Diovan information Center
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 a Novartis employee who was allegedly involved in the trials and who was not disclosed as a Novartis employee.
Novartis takes these allegations very seriously and has 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.
Novartis will review the findings of the independent third party investigation and will take appropriate action, if required.
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.
The results of these valsartan investigator initiated trials in Japan were not used by Novartis for registration 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 more information on the Novartis Code of Conduct, visit:
- 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.
- 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.
