A lawsuit filed yesterday against Pfizer is claiming that the world’s largest drugmaker inappropriately marketed its cholesterol-lowering drug Lipitor (atorvastatin) to patients who have not been proved to benefit from the product.

The suit, brought by a group of consumer organisations and a union health plan, say that Pfizer has promoted the use of Lipitor as a way to reduce the risk of heart disease by reducing cholesterol in direct-to-consumer advertising. However, the plaintiffs claim that while there is evidence to support this view in men, Pfizer overstepped the data by promoting Lipitor for this use in women and the elderly.

The lawsuit is an additional distraction for Pfizer at a time when its legal teams are already fighting to defend the company’s patent estate on Lipitor - the world's top-selling drug with sales of $11 billion dollars last year - from attack by Indian drug company Ranbaxy. If Ranbaxy is successful, Lipitor could face generic competition in the USA as early as 2007, although Pfizer maintains its patents protect the drug to 2011 [[23/06/05b]].

Pfizer needs Lipitor to support the business while it shores up its product pipeline, which suffered two rejections by the US Food and Drug Administration earlier this month, for osteoporosis drug Oporia (lasofoxifene) and injectable COX-2 inhibitor Dynastat (parecoxib sodium) [[14/09/05b]] [[21/09/05b]]. Meanwhile, it also faces generic competition within the next two years for two of its big-selling products - the blood pressure drug Norvasc (amlodipine) and the antidepressant Zoloft


The legal merits of the DTC lawsuit remain to be established, but from a clinical perspective it could be argued that Pfizer‚s campaign goes some way to address the well-recognised fact that too few patients with elevated cholesterol receive drug treatment. Moreover, earlier this week Pfizer was granted approval for two new indications for Lipitor, one of which included its use in the prevention of heart disease in high-risk patients [[28/09/05c]]. This indication applies to patients with one or more risk factors for heart disease, including high cholesterol, high blood pressure, being older than 55, obesity and family history.