If Dr. Ge is Telling the Truth, Takeda Pharmaceutical is Lying

In the last two years, more than 3,000 lawsuits have been filed against Takeda Pharmaceutical over bladder cancer and other adverse effects which plaintiffs believe resulted from their use of the prescription drug, Actos.

“[A]fter exposing Actos patients to 13 years of non-cytology screened exposure to Actos … Takeda will get the benefit of tens of billions of dollars in Actos sales while awaiting the bladder cancer results which ought to have been labeled and warned of to begin with.”

Actos (pioglitazone) is prescribed to treat Type 2 diabetes. It is manufactured by Takeda Pharmaceutical, Japan, one of the largest pharmaceutical companies in the world. In 2011, the U.S. Food and Drug Administration issued a warning about Actos’s association with bladder cancer, but Actos has not been removed from the market in the U.S., as it has been in France and Germany.

One reason users have concluded that Actos is to blame for bladder cancer and other health problems are the claims of Helen Ge, a medical doctor who was hired by Takeda to serve as a safety consultant reviewing Actos. Dr. Ge filed a “whistleblower lawsuit” in 2010, claiming that Takeda knew about the link between Actos and serious health effects years before that knowledge became public, but Takeda concealed that information.

Just three months after Ge filed her lawsuit, the FDA launched a probe into Actos, which led the next year to the 2011 FDA announcement that “a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk [of bladder cancer].”

Dr. Ge’s Whistleblower Suit

Dr. Ge was hired for Takeda’s pharmacovigilance department in 2008 and fired in 2010 after she voiced concerns about how Takeda was reporting its data. Her whistleblower lawsuit, filed under the federal False Claims Act, was dismissed in November by Judge F. Dennis Saylor IV of the U.S. District Court of Massachusetts.

However, new life has been breathed into Ge’s litigation efforts. In August, the Department of Justice submitted a brief asking the First Circuit Court of Appeals to reverse Judge Saylor’s decision. The DOJ contends that the reasoning behind Saylor’s decision, if left to stand, would take the teeth out of the False Claims Act.

“Takeda’s Culture of Fraud”

Dr. Ge’s False Claims Act complaint is 116 pages long. It makes interesting reading, if you want to curl up to Ge’s detailed description of “Takeda’s culture of fraud” (her phrase in the complaint). If Dr. Ge is telling the truth, then Takeda has been lying to doctors and  the public for many years about the potential risks of using Actos.

In case you don’t have time for the full 116-page version, here are a few choice excerpts from Ge’s complaint. I have highlighted a few especially intriguing phrases in bold:

• “Dr. Ge … encountered resistance from her superiors when she tried to report bladder cancer as related to Actos. Dr. Ge claims her supervisors directed her to change her ‘related’ assessment to ‘unrelated.’”

• “According to her recollection of reviewing Takeda’s adverse event database for Actos, there were more than 100 bladder cancers reported to the company, but only 72 reported to the FDA.”

•“[C]arcinogenesis from Actos was discovered during the initial Actos animal studies” [which were conducted before Actos was ever even approved by the FDA in 1999].

• “When Dr. Ge complained to her superiors that her medical assessments were being downgraded from ‘serious’ to ‘non-serious,’ and that, as a result of this, the CHF [congestive heart failure] events were being under-reported to the FDA, her contract with Takeda was terminated.”

• “Takeda was able to capture a majority of the Diabetes drug market by falsely portraying Actos as safer than it actually was. Actos, however, is not as safe as Takeda has led the FDA, healthcare professionals and the general public to believe. Rather, the FDA and the public were led to believe that Actos is safer because Takeda failed to properly report all of the Actos-related adverse events to the FDA.”

• “Takeda’s culture of fraud: … [T]he corporate culture at Takeda is riddled with systemic fraud and deceit with motivation to falsely report and under report not only serious Congestive Heart Failure events, but other serious side effects experienced by people taking Actos.”

• “Dr. Ge has direct knowledge by observation and experience of Takeda’s publicly denying the causal relationship between the Bladder cancer and Actos, even though Takeda knew otherwise as far back as the [19]90s, when Actos was tested in animals and bladder cancer was detected.”

• “After the FDA approved Actos for marketing in the U.S., Takeda received an average of more than 180 cancer reports each year (1,813 over 10 years) from spontaneous sources, but Takeda never included these cancer reports in the label, and never issued a Dear Doctor’s letter in the last 10 years (as required by 21 CFR 200.5) to warn the medical community of the risk of getting cancer while taking Actos.”

• “In late 2005, Takeda presented results from its first post-marketing study, the PROactive trial … In the PROactive trial, there were 16 bladder cancers reported from patients given Actos, which was four times higher than those who received other drugs.”

• “[W]hen directed by the FDA to conduct a PMC [Post Marketing Commitment] study regarding Actos and bladder cancer, Takeda delayed initiating such a trial until 2003 at Yale University. It was constructed as a 10-year trial, so the results of the study were intentionally arranged to become available after Takeda’s exclusive Actos patent had expired, after exposing Actos patients to 13 years of non-cytology screened exposure to Actos. Thus, Takeda will get the benefit of tens of billions of dollars in Actos sales while awaiting the bladder cancer results which ought to have been labeled and warned of to begin with.”

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To learn more about Actos and to learn more about your legal rights, if you or a loved one have used Actos and have been diagnosed with bladder cancer, see our page on Actos Linked to Bladder Cancer.