Novartis research scrutinised in Japan

High blood pressure is a widespread problem Keystone

The Basel-based pharmaceutical firm Novartis has admitted that there was an undisclosed conflict of interest in a study of one of its drugs carried out at a Japanese university, but says guidelines now in place are followed by all its employees.

An unnamed researcher, reported to be an adjunct lecturer at Osaka City University, had hidden the fact that he was an employee of the Japanese unit, Novartis Pharma K.K., when he was taking part in a study of the Novartis drug Valsartan, the Japanese health minister said on Friday, describing this as “extremely regrettable”.

The Kyoto Prefectural University of Medicine said on Thursday that incomplete clinical data had been used in the study of the drug, marketed in Japan under the name of Diovan, which is commonly prescribed for high blood pressure.

It said that if the researchers had used the patients’ records in their entirety, it was “highly likely” they would have reached a different conclusion. The Kyoto heart study had already been retracted from the European Heart Journal earlier in the year

The university did not dispute the drug’s ability to control high blood pressure, but said it was not necessarily able to prevent strokes and angina, as the study claimed.

The minister, Norihisa Tamura, said he would set up a special committee to work out ways to avoid similar cases in future, and to review ethical guidelines.

Code of conduct

In a statement emailed to swissinfo.ch, Novartis International said it had launched a third party investigation into allegations of conflict of interest back in April. It pointed out that when the Valsartan trial started between 2001 and 2004 there had been no specific guidelines over conflicts of interest in such so-called investigator initiated trials (IITs).

“The former employees and their managers misunderstood the appropriate level of involvement in IITs of employees of a pharmaceutical company,” the statement said.

It said guidelines were now in place across the industry, and that these were followed by all Novartis Pharma employees.

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

The statement said Novartis could not comment on the university findings about the results of the study, since it did not know how the university had conducted its review.

For its part, Novartis Pharma, which is active in sales and research in Japan, said nothing found so far had indicated “intentional data manipulation” as the university had suggested.