These 241 "New" Documents Show How Drug Company Obscured Potential For Patient Weight Gain And Diabetes

(Posted by Tom Lamb at DrugInjuryWatch.com)

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, let us know about some "new" documents concerning the drug Seroquel that are now available on the DIDA web site:

I’m pleased to announce that we’ve added to the Drug Industry Document Archive (http://dida.library.ucsf.edu) 241 documents about the marketing of Seroquel from the files of AstraZeneca.  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.  You can find these documents by entering “ddu:2010*” without the quotation marks in the query box.

Further, Kim listed some of what she thought were the more "interesting" (my characterization, not hers) Seroquel documents for us:

1)  “[Do] not to discuss details surrounding trial 41 with any external customers” who include investigators.

2)  How to spin and de-emphasize weight gain.

3)  AstraZeneca Director of Clinical Research asks for information about BristolMyersSquibb’s trials in exchange for sexual favors (I’m not kidding).

4)  Suggests data mining of Study 50 focusing on efficacy by measuring psychotic relapse.

5)  Suggests that AZ-supported research has suspect results.

6)  Discusses how much to disclose about Study 15.

7)  Suggests pooling data to achieve certain efficacy claims.

8)  “all off-label slides are financed outside of commercial for obvious legal reasons”

9)  “R&D is no longer responsible for Seroquel research – it is now the responsibility of Sales and Marketing.”

10)  Discusses giving limited data to an investigator on Trial 31 because he is perceived to be a “Lily advocate.”  “I don't want to irritate him nor give him the impression that we are hiding data.”

11)  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.

12)  Questions why “limited” would remain as a qualifier to weight gain in the Core Data Sheet even though SERM [Safety Evaluation and Review Meeting] had decided otherwise.

13)  Email re the request of Dr. Ghaemi, who was asked to be an author on the Trial 104 manuscript, for the study’s raw data. Suggests dropping Dr. Ghaemi as an author.

14)  Contemplates Study 125 endpoints based on potential adverse effects on US sales.

As some of you may recall, we have written previously about this DIDA project:

• Drug Industry Document Archive Has Over 1500 Documents Regarding Big Pharma Conduct — Includes Previously Secret Documents That Were Released During Lawsuits Against Merck & Co., Parke-Davis, Warner-Lambert, and Pfizer
   
• Drug Industry Document Archive (DIDA) Adds 15 More Pharma-Related Documents To Collection In November 2009 — This Archive Contains Some "Secret" Documents Only Made Public In The Course Of Lawsuits Filed Against Pharmaceutical Companies

We thank Kim for letting us know about these Seroquel-AstraZeneca documents that are now available to the public at the DIDA web site, and look forward to receiving her future notices (which, in turn, we will let you know about).

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