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The Bad Science That Created the Cholesterol Con

By Maggie Mahar, Health Beat. Posted March 3, 2008.


The war against cholesterol has become a profitable cottage industry. But the science behind it has more than a few gaps. (Part two in a series)

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The widespread belief that "bad Cholesterol" ( LDL cholesterol) is a major factor driving heart disease -- and that cholesterol-lowering drugs like Lipitor and Crestor can protect us against fatal heart attacks -- is turning out to be a theory filled with holes. These drugs, which are called "statins," are the most widely-prescribed pills in the history of human medicine. In 2007 world-wide sales totaled $33 billion. They are particularly popular in the U.S., where 18 million Americans take them.

We thought we knew how they worked. But last month, when Merck/Schering Plough finally released the dismal results of a clinical trial of Zetia, a cholesterol-lowering drug prescribed to about 1 million people, the medical world was stunned. Dr. Steven E. Nissen, chairman of cardiology at the Cleveland Clinic called the findings "shocking." It turns out that while Zetia does lower cholesterol levels, the study failed to show any measurable medical benefit. This announcement caused both doctors and the mainstream media to take a second look at the received wisdom that "bad cholesterol" plays a major role in causing cardiac disease. A Business Week cover story asked the forbidden question, "Do Cholesterol Drugs Do Any Good?"

The answer, says Dr. Jon Abramson, a clinical instructor at Harvard Medical School, and the author of Overdosed America, is that "statins show a clear benefit for one group -- people under 65 who have already had a heart attack or who have diabetes. But," says Abramson, "there are no studies to show that these drugs will protect older patients over 65 -- or younger patients who are not already suffering from diabetes or established heart disease from having a fatal heart attack. Nevertheless, 8 or 9 million patients who fall into this category continue to take the drugs, which means that they are exposed to the risks that come with taking statins -- which can include severe muscle pain, memory loss, and sexual dysfunction."

Finally -- and here is the stunner -- it turns out we don't have any clear evidence that statins help the first group by lowering cholesterol levels. It's true that they do lower cholesterol, but many researchers are no longer convinced that this is what helps patients avoid a second heart attack. It now seems likely that they work by reducing inflammation. In other words, these very expensive drugs seem to do the same thing that aspirin does. (Are they more effective than the humble aspirin? We'll need head-to-head studies to find out.)

In the past, some physicians have questioned the connection between high cholesterol and heart disease. After all, as Dr. Ronald M. Krauss, director of atherosclerosis research at the Oakland Research Institute, told Business Week, "When you look at patients with heart disease, their cholesterol levels are not that [much] higher than those without heart disease ... Compare countries, for example. Spaniards have LDL levels similar to Americans, but less than half the rate of heart disease. The Swiss have even higher cholesterol levels, but their rates of heart disease are also lower. Australian aborigines have low cholesterol but high rates of heart disease."

Why then, were we all so certain that LDL cholesterol led to fatal heart attacks? The truth is that we were not "all" so sure. Within the medical profession, there have always been skeptics -- particularly in the U.K. But in the U.S., the Popes of cardiology, the American Heart Association and the College of Cardiologist each put their imprimatur on the cholesterol story, insisting on its truth, until finally, it became dogma.

As science writer Gary Taubes pointed out in a recent New York Times Op-ed: "The idea that cholesterol plays a key role in heart disease is so tightly woven into modern medical thinking that it is no longer considered open to question." Taubes, whose work has appeared in The Best American Science Writing, Science, and the New York Times Magazine, explains that "because medical authorities have always approached the cholesterol hypothesis as a public health issue, rather than as a scientific one, we're repeatedly reminded that it shouldn't be questioned. Heart attacks kill hundreds of thousands of Americans every year, statin therapy can save lives, and skepticism might be perceived as a reason to delay action. So let's just trust our assumptions, get people to change their diets and put high-risk people on statins and other cholesterol-lowering drugs."


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Maggie Mahar is a fellow at The Century Foundation and the author of Money-Driven Medicine: The Real Reason Health Care Costs So Much (Harper/Collins 2006).

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View:
Yes, some doctors have been questioning drug "solutions" for decades...
Posted by: jparsons on Mar 3, 2008 8:33 PM   
Current rating: 5    [1 = poor; 5 = excellent]
Yes, it's my favorite again, Dr McDougall!

Intensive therapy

Sadly, of course, there are 2 problems.

1) Most doctors think most patients will only
follow a magic pill regimen, not a lifestyle
change, so they don't mention the lifestyle
change (assuming they know about it or support
it)

2) In many cases, they are right about their patients

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» In addition Posted by: jparsons
» RE: In addition Posted by: JERSEYDAN
One of thousands of examples
Posted by: talkville on Mar 6, 2008 3:53 AM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
I recall reading somewhere that when A. Einstein was posed a question about science, he responded to the effect that a great scientists seeks after the truth and refuses to make rotten compromises.

It would be well, especially here in the USA, to bear such things in mind when one media outlet or another leads off stories with "Scientists say...." or "Scientists find...." or "Studies reveal...."

Of all countries, we are un-surpassed in "rotten compromises" made (and not only willingly) in the name of Science and Research for Profit. There are Interests and there is Power. It's up to each of us to question with care what are more often than not mere assertions dressed in white coats and technological paraphernalia as opposed to dark cloaks and hoods and the aroma of incense.

No one can say that scientific endeavors are entirely devoid or immune to the fascinations of metaphysics, magic or religion. Any pharmaceutical advertisement would bear this out.

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How can Maggie be a Fellow?
Posted by: douglashoyt on Mar 6, 2008 5:16 AM   
Current rating: 5    [1 = poor; 5 = excellent]
What is the feminine of fellow? Fellowette?

I like her article, however. She writes very well and has reasonably raised questions about the use of those statin drugs.

I am going to stop taking mine on the strength of this article.

Before my bi pass surgery, my undrugged cholesterol level was lower than the bottom end of the recommendation. I got plenty of exercise, I don't smoke; I drink moderately, wine and beer mostly. I have a stress free life, too.

The doctors found no risk factors in my life. My doctors said the CHD was genetic.

This is my story.

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» RE: How can Maggie be a Fellow? Posted by: JERSEYDAN
Severe muscle weakness,pain and memory loss
Posted by: blondesprite on Mar 6, 2008 6:36 AM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
these are very serious side effects of these drugs that need a great deal more scrutiy.
My husband no longer takes Plavix or aspirin. He experienced gastrointestional bleeding, as a result of taking these drugs, prescibed by his physicians, which nearly killed him. Hello, the colon and the heart are muscles!
Memory loss, too, is no laughing matter. My mother-in-law, 80, is still being prescribed these drugs. Very recently, she made a very serious financial blunder which was largely due to her loss of memory. She has never done anything like this, was rather shocked by it and is now very depressed over it.

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Doug,others, check out "Russell Blaylock" great newsletter
Posted by: plantland on Mar 6, 2008 7:02 AM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
Blaylock also writes about about the cholesterol myth, and more importantly, what steps to take to protect your heart.

A subscription to his newsletter will also give you access to his thoughtful and well researched archives.

He wrote a book about excitotoxins, common food additives which affect children's ability to concentrate.

Alternet readers will be put off by his conservative political views ( he is from Mississippi.) On the other hand, I am waorried aabout being forced to buy helath insurance for myself- prefer spenhd on vitamins, organic food, fluoride free water, a gym membership, and health letters- none of which I could afford if forced to buy insurance and support big Pharma. I am starting to worry about what a fixation on universal health INSURANCE will do to our ability to protect our own HEALTH.

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SAFETY FIRST- THEN EFFICACY
Posted by: drricklippin on Mar 6, 2008 8:23 AM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
This statin story-told well by journalist Maggie Mahar- comes after a series of questions about the safety of many commonly and widely used over-the-counter and prescribed meds.

WE NEED A MASSIVE PUBLIC EDUCATION CAMPAIGN ABOUT THE FAILURE OF THE GREEDY PHARMACEUTICAL INDUSTRY TO NOT INFORM US ADEQUATELY ABOUT THE DANGER OF DRUGS FIRST.

This is all worsened of course by the efficacy issues(do drugs work?)

THE US FDA HAS FAILED US! BIG TIME!

For more about the dangers of statins Dr. Jay Cohen has a great e-newsletter and Dr. Cohen has also written a book

Dr. Rick Lippin
Southampton,Pa

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Many people die of heart attacks
Posted by: Ignatz deFyre on Mar 6, 2008 8:54 AM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
because they eat the processed crap manufactured by BigFood. Then, BigPharma sells them pills to deal with the problems thus created.

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I think God every day
Posted by: g50 on Mar 6, 2008 10:02 AM   
Current rating: 5    [1 = poor; 5 = excellent]
That my mother is a dietary nutritionist. I learned that eating is so ridiculously simple and is a huge component of a healthy lifestyle. Vegetables, fruit; nuts, dairy. She eats meat but that is justifiable and probably was healthy growing up, fish & eggs now. Things that are actual foods grown or killed and then you cook them according to ancient cooking techniques. Junk food & processed food are energy of last resort. Wine & beer is healthy in moderation and even adds unique benefits. Eat a diverse diet. You don't always need to cook your vegetables, some are really good raw. Combine simple eating practices with exercise, and you can ever do bad things like smoke but still maintain good health.

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» RE: bad things like smoke Posted by: Urstrly
Important question not answered
Posted by: partisan on Mar 6, 2008 11:07 AM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
An important question not answered here is: If cholesterol blocks arteries and blocked arteries prohibit adequate blood flow that can result in heart failure, then how is cholesterol not the serious problem the anti-cholesterol lobby claims?

BLOCKED ARTERIES:
Ten years ago I was an athletic, bike-riding, wild-water swimming, backpacking man in my sixties. Then within a few months I begin feeling exhausted, out of breath, and my GP sent me to a leading cardiologist in a major cardiology clinic who, after the usual tests, set me up for an angiogram. I looked at the screen at what appeared to be almost entirely blocked arteries and asked the doc: "I don't see how blood can get through those arteries." The doc murmured, "Neither do I. Hold on, I'm calling another doctor."

I twisted my head around to see a cardio surgeon enter, look at the angiogram screen, and exclaim, "Oh, my god!" They wheeled me into the hospital and I had a five-way bypass in the morning.

LIPITOR "THERAPY":
I didn't want a repeat with blocked arteries and thereafter dutifully took a daily dose of Lipitor. All was fine for three years or so, or so I thought. I did have a bit of strange muscle pains, but I just thought that was due to the effect swimming and other vigorous exercise was having on my not-so-young body.

MASSIVE MEMORY LOSS:
Then one day in a phone call my oldest son mentioned an outing his family and I had been to the year before. I insisted it never happened. He insisted it did happen and sent pictures to prove it.

I was shocked and confused. I couldn't remember the outing. A few days later I thought of my son's mom, an ex-wife, and realized I COULDN'T REMEMBER THE NAME OF THE WOMAN I WAS MARRIED TO FOR TWENTY YEARS! I couldn't remember much of my life. I was convinced I had Alzheimer's.

Then one day the lovely young thing that has been my domestic partner for the past decade brought in an article on Lipitor and memory loss. I immediately stopped taking Lipitor. My memory improved within a few weeks and within two or three months, I was amazing others and myself with my recall. I was lucky: others in that article didn't get their memories back.

ANSWER PLEASE:
I'd rather die from a heart attack than lose my mind from statins. Still, somebody answer the question: if cholesterol blocks arteries and that causes heart failure, why isn't cholesterol a problem???

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Great article! And to take it one step further...
Posted by: tigrita on Mar 6, 2008 11:53 AM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
I am a student of clinical nutrition and herbalism at the North American Institute of Medical Herbalism, and this article is definitely in alignment with what I’ve been learning. But I would take it one step further. I would love to see a follow-up article examining the relationship between the dramatic increase in sugar consumption in the U.S. over the last century and the widespread systemic inflammation that is possibly the most significant cause of the severe rise in coronary heart disease we are seeing. In the late 1800’s, the average annual sugar consumption of Americans was about 5 pounds per person. Now it is closer to 135 pounds per person, possibly much higher! The economics of the sugar industry are complex, deep rooted and widespread, and my guess is that any research suggesting a significant connection between sugar consumption and disease is somewhat suppressed and certainly not easily disseminated to the general public. All the more reason to believe there is a real story to be told here…

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Aspirin and Statin Drugs
Posted by: wmholt on Mar 6, 2008 12:07 PM   
Current rating: 3    [1 = poor; 5 = excellent]
As a physician, it is alarming to see so many myths and misused facts about a complex subject. However, I will focus on one of your statements:

"It now seems likely that they work by reducing inflammation. In other words, these very expensive drugs seem to do the same thing that aspirin does. (Are they more effective than the humble aspirin? We'll need head-to-head studies to find out.)"

Aspirin helps, not as an anti-inflammatory, but as an anti-platelet drug. Aspirin renders the platelets less "sticky", so they tend to form clots less easily.

I understand that you wrote your book about expensive medicine. I work for a free clinic and agree with much of your premise.

However, why don't you get a knowledgeable physician to fact-check your articles before you post them. You really don't know enough to do this on your own.

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» RE: Aspirin and Statin Drugs Posted by: JERSEYDAN
» RE: Aspirin and Statin Drugs Posted by: maggiem
rsmohio
Posted by: rsmohio on Mar 6, 2008 4:30 PM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
A great book that talks about this issue and many others in undertandable language is "In Defense of Food" by Michael Pollan. It not only hits upon this issue but also upon the industry that seems to emphasize additives in food. Many items in it are a revelation. Also, there are some recommendations on how to get away from food created by nutritionists and scientists and get back to real food created by nature.

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Clogged arteries kill and is neglected subject here
Posted by: partisan on Mar 6, 2008 5:58 PM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
Maggie Mahar and various commentators here keep referring to inflammation causing heart "disease" which may lead to heart attack or heart failure.

Could be, but what does that have to do with the claim by statin producers that statins reduce clogging? No one here, including Maggie Mahar, has addressed clogging, which is what statins are supposed to prevent.

Inflammation may lead to a heart attack, even heart failure, but statins aren't sold for reducing inflammation, they are sold to lower cholesterol that may cause plaque that may clog arteries.

Pfizer, for example, doesn't claim Lipitor has any effect on inflammation, they do claim: "LDL can sometimes build up in your arteries. This buildup can slow or clog the flow of blood. This can put you at risk for heart disease."

Heart attack caused by inflammation is one subject, heart failure caused by insufficient blood flowing through the heart due to blocked arteries is a different subject, and the one that statins have been claimed to be effective in preventing.

If enough blood can't get into the heart because the arteries are clogged, the heart will fail: it doesn't need inflammation to trigger failure.

If lowering cholesterol doesn't "show any measurable medical benefit" as the study referred to in the article claims, then cholesterol must not cause arteries to clog, because preventing this clogging of the arteries to the heart will indeed have a "major medical benefit": preventing death.

Clogged arteries can kill and that subject's connection to statins is a neglected subject here.

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» LIFE kills... Posted by: undrgrndgirl
Actually, there's good evidence that treating with statin drugs.....
Posted by: mjabele on Mar 6, 2008 7:30 PM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
.....DOES lead to reduced incidence of heart disease, but for some reason the author of the article didn't want to bring up these studies. One has to wonder why.

In point of fact, the West of Scotland study (1995) DID find a significant decrease in the incidence of "primary" (i.e., "first-time") fatal / non-fatal heart attacks in a large group of middle-aged men with elevated cholesterol levels who were treated with a statin drug (pravastatin) compared with a comparator group who were not.

Of note, this study encompassed about 6,500 patients, as compared with the recent Enhance Trial quoted by the author, which dealt with only about 750 patients and which was NOT, in fact, designed to determine whether there was any difference in CLINICAL outcomes - i.e., rates of heart disease - between the two groups.

Indeed, the ACTUAL purpose of the Enhance Trial was to compare two relatively small groups of patients (each about 360 patients) suffering from a relatively rare genetic condition causing VERY high blood cholesterol levels (i.e., familial heterozygous hypercholesterolemia, which has a population-wide prevalence of about 1 in 500 individuals), BOTH of which were being actively treated with cholesterol medication, with regard to a RADIOLOGIC rather than clinical outcome - i.e., atherosclerotic plaque build-up in the carotid arteries of the neck. To put it more simply, 1) the primary endpoint of the study was not heart disease rates, but an "X-ray result", 2) the number of patients studied was much smaller than the WOS or ASCOT trials which had previously looked at actual heart disease rates, and 3) there was in fact no "un-treated" group here that would enable one to conclude that statins don't in fact have an effect on the incidence of heart disease - one of the two groups was receiving simvastatin, and the other group was receiving simvastatin + Zetia (Zetia being a non-statin drug).

What the manufacturers of Zetia were presumably hoping was that the Enhance Trial would show that their drug, when added to a statin, would slow down the development of atherosclerotic plaque in the carotid arteries even more so than just treating with a statin alone. This didn't prove to be the case - there turned out to be no significant difference in the progression of plaque between the two groups.

More surprisingly perhaps, there was no significant difference in the incidence of heart disease between the two groups, even though the "simvastatin + Zetia" group ended up with lower LDL levels than the "simvastatin alone" group. The caveat here, of course, is that this was a small and relatively short study, with relatively few patients, meaning that clinical outcomes couldn't really be assessed with any significant degree of statistical accuracy. Nevertheless, this observation was (correctly, I think) felt to be intriguing and potentially worthy of further study, suggesting as it does that lowering LDL cholesterol may not, in all circumstances, correlate with lower risk of heart disease.

Given the way it was designed, the one thing the Enhance Trial clearly DIDN'T show was that statins are somehow "ineffective" in terms of preventing heart disease. Indeed, it might be better to say that the study COULDN'T (and wasn't even intended to try to) show this, given that there was no "control" group in the study that WASN'T being treated with a statin. On the other hand, the study did raise the possibility that lowering LDL cholesterol may not, in fact, be the only or even principal way that statin drugs work - i.e., suggesting there may be some merit to the "anti-inflammatory" hypothesis mentioned by the author, which has in fact been in medical circulation for some time.

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» My perspective..... Posted by: mjabele
The Author's Point
Posted by: gellero on Mar 7, 2008 2:57 AM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
"I feel it was dishonest of the author to have ignored well-known trials done in the past that were much larger and much better designed to answer this far more important question of clinical efficacy, versus the narrower (albeit interesting) issue of "mechanism of action". "

Your comments, Mjelble, above were brilliant and say more about the lay authors of AlterNet articles.

They are unqualified to evaluate scientific data, and manipulate 'facts' to make a point, usually political in nature.

The sad part is, I think they do this unconsciously, and truly believe their own BS.

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The Statin Controversy -- Effective For Some
Posted by: maggiem on Mar 7, 2008 9:09 AM   
Current rating: Not yet rated    [1 = poor; 5 = excellent]
Thanks for your many comments.

Just two points:

First, if you actually read the entire article (and Part I, also reprinted on Alternet and available on my blog www.healthbeatblog.org)
you would know that I am not saying that statins are ineffective.

I am saying that statins are effective for some people--in particular those who are under 65 and have already had a heart attack or diabetes. Statins seem to prevent a second attack. But this group represents only about half of the Americans taking statins today.

Secondly, Dr. John Abramson, of Harvard, who specializes in statins and heart disease did read and fact-check this article before I first posted it on my blog. Everything in it reflects the most up-to-date research.

As to cholesterol clogging arteries, all we know is that there are some cultures with very high levels of bad cholesterol and very low levels of heart disease--and cultures with low levels of cholesterol and high levels of heart disease. It just isn't as simple as cholesterol clogging equals heart attacks.

You'll note that I quote one specialist saying that bad cholesterol seems to create the preconditions for heart attack, but something else has to happen to triggger it. We dont' know what that something else is.

Finally, in some cases the risks of statins clealy outweighs the benefits.

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» You seem to be saying... Posted by: mjabele