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Novartis AG. (5/24/13). "Press Release: Valsartan Investigator Initiated Trials in Japan".

Region Region Japan
Organisation Organisation Novartis Pharma K.K. (NPKK)
  Group Novartis (Group)
Products Product clinical research
  Product 2 Diovan®

There has been recent media coverage on Japanese post registration investigator initiated valsartan trials. Investigator initiated trials are conceived, designed and conducted by independent steering committees of physicians and make a significant contribution to research and scientific understanding. Novartis believes it is crucial that investigator initiated trials continue in the way that they were intended and that the output of the trials is trusted, credible and independent.

There have been allegations of an undisclosed conflict of interest related to these Japanese post registration investigator initiated valsartan trials. The conflict of interest allegations include two former Novartis employees who were allegedly involved in the trials and who were not disclosed as Novartis employees.

Novartis takes these allegations very seriously and in April launched a comprehensive investigation with independent third party experts to review these allegations related to valsartan investigator initiated trials started in Japan between 2001-2004.
While the comprehensive investigation with independent third party experts is ongoing, Novartis recently submitted an update to the relevant medical societies in Japan. We have also provided an update to the principal investigators from the investigator initiated trials included in this investigation. Below are the key points from these updates:

> Our current understanding is that one of our former employees had varying levels of involvement in five investigator initiated valsartan trials in Japan. In addition, a second former employee (who reported to the first former employee) had involvement which was limited to one of these trials. The investigation is still ongoing to determine the full scope of their involvement, however the following is what we learned to date:

o The first former employee was mentioned in the acknowledgements of several papers for investigator initiated studies of valsartan in Japan. We acknowledge that he should have requested the studies' authors to identify him as a Novartis employee on all publications.

o The investigation has yielded that in some cases this former employee's activities included data analysis, however, there has been no indication in the investigation to date that his involvement led to any manipulation of the data in these studies. Novartis is supportive of any activities that the investigators consider appropriate to validate these study results. This would help to conclude the comprehensive investigation with independent third party experts.

o Our current findings indicate that there was no specific company strategy to integrate the first former employee into the five valsartan investigator initiated trials. The investigation has also revealed that that some of this former employee's superiors in Japan knew of his participation in these trials and were supportive of him in these activities. They believed that employees of a business that had academic titles could perform clinical research support as academics, without any conflict of interest issues arising. In addition, there is no indication that any of his supervisors knew or approved of the incomplete disclosure of his affiliation in the published papers for these studies.

o While the former employee's involvement in these studies was inappropriate according to Novartis current standards and the basic principles of investigator initiated trials, the investigation has revealed that some, if not all, of the physicians involved in conducting the studies were aware of his employment by Novartis.

> Our current understanding is that the former employee believed he was allowed to engage in research if this was done in his capacity as a part-time lecturer of Osaka City University and took steps to separate his involvement in the studies from his work for the company. This employee, some of his supervisors, and the trial investigators believed that employees of a business that had academic titles could perform clinical research support as academics, without any conflict of interest issues arising.

When previous statements were made about the involvement of Novartis Pharma K.K. (NPKK), Japan in the Kyoto Heart study, they were provided based on the information which was available at the time and were believed to be accurate. We are correcting those statements by issuing this update based on the latest information which was obtained from the ongoing independent investigation.

At Novartis, we expect all employees to follow the Novartis Code of Conduct, which sets out principles for ethical behavior, professionalism and good business practice and forms an integral part of the terms of employment of all associates of Novartis Group companies.

Novartis is committed to high standards of ethical business conduct and regulatory compliance in all aspects of its work. The Novartis Code of Conduct is routinely revised and updated to reflect the continuing evolution of the healthcare business and the legal landscape.

Novartis takes this matter very seriously and will take appropriate corrective actions in light of the investigation. We will also be working closely with the medical societies and clinical community to implement any changes that are recommended.
The results of these valsartan investigator initiated trials in Japan which are included in the investigation were not used by Novartis for registration or labeling purposes. Valsartan has a proven safety and efficacy profile and has been prescribed to millions of patients worldwide. Valsartan has been approved and marketed worldwide for over 15 years. There are multiple major morbidity and mortality clinical trials conducted outside of Japan, including Val-HeFT1 and VALIANT2, which have demonstrated the benefits of valsartan beyond its proven blood pressure-lowering efficacy. Valsartan is the only ARB approved in the US and EU for treatment of both post-MI and heart failure patients.

> For information in Japanese, visit the Novartis Pharma Japan website
For more information on the Novartis Code of Conduct, visit:
> Ethics, governance and compliance
> Establishing values and standards
> Code, policies and guidelines

1. Cohn JN, and Tognoni G. for the Valsartan Heart Failure Trial Investigators. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure. N Engl J Med. 2001 Dec 6;345(23):1667-75.

2. Pfeffer MA, McMurray JJ, Velazquez EJ, Rouleau JL, Køber L, Maggioni AP, Solomon SD, Swedberg K, Van de Werf F, White H, Leimberger JD, Henis M, Edwards S, Zelenkofske S, Sellers MA, Califf RM; Valsartan in Acute Myocardial Infarction Trial Investigators. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. N Engl J Med. 2003 Nov 13;349(20):1893-906.

Record changed: 2019-06-09


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