Bioidentical Hormones 101 
The Book, by Jeffrey Dach MD

Chapter 40. Cholesterol Lowering Statin Drugs for Women, Just Say No

Chapter 40. Cholesterol Lowering Statin Drugs for Women, Just Say No

A Woman on Crestor With Leg Muscle Pain

Sally, a 56 year old retired real estate agent, came to see me in the office with the chief complaint of hot flashes, night sweats, mood disturbance and weight gain which are all fairly typical post-menopausal symptoms. In addition, leg pain for the past 3 months prevented exercising.  An MRI scan of the Lumbar Spine to evaluate the leg pain showed only a bulging disk and was otherwise negative.  About 6 months ago, Sally’s cholesterol was 245, and her cardiologist prescribed a cholesterol lowering statin drug, Crestor™. Sally has no history of heart disease, does not smoke, eats a healthy diet, and takes a few vitamins, and doesn’t supplement with CoEnzyme Q-10.  I explained to Sally that her leg pain was a well known adverse side effect of Crestor™, a statin drug which lowers cholesterol, and this is a valid reason for stopping the drug.(41)  The leg muscle pain is caused by statin drug depletion of Co-enzyme Q-10,  a substance critical for energy production in the muscle cells.(42-44) I suggested to Sally that she supplement with Co-Enzyme Q-10, and strongly recommended stopping the statin drug.

The New Cholesterol Guidelines -What is elevated cholesterol?

When I was a medical student in 1976, normal cholesterol was 240 mg/dl. However, this was changed in 1993 by new guidelines. Above 240 is high, from 200-240 is borderline high and below 200 is desirable (see below chart).

New Blood Cholesterol Guidelines as of 1993 (1-3)

Above 240 mg/dl

High

From 200-240 mg/dl

Borderline High

Below 200 mg/dl

Desirable.


These new cholesterol guidelines came from a committee of nine doctors, eight of whom were receiving money from statin drug companies, a blatant conflict of interests. In addition, there was no science behind this revision. (1-3)   A 2006 article in the Annals of Internal Medicine argues that there is NO EVIDENCE to support the target numbers outlined by the Cholesterol Guidelines panel, challenging the mainstream medical belief that lower cholesterol levels are always better.(45)   A 2004 petition letter to the NIH by thirty prominent MD's complains about the faulty 1993 Cholesterol Guidelines and asks for a revision. (46)

A number of prominent experts in the field have been critical of the new guidelines.

Mary Enig says cholesterol and heart disease is a “Phoney Issue”(4): "Blood cholesterol levels between 200 and 240 mg/dl are normal. These levels have always been normal. In older women, serum cholesterol levels greatly above these numbers are also quite normal, and in fact they have been shown to be associated with longevity. Since 1984, however, in the United States and other parts of the western world, these normal numbers have been treated as if they were an indication of a disease in progress or a potential for disease in the future. For women, a total cholesterol result 240 should not be considered elevated. This is quite normal for women and compatible with good health.  (4)

No Female Should Ever Take a Statin Drug

The obvious message here is that NO woman should ever be prescribed statin drugs for elevated cholesterol.   Dr. Colin Rose says, "There are no statin trials with even the slightest hint of a mortality benefit in women and women should be told so".(5)  In other words, statin drugs don’t work for women.   Yes, statin drugs work quite well at lowering cholesterol levels, but this does not equate with improved health or longer life span.   

Let me repeat that so this is very clear: No female should ever take a statin drug to lower cholesterol for primary prevention of heart disease. These drugs do not provide a health benefit for women. Women who take Lipitor or any other statin drug to lower cholesterol do not live any longer than women who do not take the drug. There is no benefit in terms of prolonging life for women.  On the other hand, statin drugs carry numerous adverse effects such as muscle pain, cognitive impairment, neuropathy, congestive heart failure, transient global amnesia, dementia, cancer and erectile dysfunction (impotence) and CoQ10 depletion. (47-49)

Why Do Cardiologists Give Statin Drugs to Women?

You might be asking yourself the question: In spite of the lack of health benefit and known adverse effects, why do cardiologists and mainstream doctors continue to prescribe statin drugs for women?  The answer is mainstream doctors and cardiologists succumb to the drug company “spin” from the drug reps and the medical journals slanted in favor of statin drugs downplaying adverse effects.  In addition, the mainstream doctors yield to their patients’ demand for statin drugs created by celebrity television drug ads.

Are You Still Not Convinced?

Mary Enig writes:  "No study has shown a significant reduction in mortality in women treated with statins. The University of British Columbia Therapeutics Initiative came to the same conclusion, with the finding that statins offer no benefit to women for prevention of heart disease." (6) (7)

Are you still not convinced that women should NOT take Statin Drugs? Don’t take my word for it. Take the word of Judith Walsh MD who wrote this in JAMA article entitled, Treatment of Hyperlipidemia in Women:  "For women without cardiovascular disease, lipid lowering does not affect total or CHD (Cardiovascular Heart Disease) mortality. Lipid lowering may reduce CHD events, but current evidence is insufficient to determine this conclusively. For women with known cardiovascular disease, treatment of hyperlipidemia is effective in reducing CHD events, CHD mortality, nonfatal myocardial infarction, and revascularization, but it does not affect total mortality."(8)  Translation: Cholesterol lowering with statin drugs does not reduce total mortality in women, PERIOD. It doesn’t reduce mortality in women without heart disease, called primary prevention. It doesn’t reduce mortality in women with heart disease, called secondary prevention.

Still not convinced? Then read this article by Malcolm McKendrick, a doctor in England, in the British Medical Journal, May 2007, entitled: "Should Women be Offered Cholesterol Lowering Drugs? NO "… "To date, none of the large trials of secondary prevention with statins has shown a reduction in overall mortality in women. Perhaps more critically, the primary prevention trials have shown neither an overall mortality benefit, nor even a reduction in cardiovascular end points in women. This raises the important question whether women should be prescribed statins at all. I believe that the answer is clearly no."(50)  Note: Secondary prevention means women with known heart disease. Primary prevention means women without known heart disease.

Still not convinced? Then read this June 2007 article by Electra Kaczorowski, of the National Women’s Health Network : "There is currently no indication that women of any age or any risk level will benefit from taking statins to prevent CHD and other heart conditions – yet this is precisely how statins are being marketed to women. " (9)

Still not convinced? Are statin drugs good for anybody? Read this 2003 review article by Joel Kauffman PhD, in which he points out the best statin trial, the HPS Simvastatin Study (50), had an absolute reduction of all cause mortality of only 0.38% per year, a result inferior to that obtained with less expensive buffered aspirin.(10)(50)

Still not convinced ? Then read this article by Harriett Rosenberg from Women and Health Protection  June 2007, “Do Cholesterol Lowering Drugs Benefit Women ?  Evidence for Caution: Women and Statin Use”,  by Harriet Rosenberg: "Our review of these fields identifies a troubling disjuncture between the widespread use of statin medication for women and the evidence base for that usage. What we found instead was evidence for caution."(11)

Still not convinced? Then read this Jan 2007 Lancet article by Harvard trained MD, John Abramson, "Are lipid-lowering guidelines Evidence-Based ? ". (14)   " No studies have shown statin cholesterol-lowering drugs to be effective neither for women at any age, nor for men 69 years of age or older, who do not already have heart disease or diabetes. Better than fifty adults have to take a cholesterol-lowering drug for one patient to avoid a mortal heart attack, and that figure only applies to high-risk patients. There is a vanishing benefit to lowering cholesterol for healthy adults." (14) Dr. John Abramson joined with thirty MD's in a 2004 letter to the NIH calling for a complete revision of the faulty cholesterol treatment guidelines.   Can't convince your doctor NOT TO prescribe statin drugs for you? Print out this chapter and give it to your doctor.

For references and links, see my web site: www.bioidenticalhormones101.com

References for Chapter 40. Cholesterol Lowering Statin Drugs for Women, Just Say No

(1) http://www.postgradmed.com/issues/2002/08_02/pearlman.shtml The new cholesterol guidelines, Applying them in clinical practice, Brian L. Pearlman. Vol 112 , N 2, Aug 2002, Postgraduate Medicine

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2) http://hp2010.nhlbihin.net/ncep_slds/atpiii/slide25.htm The new cholesterol guidelines

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3) http://www.usatoday.com/news/health/2004-10-16-panel-conflict-of-interest_x.htm
USA Today, 2004, Cholesterol guidelines become a morality play the Associated Press

(4)
http://www.westonaprice.org/know-your-fats/538-cholesterol-and-heart-disease-a-phony-issue?qh=YToyOntpOjA7czo0OiJlbmlnIjtpOjE7czo1OiJlbmlnZSI7fQ==
Cholesterol and Heart Disease: A Phony Issue. by Mary G. Enig, PhD June 30 2001, at
www.westonprice.com

(5) http://www.cmaj.ca/cgi/content/full/173/10/1207-a
Questioning the benefits of statins Eddie Vos and Colin P. Rose , CMAJ • November 8, 2005; 173 (10). doi:10.1503/cmaj.1050120.

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6) http://www.westonaprice.org/moderndiseases/statin.html
Dangers of Statin Drugs: What You Haven’t Been Told About Popular Cholesterol-Lowering Medicines By Sally Fallon and Mary G. Enig, PhD

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7) http://www.ti.ubc.ca/pages/letter48.htm
Therapeutics Initiative, Do Statins have a Role in Primary Prevention? There were 10,990 women in the primary prevention trials (28% of the total). Only coronary events were reported for women, but when these were pooled they were not reduced by statin therapy, RR 0.98 [0.85-1.12]. Thus the coronary benefit in primary prevention trials appears to be limited to men, RR 0.74 [0.68-0.81], ARR 2.0%, NNT 50 for 3 to 5 years.

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8) http://jama.ama-assn.org/cgi/content/abstract/291/18/2243
Drug Treatment of Hyperlipidemia in Women Judith M. E. Walsh, MD, MPH; Michael Pignone, MD, MPH JAMA. 2004;291:2243-2252.

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9) http://www.nwhn.org/newsletter/article.cfm?content_id=134
Women's Health Activist May/ June 2007: Exploring Statins: What Does the Evidence Say? By Electra Kaczorowski, National Women’s Health Network

(10)
http://www.laleva.org/eng/2004/04/statin_drugs_-_a_critical_review_of_the_riskbenefit_clinical_research.html
Statin Drugs: A Critical Review of the Risk/Benefit Clinical Research, Joel M. Kauffman, Ph.D. Professor of Chemistry Emeritus USP Philadelphia, PA, USA 9 Dec 2003. Also see:
http://www.healthyskepticism.org/global/library/item/11630

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11) http://www.whp-apsf.ca/pdf/statinsEvidenceCaution.pdf
Evidence for Caution: Women and statin use By Harriet Rosenberg Danielle Allard Women and Health Protection June 2007

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12) http://www.health-heart.org/malpractice.pdf
LETTER TO THE EDITOR: Statins for women, elderly: Malpractice? Nutrition, Metabolism & Cardiovascular Diseases (2007) 17, e19ee20 Eddie Vos 127 Courser Rd, Sutton (Qc),

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13) http://www.lewrockwell.com/sardi/sardi69.html
Who Will Tell the People? It Isn't Cholesterol! by Bill Sardi

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14) http://overdosedamerica.com/articles.php
Lancet: Vol 369 January 20, 2007 Are lipid-lowering guidelines evidence-based? J Abramson and JM Wright

(
15) http://www.health-fx.net/eBook.pdf
The Hidden Truth About Cholesterol-Lowering Drugs, by Shane Ellison, MS, Organic Chemistry

(
16) http://www.nytimes.com/2008/01/17/business/17drug.html
New Questions on Treating Cholesterol, By ALEX BERENSON, New York Times January 17, 2008

(
18) http://www.lewrockwell.com/sardi/sardi79.html 
Government Health Agencies Complicit in Cholesterol Ruse by Bill Sardi on Lew Rockwell.com

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19) http://pharmamkting.blogspot.com/2008/01/should-i-stop-taking-zetia.html
Pharma Marketing Blog by Shaun McIver, of Streamlogics, Inc discussion of Zetia Enhance trial.

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20) http://blogs.wsj.com/health/2008/01/14/zetia-doesnt-enhance-zocor/
January 14, 2008, 9:11 am Zetia Doesn’t Enhance Zocor Posted by Shirley S. Wang Wall Street Journal

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21) http://www.youtube.com/watch?v=kBfWybm0218
Vytorin video AD on You Tube 30 sec, Humorous clothes which look like the food. These ads have been pulled from national television.

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22) http://energycommerce.house.gov/Press_110/110-ltr.010708.Pfizer.Jarvik.pdf
Letter from John Dingel Mich to CEO of Pfizer asking for records on Jarvik and Lipitor, celebrity endorsement of Lipitor Ads.

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23) http://blogs.wsj.com/health/2008/01/16/congress-investigates-vytorin-ads/
Wall Street Journal January 16, 2008, 3:44 pm Congress Investigates Vytorin Ads Posted by Anna Wilde Mathews

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24) http://blogs.wsj.com/health/2008/01/07/congress-to-pfizer-why-is-robert-jarvik-the-lipitor-man/
January 7, 2008, Wall Street Journal, Congress to Pfizer: Why is Robert Jarvik the Lipitor Man? Posted by Shirley S. Wang

(
25) http://video.search.yahoo.com/video/play?vid=1298285495&vw=g&b=0&pos=4&p=lipitor&fr=yfp-t-501  Lipitor Ad with Robert Jarvik 60 seconds.  This ad has been pulled and no longer shown on national television. 

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26) http://www.nytimes.com/2008/01/17/business/17drug.html
New Questions on Treating Cholesterol By ALEX BERENSON Published: January 17, 2008. NY Times.

(
27) http://www.jpands.org/vol10no3/colpo.pdf
LDL Cholesterol, Bad Cholesterol or Bad Science by Anthony Colpo, Journal of American Physicians and Surgeons Volume 10 Number 3 Fall 2005

(
28) http://www.joplink.net/prev/200411/200411_10.pdf
Recurrent Acute Pancreatitis Possibly Induced by Atorvastatin and
Rosuvastatin. Is Statin Induced Pancreatitis a Class Effect? JOP. J Pancreas (Online) 2004; 5(6):502-504.

(
29) http://www.cmellc.com/geriatrictimes/g040618.html
Statin Adverse Effects: Implications for the Elderly by Beatrice A. Golomb, M.D., Ph.D. Geriatric Times  May/June 2004  Vol. V  Issue 3. "No survival benefit with statin drugs is seen in elderly patients at high risk for cardiovascular disease (Shepherd et al., 2002). For patients older than 85, benefits may be more attenuated and risks more amplified (Weverling-Rijnsburger et al., 1997). In fact, in this older group, higher cholesterol has been linked observationally to improved survival.

(30) http://www.bmj.com/cgi/content/full/335/7614/285
Preventive health care in elderly people needs rethinking, BMJ  2007;335:285-287 (11 August), "Preventive use of statins shows no overall benefit in elderly people as cardiovascular mortality and morbidity are replaced by cancer".

(31) http://image.thelancet.com/extras/02art8325web.pdf
Pravastatin in elderly individuals at risk of (PROSPER): a randomised controlled trial. THE LANCET • Published online November 19, 2002 •

(32) http://www.spacedoc.net/index.html
SpaceDoc, Duane Graveline MD Author of Statin Drugs Side Effects

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33) http://www.thincs.org/index.htm
THINCS The International Society of Cholesterol Sceptics

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34) http://www.jpands.org/vol12no1/kauffman.pdf
Misleading Recent Papers on Statin Drugs in Peer-Reviewed Medical Journals Joel M. Kauffman, Ph.D. Journal of American Physicians and Surgeons Volume 12 Number 1 Spring 2007

(
35) http://www.scientificexploration.org/jse/articles/pdf/18.4_bauer.pdf
Science in the 21st Century: Knowledge Monopolies and Research Cartels. Henry H. Bauer. Journal of Scientific Exploration, Vol. 18, No. 4, pp. 643–660, 2004

(
36) http://www.ajronline.org/cgi/reprint/151/4/667
Radiologic Appearance of the Jarvik Artificial Heart Implant Its Thoracic Complications AJR 151:667-671, October 1988  Laurie L. Fajardo

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37) http://query.nytimes.com/gst/fullpage.html?res=9A0DE0DC1F3FF93AA15755C0A960948260
The End of Life: Euthanasia and Morality (Oxford University Press, 1986).] 
SUICIDE AND EUTHANASIA Barney Clark’s key to turn off artificial heart.

(
38) http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=11678788
Statins for primary prevention: at what coronary risk is safety assured? Peter R Jackson Br J Clin Pharmacol. 2001 October; 52(4): 439–446.

(
39) http://www.ncbi.nlm.nih.gov/pubmed/16815382?dopt=AbstractPlus
Statins act like Vitamin D !! Lancet. 2006 Jul 1;368(9529):83-6. Grimes DS.

(
40http://www.reuters.com/article/governmentFilingsNews/idUSN2525934020080225
Pfizer pulls TV ads with heart expert Jarvik . By Lisa Richwine Mon Feb 25, Reuters

(41) http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2004/2004_34-eng.php  Updated safety information regarding Crestor® Warning 2004-58 November 24, 2004. Canadian Adverse Drug Reaction Monitoring Program (CADRMP) - HEALTH CANADA. Health Canada is advising Canadians about a possible association between Crestor® and rhabdomyolysis, and muscle pain.

(42) http://www.ncbi.nlm.nih.gov/pubmed/14695925  Biofactors. 2003;18(1-4):101-11. The clinical use of HMG CoA-reductase inhibitors and the associated depletion of coenzyme Q10. A review of animal and human publications. Langsjoen PH, Langsjoen AM.

(43) http://www.ncbi.nlm.nih.gov/pubmed/17482884  Mitochondrion. 2007 Jun;7 Suppl:S168-74.   Coenzyme Q10 and statins: biochemical and clinical implications. Littarru GP, Langsjoen P.

(44) http://www.ncbi.nlm.nih.gov/pubmed/17493470 Am J Cardiol. 2007 May 15;99(10):1409-12. Effect of coenzyme q10 on myopathic symptoms in patients treated with statins. Caso G, Kelly P, McNurlan MA, Lawson WE.

(45) http://www.annals.org/content/145/7/520.full Ann Intern Med. 2006 Oct 3;145(7):520-30. Narrative review: lack of evidence for recommended low-density lipoprotein treatment targets: a solvable problem. Hayward RA, Hofer TP, Vijan S.

(46) http://cspinet.org/new/pdf/finalnihltr.pdf  Petition To The National Institutes of Health Seeking an Independent  Review Panel To Re-Evaluate The National Choesterol Education Program Guidelines, September 23, 2004. Merrill Goozner, Director, Integrity in Science Project, Center for Science in the Public Interest.

(47)
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2849981/ Am J Cardiovasc Drugs. 2008; 8(6): 373–418.  Statin Adverse Effects: A Review of the Literature and Evidence for a Mitochondrial Mechanism by Beatrice A. Golomb, M.D., Ph.D.ab and Marcella A. Evans, B.S.ac

(48) http://fampra.oxfordjournals.org/content/19/1/95.full Family Practice (2002) 19 (1): 95-98. Do lipid-lowering drugs cause erectile dysfunction? A systematic review by Kash Rizvi, John P Hampson and John N Harvey

(49) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1732626/ Epidemiol Community Health. 2004 December; 58(12): 1047–1051. Lipid lowering drugs prescription and the risk of peripheral neuropathy: an exploratory case-control study using automated databases G. Corrao, A. Zambon, L. Bertu, E. Botteri, O. Leoni, and P. Contiero

(50) http://www.bmj.com/cgi/content/full/334/7601/983
BMJ 2007;334:983 (12 May), Should women be offered cholesterol lowering drugs to prevent cardiovascular disease? No, says Malcolm Kendrick, general practitioner.

(51) http://www.ctsu.ox.ac.uk/~hps/pubs/Lancet%20360;7-22.pdf http://www.ncbi.nlm.nih.gov/pubmed/12114036  Lancet. 2002 Jul 6;360(9326):7-22. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial.Heart Protection Study Collaborative Group.

Author: Jeffrey Dach MD   Dr Dach

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