KYOTO--Kyoto Prefectural University of Medicine has admitted that data recorded by its research team during clinical studies of Novartis Pharma AG’s blockbuster hypertension drug Diovan was falsified, possibly to claim additional side benefits.
“Data was manipulated,” Toshikazu Yoshikawa, president of the university, told a news conference July 11, referring to clinical studies conducted by the university on Diovan. “We apologize for causing serious trouble.”
Yoshikawa said he will return his salary to take responsibility for the scandal, but did not clarify the figure and for how long.
Diovan has been a best-selling drug in the Japanese market, raking in 108.3 billion yen ($1.09 billion) last year alone.
Novartis Pharma KK, the Japanese sales arm of the Swiss drug giant, touted its benefits for other ailments in addition to reducing high blood pressure, such as reducing the risk of stroke and angina, in literature presented to doctors based on the reports by the university.
Hiroaki Matsubara, former professor of cardiovascular internal medicine at the university, led the group that analyzed the effectiveness of Diovan in clinical studies. The group released a report in 2009 that concluded the drug was also effective in preventing stroke and angina, compared with other hypertension drugs.
Matsubara left the university in February after allegations surfaced about the credibility of the report.
The group’s study involved about 3,000 Japanese patients.
The university put together an investigative panel that looked at the medical records of 223 of those involved in the study. Of the 223, the records of 34 patients falsely stated that they may or may not have suffered a stroke.
Based on their new statistical analysis, the panel concluded that Diovan was no more effective than other similar drugs in reducing the risks of stroke and angina.
Similar clinical studies concerning Diovan were also conducted at Jikei Unversity, Shiga University of Medical Science, Chiba University and Nagoya University. Investigations are under way to find out if data was also falsified in those studies.
In the research conducted by Kyoto Prefectural University of Medicine, an employee of Novartis Pharma in Japan was involved in conducting statistical analysis for the study, a fact not listed in the university’s report.
The university’s panel contacted Novartis Pharma in Japan with a request to interview the former employee. The drug company declined, stating the person had left the company.
Novartis Pharma in Japan has denied the allegations.
“No intentional data manipulation has been confirmed,” the company said in a statement on July 12.
In regards to the interview of its former employee, the drug company said, “Novartis Pharma did not decline a request to interview the former employee. Although we contacted the former employee about the request, the interview did not materialize because the former employee strongly wanted it that way.”
Shinji Fushiki, the university’s vice president who also attended the news conference, said the panel was at a loss over how to determine who altered the data. But he added that the university will not investigate further into the matter.
“The university is limited in what it can do,” Fushiki said.
University officials said they will take steps to prevent the recurrence of data manipulation in the future by bolstering their ability to confirm the veracity of such studies.
The university’s panel opened its investigation in March after suspicions outside the university were raised about the credibility of the data, and after the university had earlier denied allegations of rigged data in January.
Asked about the disparity in the university’s recent conclusion, Fushiki said, “In January, we concluded that there were errors in inputting data, which had nothing to do with impropriety. But this time, we found that there was manipulation that puts the very substance of the clinical studies at stake.”
An official overseeing such clinical studies in the health ministry expressed regret over the university’s findings.
“The allegations that data was possibly manipulated is highly regrettable,” the official said. “We intend to weigh the best possible preventive measures once we receive the reports from the four other universities on their investigations into the matter.”
(This article was written by Ryoma Komiyama, Nobutaro Kaji and Ryosuke Nonaka.)
- « Prev
- Next »