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Finally, A Reason to Cheer the FDA


For a blog generally concerned with overzealous government regulation, readers might be surprised to find an article applauding the FDA. However, the regulatory agency has remained an ally of the American people by fulfilling its mandate – carefully evaluating every issue without bowing to outside pressure.


In the case of statins, which are drugs designed to lower cholesterol levels, a small group of opponents mistakenly believe these drugs can cause more harm than good. Fortunately, the FDA has dismissed their petitions – and rightly so – because of the overwhelming lack of scientific evidence to support the outrageous claims made.

Instead, statins have been on the market for quite some time, and have unquestionably saved lives. The FDA’s most recent laudable move was to approve the statin Crestor for use in patients who don’t exhibit high cholesterol, but are at risk for heart disease.

This could mean you, so read on, because this drug might save your life.

I’ve previously discussed the results of the groundbreaking JUPITER study by AstraZeneca, and the importance of the results for women. However, the JUPITER study also revealed another critical component of heart disease. You don’t need to have high cholesterol to be at risk for a cardiovascular-related event. 50% of people who suffer heart attacks or other cardiovascular problems have normal cholesterol levels. AstraZeneca wanted to see if Crestor could help out those folks.

It turns out that if you are a man over 50 or woman over 60; have a high level of a certain protein in your body (C-reactive protein, or CRP); and you have one other risk factor such as smoking, hypertension, or family history of cardiovascular disease, you may be helped by using this statin. Of the 18,000 people in the study, 2.8% experienced cardiovascular problems when treated only with a placebo. That dropped to 1.6% for those treated with Crestor – a 45% improvement.

The FDA’s approval of the drug provides yet another example of why we must be wary of health reform specifics. As much as people may be unhappy with the current system, any new health care initiative must be properly vetted so that those in need of life-saving drugs like statins are still able to get them.

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