The New York Times reports Wednesday that some experts are questioning the safety of prescribing Crestor, made by AstraZeneca, to otherwise healthy people.
The FDA's approval hinges essentially on a change in the criteria used to assess an adult's risk of developing heart disease or suffering strokes.
Previously, doctors sought evidence of high levels of "bad" cholesterol in the bloodstream before prescribing statins (Wiki), which are currently the most widely-prescribed drugs in America with about 40 million people taking them, according to The Times' report.
Under the new evaluation process approved for Crestor by the FDA, doctors who detect certain levels of inflammation in the blood stream, in addition to one or more common risk factors for heart disease, such as smoking or elevated blood pressure, can prescribe the drug. The problem, according to The Times, is that there's no agreement among medical professionals that inflammation causes heart problems.
CBS News Medical Correspondent Dr. Jennifer Ashton agreed on "The Early Show," saying the issue is "incredibly controversial" based on a number of factors, including politics and money.
"They're very far-reaching and best left to those experts," she said. "But within the medical community, even, the controversy really stems from two reasons: One, the issue of risk versus benefit to this class of medications. Some people feel that the risks really outweigh the benefits. And even within the field of cardiology, there's some debate. And also now, and we're seeing it particularly with this indication, the question of prevention versus treatment. They are now using a marker to determine whether someone would be at risk for having high cholesterol, which is really an inflammatory marker. It's not the same thing as measuring your total cholesterol. And there's very little consensus within the field of medicine whether that is an adequate marker to judge one's risk."
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"It's a good thing to be skeptical about whether there may be long-term harm from healthy people taking a drug like this," Dr. Mark A. Hlatky, a heart disease expert at Stanford University's medical school told the Times.
Hlatky's concerns have been piqued by new evidence from a study published in Britain's medical journal The Lancet which shows people on statins have a nine percent greater risk of developing Type 2 diabetes.
Ashton added on "The Early Show" that the marker seen in many people that precipitates statin use -- known as CRP -- may not be enough to indicate a risk for future heart disease. She explained CRP is a measure found in blood of generalized inflammation. But even in cardiology, Ashton said, things aren't necessarily clear.
"It isn't known whether high cholesterol causes inflammation or whether inflammation can then lead to plaque buildup, which is seen as a risk factor for cardiovascular disease. It's a which comes first the chicken or the egg question."
AstraZeneca calls the FDA's decision last month to permit Crestor's use as a preventative treatment for healthy people "an important milestone for the company and for the patient."
Jim Helm, the drugmaker's vice president for cardiovascular products, told The Times his company was "already discussing this with physicians."
Soon, that dialogue will be aimed directly at the American public. According to The Times' report, AstraZeneca is working on a new advertising campaign for Crestor - targeting a new audience of 6.5 million people under the new diagnosis criteria.
Ashton pointed out statins are the most widely prescribed class of drugs in the U.S.
But how does risk versus benefit weigh out for the millions on these drugs?
"For most people the risks are quite low. But the ones we hear about are muscle aches and fatigue in the muscles, and there's also because it's metabolized in the liver, the risk of liver toxicity leading to liver damage. Those risks are thought to be very low. The most recent risk which has gotten a lot of attention is a nine percent increase risk for the development of Type 2 diabetes seen in people over the age of 60 taking statins. Again when you ask the experts, they feel that the benefits in reducing cardiovascular events far outweigh the risk of developing diabetes."
Ashton added once you take statins, you have to do so for life.
"They base worked on how the liver produces your body's own cholesterol. This is really a band-aid. If you stop taking it, your body will start producing the cholesterol again."
To lower your risk of high cholesterol without medication, Ashton said diet and exercise are key. However, she added, people can't change their family history.
"For people who are prone to high cholesterol this might be very, very important, if not necessary."