Zyprexa: Courts Can Help

Brooklyn, NYSomewhere on YouTube is a video clip featuring Shahram Ahari, a former account executive at Eli Lilly, claiming that he was told to play down the adverse side effects of Zyprexa, which he used to sell on behalf of the company.

A spokesperson from Eli Lilly & Co. counters that Ahari is a paid witness in a case against a New Hampshire law prohibiting the sale of prescription data.

The fact remains, however that Zyprexa is a huge seller for Eli Lilly: $4.4 billion worth in 2006 in the United States alone. That doesn't include revenues from other countries.

So it's hardly surprising that when such a high-performer comes under attack, you adopt a bunker mentality and do what you can to protect the franchise.

In this case, not only play down the adverse side effects, but also actively market off-label use of the drug, which is the allegation contained in a class-action lawsuit brought by the New York based Sargeants Benevolent Association Health and Welfare Fund.

In part, the class action alleges that Eli Lilly & Co. marketed Zyprexa for off-label use, an activity that is not within the normal code of conduct for drug companies. In other words, only medical doctors have the authority to prescribe a drug within the context of a condition for which it was not originally approved, based on his or her assessment of the patient, the condition, and any off-label benefits the drug may have.

Some of the alleged off-label targets of Eli Lilly's active marketing of Zyprexa were elderly patients presenting symptoms of dementia. Zyprexa was never approved by the FDA for use in the elderly.

As an aside, the Agency for Healthcare Research and Quality (AHRQ) based in Rockville, Maryland reported in a study released in January 2007 that there was little scientific evidence to support the off-label use of Zyprexa, and other atypical antipsychotics. The agency is affiliated with the U.S. Department of Health & Human Services.

In issuing his decision regarding the Sargeants Benevolent Association Health and Welfare Fund class-action, U.S. District Court Judge Jack B. Weinstein stressed the importance of the courts when it comes to the well-being of the public with regard to prescription drugs.

In his written Opinion, Judge Weinstein states, in part:

"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."

There have been 288 reported cases of diabetes in Zyprexa patients.

23 of those patients have died.