Atypical antipsychotics - The Healthy Skepticism Files

Internal company documents regarding 3 atypical antipsychotic drugs

The so called “Zyprexa documents” are examples of internal pharmaceutical company (in this case Eli-Lilly) documents that have been subpoenaed to court cases in the USA and other countries. They are available in full at http://www.furiousseasons.com/zyprexadocs.html with a description by the website’s host, Philip Dawdy.

The so called “Seroquel documents” relate to a similar trial involving Astra-Zeneca. Jim Edwards gives a description of some of the documents which pertain to weight gain and diabetes athttp://industry.bnet.com/pharma/10001228/e-mail-astrazeneca-knew-in-1997-that-seroquel-caused-weight-gain/. They are available in full, along with other commentary, via Philip Dawdy's Furious Seasons site again, at: http://www.furiousseasons.com/zip/seroqueldocs.zip (43.9 MB).

A third set of documents, regarding Janssen's atypical antipsychotic, Risperdal, and the Janssen/MGH Center for Child & Adolescent Bipolar Disorders, is available at:http://psychrights.org/research/Digest/NLPs/Risperdal/081112Opp2BiedermanQuash-Seal.pdf(14MB)

The series of powerpoint presentations linked here contain excerpts from the Zyprexa documents (9 powerpoints - 1 2 3 4 5 6 7 8 9) and Seroquel documents (1 powerpoint at this time). The excerpts highlight issues to do with:

1. Marketing and the desire of companies to maximize sales, suggestive of practices that can be described as “disease mongering” to expand indications for the drug in question.

2. Sophisticated marketing science and strategies to “influence”, applied to “key players” i.e. mainly physicians, researchers, academics, “thought leaders” and pharmacists, but also to allied health professionals, health institutions, government, private payers and patient advocacy groups.

3. Efforts suggestive of pharmaceutical companies seeking to control the research, the scientific literature and regulatory product labeling to enhance emphasis on benefits and minimize emphasis on harms of the drugs in question.

However the companies argue that the documents need to be read in context. To some extent these powerpoints can be accused of “cherry-picking” (a practice referred to in the Seroquel documents, which describes the selection for publication of only limited sections of the data analysis). The presentations do highlight a limited selection of the documents which illustrate the issues above, but our reading of the documents found plentiful examples of all 3 issues. Readers are therefore encouraged to access the original documents by using the file code number on each slide and matching it with the original documents located via the links above.

The powerpoint slides were created by Dr Peter Parry, Senior Lecturer in Child & Adolescent Psychiatry, Flinders University, South Australia in collaboration with A/Prof Glen Spielmans, Dept. of Psychology, Metropolitan State University, Minnesota, USA.

An abbreviated version was presented at the Royal Australian and New Zealand College of Psychiatrists (RANZCP) Congress 2009 in Adelaide, South Australia. Click here for a pdf (6.2 MB) of the handout from that talk. Glen Spielmans' paper "The promotion of olanzapine in primary care: an examination of internal industry documents" has been published online as an article in press at Social Science & Medicine.

Powerpoint presentations:
1. Zyprexa-Marketing Issues 1 (9.3 MB)
2. Zyprexa-Marketing Issues 2 (4.1 MB)
3. Zyprexa-Marketing Issues 3 (8.7 MB)
4. Zyprexa-Managing Adverse Drug Events 1 (6.5 MB)
5. Zyprexa-Managing Adverse Drug Events 2 (9.2 MB)
6. Zyprexa-Managing Adverse Drug Events 3 (10.1 MB)
7. Zyprexa-Influencing Key Players 1 (8.6 MB)
8. Zyprexa-Influencing Key Players 2 (7.0 MB)
9. Zyprexa-Global Value Committee Review (5.5 MB)
10. Seroquel (5.7 MB)

**A remarkably revealing recently released document is: Astrazeneca correspondence on Investigator Initiated Trials

These documents, particularly perhaps the last one of AZ correspondence re IIT's, help to give background to the views expressed by Richard Smith, former editor of the BMJ group of 25 journals, in PLoS Medicine 2005 - "Medical journals are an extension of the marketing arm of pharmaceutical companies."

Peter would like to acknowledge Philip Dawdy, journalist, and his very insightful blog www.furiousseasons.comwho bravely performed the public service of first posting the documents online.

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