Common Schizophrenia Drug on Trial
By MedHeadlines • Mar 8th, 2008 • Category: Bipolar Disorder, Diabetes, Drugs, FDA, Prevention, Schizophrenia
The pharmaceutical giant, Eli Lilly, is being sued by the state of Alaska over allegedly covering up the potential risks of Zyprexa (olanzapine). Attorneys for the state argue that the company knew that the drug, approved for the treatment of Schizophrenia and acute manic and mixed episodes of Bipolar Disorder, may cause diabetes in patients taking it.
According to the prosecution, the presented evidence suggests that Lilly’s management was aware of the drug’s potential risks soon after its introduction to the market in 1996, but chose to limit the public’s awareness, in order to keep the drug’s sales numbers up. The state wants Eli Lilly to pay Medicaid expenses of patients who developed diabetes and other illnesses after taking the medication.
Attorneys for Eli Lilly claim that the company has properly disclosed all of the drug’s side-effects to the Food and Drug Administration and that company has done nothing wrong. It is proud to offer the breakthrough drug to individuals suffering from mental illness. Zyprexa continues to be covered by Alaska’s Medicaid.
Zyprexa is one of the top-selling drugs worldwide, being used by over 20 million patients. According to a large National Institute of Mental Health study published in 2005, Zyprexa helps patients control their symptoms for a significantly longer period of time than with other antipsychotic drugs.
Sources: Zyprexa.com, The New York Times
Associated Press:
Quote:
FDA official testifies against Eli Lilly over schizophrenia drug
Associated Press - March 8, 2008 5:44 PM ET
ANCHORAGE, Alaska (AP) - A retired medical officer with the federal Food and Drug Administration says drug maker Eli Lilly downplayed the health risks of its schizophrenia drug Zyprexa to make more money.
John Gueriguian worked at the FDA for 20 years and is now a consultant.
He testified in Anchorage Superior Court on behalf of the state of Alaska.
The state is suing Eli Lilly and Co., arguing that it needs to recover costs to its Medicaid system for serious health problems caused by Zyprexa.
Alaska is 1 of 9 states suing Lilly over Zyprexa and the first go to trial.
Lilly attorney John Brenner told reporters the company turned over its data to the FDA, which approved the drug in 1996.
Zyprexa remains on the market in the United States and more than 80 other countries.
Copyright 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
NY Times:
Quote:
Lilly Waited Too Long to Warn About Schizophrenia Drug, Doctor Testifies
By ALEX BERENSON
Published: March 8, 2008
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.
The mountain of evidence against Eli Lilly is rather condemning. The lack of up-front information on Eli Lilly's part certainly makes a person think twice before putting their health in the hands of a major corporation. This is scary stuff; hopefully some sort of precedent will be set.
09-03-2008, 03:16
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