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

Murata, Nanami; Ozaki, Akihiko; Murayama, Anju; Sawano, Toyoaki; Tanimoto, Tetsuya

doi:10.1038/s41371-022-00680-2

Cited by 5 publications

(9 citation statements)

References 7 publications

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“…28 In 2021, Japan's Supreme Court refused to entertain an appeal by prosecutors, thereby upholding the lower court acquittal, even though they too concluded that Shirahashi had, indeed, altered data. 2 In this case, there was never any investigation of whether Shirahashi's apparent wrongdoing was intentional or simply an error or ineptitude, although it would clearly have benefitted his employer. Nevertheless, it was unequivocally a breach of regulations for him and other individuals not to have identified his clear COI.…”

Section: Criminal Lawsuitmentioning

confidence: 97%

“…(Novartis) company. [2][3][4] It embroiled five renowned Japanese medical establishments (Kyoto Prefectural University of Medicine, the Jikei University School of Medicine, Shiga University of Medical Science, Chiba University and Nagoya University).…”

Section: Introduction 1| Diovan ® /Valsartan Scandal In Japanmentioning

confidence: 99%

“…A decade later, despite institutional and independent investigations and several court cases, no individual, institution or the Novartis company has been found guilty of any misconduct. 2 Furthermore, regulations introduced to help prevent any recurrence, namely the 2018 Clinical Trial Act, has been criticized as it has increased the amount of bureaucracy surrounding clinical trials. 5 Important scientific, commercial, legal, and ethical questions have been raised -the majority of which remain unanswered -and the questionable roles of various parties have never been evaluated.…”

Section: Introduction 1| Diovan ® /Valsartan Scandal In Japanmentioning

confidence: 99%

“…However, the comparatively little‐known 2012 Diovan ® Scandal in Japan was altogether different, encompassing apparent scientific misconduct, such as conflicts of interest (COI), falsification of research results, retraction of published papers and possible financial and ethical malpractice in clinical trials of the approved valsartan (sold as Diovan ® ) marketed by Japan's Novartis K.K. (Novartis) company 2–4 . It embroiled five renowned Japanese medical establishments (Kyoto Prefectural University of Medicine, the Jikei University School of Medicine, Shiga University of Medical Science, Chiba University and Nagoya University).…”

Section: Introductionmentioning

confidence: 99%

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Japan's valsartan clinical trials shambles; time for fundamental changes

Ozaki

Harada

Murayama

et al. 2023

Health Planning & Management

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Japan's Diovan ® /valsartan 'scandal' has received sensational coverage in the nation's media since 2012. Publication of fraudulent research and their subsequent retraction boosted and then curtailed the use of what was a useful therapeutic drug. Some authors of the papers resigned, others disputed the retractions and resorted to legal counsel to protect themselves. One individual, an undeclared Novartis employee involved in the research, was arrested. A complex and virtually unwinnable case was brought against him and Novartis, claiming that data alteration amounted to false advertising, but lengthy criminal court cases resulted in the case failing. Unfortunately, key elements, including conflicts of interest, pharmaceutical company interference in trials of its product, and the role of the institutions involved, have been effectively ignored. The incident also emphasised the fact that Japan's unique society and approach to science does not conform well to international standards. Although the supposed impropriety caused the appearance of a new Clinical Trials Act in 2018, the law has been criticized for being ineffectual and simply increasing clinical trial bureaucracy. This article examines the 'scandal' and identifies where changes must be made to clinical research and the roles of the various stakeholders in Japan to increase public trust in clinical trials and biomedical publications.

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Section: Criminal Lawsuitmentioning

confidence: 97%

Section: Introduction 1| Diovan ® /Valsartan Scandal In Japanmentioning

confidence: 99%

Section: Introduction 1| Diovan ® /Valsartan Scandal In Japanmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Japan's valsartan clinical trials shambles; time for fundamental changes

Ozaki

Harada

Murayama

et al. 2023

Health Planning & Management

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“…Transparency in the management of financial conflicts of interest (FCOIs) and making recommendations based on the best available evidence are the two foundations necessary for developing evidence-based clinical practice guidelines [1]. FCOIs potentially bias recommendations for the benefit of the healthcare industry over patients, as shown in several medical scandals concerning clinical guidelines and clinical trials [2][3][4][5][6][7]. One systematic review showed that there were associations between authors' conflicts of interest and more favorable recommendations [8].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Financial Conflicts of Interest and Quality of Evidence Underlying the American Diabetes Association Clinical Practice Guidelines: The Standards of Medical Care in Diabetes, 2021

Shigeta¹,

Murayama²,

Kamamoto³

et al. 2023

Cureus

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Background: Clinical practice guidelines make recommendations based on the best available evidence. Proper management and disclosure of financial conflicts of interest (FCOIs) are necessary for trustworthy clinical practice guidelines. This study evaluated the prevalence of FCOIs and quality of evidence underlying the American Diabetes Association (ADA) guidelines.Methods: Using the Open Payments Database (OPD) between 2018 and 2020, we examined the research and general payments to all authors of the Standards of Medical Care in Diabetes, 2021. The quality of evidence and tone of recommendations were assessed and the associations between the two were evaluated by logistic regression analysis.Results: Of the 25 guideline authors, 15 (60.0%) were United States (US)-based physicians eligible for the OPD search. Eight (32.0%) and 12 (48.0%) received one or more industry payments one year and three years prior to the guideline publication, respectively. The median total payments (interquartile range

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Financial Relationships Between Pharmaceutical Companies and Rheumatologists in Japan Between 2016 and 2019

et al. 2022

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Backgrounds: Given the increasing number of novel and expensive drugs for rheumatoid diseases, the financial relationships between pharmaceutical companies and rheumatologists could be prevalent and substantial. However, little was known about the information in Japan.Methods: Using payment data publicly disclosed by 92 major pharmaceutical companies, we evaluated the financial relationships between pharmaceutical companies and rheumatologists who were board certified by the Japan College of Rheumatology between 2016 and 2019. The trends in payments were estimated by the generalized estimating equations with 4-year payment data. Differences in payments between general and leading rheumatologists including the board members, clinical practice guideline authors, and medical journal editors were assessed.Results: Of the board-certified rheumatologists, 70.7% (3563 of 5038) received a total of $55,246,485 in personal payments for lecturing, writing, and consulting from 79 pharmaceutical companies between 2016 and 2019. The median payments per rheumatologist receiving payments were $3447 (interquartile range, $1124-$11,974) in payment amounts. There were increasing trends in the payments per rheumatologist and the number of rheumatologists with payments, with average yearly change rates of 5.9% (95% confidence interval, 3.9%-7.9%; p < 0.001) and 1.2% (95% CI, 0.3%-2.0%; p = 0.008). The leading rheumatologists such as the society board members, clinical practice guideline authors, and medical journal editors received much more payments than other rheumatologists. Conclusion:Most rheumatologists increasingly received personal payments for lecturing, consulting, and writing reimbursements from pharmaceutical companies in Japan. These payments were significantly concentrated on rheumatologists in authoritative and influential positions.

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

Cited by 5 publications

References 7 publications

Japan's valsartan clinical trials shambles; time for fundamental changes

Japan's valsartan clinical trials shambles; time for fundamental changes

Evaluation of Financial Conflicts of Interest and Quality of Evidence Underlying the American Diabetes Association Clinical Practice Guidelines: The Standards of Medical Care in Diabetes, 2021

Financial Relationships Between Pharmaceutical Companies and Rheumatologists in Japan Between 2016 and 2019

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