Furious Seasons

April 25, 2007

The Zyprexa Chronicles: FDA Investigates Lilly Hyperglycemia Data

The New York Times' Alex Berenson is at it again, this time spurring an investigation by the FDA of possible misreporting of hyperglycemia caused by Zyprexa in 2000. A February 2000 document reported that patients in clincial trials who took Zyprexa were three and one-half times more likely to develop high blood sugar as patients who did not take the drug. Lilly later reported to the FDA that there was no difference at all. A Lilly spokesman told the paper that some patients had been improperly included in the company's data analysis and once their data was corrected they submitted their data to the FDA. The FDA is looking into the matter, but has reached no decision on what action, if any, to take.

If I had time to go through my notes on the Zyprexa documents tonight, I'd point you right to the memo itself. I will make it available as soon as I figure out exactly what document Berenson is referring to.

UPDATE: The document in question is this one. In addition, CL Psych has a good post on this matter.

Posted by Philip Dawdy at April 25, 2007 12:05 AM

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Comments

I think you are on the mark about Zyprexa being the story. My colleague and i have four podcasts about the story including interviews with Jim Gottstein, the attorney who helped the Times get the Zyprexa papers in the forst place as well as the mother of one of the victims of Zyprexa.
Larry

Posted by: Larry at April 25, 2007 05:35 AM

Due to my daughter taking Zyprexa from 1999>2006 and experiencing "unexplained" hyperglycemia, to the point of having to take high protein bars to school; without prior history of hyperglycemia or diabetes, I bookmarked several of these documents. I can't find the Feb one discussed, or maybe it's not linked up here--but I did find a few readers might be interested in reading:

This is a 2 page memo from 1998

weight gain strategy and tactics January 2000
informs a rep to"create a problem for risperidone"

august 2000 hyperglycemia literature review

Posted by: Stephany at April 25, 2007 06:01 AM

Do you know if it matters how much you take? If it's just a small amount does it still cause hyperglycemia?

Posted by: Jo at April 25, 2007 11:55 AM

February 2000, why does that date ring a bell?

Oh, I know! It's when I was first put on Zyprexa, followed by a 50 lb. weight gain over 14 weeks, which doc (witch doc?) said was most definitely not due to Zyprexa! What a hoot!

Posted by: manxome at April 25, 2007 02:52 PM