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AstraZeneca digs in over advertising criticisms
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     AstraZeneca is refusing to give ground in a war of words with the watchdog group Healthy Skepticism, an international non-profit organisation, over advertising claims made for its bestselling proton pump inhibitor, esomeprazole (Nexium).

    Before the 2003 Rugby World Cup tournament in Australia, AstraZeneca sponsored an advertisement featuring a footballer diving to score a try. "Experience the power. Feel the relief," the advertisement in the September edition of Australian Family Physician magazine proclaimed. It added: "Nexium 40 mg offers greater healing power than either omeprazole or lansoprazole: with no compromise in tolerability," with the punchline "it's got the power¡ªNexium."

    Ever since Healthy Skepticism's director, Dr Peter Mansfield, has pressed AstraZeneca to acknowledge that esomeprazole offers no clinically proved advantages for most patients with gastro-oesophageal reflux seen by GPs. "What we want them to concede is that this is not one size fits all for everybody and that Nexium's use is not justified for mild to moderate cases of gastro-oesophageal reflux," he said.

    Dr Mansfield argues that comparing esomeprazole 40 mg with various brands of omeprazole 20 mg and lansoprazole 30 mg is inappropriate and was disclosed only in the advertisement's small print.

    As part of its web based Adwatch project, Healthy Skepticism encouraged comments on the advertisement's claims. After feedback from 108 contributors, the group drafted recommendations for reflux treatment that recommended a role for esomeprazole 40 mg in only the more serious cases.

    AstraZeneca's global promotional consultant, Paul Woods, dismisses Health Skepticism's process and criticisms. "AstraZeneca believes that the Adwatch criticism of Nexium advertising is scientifically unsound and misleading," he protested to Dr Mansfield.

    For AstraZeneca there is a lot at stake. According to IMS Health, the pharmaceutical industry market intelligence company, esomeprazole globally earned $3.8bn (?.1bn; €3.2bn) in 2003 and is the seventh largest and the fastest growing drug (up 62% on the previous year).

    In a reference to complaints lodged under the self regulatory marketing code developed by the Australian drug industry group, Medicines Australia, Mr Woods informed Mansfield that the advertisement had been "judged as acceptable (twice) under a well established and respected code of conduct involving independent adjudicators."

    According to the recently released Code of Conduct report for 2002-3, Wyeth Australia complained on at least one occasion that promotional material for Nexium, entitled "more effective acid control than other PPIs," was false and misleading and lacking supporting data.

    Although several sections of Wyeth's complaints were rejected by a majority of the industry appointed committee, the report noted that AstraZeneca "agreed to modify the claim considered to be misleading." Wyeth was unavailable for comment.

    Frustrated by the failure of the company to change the advertisements, Dr Mansfield has written to AstraZeneca's chief executive, Tom McKillop, suggesting they jointly develop more accurate advertisements. If rebuffed, Dr Mansfield plans to test whether the industry's self regulatory code committee will require changes.

    In England and Wales, the National Institute for Clinical Excellence (NICE) recommends the use of proton pump inhibitors for gastro-oesophageal reflux disease only when the symptoms are severe.(Canberra Bob Burton)