Regarding the civil settlement, Lilly said in a January 15 press statement, “Even though the company disagrees with and does not admit to the civil allegations, the company has agreed to settle the dispute over these allegations.”
We have been cooperating with the government for 5 years on this investigation, Sekston said, adding that it has been a costly and significant distraction from the company’s core mission.
“With this settlement approved, we are pleased to be putting a significant amount of the Zyprexa litigation matters behind us,” she said.
Beyond the current criminal and civil settlement, last October Lilly agreed to pay $62 million to 33 states to settle claims that it improperly marketed Zyprexa to patients who did not have schizophrenia or bipolar disorder, the drug’s only approved uses. Last March, Lilly agreed to pay $15 million to Alaska to settle a lawsuit claiming that Zyprexa triggered the development of diabetes.
More civil cases are expected. According to press reports, insurers, pension funds, and unions have accused Lilly of suppressing information about the adverse effects of Zyprexa, such as weight gain and diabetes, and promoting the drug for other uses.
While the fines and settlement costs surrounding Zyprexa are substantial, a New York Times article (January 15) reported that since 1996, Zyprexa has generated more than $39 billion in sales. Roughly half of those sales were for off-label use. For 2008, Lilly reported worldwide Zyprexa sales of $4.696 billion—a 1% decrease from 2007. Sales in this country were $2.203 billion—a 1% decrease “driven by lower demand, partially offset by higher prices.”
Compliance and physicians
Of particular importance to clinicians and continuing education providers is a 5-year Corporate Integrity Agreement (CIA) that the company has entered into with the Health and Human Services’ Office of Inspector General as part of its settlement. It requires Lilly to cease off-label marketing and to establish programs to prevent the illegal conduct from recurring.
The CIA requires, among other things that Lilly send doctors a letter notifying them about the global settlement and how they can report questionable practices by Lilly’s representatives. It also requires Lilly to disclose its financial support of third-party educational activities and financial relationships with faculty, speakers, or organizers. The company must also post on its Web site, information about payments to US-based doctors or “related entities,” for honoraria, consultant services, and reimbursement for travel or lodging.
Sekston pointed out that Lilly is committed to its transparency initiative. Since 2004, it has had a clinical trial registry Web site (www.lillytrials.com) and since 2007, has posted online all educational grant funding and other monetary contributions provided to US-based organization, www.lillygrantoffice.com.
“We have also committed to launch the health care professional payment registry this year . . . in an effort to build further trust among the public,” she said.