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The Seroquel documents

Seroquel (quetiapine): AstraZenecas


atypical antipsychotic
Many issues raised in documents
released through litigation process
(Federal court in Florida)
Particularly relevant: Selective publication of
clinical trial data and perhaps misleading
analyses appearing in journals/presentations

Available at blog:
http://industry.bnet.com/pharma/10001228/e-mail-astrazeneca-knew-in1997-that-seroquel-caused-weight-gain/

Seroquel documents
These slides are excerpts from the
files, and illustrate issues suggestive
of buried trials, data manipulation and
possible obscuring of adverse drug
event information.
Thus they are selective excerpts.
To read in full context go to the
relevant file according to the code
number.

Omnibus MSJ Exhbit 43 declaration by expert witness, psychiatrist


Dr Wirshing
AZ obscured weight gain & diabetes issues re Seroquel for years

Omnibus MSJ Exhibit 44 testimony of expert witness,


pharmacologist Dr Plunkett
AZ s buried study 15: weight gain rapid, consistent, significant, dose related,
doesnt stop

Omnibus MSJ Exhibit 44 testimony of expert witness,

pharmacologist Dr Plunkett
the sales messages contradicted what AstraZeneca knew to be true
about...weight gain

Omnibus MSJ Exhibit 44 testimony of expert witness,

pharmacologist Dr Plunkett
AZ aware of Seroquel association with diabetes/hyperglycemia
1999

Omnibus MSJ Exhibit 44 testimony of expert witness,

pharmacologist Dr Plunkett
Seroquel package insert distorts risk of diabetes/hyperglycemia

Omnibus MSJ Exhibit 44 testimony of expert witness,

pharmacologist Dr Plunkett
Discredited AZ sponsored study claimed Seroquel cured diabetes

Omnibus MSJ Exhibit 44 testimony of expert witness,


pharmacologist Dr Plunkett
As late as 2007 Seroquel label understates risk of
diabetes/hyperglycemia

Omnibus MSJ Exhibit 44 testimony of expert witness,

pharmacologist Dr Plunkett
FDA admonish AZ in 2006 but in Oct 2007 label still inadequate

Omnibus MSJ Exhibit 44 testimony of expert witness,

pharmacologist Dr Plunkett
Diabetes level blood sugar changes downplayed as
hyperglycemia

04_exhibit_27

from email Aug 1997

04_exhibit_27

from email Aug 1997

Omnibus MSJ Exhibit 13

positive spin on cursed


study 15

emails re buried trials,


managing data

Omnibus MSJ Exhibit 14

1st email 2 Dec 99 EPS data (presumably favourable) for symposium

emails re buried trials,


managing data

Omnibus MSJ Exhibit 14

2nd email 6 Dec 99 - can we present the EPS data in isolation given nature of
other results

emails re buried trials,


managing data

Omnibus MSJ Exhibit 14

3rd email 6 Dec 99 we can be accused of cherry picking...may fuel demands


to see entire study

emails re buried trials,


managing data

Omnibus MSJ Exhibit 14

4th email 6 Dec 99 a short-term solution (given impending


APA deadline) is avoid reference to COSTAR in proposed APA
abstract

data
5th email 6 Dec 99 thus far we have buried Trials 15, 31, 56 and now
considering COSTAR
how do we face the world when they begin to criticize us for suppressing
data

emails re buried trials,


managing data

Omnibus MSJ Exhibit 14

other emails in chain 7 Dec 99

emails re buried trials,


managing data

Omnibus MSJ Exhibit 14

other emails in chain 7 Dec 99

Omnibus MSJExhibit 2

AstraZenecas Internal Efficacy Analysis


March 2000

*Based on same four studies presented in prior slide


*Finds advantages for Haldol, not Seroquel
*no better than CPZ, worse efficacy than Risp and other
(un-named typicals

Omnibus MSJ Exhibit 2

emails re buried trials,


managing data

Omnibus MSJ Exhibit 14

5th full email 8 Dec 99 if (JAMA) thought we were publishing positive


data...whilst results from a second trial were being buried, theyd be onto it in
a flash.

slides for KOL speaker,


email says have been tweaked

Omnibus MSJ Exhibit 6

Omnibus MSJ Exhibit 5


AZ marketing director
deposition Apr 2008

Omnibus MSJ Exhibit 5

AZ marketing
director
deposition Apr 2008

Omnibus MSJ Exhibit 5

AZ marketing director deposition


Apr 2008

Omnibus MSJ Exhibit 5

AZ
marketing
director
deposition
Apr 2008

Omnibus MSJ Exhibit 5

AZ marketing director
deposition Apr 2008

Omnibus MSJ Exhibit 9 statement of expert witness, epidemiologist

Dr Arnott

Omnibus MSJ exhibit 9 statement of expert witness, epidemiologist

Dr Arnott

study 15 may have been buried


but another study published in Int J Psychiatry in Clin Prac 2000
43_exhibit_12

43_exhibit_12

study published in Int J Psychiatry in Clin Prac 2000

43_exhibit_15

may be rationale...return to normal


eating

43_exhibit_15

Despite the argument in these emails, Haldol and Risperidone


comparison groups had more efficacious response in the studies
but didnt get the normal eating weight gain to same extent as
Seroquel group.

Omnibus MSJ Exhibit 32

weight & diabetes sell sheet


Aug 2005

Omnibus MSJ Exhibit 32

weight & diabetes sell sheet


Aug 2005

the truth is in there but appears underemphasised in the overall wording

Omnibus MSJ Exhibit 34 FDA to AZ re false or misleading

promotional material

Omnibus MSJ Exhibit 34 FDA to AZ re false or misleading

promotional material

Seroquel docs 43_exhibit_10


Int memo Dec 2007