The best-selling statin drug, rosuvastatin, which is sold under the Crestor brand, "should not be used," according to a doctor writing in The BMJ - because the evidence of benefit has been weak, and there is growing evidence of side-effects.
Writing as founder of the health research arm of the consumer group Public Citizen, Dr. Sidney Wolfe says that he hopes Crestor's position as the most prescribed brand name drug in the US in 2014 "declines" - because, says the opinion piece in The BMJ, the evidence of clinical benefit has "fallen" along with "more evidence of risks."
Dr. Wolfe suggests that Crestor's annual multibillion dollar success is explained by rosuvastatin having, milligram for milligram, the best cholesterol-lowering potency of all statins - a "fact exploited in advertising campaigns."
In spite of its success, the drug should have been withdrawn, the article argues, when Public Citizen first called on the US Food and Drug Administration (FDA) to consider "serious problems [that] were identified before rosuvastatin's [FDA] approval."
He asks: "Given the evidence of more serious risks and less clinical benefit than other statins, how has the drug fared so well for so long?"
The FDA license for Crestor specifies preventive prescribing for "slowing the progression of atherosclerosis" in addition to treating primary hyperlipidemia and other disorders of cholesterol levels. In the US in 2014, some 22.3 million prescriptions were filled for the drug.
"There is also growing evidence that the drug carries a higher risk of serious adverse effects compared with other statins, such as an increased risk of developing diabetes."
Marketing campaigns in the 'statins war'
Dr. Wolfe believes safety concerns have not been taken into account in marketing activities for the drug amid a so-called statins war.
He describes a row that played out in another leading medical journal, The Lancet, about whether AstraZeneca, the pharmaceutical company responsible for Crestor, "pushed its marketing machine too hard and too fast."
That editorial was in 2003, and Dr Wolfe goes on to cite a 2004 warning from the FDA against AstraZeneca's marketing - specifically, a clarification about the accuracy of an advert that the company took out in response to Public Citizen's campaign against the drug, he says.
The FDA was concerned on that occasion about how far the company claimed its statin was safer than the other drugs in the class, and later warned the company again, writes Dr. Wolfe, about the way it made a claim in other promotions for the comparative efficacy of Crestor.
Dr. Wolfe concludes his argument against rosuvastatin by saying he hopes "the drug's disadvantages will lead to a sharp decline in its use" before the AstraZeneca patent for rosuvastatin expires in 2016.
He worries that, without the points he raises being widely heard, the drug could continue to enjoy success in the same way that other statin drugs have done so after coming off patent. Dr. Wolfe says:
"When patents expired for simvastatin, pravastatin and atorvastatin, the rise in generic prescriptions quickly equaled or exceeded the sharp decreases in brand name prescriptions."
Dr. Wolfe ends The BMJ's feature article by hoping that because "AstraZeneca's need to promote" the drug would stop in 2016 with the patent loss, the campaign against rosuvastatin would have an effect "for the sake of the public's health."
MNT asked a spokesperson for AstraZeneca to respond to Dr. Wolfe's article. The company said: "Crestor is an effective treatment for lowering LDL-cholesterol and raising HDL-cholesterol, when compared to other statins, and it has been shown to slow the progression of atherosclerosis."
The company added that it took its commitment to patient safety "extremely seriously" and that Crestor "has a well-established safety profile." AstraZeneca also responded that Crestor "is approved by health care authorities in over 109 countries and used by tens of millions of patients worldwide."
In other news about cholesterol-lowering drugs this week, a new type of treatment, a monoclonal antibody, could be more effective than statins. The drug, evolocumab, has been submitted to the FDA and UK and EU regulators in application for marketing licenses.