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The Diovan scandal in Japan; don’t let bygones be bygones

Journal of Human Hypertension volume 36, pages 500–501 (2022)Cite this article

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Novartis conducted post-marketing clinical trials at five university hospitals in Japan to investigate additional effectiveness of Diovan. The results of the clinical trials were published in prominent medical journals such as the Lancet and the European Heart Journal from 2007 to 2012 [1]. However, there have been a lot of doubts about the content since the publication, and factitious study results were statistically pointed out in 2012 [2]. The indefensible accusation provoked thorough investigations, and it revealed that a Novartis employee had been involved in the trials under a hidden identity and had falsified data, causing retraction of all published papers about these trials by 2018.

After approval in 2000, the company expanded its market share to become the second-largest selling angiotensin receptor blocker in Japan at the time and the total domestic sales of more than $10 billion by 2012 [3]. The results of these papers had been advertised by Novartis to support the sales of Diovan before retraction. In this way, Diovan had brought enormous profits to Novartis by the time the paper was retracted. Based on the above facts, the Ministry of Health, Labor and Welfare of Japan charged criminal accusation against Novartis and its former employees, claiming that the marketing of Diovan using academic publications that exaggerated the effectiveness of Diovan was a violation of Article 66 (prohibition of false and exaggerated advertising) of the Pharmaceutical Affairs Law in 2014. However, after more than 7 years of the court struggle, on June 28, 2021, the Supreme Court dismissed a final appeal and eventually acquitted them.

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Data availability

The data that support the findings of this study are available from the corresponding author, upon reasonable request.

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Authors and Affiliations

  1. Medical Governance Research Institute, Minato-ku, Tokyo, Japan

    Nanami Murata, Akihiko Ozaki, Anju Murayama & Tetsuya Tanimoto

  2. Department of Breast Surgery, Jyoban Hospital of Tokiwa Foundation, Iwaki, Fukushima, Japan

    Akihiko Ozaki

  3. Department of Surgery, Jyoban Hospital of Tokiwa Foundation, Iwaki, Fukushima, Japan

    Toyoaki Sawano

  4. Department of Internal Medicine, Navitas Clinic Kawasaki, Tokyo, Japan

    Tetsuya Tanimoto

Authors
  1. Nanami Murata
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  2. Akihiko Ozaki
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  4. Toyoaki Sawano
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  5. Tetsuya Tanimoto
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Contributions

NM was responsible for designing the study concept, drafting of the manuscript, and updating reference lists. AO contributed to writing the manuscript and provided feedback on the report. AM, TT, and TS provided feedback on the report.

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Correspondence to Nanami Murata.

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Competing interests

AO and TT received personal fees from Medical Network Systems outside the scope of the submitted work. TT also received personal fees from Bionics Co. Ltd, outside the scope of the submitted work. Other authors declare no competing interests.

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Murata, N., Ozaki, A., Murayama, A. et al. The Diovan scandal in Japan; don’t let bygones be bygones. J Hum Hypertens 36, 500–501 (2022). https://doi.org/10.1038/s41371-022-00680-2

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