Healthy Skepticism Library item: 13114

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Demer L.
State claims drug maker hid data
Anchorage Daily News 2008 Mar 6
http://www.adn.com/front/story/336455.html

Full text:

SUIT: Zyprexa risks weren’t disclosed by Eli Lilly, lawyer says.

Drug maker Eli Lilly knew from the start that its schizophrenia drug Zyprexa was linked to health problems in patients but hid that information because it wanted a big moneymaker, a lawyer for the state told jurors in Anchorage Superior Court on Wednesday.

But a lawyer for Lilly shot back that every prescription drug has side effects and that Zyprexa is a life-saving and effective treatment for serious mental illness. It’s been on the market since 1996, is approved in the United States and more than 80 other countries. The state of Alaska hasn’t done one thing to restrict its use, Lilly’s lawyers told jurors.

Alaska is suing Eli Lilly and Co. to recover the costs of treating Medicaid patients for what it contends are health problems caused by Zyprexa, including significant weight gain and diabetes.

It’s the first case against Lilly over Zyprexa to go to trial. Cases brought by eight other states are pending, as are 1,200 individual claims. Both sides are going all-out with lawyers and support staff brought in from around the country.

An Anchorage jury of 12 with two alternates was seated Wednesday morning for what’s expected to be a three-week trial heavy on medical experts, technical details and insider Lilly documents that the corporation never expected to become public.

This jury is only considering liability. If the state wins, there will be a second trial in Anchorage before a new jury to determine damages. Ed Sniffen, a senior assistant attorney general, said the state is seeking hundreds of millions of dollars.

Lilly represented Zyprexa as an anti-psychotic that had comparable rates of “adverse effects” as other similar drugs, but that’s not true, Scott Allen, a lawyer from Houston, Texas, said in his opening statement.

Patients on Zyprexa suffer increased cholesterol levels, high blood sugar, diabetes and significant, devastating weight gain, he said. Before the drug was even approved, he said, a study found that patients gained 24 pounds after 12 months on Zyprexa.

“Eli Lilly did not tell doctors, the state of Alaska Medicaid system or patients what they knew about this drug,” said Allen, in an opening that took nearly two hours. Patients should be able to make an “informed choice,” he said.

“But if they put a warning on this product, their sales would fall. They would lose money. People would choose another drug, and they decided not to disclose what they knew,” Allen said.

Lilly never advertised Zyprexa on TV or in magazines. It relied on its huge force of sales representatives to pitch the drug to doctors. In 2000, when Lilly’s patent on the highly profitable antidepressant Prozac ran out, the company began marketing Zyprexa not just to psychiatrists but also to primary care doctors, Allen told jurors.

The company needed a new “billion-dollar blockbuster,” he said, and it dubbed its campaign “Viva Zyprexa.”

The elderly were considered an especially lucrative patient group, and if they gained weight, that was a plus because they tend to waste away, the head of the Zyprexa team said in a recorded talk handed out on cassette to sales representatives, Allen told jurors.

A July 2001 slide show created by Lilly reveals how important the drug was to the corporate bottom line.

“The company is betting the farm on Zyprexa,” Allen said, quoting from an internal company document flashed on the screen for jurors. “The ability of Eli Lilly to remain independent and emerge as the fastest growing pharma company of the decade depends solely, solely, only on our ability to achieve world class commercialization of Zyprexa.”

The “Viva Zyprexa” campaign material was only for sales people and was never supposed to become public, a company spokeswoman said during a break in the trial.

Eli Lilly’s take on Zyprexa is vastly different from the state’s.

Doctors considered Zyprexa a “breakthrough” medicine for people with debilitating schizophrenia and it was later approved for bipolar disorder as well, Nina Gussack, a Philadelphia-based lawyer with Pepper Hamilton, told the jury.

The state of Alaska’s own expert, Dr. William Wirshing, called Zyprexa and others in its class “the closest thing to magic” that he’s ever seen in his professional life, according to a snippet of a video deposition that Gussack played for jurors.

And no one in the state has done anything to restrict or limit the continued prescribing of Zyprexa, she said.

Doctors always must weigh risks versus benefits, and they knew the risk of weight gain with Zyprexa because the company listed it under the “adverse events” portion of the drug’s label, Gussack said. But state lawyers say that information should have been listed on a more significant warning label.

The label for Zyprexa evolved over time, as more information was known, another lawyer for Lilly, George Lehner of Pepper Hamilton’s D.C. office, told jurors. The state says the label wasn’t significantly changed until 2007, after the New York Times reported from leaked documents that clinical trials found elevated blood sugar levels and weight gain.

The head of Alaska’s Medicaid pharmacy program told Lilly that as far as he knows, Lilly never deceived the state about the safety or effectiveness of Zyprexa, Lehner said.

“This case should never have been brought,” he told jurors.

The state is suing under consumer protection law and doesn’t have to prove that any individual person was misled or even harmed by Lilly, Allen said.