Scandal Over Conflict of Interest for Novartis Trial
May 3rd, 2013 // 2:24 pm @ marquee
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There is a scandal regarding clinical trials done by researchers in Japan for a drug sold by Novartis that is getting bigger. Novartis is acknowledging for the first time that it is conducting an investigation because a Novartis employee may have worked on a clinical trial and did not disclose a conflict of interest.
This controversy started after several white papers that were written by Hiroaki Matsurbara were withdrawn. These withdrawals included the primary publication of the Kyoto Heart Study. This claimed that the drug Diovan cut down risks of stroke and heart attack, and Novartis used these claims int their promotions. This study was a big help in making this drug a major seller in Japan, with sales reaching over $5 billion in 2011.
Another report noted that Divan helps diabetics to not get heart disease and another paper claimed that Diovan could also help patients with hypertension. Another Novartis employee was noted to be a statistician on another paper about Diovan, which was the Jikei heart trial. However, that person was listed to be from Osaka City University, and that university got more than $1 million in donations from Novartis.
Novartis has created a Diovan Information Center on its site and put up the first statement about the growing scandal. The statement said that Novartis is not using the Kyoto Heart and Jikei Heart trials for registration reasons. It added that there are several major trials outside of the country of Japan that have shown the benefit of the drug, beyond its ability to lower hypertension.
This is a bit of a change since March. The head of Novartis in Japan stated in the media that the employee that was in question only gave advice on statistics and he was not consulted on the study design or the contents of it.
