Monday, December 29, 2008

The Latest Lies about Statins for High Cholesterol

"Game-changing."

"Paradigm-shifting."

"A colossal breakthrough."

These are just a few of the phrases used to describe the recently published study led by a Brigham and Women's Hospital researcher purporting to show that, in patients with normal cholesterol but high levels of inflammation, the use of Crestor (a new-generation statin drug), should reduce the rates of heart attack, stroke, and death, and all for a mere $100 per month per patient, or up to $30 billion a month to the drug manufacturer should treatment eventually be extended to essentially all adults everywhere.

There's just one problem with this headline-grabbing story. The study didn't show what the mainstream media seems to believe it showed. And even the scientists themselves admitted that their drug seemed to increase the risk of diabetes.

There's so much wrong with the reporting that this is going to be a very long post. I'll start with the obvious. The publicists for the study would have us believe that it proved that Crestor is practically candy for everyone, but the study limited its work to a very select group.

They studied Crestor in older people. The median age in the study was 66, which is to say, half of study participants were older.

Study participants also were somewhat overweight. Their median BMI was 28.3. That's about 192 pounds (88 kilos) for a man who's 5'9" (180 cm) or 165 pounds (75 kilos) for a woman of 5'4" (163 cm).

And most of the study's participants were "prediabetic." The median HbA1C was 5.7%. Endocrinologists do not all agree, but an HbA1C of 5.7% can indicate undiagnosed diabetes.

But most importantly, the study group had elevated blood pressure. While the elevation was slight, a median 134/80, that's enough to suggest a risk for heart disease.

So the Crestor study didn't focus on healthy people.

It also excluded people with the complaints many 50- and 60-somethings have: thyroid disease, any use of hormone replacement therapy, any indicator of kidney or liver abnormality, anyone with diagnosed high blood pressure, anyone with any autoimmune disease, and any with a history of drug abuse or alcoholism. In other words, the researchers were looking for senior citizens with beginning diabetes or heart disease but no other complaints--and how many people even over 50 don't have some ongoing medical condition?

The next thing to look at is results. The study conveniently lists "any myocardial infarctions" and "non-fatal myocardial infarctions." What it does not list is "fatal myocardial infarctions," but you can compute that by subtracting "non-fatal myocardial infarctions" from "total myocardial infarctions."

There's a reason the scientists did not list that figure.

Among the 8901 people not taking Crestor, six died of a heart attack. Among the 8901 people who did take Crestor, nine died of a heart attack.

How many people had non-fatal heart attacks during the three years of the study? If you were in the study and you weren't taking Crestor, your risk of a heart attack was about 1 in 300. If you were taking Crestor, risk of heart of attack was about 1 in 600.

So the drug company can honestly claim that their product seems to reduce the risk of having a non-fatal heart attack by 50% (even though it raises the risk of having a fatal heart attack by the same 50%). What isn't told is that the reduction in risk was from 1 in 300 to 1 in 600.

And to be fair, there were 31 fewer strokes in the Crestor group and 3 fewer deaths from stroke. But 54 more people in the Crestor group developed diabetes.

So what's the bottom line?

Any difference Crestor makes in heart health, good or bad, is small. The absolute improvement in risk of heart attack was 1 in 300, or 0.3%.

The study seems to confirm the idea that inflammation, not cholesterol levels, are what count.

Crestor reduces risk of stroke and heart attack, but raises rate of deaths from heart attack. It's important to note that only 1 in 1000 participants died of heart attack, with or without the drug.

Crestor seems to increase the risk of progressing from prediabetes to diabetes.

The study did not look at memory loss, dementia, or kidney and liver damage in people already known to be susceptible to those conditions. Nor did the study look at the impact of cheaper generic statin drugs such as Zocor (simvastatin).

You have to look at the find print to find essentially all the authors receive money from AstraZeneca, Novartis, Merck, Abbott, Roche, Sanofi-Aventis, Vascular Biogenics, Genentech, Relians, Aegerion, Reaverlogis, Pfizer, or Schering-Plough.

So what should you do?

If inflammation is more than cholesterol as the study suggests, make sure you have an inflammation problem before your doctor gives you a statin drug. That means a test for CRP rather than just a cholesterol reading.

Make sure your doctor runs a liver panel before giving you Crestor and repeats blood tests for liver disease regularly.

Don't take Crestor if you have a family history of age-related memory loss or dementia, and stop taking Crestor if you experience muscle pain (and call your doctor).

But before taking any drug for inflammation, consider taking supplement fish oil and lowering the amount of carbohydrate in your diet, following up with your doctor after you've tried them for at least 3 months. The natural approach just might save you both side effects and $100 a month.

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