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【drug-news】医生作证指出礼来早该对精神分裂症
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Lilly Waited Too Long to Warn About Schizophrenia Drug, Doctor Testifies
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. John 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At the F.D.A., he recommended against the approval of Rezulin, a diabetes drug that was later withdrawn for causing severe liver damage in patients.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. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 Lilly Waited Too Long to Warn About Schizophrenia Drug, Doctor Testifies
医生证实，礼来久等等来精神分裂症药物的警告
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.
安克雷齐——星期五，专家证人在一项指控再普乐(Zyprexa,奥氮平)导致多例精神病人发展成糖尿病的诉讼中告诉陪审员，早在1998年礼来制药就能也应该告诉医师其治疗精神分裂症的畅销药物再普乐与糖尿病有关。
Instead, Lilly hid Zyprexa’s risks from doctors to protect the drug’s sales, according to the witness, Dr. John 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.
恰恰相反，根据证人John Gueriguian博士的证词，礼来公司出于药品销售的保护而对医生隐瞒了再普乐的风险。直到2007年礼来公司才在再普乐的标签中增加了反映药物有导致体重明显增加和血糖改变的趋势的严重警告。
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作者:admin@医学,生命科学 2011-02-08 17:14
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