When a new drug hits the market….

When I was in medical school, wise old Dr. George Wolf told me, tongue in cheek:

`”Brad, remember, when a new drug hits the market, use as much of it as you can…. while it is still available!”

Of course he was referring to the alarming track recotrd of FDA approved drug being rushed to market before they are really determined to be safe and then, once on the market and wreaking more harm than benefit, they are pulled with little notice or explanation. Since Dr. Wolf taught me this important lesson, I have never ‘been the first” to prescribe a new drug when it “hits the market” because I don’t like to experiment on my patients and new drugs rarely have been adequately vetted for safety before the sales begin.

And that is why I would not have used Pfizer’s recent debacle, torcetrapib, which never made it to market despite the drug company spening more than $900 million (yes, that is almost a billion dollars!) testing is as a potential heart drug.

The drug increased levels of “good” cholesterol (HDL) by 50 percent and reduced “bad” cholesterol (LDL) by 20 percent. But in December 2006, a 15,000-patient study revealed that torcetrapib increased, rather than reduced, death rates.

Pfizer had hoped that torcetrapib would lead to a wave of new drugs that raise good cholesterol levels and reduce heart attack rates.

But studies examining the neck and coronary arteries of patients on the drug, using ultrasound imaging, showed that it did not actually clear clogged arteries. The drug also raised blood pressure by 4.6 points, and it may even have increased plaque buildup in arteries.

Torcetrapib works by blocking cholesterol ester transfer protein (CETP); it has long been debated whether this approach is beneficial. Other experimental HDL-boosting drugs have also either failed or produced mixed results.

For example, a pill developed by Eli Lilly to raise HDL and cut triglycerides heightened the risk for serious kidney and heart problems and proved no more effective than older heart drugs. CETP-blocking drugs being developed by Merck and Roche Holding may encounter problems similar to those faced by torcetrapib.

The real story, however, was in the New York Times article which relayed this shocking news to the financial markets (Pfizer’s shareholders were not happy!). In it a well-respected researcher Brown at U.W. was quoted as saying:

Yahoo News March 26, 2007

Forbes.com March 26, 2007

Dr. Mercola’s Comment:

Although torcetrapib boosted a person’s HDL cholesterol by as much as 61 percent in one report, generally all the negatives — cholesterol buildup in the arteries and the risk of heart attack or death — stayed the same.

What a surprise!

Not really, this is precisely what I would predict.

Although cholesterol and heart disease have been almost synonymous for the last half-century, the evidence for this is actually fairly weak. In fact, because the correlation of total cholesterol with heart disease is so weak, many years ago the makers of cholesterol-lowering drugs sought a stronger correlation, and found a so-called “good cholesterol” called HDL, and started blaming a “bad cholesterol” called LDL.

But the concept of something as simple as a good and bad choleterol is seriously flawed. LDL particles come in many sizes, and large LDL particles are not a problem. Only small dense LDL particles can even potentially be a problem. Also, some HDL particles are better than others.

Knowing your total cholesterol tells you very little, and knowing your LDL and HDL levels does not tell you very much. In reality, your cholesterol levels are symptoms of other problems, so changing them will not help your heart problems. Only addressing the underlying causes of both your cholesterol levels and your heart problems will do that.

So it’s no wonder that, as one expert aptly put it, drugs that give HDL a boost aren’t “ready for prime-time” — and they never will be. Instead of taking drugs, follow the simple lifestyle guidelines below to take care of your heart and arterial health.

It is VERY rare for anyone to need cholesterol-lowering drugs. In my practice of over 20,000 patients I only put four or five patients on them, as they had genetic problems that required it. If you or someone you know is taking them, odds are very high, greater than 100 to 1, that you don’t need it.

Joseph Mercola

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