Japan's health ministry said yesterday it was probing claims falsified data was used in an Alzheimer's disease study involving major drug makers.
Health officials said they were questioning researchers after being told false data was used in clinical testing for the US$28 million, government-backed Alzheimer's study, aimed at improving diagnosis of the disease.
The research involved 11 drugs firms, including Pfizer and Bristol-Myers Squibb and Japanese firms Takeda Pharmaceutical and Astellas Pharma, medical imaging companies and nearly 40 hospitals and medical organisations. The public- and privately financed study began in 2007.
The allegations came to light a day after Japanese officials slapped Novartis with an unrelated criminal complaint which alleged its local unit exaggerated advertising for blood-pressure drug Diovan. A former Tokyo University professor and project researcher on the Alzheimer's study reported the false data claims to health officials. Novartis was not involved in the study.
"After verifying the facts about these allegations, we will deal with the issue appropriately, setting up an investigation team if necessary," a health ministry official said.
The minister for health, Norihisa Tamura, said in Tokyo yesterday that the probe would get to the bottom of whether the data was made up and, if so, how it made its way into the high-profile study.
"If there really has been data falsification, that would be a grave problem, so we are investigating carefully," he said.
The Asahi newspaper reported yesterday it had obtained internal documents highlighting at least four instances where researchers linked to the drug makers and medical institutions tried to falsify data.
Health officials lodged the unrelated claims against Novartis months after a university said data in clinical studies might have been skewed to falsely promote Diovan's use in the prevention of strokes and angina.
There is no suggestion that Diovan is ineffective in combating blood pressure problems.