Originally published September 6 2008
Former FDA Official Testifies that Eli Lilly Lied about Drug Side Effects
by David Gutierrez, staff writer
(NaturalNews) Pharmaceutical company Eli Lilly concealed the risks of its schizophrenia drug Zyprexa from U.S. regulators in order to increase its profits, a former FDA official has testified in Alaska court.
The state of Alaska is suing Eli Lilly to recover the money that the state Medicaid system paid out to treat the serious health problems caused by Zyprexa. John Gueriguian, who was an FDA employee for 20 years, was hired by the prosecution to analyze internal Eli Lilly documents.
Gueriguian testified that Eli Lilly knew as early as 1998 that Zyprexa increased the risk of developing diabetes, but did not issue warnings about those effects until 2007.
"Simply put, it's putting profit over the concern of the consumer," Gueriguian said.
Zyprexa is Eli Lilly's top-selling drug, generating $4.8 billion in 2007 alone. It is sold in more than 80 countries worldwide.
When the drug was approved by the FDA in 1996, doctors quickly began to report that patients were experiencing severe weight gain, high blood sugar and diabetes. By 1998, the evidence from these reports and from clinical trials was overwhelming enough that Eli Lilly should have warned doctors about the side effects, Gueriguian said.
Internal emails show that company employees were aware of the risks, and that consultants had raised concerns about them.
"I do believe [the consultants] made a very strong point that unless we come clean on this, it could get much more serious than we might anticipate," an email from October 2000 read.
In 2002, Japanese regulators imposed requirements that Eli Lilly warn doctors about Zyprexa's diabetes risks. Even after this occurred, however, the company's U.S. policy was still to pretend the issue did not exist.
"We will NOT proactively address the diabetes concerns," an internal company memo reads, instructing sales representatives to talk about diabetes only if doctors bring it up first.
In 2007, Eli Lilly updated Zyprexa's label to warn of severe increases to weight and blood sugar.
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