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Zyprexa on Trial in Alaska: Lilly Accused of Putting Profit Before Patients

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Anchorage, AKSpectators in a courtroom in Anchorage are getting an earful about how Zyprexa maker Eli Lilly waited, according to a witness, almost nine years to add warnings to Zyprexa with regard to a risk for diabetes, elevated blood sugar levels and weight gain.

Instead, Lilly is alleged to have hid data that cast Zyprexa in a bad light, and instructed its drug reps to only articulate the diabetes issue if a doctor brought it up first. Otherwise, an internal Lilly document allegedly shows, reps were forbidden to proactively address the diabetes issue.

The most damning testimony so far has come from Dr. John Gueriguian, a diabetes specialist and a medical reviewer for the US Food and Drug Administration (FDA) before taking his retirement in 1998.

Diabetes PatientZyprexa was introduced to the market in 1996 and hailed as a breakthrough drug for the treatment of schizophrenia and bipolar disorder. However, according to the witness, it soon became apparent that Zyprexa had a nasty alter ego when it came to elevated blood sugar levels, diabetes and weight gain. Doctors began reporting their findings to Eli Lilly starting in 1998.

By the fall of that year, according to Dr. Gueriguian, Lilly had gathered sufficient data from adverse reactions, clinical studies and animal study data to warn doctors about a link between Zyprexa and diabetes. However, according to the expert witness testifying on behalf of the State of Alaska, the manufacturer did nothing.

Eli Lilly is alleged to have remained silent for the next two years as well, according to documents allegedly showing that Lilly was continuing to accumulate evidence of a real link between Zyprexa, and the onset of diabetes.

An interesting parallel emerged from Japan, a country which took the manufacturer to task and required Lilly to issue a warning to doctors against using Zyprexa in diabetic patients. Zyprexa had only been sold in Japan for 10 months before the Japanese health authorities, in 2002, issued the order to Lilly about Zyprexa.

While Lilly complied in Japan, the manufacturer issued no such statement in the US. It is not clear how much the FDA knew over that same period of time, and what role, if any, the FDA played within the context of Zyprexa's availability, without warnings for diabetes, in the United States.

Those warnings were finally added in 2007. Dr. Gueriguian, an expert witness who recommended to the FDA against the approval of Rezulin out of concern for severe liver damage, testified Friday that in his view the manufacturer put "profit over concern of the consumer."

Zyprexa is Eli Lilly's top-selling product, with sales of $4.8 billion last year.

A spokesperson for Lilly stated that the company shared everything it knew with the FDA, and that the link between Zyprexa and diabetes was still subject to scientific debate.

The State of Alaska is suing Eli Lilly to recover costs associated with dispensing Zyprexa to Medicaid patients. The trial is being held in Alaska State court in Anchorage, and resumes Monday.



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