Don't ride the Crestor wave, says Lancet

Related tags Statin Astrazeneca

AstraZeneca is roundly rebuked by The Lancet in an editorial that
describes the firm's development of its new cholesterol-lowering
drug Crestor as a "triumph of marketing over science".

Until relatively recently the medical journals have on the whole enjoyed a cordial relationship with the pharmaceutical industry, with company research on new drugs providing a useful source of articles for publication.

In the last couple of years there have been general articles complaining about the marketing practices used to promote new drugs which appear to offer little benefit over existing treatments, but carry much higher prices. Only rarely, however, has a journal felt the need to castigate a specific company for its actions. The editor of The Lancet, Dr Richard Horton, has done just that in the latest issue with a stinging attack on AstraZeneca and its high-profile chief executive Sir Tom McKillop.

In the editorial, Horton rebukes the company, and Sir Tom personally, for the handling of the development of Crestor (rosuvastatin), a new drug in the HMG-CoA reductase inhibitor or statin class that AstraZeneca has tipped as its next blockbuster product.

'AstraZeneca's tactics in marketing its cholesterol-lowering drug, rosuvastatin, raise disturbing questions about how drugs enter clinical practice and what measures exist to protect patients from inadequately investigated medicines,"​ according to the editorial.

Crestor is addressing the market for cholesterol-lowering drugs, headed by Pfizer's $8 billion (€6.8bn) statin drug Lipitor (atorvastatin). The drug was billed as a 'super-statin' during its clinical development, claimed to offer a high potency and improved cholesterol reduction compared to its rivals in the class.

However, Crestor ran into difficulties in the wake of the withdrawal in 2001 of another statin drug, Bayer's Baycol/Lipobay (cerivastatin). Cerivastatin was pulled from the market after cases of fatal rhabdomyolysis (in which skeletal muscle cells are destroyed) brought its safety into question and this heightened the scrutiny of other drugs in the class. AstraZeneca subsequently withdrew the top dose of the drug (80mg)

Crestor's launch was delayed by several months, but it finally reached the market last month and has already taken a 2 per cent share of the statin market.

""AstraZeneca has pushed its marketing machine too hard and too fast."

AstraZeneca responds

Sir Tom's response is no less harsh, calling the editorial "flawed and incorrect" and slamming the journal for making "such an outrageous critique of a serious, well-studied medicine."

In defense of Crestor, Sir Tom points to the 200,000 patients who have received the drug in clinical trials with no evidence of a safety profile that differs from other statins, and the fact that the drug has been reviewed and approved by 30 regulatory authorities around the world.

On the issue of efficacy, he points out that Crestor is better than any other statin in getting patients to their low density lipoprotein (LDL) cholesterol level targets, achieving this in more than 80 per cent of cases. He also notes that outcome data is rarely available at launch, and has never been so in drugs for hypertension and cholesterol-lowering. Trials are ongoing, but will take several years to complete.

"Millions of people are at risk of cardiovascular disease because they are either untreated or not being effectively treated with current lipid-lowering therapies,"​ continued Sir Tom. "With this compelling medical need, it is unthinkable that we should desist from our efforts to make this medicine more widely available to physicians and patients."

Related topics Drug Delivery

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