イレッサ訴訟―和解に向け、協議進めよ

2011/01/10
--The Asahi Shimbun, Jan. 8
EDITORIAL: Deadly cancer drug
イレッサ訴訟―和解に向け、協議進めよ

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.
　薬害エイズ事件の後、厚生労働省の敷地内に建てられた薬害根絶の「誓いの碑」の一節だ。

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.
　悲惨な被害を再び発生させることのないよう医薬品の安全性・有効性の確保に最善の努力を重ねていく――。

We wonder if the ministry has really made good use of the lessons learned from the public health disaster.
その反省はどこまで生かされているだろうか。

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.
　建立から３年後の２００２年夏、肺がん治療薬イレッサは世界に先駆けて日本で承認された。

The Osaka and Tokyo District Courts, which heard lawsuits filed by victims and families, have recommended negotiated settlements.
その薬を飲んだ患者や遺族が副作用の被害を訴えた裁判で、大阪、東京両地裁が和解を勧告した。

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.
患者側が明らかにした裁判所の所見の骨子は、製薬企業と国の責任を明確に認める内容になっている。

The parties concerned should accept the courts' recommendations and start negotiating settlements immediately. 　関係者はこれに応じ、直ちに話し合いのテーブルにつくべきだ。

The plaintiffs are 15 people from four families. But more than 800 people to date have died from the drug's side effects.
　原告は４家族１５人だが、副作用による死者はこれまでに８００人を超す。

How much responsibility the companies and the government should take for specific cases depends, to some extent, on when the drug was administered.
使った時期によって企業や国の責任の度合いも微妙に異なる。

It would be unrealistic to expect cumbersome and time-consuming judicial procedures to speedily produce a fair and total solution to the dispute.
手間と時間がかかる裁判手続きで、早期に公平かつ全面的な解決を図るのはおのずと限界がある。

As in other cases of drug-induced suffering, seeking a settlement through negotiation is the wisest choice for the parties to this suit.
これまでの薬害と同じく和解の道をとるのが賢明な選択だ。

Every drug has side effects. But Iressa has caused a far larger number of deaths than any other cancer drug. 　薬に副作用はつきものだ。だがイレッサの場合、死者の数は他の抗がん剤と比べても極端に多い。

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.
発売から２年半後に使用方法が制限されると、被害は急速に減った。

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.
製造から承認、医療現場への周知、市販後の追跡と監視。それぞれの局面で省みるべき点があったのは疑いない。

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.
　大阪地裁は、イレッサの添付文書に副作用のことがしっかり書かれていなかった問題を指摘するとともに、「重い副作用のない抗がん剤」として患者らの期待を高めた企業の姿勢に言及した。

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.
裁判では直接争われていないが、イレッサをめぐっては専門でない医師が大量に処方したことが被害の拡大をもたらしたとも言われている。

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.
　患者や遺族一人ひとりの救済はもちろんだが、薬害を生んだこうした様々な原因の解明とその改善こそ、国民が期待する最も重要なことだ。

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.
　和解を成立させ、一連の経緯を徹底的に検証する。それは、現にイレッサを使用し、効果を上げている患者たちの不安をぬぐうことにもつながる。

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.
　薬害肝炎を機に厚労省に置かれた検証委員会は昨年、医薬品行政の見直しや企業のあり方について提言をまとめた。

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.
内容は多岐にわたるが、それらを貫くのは生命・健康の尊重であり、被害の予防を何よりも優先させて迅速に対策を講じなければならないという、至極当然の考えである。

We will see more powerful cancer drugs that carry risks of serious side effects if they are not used properly.
　よく効く半面、使い方を誤れば副作用も強い。

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.
そんな新しい抗がん剤はこれからも登場するはずだ。がん治療薬を対象外としている現在の健康被害救済制度や、専門医の養成についても検討を深める。

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.
提言の精神を生かした真摯（しんし）できめ細かな対応こそ、多くの被害者に対するせめてもの報いである。