Japan's health ministry
said Friday it was probing claims falsified data was used in an Alzheimer's
disease study involving major pharmaceutical firms, a day after filing an
unrelated criminal complaint against Swiss drugs giant Novartis.
Health officials said they
were questioning researchers after being told false data was used in clinical
testing for the $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 giants
Takeda Pharmaceutical and Astellas Pharma, medical imaging companies and nearly
40 hospitals and medical organisations. The public and privately-financed
study, dubbed J-ADNI, began in 2007.
The allegations came to
light just a day after Japanese officials slapped Novartis with a criminal
complaint which alleged its local unit exaggerated advertising for popular
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
Read: Alzheimer's – the facts
Health Minister Norihisa
Tamura told reporters in Tokyo Friday 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
"If there really has
been data falsification, that would be a grave problem, so we are investigating
carefully," he said.
A report in the Asahi
Shimbun said the newspaper had obtained internal documents highlighting
at least four instances where researchers linked to the drugs makers and
medical institutions tried to falsify data.
In response, a Pfizer
spokesman in Japan said the drugs giant supplied some financing for the
research, but did not employ any researchers.
Others firms could not
immediately be reached for comment.
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, which is
also known as Valsartan, in the prevention of stroke and angina.
There is no suggestion that
Diovan is ineffective in combating blood pressure problems.
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