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2013年4月 6日 (土)

イレッサ訴訟 重い教訓を薬事行政に生かせ

[The Yomiuri Shimbun] April 6, 2013
イレッサ訴訟 重い教訓を薬事行政に生かせ(4月5日付・読売社説)
EDITORIAL / Govt must use lessons in Iressa suit?to make drug administration sound

The government should consider the problems that became clear in the Iressa case as bitter lessons. It now faces a test as to whether it can effectively utilize those lessons in its administration of pharmaceutical affairs hereafter.
 裁判で浮き彫りになった問題点を教訓とし、今後の薬事行政にどう生かすかが問われよう。

Claiming that patients died from side effects of the lung cancer drug Iressa, bereaved family members filed a damages lawsuit against the government and AstraZeneca K.K., the importer and seller of the drug. It is clear now the suit will end in a total defeat for the plaintiffs.
 肺がん治療薬「イレッサ」の副作用で死亡したとして、患者の遺族が国と販売元のアストラゼネカ社に損害賠償を求めた訴訟は、原告の全面敗訴で終結することが確実になった。

The Supreme Court has decided to dismiss an appeal by the plaintiffs against the state. The decision confirmed the ruling by the Tokyo High Court in not holding the government liable for damages for the deaths. The court is also expected to render a decision in favor of AstraZeneca shortly. The case, which has lasted about eight years, raises questions about how the government should administer pharmaceutical affairs.
 最高裁が、国に対する原告側の上告を受け付けないことを決め、国の勝訴が確定した。ア社の勝訴も近く確定する見通しだ。約8年間にわたり、薬事行政の在り方が問われた裁判の区切りである。

Iressa is an orally administered tablet, which was approved by the Health, Labor and Welfare Ministry in July 2002, before its approval in other countries. It was an unusually quick process, with approval coming just five months after the application was filed. The reputation of the drug being easy to swallow with few side effects was widespread and its usage spread quickly.
 イレッサは錠剤の飲み薬で、2002年7月、厚生労働省が世界に先駆けて承認した。申請から5か月という異例のスピード承認だった。「飲みやすく、副作用が少ない」との評判が広がり、医療現場で一気に普及した。

However, many patients began dying one after another after undertaking Iressa treatment. The number of deaths suspected to have been caused by Iressa side effects, such as interstitial pneumonia, has reached about 860.
 ところが、服用後に死亡する患者が相次いだ。間質性肺炎など、イレッサの副作用が疑われる死亡例は約860件に上っている。

A major bone of contention in the trial was whether AstraZeneca's provision of information on Iressa's side effects to medical institutions was sufficient. Another issue was whether the health ministry had given appropriate instructions to the pharmaceutical firm.
 裁判の争点となったのは、ア社の医療機関への副作用情報の提供は十分だったか、という点だ。厚労省がア社に適切な指導を行っていたかどうかも争われた。

Many problems must be solved

With the decision, we can say the Supreme Court has found no fault requiring compensation by either the firm or the state. However, the case highlighted mounting problems that the company and government must reflect upon.
 最高裁は、ア社、厚労省には賠償を命じるべき落ち度はないと判断したと言える。だが、反省すべき問題は山積している。

During clinical tests, Iressa's side effects were already known. Despite this, AstraZeneca emphasized the efficacy of the drug in its advertising. The question remains whether this attitude may have exacerbated the problem.
 臨床試験段階で、イレッサの副作用は既に確認されていた。にもかかわらず、新薬の効き目にPRの比重を置いたア社の姿勢が、問題を大きくした側面はないか。

Although the correlation between the consumption of Iressa and the deaths was not clear, it took three months after approval for the health ministry to issue instructions to the drug firm to issue emergency information advising doctors to carefully administer the drug.
 死亡とイレッサの因果関係は明確でなかったにせよ、慎重な投与を求めるため、厚労省がア社に緊急情報を出すよう指示したのは、承認から3か月も後だった。

Another problem is that the risks of side effects were not thoroughly made clear to doctors, creating a situation in which sufficient explanations were not provided to patients.
 副作用の危険性が医師に周知されず、患者に十分な説明がなされなかったという問題もある。

The health ministry must use this trial as a signal to its pharmaceutical affairs administration, which consequently did not respond seriously enough to the side effects of the drug.
 今回の裁判について、厚労省は、副作用への対応を結果的に軽んじた薬事行政に対する警鐘と受け止めるべきだ。

Speedy approval still necessary

However, on the other hand, the ministry should not be excessively cautious in approving medicines. Accelerated approval of drugs suits the current times.
 ただ、一方で、医薬品の承認が過度に慎重になってはならない。承認のスピードアップは、時代の要請である。

In cases where patients have severe diseases, such as terminal cancer, many of them want to take new drugs, even being keenly aware of possible side effects. Regarding Iressa, last year about 7,500 patients began taking the drug.
 末期がんなど、重篤な患者の場合、副作用を承知した上で、新薬を望むケースは少なくない。イレッサについても、昨年は新たに約7500人が服用している。

The health ministry must create a situation in which drugs are available to patients as quickly as possible. For their part, pharmaceutical firms need to ensure doctors thoroughly understand all information on new drugs, including the negative factors such as side effects. It is important for the government to thoroughly observe these basics of pharmaceutical administration.
 厚労省は、新薬を患者にできるだけ早く投与できるようにする。製薬会社は、副作用などのマイナス面を含む全ての情報を周知する。こうした薬事行政の基本を徹底することが重要である。

(From The Yomiuri Shimbun, April 5, 2013)
(2013年4月5日01時49分  読売新聞)

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