Corp-Ethics.com - Report: GSK hid paxil suicide link

Company	GlaxoSmithKline [Company Info]
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Date	Issue	Title
29th Jan 2007	Questionable Practice	GSK hid paxil suicide link

Report

Secret emails reveal that the UK's biggest drug company distorted trial results of an anti-depressant, covering up a link with suicide in teenagers.

Panorama reveals that GlaxoSmithKline (GSK) attempted to show that Seroxat worked for depressed children despite failed clinical trials.

And that GSK-employed ghostwriters influenced 'independent' academics.

GSK told BBC's Panorama program: "GSK utterly rejects any suggestion that it has improperly withheld drug trial information."

GSK faces action in the US where bereaved families have joined together to sue the company.

As a result, GSK has been forced to open its confidential internal archive.

Karen Barth Menzies is a partner in one of the firms representing many of the families.

She has examined thousands of the documents which are stored, box upon box, in an apartment in Malibu, California.

She said: "Even when they have negative studies that show that this drug Seroxat is going to harm some kids they still spin that study as remarkably effective and safe for children."

GSK's biggest clinical trial of Seroxat on children was held in the US in the 1990s and called Study 329.

Child psychiatrist Dr Neal Ryan of the University of Pittsburgh was paid by GSK as a co-author of Study 329.

In 2002 he also gave a talk on childhood depression at a medical conference sponsored by GSK.

He said that Seroxat could be a suitable treatment for children and later told Panorama reporter Shelley Jofre that it probably lowered rather than raised suicide rates.

In amongst the archive of emails in Malibu, Shelley was surprised to find that her own emails to Dr Ryan from 2002 asking questions about the safety of Seroxat had been forwarded to GSK asking for advice on how to respond to her.

She also found an email from a public relations executive working for GSK which said: "Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results.

"Essentially the study did not really show it was effective in treating adolescent depression, which is not something we want to publicise."

But the article was published in the Journal of the American Academy of Child and Adolescent Psychiatry which says it ranks as number one in child mental health in the world.

The editor in chief of the British Medical Journal, Fiona Godlee, said that what she calls the "blind-eye culture of medicine" should be exposed by professionals.

She has written in response to the Panorama film: "We shouldn't have to rely on investigative journalists to ask the difficult questions.

"Reputations for sale are reputations at risk. We need to make that risk so high it's not worth taking."

The Medicine and Healthcare Products Regulatory Authority (MHRA) began a criminal investigation into GSK three years ago but no action has been taken yet.

A spokesperson told Panorama that the investigation has been given substantial additional resources and remains a high priority.

Seroxat was banned for under 18s in 2003 after the MHRA, revealed that GSK's own studies showed the drug actually trebles the risk of suicidal thoughts and behaviour in depressed children.

Other Reports on GlaxoSmithKline
Date	Issue	Company	Report
10th Aug 2006	Other Issue	GlaxoSmithKline	Glaxo pays $70m to end price row
29th Mar 2006	Questionable Practice	GlaxoSmithKline	Glaxo agrees US Paxil settlement
18th Mar 2005	Other Issue	GlaxoSmithKline	Glaxo shares dip on factory probe
22nd Sep 2004	Questionable Practice	GlaxoSmithKline	Glaxo drops appeal in Aids drug pricing case
6th Sep 2004	Other Issue	GlaxoSmithKline	GSK faces anti-depressant lawsuit
19th May 2004	Other Issue	GlaxoSmithKline	New York sues GlaxoSmithKline
11th May 2004	Fraud Investigation	GlaxoSmithKline	GlaxoSmithKline faces antitrust investigation
22nd Jan 2004	Fraud Investigation	GlaxoSmithKline	$11.1 Million settlement
8th Jan 2004	Questionable Practice	GlaxoSmithKline	£1.5bn Tax Bill
16th Dec 2003	Questionable Practice	GlaxoSmithKline	Glaxo's CEO to scoop 5.7 mln stg a year
25th Jun 2003	Questionable Practice	GlaxoSmithKline	FDA tells Glaxo to pull misleading Flonase ads
25th Jun 2003	Questionable Practice	GlaxoSmithKline	Ordered to pull misleading adverts

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