Eli Lilly Knew Zyprexa Could Cause Diabetes

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. 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At the F.D.A., he recommended against the approval of Rezulin, a diabetes drug that was later withdrawn for causing severe liver damage in patients.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.

Comments

There is a similar situation with the anti depressants. Glaxo Smith Kline have known for quite awhile that their drugs cause suicidal thoughts in (some) under 18's.

However, because the drug (in the UK at least, maybe worldwide) is licensed to OVER 18 year olds, they were not obliged to divulge the information.

I think drug companies withhold information a little while for the $$$/£££.
 
oh yes it is all about money. I am a REGISTERD NURSE and work with mentally ill patients. They usually have enough problems with gaining diabetes! great info---thanks for sharing!
 
actually the suicidal thoughts thing is very complicated, and there is no proof that it is the medication per se that does it or that it's limited to teens. still, it's a problem-- for a very long time doctors and pharma companies refused to say that SSRIs have a discontinuation syndrome-- meanwhile people going cold turkey off of their antidepressants were having an awful time of it.

on the other side, Lamictal, an anticonvulsant used to treat epilepsy and bipolar disorder, has a black box warning like the SSRIs do. It has caused many doctors to refuse to prescribe it because it can cause a serious and sometime fatal illness called Stephen's Johnson Syndrome. Of course, many other medications (including some antibiotics and other anticonvulsants) can cause SJS and don't have the black box warning. As well, SJS is exceedingly rare and can be taken care of if caught soon enough which only requires good doctor and patient education. Sometimes these warnings are overused and/or badly used.

Doctors have known for a long time the effect of Zyprexa on weight gain and other metabolic issues whether the pharma company told them or not, but it's been more anecdotal than scientific. The issue has always been risk versus benefit-- and Zyprexa has the ability to knock out psychosis and knock down mania in a way that few other drugs do. Though Lilly should be more proactive in their approach, it doesn't negate the fact that Zyprexa is a powerful, useful drug in the psychiatric arsenal.
 

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