By Miriam Hill
INQUIRER STAFF WRITER
Robert Rudolph knew he was about to end his lucrative career at Eli Lilly & Co., but he had to say something.
Why, he asked management, was the Indianapolis pharmaceutical company marketing its antipsychotic drug Zyprexa to elderly people when the drug was not approved for that group?
Why had the company violated privacy rules by culling patient lists at doctors' offices?
Why was the company counting drug samples as sales, which would boost the stock price?
He went on for about 10 minutes during a sales meeting in 2002. The other 25 Lilly sales representatives stared at him, stunned.
"I'd just been wrestling with this stuff for so long," he said in a telephone interview today. "I was put in a position of breaking the law, in my view, or quitting."
Rudolph and eight other whistle-blowers brought their allegations to federal prosecutors. That led Lilly to agree Thursday to a record $1.4 billion fine to settle charges of marketing Zyprexa illegally.
Zyprexa had been approved by the Food and Drug Administration for schizophrenia and bipolar disorder - but in 2001, the company began promoting it for other uses, such as treating anxiety, agitation and confusion in the elderly.
Drug companies are permitted to market drugs only for approved uses, though doctors may prescribe as they see fit. Lilly did an end run around the process by telling doctors Zyprexa could ease agitation, anxiety, and other everyday symptoms, according to the Philadelphia U.S. Attorney's Office, which brought the case.
In a statement today, Lilly insisted its employees always adhered to strict ethics. "Doing things the right way at Lilly is more important than securing a prescription," the statement said.
Rudolph and several other whistle-blowers found their way to prosecutors through their attorneys, Steve Sheller of Sheller P.C. and Michael Mustokoff of Duane Morris L.L.P., both of Philadelphia, and Gary Farmer of Florida.
Lilly's Zyprexa marketing material included pictures of composite patients such as Martha, a confused and agitated widow.
"If you looked at it, you would say this was an Alzheimer's dementia patient," Rudolph said in the interview from his home in Oregon.
Other tactics bothered him, too. Company employees were allowed into doctors' offices on weekends to collect names of patients taking certain drugs in hopes of switching them to Lilly products.
"We're not selling soap. We're selling chemicals that can be dangerous if they're not used in the right way," he said.
That was especially true of Zyprexa, which caused weight gain. And diabetes is a risk of the drug.
Rudolph, who was a pharmacist before joining Lilly in 1976, chose the company because of its sterling reputation.
But gradually, as financial markets boomed and stock options became a bigger part of executive pay, Lilly's culture began to change, Rudolph said.
Instead of the pharmacists it had traditionally hired, Lilly started bringing in recent college graduates who had no medical background and were easy to train to parrot the company line. Instead of a profit-sharing program that all employees participated in - "even the guy who swept the floor," Rudolph said - compensation shifted to rewards-based on sales.
"This new way of compensation kind of opened the door for a lot of unscrupulous practices, I felt," Rudolph said.
He warned management of his concerns. Their response: "You're not a team player."
He began talking to other sales representatives about the issue, including Hector Rosado, another whistle-blower in the case.
As he pondered what to do, Rudolph's son, then 15, provided a moment of clarity:
"He came up to me and said, 'Dad, what's wrong is wrong.' I had taught my kids that. It was wrong, and I wanted to make it right."
So he raised his hand at the Lilly district sales meeting in Sacramento, Calif., in January 2002.
The stress of the job had thrown him into a depression. Managers made it clear they wanted him to leave, so six months after he made his stand at the meeting, he retired from his $115,000-a-year job.
He and the eight other whistle-blowers will split $78 million to $100 million of the settlement. Rudolph, 60, says the settlement against Lilly will only go so far in changing business practices. He wants jail time for wrongdoing by companies and executives.
Zyprexa sales were about $39 billion since FDA approval in 1996. Lilly did plead to a single misdemeanor of misbranding of a drug.
"You have to remember, with Zyprexa," he said, "people lost their lives."
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**Lilly will pay $800 million in civil penalties and plead guilty to criminal charges, paying an additional $600 million fine. The six whistleblowers who brought the Complaint against the drug company will share in approximately 18 percent of the federal and qualifying states' recoveries.
Quite a carrot to dangle for any whistleblower!
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