Japan Sues Novartis, Probes Alleged False Claims in Alzheimer’s Study

japan-sues-novartisNearly one-dozen major pharmaceutical firms were involved in a key Alzheimer’s drug research product that allegedly used false data, according to the Japanese government.

The Alzheimer’s drug research project, J-ADNI, is at the center of an investigation implemented by the Japanese government, in which Japan alleges that falsified data was used in the research, according to Pharmaceutical Online. Meanwhile, Japan’s health ministry filed an unrelated criminal complaint against drug maker, Novartis, the day prior, according to Agence France Presse (AFP).

The criminal complaint, which is not connected to the study, alleges that a local Norvatis unit overstated marketing for its drug thinner, Diovan, according to AFP. The way in which Japan’s health ministry is proceeding points to its commitment to battle drug companies that break sanctioned regulations, Pharmaceutical Online explained.

A former Tokyo University professor and project researcher involved in the 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.

Japan health officials indicated that they were in the processing of questioning researchers after they were advised that false data was used during the clinical testing for the $28 million government-sponsored Alzheimer’s study, AFP wrote.

The Japanese government invested close to $28 million of its money to create the study, which was meant to ease and produce more accurate Alzheimer’s disease diagnoses. Takeda Pharmaceutical, Astellas Pharma, Bristol-Myers Squibb, and Pfizer; medical imaging firms; and 40 medical centers and organizations were involved in the research project, according to Pharmaceutical Online. The J-ADNI study was both publicly and privately financed and began in 2007

Japan’s health minister, Norihisa Tamura, said that health data falsification is a very serious issue. “If there really has been data falsification, that would be a grave problem, so we are investigating carefully.” The Japanese government is preparing an investigative team to look into the study’s results, another health ministry official said, Pharmaceutical Online reported.

Should the team confirm that falsification of the Alzheimer’s project research occurred, the reputations of the drug companies involved might be damaged. In fact, some of the firms involved in the research are pushing away from the project. For instance, a Pfizer spokesman said that the firm only helped with financing and provided no scientists or researchers to review data, according to Pharmaceutical Online.

Should the data be found to have been falsified, the pharmaceutical firms involved may face challenges when looking to collaborate with the Japanese government in the future. Also, other investigations may be opened on state-sponsored research, Pharmaceutical Online noted.

An Asahi Shimbun report indicated that the newspaper obtained internal documents revealing no less than four instances in which researchers associated with the drugs makers and medical institutions attempted to falsify data, according to AFP.

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