In Case AUTH/2294/1/10 a journalist alleged that a Seroquel advertisement in the British Journal of Psychiatry, April 2004 featured a claim for ‘no weight gain’, long after AstraZeneca was aware of precisely such effects.
In Case AUTH/2296/1/10 a member of the public asked the Authority to review an online BBC news item, ‘Firm “suppressed” drug test data’, published 26 January 2010 in relation to the Code.
The news item stated that a former medical adviser for Seroquel was pressurised to approve promotional material which stated that weight gain was not an issue. The medical adviser stated that clinical data available when Seroquel was launched showed patients gained statistically and clinically significant weight. The medical adviser further stated that he was put under quite significant pressure to sign off claims with regard to lack of weight gain and he was unwilling to sign that off. The news item stated that in the US Seroquel 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, April 2004.
In Case AUTH/2297/1/10 an ex-employee of AstraZeneca referred to a Radio 4 documentary, File on 4, broadcast on Tuesday, 26 January 2010, which criticised promotional claims for Seroquel. In particular the complainant referred to an advertisement which was published in the British Journal of Psychiatry, 2004. The complainant provided a web-link to the File on 4 programme and also to articles in the Washington Post, 18 March 2009, and New York Times, 29 October 2009. The complainant stated that the links were provided to assist in the investigation.
The detailed response from AstraZeneca is given below. The cases were considered under the 2003 Code using the 2008 Constitution and Procedure.
In Case AUTH/2294/1/10 the Panel noted that the Seroquel advertisement at issue featured the claim ‘The only atypical with placebo level EPS [extra-pyramidal symptoms] (including akathisia) and placebo level prolactin concentrations and a favourable weight profile across the full dose range’. The Panel thus considered that the claim in full sought to establish Seroquel as an atypical antipsychotic which was distinctly different to the others in the class in that it was the only one to have placebo level EPS, placebo level prolactin concentrations and a favourable weight profile across the full range.
The Panel noted that in the absence of any explanation it was left to the readers’ judgement as to what was meant by a ‘favourable weight profile’. The Panel noted that Allison et al (1999) had estimated and compared the effects of antipsychotics (both conventional and atypical) on bodyweight and concluded that all were associated with weight gain. Among the atypical agents the mean increases in weight were 4.55kg (clozapine), 4.15kg (olanzapine), 2.92kg (sertindole), 2.1kg (risperidone) and 0.04kg (ziprasidone). The mean increase in weight with Seroquel was not calculated due to lack of data.
The Panel considered that if all of the other atypical antipsychotics were known to cause weight gain then it was not unreasonable for readers to assume that if Seroquel was ‘The only atypical with … a favourable weight profile across the full dose range’ then it might be an atypical with no effect on bodyweight. This was not so. Arvanitis and Rak (1997) reported that the mean increase in weight was 2.2kg (n=1085). (Allison et al had reported that the mean increase in weight for risperidone was 2.1kg and 2.92kg for sertindole). Across the dose range for Seroquel, 75/150/300/600/750mg daily, the mean increase in weight was 0.9/2.9/2.0/2.6/2.3kg respectively. Jones and Huizar (2003) reported a mean increase in weight of 1.8kg with Seroquel therapy. Brecher et al (2000) reported on the long-term weight changes in 427 patients over 18 months. Weight change differed over time from -1.53kg after weeks 40-52 (n=41) to +1.94kg after weeks 53-78.
The Panel noted that the relevant Seroquel SPC listed weight gain as a common (≥1% - <10%) adverse event which occurred predominantly during the early weeks of therapy.
Overall the Panel considered that the advertisement was misleading with regard to the effect on bodyweight that would be expected with Seroquel therapy compared with the other atypical medicines. Although the advertisement did not state ‘no weight gain’ as alleged it sought to differentiate Seroquel from other medicines in the class in that it was the only one with a ‘favourable weight profile across the full dose range’. Given that the other medicines caused weight gain, the advertisement could be read as implying that Seroquel did not. This was not so. Similarly, the advertisement could be read as implying that Seroquel had a clear advantage regarding its ‘favourable weight profile …’ and this was not supported by the data submitted by AstraZeneca. The claim ‘The only atypical with … a favourable weight profile…’ was thus misleading and could not be substantiated. Breaches of the Code were ruled.
In Case AUTH/2296/1/10 the Panel considered that its rulings above in Case AUTH/2294/1/10 applied here also. The Panel further considered that, given the data, high standards had not been maintained. A breach the Code was ruled.
Misleading prescribers about a potential side-effect of therapy could prejudice patient safety and was of an activity likely to be in breach of Clause 2. On balance, however, the Panel considered that the circumstances were not such as to warrant a ruling of a breach of that clause which was reserved as a sign of particular censure. No breach of Clause 2 was ruled.
In Case AUTH/2297/1/10 the Panel only considered allegations regarding material used in the UK. The Panel considered that its rulings above in Cases AUTH/2294/1/10 and AUTH/2296/1/10 applied here also. The complainant in this case unsuccessfully appealed the Panel’s ruling of no breach of Clause 2.
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