A prominent researcher has been implicated in an alleged cover-up of Actos side effects, according to a report from TheHeart.org. An Actos whistleblower lawsuit unsealed earlier this year has alleged financial connections between the Cleveland Clinic’s Dr Steven Nissen and the maker of Actos “should be considered when analyzing Actos’s risks compared with Avandia’s.”
In 2007, Nissen authored a meta-analysis that showed Avandia, a rival to Actos made by GlaxoSmithKline, increased the risk of heart attacks and other heart side effects by as much as 40%. A black box safety warning regarding heart attacks was eventually added to Avandia’s label, and sales of the type 2 diabetes drug were later severely restricted by the U.S. Food & Drug Administration.
Actos benefited from the Avandia controversy, soon becoming the best-selling type 2 diabetes drug in the world.
The Actos whistleblower lawsuit was filed in 2011 by Helen Ge, a former medical reviewer for Takeda Pharmaceuticals, and unsealed in federal court in Massachusetts this past February. As we’ve reported previously, Ge alleges that Takeda Pharmaceuticals, the maker of Actos, repeatedly directed its medical reviewers to downplay cases of Actos bladder cancer, heart failure, and other side effects when reporting to the U.S. Food & drug Administration (FDA).
According to TheHeart.org, Ge’s suit cites the Nissen paper as a key factor in Takeda’s efforts to position Actos as a safer alternative to Avandia. Nissen, the suit notes, was principal investigator for Actos’ phase 3 PERISCOPE trial. The trial also utilized imaging technology invented by Nissan. Ge’s suit estimates that “payment Nissen received from Takeda through Cleveland Clinic Foundation was estimated to be $8 million to $10 million” for PERISCOPE and that imaging procedures likely brought in over $13 million in revenue for the Cleveland Clinic.”
According to TheHeart.org, Nissan has gone on the record to claim that that Ge’s calculations regarding the reimbursement the Cleveland Clinic received from Takeda were off base, since the that would have been divided among all of the 100 enrolling centers scattered around the world. Nissan says he received no personal income from Takeda.
Nissan also points out that the U.S Justice Department has declined to intervene in Ge’s whistleblower lawsuit, and that in his view, Ge’s complaint is “completely dead.”
However, according to TheHeart.org, Ge’s attorney brushed off that assertion, pointing out that the federal government declines to intervene in the majority of whistleblower complaints. Her attorney also pointed out that Ge’s Actos Whistleblower lawsuit does not target Nissen, but that “we want to see what communications occurred between Dr. Nissen and Takeda and see what information Takeda was funneling to him.”
Actos Side Effects Lawsuits
Ge’s whistleblower lawsuit is not the only litigation Takeda is facing over Actos. Last June, the FDA issued a safety communication stating that use of Actos for more than one year may be associated with an increased risk of bladder cancer. Bladder cancer concerns also caused regulators in France and Germany to suspend sales of Actos in those countries last summer. Takeda officially recalled Actos from the French market in July.
Since the FDA issued its warning, scores of people throughout the U.S. have filed bladder lawsuits against Takeda. As we’ve reported previously, all federally filed Actos bladder cancer lawsuits were ordered transferred to U.S. District Court, Western District of Louisiana, by the U.S. Judicial Panel on Multidistrict Litigation in December. Plaintiffs in the Actos multidistrict litigation accuse Takeda Pharmaceuticals and other defendants of concealing knowledge of Actos’ bladder cancer risks and failing to adequately warn consumer and health care providers about its association with bladder cancer.