causes – which lie
deep-rooted in Japanese institutions – rather than trying to avoid
responsibility, it won’t be too long.
















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