EDITORIAL: Deadly cancer drug

After hundreds of hemophiliacs were infected with HIV by tainted blood products, a monument was put up at the Ministry of Health, Labor and Welfare to express the ministry's determination to stop future suffering from dangerous medical products.

The inscription on the monument pledges to continue to make the greatest possible effort to ensure the safety and efficacy of medical products so that people do not suffer disastrous harm like that inflicted upon the HIV-infected hemophiliacs.

We wonder if the ministry has really made good use of the lessons learned from the public health disaster. In the summer of 2002, three years after the monument was erected, Japan became the first country to approve the new lung cancer drug Iressa. Since then, many cancer patients have died or have been harmed by the drug's side effects. The Osaka and Tokyo District Courts, which heard lawsuits filed by victims and families, have recommended negotiated settlements.

The courts clearly acknowledged the responsibility of both the drug makers and the state for the suffering, according to outlines of the courts' opinions revealed by the plaintiffs. The parties concerned should accept the courts' recommendations and start negotiating settlements immediately. The plaintiffs are 15 people from four families. But more than 800 people to date have died from the drug's side effects.

How much responsibility the companies and the government should take for specific cases depends, to some extent, on when the drug was administered.

It would be unrealistic to expect cumbersome and time-consuming judicial procedures to speedily produce a fair and total solution to the dispute. As in other cases of drug-induced suffering, seeking a settlement through negotiation is the wisest choice for the parties to this suit.

Every drug has side effects. But Iressa has caused a far larger number of deaths than any other cancer drug. When restrictions were imposed on the use of the drug two and a half years after it was put on the market, the number of reported cases of Iressa side effects dropped sharply. Undoubtedly, there were problems with each aspect of the process of getting this drug to patients: manufacturing, approval, supply of related information to medical institutions, and monitoring after the drug began to be sold.

The Osaka District Court pointed out that the instructions for Iressa did not provide adequate information about possible side effects. The court also referred to questionable marketing tactics that raised expectations among patients for an effective cancer treatment without serious side effects.

The number of victims may have been increased because doctors who were not cancer specialists administered the drug in large quantities, but this issue was not directly addressed during the trials.

Providing effective relief to each of the victims and members of their families is vital. However, the public also expects that another, equally important, job to be carried out. That is to identify and fix the problems that led to the disaster.

Working out a settlement and making an exhaustive investigation into what happened would help alleviate anxiety among the patients who are currently benefiting from the use of Iressa.

Last year, a health ministry investigative committee set up in response to thousands of cases of hepatitis infection from the blood product fibrinogen proposed a review of the government's regulation and supervision of medical products and pharmaceutical companies. The themes that run through the committee's wide-ranging recommendations are an insistence on respect for human life and health, and the concept that quick responses should be made to any drug-related risk, with top priority placed on preventing damage.

We will see more powerful cancer drugs that carry risks of serious side effects if they are not used properly.

The government should take a hard look at the current relief system for people suffering health damage from drugs, which does not cover cancer treatments, as well as the way specialists are trained.

Making sincere and meticulous policy responses consistent with the spirit of the investigative committee's recommendations is the least the government must do to compensate the many victims.

--The Asahi Shimbun, Jan. 8