API patients on Zyprexa got diabetes, official says – TRIAL: Medical director testifies risks weren’t fully known.

Anchorage Daily News

By LISA DEMER ldemer@adn.com

Patients taking the anti-psychotic drug Zyprexa needlessly developed diabetes because doctors didn’t have all the information about risks, the medical director of Alaska’s only public mental hospital said in court Wednesday.

The state of Alaska is suing drug maker Eli Lilly and Co. over Zyprexa, contending the company failed to warn of problems including weight gain, high blood sugar and diabetes. The state wants Lilly to pay the costs to Medicaid of treating those health problems.

In opening statements last week in Anchorage Superior Court, a lawyer for Lilly told jurors that the company, not the state, would call Duane Hopson, medical director of Alaska Psychiatric Institute, to testify, and that he would talk about how Zyprexa was still prescribed at the hospital.

But when Hopson, a psychiatrist and president of the Alaska Psychiatric Association, testified Wednesday, it was as the state’s witness.

 

LABEL CHANGES

Zyprexa was approved for treatment of schizophrenia in 1996 and in 2000 for treatment of bipolar mania. The drug’s label was changed a number of times over the years and eventually included warnings and recommendations to test patient glucose levels for signs of diabetes.

But only in 2007 — 11 years after Zyprexa came on the market — did the label say it was more likely to raise a patient’s blood sugar than most similar anti-psychotic drugs.

“Do you believe patients who were placed on Zyprexa developed diabetes who otherwise would not have developed diabetes if you knew then what you’ve been told now?” asked attorney Scott Allen, a lawyer from Houston, Texas, who is part of the team representing the state.

“I think there are,” Hopson answered.

Even before Lilly advised it, API began closely monitoring patients on Zyprexa, he said. The hospital in October 2004 changed its protocol and began to weigh patients and test their blood for glucose and lipids as concerns about Zyprexa mounted, he said. Patients with elevated blood sugar would probably be given another drug, he said.

Allen also asked Hopson about seemingly contradictory information from Lilly. In February 2000, the company was working to change the drug’s label and was reviewing data from clinical trials that showed 3.6 percent of patients on Zyprexa had elevated blood sugar compared with 1 percent on a placebo.

But it submitted different information to the federal Food and Drug Administration, and the 2001 Physician’s Desk Reference — a thick guide to medications used by doctors — said the clinical trials found almost no difference between the drug and a placebo in terms of blood sugar.

Hopson agreed with Allen that the company was implying the drug is safe, and that the information was inconsistent with what it said in 2000.

After court ended for the day, a spokeswoman for Lilly said that the 2000 report was preliminary and that further study went into the information eventually sent to the FDA. The science is constantly evolving, Lilly has maintained.

STILL PRESCRIBED AT API

Hopson also told jurors that Zyprexa is still prescribed for patients at API, but that doctors try not to use it if something else is effective. It might be needed for patients who are seeing hallucinations, hearing voices, delusional or violent — those who are in “psychic turmoil and a lot of psychic pain,” he said.

But don’t psychiatrists at API prescribe it without restriction? Nina Gussack, a lawyer for Lilly, asked Hopson under cross-examination.

They do, he said. If a patient won’t agree to take it, the state may even go to court to force them to do so, he said.

Gussack asked Hopson if he was consulted about the lawsuit before it was filed.

He wasn’t, he said. He only learned about the case in the newspaper. He never was asked by the lawyers suing to give his views on the case, he said.

The court day started with a scare. Just as jurors were filing into the courtroom, a juror in his 60s became light-headed and collapsed, hitting his head on the way down. Someone called 911. A psychiatrist who may testify for the state rushed in to help. Medics came and took Juror No. 13 away on a gurney. He wasn’t at either Providence Alaska Medical Center or Alaska Regional Hospital later in the day, so it wasn’t possible to get his condition.

Lilly asked for a mistrial. Superior Court Judge Mark Rindner ruled against the company.

The trial resumed, with 12 jurors. Both alternates now have been excused. Testimony began a week ago and is expected to take another seven days or so.

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