Takeda Pharmaceuticals: What Didn't They Know (And When Did They Decide They Didn't Know It)?
It's a sad and all-too common story, particularly in the pharmaceutical industry. They know there is a risk or potentially dangerous side effect to one of their profitable products and they don't yank it off the market (at least until they are forced to – either for legal or economic reasons). Instead, the company's bean counters crunch some numbers and decide how much a few legal settlements would cost versus how much profits would suffer if the product was recalled or the problem addressed. In too many cases, these corporations decide that a few human lives are not too much to sacrifice in order to maximize profits and maintain stock prices.
The following story is yet another illustration of how profit-driven medical care is murdering people – so a very few can get very, very rich...
The FDA has known since 2007 that Actos and its competitor Avandia have been responsible for exacerbating heart failure. Japanese pharmaceutical company Takeda is already facing more than 10,000 Actos lawsuits related to bladder cancer due to the use of the medication. Now, it is facing additional Actos litigation because its U.S. division, Takeda Pharmaceuticals North America Inc., allegedly manipulated data and deliberately withheld information when filing reports to the FDA regarding the drug's effect on heart patients.
According to a former company medical reviewer, Takeda management ordered its U.S. division not to file reports when coronary events were not fatal or did not result in hospitalization. The reason, according to the reviewer, was simple: Takeda's profits have been slipping. This failure to report cases of congestive heart failure not resulting in a patient's death were an attempt to make Actos look “better” than its competitor, Avandia.
The reviewer, Helen Ge, was fired from her job when she spoke out. Last June, she filed a law suit in Boston federal court on behalf of the government under the False Claims Act. Also known as the “Lincoln Law,” this legislation allows private citizens who act as “whistleblowers” to file such suits on the government's behalf (the legal term is qui tam, which is short for a Latin phrase meaning the person is acting on behalf of the public as well as him or herself). According to news sources, Takeda's actions may have cost U.S. taxpayers amounts in the nine-figure ranges in fraudulent claims against state and federal health care programs such as Medicare.
Unfortunately, the Department of Justice (which only joins about 20% of all lawsuits filed under the False Claims Act) and 24 other state courts declined to get involved after examining her claims. Ms. Ge states that adverse cardiac events “...were not properly identified or reported” to the FDA, and that the motivation to withhold this data was “driven by an economic desire ...to increase sales” of its flagship product. Ms. Ge added that the corporate culture at Takeda is “riddled with systematic fraud and deceit.”
Indeed it does, and according to the complaint, it doesn't stop with Actos. Ms. Ge's lawsuit identifies several Takeda products. According to the case summary:
“...several unlabeled fatal or life-threatening adverse reactions have been known by Takeda to occur as a result of these drugs’ interaction with other drugs commonly used by the same patient population...these drugs’ package insert warnings encourage their co-administration with other commonly used drugs, deny the drug interaction or downplay the interaction....adverse events are consistent with the pre-approval data that went unwarned, yet Takeda has not revised these drugs’ labeling accordingly....patients are placed at risk and harmed as a result of this misleading conduct...”
Naturally, a Takeda spokesperson in Osaka, Japan insists there was no wrongdoing and that all procedures were properly followed. However, he refuses to elaborate because, although the DoJ and other courts have chosen not to intervene in the Actos litigation at the present time, the lawsuit is still pending; Ms. Ge's lawyer says that as “additional evidence” comes to light during the discovery process, the government will change its mind and agree to join the suit.
It should also be noted that people who prevail in a lawsuit under the False Claims Act generally receive 15-25% of any money that is recovered – just a little incentive to expose such actions and bring corporate wrongdoers to justice.
Stanton, Tracy. “Whistleblower Claims Takeda Blunted Actos Heart Reports.” FiercePharma, 7 March 2012.
U.S. District Court For The District of Massachusetts. Helen Ge, MD v. Takeda Pharmaceutical Company Ltd. And Takeda Pharmaceuticals North America, Inc. CIVIL ACTION NO.
1-11-cv-10343-PBS, Filed 25 January 2012.
Voreacos, David. “Takeda Hid Actos Adverse Effects From Regulators, Suit Says.” Bloomberg, 6 March 2012.
Learn more about Actos Lawsuits