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DIDA: Wyeth HRT ghostwritting

Kim Klausner announces the addition to the Drug Industry Document Archive (DIDA) of internal documents from Wyeth and DesignWrite regarding ghostwritting about the Premarin family of hormone replacement products.

 

by Kim Klausner

We’re pleased to announce the addition to the Drug Industry Document Archive (DIDA) of the Wyeth ghostwriting documents unsealed by a Federal judge last month at the request of PLoS, represented by Public Justice, and the New York Times.

As you are probably aware, the documents illustrate how Wyeth Pharmaceuticals contracted with DesignWrite, a medical communications company, to write articles for top-tier medical journals with the intention of bolstering the sales of the Premarin family of hormone replacement products. After the articles were written, DesignWrite solicited prominent health professionals to appear as “authors.”

The documents are full-text searchable and limited metadata, such as names of people and organizations mentioned, has been created for most documents to aid searching. The documents can be found by entering “ddu:2009*” without the quotation marks in the query box on DIDA’s home page (http://dida.library.ucsf.edu).

I have selected a few of the 1,120 documents that, taken together, show how the integrity of the scientific process was compromised:

* A summary of DesignWrite’s work: a “comprehensive publication program for Premarin… [which] includes peer-reviewed journal articles, editorials, letters to the editor, sales training backgrounders, and critiques of the current literature, all designed to support the [company’s] marketing efforts.”

* An August 2000 contract between DesignWrite and Stephen Gutkin, President and founder of Rete Biomedical Communications, to write 8- to 10-page manuscript on “Can a Healthy Endothelium Influence the Cardiovascular Effects of HRT?”

* A September 12 letter (page 4 of the document) to Gutkin paying him for completing the outline.

* A DesignWrite document (page 2 of the document) from September 27 indicates that Professor Kwang Kon Koh has been approached to “author” the paper but “needs to be confirmed.”

* An October 13 letter (page 3 of document) from DesignWrite Medical Editor to Gutkin about revisions to the manuscript: “Anything that doesn’t bolster the main message that early intervention with estrogen in order to maintain a healthy endothelium in postmenopausal women can go.”  The Editor accepts that the academic “author’s” “own additions will probably have to stay [in the article] no matter what.”

* A letter (page 2 of document) from DesignWrite to Gutkin asking for further revisions to the manuscript in January, 2001.

* In April, Koh suggests in an email that DesignWrite staffer Karen Mittleman be listed as co-author of the paper.  (This document should be read from page 4 to page 1.)

* The paper is published in the International Journal of Cardiology in 2003. Mittleman’s “editorial assistance” is acknowledged.  Stephen Gutkin’s name is nowhere to be found.

Please contact me if you have any questions or comments about DIDA.


Kim Klausner
Tobacco Digital Library Manager

University of California, San Francisco

530 Parnassus Avenue, Room 115
San Francisco, CA 94143-0840
(415) 514-0507
.(JavaScript must be enabled to view this email address)

 

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