Eli Lilly and Zyprexa Under the SpotlightEli Lilly & Co.’s atypical antipsychotic medication, Zyprexa, was not only marketed to doctors for an unapproved, off-label use — the treatment of dementia in elderly patients — but it was done despite Lilly’s access and knowledge of at least seven studies that showed the drug was apparently ineffective for the treatment of dementia.

The studies also showed that the use of the drug resulted in “significantly” more deaths than patients taking placebo pills in the studies.

Eli Lilly plead guilty to federal charges in January 2009 for illegally marketing Zyprexa for off-label uses to older Americans from 1999 to 2001.

The latest Zyprexa revelation comes as Eli Lilly continues to fight in U.S. District Court in New York against claims brought against the company by pension plans and health care insurance companies seeking to get back money spent on purchasing Zyprexa for their customers. Lilly has settled numerous previous cases related to Zyprexa for approximately $2.62 billion, including a $615 million fine for the federal charge of marketing the drug for off-label uses.

Eli Lilly claims that the off-label marketing of Zyprexa for dementia in elderly patients ended in 2001. However, the groups suing Lilly claim that the drug manufacturer continued to promote Zyprexa to physicians treating elderly patients even the company claimed it had stopped, according to its own internal emails and documents.

According to the Bloomberg news agency, “The plaintiffs cite documents including a 2002 business plan calling for expanding prescriptions in off-label use. They also point to notes from Lilly sales representatives through 2003 recording efforts to press doctors to prescribe elderly patients Zyprexa for mood symptoms, irritability and insomnia.”

“Insurers and other so-called third-party payers contend Lilly should pay as much as $6.8 billion in damages for downplaying Zyprexa’s health risks, including excessive weight gain and the risk of contracting diabetes, and marketing the drug for unapproved uses to pump up profits,” Bloomberg further noted.

Notes written by Eli Lilly salespeople during their sales calls to doctors allegedly demonstrated their continued push to primary care physicians to prescribe Zyprexa for off-label, unapproved uses — something that is illegal for a drug company to do. As late as 2003, such notes indicated that salespeople were apparently still recommending Zyprexa for off-label uses such as helping elderly patients sleep, manage irritability, decrease hostility and improve unclear thinking — some of which are typical symptoms of dementia. Without using the word “dementia,” Lilly salespeople apparently continued to tout the benefits of Zyprexa for common dementia symptoms.

Side effects were, according to the latest unsealed documents, acknowledged, but minimized. According to Bloomberg, “‘Acknowledge weight gain but present it as a manageable side effect,” Lilly advised its sales force, according to the documents. “With most customers, we will continue to address the diabetes concern only when it arises,” the December 2001 document said. “Get back to selling!”’

The latest set of documents unsealed also showed that Lilly company employees wrote a number of the medical studies that demonstrated Zyprexa’s effectiveness. The studies were then submitted to medical journals and published under doctors’ names who agreed to put their names on the studies. The ghostwriting effort by Lilly was not publicly known before the unsealing of the court documents.

The seven studies that did not show Zyprexa’s effectiveness for dementia were not published in medical journals.

Zyprexa is Eli Lilly’s most profitable and lucrative drug, accounting for $4.7 billion in international sales in 2008 — accounting for over 30 percent of all atypical antipsychotics sales in the U.S.

Source: Bloomberg news agency and wire reports