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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.

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.

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.

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.

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.

Investigators must determine whether the corporate entity of Novartis Pharma as a whole was involved in the data falsification.

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.

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.

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.

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.

Pharmaceutical firms and university hospitals should take actions to put an end to such irregularities in the industry.

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.

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.

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.

(From The Yomiuri Shimbun, June 15, 2014)


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