Cholesterol - what a business plan

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Health

Pharma

When cholesterol was identified as health-enemy number one, we switched from butter to margarine and did without eggs for years, in an effort to avoid falling prey to the oily killer.

At the same time, a whole pharmaceutical product sector, accounting for revenues in the $ billions, magically appeared to sell us pills. The sales pitch was: "Protect your heart - lower your cholesterol" or any variation of that mantra.

In reality, cholesterol is just about irrelevant in heart disease. This well known but not well publicized truth has just received further scientific confirmation, Jenny Thompson of the Baltimore Health Sciences Institute tells us in her latest e-Alert.

But no fear - che cholesterol business will not be suffering. Everything is still going according to plan. AstraZeneca is set to spend as much as $1 billion to promote Crestor - a cholesterol lowering drug like Pfizer's Lipitor - in the U.S this year and guess how many billions they expect to make.

Probably there has not been a more profitable myth than the one built around cholesterol, in the history of the pharmaceutical industry. Do we really have to support this business?

A growing number of researchers and health professionals think we shouldn't. See The International Network of Cholesterol Skeptics. See particularly this article by Uffe Ravnskov: The Benefits of High Cholesterol
People with high cholesterol live the longest. This statement seems so incredible that it takes a long time to clear one´s brainwashed mind to fully understand its importance. Yet the fact that people with high cholesterol live the longest emerges clearly from many scientific papers.

Another recent article: THE HIDDEN ORIGIN OF STATIN DRUGS

Cresting the Wave

Health Sciences Institute e-Alert

October 15, 2003

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Less than a month ago, international drug giant AstraZeneca (AZ) launched a new cholesterol-lowering statin drug called Crestor. AZ reps claim their Crestor is less expensive and more effective than Lipitor (made by Pfizer), the drug that dominates the statin market, grossing about $8 billion per
year.

But in light of a recent study that reveals conclusions about LDL levels and arterial plaque that would shock the mainstream, these are hard times for any statin drug manufacturer.

I'm just kidding, of course. Not about the study. That's real. But the study received almost no mainstream media coverage whatsoever. By all appearances, the astronomical profits of Lipitor and its new competitor, Crestor, are quite safe.

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Voice in the crowd
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In what should have been terrible news for any statin drug manufacturer, a recent study reported in the American Journal of Cardiology casts serious doubts on the commonly held mainstream belief that lowering your LDL cholesterol is the most effective way to reduce arterial plaque.

Researchers at Beth Israel Medical Center (BIMC) in New York City examined the coronary plaque buildup in 182 subjects who took to lower cholesterol levels. One group of subjects used the drug aggressively (more than 80 mg per day), while the balance of the subjects took less than 80 mg per day. Using electron beam tomography, the researchers measured plaque in all of the subjects before and after a study period of more than one year.

The subjects were generally successful in lowering their cholesterol, but in the end there was no statistical difference in the two groups in the progression of arterial calcified plaque. On average, subjects in both groups showed a 9.2 percent INCREASE in plaque buildup. The BIMC concluded that the LDL cholesterol mantra that "lower is better" could not be supported by their findings.

Now, did you hear this news shouted from the rooftops? Of course not. Did you hear it at all before today? Reuters Health covered it, but not one major news outlet picked it up. And while further research is called for to corroborate the results, this was a significant trial that flies in the face of the cholesterol message we're bombarded with daily in commercials and mainstream commentary.

It's as if the little boy who cried out, "The emperor has no clothes!" made his observation during rush hour in Times Square. What's that, kid? Cholesterol what? Sorry, can't hear you. Gotta run.

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Not one, but two...
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The BIMC study is far from the last word on the cholesterol issue. But it's not the first time research has concluded that LDL cholesterol is not quite the terrible killer that drug ads and cereal commercials tell us to fear.

Last year the Journal of the American Medical Association published a study that used data from more than 10,000 participants in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial; better known as ALLHAT. Following the subjects over a period of four years, researchers compared the use of a statin drug to "usual care" (maintaining proper body weight, no smoking, regular exercise, etc.) in treating subjects with moderately high levels of LDL cholesterol.

Of the 5170 subjects in the group that received , 28% lowered their LDL cholesterol significantly. And of the 5185 usual-care subjects, about 11% had a similar drop in LDL. More importantly, however, both groups showed the same rates of death, heart attack and heart disease.

So the statin group lowered its LDL more than twice as effectively as the usual-care group, but didn't experience any fewer heart attacks than the usual-care group; not exactly a ringing endorsement for risking the side effects of .

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The right track
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One report I read estimates that AstraZeneca is planning to spend as much as $1 billion to promote Crestor in the U.S this year. With drug companies willing to devote that kind of money to convince us that cholesterol should be our number one health fear, I'm afraid it's going to be a long time before the general public gets the message that lowering LDL cholesterol is not the urgent end-all and be-all of heart health.

Next week I'll take a closer look at the fascinating marketing battle that's already underway between AstraZeneca's Crestor and Pfizer's Lipitor. In the meantime, we'll continue to focus on this reality: Reducing homocysteine, triglyceride, and C-reactive protein levels is much more important to heart health than worrying about your cholesterol. And the best way to reduce all of those levels is to exercise, maintain a proper body weight, don't smoke, limit alcohol consumption, increase your intake of omega-3 fatty acids, cut out the junk foods in favor of the soluble fiber in fruits and vegetables, and take supplements that are known to protect the heart.

Easy as popping a pill? No. Effective? Yes. And worlds safer than prescription drugs.

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To start receiving your own copy of the HSI e-Alert, go here

Related articles:

The Cholesterol Myths - by Uffe Ravnskov, MD, PhD

Forget cholesterol

Fat and cholesterol - a nutty myth

The disease racket

Ban Trans Fats - The campaign to ban partially hydrogenated oils

Here is an update of 20 October - courtesy of Jenny Thompson, Health Sciences Institute

Crashing the Market

Health Sciences Institute e-Alert

October 20, 2003

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Dear Reader,

Most of us can't help it. When we see a car wreck on the highway, we slow down to catch a glimpse. That's the feeling I had while reading about two drug giants colliding in the marketplace. And it's shaping up to be quite a car wreck. So we're going to slow down a bit to take a look.

In last week's "Cresting the Wave" (10/15/03) I told you about the launch of a new cholesterol-lowering statin drug called Crestor, manufactured by AstraZeneca (AZ), the fifth largest drug company in the world. AZ reps have made no secret of their hopes that Crestor will effectively rival Pfizer's Lipitor, the long-time statin king with annual sales of about $8 billion. Excuse me for saying it, but that takes some brass.

Brass bumpers, that is. Because when you gun your car through that kind of heavy traffic, you're bound to get banged around by the FDA approval process and insurance companies, while charting a high-speed collision course with the big Hummer: Lipitor.

Quick - someone call 911!

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How fast was I going, officer?
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AstraZeneca's pitch for Crestor is that it's less expensive and more effective than Lipitor, with similar side effects. And the new drug is already selling like hotcakes in the U.K., Canada, and several other countries where it's been available since last February.

Meanwhile, here in the U.S., the FDA pulled Crestor over for doing 80 in a 40.

In the original clinical trials presented to the FDA, some of the subjects who took 80 mg developed kidney damage. (Not really all that shocking given that, as a class of drugs, statins have always been associated with kidney toxicity.) So the folks at the FDA said, "Try again," and AZ resubmitted Crestor at doses of 40 mg or less. The FDA gave the green light, and Crestor was introduced in the U.S in September.

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Stuck in traffic
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Within just a couple of weeks of Crestor's U.S. launch, AstraZeneca announced that the new drug had already captured more than 2 percent of the new prescriptions written for in the U.S. These impressive stats were released at a high-profile meeting with investors at AZ's U.S. headquarters in Fairfax, VA. But the party was spoiled when, that very same day, Wellpoint (the second largest private health insurer in the U.S.) announced that prescriptions for Crestor would not be covered because of concerns over the safety of the drug.

This was a blow. It meant that more than 13 million Americans in the Wellpoint system would have to pay for Crestor out of pocket. But perhaps even worse than that, when reps forWellpoint made the announce