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Wednesday, Nov. 23, 2011

EDITORIAL

Disturbing Iressa ruling

The Tokyo High Court on Nov. 15 overturned a lower court ruling that had ordered the government and the Japanese unit of the British drugmaker AstraZeneca PLC to pay compensation to bereaved family members of two people who died allegedly because of a side effect caused by the lung cancer drug Iressa. The plaintiffs appealed the ruling to the Supreme Court two days later.

The high court appeared in a rush to make its ruling in the trial, which started in September. It held only two hearings and it took only three weeks to reach a decision after the conclusion of hearings. While it reviewed the same material presented in the first trial, the high court reached the opposite conclusion. One wonders whether it fully examined the case.

The focal point of the trial was whether instructions attached to the drug sufficiently warned against the possibility of its side effects. The lawsuit was filed by four bereaved family members of three dead lung cancer patients. They called on the government and AstraZeneca K.K., the Osaka-based importer of the drug, to pay a total of ¥77 million in compensation.

Iressa raised hope among lung cancer patients because it directly targets cancer cells and it only has to be taken once a day and is ingested. AstraZeneca K.K. asked the health ministry to approve the import and sale of the drug on Jan. 25, 2002. The ministry gave the approval on July 5 that year, only about five months after the request for the approval was submitted — an unusually quick action for a country where drug approval normally takes a long time. Japan became the first country to approve the drug's import and Iressa went on sale 11 days after the approval was given. The drug began to be widely prescribed to lung cancer patients who cannot undergo operations and those who have suffered a relapse of lung cancer.

But during the first three-month period from the approval of the drug, some 160 patients treated with it died of interstitial pneumonia. The death rate among users immediately after the start of the drug's sale was 3 percent to 4 percent — quite high for a cancer drug. Annually 8,000 to 9,000 patients start taking the drug and many patients are benefiting from it. But the health ministry says that as of the end of September 2011, 843 patients died of interstitial pneumonia and other side effects of the drug.

In its March 2011 ruling, the district court said that the health ministry violated the State Tort Liability Law by failing to have AstraZeneca state in the instructions for the drug from July 5, 2002, (the date of the approval) that Iressa can cause interstitial pneumonia as a side effect and that the disease can cause death.

The district court said that it was difficult for ordinary doctors to understand that the side effect can be fatal just by reading the drug's instructions. Pointing out the fact that interstitial pneumonia was the fourth from the top in the order of side effects in the instructions accompanying the drug through Oct. 15, 2002 (the date when an emergency noticed was issued), the court said that it should have been placed ahead of other side effects. It also said that AstraZeneca failed to ensure safety as acquired by the Produce Liability Law because it failed to provide sufficient information about interstitial pneumonia as a side effect.

Thus the court held both the government and AstraZeneca responsible for compensation and ordered them to pay ¥17.6 million in compensation to two family members of two deceased patients. The previous month, the Osaka District Court had held only AstraZeneca responsible for compensation in a similar lawsuit.

In its Nov. 15 ruling, the Tokyo High Court said that doctors specializing in cancer or anti-cancer drugs should have been able to know that interstitial pneumonia can cause death even if the instructions did not clearly mention the possibility of death.

It pointed out that three cases of interstitial pneumonia that occurred during the clinical tests of the drug in Japan did not cause death and that four deaths reported abroad cannot be attributed to the use of the drug. The high court concluded that even if the instructions for the drug did not state that interstitial pneumonia can cause death, and even if pneumonia was listed fourth from the top in the order of side-effect frequency, the instructions and warnings were not deficient.

It is regrettable that the high court quashed the district court's position that a drug company has a responsibility to make its product safe and that the government has administrative responsibility to have the drug company sufficiently explain possible side effects.

The clinical tests of Iressa were carried out on only about 150 patients. The high court should have considered whether the government sufficiently controlled the use of the drug once it was put on sale. It is predictable that when a large number of patients use a drug, unexpected incidences of side effects increase.

It is also notable that the U.S. approved the drug's import on May 5, 2003, but it prohibited in principle giving the drug to new patients on June 17, 2005, after it was determined that the drug did not show a survival benefit.

The government should strengthen the system to test new drugs so that they can be approved in a short time with their safety fully ensured as well as set up a system to provide relief to people who have suffered side effects from cancer drugs. The Pharmaceutical Affairs Law also should be revised to make clear the government's responsibility concerning instructions attached to drugs.



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