Lane's Shyness and The Age of Doubt: The Paxil Papers

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http://www.christopherlane.org/paxil_papers.html

The Paxil Papers

This Paxil Fact File, containing confidential information about one of our most

widely prescribed antidepressants and anti-anxiety medications, was drafted and

distributed by Kline Beecham in 1998 for internal use only. Now

GlaxoKline, the drug maker acknowledges in these pages that Paxil/Seroxat

causes serious, widespread side effects and withdrawal symptoms—in the February

2001 paper below, it put that number at a staggering 20% of patients. But it

continued to press for an FDA license to treat social anxiety disorder (with

symtoms including “fear of eating alone in a restaurant”), and advised its staff

on how to spin or mask the problem of withdrawal (change the subject or put the

side effects “in context”). The FDA awarded the license in March 1999, just a

few months after the fact file circulated.

In the BBC Panorama segments below, which aired in Britain on October 3, 2004,

Healy says that we may come to see GSK's masking of data about these

withdrawal symptoms as “one of the biggest medical scandals ever.” Senior

pharmaceutical regulators in the UK acknowledge that they were “disgusted” and

“horrified” by the deliberate withholding of information. The President of the

Royal College of Psychiatrists, Dr. Mike Shooter, argues that the deception “has

serious implications for the whole of psychiatry; it has serious implications

for the whole of medicine.” An investigative body in Britain is considering

whether to indict the drug maker on criminal charges.

Foreword by N. Jenner, Director and Vice President of Neuroscience and

Strategic Product Development

Section 1: Towards the Second Billion—All SSRIs Are Not the Same

Section 2: New Indications: Social Anxiety Disorder / Social Phobia

Section 3: Issues Management: Managing the Discontinuation Issue.

 

Related Papers and Programs

“Duration of Treatment and Depression: Relapse and Recurrence Rates” (February

2001; GlaxoKline Confidential—Internal Use Only).

“Paxil CR” Product Monograph (GlaxoKline; November 1, 2005).

Paxil Litigation Documents (Filed Under Seal; November 11, 2007).

GSK’s Ghostwriting Agency “Budgeted for 50 articles in 2000,” According to the

Drug Maker Itself (April 2000).

BBC Panorama program “Taken on Trust” (UK; October 3, 2004):

Part 1 of 7 (9:36 minutes); part 2 (9:47 minutes); part 3 (9:41 minutes); part 4

(8:46 minutes); part 5 (9:39 minutes); part 6 (7:28 minutes); part 7 (7

minutes).

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