Statin Drugs

The New JUPITER Study on Statins (Nov 2008) PROVES that Heart Disease is an Inflammatory Process 

Big PharmaI was concerned several years ago as the American Heart Association, backed by the pharmaceutical companies, continued to make and revise recommendations regarding how low doctors should reduce their patients' LDL cholesterol levels. At first LDL cholesterol levels were "normal" if they were 130 or below, then the standard was 100 or below, and finally, 70 or below became what we now consider medically "acceptable." With each recommendation the number of people who instantly had the made-up disease of "high cholesterol" increased, and more and more patients were prescribed statin drugs to lower their LDL cholesterol levels. Statin drugs are the top-selling drugs in the world, bringing in more money for Big Pharma than any other class of drugs. It was this con of convincing the public that high cholesterol was the cause of atherosclerosis, heart disease, and stroke that caused me to write the first edition of my book, The Cholesterol Conspiracy, in 2004. It has since been updated (2006) and is in its Second Edition; however, after the latest news from the American Heart Association conference in New Orleans on Nov. 8th, 2008 it appears that I will need to update my book again.

My contention has always been that it is NOT high cholesterol that is the main cause of plaque formation, heart disease, and stroke, but rather it is the OXIDATION of LDL cholesterol and the INFLAMMATION of the arterial lining (called the endothelium) that is the culprit to the number one cause of death for both men and women. As I discuss in my book, more than half of people who die of heart disease have NORMAL LDL cholesterol levels, ...thus it is NOT high cholesterol that is killing them, but the CONDITION of the LDL cholesterol and the inflammation of the endothelium that leads to the deadly disease. Likewise, there are cases of people with high cholesterol levels who show no signs of arterial plaque due to their high intake of vitamins, minerals, antioxidants, and the essential fatty acids that reduce the oxidation to LDL cholesterol and inflammation to the endothelium. What's more, antioxidants reduce endothelial inflammation an LDL oxidation better than any drug, ...and without the side effects.

The recent study reported at the American Heart Association in New Orleans, known as JUPITER, proved my case: if you reduce oxidation and inflammation you can reduce the risk of death from heart disease and stroke!  However, unlike the JUPITER study, which proposed the way to do it is with statin drugs, I believe the best course to reduce LDL oxidation and arterial inflammation is with nutritional supplements.

JupiterIf you were to believe the JUPITER study and what is being suggested by the doctors who spoke at the American Heart Association conference on Nov. 8, 2008 in New Orleans you would have to believe that "EVERYONE," young and old, sick and healthy, those with high cholesterol and those with normal cholesterol levels ALL should be on the "life-saving, miracle drugs of this or any other generation" …the statin drugs!  

The JUPITER (Justification for the Use of Statins in Primary Prevention) Study, funded by AstraZeneca, makers of Crestor, was unveiled to the delight and awe of doctors and pharmaceutical companies. The study showed that 20 mg of Crestor cut in half one’s risk of heart attacks and stroke, whether they had high cholesterol or not!  In other words, healthy people without elevated cholesterol levels ... could now be "saved" by the statin drugs, and like the IRS, the pharmaceutical companies are "here to help."

Doctors and pharmaceutical representatives got on the stage to proclaim that because statin drugs have been shown (in this study of just under two years) to reduce the risk of heart attack and stroke in HEALTHY people (those without signs or symptoms of heart disease and normal cholesterol levels) that governments around the world should push the campaign to put every single person on statin drugs. 

As has been proposed earlier (documented in my book), they again proposed at this conference that we "drip statin drugs into our water supply" as the best way to get everyone on these "all-important" drugs.  They want to take the decision out of our control and force these drugs, which ...oh, by the way, have dangerous, even deadly side effects, upon us ....and of course, run up a huge national medical cost.

Statin drugs are already the number one-selling drug in the world with over $18 billion dollars in sales, and now due to this study, they will likely double in sales.  USA Today calculated that the ever-increasing prescribing of statin drugs which this study will generate would add $10 billion a year to the U.S. national debt. (http://www.usatoday.com/news/health/200

BUT, what are the facts of this study; what about the risks of such widespread use of statin drugs, particularly in healthy people? …and, more importantly, what about alternatives to statins?  Interestingly enough, one of the authors of this study also appeared as an author on another study released the same week of the announcement of this study, showing that vitamin E and vitamin C did NOTHING to reduce the risk of heart disease; ....in fact vitamin E, they reported, might increase the risk for hemorrhagic stroke. So, in a one-two punch knock out …. Big Pharma apparently established that statin drugs are the ONLY salvation for the number one cause of death.

Now, not only are antioxidants NOT the answer, according to Big Pharma, they are the problem.  It must be that we, as human beings, are born deficient of statin drugs, ….some kind of an "inborn error of metabolism," and that it is not nutrients that we lack today, but drugs!  Apparently Big Pharma is not satisfied with treating the sick, they want to provide “therapy” to the healthy, by actively putting more drugs into our drinking water …as if there are not enough drugs swirling around in the water supply already.

Again, I would like to point out that this JUPITER study proves my point made in my book, The Cholesterol Conspiracy , ....that heart disease (atherosclerosis) is not caused by high cholesterol, but rather oxidation of LDL cholesterol and inflammation of the arterial lining.  In my book, I make a case (backed up by medical research) that oxidized LDL cholesterol and homocysteine-induced nicking and inflammation of the arteries leads to arterial plaque and inflammation. 

Vascular InflammationC reactive protein (CRP) is an indirect measure of arterial inflammation (or any inflammation). The more oxidation and inflammation of the arteries, NO MATTER WHAT THE LDL CHOLESTEROL LEVEL (normal or not), the more plaque will build within the arterial lining (known as the endothelium). By reducing oxidation and inflammation (which can be measured directly with lipid peroxides, or indirectly with CRP levels) there is less damage to the LDL cholesterol and the endothelium, and less plaque will form.  Less plaque means less heart disease and death.

Vitamins, minerals, antioxidants, and omega-3 essential fatty acids have all been shown to decrease CRP, homocysteine, and lipid peroxides levels, and in some cases restore endothelial function ….without any toxic side-effects (unlike statin drugs).

Although I discuss CRP in The Cholesterol Conspiracy, as a review, CRP is a protein produced by the liver in response to inflammation.  Any condition that leads to inflammation will cause the production and release of CRP. Smoking, genetics, stress, arthritis, diabetes, obesity, rheumatoid arthritis, dementia, high blood pressure colorectal cancer, the aging process, and damaged and an inflamed arterial endothelium will all cause an elevation of C reactive protein.  It is an indirect, non-specific measurement of inflammation and oxidation. Statin drugs have been shown to exert an anti-inflammatory effect, and it is the modest anti-oxidant, anti-inflammatory effect that is responsible for a reduction in oxidized LDL cholesterol and arterial inflammation. Less oxidized LDL cholesterol and less arterial inflammation, the less plaque that will build up within the arterial endothelium.

vitaminsHowever, natural antioxidants, vitamin C, turmeric extract, essential fatty acids (fish oil) do more to reduce oxidized LDL cholesterol and arterial inflammation and lower CRP than cholesterol-lowering statin drugs, AND without the dangerous side-effects of statins (liver, nerve, muscle, and heart damage, ….let alone death). The B complex vitamins and betaine (tri-methly-glycine) lower homocysteine levels, which means less “scratching up” of the endothelium, i.e., less arterial inflammation, and lower CRP levels.

The JUPITER study showed how important it is to lower inflammation of the arteries in order to reduce the risk of heart disease and stroke, ….as measured by CRP levels, and that people are susceptible to heart attack and stroke even with normal LDL cholesterol levels because oxidation and inflammation. So, let’s look at the facts and my concerns of the JUPITER Study:

Facts of the JUPITER STUDY:

1. Nearly 18,000 men and women with low LDL cholesterol levels (median 108 mg/dL), and C reactive protein levels (CRP) greater than 2.0 mg/L were placed on 20 mg of Crestor or a placebo, and followed for just under 2 years.
2. The group on 20 mg of Crestor decreased their cholesterol levels EVEN FURTHER (to as low as 53 mg/dL), reduced their triglyceride levels, and cut their risk of nonfatal heart attacks by 55%, a 48% reduction in nonfatal strokes, and a 47% reduction in hard cardiac “events” (a composite of nonfatal and fatal heart attack and stroke).

Concerns about the JUPITER STUDY:

1. What are the long-term effects of lowering one’s LDL cholesterol to such low levels? There is already concern about depression, violent behavior, suicide, etc. from lowering one’s LDL cholesterol below 70 (see my book, The Cholesterol Conspiracy). However, what other problems may arise from such low LDL cholesterol, given that the body REQUIRES LDL cholesterol to function properly? Having high LDL cholesterol levels in and of itself is not a problem, it is the oxidation of LDL cholesterol and triglycerides (lipid peroxides) and the inflammation of the endothelium (from homocysteine) that leads to plaque formation.
2. With the study only being 2 years long, AstraZeneca virtually eliminated discovering the long-term effects of such low LDL cholesterol levels AND the long-term effects of statin drugs in this population. However, we do know the long-term of statin drugs, and they are not pretty, ….dangerous and severe side-effects; occasional deadly.
3. Was the study designed to yield the desired results and minimize negative outcomes that would have been revealed had it gone on longer?
4. There was a higher incidence in insulin resistence and type 2 diabetes among those who took Crestor than in the control group. And, this was all happened within 2 years. As mentioned, what other complications would we have seen had the study gone longer than 2 years, ...especially since now all people, even those with normal cholesterol levels, are "supposed" to be on statin drugs for the REST OF THEIR LIVES? It would be good to know what people can expect.
4. According to Stanford University cardiologist Dr. Mark Hlatky, about 120 people would have to take Crestor for two years in order to prevent a single heart attack, stroke or death; and how many people would then suffer moderate to severe side-effects over the long-term? Again, as people would be encouraged to be on these drugs for the rest of their lives!
5. Crestor gave clear benefit in the study, but with so few heart attacks and deaths occurred among these low-risk people that treating EVERYONE in the U.S. alone with statin drugs would cost up to $10 billion a year.
6. Big Pharma presents statin drugs as the only choice to reduce CRP levels, when this is not the case.

What We Can Learn From This Study:

1. It is important to lower C Reactive Protein levels as a means to lower inflammation, which in turn reduces the risk of heart disease and stroke.
2. This study confirms that it is NOT the lowering of LDL cholesterol that is key to reducing the risk of heart attack and stroke, but the reducing of inflammation, as is evident by the lowering of C reactive protein (CRP). Therefore, what about all the studies that show alternative means (vitamins, minerals, antioxidants, and essential fatty acids) for lowering CRP, inflammation, and lipid peroxidation without any adverse effects?

What Can You Do?

1. Know, and lower your high-sensitivy CRP levels (as mentioned in my book):
a. CRP less than 1.0 mg/L = Low Risk for CardioVascular Disease (CVD)
b. CRP of 1.0 – 2.9 mg/L = Moderate Risk for CVD
c. CRP greater than 3.0 = High Risk for CVD
2. Know, and lower your Homocysteine levels:
a. Homocysteine less than 6.5 = Low Risk for CVD
b. Homocysteine 6.6 to 8.0 = Low-Moderate Risk for CVD
c. Homocyseine 8.1 to 10.4 = Moderate-High Risk for CVD
d. Homocysteine greater than 10.4 = High Risk for CVD
3. Know, and lower your Lipid Peroxides
a. This test is not commonly performed by most labs, but can be obtained.
b. Keep Lipid Peroxidation low (according to print out on lab results)

How You Can Lower CRP, Homocysteine, and Lipid Peroxidation to Reduce Heart Attack & Stroke:

1. Statin Drugs: expensive; dangerous and sometimes deadly side-effects.
a. See list of side-effects in The Cholesterol Conspiracy.

OR, .... even BETTER:

2. Lifestyle Changes: inexpensive, non-dangerous, …and it promotes health!
a. Maintain a Healthy Weight
b. Maintain a Low-Glycemic Diet (plenty of vegetables)
c. Exercise
d. Don’t Smoke
e. Reduce Stress
f. Adequate Sleep
g. Drink Plenty of Pure Water
h. Maintain Gum Health (brush, floss, and use Co-Q10)
i. Use Full-Range Vitamins, Minerals, Antioxidants, and Omega-3 Essential Fatty Acids: (a few examples of many vitamins and antioxidants are shown below, though I personally recommend a full-range of vitamins, minerals, antioxidants, and essential fatty acids):

Vitamin C 2000 mg/day (vitamin C alone reduces CRP similar to statins) 
B Complex Vitamins 
Fish Oil (4000 mg per day) 
Vitamin D (1000 to 5000 IU/day) 
Turmeric Extract (400 to 800 mg/day) 
Olive Extract (75 to 200 mg/day) 
Grape Seed Extract and Resveratrol (200 to 400 mg/day) 
Co-Enzyme Q10 (200 to 400 mg/day) 
Betaine (TMG) (1800 to 3000 mg/day) 
Magnesium (400 mg/day)

 

References:

Block G, Jensen CD, et al. Vitamin C treatment reduces elevated C-reactive protein. Free Radic Biol Med. 2008 Oct 10. [Epub ahead of print]

Block G, Jensen C, Dietrich M, et al. Plasma C-reactive protein concentrations in active and passive smokers: influence of antioxidant supplementation. J Am Coll Nutr. 2004 Apr;23(2):141-7.

Boekholdt SM, Meuwese MC, Day NE, et al. Plasma concentrations of ascorbic acid and C-reactive protein, and risk of future coronary artery disease, in apparently healthy men and women: the EPIC-Norfolk prospective population study. Br J Nutr. 2006 Sep;96(3):516-22.

Chang TY, Chou KJ, Tseng CF, et al. Effects of folic acid and vitamin B complex on serum C-reactive protein and albumin levels in stable hemodialysis patients. Curr Med Res Opin. 2007 Aug;23(8):1879-86.

Ullegaddi R, Powers HJ, Gariballa SE.  Antioxidant supplementation with or without B-group vitamins after acute ischemic stroke: a randomized controlled trial. JPEN J Parenter Enteral Nutr. 2006 Mar-Apr;30(2):108-14.

Chen C, Nan B, Lin P, Yao Q.  C-reactive protein increases plasminogen activator inhibitor-1 expression in human endothelial cells. Thromb Res. 2008;122(1):125-33. Epub 2007 Oct 22.

Nan B, Yang H, et al.  C-reactive protein decreases expression of thrombomodulin and endothelial protein C receptor in human endothelial cells. Surgery. 2005 Aug;138(2):212-22.

Chun OK, Chung SJ, Claycombe KJ, Song WO.  Serum C-reactive protein concentrations are inversely associated with dietary flavonoid intake in U.S. adults.  J Nutr. 2008 Apr;138(4):753-60.

Harikumar KB, Aggarwal BB.  Resveratrol: a multitargeted agent for age-associated chronic diseases.  Cell Cycle. 2008 Apr 15;7(8):1020-35.

Kaur G, Rao LV, Agrawal A, Pendurthi UR.  Effect of wine phenolics on cytokine-induced C-reactive protein expression. J Thromb Haemost. 2007 Jun;5(6):1309-17.

Terra X, Montagut G, Bustos M, et al.  Grape-seed procyanidins prevent low-grade inflammation by modulating cytokine expression in rats fed a high-fat diet.  J Nutr Biochem. 2008 Jul 3. [Epub ahead of print]

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