A preliminary ruling by the Prescription Medicines Code of Practice Authority says AstraZeneca broke advertising rules by failing to accurately reflect the side-effects of its antipsychotic Seroquel.
The policing arm of the Association of the British Pharmaceutical Industry has allegedly found the Anglo-Swiss drugmaker to be in breach of the Code on three counts, with claims made in an ad – published in the British Journal of Psychiatry in 2004 - that Seroquel (quetiapine) has a favourable weight profile compared with rival drugs, according to media reports.
Because weight gain is in fact a fairly common side effect of Seroquel, the PMCPA ruled that the company’s ad was misleading and had breached ethical code requirements that marketing information should be “accurate and fair, and be capable of substantiation”, according to the Financial Times.
A spokeswoman for the PMCPA could not divulge any details regarding the ruling, as, she stressed, the information is only intended for full disclosure when a final decision is reached, and should not have been made public at this point.
However, she was able to confirm to PharmaTimes UK News that the PMCPA received three separate complaints regarding AZ’s promotion of Seroquel in January – one from a healthcare professional, one from a journalist and one from a member of the public – and that letters regarding the initial ruling on these cases had been sent out on Monday, allowing the claimants and AZ until the end of the week to lodge any appeals.
In defence, AZ is arguing that the intended audience for the advert would have understood that the information was in fact claiming that while Seroquel did result in weight gain, its profile was still favourable to other antipsychotics on the market at that time. "The intended audience for the advertisement was UK healthcare professionals, including UK specialist psychiatrists who we believe would have understood the statement in the broader context of the debate around weight gain and atypical antipsychotics in UK" the company said in an emailed statement to PharmaTimes.
Furthermore, AZ said it has long worked with regulatory authorities “to ensure that the safety profile of Seroquel is reflected appropriately in the label so that doctors can weigh the risks and benefits of medicines when making treatment decisions”, and that when Seroquel was first cleared for use in the UK, “the label alerted physicians that ‘weight gain’ had been observed”.
Misleading claims?
However, earlier this year a former employee of AZ has told the BBC he was pressured by the firm’s marketeers to approve claims that Seroquel was not linked with weight gain, despite evidence to the contrary.
John Blenkinsopp, the company's former UK medical manager, told the BBC Radio 4’s File on 4 programme that, while clinical studies at the time Seroquel’s launch “showed patients developed significant weight gain, significant both statistically and clinically”, the company’s 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”.
Launched in 1997 for the treatment of schizophrenia and later bipolar disorder, Seroquel quickly became one of the world’s top 10 selling drugs and, with annual sales of around $4.45 billion a year, AZ’s second-biggest earner.
News of the ruling will likely come as a bitter blow to the firm, which is currently battling thousands of lawsuits in the US alleging that it withheld information and failed to adequately warn patients of Seroquel’s side effects such as significant weight gain and an increased risk of diabetes.
A spokesperson for AZ could not comment on the ruling but told PharmaTimes UK News that the company was still examining the PMCPA's decision in detail, before deciding on whether or not to lodge an appeal.
By Selina McKee
PharmaTimes
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