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“Medical Journal Criticizes Crestor Marketing” An editorial in the British medical journal The Lancet argues that AstraZeneca is inappropriately promoting Crestor (rosuvastatin), despite allegedly weak safety and outcome data for the statin. "AstraZeneca's tactics in marketing its cholesterol-lowering drug ... raise disturbing questions about how drugs enter clinical practice and what measures exist to protect patients from inadequately investigated medicines," the Oct. 25 editorial states. The FDA approved Crestor in August and it was launched in September. The Lancet charged that AstraZeneca will do "whatever it takes" - including spending an estimated $1 billion on a first-year promotional campaign - to gain a percentage of the lucrative and competitive statin market. The editorial criticizes AstraZeneca's strategy of promoting Crestor based on its cholesterol-lowering properties, a surrogate endpoint, instead of its long-term effects on preventing cardiovascular disease. The Lancet also expressed concern about Crestor's safety, noting that AstraZeneca withdrew the 80 mg. dose of the drug and that some critics still are "anxious" about the 40 mg. dose. "Physicians must tell their patients the truth about rosuvastatin - that compared with its competitors, rosuvastatin has an inferior evidence base supporting its safe use," the editorial states. "AstraZeneca has pushed its marketing machine too hard and too fast." In response to the editorial, AstraZeneca's Chief Executive Officer Tom McKillop defended Crestor as an "extensively studied and well tolerated drug with a safety profile comparable to other marketed statins." The company noted that drug regulatory agencies worldwide have assessed Crestor's benefit-risk profile and "approved it in a very demanding regulatory climate." Furthermore, McKillop argued that it is disingenuous for The Lancet to criticize the lack of outcomes data on Crestor because such studies rarely exist on any new medicine at the time of launch, and lipid surrogate endpoints are widely accepted in the medical community. For more information about medical products advertising, please see the FDA Advertising and Promotion Manual. SOURCE:
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