In March I wrote: “… how does a drug such as Zyprexa, that was approved for the treatment of adults with schizophrenia, and a few years later, was approved for short-term treatment of adults with manic episodes associated with bipolar disorder, become such a HUGE selling medicine?
Despite its extremely limited original approved uses, Zyprexa has gone on to become the top selling antipsychotic worldwide with an estimated 20 million people having used the drug and Lilly’s best-selling product, with $4.2 billion in sales in 2005, which translates into 30% of its total revenues.”
Well, we might be able to find out soon how Zyprexa became such a blockbuster – a U.S. District Court judge yesterday issued a decision allowing to go forward a class action lawsuit that alleged that Eli Lilly & Co. (NYSE: LLY) fraudulently marketed the atypical antipsychotic drug, Zyprexa, for uses not approved by the FDA. Judge Jack B. Weinstein, of the U.S. District Court, Eastern District of NY, denied Eli Lilly’s motion for summary judgment, as well as a summary judgment motion filed by the plaintiffs. (Thanks to CL Psych for this breaking news.)
The 14-page order highlighted the importance of the Courts in protecting the public in the arena of prescription drugs. The Judge stated: “Under the present organization of the pharmaceutical industry, the official federal Food and Drug Administration (FDA), and the plaintiffs’ bar, the courts are arguably in the strongest position to effectively enforce appropriate standards protecting the public from fraudulent merchandising of drugs.”
Here’s some more, again from March:
The State of Montana has sued Eli Lilly for its marketing of Zyprexa. Phil Dawdy at Furious Seasons obtained a copy of the complaint. Here are some key portions:
Lilly “put users at risk for developing severe and harmful health conditions including, but not limited to, hyperglycemia, acute weight gain, diabetes mellitus, exacerbation of of diabetes mellitus, pancreatitis, cardiac problems and death. Furthermore, Defendant has been aware of studies linking Zyprexa to these conditions since 1996 and has known since at least 1999 that Olanzapine causes diabetes at a rate far in excess o fthe risk of most atypical antipsychotics, yet has failed to fully and adequately warn the State, physicians, and consumers of these risks.”
The state further accuses Lilly of off-label marketing of Zyprexa for Alzheimer’s, dementia, Tourette’s, pervasive developmental delay, autism, anorexia nervosa and general depression. And there’s more:
“Lilly’s sales force concentrated on primary care physicians, rather than pyschiaitrsts, and focused upon marketing and selling the drug as treatment for depression and anxiety, rather than the psychotic conditions for which Zyprexa had been approved.”
The state also alleges that Lilly “created a 280-person sales force exclusively for off-label uses especially for long-term care facilities.” And:
“Lilly gave promises of financial benefits, in cash and in kind, to numerous physicians who attended the elderly to cement this unlawful marketing of Zyprexa.” And:
“Lilly management participated, encouraged and authorized the unlawful payment of illegal kickbacks to physicians in order to continue generating sales of Zyprexa.”
The state also alleges that Lilly paid off the long-term care sales manager in Florida in 2006, who had apparently threatened to go public with what he knew of the company’s marketing activities, in order to keep him quiet. Also, according to the complaint, Lilly budgeted $100,00 annually for a sales rep to spend on speaker fees and honoraria. The company paid huge amounts for speakers’ travel, first-class lodging, extravagant meals and entertainment for doctors and their spouses.
The complaint states that Lilly gave gifts to doctors in the form of chartered fishing trips for doctors and their friends, sporting events, expensive dinners and entertaining in order to induce doctors to write off-label prescriptions of Zyprexa among the elderly.
Strong stuff indeed… but really though, how much longer are we going to allow this kind of practice to continue?