DID SEALING BOSTON WHISTLEBLOWER CASE AGAINST TAKEDA HIDE DANGERS OF ACTOS?

Under a whistleblower law called The False Claims Act, cases with primary and unique information concerning fraud on the government can yield significant rewards for the whistleblower. Just such a case was filed under seal, AS REQUIRED, and hidden from the public by a whistleblower Helen Ge in 2010, against a U.S. unit of Takeda Pharmaceutical Co. It alleged that the company failed to give accurate reports to regulators about hundreds of congestive heart failure cases associated with its Diabetes drug Actos. Ge is a former medical reviewer and she filed the case in the federal court in Boston. Since that filing, sales of Actos generated 27 percent of the revenue for the company. What is still unclear is how many people took the drug since the date of the case filing and the date it was unsealed within the past two weeks. The complain says that on multiple occasions, Takeda improperly instructed its medical reviwers to change their professional opinion regarding adverse event classifications and assessments. In 2007 the FDA ordered the company to place the strongest warning on the label. However, it was not until June 15, 2011 that the FDA warned patients that taking Actos for more than 12 months may have a higher bladder cancer risk. in addition, in 2010 alone, Actos generated $3.4 billion in sales for Takeda. These facts and more raise troubling issues about sealing critical information from the public about significant disease risks of drugs sold on a major scale in this country. The False Claims Act has been a major weapon in the fight against fraud but many of its provisions are arcane and unecessary including sealing such information from anyone but the government.