FDA Approves Dangerous and Worthless Cholesterol Drug - Brownstein

FDA Approves Dangerous and Worthless Cholesterol Drug

by Dr. David Brownstein

On May 3, 2013, the FDA approved a Big Pharma Cartel founding member Merck drug Liptruzet.  Liptruzet is a combination drug of Zetia and Lipitor.  I wrote to you about the failure of Zetia in three separate blog posts.  They can all be found by clicking here:  http://blog.drbrownstein.com/?s=zetia.
Zetia is a failed drug.  It should never be prescribed and should have been pulled from the market years ago.  There is no excuse for any doctor prescribing Zetia for any condition.  Zetia works by blocking cholesterol absorption in the gut.  Conventional doctors believe that drug therapies that lower cholesterol levels reduce the risk of heart disease.  However, Zetia, which has been around for over 10 years, has never been shown to lower the risk of developing a heart attack or stroke.  Furthermore, Zetia has never been shown to prolong life.

Why the FDA would approve this combination of Zetia and Lipitor is beyond belief.  The previous combination of Zetia and Zocor, known as Vytorin, was proven to be a colossal failure in multiple studies—see my previous blog posts.

FDA’s action is a perfect example of why we spend more money on health care than any other people on the planet.  Liptruzet will cost $5.50 per pill.  This means a patient prescribed Liptruzet will spend over $2,000.00 per year on a worthless drug that will be associated with side effects such as muscle aches and pains, memory loss, and neurological disorders.  We take too many ineffective drugs that are too expensive.  Do all of these drugs translate into better healthcare outcomes?  Heck no.  As compared to every other wealthy Western country, we finish last or near the bottom on every single health indicator.  In Liptruzet’s case, there is no justifiable reason for the FDA to approve it.  This is another example, amongst many, of why the FDA should be disbanded.  The FDA gives false credibility to Big Pharma.

If you are on Zetia, I suggest talking to your doctor about stopping it.  Ask him/her for any studies showing a clinical benefit such as a significantly lowered risk for heart disease, heart attack, stroke, or increased longevity.  I can assure you that you won’t be getting any articles from your doctor since they don’t exist.   More information about cholesterol-lowering medications can be found in my book, Drugs That Don’t Work and Natural Therapies That Do. 
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Merck Uses Legal Threats To Stifle Negative Advice About Zetia And Vytorin

Merck Uses Legal Threats To Stifle Negative Advice About Zetia And Vytorin In Italy

   

 

In response to repeated legal threats, a public health doctor in Italy has withdrawn advice to curtail use of a controversial drug. The drug, ezetimibe, is a key ingredient in Zetia and Vytorin, which is manufactured by Merck Merck. The cholesterol-lowering drug has been the subject of fierce controversy because it has never been shown to improve clinical outcomes. Despite the controversy, in 2013 the drugs had combined sales of more than $2.6 billion.
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Fish oil, sterol absorption, and Zetia - Blanchet

Dr. Blanchet podcast on fish oil and sterol absorption re heart disease.

http://tuesdaytalkshow.podomatic.com/entry/2013-10-08T10_41_51-07_00


Questions -
     Are you a hyper absorber of plant sterols?
     What is optimal range of EPA/DHA intake?
     What about Zetia?

Licence for another unproven cholesterol drug - Briffa

The FDA grants licence for another unproven cholesterol drug

By Dr John Briffa on 8 May 2013

 

Ezetimibe is a drug that lowers cholesterol levels by blocking its absorption from the gut. The drug is available under the brand name Zetia. Doctors can also prescribe ezetimibe in combination with the statin drug simvastatin. This combination medication is sold under the name Vytorin. Both Zetia and Vytorin have racked up billions of dollars in sales. What a shame, then, that neither of them has been found to have any benefit at all in terms of reducing the risk of heart disease, heart attacks, strokes or risk of death.

Zetia and Vytorin are licenced on the basis of their impact on cholesterol levels. The thinking is that LDL-cholesterol must be bad, so anything that reduces it must be good. However, we know from experience that many things that ‘improve’ cholesterol do not bring broad benefits to health. And besides, it’s simply not good science or medicine to assume that a drug has benefits for health based on its impact on what is known as a ‘surrogate marker’ such as cholesterol. I mean, if arsenic reduced cholesterol it still would not make sense for us to swig back arsenic each day, would it?

This seems like perhaps an extreme analogy, but it should be borne in mind, I think, the Vytorin use has in some studies been associated with an increase (not statistically significant) in the thickening of the arteries compared to simvastatin alone. Also, there was some early evidence the Vytorin increased the risk of death from cancer, though some more recent evidence is said to have allayed fears here.

While some doctors continue to prescribe Zetia and Vytorin it’s difficult (for me) to justify this. There is some evidence that since 2008 (when we saw the first of a few negative studies on Zetia/Vytorin emerge) sales of these drugs have fallen considerably, though profit remains considerable. Make no mistake, though, the fact that Zeta/Vytorin is still on the market and was licensed in the first place is seen by some doctors and researchers as testament to the ability of drug companies to bamboozle regulatory authorities such as the Food and Drugs Administration (FDA) in the US. Either that, or the FDA is perhaps putting the needs of drug companies above those of patients.

Against this background, it is interesting to note that Merck (manufacturer of Vytorin) has been for some years attempting to get another similar drug combination passed by the FDA. The drug combines ezetimibe with the statin atorvastatin and has the brand name Liptruzet. As with Vytorin, there exists no evidence that Liptruzet benefits so-called ‘clinical’ outcomes such as incidence of heart disease and stroke.

Now, given all the controversy around Vytorin and the lack of evidence for the benefit of this product, you might imagine the FDA would be keen not to repeat its mistake by granting Liptruzet a licence. Astonishingly, though, the FDA did just this last week.

Now, normally, when a new drug hits the market the press reports parrot the drug company rhetoric about, say, the benefits of the drug and the lives it could save. What is interesting about the press reports on the licensing of Liptruzet is how many of them report scepticism regarding the wisdom of this decision expressed by doctors and researchers. See here for an example.

The piece quotes Steven Nissen, chairman of cardiology at the Cleveland Clinic in the US. According to Dr Nissen, the FDA’s decision to approve the Liptruzet “just doesn’t make any sense.” He is quoted as saying:

I find it astonishing that after all the controversy about ezetimibe the FDA would approve another combination product with a drug that has been on the market for a decade and has not been shown to improve cardiovascular outcomes. It seems like the agency is just tone deaf to the concerns raised by many members of the community about approving drugs with surrogate endpoints like cholesterol without evidence of a benefit for the disease we are truly trying to treat – cardiovascular disease.

And what does Merck have to say for itself? According to spokeswoman Pamela Eisele, Merck is “confident in ezetimibe and in the established relationship between lowering LDL cholesterol and reducing cardiovascular events.”

Merck can be confident all it likes in ezetimibe and its products Zetia, Vytorin and Liptruzet, but the fact is, none of these have been shown to lower ‘cardiovascular events’. My personal opinion is that either Merck is full of idiots or is taking us for idiots. The good news is that the sort of rhetoric spouted by Merck is immediately being recognised by some as having a distinct whiff of b.s. about it.
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Reaqd complete article here.

Why Women Should Stop Their Cholesterol Lowering Medication - Hyman

Why Women Should Stop Their Cholesterol Lowering Medication

by Dr Mark Hyman   January 19th, 2012

If you are a post-menopausal women with high cholesterol, your doctor will almost certainly recommend cholesterol lowering medication or statins. And it just might kill you. A new study in the Archives of Internal Medicine found that statins increase the risk of getting diabetes by 71 percent in post-menopausal women.

Since diabetes is a major cause of heart disease, this study calls into question current recommendations and guidelines from most professional medical associations and physicians. The recommendation for women to take statins to prevent heart attacks (called primary prevention) may do more harm than good.

Statins have been proven to prevent second heart attacks, but not first heart attacks.

Take it if you already have had one, but beware if your doctor recommends it for you if have never had a heart attack.

This current study adds to an increasing body of literature questioning the benefits of statins, while highlighting their potential risks.

New Study Shows 48 Percent Risk of Diabetes in Women Who Take Statins

This study examined the data from the large government sponsored study called the Women’s Health Initiative, the same study that disabused us of the idea that Premarin prevented heart attacks in postmenopausal women.

In fact, based on this randomized controlled trial, estrogen replacement therapy, once considered the gold standard of medical care for the prevention of heart disease, was relegated to the trash bin of history joining medicine’s many other fallen heroes including DES, Thalidomide, Vioxx, Avandia, and more.

In this new study researchers reviewed the effect of statin prescriptions in a group of 153,840 women without diabetes and with an average age of 63.2 years. About 7 percent of women reported taking statin medication between 1993 and 1996. Today there are many, many more women taking statin medications, thus many more are at risk from harm from statins.

During the 3-year period of the study, 10,242 new cases were reported – a whopping 71 percent increase in risk from women who didn’t take statins. This association stayed strong at a 48 percent increased risk of getting diabetes, even after taking into account age, race/ethnicity, and weight or body mass index. These increases in disease risk were consistent for all statins on the market.
This effect also occurred in those with and without heart disease. Surprisingly disease risk was worse in thin women. Minority women were also disproportionately affected. The risk of diabetes was 49 percent for white women, 57 percent for Hispanic women, and 78 percent for Asian women.
But in a typical “my mind’s made up, don’t confuse me with the facts” statement by the medical establishment, the researchers said we should not change our guidelines for statin use for the primary prevention of heart disease.

In a large meta-analysis published in the Lancet last year, scientists found that statins increased the risk of diabetes by 9 percent. If current guidelines were followed for those who should take statins, and people actually took them (thank God only 50 percent of prescriptions are ever filled by patients), there would be 3 million more diabetics in America. Oops.

Other studies have recently called into question the belief that high cholesterol levels increase your risk of heart disease as you get older. For those over 85 it turns out having high cholesterol will protect you from dying from a heart attack, and, in fact, from death from any cause.

Low Cholesterol May Kill You

A recent study showed that in healthy older persons, high cholesterol levels were associated with lower non-cardiovascular-related mortality. This is extremely concerning because millions of prescriptions are written every day to lower cholesterol in the older population, yet no association has been found between higher cholesterol and heart disease deaths for those aged 55 to 84; and for those over 85, the association seems to be inverse — higher cholesterol predicts lower risk of death from heart disease.

The pharmaceutical industry, medical associations, and academic researchers whose budgets are provided by grants from the pharmaceutical industry continue to preach the wonders of statins, but studies like these should have us look good and hard at our current practices. Are we doing more harm than good?

Cardiologists recommend putting statins in the water and giving them out at fast food restaurants and having them available over the counter. They believe in driving cholesterol as low as possible. Statin prescriptions are handed out with religious fervor, but do they work to prevent heart attacks and death if you haven’t had a heart attack already?

Bottom line: NO! If you want to learn why this is true, read on.

Statins Don’t Work to Prevent First Heart Attacks

Recently, the Cochrane Group did a review of all the major statin studies by an international group of independent scientists. The review failed to show benefit in using statins to prevent heart attacks and death. In addition, many other studies support this and point out the frequent and significant side effects that come with taking these drugs. (i) If scientists found that drinking two glasses of water in the morning prevented heart attacks, even if the evidence was weak, we would jump on board. Big up side, no down side.

But this is not the case with statins. These drugs frequently cause muscle damage, muscle cramps, muscle weakness, muscle aches, exercise intolerance (ii) (even in the absence of pain and elevated CPK – a muscle enzyme), sexual dysfunction, liver and nerve damage and other problems in 10-15 percent of patients who take them. (iii) They can also cause significant cellular, muscle, and nerve injury as well as cell death in the ABSENCE of symptoms. (iv)

There is no lack of research calling into question the benefits of statins. Unfortunately, that research doesn’t get the benefit of billions of dollars of marketing and advertising that statins do. One big trial was touted as proving statins work to prevent heart attacks, but the devil is in the details.

It was the JUPITER (v) trial that showed that lowering LDL (or bad cholesterol) without a reduction in inflammation (measured by C-reactive protein) didn’t prevent heart attacks or death. (vi) Statins happen to reduce inflammation so the study has been touted as proof of the effectiveness of these medications.

Mind you it wasn’t lowering the cholesterol that helped (which is the intended purpose of statins), but the fact that they lower inflammation. What is ignored by people who use this study to “prove” that statins work is the fact that there are so many better ways to lower inflammation than taking these drugs.

Yet other studies have shown no proven benefit for statins in healthy women (vii) with high cholesterol or in anyone over 69 years old. (viii) Some studies even show that aggressive lowering of cholesterol can cause MORE heart disease. The ENHANCE trial showed that aggressive cholesterol treatment with two medications (Zocor and Zetia) lowered cholesterol much more than one drug alone, but led to more arterial plaque and no fewer heart attacks. (ix)

Other research calls into question our focus on LDL or the bad cholesterol. We focus on it because we have good drugs to lower it, but it may not be the real problem. The real problem is low HDL that is caused by insulin resistance (diabesity).

In fact studies show that if you lower the bad (LDL) cholesterol in people with low HDL (good cholesterol) that is a marker of diabesity – the continuum of obesity, prediabetes and diabetes – there’s no benefit. (x)

Most people simply ignore the fact that 50-75 percent of people who have heart attacks have normal cholesterol. (xi) The Honolulu Heart Study showed older patients with lower cholesterol have higher risks of death than those with higher cholesterol. (xii)

Some patients with multiple risk factors, or who have had previous heart attacks do benefit, but when you look closely the results are underwhelming. It’s all in how you spin the numbers. For high-risk males (those who are overweight and have high blood pressure, diabetes, and/or a family history of heart attacks) and are younger than 69 there is some evidence of benefit, but one hundred men would need to be treated to prevent just one heart attack.

That means that 99/100 men who take the drug receive no benefit. Drug ads say the risk is reduced by 33 percent. Sounds good, but that just means the risk of getting a heart attack goes down from 3 percent to 2 percent.

Despite the extensive data showing that statins are a questionable therapy at best, they are still the number one selling drug in the US. What isn’t so well known is that 75 percent of statin prescriptions are written for people who will receive no proven benefit. The cost of these prescriptions? Over $20 billion a year.

Yet somehow the 2004 National Cholesterol Education Program guidelines expanded the previous guidelines to recommend that even more people without heart disease take statins (from 13 million to 40 million) (xiii) What are we thinking?

Why would respected scientists go against the overwhelming research that statins don’t prevent heart disease in people who haven’t already had a heart attack?

You can find the answer if you follow the money. Eight of the nine experts on the panel who developed these guidelines had financial ties to the drug industry. Thirty-four other non-industry affiliated experts sent a petition to protest the recommendations to the National Institutes of Health saying the evidence was weak.

What Should Women Do?
It is time to push the sacred cow of statins overboard.
But first let me say this. If you have had a heart attack, or have heart disease, the evidence shows they do in fact help protect against a second heart attack, so keep taking them. However, you should be aware that most prescriptions for statins are given to healthy people whose cholesterol is a little high. For these folks the risk clearly outweighs the benefit.

The editorial that accompanies the recent study on women taking cholesterol-lowering medication that I opened this article with was quite clear. Dr. Kirsten Johansen from the University of California, San Francisco said that the increased risk of diabetes in women without heart disease has “important implications for the balance of risk and benefit of statins in the setting of primary prevention in which previous meta-analyses show no benefit on all-cause mortality.”

In plain English, she said that we shouldn’t be using statin drugs for women without heart disease because:

1. The evidence shows they don’t work to prevent heart attacks if you never had one.
2. They significantly increase the risk of diabetes.

Treating risk factors like high cholesterol is misguided. We must treat causes – what we eat, how much we exercise, how we handle stress, our social connections and environmental toxins are all more powerfully linked to creating health and preventing disease than any drug on the market.
Remember what you put at the end of your fork is more powerful than anything you will ever find at the bottom of a pill bottle.

My new book The Blood Sugar Solution, which comes out at the end of February, gives exact details on what you should put at the end of your fork to prevent and reverse diabesity. It provides a comprehensive solution to the health problems facing our nation today.

Now I’d like to hear from you …

What do you think of statins?

Have you taken statins? What has your experience been?

Why do you think the medical establishment prescribes drugs that research shows don’t work?
Please leave your thoughts by adding a comment below – but remember, we can’t offer personal medical advice online, so be sure to limit your comments to those about taking back our health!

To your good health,
Mark Hyman, MD

References:

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(i) Abramson J, Wright JM. Are lipid-lowering guidelines evidence-based? Lancet. 2007 Jan 20;369(9557):168-9

(ii) Sirvent P, Mercier J, Lacampagne A. New insights into mechanisms of statin-associated myotoxicity. Curr Opin Pharmacol. 2008 Jun;8(3):333-8.

(iii) Kuncl RW. Agents and mechanisms of toxic myopathy. Curr Opin Neurol. 2009 Oct;22(5):506-15. PubMed PMID: 19680127.

(iv) Tsivgoulis G, et. al, Presymptomatic Neuromuscular Disorders Disclosed Following Statin Treatment, Arch Intern Med. 2006;166:1519-1524

(v) Mora S, Ridker PM. Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER)–can C-reactive protein be used to target statin therapy in primary prevention? Am J Cardiol. 2006 Jan 16;97(2A):33A-41A.

(vi) Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, MacFadyen JG, Nordestgaard BG, Shepherd J, Willerson JT, Glynn RJ; JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008 Nov 20;359(21):2195-207.

(vii)Abramson J, Wright JM. Are lipid-lowering guidelines evidence-based? Lancet. 2007 Jan 20;369(9557):168-9

(viii) IBID

(ix) Brown BG, Taylor AJ Does ENHANCE Diminish Confidence in Lowering LDL or in Ezetimibe? Engl J Med 358:1504, April 3, 2008 Editorial

(x) Barter P, Gotto AM, LaRosa JC, Maroni J, Szarek M, Grundy SM, Kastelein JJ, Bittner V, Fruchart JC; Treating to New Targets Investigators. HDL cholesterol, very low levels of LDL cholesterol, and cardiovascular events. N Engl J Med. 2007 Sep 27;357(13):1301-10.

(xi) Hansson GK Inflammation, Atherosclerosis, and Coronary Artery Disease N Engl J Med 352:1685, April 21, 2005

(xii) Schatz IJ, Masaki K, Yano K, Chen R, Rodriguez BL, Curb JD. Cholesterol and all-cause mortality in elderly people from the Honolulu Heart Program: a cohort study. Lancet. 2001 Aug 4;358(9279):351-5.

(xiii) http://www.nhlbi.nih.gov/about/ncep/index.htm

About Dr Mark Hyman

MARK HYMAN, MD is dedicated to identifying and addressing the root causes of chronic illness through a groundbreaking whole-systems medicine approach called Functional Medicine. He is a family physician, a four-time New York Times bestselling author, and an international leader in his field. Through his private practice, education efforts, writing, research, and advocacy, he empowers others to stop managing symptoms and start treating the underlying causes of illness, thereby tackling our chronic-disease epidemic. More about Dr. Hyman or on Functional Medicine. Click here to view all Press and Media Releases

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Why Cholesterol May Not Be the Cause Of Heart Disease - Hyman

Why Cholesterol May Not Be the Cause Of Heart Disease

by Dr Mark Hyman

WE HAVE ALL BEEN LED TO to believe that cholesterol is bad and that lowering it is good. Because of extensive pharmaceutical marketing to both doctors and patients we think that using statin drugs is proven to work to lower the risk of heart attacks and death.

But on what scientific evidence is this based, what does that evidence really show?

Roger Williams once said something that is very applicable to how we commonly view the benefits of statins. “There are liars, damn liars, and statisticians.”

We see prominent ads on television and in medical journals — things like 36% reduction in risk of having a heart attack. But we don’t look at the fine print. What does that REALLY mean and how does it affect decisions about who should really be using these drugs.

Before I explain that, here are some thought provoking findings to ponder.

• If you lower bad cholesterol (LDL) but have a low HDL (good cholesterol) there is no benefit to statins. (i)
• If you lower bad cholesterol (LDL) but don’t reduce inflammation (marked by a test called C-reactive protein), there is no benefit to statins. (ii)
• If you are a healthy woman with high cholesterol, there is no proof that taking statins reduces your risk of heart attack or death. (iii)
• If you are a man or a woman over 69 years old with high cholesterol, there is no proof that taking statins reduces your risk of heart attack or death. (iv)
• Aggressive cholesterol treatment with two medications (Zocor and Zetia) lowered cholesterol much more than one drug alone, but led to more plaque build up in the arties and no fewer heart attacks. (v)
• 75% of people who have heart attacks have normal cholesterol
• Older patients with lower cholesterol have higher risks of death than those with higher cholesterol. (vi)
• Countries with higher average cholesterol than Americans such as the Swiss or Spanish have less heart disease.
• Recent evidence shows that it is likely statins’ ability to lower inflammation it what accounts for the benefits of statins, not their ability to lower cholesterol.

So for whom do the statin drugs work for anyway? They work for people who have already had heart attacks to prevent more heart attacks or death. And they work slightly for middle-aged men who have many risk factors for heart disease like high blood pressure, obesity, or diabetes.

So why did the 2004 National Cholesterol Education Program guidelines expand the previous guidelines to recommend that more people take statins (from 13 million to 40 million) and that people who don’t have heart disease should take them to prevent heart disease. Could it have been that 8 of the 9 experts on the panel who developed these guidelines had financial ties to the drug industry? Thirty-four other non-industry affiliated experts sent a petition to protest the recommendations to the National Institutes of Health saying the evidence was weak. It was like having a fox guard the chicken coop.

People with the lowest cholesterol as they age are in fact at highest risk of death. Under certain circumstances, higher cholesterol can actually help increase life span.

It’s all in the spin. The spin of the statistics and numbers. And it’s easy to get confused. Let me try to clear things up.

When you look under the hood of the research data you find that the touted “36% reduction” means a reduction of the number of people getting heart attacks or death from 3% to 2% (or about 30-40%).
And that data also shows that treatment only really works if you have heart disease already. In those who DON’T have documented heart disease, there is no benefit.

In those at high risk for heart disease about 50 people would need to be treated for 5 years to reduce one cardiovascular event. Just to put that in perspective: If a drug works, it has a very low NTT (number needed to treat). For example, if you have a urine infection and take an antibiotic, you will get near a 100% benefit. The number needed to treat is “1″. So if you have an NTT of 50 like statins do for preventing heart disease in 75% of the people who take them, it is basically a crap shoot.

Yet at a cost of over $28 billion a year, 75% of all statin prescriptions are for exactly this type of unproven primary prevention. Simply applying the science over 10 years would save over $200 billion. This is just one example of reimbursed but unproven care. We need not only prevent disease but also prevent the wrong type of care.

If these medications were without side effects, then you may be able to justify the risk – but they cause muscle damage, sexual dysfunction, liver and nerve damage and other problems in 10-15% of patients who take them. Certainly not a free ride.

So if lowering cholesterol is not the great panacea that we thought, how do we treat heart disease, and how do we get the right kind of cholesterol – high HDL, low LDL and low triglycerides and have cholesterol particles that are large, light and fluffy rather than small, dense and hard, which is the type that actually causes heart disease and plaque build up.

We know what causes the damaging small cholesterol particles. And it isn’t fat in the diet. It is sugar. Sugar in any form or refined carbohydrates (white food) drives the good cholesterol down, cause triglycerides to go up, creates small damaging cholesterol particles, and causes metabolic syndrome or pre-diabetes. That is the true cause of most heart attacks, NOT LDL cholesterol.

One of the reasons we don’t hear about this is because there is no good drug to raise HDL. Statin drugs lower LDL — and billions are spent advertising them, even though they are the wrong treatment.

If you’re like most of the patients I see in my practice, you’re convinced that cholesterol is the evil that causes heart disease. You may hope that if you monitor your cholesterol levels and avoid the foods that are purported to raise cholesterol, you’ll be safe from America’s number-one killer.

We are all terrified of cholesterol because for years well-meaning doctors, echoed by the media, have emphasized what they long believed is the intimate link between cholesterol and death by heart disease. If only it were so simple!

The truth is much more complex.

Cholesterol is only one factor of many — and not even the most important — that contribute to your risk of getting heart disease.

First of all, let’s take a look at what cholesterol actually is. It’s a fatty substance produced by the liver that is used to help perform thousands of bodily functions. The body uses it to help build your cell membranes, the covering of your nerve sheaths, and much of your brain. It’s a key building block for our hormone production, and without it you would not be able to maintain adequate levels of testosterone, estrogen, progesterone and cortisol.

So if you think cholesterol is the enemy, think again. Without cholesterol, you would die.

In fact, people with the lowest cholesterol as they age are at highest risk of death. Under certain circumstances, higher cholesterol can actually help to increase life span.

In reality, the biggest source of abnormal cholesterol is not fat at all — it’s sugar. The sugar you consume converts to fat in your body. And the worst culprit of all is high fructose corn syrup.

To help clear the confusion, I will review many of the cholesterol myths our culture labors under and explain what the real factors are that lead to cardiovascular disease.

Cholesterol Myths
One of the biggest cholesterol myths out there has to do with dietary fat. Although most of us have been taught that a high-fat diet causes cholesterol problems, this isn’t entirely true. Here’s why: The type of fat that you eat is more important than the amount of fat. Trans fats or hydrogenated fats and saturated fats promote abnormal cholesterol, whereas omega-3 fats and monounsaturated fats actually improve the type and quantity of the cholesterol your body produces.

In reality, the biggest source of abnormal cholesterol is not fat at all — it’s sugar. The sugar you consume converts to fat in your body. And the worst culprit of all is high fructose corn syrup.
Consumption of high fructose corn syrup, which is present in sodas, many juices, and most processed foods, is the primary nutritional cause of most of the cholesterol issues we doctors see in our patients.
So the real concern isn’t the amount of cholesterol you have, but the type of fats and sugar and refined carbohydrates in your diet that lead to abnormal cholesterol production.

Of course, many health-conscious people today know that total cholesterol is not as critical as the following:

• Your levels of HDL “good” cholesterol vs. LDL “bad” cholesterol
• Your triglyceride levels
• Your ratio of triglycerides to HDL
• Your ratio of total cholesterol to HDL

Many are also aware that there are different sizes of cholesterol particles. There are small and large particles of LDL, HDL, and triglycerides. The most dangerous are the small, dense particles that act like BB pellets, easily penetrating your arteries. Large, fluffy cholesterol particles are practically harmless–even if your total cholesterol is high. They function like beach balls and bounce off the arteries, causing no harm.

Another concern is whether or not your cholesterol is rancid. If so, the risk of arterial plaque is real.
Rancid or oxidized cholesterol results from oxidative stress and free radicals, which trigger a vicious cycle of inflammation and fat or plaque deposition under the artery walls. That is the real danger: When small dense LDL particles are oxidized they become dangerous and start the build up of plaque or cholesterol deposits in your arteries.

Now that we’ve explored when and how cholesterol becomes more problematic, let’s take a look at other factors that play a more significant role in cardiovascular disease.

Prime Contributors to Cardiovascular Disease
First of all, cardiovascular illness results when key bodily functions go awry, causing inflammation, (vii) imbalances in blood sugar and insulin and oxidative stress.

To control these key biological functions and keep them in balance, you need to look at your overall health as well as your genetic predispositions, as these underlie the types of diseases you’re most likely to develop. It is the interaction of your genes, lifestyle, and environment that ultimately determines your risks — and the outcome of your life.

This is the science of nutrigenomics, or how food acts as information to stall or totally prevent some predisposed disease risks by turning on the right gene messages with our diet and lifestyle choices. That means some of the factors that unbalance bodily health are under your control, or could be.
These include diet, nutritional status, stress levels, and activity levels. Key tests can reveal problems with a person’s blood sugar and insulin, inflammation level, level of folic acid, clotting factors, hormones, and other bodily systems that affect your risk of cardiovascular disease.

Particularly important are the causes if inflammation, which are many, and need to be assessed. Inflammation can arise from poor diet (too much sugar and trans and saturated fats), a sedentary lifestyle, stress, autoimmune disease, food allergies, hidden infections such as gum disease, and even toxins such as mercury. All of these causal factors need to be considered anytime there is inflammation.

Combined together, all of these factors determine your risk of heart disease. And I recommend that people undergo a comprehensive medical evaluation to see what their risk really is.

Zeroing in on Key Factors for Heart Disease
There’s no doubt about it, inflammation is key contributor to heart disease. A major study done at Harvard found that people with high levels of a marker called C-reactive protein (CRP) had higher risks of heart disease than people with high cholesterol. Normal cholesterol levels were NOT protective to those with high CRP. The risks were greatest for those with high levels of both CRP and cholesterol.

Another predisposing factor to heart disease is insulin resistance or metabolic syndrome, which leads to an imbalance in the blood sugar and high levels of insulin. This may affect as many as half of Americans over age 65. Many younger people also have this condition, which is sometimes called pre-diabetes.

Although modern medicine sometimes loses sight of the interconnectedness of all our bodily systems, blood sugar imbalances like these impact your cholesterol levels too. If you have any of these conditions, they will cause your good cholesterol to go down, while your triglycerides rise, which further increases inflammation and oxidative stress. All of these fluctuations contribute to blood thickening, clotting, and other malfunctions — leading to cardiovascular disease.

What’s more, elevated levels of a substance called homocysteine (which is related to your body’s levels of folic acid and vitamins B6 and B12) appears to correlate to cardiovascular illness. Although this is still somewhat controversial, I often see this inter-relationship in my practice. While genes may play a part, tests done as part of a comprehensive evaluation of cardiac risk can easily ascertain this factor. Where problematic levels occur, they can be easily addressed by adequate folic acid intake, along with vitamins B6 and B12.

Testing for Cardiovascular Risk Factors
Heart disease is not only about cholesterol. It is important to look at many factors that contribute to your overall risk. And it seems that insulin and blood sugar imbalances, and inflammation are proving to be more of a risk that cholesterol.

If you want to test your overall risk, you can consider asking your doctor to perform the following tests:

1. Total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides. Your total cholesterol should be under 200. Your triglycerides should be under 100. Your HDL should be over 60. Your LDL should be ideally under 80. Your ratio of total cholesterol to HDL should be less than 3.0. Your ratio of triglycerides to HDL should be no greater than 4, which can indicate insulin resistance if elevated.
2. NMR Lipid Profile. This looks at your cholesterol under an MRI scan to assess the size of the particles, which can determine your cardiovascular risk. This is a very important test that can further differentiate the risk of your cholesterol and can be an important factor to track as your system improves and your cholesterol transforms from being small dense and dangerous to light and fluffy and innocuous. It is done by a company called Liposcience and is also available through LabCorp.
3. Glucose Insulin Tolerance Test. Measurements of fasting and 1 and 2 hour levels of glucose AND insulin helps identify pre-diabetes and excessively high levels of insulin, and even diabetes. Most doctors just check blood sugar and NOT insulin, which is the first thing to go up. By the time your blood sugar goes up, the train has left the station.
4. Hemaglobin A1c. This measures your average blood sugar level over the last 6 weeks. Anything over 5.5 is high.
5. Cardio C-reactive protein. This is a marker of inflammation in the body that is essential to understand in the context of overall risk. Your C-reactive protein level should be less than 1.
6. Homocysteine. Your homocysteine measures your folate status and should be between 6 and 8.
7. Lipid peroxides or TBARS test, which looks at the amount of oxidized or rancid fat. This should be within normal limits of the test and indicates whether or not you have oxidized cholesterol.
8. Fibrinogen, which is another test looking at clotting in the blood. It should be less than 300.
9. Lipoprotein (a), which is another factor that can promote the risk of heart disease, often in men. It should be less than 30.
10. Genes or SNPs may also be useful in terms of assessing your situation. A number of key genes regulate cholesterol and metabolism, including Apo E genes and the cholesterol ester transfer protein gene. The MTHFR gene, which regulates homocysteine is also important and may be part of an overall workup.
11. Get a high-speed CT or (EBT) scan of the heart if you are concerned that you have cardiovascular disease. This may be helpful to assess overall plaque burden and calcium score. A score higher than 100 is a concern, and a score higher than 400 indicates severe risk of cardiovascular disease.

Next I will review how to lower your risk of heart disease and fix your cholesterol. We’ll do this not by lowering the LDL, but by getting more light and fluffy LDL particles, which are protective and more HDL cholesterol, which is THE most important cholesterol.

References
(i) Barter P, Gotto AM, LaRosa JC, Maroni J, Szarek M, Grundy SM, Kastelein JJ, Bittner V, Fruchart JC; Treating to New Targets Investigators. HDL cholesterol, very low levels of LDL cholesterol, and cardiovascular events. N Engl J Med. 2007 Sep 27;357(13):1301-10.
(ii) Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, MacFadyen JG, Nordestgaard BG, Shepherd J, Willerson JT, Glynn RJ; JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008 Nov 20;359(21):2195-207.
(iii) Abramson J, Wright JM. Are lipid-lowering guidelines evidence-based? Lancet. 2007 Jan 20;369(9557):168-9
(iv) IBID
(v) Brown BG, Taylor AJ Does ENHANCE Diminish Confidence in Lowering LDL or in Ezetimibe? Engl J Med 358:1504, April 3, 2008 Editorial
(vi) Schatz IJ, Masaki K, Yano K, Chen R, Rodriguez BL, Curb JD. Cholesterol and all-cause mortality in elderly people from the Honolulu Heart Program: a cohort study. Lancet. 2001 Aug 4;358(9279):351-5.
(vii) Hansson GK Inflammation, Atherosclerosis, and Coronary Artery Disease N Engl J Med 352:1685, April 21, 2005
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Read the complete article here.

Death blow for Zetia? (ezetimibe) Dr. William Davis

Posted: 11/25/2009 11:14:54 AM
The recent results of the ARBITER6-HALTS trial, I believe, should cause us to eliminate Zetia (ezetimibe) from our list of agents regarded as safe. In all honesty, despite some of the negative press on Zetia, especially in regards to the data suggesting no effect on carotid plaque in people with heterozygous familial hypercholesterolemia, I had maintained hope that a subset of people who are "hyperabsorbers" of sterol-backbone substances, such as the various forms of sterols, would benefit from Zetia's capacity to block their absorption. But the ARBITER trial, I believe, essentially closes the lid on Zetia, regardless of any potential effect on sterol absorption. The study demonstrates that niacin in combination with a statin (mostly Lipitor or Crestor) reduces carotid intimal-medial thickness (CIMT) modestly; while Zetia does not when added to statin. Most concerningly, greater LDL-reducing efficacy with Zetia was associated with an increase in CIMT.  The authors raise the question, suggested in prior studies, that Zetia, despite being billed as only a cholesterol absorption inhibitor, exerts other effects when systemically absorbed, including impairment of reverse cholesterol transport. I believe that enough doubt has been cast on the efficacy and safety of Zetia that we should avoid its inclusion. Of course, speak to your doctor before making any changes.  =============================================================

Seniors, Statins, and Side Effects

by Thomas D. Meade, M.D.
How many seniors with heart disease are told that statins may cause shortness of breath or worsen their heart failure? Probably very few.

Most would be astonished to think their cardiologist would prescribe a drug that could worsen their condition, but that is exactly what was reported at the November 2009 CHEST - the national meeting of chest physicians.Ref: www.medscape.com/viewarticle/712329

In addition to this information, what if your physician told you there are other possible side effects including memory loss, muscle and joint pain, liver damage death from muscle necrosis, decreased libido and testosterone inhibition, and many of these drugs have not been proven to decrease your chance of death from fatal heart attacks or strokes?

What if they told your chance of worsening nerve pain (peripheral neuropathy from diabetes or other causes), fibromyalgia pain, spinal stenosis and possibly lymphedema exists from taking statins?
How about if you were told that after 30 years of taking these powerful medications your lifespan may not increase one day or in a best case scenario a few months. How about if they told you the data on statins in women or men without heart disease is extremely weak or nonexistent? How many patients would still pay for these expensive drugs?

How many patients are on Crestor® or Zetia® that are not told what the package insert states? Let me help you..... On the CRESTOR® package safety information, it states, ‘CRESTOR® has not been approved to prevent heart, disease, heart attacks, or strokes'. One might ask why am I taking this? Ask your prescribing physician.

On the Zetia® patient product information it states, ‘ ....ZETIA® has not been shown to prevent heart disease or heart attacks.' Chances are CRESTOR® and ZETIA® patients are hearing this information for the first time, yet it is dispensed with the package insert, but rarely emphasized by the prescribing physician.

This is not to say there isn't a role for statins, but certainly it is far less and at a much lower dose than is being recommended today. It is now being recognized that the major benefit of statins lies in a recently discovered anti-inflammatory effect and not so much, if at all from the cholesterol lowering effect.

However, since inflammation is much harder to quantify and track, the quantity of statins sold and the profitability would not nearly approach that of recommending them for their cholesterol blocking effect.

Additionally, there are many other less expensive ways to get anti-inflammatory benefits both naturally with anti inflammatory foods such as berries, omega-3 fatty acids, olive oil, fresh fish, certain spices including ginger, curcumin, and even the lowest dose of aspirin.

I always believed there should be something in medicine similar to the financial world's ‘Truth in
Lending', well-known to any homeowner who has finalized a mortgage and finds out that their 5% or 6% rate quote is really significantly higher due to add on closing expenses and fees. This information is not provided up front but usually after walking down the buyer's pathway a bit.

In medicine, this would be analogous to a patient being convinced by his physician he or she should be on statins and given a prescription in the exam room, and while checking out the ‘Truth in Medicine' clerk stopped the patient and handed them a document stating

"..the prescription just provided to you has not been approved to prevent heart attacks, heart disease, or strokes. If you take this drug for everal decades you might live a few weeks or months longer, but you could die from rhabdomyolysis sooner. It may cause liver disorders, it may cause you to completely lose your memory, and it will stop cholesterol production in your liver, which is the building block of testosterone, which controls your sex drive. It also has been shown to cause genetic mutations of your vital cell components  (i.e. the mitochondrion - also know as the powerhouse of the cell). It can zap your energy and cause weakness and predispose you to tendon and ligament ruptures. It will deplete your CoQ-10 by 50% so you should go to the health food store and buy some,....'

Now most patients would crumple up the prescription and leave the office, deciding the risks are not worth the benefits. Some may not, but the ‘Truth in Medicine' approach would at least level the playing field and not shower the patients with one sided information from direct to consumer TV advertisements and little information on the side effects from hurried and overworked but well meaning physicians.

Thomas D. Meade, M.D.March 2010

Dr. Tom Meade serves as The Senior Partner of OAA Orthopaedic Specialists. He co-developed the 300,000 sq. ft. Integrated Health Campus, a landmark national showcase medical facility. He also hosts two educational cable TV programs, "Real Life in the OR" and "Inside Medicine." (www.ssptv.com)

Dr John Briffa on ezetimibe (Zetia)

More bad news for the makers (and takers) of cholesterol-reducing drug ezetimibe (Zetia) http://www.drbriffa.com

Posted By Dr John Briffa On November 16, 2009

Previously, I have written about the drug combination of simvastatin and ezetimibe (sold as Vytorin in the US). Both of these drugs reduce cholesterol, but through different mechanisms. Taken together, these drugs do do a good job of reducing cholesterol levels And we all know that the lower we get the cholesterol levels down the better, right? Well, actually, results show that Vytorin [1] did not work to halt the progression of the ‘plaques’ that gum up arteries and can precipitate heart attacks and strokes.

And then another thing is that giving people simvastatin and ezetimibe is associated with an increased risk of [2] death due to cancer. This finding was inexplicably waved away by scientists as a [3] chance finding (even though the statistics showed that the finding was very unlikely to be due to chance).

Anyway, this week sees more bad news for the manufacturers of Vytorin and also those who take it. The New England Journal of Medicine has just published a study in which individuals on a statin were additionally treated with ezetimibe or niacin (vitamin B3) over 14 months [1]. All of the individuals in the trial had either been diagnosed with heart disease or were deemed to be at high risk of this condition.

The researchers measured a number of parameters including:

LDL-cholesterol (a form of cholesterol said to be associated with a higher risk of cardiovascular disease)

HDL-cholesterol (a form of cholesterol said to be associated with a lower risk of cardiovascular disease)

Triglyceride levels (a form of blood fat said to be associated with higher risk of cardiovascular disease)

Carotid artery intima thickness (the thickness of the wall of the major blood vessel supplying blood to the head – increased thickness is generally taken as a sign of worsening cardiovascular disease risk)

In the group taking a statin and ezetimibe, LDL, HDL and triglyceride levels went down.

In the group taking a statin and niacin, LDL and triglyceride levels went down, and HDL levels went up.

On paper, at this point, the group taking the niacin and statin fared better. However, more important than these results were those relating to the carotid artery intima thickness. Guess what? The group taking the niacin did better than the group taking ezetimibe on this score too.

One other outcome the researchers kept tabs on was ‘major cardiovascular events’ such as heart attacks and strokes. Here again, the niacin group fared better – 1 per cent of them had such an event compared to 5 per cent in the group taking ezetimibe.

The New York Times reports [4] here that Dr Peter Kim, the president of Merck Research Laboratories (makers of ezetimibe) claimed that the study was limited because it did not compare the groups of patients taking a statin and a second drug to a placebo group. He also claims that a drug’s ability to improve artery-wall thickness has not been proved to automatically correlate with a reduction in heart attacks. Moreover he stated that ezetimibe lowers bad cholesterol and lowering bad cholesterol is a “known good”.

Ezetimibe has been licenced on the basis of its ability to reduce LDL-cholesterol – something that is referred to as a ‘surrogate marker’. So, Merck it seems that Merck is happy for its drug to be sold and promoted on the basis of one surrogate marker (reduced cholesterol), but none-too-keen for its drug to be criticised on the basis of another surrogate measure (carotid artery intima thickness).

Dr Kim also describes a reduction in bad (LDL) cholesterol as a “known good”. However, the new England Journal of Medicine study found that lower levels of LDL cholesterol were actually associated with an increase in carotid artery intima thickness. And never mind this, do we really think that just because something reduces LDL cholesterol levels, that has to be a good thing. I mean, if arsenic and cyanide were found to reduce LDL cholesterol levels, would that mean we should all be taking arsenic and cyanide every day?

The New York Times article also quotes Dr James Stein, professor at the University of Wisconsin medical school, who points out that as far as ezetimibe is concerned, “there is not a shred of evidence that it does anything good for blood vessels or heart disease.”

References:

1. Taylor AJ, et al. Extended-Release Niacin or Ezetimibe and Carotid Intima–Media Thickness NEJM 15th November 2009 [epub ahead of print]


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Article printed from Dr Briffa’s Blog: http://www.drbriffa.com

URL to article: http://www.drbriffa.com/blog/2009/11/16/more-bad-news-for-the-makers-and-takers-of-cholesterol-reducing-drug-ezetimibe-zetia/

URLs in this post:
[1] did not work: http://www.drbriffa.com/blog/2008/01/28/trial-results-forced-out-of-drug-company-support-the-concept
-that-cholesterol-may-not-cause-cardiovascular-disease/

[2] death due to cancer: http://www.drbriffa.com/blog/2008/07/23/cholesterol-lowering-combination-found-to-have-limited-benef
it-again-and-now-is-linked-with-increased-risk-of-cancer/

[3] chance finding: http://www.drbriffa.com/blog/2008/09/03/is-it-right-for-scientists-to-put-the-links-between-choleste
rol-reducing-medication-and-cancer-down-to-chance/

[4] here: http://www.nytimes.com/2009/11/16/health/research/16heart.html

What makes statins so dangerous?

In his popular newsletter, Dr. Mercola provides this analysis of the ubiquitous, cure all statin drug and the stance by the Mayo clinic.

What You Need to Know About Cholesterol in Order to Understand the Dangers of Statins

Statin drugs work by preventing the formation of cholesterol, and reduce LDL cholesterol, which is considered the "bad" cholesterol.

There is no argument that these drugs do work very well at lowering your cholesterol levels. However, was has not been proven is that they significantly lower your risk of dying from heart disease. In no way, shape or form, do they treat the cause of your problem. They are nothing more than a toxic band-aid.

So just what makes statins so dangerous, and why are they not the answer for managing your cholesterol levels?

First you need to understand the biological workings of cholesterol.

In fact, there is no such thing as “good” or “bad” cholesterol. Both HDL and LDL
cholesterol perform vital functions in your body, which is why it’s actually dangerous to bring your LDL levels down too low.

HDL (high density lipoprotein) and LDL (low density lipoprotein) are actually proteins that transport the cholesterol to and from your tissues.

Cholesterol in turn is a precursor to steroid hormones. For example, you can’t make testosterone or estrogen, cortisol, DHEA or pregnenolone, or a multitude of other steroid hormones that are necessary for health, without cholesterol.

Even more importantly, your cells cannot regenerate their membranes without it. The reason you have LDL to begin with is to transport the cholesterol to the tissues in order to make new cells and repair damaged ones.

However, there are different sizes of LDL particles and it’s the LDL particle size that is relevant, and statins do not modulate the size of the particles. Unfortunately, most people don’t know about that part, and very rarely, if ever, get tested for particle size.

The particles are sticky, so very small LDL’s can easily get stuck in different areas, and the build-up eventually causes inflammation and damage.

The only way to make sure your LDL particles are large enough to not cause damage is through your diet. In fact, it’s one of the major functions of insulin.

Conveniently enough, a healthy diet is also the answer for type 2 diabetes, so by focusing on what you eat, you’re treating both your diabetes and your cholesterol levels, and reducing your associated risk of heart disease.

If you eat properly, which is really the only known good way to regulate LDL particle size, then it does the right thing; it takes the cholesterol to your tissues, the HDL takes it back to your liver, and no plaque is formed.

The second thing you need to know is that statins work by reducing the enzyme that causes your liver to make cholesterol when it is stimulated by high insulin levels.

Again, you can achieve the same, or better, result by simply reducing your insulin levels by eliminating sugar and most grains, which is also what you need to do to successfully address type 2 diabetes.

Read the complete article here. Thank you Dr Mercols for a clear, concise explanation.