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Download The Seroquel documents Seroquel (quetiapine): AstraZeneca’s atypical antipsychotic Many issues raised in documents released through litigation process

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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-in-1997-that-seroquel-caused-weight-gain/ http://industry.bnet.com/pharma/10001228/e- mail-astrazeneca-knew-in-1997-that-seroquel-caused-weight-gain/ Slide 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. Slide 3 Omnibus MSJ Exhbit 43 declaration by expert witness, psychiatrist Dr Wirshing AZ obscured weight gain & diabetes issues re Seroquel for years Slide 4 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 Slide 5 Omnibus MSJ Exhibit 44 testimony of expert witness, pharmacologist Dr Plunkett the sales messages contradicted what AstraZeneca knew to be true about...weight gain Slide 6 Omnibus MSJ Exhibit 44 testimony of expert witness, pharmacologist Dr Plunkett AZ aware of Seroquel association with diabetes/hyperglycemia 1999 Slide 7 Omnibus MSJ Exhibit 44 testimony of expert witness, pharmacologist Dr Plunkett Seroquel package insert distorts risk of diabetes/hyperglycemia Slide 8 Omnibus MSJ Exhibit 44 testimony of expert witness, pharmacologist Dr Plunkett Discredited AZ sponsored study claimed Seroquel cured diabetes Slide 9 Omnibus MSJ Exhibit 44 testimony of expert witness, pharmacologist Dr Plunkett As late as 2007 Seroquel label understates risk of diabetes/hyperglycemia Slide 10 Omnibus MSJ Exhibit 44 testimony of expert witness, pharmacologist Dr Plunkett FDA admonish AZ in 2006 but in Oct 2007 label still inadequate Slide 11 Omnibus MSJ Exhibit 44 testimony of expert witness, pharmacologist Dr Plunkett Diabetes level blood sugar changes downplayed as hyperglycemia Slide 12 04_exhibit_27 from email Aug 1997 Slide 13 Slide 14 Omnibus MSJ Exhibit 13 positive spin on cursed study 15 Slide 15 Omnibus MSJ Exhibit 14 emails re buried trials, managing data 1 st email 2 Dec 99 EPS data (presumably favourable) for symposium Slide 16 Omnibus MSJ Exhibit 14 emails re buried trials, managing data 2 nd email 6 Dec 99 - can we present the EPS data in isolation given nature of other results Slide 17 Omnibus MSJ Exhibit 14 emails re buried trials, managing data 3 rd email 6 Dec 99 we can be accused of cherry picking...may fuel demands to see entire study Slide 18 Omnibus MSJ Exhibit 14 emails re buried trials, managing data 4 th email 6 Dec 99 a short-term solution (given impending APA deadline) is avoid reference to COSTAR in proposed APA abstract Slide 19 Omnibus MSJ Exhibit 14 emails re buried trials, managing data 5 th 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 Slide 20 Omnibus MSJ Exhibit 14 emails re buried trials, managing data other emails in chain 7 Dec 99 Slide 21 Slide 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 Slide 23 Omnibus MSJ Exhibit 14 emails re buried trials, managing data 5 th 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. Slide 24 Omnibus MSJ Exhibit 6 slides for KOL speaker, email says have been tweaked Slide 25 Omnibus MSJ Exhibit 5 AZ marketing director deposition Apr 2008 Slide 26 Slide 27 Slide 28 Slide 29 Slide 30 Omnibus MSJ Exhibit 9 statement of expert witness, epidemiologist Dr Arnott Slide 31 Omnibus MSJ exhibit 9 statement of expert witness, epidemiologist Dr Arnott Slide 32 43_exhibit_12 study 15 may have been buried but another study published in Int J Psychiatry in Clin Prac 2000 Slide 33 43_exhibit_12 study published in Int J Psychiatry in Clin Prac 2000 Slide 34 43_exhibit_15 may be rationale...return to normal eating Slide 35 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. Slide 36 Omnibus MSJ Exhibit 32 weight & diabetes sell sheet Aug 2005 Slide 37 Omnibus MSJ Exhibit 32 weight & diabetes sell sheet Aug 2005 the truth is in there but appears underemphasised in the overall wording Slide 38 Omnibus MSJ Exhibit 34 FDA to AZ re false or misleading promotional material Slide 39 Slide 40 Seroquel docs 43_exhibit_10 Int memo Dec 2007

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