Sunday, September 11, 2011
AstraZeneca 'suppressed' drug test data on weight gain for Seroquel: former medical advisor speaks
From BBC January 2010
AstraZeneca 'suppressed' drug test data
"The marketing team sued over a drug's alleged side effects tried to suppress key data, an ex-employee has claimed.
Seroquel's former UK medical adviser told the BBC he was pressured to approve promotional material which said weight gain was not an issue.
Maker AstraZeneca, which faces fresh legal action next month, said it took concerns about its conduct seriously.
In the same programme, the British Medical Journal editor urged that the medicine licensing system be reviewed.
Dr Fiona Godlee said industry should no longer provide the evaluations of its own drugs which the licensing body considered.
Thousands of patients are suing AstraZeneca in US courts, claiming the anti-psychotic drug Seroquel caused weight gain and diabetes.
The patients allege Seroquel, its second biggest selling drug worth $4.5bn (£2.7bn) a year, was marketed without adequate warning about possible side effects such as massive weight gain and the development of diabetes. However, this is denied by the company.
AstraZeneca, which is facing renewed legal action next month, said the company took concerns about its conduct seriously.
Seroquel was launched in 1997 for treating schizophrenia and later for bipolar disorder. Dr John Blenkinsopp, the company's former UK medical manager, claimed he was pressurised by the company's marketing arm to approve claims about the drug which he felt did not reflect the medical evidence.
"The clinical studies at the time of the launch of Seroquel showed patients developed significant weight gain, significant both statistically and clinically," he told the BBC's File on 4.
"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," added Dr Blenkinsopp who was speaking publicly for the first time since he left the company in 2000.
He said: "I understood where they were coming from. I had some robust discussions and exposed them to the data but that didn't seem to stop them because they were desperate for a differential advantage over one of the competitor products and they didn't have one.
"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," Dr Blenkinsopp added.
In the US the drug was marketed with claims that it would not cause weight gain. That was not done in the UK except for one advertisement, published in the British Journal of Psychiatry in April 2004."
Continue reading HERE.
LISTEN to John Blenkinsopp BBC audio interview