Sunday, April 25, 2010

FDA Approves Crestor for People with No Cholesterol Problems

On March 30th, the New York Times reported that the FDA had approved new criteria suggesting that an estimated 6.5 million Americans who have no cholesterol problems and no sign of heart problems be considered candidates for long-term use of cholesterol-lowering statin drugs. Specifically, the nation's drug watchdog agency approved the new criteria for Crestor, which is made by AstraZeneca and is the nation’s second best-selling statin. The company is already preparing its marketing campaign. (“Feeling healthy? Don’t Be Too Sure . ..)

While statin drugs have been undeniably successful in lowering cholesterol, they come with numerous and serious side effects. Among the possible side effects acknowledged by AstraZenica are headache, muscle pain (myalgia), abdominal pain, weakness and nausea. Other side effects known to be associated with the drug include increased risk of type 2 diabetes, liver enzyme abnormalities, memory loss, rhabdomyolysis (the breakdown of muscle fiber) and kidney failure. Here is a good summary of the side effects of statin class drugs.

You would think that recommending the drug to millions of people with none of the symptoms it is intended to treat would at least result in significant health benefits in exchange for assuming these additional risks. But the single study leading to the expanded approval produced only a 0.2% improvement vs the control group. That is, 2 people out of 1,000 did better than those taking sugar pills. In the case of this seeming healthy group of patients, “Ultimately, the benefit is statistically significant but not clinically significant," says Dr. Steven W. Seiden, a cardiologist in Rockville Centre, N.Y. “The benefit is vanishingly small,” Seiden added. “It just turns a lot of healthy people into patients and commits them to a lifetime of medication."

A lifetime of very expensive medication.
“Crestor, which had sales of $4.5 billion last year, will not be subject to generic competition until 2016 — and so (AstraZenica) has more years to benefit from expanded use of the product at name-brand prices,” observed NYTimes reporter Duff Wilson, the Times article's author. “The drug, taken as a daily pill, sells for at least $3.50 a day, compared with only pennies a day for some generic statins." You can do the math. Pharmaceutical companies are on record that they want to have half the population of the USA on statin drugs (Lipitor, Crestor, Zocor, etc).

Given their serious potential side effects, given that there is no definitive proof that the drugs actually reduce the risk of heart attack (that they lower cholesterol levels is proven) and given that numerous alternatives for reducing cholesterol exist, many medical experts question whether this loosening of the regulatory guidelines is a healthy move. You should too.

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