Furious Seasons

March 04, 2009

Seroquel Documents: AZ Knew Of Weight Gain Problems In 1997

One reason I'm glad I made the Seroquel documents publicly available the other day is because I knew people like Jim Edwards at BNET.com would go dig through them and post their findings, saving me from writing too much about a drug that injured me personally.

Edwards wrote an excellent post yesterday detailing what AstraZeneca knew about weight gain problems with Seroquel and it appears the company knew about it as far back as 1997, the year the drug was first approved.

"Feb 12, 1997, memo from Richard Lawrence: I am not 100% comfortable with this data being made publically available at the present time … however I understand we have little choice … Lisa has done a great ’smoke-and-mirrors’ job!
"Aug. 13, 1997, memo from Lisa Arvanitis to her colleagues:
1. Is there a competitive advantage for SEROQUEL re-weight gain which we can articulate in posters/talks/vis aids? We know we have weight gain but is it limited to the short term …? … I was really struck by how consistent the data was.

"Feb 24, 1999, memo from Nick Hough, regarding a single study that appeared to find weight loss among users:
We must not get too carried away with ‘weight loss’ when we know the rest of our data appears to point in the other direction…

"Dec. 6, 1999, email from John Tumas:
The larger issue is how do we face the outside world when they begin criticizing us for suppressing data.

"1998 draft paper intended for 11th ECNP conference in Paris:
Clinically significant weight gain , that is more than 7 percent increase in body weight, was seen more with quetiapine [Seroquel] than placebo - 24 percent compared with four percent …"

It goes from there, basically with AZ admitting internally that it knew it had issues with weight gain and some reports of diabetes and deaths, but with the company seeking to minimize those problems and clearly directing its sales force to not tell the whole truth about the matter.

Then, this:

"Dec. 18, 2008, memo from FDA: The weight gain signal is significant for both adult and pediatric populations and should be elevated to the Warnings and Precautions section [of the drug's label]."

Gee, nice of the FDA to catch on to this problem so quickly.

As I've mentioned before, it'll be a while before I can write about these documents more formally. Right now, when I look at them, it's like watching a drugmaker dance around issues which have directly affected my personal life.

Posted by Philip Dawdy at March 4, 2009 12:03 AM

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Comments

It's the same way I feel when I read about Risperdal and Zyprexa.

As a parent, it makes me feel like a complete and utter fool.

How could a child at age 11, in 1999 be placed on Risperdal, then Zyprexa, gain 100+lbs and then be placed on Abilify and Seroquel at age 17 in 2005?

Without any warnings at all, or concern over her weight gain, all rx'ed by inpatient psychiatrists.

I've cried, and been so disgusted with this topic (that appears to be repeating itself with regard to ALL of the above listed meds)that it takes its toll on me even now.

The word injury is so nothing in stories like my daughters, or Philip's and the countless others affected with the worst outcome possible:

Screwed over by these companies burying data that could have prevention major life altering, permanent damage to bodies and the worst part, to a life. To a life, that somehow we feel we are in control of, when in fact these drugs changed without warning, forever.

I'm a good mother and feel like a piece of shit, a stupid one at that. Then the anger rises, and all I can do....NOTHING!

These people are criminals, the FDA is corrupt, Thomas Laughren is a joke, I mean this is a crock, based on lies, greed, lack of ethics, and all for fucking profit!!

Read that and read my blog again and again AstraZeneca, just like you've been doing for a week, you've caused undue harm to innocent people, and posed and still pose a public safety hazard with a drug that should be removed from the market the same as Zyprexa!

Posted by: Stephany at March 4, 2009 01:43 AM

Philip,

Seroquel seems to be the most powerful drug of all the antipsychotics!

In this list of ten antipsychotics, [four typicals & six atypicals] quetiapine [Seroquel] is listed as blocking the serotonin 5-HT2a receptors at 294 compared to Zyprexa at 4, Haldol at 36 and Thorazine at 1.4. Also, it blocks the Dopamine D2 receptor at 160 compared to Zyprexa at 11, Haldol at 4 and Thorazine at 19. This is very shocking. Here is the Website for this information:

http://www.cmaj.ca/cgi/content/full/172/13/1703/T235

This is the original website from which this data was obtained.

http://www.cmaj.ca/cgi/content/full/172/13/1703

Posted by: Rosie at March 4, 2009 07:19 AM