January 15, 2008

The U.S. Justice Deparment settled with Eli Lilly and Company over the pharmaceutical company's promotion of the drug Zyprexa for uses not approved by the FDA.  The so-called "off-label" markting of a drug for non-FDA approved uses is criminal, and Lilly settled the matter for $1.4 billion, including $515 million, the lagest criminal fine in history, federal prosecutors said on January 15.  

According to prosecutors, Zyprexa was approved by the FDA to treat forms of manic depression and schizophrenia.  However, Lilly marketed the drug to elderly patients as a treatment for dementia, Alzheimer's agitation, depression and generalized sleep disorder.  The company also pressed pediatricians and family practice doctors to treat disruptive children with Zyprexa, court documents show, even though the medicine’s tendency to cause severe weight gain and metabolic disorders is particularly pronounced in children. Over the last decade, Zyprexa’s use in children has soared. 

See January 15, 2008 CBS Evening News report:

Prosecutors said that in doing so, Lilly ignored FDA warnings that Zyprexa should not be so widely perscribed because of side effects such as weight gan that could lead to obesity and even the onset of diabetes in some patients.  

The case came to light through disclosures made by nine former Lilly sales reps. The acting U.S. Attorney overseeing the case, Laurie Magid, said Lilly knew that its patent for Prozac was expiring and "wanted Zyprexa to be their new blockbuster drug." Magid said Lilly mounted an "elaborate marketing campaign" and deployed an "army" of sales representatives who were trained to persuade doctors to use Zyprexa for a much larger patient base than the relatively narrow category of schizophrenics and manic depressives.

Because one of Zyprexa's side effects is sedation, Magid said, Lilly instructed its long-term care sales force to tell doctors in nursing homes that Zyprexa would help patients with sleep problems, behavioral issues and dementia.

"They claimed this side effect was a therapeutic benefit, not an adverse event, with the sales slogan '5 at 5,' meaning that five milligrams of Zyprexa at 5 p.m. would help their patients sleep," Magid said.

Comments

[Jehovahinfo]

Google search shows that I have made about 70,000 Zyprexa ' whistle-blowing' pages over 4 years AND I took the stuff pre-black label 1996-2000 got type two diabetes which will shorten my life.

I don't get a dime! Amazing

Daniel Haszard