[Ip-health] Wyeth Ghostwriting Documents Fully Text Searchable

[Klausner, Kim]

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We're pleased to announce the addition to the Drug Industry Document Archiv=
e (DIDA) of the Wyeth ghostwriting documents<http://dida.library.ucsf.edu/s=
earch?query=3Dcs%3Aprempro&ct=3D1&page=3D1> unsealed by a Federal judge las=
t month at the request of PLoS<http://www.plosmedicine.org/static/ghostwrit=
ing.action>, represented by Public Justice<http://www.publicjustice.net/New=
sroom/News/federal-judge-unseals.aspx>, and the New York Times<http://www.n=
ytimes.com/2009/08/05/health/research/05ghost.html?ref=3Dresearch>.

The documents illustrate how Wyeth Pharmaceuticals contracted with DesignWr=
ite, a medical communications company, to write articles for top-tier medic=
al journals with the intention of bolstering the sales of the Premarin fami=
ly of hormone replacement products.  After the articles were written, Desig=
nWrite 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*" withou=
t the quotation marks in the query box on DIDA's home page (http://dida.lib=
rary.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<http://dida.library.ucsf.edu/pdf/rgc37b10> of DesignWrite's work:=
 a "comprehensive publication program for Premarin... [which] includes peer=
-reviewed journal articles, editorials, letters to the editor, sales traini=
ng backgrounders, and critiques of the current literature, all designed to =
support the [company's] marketing efforts."

An August 2000 contract<http://dida.library.ucsf.edu/pdf/hzc37b10> between =
DesignWrite and Stephen Gutkin, President and founder of Rete Biomedical Co=
mmunications<http://www.retebiomed.com/index.htm>, to write 8- to 10-page m=
anuscript on "Can a Healthy Endothelium Influence the Cardiovascular Effect=
s of HRT?"

A September 12 letter<http://dida.library.ucsf.edu/pdf/ktc37b10> (page 4 of=
 the document) to Gutkin paying him for completing the outline.

A DesignWrite document<http://dida.library.ucsf.edu/pdf/cwb37b10> (page 2 o=
f the document) from September 27 indicates that Professor Kwang Kon Koh ha=
s been approached to "author" the paper but "needs to be confirmed."

An October 13 letter<http://dida.library.ucsf.edu/pdf/kub37b10> (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 inte=
rvention with estrogen in order to maintain a healthy endothelium in postme=
nopausal women can go."  The Editor accepts that the academic "author's" "o=
wn additions will probably have to stay [in the article] no matter what."

A letter<http://dida.library.ucsf.edu/pdf/ktc37b10> (page 2 of document) fr=
om DesignWrite to Gutkin asking for further revisions to the manuscript in =
January, 2001.

In April, Koh suggests in an email<http://dida.library.ucsf.edu/pdf/ewb37b1=
0> that DesignWrite staffer Karen Mittleman be listed as co-author of the p=
aper.  (This document should be read from page 4 to page 1.)

The paper<http://dida.library.ucsf.edu/pdf/swc37b10> is published in the In=
ternational Journal of Cardiology in 2003.  Mittleman's "editorial assistan=
ce" 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
kim.klausner@ucsf.edu