Third-party investigation confirms Takeda’s systematic involvement in CASE-J Study, but no data tampering

Japan’s largest drugmaker Takeda Pharmaceuticals (TYO: 4502) has updated on the third-party surrounding the results of the CASE-J study,  a clinical study related to the hypertension drug Blopress (candesartan cilexetil), namely “potential involvement in data analysis and data falsification,” “potential conflicts of interest,” and “inappropriate promotional activities.”

While the results of the internal investigation did not confirm “data falsification” or “possible conflicts of interest,” it was found that “a portion of promotional activities were inappropriate" in their use of the CASE-J study results.” Takeda explained this and apologized to patients and health care professionals. Furthermore, as a continuation of the internal investigation, Takeda announced the appointment of the law firm Jones Day as a third-party organization to conduct an investigation to address points that were insufficiently clear.

Over the course of the three-month Jones Day investigation, Takeda has not issued objections to any part of the methods or scope as specified, and has been fully cooperating with the investigation. In accordance with this, the drugmaker has received Jones Day's statement that their independence has not been jeopardized throughout the process of the investigation.