A major Alzheimer’s drug research project, funded, in part, by the Japanese government, is at the center of a debacle in which allegations of the use of false data have been made. Nearly one-dozen drug firms are involved.
J-ADNI, is the Alzheimer’s drug research project under investigation by the Japanese government. Japan alleges that the research used falsified data, according to Pharmaceutical Online. Just prior to the announcement of the probe, Japan’s health ministry filed an unrelated criminal complaint against drug maker, Novartis, according to Agence France Presse (AFP).
The criminal complaint is not related to the Alzheimer’s study and includes allegations that a local Norvatis unit overstated marketing for Diovan, a Novartis blood thinner, according to AFP. Japan’s health ministry’s action is indicative of that country’s commitment to fight drug makers that break sanctioned regulations, Pharmaceutical Online explained.
A prior Tokyo University professor and one of the project researchers involved in the Alzheimer’s study reported the false data claims to health officials. Novartis was not among the drug makers 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 said that they are questioning researchers after being told that false data was used during the clinical testing for the $28 million government-sponsored Alzheimer’s study, AFP wrote.
The Japanese government invested nearly $28 million to create the study, which was meant to both simplify Alzheimer’s disease diagnosis and produce more accurate diagnosis results. Takeda Pharmaceutical, Astellas Pharma, Bristol-Myers Squibb, and Pfizer; a number of medical imaging firms; and 40 medical centers and organizations were involved in the research, Pharmaceutical Online reported. The J-ADNI study, which was implemented in 2007, was both publicly and privately financed.
Norihisa Tamura, Japan’s health minister, said that falsification of health data is an extremely serious issue. “If there really has been data falsification, that would be a grave problem, so we are investigating carefully.” An investigative team is being coordinated by the Japanese government to assess the study’s results, another health ministry official said, Pharmaceutical Online reported.
Should falsification of the Alzheimer’s project research be confirmed, drug company reputations will likely be tainted. Since the Japanese government’s announcement, some of the firms involved in the research have pushed back on the project. In fact, a Pfizer spokesman said that the firm simply assisted with financing and did not provide scientists or research 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 work with the Japanese government on future projects. Also, other investigations may be opened on state-sponsored research, Pharmaceutical Online noted.
According to the news outlet, Asahi Shimbun, it obtained internal documents that reveal at least four instances in which researchers tied to the drug firms and medical institutions attempted to falsify data, according to AFP.