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The Statin Wars: Why AstraZeneca Must Retreat (p 1341)
October 22, 2003On Thursday 23 October, AstraZeneca, one of the world's largest pharmaceutical companies, will announce its third-quarter financial results. This coincides with a robust editorial in this week's issue of THE LANCET which calls into question AstraZeneca's high-profile marketing of rosuvastatin, a drug launched into the global statin market last month on the basis of as yet incomplete research findings.
The editorial comments: 'The statin market is vast. Pfizer's atorvastatin-the world's best-selling drug-had sales in 2002 of US$ 8 billion. AstraZeneca predicts that it can take a 20% share of this global market. It needs to. The company reported a 17% drop in pre-tax profits in the second quarter of this year. After a damaging delay over safety concerns, rosuvastatin finally won US FDA approval in August and was launched last month, winning a 2% market share after only three weeks. [Tom] McKillop [AstraZeneca's Chief Executive] has pledged to do whatever it takes to persuade doctors to prescribe rosuvastatin, including launching an estimated $1 billion first-year promotional campaign. "We've got to drive the momentum", he said at a recent investors meeting. "You get one shot at launching a major new product. This is our shot."'
Galaxy-the umbrella consortium of randomised trials that have tested rosuvastatin in different clinical settings-is the marketing tool for the drug; the Lancet editorial points out weaknesses of many of the trials, commenting that 'with no clinical end-point trial yet completed, the company has chosen to market rosuvastatin by applying adventurous statistics to an overinterpreted syllogism.'
The editorial concludes: 'Since there are no reliable data about efficacy and safety-and AstraZeneca is facing unusually acute commercial pressure to force rosuvastatin into the market-doctors should pause before prescribing this drug. Physicians must tell their patients the truth about rosuvastatin-that, compared with its competitors, rosuvastatin has an inferior evidence base supporting its safe use. AstraZeneca has pushed its marketing machine too hard and too fast. It is time for McKillop to desist from this unprincipled campaign.'
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