Lilly Waited Too Long to Warn About Schizophrenia Drug,Doctor Testifies: should have warned physicians as early as 1998 ...NY Times March 8, 2008

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NY Times March 8, 2008 Lilly

Waited Too Long to Warn About Schizophrenia Drug, Doctor Testifies By ALEX BERENSON ANCHORAGE

— Eli Lilly, the drug maker, could and

should have warned physicians as early as 1998 about the link between Zyprexa,

its best-selling schizophrenia medicine,

and diabetes, an expert witness told jurors

Friday in a lawsuit that claims that Zyprexa has caused many mentally ill

people to develop diabetes. Instead, Lilly hid

Zyprexa’s risks from doctors to protect the drug’s sales, according to the

witness, Dr. Gueriguian. Lilly waited until 2007 to add strong warnings to

Zyprexa’s label to reflect the drug’s tendency to cause severe weight gain and

blood sugar changes. Lilly put “profit over

concern of the consumer,” Dr. Gueriguian said Friday near the end of four hours

of testimony. Zyprexa, a drug for

schizophrenia and bipolar disorder, is by

far Lilly’s top-selling product, with worldwide sales of $4.8 billion last

year. The company has said

it did nothing wrong and fully disclosed what it knew about Zyprexa to the Food

and Drug Administration. Dr. Gueriguian is

testifying on behalf of the State of Alaska ,

which has sued Lilly to recover its costs for treating Medicaid patients who

developed diabetes after taking Zyprexa. The trial is being heard in state

court in downtown Anchorage before a jury of seven women and five men. Dr. Gueriguian is a

specialist on diabetes and was a medical reviewer for the Food and Drug

Administration for 20 years before retiring in 1998. At the F.D.A., he

recommended against the approval of Rezulin, a diabetes drug that was later

withdrawn for causing severe liver damage in patients. Under examination by

Tommy Fibich, a lawyer from Houston who is

representing Alaska ,

Dr. Gueriguian methodically reviewed about a dozen documents in which Lilly

scientists and executives discussed the potential links between Zyprexa and

diabetes. Zyprexa was introduced

in September 1996 and hailed as a breakthrough medicine for the treatment of

schizophrenia. But doctors quickly

began to report to Lilly that patients suffered severe weight gain, high blood

sugar and even diabetes after taking the drug. By the fall of 1998,

the combination of adverse-event reports, clinical trial data that showed

hyperglycemia and weight gain, and problems in animal studies should have been enough

for Lilly to warn doctors about Zyprexa’s links to diabetes, Dr. Gueriguian

said. Instead, the company did nothing. Documents from 1999

and 2000 also showed that Lilly was accumulating evidence of Zyprexa’s risks

but not sharing it with doctors, he testified. And in 2002, only 10

months after Lilly began selling Zyprexa in

Japan , medical regulators in that

country required Lilly to warn doctors against using Zyprexa in diabetic

patients. But Lilly did not

issue a similar advisory to doctors in the

United States . Instead, the company

advised its sales representatives not to discuss diabetes with doctors unless

the doctors brought it up first, according to another document presented at the

trial. “We will NOT

proactively address the diabetes concerns,” the document, an internal Lilly

memorandum, said. Court recessed on

Friday before lawyers for Lilly could cross-examine Dr. Gueriguian. They will

have the opportunity to do so on Monday. A lawyer for Lilly

said after Dr. Gueriguian’s testimony that the company had shared all it knew

with the F.D.A. and that the question of the link between Zyprexa and diabetes

was still a subject of scientific debate.

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