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Japan made Zyprexa labels reflect risk to diabetics

Lisa Demer

When health officials in Japan learned of serious health complications from the schizophrenia drug Zyprexa back in 2002, they forced the drug maker to put a strong warning on its label: Do not give to patients with diabetes.

Sales took an immediate dive. So did the reputation of manufacturer Eli Lilly and Co., and not just with the Japanese health ministry, jurors were told Thursday in Anchorage Superior Court.

"Market research shows we have also lost quite a bit of credibility with prescribers and opinion leaders, basically because they felt left in the dark with what they perceived as the late sharing of safety information," two Lilly executives wrote that year in a memo to John Lechleiter, the company's chief operating officer and president.

The controversy in Japan over the drug was front and center in Anchorage Superior Court on Thursday.

The state of Alaska is suing Lilly over Zyprexa, accusing it of failing to warn doctors about dangerous side effects. The state wants Lilly to pay hundreds of millions to recover costs to Medicaid for treating what it says are Zyprexa-caused health problems, including diabetes.

Lilly's defense team says all drugs have side effects and Zyprexa allows millions of people suffering from mental illness to get their lives back.

Lawyers for the state said they couldn't legally force Lechleiter to come to Alaska to testify in person, so Thursday they were allowed to use snippets from a video deposition taken in March 2007. Scott Allen, a Texas lawyer working for the state on the suit, asked Lechleiter about a number of internal Lilly documents.

In April 2002, health officials in Japan made Lilly send out a "Dear Doctor" letter in response to nine reported cases of serious diabetic complications involving Zyprexa, including two deaths "for which causal relationship with this product cannot be denied," according to the letter. That was out of an estimated 137,000 patients. As a result, Lilly had to put new warnings on the drug label.

That June, the head of Lilly's Zyprexa product team and another executive went to Japan and assessed the damage.

Lilly didn't agree with the health ministry's ruling, and said so, arguing against the warning on the drug label, Lechleiter said in his video deposition, played in the courtroom. That might explain why one of the executives thought the company "lost substantial ground and trust" with the government in Japan, he said.

A Lilly memo also described what happened to sales after Japanese doctors learned of the health risks: "A 75% drop in new patients who are being put on the drug, and a continuing fairly high drop-out rate."

In the United States, Zyprexa's label, which guides doctors and other prescribers, has gradually been strengthened since the drug was first approved in 1996. Doctors now are told to closely monitor patients with diabetes. But they are not told diabetics should never be given Zyprexa.

After the trial ended for the day, a Lilly spokeswoman and an attorney said the company shared all the data from Japan with the U.S. Food and Drug Administration, which didn't see it the same way as officials in Japan and didn't require the same warnings.

Allen also questioned Lechleiter about how important Zyprexa was to the company's bottom line. In 2000, the company learned it was losing its patent on best-seller Prozac three years early.

"Now, you didn't expect this, to lose this patent. You were surprised to have lost this patent?" Allen asked.

"Sir, we were surprised, but we were prepared," Lechleiter answered.

Not only surprised, but "very surprised," Allen emphasized, reading from the company's 2000 annual report.

Allen noted that in the report, under the heading "So, what now?" the first product listed is Zyprexa.

In fact, Zyprexa sales passed $2 billion that year, making it a "genuine blockbuster," according to the report.

Last year, global Zyprexa sales approached $4.8 billion. It is now Lilly's best seller and remains on the market in more than 80 countries, the company says. In the United States, it is approved for schizophrenia and bipolar disorder.

Late on Thursday, lawyers were told that a juror who collapsed and was taken to the hospital on Wednesday was treated and released, and is recovering. Superior Court Judge Mark Rindner let the lawyers sign a get-well card. The judge also instructed the lawyers not to contact that juror or another one excused for a dental emergency until after the trial.

Twelve jurors are continuing to hear the case. Lilly will present its evidence next week.

Find Lisa Demer online at or call 257-4390.

PDF: Eli Lilly opening statement slides