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2014年6月16日 (月)

薬効改竄逮捕 産学のもたれ合いも解明せよ

The Yomiuri Shimbun
Business-academia collusion must be exposed regarding clinical drug trials
薬効改竄逮捕 産学のもたれ合いも解明せよ

The alleged data falsification in the clinical research of a drug has developed into a criminal case. The entire picture of the problem must be clarified to prevent such an irregularity from recurring.
 臨床研究のデータ改竄かいざん問題が、刑事事件に発展した。全容を解明し、再発防止につなげなければならない。

The Tokyo District Public Prosecutors Office’s special investigation squad has arrested a former employee of Novartis Pharma K.K., the Japanese subsidiary of Swiss pharmaceutical giant Novartis AG, on suspicion of violating the Pharmaceutical Affairs Law in connection with Diovan, a Novartis drug used to treat high blood pressure.
 東京地検特捜部が、高血圧治療薬「ディオバン」を販売する大手製薬会社「ノバルティスファーマ」の元社員を、薬事法違反容疑で逮捕した。

The man is suspected of having provided falsified data to doctors and researchers at such institutions as Kyoto Prefectural University of Medicine to make the drug appear effective in preventing cerebral apoplexy, in a bid to have the data included in their research papers.
 京都府立医大の医師らに、薬が脳卒中の予防に効果があるかのように改竄した虚偽のデータを提供し、論文などに掲載させた疑いが持たれている。

The former Novartis employee has reportedly denied any wrongdoing. The special investigation squad must do everything it can in its investigation to determine exactly how the suspected falsification of the clinical research data occurred as well as the motives behind the irregularities.
 元社員は容疑を否認しているとされる。特捜部は捜査を尽くし、データ改竄の経緯や動機を明らかにすることが求められる。

With annual sales of about ¥100 billion, Diovan has been widely used by the nation’s medical institutions. Novartis has allegedly used the research papers based on the falsified data for advertising purposes—an action that is nothing less than completely undermining the public’s confidence in medicine and a betrayal of the trust of patients who placed their expectations on the drug’s efficacy.
 ディオバンは医療機関で広く使用され、売り上げは年間約1000億円に上る。ノバ社は、不正データに基づく論文を宣伝に利用していた。医薬品の信頼を著しく損なう行為であり、薬効を期待した患者への背信にほかならない。

Investigators must determine whether the corporate entity of Novartis Pharma as a whole was involved in the data falsification.
 会社による組織ぐるみの関与がなかったのか、究明が必要だ。

The former Novartis employee was involved in data analyses during Diovan clinical research at four universities in addition to Kyoto Prefectural University of Medicine, including Jikei University School of Medicine in Tokyo. Prosecutors say the data were ascertained to have been altered in many cases. We cannot help but wonder why the medical doctors at the universities were unaware of what happened.
 元社員は京都府立医大のほか慈恵医大など4大学の臨床研究でデータ解析に携わり、その多くでデータ操作が判明している。各大学の医師たちは、なぜ不正に気づかなかったのだろうか。

Urgent need for impartiality

Laboratories of those universities have so far received more than ¥1.1 billion in research funding from Novartis Pharma. The possibility is high that the back-scratching relations between universities, who are eager to obtain cash from businesses, and Novartis, out to exploit research results to promote its drug sales, may have formed a hotbed of wrongdoing.
 これらの大学の研究室には、ノバ社からこれまでに計11億円を超える奨学寄付金が提供された。企業から資金を得たい大学と、研究成果を販売促進に役立てたい企業のもたれ合いが、不正の温床となった可能性がある。

Clinical research for such medicines as Diovan should be conducted primarily for the purpose of collecting data conducive to helping patients and their doctors choose an optimum method of treatment. The special investigation squad must get to the bottom of the alleged collusion between the pharmaceutical company and the universities.
 ディオバンのような処方薬の臨床研究は本来、医師や患者が最適な治療を選択するためのデータを集めるのが目的だ。特捜部は、製薬会社と大学の癒着構造にも切り込んでもらいたい。

There has been no end to irregularities in clinical research activities. It has been disclosed, for instance, that Novartis illegally obtained data on participants in the trials of its leukemia drug that were conducted at the University of Tokyo Hospital and elsewhere. The company also failed to report the drug’s side effects to the Health, Labor and Welfare Ministry.
 臨床研究を巡る不正は後を絶たない。ノバ社は東京大病院などが実施した白血病治療薬の研究に関与し、患者の個人情報を不正に取得した。副作用についても厚生労働省に報告しなかった。

Pharmaceutical firms and university hospitals should take actions to put an end to such irregularities in the industry.
 製薬会社と大学病院は、自浄作用を高めるべきだ。

The Japan Pharmaceutical Manufacturers Association, for that matter, has decided that its member firms will not make donations to universities engaged in clinical tests of their products and refrain from accepting requests from universities for undertaking related data analyses.
 日本製薬工業協会は、自社製品の臨床研究を行う大学に対しては、寄付金を提供せず、データ解析を引き受けないことを申し合わせた。

The Science Council of Japan, for its part, has come out with a proposal for establishing a governmental organization tasked with conducting unbiased clinical research on medical products.
日本学術会議は、医薬品の臨床研究を中立的に運営する公的組織の整備を提言している。

The government is currently working out a set of ethical guidelines that will call for universities to preserve their clinical research data for a long period and have the outcomes examined by third parties. It is undoubtedly of great significance to create arrangements truly effective in addressing the task of ensuring that clinical research is conducted properly.
 政府は現在、データの長期保存や第三者による研究のチェックを大学側に求める倫理指針を策定中だ。実効性のある取り組みで、臨床研究の公正性を担保することが肝要である。

(From The Yomiuri Shimbun, June 15, 2014)

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