And Now for the Rest of the Story

Just this past Sunday (9 November, 2008) I posted this article on Natural Health News: Boosting Drug Sales with Studies.

I added one follow-up article earlier today, and now I am happy to give you something to think about in terms of why sound nutrition is a better option than wholesale use of drugs. Supplements certainly do edge out the pharmaceuticals in this study.

You'll also see how it is totally possible to fool a lot of the people a lot of the time -

Why treat nutritional deficiency with drugs?
(OMNS, November 13, 2008) A recent study suggested that statins might be used to avoid the effects of nutritional deficiency. Writing in the New England Journal of Medicine, the Jupiter group described a study of statin drugs in people with high C-reactive protein and low cholesterol. (1) High C-reactive protein levels are associated with inflammation and heart disease/stroke. The authors concluded that, in apparently healthy persons with elevated C-reactive protein levels, rosuvastatin (Crestor) significantly reduced the incidence of major cardiovascular events.

Their much-publicized claim, that this statin lowers the risk of heart attack by approximately one half, is technically correct though highly misleading. The reported annual incidence of coronary events was 37 people in 10,000 (controls) and 17 people in 10,000 (treated). Similar results were reported for risk of stroke. When expressed as a proportion, a 46% improvement (17/37) sounds large. However, an improvement of 20 events (37-17) in 10,000 people known to be at risk is less impressive. Such an improvement means that 500 people (10,000/20) with this increased risk would need to take the tablet daily for a year, to prevent one person suffering an event.

The paper does not explicitly report deaths. One reason for this may be that if a person on statins suffered a heart attack, that person was about three times more likely to die than a control who was not on statins.

The cost of rosuvastatin per person is approximately $1000 per year. So, treating enough people to prevent one heart attack costs $500,000 per year. Since about 70% of the heart attacks were not fatal, prevention of a single death from heart attack would cost even more, approximately $1,700,000. Giving the benefit of the doubt, we may allow for a similar reduction in stroke and say that "only" $250,000 is needed to protect one person from a stroke or heart attack. It is hardly surprising that Astra Zeneca's share price increased by $1.3 billion dollars on release of this paper and the corresponding media hype. (2)

The media suggested millions of healthy people could cut their risk of heart disease by taking statins. (3) They also claimed that statins could cut the risk of heart attack for "everyone". (4) This is inaccurate and incorrect. The study did not include normal healthy people, only a sample of a relatively small number of people, suffering from inflammation (increased C-reactive protein) - a known cause of heart disease and stroke. Out of 89,890 people considered for inclusion, 17,802 people (19.8%) met the specific criteria of poor health for the study. Widespread prescription of statins to healthy people is not supported by these findings.

The fact that statins produce a modest improvement is unsurprising, since they are known to lower inflammation, as do many nutritional supplements. It has pointed out that Crestor lowered C-reactive protein by 37%, but vitamin E lowers it (C Reactive Protein) by 32%, (5) and vitamin C by 25.3%. (6,7) These effects are similar to those of statins and would be expected to provide comparable benefits, without side effects and at a lower cost.

Crestor and other statin drugs have serious side effects. The incidence of established side-effects, such as rhabdomyolysis (0.3 per 10,000 per year), myopathy (1.1 per 10,000) and peripheral neuropathy (1.2 per 10,000 per year) seems low, (8) but may be underestimated as it takes time to establish long-term side-effects. (The depletion of coenzyme Q10 by statins is a particular concern.) The figures imply that for every ten people who avoid a cardiovascular event, at least one previously healthy person will suffer a non-trivial side effect of the statin drug.

The doctors reported a statistically significant increase (270) in diabetes in the statin group compared to the placebo group (216). Over the course of the study, this corresponds to an increased risk of approximately 61 in 10,000 people. So, the number of people on statins reported to become diabetic was greater than the number that avoided a heart attack! These people might have shorter lives and be at greater risk of heart disease in the long term.

Notably, the Jupiter study was stopped early, which the authors admit prevents assessment of how side-effects might outweigh reported benefits in the longer term. The study was to last 3-5 years and the criteria for stopping were not included in the original published design. (9) The paper claims that when the study was stopped "these [diabetic] events were not adjudicated by the end-point committee". The committee either knew about the diabetes in which case it was considered, or it did not and the committee was not doing its job properly.

The Jupiter name stands for Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin; the reader might think this "justification" sounds more like a marketing plan than a scientific endeavor. The researchers did not address the underlying cause of the inflammation and increased C-reactive protein: they simply treated the condition with drugs. In many cases, raised C-reactive protein is a result of nutritional deficiency. (10)

It is worth mentioning that several nutritional supplements inhibit inflammation and lower C-reactive protein, without causing known side effects. Deficiency in vitamins A, (11) B6, C, E, A, folate, carotenoids and lycopene, (12) and selenium (for example) is associated with raised C-reactive protein. (13,14,15) We suggest that the $250,000 cost of preventing a single cardiovascular event with rosuvastatin might be better spent funding a study of such inexpensive alternatives the deficiency of which may be the cause of the problem.

The people at risk could be encouraged to supplement their diet and restore their health without using these expensive drugs to conceal their underlying sickness.

Stick with the supplements!

References:

(1) Ridker P.M. Danielson E. Fonseca F.A.H. Genest J. Gotto A.M. Kastelein J.J.P. Koenig W. Libby P. Lorenzatti A.J. MacFadyen J.G. Nordestgaard B.G. Shepherd J. Willerson J.T. Glynn R.J. for the JUPITER Study Group (2008) Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein, NEJM, 359(21), 2195-2207.

(2) Mail Online (2008) Crestor news helps AstraZeneca market value leap by more than £1.3bn, 9:25 PM, 10th Nov.

(3) Smith R. (2008) Millions could cut heart attack risk by taking statins, study finds, telegraph.co.uk, 7:55AM GMT, 10 Nov.

(4) Hope J. (2008) The new statin drug that cuts the risk of heart attacks and strokes for EVERYONE, Daily Mail, 11th Nov.

(5) Devaraj S. Tang R. Adams-Huet B. Harris A. Seenivasan T. de Lemos J.A. Jialal I. (2007) Effect of high-dose alpha-tocopherol supplementation on biomarkers of oxidative stress and inflammation and carotid atherosclerosis in patients with coronary artery disease, Am J Clin Nutr, 86(5), 1392-1398.

(6) Block G. Jensen C.D. Dalvi T.B. Norkus E.P. Hudes M. Crawford P.B. Holland N. Fung E.B. Schumacher L. Harmatz P. (2008) Vitamin C treatment reduces elevated C-reactive protein, Free Radic Biol Med, Oct 10. [Epub]

(7) Sardi B. (2008) The Headline You Should Be Reading: Statin Drugs Don't Save Lives And May Increase Your Risk For Diabetes, Knowledge of Health Report, Nov 11.

(8) Law M. Rudnicka A.R. Statin Safety: A Systematic Review, The American Journal of Cardiology, 97(8), Suppl 1, S52-S60.

(9) Ridker P.M. JUPITER Study Group (2003) Rosuvastatin in the primary prevention of cardiovascular disease among patients with low levels of low-density lipoprotein cholesterol and elevated high-sensitivity C-reactive protein: rationale and design of the JUPITER trial, Circulation, 108(19), 2292-2297.

(10) Ford E.S. Liu S. Mannino D.M. Giles W.H. Smith S.J. (2003) C-reactive protein concentration and concentrations of blood vitamins, carotenoids, and selenium among United States adults, European Journal of Clinical Nutrition, 57, 1157-1163.

(11) Root M.M. Hu J. Stephenson L.S. Parker R.S. Campbell T.C. (1999) Determinants of plasma retinol concentrations of middle-aged women in rural China. Nutrition 15, 101-107.

(12) Boosalis M.G. Snowdon D.A. Tully C.L. Gross M.D. (1996): Acute phase response and plasma carotenoid concentrations in older women: findings from the nun study, Nutrition, 12, 475-478.

(13) Friso S. Jacques P.F. Wilson P.W. Rosenberg I.H. Selhub J.(2001) Low circulating vitamin B(6) is associated with elevation of the inflammation marker C-reactive protein independently of plasma homocysteine levels, Circulation, 103(23), 2788-2791.

(14) Devaraja S. Jialal I. (2000) Alpha tocopherol supplementation decreases serum C-reactive protein and monocyte interleukin-6 levels in normal volunteers and type 2 diabetic patients, Free Radical Biology and Medicine, 29(8), 790-792.

(15) Upritchard J.E. Sutherland W.H. Mann J.I. (2000): Effect of supplementation with tomato juice, vitamin E, and vitamin C on LDL oxidation and products of inflammatory activity in type 2 diabetes, Diabetes Care, 23, 733-738.

Nutritional Medicine is Orthomolecular Medicine

Low Cholesterol Risks

Professionals only supplements resources that I rely on in my clinical work usually publish reports on studies of natural supplements that help health concerns.

While most hear about how high cholesterol is so bad and how many risky drugs you need, often you don't hear that low cholesterol can impair your immune function or defer review of other more risky markers. Triglycerides included.

I've educated on triglyceride issues for so long it seems funny to me that its just hitting headlines. Still its not prominent in the media to equal the risk to your health.

The real warning should be that yes, high triglycerides will kill you.

The Deadly Truth about Low Cholesterol
It’s a common misconception with fatal consequences: Many people still believe that low total cholesterol levels mean you’re not at risk for stroke, heart attack, or any of the other deadly risks that come with cardiovascular disease.

But in reality, nothing could be further from the truth—and unless you’re paying close attention to one particular group of fats called triglycerides, your heart could be a ticking time bomb, no matter how healthy your cholesterol might look.

Triglycerides are naturally manufactured and stored by both your liver and fat cells. At normal levels, they’re a crucial source of energy for your body—but start producing more than you can store, and those excess triglycerides will be dumped into your bloodstream, where they can wreak havoc on your arteries, heart, pancreas, and liver.1

Studies have shown that abnormally high triglyceride levels raise your risk of heart attack threefold—and when accompanied by low levels of high-density lipoproteins (HDL, or “good” cholesterol), your risk jumps a staggering 16 times higher. In fact, this ratio is one of the single strongest predictors of heart attack risk, even more accurate than the better-known LDL (low-density lipoprotein, or “bad” cholesterol) to HDL ratio.2 And it isn’t just your heart that suffers. Studies show that risk of stroke, obesity, diabetes, and liver disease are all linked to these dangerous fats.3-5

Keeping triglycerides in check is absolutely critical to your health—and a simple combination of omega-3 fatty acids, niacin and a supplement blend™ can make all the difference. One recent trial showed that supplementing with fish oil daily slashed triglyceride levels by 46 percent in as little as eight weeks.6 And niacin boasts nearly five decades of research demonstrating that it not only reduces triglycerides and LDL cholesterol, but also increases HDL levels by up to 29 percent.7-8

Finally, be wary of your blood sugar: Numerous clinical trials have shown that refined carbs and sugar can actually double triglyceride production.9-10 Tossing sugary sodas and boosting protein intake can help.11 So can supplementing with natural blood sugar managing agents like bitter melon, goat’s rue and quercetin.12-13A comprehensive formulas like some we use in our work contain these ingredients along with several others, including cinnamon. Clinical trials reveal that this popular spice can reduce triglycerides by 23 to 30 percent.14

References:

1. Webster’s New World Medical Dictionary, 3rd edition, William Schiel, Jr, MD, Author, 2008, Webster publishing.

2. Gaziano, JM., Hennekens, CH. Fasting triglycerides, high-density lipoprotein, and the risk of myocardial infarction. Circulation. 1997 Oct 21; 96(8):2520-5.

3. Grundy, SM., Cleeman, JI., Merz, CN., Brewer, HB, Jr., Clark, LT., Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004 Jul 13; 110(2):227-39. Review. Erratum in: Circulation. 2004 Aug 10; 110 6):763.

4. Tanne, D., Koren-Morag, N., Graff, E. Blood lipids and first-ever ischemic stroke/transient ischemic attack in the Bezafibrate Infarction Prevention (BIP) Registry: high triglycerides constitute an independent risk factor. Circulation. 2001 Dec 11; 104(24):2892-7.

5. Kadikoylu G, Yavasoglu I, Bolaman Z. Plasma exchange in severe hypertriglyceridemia, a clinical study. Transfus Apher Sci. 2006 Jun; (3):253-7.

6. Vega GL, Chandalia M, Szczepaniak LS, Grundy SM. Effects of N-3 fatty acids on hepatic triglyceride content in humans. J Investig Med. 2008 Jun; 56(5):780-5.

7. Crouse, JR. 3rd. new developments in the use of niacin for treatment of hyperlipidemia: new considerations for use of an old drug. Coron Artery Dis. 1996 Apr; 7 (4):321-6.

8. Drexel H. Nicotinic acid in the treatment of hyperlipidaemia. Fundam Clin Pharmacol. 2007 Nov;21 Suppl 2:5-6.

9. Teff, KL., Elliott, SS., Tschop, M., Dietary fructose reduces circulating insulin and leptin, attenuates postprandial suppression of ghrelin, and increases in triglycerides in women. J Clin Endocrinol Metab. 2004 Jun;89(6):2963-72.

10. Furtado, JD., Campos, H., Appel, LJ., Miler, ER. Effects of protein, unsaturated fat, and carbohydrate intakes on plasma apolipoprotein B and VLDL and LDL containing apolipoprotein C-III: results from the OmniHeart Trial. Am J Clin Nutr. 2008 Jun;87 (6): 1623-30.

11. Parks, EJ., Skokan, LE. , Timlin., Dingfelder, CS. Dietary sugars stimulate fatty acid synthesis in adults. J. Nutr. 2008 Jun: 138 (6): 1039-46.

12. Sridhar MG, Vinayagamoorthi R, Arul Suyambunathan V, Bobby Z, Selvaraj N. Bitter gourd (Momordica charantia) improves insulin sensitivity by increasing skeletal muscle insulin-stimulated IRS-1 tyrosine phosphorylation in high-fat-fed rats. Br J Nutr. 2008 Apr;99(4):806-12.

13. Rivera L, Morón R, Sánchez M, Zarzuelo A, Galisteo M. Quercetin ameliorates metabolic syndrome and improves the inflammatory status in obese zucker rats. Obesity (Silver Spring). 2008 Sep;16(9):2081-7.

14. Anderson RA. Chromium and polyphenols from cinnamon improve insulin sensitivity. Proc Nutr Soc. 2008 Feb;67(1):48-53.

Should women who have paid for statins be given their money back?

I think Dr. John Briffa has a point of consideration here. If you follow this blog you know we are also big skeptics about the statins and are most concerned with the health problems they create and the ones they really do not help.

Again marketing seems to be the drive behind the sales of this class of drug. Yet more and more you read articles that seem to tell you that statins will fix just about everything.

You can do much more for your health without these drugs and other newer ones from the recombinant-GMO aisle.

Also remember that the majority of medical texts are written with men in mind and women's health - for the most part - seems to remain an aside.

The same pervasive thinking must be in the halls of Big Pharma as well.

Related to this topic are some of our posts on the benefits of vitamin C and vitamin E for heart health and other health concerns, while MSM muddies the water on the facts: Just Like the Cholesterol Myth.

By Dr John Briffa
October 24, 2008

Cholesterol-reducing drugs known as statins are hugely popular and highly profitable. It’s a shame, then, that they aren’t very effective. I say this because while they have been shown to reduce the risk of cardiovascular events such as heart attacks, they do not reduce the overall risk of death when essentially healthy individuals are being treated. This was the conclusion of an analysis of 8 studies which had been performed using individuals with no previous diagnosis of cardiovascular disease [1]. This analysis also revealed that for one individual to be protected from a cardiovascular event (heart attack or stroke) over a 5-year period, 67 people would need to be treated.

Other evidence analysing the effectiveness of the national treatment guidelines in the USA, Canada, the UK and New Zealand has revealed the so-called ‘number needed to treat’ (NNT) varies from 108-198 [2]. These startlingly high NNTs have caused some to question whether statins are really the wonder drugs some would have us believe them to be.

But wait, it gets worse. Because the limited ‘benefits’ of statins seems to be confined mainly to men. The research has found that even in women with diagnosed cardiovascular disease and/or history of heart attack or stroke, statins do not reduce overall risk of death. And in healthy women, they don’t reduce the risk of cardiovascular events (heart attacks and strokes) either. The crashing failure of statins in women was fully elucidated in an analysis from British GP Malcolm Kendrick in the BMJ last year [3].

The singular failure of statin drugs to help women was highlighted this week in the British Medical Journal [4]. In a news piece, our attention was brought to an analysis from a professor of law and a professor of clinical epidemiology in the USA. The paper focuses on the most widely prescribed statin of all - atorvastatin (Lipitor) [5]. It looks at the evidence for the effectiveness of this drug in treating essentially women with no history of cardiovascular disease. In line with previous evidence on statins, there was no significant benefit to be found.

But the authors of this analysis go further by questioning the fact that when Lipitor is promoted and advertised, there’s plenty of talk about the fact that it reduces the risk of heart attacks, but no mention of it’s stunning lack of success with regard in women. They accuse Lipitor’s manufacturers of a lack of candour here, and also ask questions of the Food and Drug Administration (FDA) in the USA. At a bare minimum, they say, the FDA should be using its muscle to protect people against misleading marketing. They also suggest that women who have paid out of their pockets as a result of false promises should be compensated for the money they’ve effectively wasted.

The authors conclude: Our findings indicate that each year reasonably healthy women spend billions of dollars on drugs in the hope of preventing heart attacks but that scientific evidence supporting their hope does not exist.
According to the BMJ new piece, Pfizer have responded to the article in the form of a statement, which I can’t locate on the web. In this statement, Pfizer claims that “Cardiovascular disease is a major cause of death in women as well as men and it ultimately kills as many women as men. However, onset of disease is delayed by some 10-15 years in women compared to men; thus the National Institutes for Health (NIH) ATP III guidelines define age as a risk factor in women at age 55, compared to age 45 for men. In addition, the AHA CVD Guidelines for Women were updated in 2007 and recommend that healthcare professionals should focus on women’s lifetime heart disease risk, not just short-term risk.”

Let this not distract us from the fact, I say, that statins have not been shown to benefit essentially healthy women. And let’s not forget either that for each person that benefits from taking statins, many, many others don’t.

References:

1. Abramson J, Wright JM. Are lipid-lowering guidelines evidence-based? Lancet 2007;369:168-169

2. Manuel DG, et al. Effectiveness and efficiency of different guidelines on statin treatment for preventing deaths from coronary heart disease: modeling study. BMJ 2006;332:1419

3. Kenrick M. Should women be offered cholesterol lowering drugs to prevent cardiovascular disease? No. BMJ 2007;334:983

4. Dobson R. Atorvastatin advertising misled over benefits for women, study claims. BMJ 2008;337:a2209

5. Eisenberg T, et al. Statins and Adverse Cardiovascular Events in Moderate-Risk Females: A Statistical and Legal Analysis with Implications for FDA Preemption Claims. Journal of Empirical Legal Studies. Published Online: Sep 5 2008
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Article from: http://www.drbriffa.com/blog/2008/10/24/should-women-who-have-paid-for-statins-be-given-their-money-back/