The Paxil Papers

paxil

This Paxil Fact File, containing confidential information about one of our most widely prescribed antidepressants and anti-anxiety medications, was drafted and distributed by SmithKline Beecham in 1998 for internal use only. Now GlaxoSmithKline, 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 symptoms 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, David Healy says 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 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 met to consider whether to indict the drug maker on criminal charges.

Foreword by Paul 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; GlaxoSmithKline Confidential—Internal Use Only).

Paxil CR” Product Monograph (GlaxoSmithKline; 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).

Additional Resources, Papers on Withdrawal Syndrome, and Advice about Tapering Safely

Antidepressant Withdrawal Syndrome: Why SSRI Antidepressants Often Produce a Withdrawal Syndrome,” Psychology Today (July 17, 2011).

Breaking Up with One’s Meds: A Chronicle of Withdrawal Syndrome from Psychiatric Meds,” Psychology Today (July 31, 2015).

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