In the last few days, more bad news about valsartan (Diovan,\u00a0Novartis) has emerged. Another major study conducted in Japan — the Jikei Heart Study — will be retracted, and Japanese health authorities said they were investigating severe skin reactions associated with use of the drug.<\/p>\n
The new events are only the latest problems for the drug and\u00a0Novartis.\u00a0As reported previously<\/a>, the current scandal first began to unfold in late 2011 when a Japanese blogger pointed to a number of apparent errors in publications authored by Hiroaki\u00a0Matsubara. This ultimately led to\u00a0a series of retractions of Matsubara papers\u00a0<\/a>and\u00a0the retraction of the main paper of the Kyoto Heart Study itself<\/a>. In February, Matsubara resigned his position at Kyoto\u00a0Prefectural University of Medicine. Earlier this month, the Japanese health minister and officials\u00a0at Kyoto Prefectural University of Medicine\u00a0said<\/a>\u00a0that data from the Kyoto Heart Study had been fabricated.<\/p>\n Now a second large trial,\u00a0the Jikei Heart Trial<\/a>, will also be retracted. Questions had been raised earlier about this trial when it became known that\u00a0Novartis\u00a0employees had worked on both the Kyoto and the Jikei trials. The relationship of the employees to the company was not disclosed in the trial publications. Now, as reported in\u00a0Pharmaceutical Processing<\/a><\/em>, the first author of the Jikei Heart Trial, Seibu Mochizuki, has said that the trial,\u00a0originally published in the\u00a0Lancet<\/em>\u00a0in 2007, will be retracted.<\/p>\n Novartis\u00a0said that an independent investigation found no evidence that its employee who worked on the trial manipulated or altered the data. An official at\u00a0Jikei University School of Medicine said that its own investigation had not ruled out such misconduct on the part of the former\u00a0Novartis\u00a0employee. The employee has denied such wrongdoing.<\/p>\n