Saturday, March 08, 2008

Ex-FDA official blasts Eli Lilly in court - Expert witness says profits came first

Anchorage Daily News
Ex-FDA official blasts Eli Lilly in court
ZYPREXA SUIT: Expert witness for the state says profits came first.

March 8th, 2008

A retired medical officer with the federal Food and Drug Administration testified Friday that drug maker Eli Lilly distorted the science and downplayed the health risks of its schizophrenia drug Zyprexa to make more money.

John Gueriguian, who worked 20 years for the FDA and is now a consultant, was on the stand in Anchorage Superior Court all day Friday as an expert witness for the state of Alaska.

The state is suing Eli Lilly and Co. to recover costs to its Medicaid system for what it contends are serious health problems, including weight gain and diabetes, caused by Zyprexa.

The state says the company failed to warn of troubles because it counted on Zyprexa to become its next big moneymaker.

Global sales of Zyprexa approached $4.8 billion last year.

At the FDA, Gueriguian worked for the division that oversaw diabetic drugs, not psychiatric medication, so he wasn't directly involved in oversight of Zyprexa. Lawyers working for the state hired him to analyze Lilly documents and e-mails and said it's impossible to get current FDA employees to testify.

If Lilly could show that diabetes was common for this class of drugs, then it would no longer be a special problem for Zyprexa, said a Nov. 28, 2001, company document.

Was it comparable? Tommy Fibich, a Houston attorney representing the state, asked.

Just the opposite, Gueriguian answered.

Zyprexa caused many more such problems than most similar drugs, he said.

"Simply put, it's putting profit over the concern of the consumer," Gueriguian told the jury.

In a 2001 guide for sales representatives, the directive from on high was clear, he said. "Our goal and focus is on creating a market with Donna. The competition wins if we are distracted into talking about diabetes," the guide said.

"Donna" was code for an effort to pitch the drug as treatment for depression and mood changes, Gueriguian said.

Lilly lawyers didn't get to cross-examine Gueriguian on Friday. After court broke for the day, 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.

"We didn't hide anything," Brenner said. Regarding Zyprexa, he said, "there's an ongoing debate being played out in the medical community."

Some tidbits presented on Friday came from a string of internal Lilly e-mails generated in 2000. Employees were talking about a meeting with consultants.

One Lilly employee wrote that the consultants were concerned how the company handled the issue of whether Zyprexa leads to diabetes.

"I do believe they made a very strong point that unless we come clean on this, it could get much more serious than we might anticipate," Thomas Brodie wrote in a Oct. 9, 2000, e-mail to others at Lilly.

The next day, another Lilly employee responded that the real concern seemed to be about weight gain, and that the consultants wanted the company to "aggressively face the issue" and work with doctors to help them manage patients' weight. Even if just 2 percent of patients on Zyprexa gained a possible 90 pounds, that amounted to 100,000 people, the employee wrote. "100,000 people putting on 90 pounds of weight is a lot."

Marni Lemons, a Lilly spokeswoman, said Friday that the state's lawyers are focusing on a few misleading or poorly worded documents out of 19 million pages of records.

One thing the jurors didn't learn: Gueriguian was one of the FDA medical officers who fiercely fought approval of the diabetes drug Rezulin, made by Warner-Lambert. It got on the market anyway only to be withdrawn after dozens of deaths and reports of liver toxicity.

Fibich tried to ask Gueriguian questions about Rezulin, but Lilly lawyers objected and he wasn't allowed to.

The trial resumes Monday.


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