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Drug company 'hid' suicide link Drug company 'hid' suicide link
(about 3 hours later)
Secret e-mails reveal that the UK's biggest drug company distorted trial results of an anti-depressant, covering up a link with suicide in teenagers.Secret e-mails 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.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. And that GSK-employed ghostwriters influenced "independent" academics.
GSK told Panorama: "GSK utterly rejects any suggestion that it has improperly withheld drug trial information."GSK told Panorama: "GSK utterly rejects any suggestion that it has improperly withheld drug trial information."
class="bodl" href="/1/hi/programmes/panorama/6291947.stm">Read a statement from GSK class="bodl" href="http://newsforums.bbc.co.uk/nol/thread.jspa?threadID=5374&edition=1&ttl=20070125150527">Send us your stories and views GSK has always been strongly conscious of the duty it owes to the millions of patients who suffer from depression GSK statement class="" href="/1/hi/programmes/panorama/6291947.stm">Read the statement in full
GSK faces action in the US where bereaved families have joined together to sue the company.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.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.Karen Barth Menzies is a partner in one of the firms representing many of the families.
'Negative studies'
She has examined thousands of the documents which are stored, box upon box, in an apartment in Malibu, California.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."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.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.Child psychiatrist Dr Neal Ryan of the University of Pittsburgh was paid by GSK as a co-author of Study 329.
HAVE YOUR SAY There is no space for companies like this in the modern world Vincent Murphy, Malaysia Send us your comments
In 2002 he also gave a talk on childhood depression at a medical conference sponsored by GSK.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.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.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.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.""Essentially the study did not really show it was effective in treating adolescent depression, which is not something we want to publicise."
'Blind-eye culture'
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.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.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.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.""Reputations for sale are reputations at risk. We need to make that risk so high it's not worth taking."
class="bodl" href="/1/hi/programmes/panorama/6298269.stm">Read Fiona Godlee's reaction to Panorama What is even more depressing is that such behaviour is still so widely tolerated within medicine Fiona Godlee, BMJ class="" href="/1/hi/programmes/panorama/6298269.stm">Fiona Godlee's reaction
Bereaved families in the UK cannot get legal aid to sue GSK.Bereaved families in the UK cannot get legal aid to sue GSK.
The Medicine and Healthcare Products Regulatory Authority (MHRA) began a criminal investigation into GSK three years ago but no action has been taken yet. The Medicine and Healthcare Products Regulatory Agency (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 addional resources and remains a high priority. 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.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.
  • Secrets of the Drug Trials will be broadcast on Monday 29 January at 2030 on BBC One and this site.
  • Secrets of the Drug Trials will be broadcast on Monday 29 January at 2030 on BBC One and this site.
  • If you are affected by any of the issues in the programme and would like to talk to someone in confidence for further information and support, please call the BBC Action Line on 0800 077 077. Lines open at 2100 GMT on Monday 29 January for a week and may be busy but the Action Line will be open from 0730 GMT until 0000 GMT. All calls are free and confidential.
  • If you are affected by any of the issues in the programme and would like to talk to someone in confidence for further information and support, please call the BBC Action Line on 0800 077 077. Lines open at 2100 GMT on Monday 29 January for a week and may be busy but the Action Line will be open from 0730 GMT until 0000 GMT. All calls are free and confidential.