Takeda Pharmaceutical Co. executives were so worried in 2003 that their diabetes drug Actos might be linked to cancer that they questioned doctors on whether they would prescribe a drug that had a warning about the disease on its label, according to court filings.
Takeda, which faces more than 3,000 lawsuits over Actos, argues in court papers that the drug doesn’t cause bladder cancer. The company secretly surveyed a dozen doctors in 2003 to see if they would use a diabetes drug with their patients that carried a warning about the potentially fatal ailment, lawyers for a former Actos user said in the filing. Actos was once the company’s top-selling drug.
The survey found “a bladder cancer warning would destroy the sales of Takeda’s most important drug,” attorneys for ex-Actos user Jack Cooper said in the Jan. 25 filing. Jurors in Los Angeles, where Actos cases are consolidated in state court, are set to hear Cooper’s claims against the drugmaker starting Feb. 19 in the first case over the drug to go to trial.
The trial comes a month after Takeda won U.S. regulatory approval for Nesina, a new diabetes drug to replace Actos, which lost patent protection last year. Takeda, based in Osaka, Japan, is Asia’s biggest drugmaker.
Takeda officials counter that they acted properly to inform doctors about Actos’s health risks and emphasized patient safety in their handling of the diabetes drug.
“Takeda has actively worked with regulators, physicians and outside medical experts to make sure health-care providers were informed and could make the most educated treatment decisions,” Kenneth D. Greisman, a spokesman for the company’s U.S. unit, said today in an e-mailed statement. “That was the case in 2003 and still is the case today.”
Actos’s sales peaked in the year ended in March 2011 at $4.5 billion for Takeda, accounting for 27 percent of the company’s revenue at the time, according to data compiled by Bloomberg.
The U.S. Food and Drug Administration approved Actos for use in the U.S. in 1999 and the drug later became the world’s best-selling diabetes treatment.
FDA officials found in 2011 that an analysis of a company-sponsored study showed some Actos users faced an increased risk of developing bladder cancer or heart problems. The company pulled the drug off the market in Germany and France that year at the request of those countries’ regulators.
Takeda said in an e-mailed statement Feb. 11 that the Actos study FDA officials reviewed is ongoing and final results should be available next year. Other information generated by the study showed that over time, patients’ risks of developing bladder cancer from the medicine decreased, Takeda said.
Cooper, a retired telephone-company employee, took Actos for more than two years before being diagnosed with bladder cancer in 2011, according to court papers. His Jan. 25 filing was a response to Takeda’s request to have his case thrown out.
The company contends in court filings that it handled the drug properly and the FDA found Actos to be a safe and effective diabetes treatment.’’
FDA officials’ interest in Actos’s bladder-cancer links surfaced in 2002 after drugmaker Novo Nordisk A/S abandoned plans to bring a diabetes medicine to market, according to court filings.
Novo Nordisk, based in Bagsvaerd, Denmark, canceled clinical testing on Ragaglitazar, another compound designed to help diabetes suffers, after finding that rats developed cancerous tumors in their bladders. The drug works in a similar fashion to Actos, according to court filings.
FDA officials began asking Takeda about Actos’s potential links to bladder cancer after the Ragaglitazar testing was halted, Cooper’s lawyers said in the filing. The FDA’s questioning prompted Takeda to survey doctors about their willingness to use a diabetes drug that contained a cancer warning, the attorney said.
During the ensuing nine years, Takeda fended off the FDA’s suggestions that it add a clear bladder-cancer warning to Actos’s label, according to the filing. Regulators ordered the company to beef up the warning last year, Cooper’s lawyers said.
The company sought to protect the drug by refusing to search its database for signs that Actos was tied to reports of bladder cancer because it would provide ammunition for stronger warnings, according to the filing.
“If there are negative findings they ignore it and if there are positive findings, they gotcha,” Takeda officials said in internal documents, according to the filing.
Takeda continued to aggressively market the drug, pushing salespeople to avoid or downplay doctors’ questions about Actos’s cancer risk, the plaintiff’s lawyers said.
The drugmaker in 2010 told its U.S. salespeople to wait to see if doctors asked about bladder cancer before providing safety information and “if no questions/concerns, do not discuss bladder cancer and sell, sell, sell!” according to the filing.
Takeda officials contend Cooper’s lawyers are cherry-picking from internal documents gathered in pretrial information exchanges to paint a misleading picture of the company’s handling of Actos.
“Individual documents, when viewed without explanation or context, do not fairly reflect the company’s conduct,” Greisman said in the e-mailed statement.
The case is Cooper v. Takeda Pharmaceuticals America, Inc., CGC-12-518535, California Superior Court (Los Angeles).