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Inquiry into Drug-Suicide Link

Posted by shutah on May 30, 2007

Extract from Hunts Post dated 16 May 2007

AN independent inquiry into the link between suicide and young people on anti-depressants has been called for – as the Government is yet again being challenged on the issue.Campaigners in the UK want to know why it has taken three years to investigate one of the world’s largest drug companies over allegations that they suppressed information about the suicide risk in young people.Since 2003, GlaxoSmithKline has been under investigation by the body that regulates drugs in Britain, the Medicines and Healthcare Regulatory Agency, MHRA.The same year, the anti-depressant, Seroxat, manufactured by GlaxoSmithKline, was banned for under-18s because of evidence that it could cause suicide and self-harming in that age group. GlaxoSmithKline is being investigated because of allegations that it had this evidence in 1997 and withheld it.

The company has denied the allegations and says that Seroxat was never licensed for under-18s – though it was prescribed by doctors.

Andrew Lansley, MP for South Cambridgeshire, has asked the Secretary of State for Health, Patricia Hewitt, when she expects the Criminal Investigation Unit of the MHRA to make a decision on whether to refer the case to the police, whether she has the authority to decide whether the matter is referred to the police and if she will make a statement.

The Seroxat Users’ Group, set up by Janice Simmons from Huntingdon, is due to meet Junior Health Minister, Lord Hunt on June 18. The meeting has been arranged by Jonathan Djanogly, MP for Huntingdon.

Mr Djanogly told The Hunts Post: “The minister’s department was clearly trying to avoid a meeting. We have asked for more information and we have been battling for over a year to try to get anything out of them and it has been very difficult. We heard that we could have a meeting only last week.”

Mrs Simmons said: “We will ask for an urgent, thorough and independent inquiry into the safety and efficacy of all SSRI anti-depressants (selective serotonin reuptake inhibitors) because they are all the same class of drug. We want the inquiry held by an independent body because we have lost confidence in the MRHA and the Government’s Commission on Human Medicine.

“We also want to know what is going on with the MRHA investigation into GlaxoSmithKline. It began on October 1, 2003, and that investigation is still in progress. Why has the investigation not been passed over to the police?

She added: “If the MRHA had looked at the original data, the risk of suicide and self-harm would have been clear. Anti-depressants have been prescribed to thousands of children world wide and many children have committed suicide.”

This month, the American medical control body, the Food and Drug Administration, (FDA) called for labels on anti-depressants to continue to contain a “black box” warning that children and teenagers who take the drugs have an increased risk of suicidal thoughts and behaviour. The warnings were put on in 2005 for under 18s.

Last year, in May 2006, GlaxoSmithKline sent a letter to UK health professionals saying that warnings should apply when Seroxat was prescribed for people aged under 30.

The FDA now says available evidence is strong enough to warn anyone under 25 that any kind of anti-depressant may increase suicide risk. However it says that the labels should also state clearly that psychiatric disorders are the major cause of suicide and that anyone taking anti-depressants should be monitored carefully.

INFORMATION: To contact the Seroxat User Group see

www.seroxatusergroup.org.uk

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2 Responses to “Inquiry into Drug-Suicide Link”

  1. According to Dr. Irving Kirsch in Prevention & Treatment , “there is now unanimous agreement that the mean difference between response to SSRI antidepressant drugs and response to inert placebo is very small. It is so small that, despite sample sizes involving hundreds of participants, 57% of the SSRI trials funded by the pharmaceutical industry failed to show a significant difference between drug and placebo. Most of these negative data were not published and were accessible only by gaining access to US Food and Drug Administration (FDA) documents.

    Various methods were used to manipulate the results of SSRI drug studies to insure a favorable outcome:

    1) Responders to the placebo are eliminated at the beginning of the study. (Placebo washout)

    2) Benzodiazepine sedatives were given to mask the SSRI induced agitation.

    3) Unfavorable drug studies are buried in the file cabinet and not disclosed to the public.

    4) Miscoding suicidal events as “emotional lability”, and homicidal events as “aggression” to hide suicidal events from regulators.

    5) False attribution of suicide to the placebo arm.

    6) Hiring ghost writers to make the medical articles more favorable.

    7) Cash settlements for SSRI drug litigants which seals records and withholds unfavorable drug studies from the public.

    For more information and links see my Paxil, Prozac, and SSRI Induced Suicide Newsletter

    Jeffrey Dach MD

  2. truthman30 said

    One would have to ask the question…

    Why is it taking 4 years to investigate the obvious… ?

    Maybe its just too much of a can of worms…

    That said, It will be interesting to see if this criminal investigation is ever going to come up with a conclusion!!!

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