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Whistleblower lawsuit claims Takeda concealed harms of diabetes drug

BMJ 2012; 344 doi: (Published 13 March 2012) Cite this as: BMJ 2012;344:e2002
  1. Jeanne Lenzer
  1. 1New York

A medical doctor and former consultant to Takeda Pharmaceuticals is charging in a whistleblower lawsuit that the company failed to report serious adverse events related to the antidiabetes drug pioglitazone (marketed as Actos).

Helen Ge states in her lawsuit that Takeda “instructed medical reviewers not to report hundreds of non-hospitalized or non-fatal congestive heart failure cases as ‘serious’ adverse events and thus avoided its responsibility of accurately analyzing and reporting these hundreds of serious adverse events to the FDA [US Food and Drug Administration].”

She also claims that the company failed to report 28 of 100 cases of bladder cancers to the FDA, which she called a “serious discrepancy,” and that Takeda told her to change her notation that the cancers were “related” to “unrelated.” The suit says that she was fired …

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