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Coverup: a British government agency refused to reveal clinical trial data for Glaxo’s Seroxat

Featured here earlier for its benevolence to the poorest, Glaxo, (Let them eat vaccines!) one of our biggest companies, has been fined £2 billion in the US for encouraging the prescription of unsuitable drugs to children, illegally promoting two antidepressants by bribing doctors, and withholding safety data about a diabetes drug.

Glaxo’s ‘encouragement’ had included: 
  • free trips for doctors, snorkelling, sailing, deep-sea fishing, balloon rides, spa treatments and cash payments, to persuade them to prescribe these drugs, or to reward them for doing so;
  • allegedly paying a medically-qualified radio host  more than £150,000 to ‘plug’ a GSK antidepressant for unapproved uses;
  • payment for articles approving its drugs to appear in reputable medical journals.
Causes for concern had been reported (and ignored) for many years. Two such instances follow: 

In 2003 Colin Whitfield, a retired headmaster, aged 56, slit his wrists in his garden shed two weeks after starting to take Seroxat. The coroner recorded an open verdict and said the drug should be withdrawn until detailed national studies were made.

In 2007 Sara Carlin, a 18-year-old Canadian student hanged herself despite official warnings (and warnings from her mother) that the drug could lead to self-harm.

In 2008 it was reported that Professor Irving Kirsch from the department of psychology at Hull University and his colleagues in the US and Canada requested and obtained a full set of trial data for four antidepressants under freedom of information rules from the Food and Drug Administration, which licenses medicines in the US and requires all data when it makes a decision.

A study then reviewed the data, including results from clinical trials that the manufacturers chose not to publish at the time.

GlaxoSmithKline which makes Seroxat, one of the named antidepressants, firmly declared the study unsound. 

Why did it take so long after the UK Medicines and Healthcare products Regulatory Agency had announced a review of Seroxat in 2002 and a British  coroner had called for Seroxat to be withdrawn in 2003? 

Clinical trial data for Seroxat given to the MHRA were not made public  

“Section 12 of the FOIA provides that public authorities are not required to comply with requests that they judge to constitute an excessive use of their resources.”

News of the Glaxo four follows