Former Novartis ($NVS) employees did work on Diovan trials in Japan and didn't disclose their relationships with the company in the studies, the company says. But Novartis also said an independent investigation found no evidence clinical trial data was manipulated. Kyoto Prefectural University of Medicine had previously said data on the drug may have been altered and retracted a study in which Novartis employees were involved.
But as Forbes reports, another major Diovan study--the Jikei Heart Trial--will now be retracted on data worries, with former Novartis employees also involved in its writing; the relationship to the company wasn't disclosed in the trial publications. And separately, health authorities are looking into severe skin reactions that may be associated with the drug.
Novartis Pharma's president in Japan, Yoshiyasu Ninomiya, apologized yesterday amid the latest scandal over potential rejigging of clinical data. "I'm deeply sorry for the trouble we caused for patients, their families, medical professionals, for the improper disclosure and promoting Diovan citing the studies," said Ninomiya (as quoted by Bloomberg).
A report commissioned by Novartis found no evidence that the former employees manipulated data, Bloomberg reports. Jikei University School of Medicine, however, said its own investigation had not ruled out misconduct on the part of the former Novartis worker. The employee himself has denied any wrongdoing, Forbes notes.
Meanwhile, as the Japan Times reports, the country's health ministry is investigating reports of skin problems in Diovan patients. Sources told the newspaper that the ministry is considering whether to add a warning about skin sores to the official list of potential Diovan side effects.
- see the story from Forbes
- read more from Bloomberg
- check out the Japan Times piece
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