A GROUP of people who went blind after taking the drug chloroquine have lost their 20-year battle to win compensation from the Japanese government. Last month, the country鈥檚 Supreme Court ruled in favour of the government, even though the Ministry of Health and Welfare knew of the drug鈥檚 harmful side effects and gave no warning. In the 1960s and 1970s hundreds of people suffered damage to their retinas after being given the drug.
Chloroquine was developed in Germany and used by the US as an antimalaria drug during the Second World War. But as early as 1946 doctors were linking it to degeneration of the blood vessels in the retina. That same year, the US Food and Drug Administration ruled that chloroquine should be given only as a prophylactic for malaria, and only with a doctor鈥檚 prescription. By 1962, drugs containing chloroquine carried warning labels which pointed out that it could cause 鈥渧irtually irreversible鈥� damage to the retina with prolonged use.
In Japan, it was a different story. From 1959, chloroquine-based drugs were used, not as a short-term antimalaria drug, but as a long-term treatment for kidney disease. The Ministry of Health and Welfare did not require any warning labels, except to advise patients that chloroquine was an 鈥渆xtremely powerful medicine鈥�.
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鈥淭here鈥檚 a big difference between the way the FDA handled the sale of chloroquine and the way it was handled in Japan,鈥� says Takanori Goto, one of the lawyers representing the victims. 鈥淭he FDA officials were very tough in requiring pharmaceuticals companies to give accurate information to medical doctors. The Ministry of Health and Welfare left things in the hands of the pharmaceuticals companies.鈥�
As a result, several hundred Japanese patients taking chloroquine developed retinopathy. When the cause of their illness was revealed in the early 1970s, 259 of them filed suit against the government for failing to issue adequate warnings or recall the drug.
It was hard for the Ministry of Health and Welfare to argue that it knew nothing about chloroquine鈥檚 side effects. Apart from the widely publicised FDA rulings, the head of the ministry鈥檚 Drug Safety Section revealed under cross-examination that he had been taking a chloroquine-based drug called Resochin in 1965, but stopped after the chairman of the industry鈥檚 Drug Safety Commission told him about the side effects. 鈥淎s a matter of fact, I myself felt that my eyesight was rapidly getting worse 鈥� so I stopped taking it,鈥� he told the court.
The ministry argued that it had not known about the side effects of chloroquine when it first approved the sale of the drug in the late 1950s. Although the ministry admitted that it learnt about the side effects later, it said it had no legal obligation to step in or to alter the licence agreement. It maintained that pharmaceuticals companies were responsible for determining the safety of drugs, not the government.
That explanation infuriates Goto. 鈥淭he government鈥檚 attitude implies that it is here to protect business, not the public,鈥� he says. Goto points out that the ministry has close ties to the drugs companies. Like many civil servants, senior officials at the ministry frequently retire to lucrative directorships in the drugs companies they spent their careers monitoring. They are known in Japan as amakudari, or 鈥渁ngels descended from heaven鈥�.
The Supreme Court agreed with the ministry that the onus lay with drugs manufacturers, not the government, to determine whether a particular drug was safe. In its ruling, the Supreme Court said: 鈥淓ven if the drug is known to have some side effects, its approval by the state does not violate the law if its benefits outweigh the side effects.鈥�
The ruling took 20 years and two appeals to work its way through the courts. In 1982, the Tokyo District Court found in favour of the victims, but the Supreme Court鈥檚 verdict overrules the earlier decision.