Following a long series of accusations, retractions, and the resignation of a prominent professor, it now is clear that data from a large Japanese study of valsartan (Diovan, Novartis) was fabricated. On Thursday officials at Kyoto Prefectural University of Medicine said that “had patient records been used in their entirety,” the Kyoto Heart Study “would have had a different conclusion,” reported AFB.
In 2009 the Kyoto Heart Study investigators, including the chief investigator, Hiroaki Matsubara, reported that treatment with valsartan resulted in significant cardiovascular benefits independent of the drug’s blood-pressure lowering effect. Now officials at the university say the drug had no such effect.
On Friday Norihisa Tamura, Japan’s health minister, said data had been “fabricated and falsified.” Tamura said he would set up a committee to prevent episodes like this from happening again.
“Data was manipulated,” said the president of the university, Toshikazu Yoshikawa, at a news conference, as reported in an article in the Asahi Shimbun. “We apologize for causing serious trouble.” (The article contains an extraordinaryphotograph of university officials bowing in apology.) The article also reported that the president would “return his salary to take responsibility for the scandal, but did not clarify the figure and for how long.”
As reported here previously, 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 Matsubara. This ultimately led to a series of retractions of Matsubara papers and the retraction of the main paper of the Kyoto Heart Study itself. In February Matsubara resigned his position at Kyoto Prefectural University of Medicine. A second large trial, the Jikei Heart Trial, also came under scrutiny when it was revealed that a Novartis employee had been involved with both studies. Novartis acknowledged that employees of the company participated in five “independent” investigator-initiated post-registration trials without disclosing their relationship to the company.
The Asahi Shimbun article reports that the Novartis employee has refused to cooperate with the university investigation.
“focused on incidences of stroke and heart failure of 223 patients whose hospital medical records have been confirmed. It found that a total of 34 cases where an illness not listed in the medical records was cited in the analysis data used for the professor’s papers or one found in the records was not in the analysis data. Data changes were made to reduce incidences of illness among the group of patients who were administered Diovan, while they were increased among the group that was not given the drug.”