Indianopolis-based drugmaker Eli Lilly & Co marketed its atypical antipsychotic medication, Zyprexa for an unapproved, off-label use – in the treatment of dementia in elderly patients, with the full knowledge of its ineffectiveness. At least seven studies conducted by the company had shown that the drug was ineffective in the treatment of dementia.
The studies also showed that the use of the drug led to 'significantly' more deaths in patients taking the drug that patients taking placebo pills.
Eli Lilly is currently embroiled in a number of claims brought by pension plans and health care insurance companies seeking to recover money spent on purchasing Zyprexa for their customers. The company has settled numerous Zyprexa related cases paying up approximately $2.62 billion.
Included in this is a $615 million fine for the federal charge of marketing the drug for off-label uses.
According to the company it had ceased the off-label marketing of Zyprexa for dementia in elderly patients in 2001, but parties that have brought charges claim the company continued to promote Zyprexa to physicians treating elderly patients beyond that date. They cite the company's internal emails and documents to corroborate their contention.
The plaintiffs have cited documents including a 2002 business plan aimed at increasing prescriptions in off-label use. They also point to notes from Lilly sales representatives through 2003 that show that the company continued to press doctors to prescribe Zprexa for treatment of mood symptom, irritability and insomnia.
Insurers and other third-party payers are demanding that Lilly pay as much as $6.8 billion in damages for failure to inform patients of the health risks associated with the use of the drug including excessive weight gain and the risk of contracting diabetes and unapproved use of the drug to push profits.
Notes written by Eli Lilly sales people have also established that the company continued to push the drug to primary care physicians for off-label, unapproved uses such as helping elderly patients sleep and other symptoms some of which are typical symptoms of dementia. Without actually using the word 'dementia' sales people were encouraged to push Zyprexa for the treatment of common dementia symptoms. Selling a drug for off-label, unapproved uses is an illegal practice for a drug company to indulge in.
According to latest unsealed documents, side effects were acknowledged but minimised with sales people directed to acknowledge side effects but present them as manageable. The management advised its sales force that with most customers it would continue to address diabetes concern only when it arose, according to a document dated December 2001.
According to the latest set of unsealed documents the company employees wrote a number of medical studies that underscored the drug's effectiveness. These were then submitted to medical journals and published under doctors' names who agreed to put their names on the studies. The ghostwriting effort came to light only after the unsealing of the court documents.
The seven studies that pointed to the ineffectiveness of the drug were not published in medical journals.
Zyprexa, which accounted for $4.7 billion of the company's international sales in 2008, is the company's most profitable and lucrative drug – making up over 30 per cent of all atypical antipsychotics sales in the US.