Zyprexa Judge: FDA Can’t Police Safety Problems
March 22nd, 2008 7:29 pm By Ed Silverman
Without lawsuits like the one the State of Alaska brought against Lilly over Zyprexa marketing, claims that drugs cause health problems “might well go unaddressed,” Anchorage Superior Court Judge Mark Rindner said from the bench this week. He made his remarks while the jury was out of the room, after the state had rested its case and Lilly asked for an immediate verdict in its favor, a routine step at that point in a trial.
As part of the proceeding, Lilly’s lawyer, George Lehner, argued that drug regulation is a matter for the FDA, not any state, and that Alaska’s Unfair Trade Practices and Consumer Protection Act shouldn’t apply to drugs. Rindner disagreed. Evidence presented by the state over the past two weeks established that the FDA “isn’t capable of policing this matter,” he told the courtroom, according to The Anchorage Daily News.
The exchange came during a closely watched trial in which Alaksa is suing Lilly to cover costs to Medicaid for treating weight gain and diabetes linked to the Zyprexa antipsychotic. The outcome - and even evidence - could influence settlement talks under way with the US Attorney in Phildelphia and state attorneys general, because an unfavorable verdict could prompt other states to file lawsuits, although nine already have.
Rindner’s remarks also focus attention on another closely watched legal battle - preemption. This concept turns on whether FDA approval of a drug supercedes state law claims challenging safety, efficacy or labeling. Drugmakers and the FDA argue preemption exists by maintaining the agency’s decisions are the final word on safety and effectiveness. The US Supreme Court will take this up in the fall.
Meanwhile, Lilly’s first witness was Silvio Inzucchi, a professor of medicine at Yale University, who is director of the Yale Diabetes Center, and internal medicine doctor who said he has treated thousands of diabetics. Under questioning by Lilly lawyer Andrew Kantra, Inzucchi testified he reviewed all the published studies on any connection between Zyprexa and diabetes. His conclusion: “Zyprexa does not cause diabetes.”
It doesn’t affect insulin resistance or production, he continued, and while weight gain increases the risk of diabetes, it doesn’t cause diabetes. Someone with a healthy pancreas who gained a lot of weight while on Zyprexa might never get diabetes, he told the court. He then added that studies found that patients may have had elevated blood sugar while on Zyprexa, but that’s not the same thing as diabetes, the Daily News reports.
Under cross-examination, however, Inzucchi acknowledged an “association between Zyprexa and diabetes” first shown in studies in the late 1990s. A diabetes expert for the state previously testified that Zyprexa did cause the disease.
Lilly also called David Kahn, a psychiatrist at Columbia University Medical Center and professor of psychiatry. He gave jurors a vivid view of the horrors of an extreme case of schizophrenia. Lilly’s team played a video of a psychiatrist’s interview with Russell Weston, who shot and killed two guards in the US Capitol in 1999 because he wanted to keep the country from being ruined by cannibals, the paper writes.
An early generation of anti-psychotics helped patients but had side effects like muscle tremors and jerking. Those drugs sedated them to the point they went through life with what felt like a “wet blanket over their head,” Kahn told the court. Drugs like Zyprexa were a “quantum leap forward” but also had risks, he told jurors. The first to come on the market, Clozaril, had a potentially fatal side effect: It could wipe out a patient’s white blood cells.
Kahn testified he began prescribing Zyprexa when it was approved in 1996 and he knew from colleagues involved in clinical trials that it brought a risk of weight gain, according to the News. But he told jurors that docs had many sources of info about drugs and their risks: medical journals, continuing education, package inserts, drug companies and their sales representatives, colleagues, and published guidelines.
Scott Allen, a Houston lawyer representing the state, pressed Kahn on whether he knew what Alaska doctors were told about Zyprexa. Kahn said he didn’t. Is there any source of information that Lilly is not involved in? Allen asked. No, Kahn said, according to the News.
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