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AstraZeneca 'suppressed' key drug data

AstraZeneca (AZ) tried to suppress data involving weight gain side-effects of its anti-psychotic drug, Seroquel, according to a former employee

One of the world's leading drug companies, AstraZeneca (AZ) tried to suppress key data involving weight gain side-effects of its anti-psychotic drug, Seroquel, according to a former employee.

Speaking to the BBC's File on 4, former UK medical adviser for the drug, John Blenkinsopp, told of how he was put under pressure to approve promotional material that overlooked experimental evidence for Seroquel which saw patients develop "significant weight gain, significant both statistically and clinically."

The accusations come as AZ face fresh legal action next month, with thousands of patients suing the company in the US over claims the drug caused weight gain and diabetes without providing an adequate warning for such side-effects in its marketing. These claims are denied by the company.

Speaking openly for the first time since 2000 about the subject, Blenkinsopp told the BBC: "They [the marketing team] came at me with a number of potential claims all of which were trying to intimate that Seroquel was not associated with weight gain - the data pointed in the opposite direction.

"In the end I was put under quite a significant amount of pressure by the marketeers to sign off claims with regards to the lack of weight gain and I was unwilling to sign that off. The marketeers made it clear it could be career limiting for me."

According to BBC News Online, 'AstraZeneca has said it would not comment specifically in reference to its former employees, but said it took seriously any concerns regarding the firm's conduct and compliance procedures and it was currently reviewing issues raised by File on 4's investigation.'

Seroquel was launched in 1997 for treating schizophrenia and later for bipolar disorder. It is currently AZ's second biggest selling drug, making a profit of $4.5bn (£2.7bn) a year.

The issue has also renewed debate on the approval process for new drugs in the UK. Speaking on the File on 4 programme, Dr Fiona Godlee, editor of the British Medical Journal, warned that the power and influence of the pharmaceutical industry 'needed to be controlled'.

She is reported by the BBC as calling for independent trials for all new drugs, in what would be a major change in the way drugs are developed and licensed.

Currently, the Medicines and Healthcare products Regulatory Authority (MHRA), who regulate what drugs are licensed, relies only on research provided by drug companies themselves when approving a medicine.

File on 4  is on BBC Radio 4 on Tuesday, 26 January, at 8pm, and is repeated Sunday, 31 January, at 5pm.

 

 


 

26th January 2010

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