Healthy Skepticism Library item: 17115

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Jack A
Weight gain played down in drugs ad
The Finanical Times 2010 Jan 27
http://www.ft.com/cms/s/0/960ec1ba-0b70-11df-8232-00144feabdc0.html?nclick_check=1

Full text:

AstraZeneca, the Anglo-Swedish pharmaceutical group, played down in a UK advertisement the risk that patients taking its anti-psychotic medicine Seroquel would gain weight.

Details of the advertisement, highlighted in a BBC File on 4 report this week, come as litigation intensifies in the US against many pharmaceutical companies over aggressive marketing.

Published in the British Journal of Psychiatry in 2004, the advertisement described the drug known generically as quetiapine fumarate as “the only atypical [antipsychotic] with . . . favourable weight profile across the entire dose range”, in spite of data showing weight gain similar to other drugs.

The claim – balanced by an acknowledgement in the small print that weight gain was a “common” side-effect – was made during fierce rivalry between manufacturers of antipsychotics.

AstraZeneca last autumn made provisions of $520m in anticipation of settlements with the US Department of Justice and two whistleblowers. It faces more than 10,000 civil cases in connection with Seroquel alone.

The company said the advertisement had been targeted at “UK healthcare professionals . . . who would have understood the statement in the broader context of the debate around weight gain and atypical antipsychotics in UK”. It was approved by staff “in the context of available clinical evidence at that time”.

“Weight gain has been observed in clinical trials with Seroquel and that information has been reflected in the product label since its launch. Seroquel has been used by millions of patients around the world, and as more has been learned about Seroquel through clinical trials this labelling information has been updated.”

Several academic studies pre-dating the advertisement suggested Seroquel did not carry a lower risk of weight gain than other antipsychotics. One, published in 2000 in the journal Acta Psychiatrica Scandinavica, concluded: “All atypical drugs, with the exception of ziprasidone, have been associated with weight increases. Clozapine seems to have the highest risk of weight gain, followed by olanzapine and quetiapine [Seroquel]. There is probably a lower risk with risperidone, sertindole and zotepine and a still lower risk with amisulpride.”

Company documents made public through the Seroquel litigation reveal internal debate at AstraZeneca over whether and how to publish data on clinical trials of the drug.

The Prescription Medicines Code of Practice Authority, the self-regulatory body of the Association of the British Pharmaceutical Industry, said it would examine the advertisement for any breaches of its code.