The Seroquel documents

1
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-in-1997-that-ser
  oquel-caused-weight-gain/

2
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.

3
Omnibus MSJ Exhbit 43 declaration by expert
witness, psychiatrist Dr WirshingAZ obscured
weight gain diabetes issues re Seroquel for
years
4
Omnibus MSJ Exhibit 44 testimony of expert
witness, pharmacologist Dr PlunkettAZ s buried
study 15 weight gain rapid, consistent,
significant, dose related, doesnt stop
5
Omnibus MSJ Exhibit 44 testimony of expert
witness, pharmacologist Dr Plunkettthe sales
messages contradicted what AstraZeneca knew to be
true about...weight gain
6
Omnibus MSJ Exhibit 44 testimony of expert
witness, pharmacologist Dr PlunkettAZ aware of
Seroquel association with diabetes/hyperglycemia
1999
7
Omnibus MSJ Exhibit 44 testimony of expert
witness, pharmacologist Dr PlunkettSeroquel
package insert distorts risk of
diabetes/hyperglycemia
8
Omnibus MSJ Exhibit 44 testimony of expert
witness, pharmacologist Dr PlunkettDiscredited
AZ sponsored study claimed Seroquel cured diabetes
9
Omnibus MSJ Exhibit 44 testimony of expert
witness, pharmacologist Dr PlunkettAs late as
2007 Seroquel label understates risk of
diabetes/hyperglycemia
10
Omnibus MSJ Exhibit 44 testimony of expert
witness, pharmacologist Dr PlunkettFDA admonish
AZ in 2006 but in Oct 2007 label still inadequate
11
Omnibus MSJ Exhibit 44 testimony of expert
witness, pharmacologist Dr PlunkettDiabetes
level blood sugar changes downplayed as
hyperglycemia
12
04_exhibit_27 from email Aug 1997
13
04_exhibit_27 from email Aug 1997
14
Omnibus MSJ Exhibit 13 positive spin on
cursed study 15
15
Omnibus MSJ Exhibit 14 emails re buried trials,
managing data1st email 2 Dec 99 EPS data
(presumably favourable) for symposium
16
Omnibus MSJ Exhibit 14 emails re buried trials,
managing data2nd email 6 Dec 99 - can we
present the EPS data in isolation given nature of
other results
17
Omnibus MSJ Exhibit 14 emails re buried trials,
managing data3rd email 6 Dec 99 we can be
accused of cherry picking...may fuel demands to
see entire study
18
Omnibus MSJ Exhibit 14 emails re buried trials,
managing data4th email 6 Dec 99 a short-term
solution (given impending APA deadline) is avoid
reference to COSTAR in proposed APA abstract
19
Omnibus MSJ Exhibit 14 emails re buried trials,
managing data5th email 6 Dec 99 thus far we
have buried Trials 15, 31, 56 and now considering
COSTARhow do we face the world when they begin
to criticize us for suppressing data
20
Omnibus MSJ Exhibit 14 emails re buried trials,
managing dataother emails in chain 7 Dec 99
21
Omnibus MSJ Exhibit 14 emails re buried trials,
managing dataother emails in chain 7 Dec 99
22
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
23
Omnibus MSJ Exhibit 14 emails re buried trials,
managing data5th 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.
24
Omnibus MSJ Exhibit 6 slides for KOL
speaker,email says have been tweaked
25
Omnibus MSJ Exhibit 5 AZ marketing director
deposition Apr 2008
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Omnibus MSJ Exhibit 5 AZ marketing director
deposition Apr 2008
27
Omnibus MSJ Exhibit 5 AZ marketing director
deposition Apr 2008
28
Omnibus MSJ Exhibit 5 AZ marketing director
deposition Apr 2008
29
Omnibus MSJ Exhibit 5 AZ marketing director
deposition Apr 2008
30
Omnibus MSJ Exhibit 9 statement of expert
witness, epidemiologist Dr Arnott
31
Omnibus MSJ exhibit 9 statement of expert
witness, epidemiologist Dr Arnott
32
43_exhibit_12 study 15 may have been buried but
another study published in Int J Psychiatry in
Clin Prac 2000
33
43_exhibit_12 study published in Int J
Psychiatry in Clin Prac 2000
34
43_exhibit_15may be rationale...return to
normal eating
35
43_exhibit_15Despite 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.
36
Omnibus MSJ Exhibit 32 weight diabetes sell
sheet Aug 2005
37
Omnibus MSJ Exhibit 32 weight diabetes sell
sheet Aug 2005the truth is in there but appears
underemphasised in the overall wording
38
Omnibus MSJ Exhibit 34 FDA to AZ re false or
misleading promotional material
39
Omnibus MSJ Exhibit 34 FDA to AZ re false or
misleading promotional material
40
Seroquel docs 43_exhibit_10Int memo Dec 2007