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

Anchorage Daily News

By LISA DEMER   

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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2 Comments

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2 responses to “Ex-FDA official blasts Eli Lilly in court – ZYPREXA SUIT: Expert witness for the state says profits came first.

  1. Ellen Liversidge

    Article in AHRP.ORG, archives prior to 2006, type in Zyprexa, and see the first article, from the Baltimore Sun, March, 2003, about the death of my son from Zyprexa and Marni Lemons from Lilly flat out denying any connection between Zyprexa and diabetes. This after both the UK and Japan had required Lilly to place warnings for diabetes, hyperglycemia, and death on Zyprexa sold in their countries.

    Of course, the FDA did nothing about warnings in this country until late 2003. early 2004

  2. I would like to link your wordpress site to mine. This is very valuable information especially in light of the attempts to put small schoolchildren on mind-altering drugs.

    Thanks for all the work you have compiled here. This is a really tremendous resource for people who have serious questions about the FDA and big pharma.

    Considering that Pharmaceuticals now finance 2/3 of the drug approvals…..I”m surprised this case even got into court or any others for that matter.

    Remember when the Medicare Prescription drug went into affect? Here in Minnesota, bus trips to Canada to buy the same drugs that cost hundreds of dollars a month here, for pennies on the dollar there….were halted. The FDA said that they might not be manufactured with our high standards here in the states. They were concerned for our safety (read: money)

    Now, Merck among many others produces medications in Mexico and China of all places which have no standards of any kind. And people are dying as a result.

    Marti Oakley

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