Lancet accuses AstraZeneca of sponsoring biased research

The Lancet last week took the unprecedented step of accusing Europe's second biggest drug company, AstraZeneca, of sponsoring biased research into its new anticholesterol drug rosuvastatin (Crestor).

Dr Richard Horton: doctors “must tell their patients the truth about rosuvastatin”

In an editorial, the journal's editor, Richard Horton, said the company's tactics “raise disturbing questions about how drugs enter clinical practice and what measures exist to protect patients from inadequately investigated medicines”(Lancet 2003;362: 1341).

The Galaxy series of clinical trials, which investigated the efficacy of rosuvastatin, included “weak data,” “adventurous statistics,” and “marketing dressed up as research,” said the editorial. “Physicians must tell their patients the truth about rosuvastatin, that, compared with competitors, it has an inferior evidence base supporting its safe use.”

The “unprincipled campaign,” said Dr Horton, had cast into shadow the glittering career of Tom McKillop, the company's chief executive. Dr McKillop reacted furiously in a letter published in the same issue.

“Regulators, doctors, and patients as well as AstraZeneca have been poorly served by your flawed and incorrect editorial,” wrote Dr McKillop. “I deplore the fact that a respected scientific journal such as the Lancet should make such an outrageous critique of a serious, well studied, and important medicine.”

“All the safety and efficacy data on Crestor have been reviewed in great depth by regulatory authorities globally, who assessed the benefit risk profile of the product and approved it in a demanding regulatory climate,” he argued.

The article coincided with the first release of sales figures for rosuvastatin, which showed the drug doing better than expected, with $88m (£52m; €75m) of worldwide sales in its first nine months. With final sales expected to reach $5bn, rosuvastatin is a key element in AstraZeneca's bid to survive the patent expiry of the bestselling antiulcer drug omeprazole.

Rosuvastatin will be competing directly against the world's bestselling drug, Pfizer's atorvastatin (Lipitor) which had sales last year of $8bn. AstraZeneca will spend an estimated $1bn this year on its promotional campaign.

Approval for rosuvastatin has been delayed in Germany, and a company spokesperson said the impasse is unlikely to be resolved until next year.

The Lancet editorial said rosuvastatin use was associated with proteinuria and microscopic haematuria, and it pointed out that the company had withdrawn the 80 mg dose because of safety concerns.