Yahoo – AFP,
10 January 2014
Japan's
health ministry is 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
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 told AFP.
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 high-profile study.
"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 Friday 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.
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