Statin Drugs: Are Profits Once Again Being Put Before Our Health?

I recently told you about the launch of a new cholesterol-lowering statin drug called Crestor, manufactured by AstraZeneca (AZ), the fifth largest drug company in the world. AZ reps have made no secret of their hopes that Crestor will effectively rival Pfizer's Lipitor, the long-time statin king.

AstraZeneca's pitch for Crestor is that it's less expensive and more effective than Lipitor, with similar side effects. And the new drug is already selling like hotcakes here in the UK, Canada, and several other countries where it's been available since last February.

But I want to look at the current situation in the US regarding this drug, which is extremely worrying considering it's being so readily prescribed by UK doctors.

Comparisons being made to Baycol
In the US, the original clinical trials presented to the US Food and Drug Administration (FDA) led to some subjects developing kidney damage after taking 80 mg of Crestor. (Not really all that shocking given that, as a class of drugs, statins have always been associated with kidney toxicity.) So the people at the FDA said, 'Try again,' and AZ resubmitted Crestor at doses of 40 mg or less. The FDA gave the green light, and Crestor was introduced in the US in September.

Within just a couple of weeks of Crestor's US launch, AstraZeneca announced that the new drug had already captured more than 2 percent of the new prescriptions written for statin drugs in the US. These impressive stats were released at a high-profile meeting with investors at AZ's US headquarters in Fairfax. But the party was spoiled when, that very same day, Wellpoint (the second largest private health insurer in the US) announced that prescriptions for Crestor would not be covered because of concerns over the safety of the drug.

This was a blow. It meant that more than 13 million Americans in the Wellpoint system would have to pay for Crestor out of pocket. But perhaps even worse than that, when reps for Wellpoint made the announcement, they used the 'B' word: Baycol.

Baycol was A.G. Bayer's entry into the statin market a few years ago, which was yanked from the market in 2001 because of adverse reactions, including acute kidney failure and more than 30 deaths. Bayer was sued by thousands of patients, and spent well over a $1 million settling many of the cases out of court.

So when Dr. Robert Seidman, Wellpoint's chief pharmacy officer, told reporters that the insurance company was being cautious because, 'We've already been Baycolled,' the seed of doubt was planted by making the association between Bayer's dangerous product and the kidney problems attributed to Crestor in those early 80 mg trials that the FDA rejected.

So was Wellpoint simply protecting clients by denying the Crestor coverage? Tom McKillop, AZ's chief executive, reportedly told a writer for TheStreet.com, 'I don't believe for a moment that it's about side effects.'

Research funding is extremely questionable
Less than a week after Wellpoint ruined AZ's day, Reuters reported that a new UK study had revealed that in a group of 14,000 heart disease patients, statins failed to lower cholesterol to recommended levels in about half the subjects. The headline read: 'Statin Drugs Fail Half UK Heart Patients-Study.'

Now you might think that on the heels of this news AZ executives would have started pulling out their hair again, but not so. Because the statin drugs this study focused on were the older statins, such as atorvastatin (brand name: Lipitor) and simvastatin (brand name: Zocor). The newer type of statin drug known as rosuvastatin (brand name: Crestor) wasn't included in the study.

So this was a lucky break for AZ, right? Well, it was perhaps more than just a break. Because the research was sponsored by AstraZeneca. I'm not saying anyone falsified the results.

They didn't need to. Previous studies have already shown that statin drugs significantly lower cholesterol in less than half of those who take them. So the 'failed' effectiveness was virtually a foregone conclusion.