FT.com - Seroquel - Regulator finds ethics breach by AstraZeneca

AstraZeneca failed to accurately reflect the side effects of its top-selling antipsychotic drug Seroquel in an advertisement to doctors, a UK regulatory panel has ruled.

The Anglo-Swedish group breached three points of the British pharmaceutical industry’s code of practice with a marketing claim that Seroquel had “a favourable weight profile across the full dose range” compared with rival drugs, according to a preliminary ruling by the Prescription Medicines Code of Practice Authority.

The decision by the authority, the self-regulatory arm of the Association of the British Pharmaceutical Industry, will be a blow to AstraZeneca as it defends itself against a series of claims brought by patients and regulators on Seroquel in the US courts totalling $1.2bn (£800m).

In the US, AstraZeneca claimed in a range of advertisements over the past decade that Seroquel – known generically as quetiapine fumarate – resulted in lower weight gain than other antipsychotic medicines, although several studies in highly respected academic journals suggested otherwise.

In the UK, the company largely avoided such comparative claims, but it made one in large print in an advertisement in the British Journal of Psychiatry in 2004, balanced in the small print with the information that weight gain was a “common” side-effect.

AstraZeneca, in its defence to the authority’s investigation panel, said that the health professionals for whom the advertisement was intended would have understood that Seroquel resulted in weight gain, with a favourable profile compared with other antipsychotics based on the data available at the time.

It quoted two scientific papers showing lower weight gain with Seroquel than one alternative drug; and an analysis of different papers showing weight gain from five drugs, but which did not include Seroquel.

But the authority highlighted shortcomings in the studies cited and ruled that the advertisement was misleading because it did not reflect the evidence.

It concluded that AstraZeneca had breached ethical code requirements that information should be accurate and fair, and be capable of substantiation.

AstraZeneca said on Monday night: “We have just received the ruling from the PMCPA and are examining the full details before considering our next steps.”

The company, whose shares fell 43p to £29.52, has five days to decide whether to appeal.

via ft.com

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