The government on Jan. 28 rejected a recommendation by the district courts in Tokyo and Osaka for a negotiated settlement of lawsuits over the side-effects caused by the lung cancer drug Iressa. The government’s rejection followed the rejection four days earlier by AstraZeneca K.K., an Osaka-based Japanese subsidiary of British drugmaker AstraZeneca PLC, which developed and manufactured the drug. The government believes that the recommendation contains provisions that would lead to the restriction of clinical trials and delay the approval process of cancer drugs.

On Jan. 12, the 15 plaintiffs accepted the courts’ Jan. 7 recommendation. The plaintiffs consist of a surviving patient who has suffered a side-effect from the drug and bereaved family members of six patients who died after using the drug. The rejection by the government and the company will only delay the relief for the plaintiffs. More than six years have passed since the plaintiffs filed the lawsuits in 2004. The lawsuits are the first over serious side-effects caused by a cancer drug.

The content of the court recommendation shows that the courts are likely to rule in favor of five of the seven patients involved in the lawsuits. The Osaka District Court will hand down a ruling on Feb. 25 and the Tokyo District Court on March 23. The lawsuit process will be prolonged because the government and the company will very likely appeal the rulings.

Expectations were high for Iressa because it directly targeted cancer cells. AstraZeneca K.K. on Jan. 25, 2002, asked the health ministry to approve the import and sale of the drug. The ministry acted speedily while the U.S. and European countries were slow in approving the import of the drug. The ministry gave the approval on July 5 that year, only about five months after the request for the approval was submitted.

For a country where drug approval takes a long time, it was an unusually quick action on the part of the ministry. In fact, Japan became the first country to approve the drug’s import. The drug went on sale 11 days after the approval was given. (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.)

Lung cancer patients had high expectations about Iressa not only because the drug directly targets cancer cells but also because it is a medicine for internal use and they can take it at home. According to the health ministry, 8,000 to 9,000 patients start taking the drug every year for lung cancer treatment and many patients are receiving benefits.

But there were not many pre-approval clinical trials and the drug was not free from adverse side-effects. About 300 users of the drug died of interstitial pneumonia in a one-year period after the approval was given to it. The health ministry issued an emergency notice on the drug’s safety on Oct. 15, 2002. As of the end of September 2010, 819 people had died of interstitial pneumonia and other side-effects of the drug, according to the ministry.

It is estimated that during the three-month period from the approval of the drug to the issuance of the notice, some 160 of the patients treated with the drug died of interstitial pneumonia. The death rate among the users of the drug immediately after the start of its sale was 3 percent to 4 percent — quite high for a cancer drug.

In the lawsuits, the 15 plaintiffs are calling for compensation totaling some ¥180 million. In the recommendation for a negotiated settlement of the lawsuits, the courts pointed out that in the initial document attached to the drug from July 5, 2002 (the date of the approval) to Oct. 15 that year (the date when the emergency notice was issued), interstitial pneumonia was the fourth from the top in the order of side-effects and that the document failed to mention the possibility that interstitial pneumonia could cause death.

Thus, the courts said that enough information was not disclosed about the drug during the period and that the government and the company should pay “reconciliation money” to the five patients who took the drug before Oct. 15, 2002. As to the remaining two patients who took the drug on or after that day, the courts said that the government and the company should sincerely negotiate with the plaintiffs concerned. The reverse side of the recommendation is that if the courts have to give rulings, their rulings concerning the two patients will be unfavorable to them since Oct. 15, 2002, will serve as a dividing line for relief and non-relief.

While rejecting the courts’ recommendation for a court-mediated settlement, the government said that it will consider setting up a system to provide relief to people who have suffered side-effects from cancer drugs and revising the Pharmaceutical Affairs Law to make clear the government’s responsibility concerning documents attached to a drug. The government should not forget the importance of preventing the suffering caused by a drug’s adverse side-effects. It should at least closely study the possible inadequacy of the process that led to the approval of Iressa and make the results public.

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