{"id":418087,"date":"2010-03-11T17:34:00","date_gmt":"2010-03-11T22:34:00","guid":{"rendered":"tag:typepad.com,2003:post-6a00d8341c89dd53ef01310f1e55e2970c"},"modified":"2010-03-12T08:32:42","modified_gmt":"2010-03-12T13:32:42","slug":"some-seroquel-documents-from-astrazeneca-now-available-at-the-drug-industry-document-archive","status":"publish","type":"post","link":"https:\/\/mereja.media\/index\/418087","title":{"rendered":"Some Seroquel Documents From AstraZeneca Now Available At The Drug Industry Document Archive"},"content":{"rendered":"
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These 241 “New” Documents Show How Drug Company Obscured Potential For Patient Weight Gain And Diabetes<\/span><\/span><\/span><\/strong><\/p>\n

(Posted by Tom Lamb at DrugInjuryWatch.com<\/strong><\/font><\/span><\/a>)<\/strong><\/font><\/strong><\/font><\/span><\/span><\/span><\/span><\/span> <\/p>\n

In mid-February 2010 Kim Klausner, the Industry Documents Digital Libraries Manager for Drug Industry Document Archive (DIDA) at the University of California, San Francisco<\/a>,\u00a0let us know about some “new”\u00a0documents concerning the drug Seroquel\u00a0that are now available on the DIDA web site:<\/p>\n

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I\u2019m pleased to announce that we\u2019ve added to the Drug Industry Document Archive (http:\/\/dida.library.ucsf.edu<\/a>) 241 documents about the marketing of Seroquel from the files of AstraZeneca.\u00a0 These documents show how the company obscured the potential for patient weight gain and diabetes from physicians and regulatory bodies and how they balanced the desire for sales with the need for scientific rigor.\u00a0 You can find these documents by entering \u201cddu:2010*\u201d without the quotation marks in the query box.<\/p>\n<\/blockquote>\n

Further, Kim listed some of what she thought were the more “interesting” (my characterization, not hers)\u00a0Seroquel documents for us:<\/p>\n

1)\u00a0 \u201c[Do] not to discuss details surrounding trial 41 with any external customers\u201d who include investigators.<\/a><\/p>\n

2)\u00a0 How to spin and de-emphasize weight gain.<\/a><\/a><\/p>\n

3)\u00a0 AstraZeneca Director of Clinical Research asks for information about BristolMyersSquibb\u2019s trials in exchange for sexual favors (I\u2019m not kidding).<\/a><\/p>\n

4)\u00a0 Suggests data mining of Study 50 focusing on efficacy by measuring psychotic relapse.<\/a><\/p>\n

5)\u00a0 Suggests that AZ-supported research has suspect results.<\/a><\/p>\n

6)\u00a0 Discusses how much to disclose about Study 15.<\/a><\/p>\n

7)\u00a0 Suggests pooling data to achieve certain efficacy claims.<\/a><\/p>\n

8)\u00a0 \u201call off-label slides are financed outside of commercial for obvious legal reasons\u201d<\/a><\/a><\/p>\n

9)\u00a0 \u201cR&D is no longer responsible for Seroquel research – it is now the responsibility of Sales and Marketing.\u201d<\/a><\/p>\n

10)\u00a0 Discusses giving limited data to an investigator on Trial 31 because he is perceived to be a \u201cLily advocate.\u201d\u00a0 \u201cI don’t want to irritate him nor give him the impression that we are hiding data.\u201d<\/a><\/p>\n

11)\u00a0 Proposal for a study on the diabetogenic and hyperlipidemia side effects of quetiapine; concern about the potential risk and damage if the study had negative results.<\/a><\/p>\n

12)\u00a0 Questions why \u201climited\u201d would remain as a qualifier to weight gain in the Core Data Sheet even though SERM [Safety Evaluation and Review Meeting] had decided otherwise.<\/a><\/p>\n

13)\u00a0 Email re the request of Dr. Ghaemi, who was asked to be an author on the Trial 104 manuscript, for the study\u2019s raw data. Suggests dropping Dr. Ghaemi as an author.<\/a><\/p>\n

14)\u00a0 Contemplates Study 125 endpoints based on potential adverse effects on US sales.<\/a><\/p>\n

As some of you may recall, we have written previously about this DIDA project:<\/p>\n