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Jeffrey Dach, M.D. NewsLetter
Cholesterol Lowering Statin Drugs for Women
Just Say No to Statin Drugs
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A Woman on Lipitor 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, she also had leg pain for the past 3 months, which prevented exercising. Lumbar Spine MRI Scan 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, Lipitor. 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 Lipitor, a valid reason for stopping the drug. The leg muscle pain is caused by Lipitor depletion of Co-Enzyme Q 10, which is important for energy production in the muscle cells. I suggested to Sally that she supplement with CO-enzyme Q-10, and strongly recommended stopping the statin drug.
What is the definition of elevated cholesterol?
When I was a medical student in 1976, normal cholesterol was 240. However, this was changed in 1993 to the new guidelines.
New Cholesterol Guidelines in 1993
above 240: high
above 200: borderline high
below 200: desirable
The cholesterol guidelines were revised downward to 200 by a committee of 9 doctors, 8 of whom were receiving money from statin drug companies. There was no science behind this revision.
(1
)
(2)
(3)
The laboratory will flag any cholesterol test results above 200 as abnormal. Please ignore this. In reality a cholesterol reading above 200 and below 240 is normal. If above 240, then nutritional supplements containing naicin, omega 3 oils, and plant sterols are used to bring it down to 240. (4)
Mary Enig says: "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. (4)
A cholesterol of 240 is NOT ELEVATED. This is normal and compatible with good health.
Medical Terrorism through Drug Company Advertising:
The reality is that there is no mortality benefit from lowering cholersterol with statin drugs: Both lines on the chart below are superimposed meaning the number of deaths in the statin drug group was identical to the number of deaths in the placebo group. Chart Courtesy of (Eddie Vos).
Just say NO When Your Doctor Prescribes a Statin Drug.
The truth is that NO woman should ever be given Lipitor or any other statin drug for elevated cholesterol. Dr. 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.
No Female Should Ever Take A Statin Drug
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. They don’t work for women. Women who take Lipitor or any other statin drug to lower cholesterol do not live any longer than women who don’t take the drug. There is no benefit in terms of prolonging your life for women. On the other hand, there are plenty of adverse side effects which include muscle pain, cognitive impairment, neuropathy, congestive heart failure, transient global amnesia and dementia,
Why do Cardiologists Give Statin Drugs to Women?
Why do cardiologists and mainstream docs continue to prescribe statins to women? It is very simple, they succumb to the drug company “spin” from the drug reps and the medical journals which are slanted in favor of statins. In addition, the mainstream doctors succumb to patient's demands and expectations for the drugs after seeing the celebrity TV ads.
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)
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, 4 years ago in an 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"."(8A) "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."(8A)
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 (9) "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 review article by Joel Kauffman PhD, Dec 2003, in which the best statin trial results (the HPS simvastatin study) had an absolute reduction of all cause death rate of 0.38% per year. Yet this performance was inferior to the less expensive alternatives of buffered aspirin or Omega-3 oils.(10)
Quote: "The most favorable (statin) trial with seemingly impeccable reporting and minimal financial conflict of interest was the Heart Protection Study (HPS), on simvastatin for 5 years, in which secondary prevention in men (86% of patients) of any unwanted vascular event gave a RR = 0.76 (5.5% absolute, 1.1% per year), and an all-cause death rate drop of 0.38% per year.16 Since this performance is inferior to that of either Bufferin in men or omega-3 fatty acid supplements, both of which have lesser side-effects, and are far less expensive, the logic of prescribing simvastatin seems faulty.".(10)
Still not convinced? Then read this article by Harriett Rosenberg from Women and Health Protection from June 2007, Do Cholesteriol Lowering Drugs Benefit Women ? (11) Evidence for Caution: Women and statin use By Harriet Rosenberg Danielle Allard Women and Health Protection June 2007
Still not convinced? Not only are statin drugs a failure for women, they also should never be prescribed to the elderly. Mortality in the elderly goes up as cholesterol goes down. Read this Letter to the Editor by Eddie Vos. (12)
Still not convinced? Then read this article by Bill Sardi, Who Will Tell the People? It Isn't Cholesterol ! (13)
Still not convinced? Then read this Jan 2007 Lancet article by Harvard trained MD, John Abramson, "Are lipid-lowering guidelines Evidence-Based ? ". (14)
Still not convinced? Then read this e-book by Shane Ellsion, "The Hidden Truth About Cholesterol-Lowering Drugs! ", by Shane Ellison, MS, Organic Chemistry. (15)
The New York Times Questions the Value of Lowering Cholesterol with Statin Drugs !!
In a surprise turnaround, The New York Times questions the value of treating cholesterol with statin drugs in this article, "New Questions on Treating Cholesterol", By ALEX BERENSON, New York Times January 17, 2008 . (16)
Quote: "In the last 13 months, however, the failures of two important clinical trials have thrown that hypothesis into question. (that cholesterol lowering is beneficial).
First, Pfizer stopped development of its experimental cholesterol drug torcetrapib in December 2006, when a trial involving 15,000 patients showed that the medicine caused heart attacks and strokes. That trial — somewhat unusual in that it was conducted before Pfizer sought F.D.A. approval — also showed that torcetrapib lowered LDL cholesterol while raising HDL, or good cholesterol.
Torcetrapib’s failure, Dr. Taylor said, shows that lowering cholesterol alone does not prove a drug will benefit patients.
Then, on Monday, Merck and Schering-Plough announced that Vytorin, which combines Zetia with Zocor, had failed to reduce the growth of fatty arterial plaque in a trial of 720 patients. In fact, patients taking Vytorin actually had more plaque growth than those who took Zocor alone.
Despite those drawbacks, that trial, called Enhance, also showed that patients on Vytorin had lower LDL levels than those on Zocor alone. For the second time in just over a year, a clinical trial found that LDL reduction did not translate into measurable medical benefits." endquote (16)
Business Week Questions the Benefit of Lowering Cholesterol
with Statin Drugs !! (ignoring LDL cholesterol altogether ", and "Cholesterol lowering is not the reason for the benefit of statins".
Both Merck and Pfizer are now under Investigation by the John Dingell's House Committee and by New York Attorney General Andrew Cuomo !!
1) Senator John Dingell’s House Committee subpoenaed both Merck and Pfizer. Merck's subpoena was for the Vytorin records. Pfizer's subpoena was for the Jarvik Lipitor Celebrity Ads.
2) The Enhance Vytorin scandal has prompted New York Attorney General Andrew Cuomo to issue a subpeana to Merck & Co and Schering-Plough Corp to investigate the allegations of deceitful marketing and insider trading.
The Vytorin Enhance Data showed no benefit for the Zetia/Zocor combination compared to Zocor alone. This created a scandal because of the late registration of the Enhance study, and accusations of insider trading at Pfizer, dumping stock in advance of the unfavorable results. Merck and Schering sat on the results
of an unfavorable study for almost two years. They claim they haven’t peeked at the data, but Schering President Carrie Cox dumped 28 Million worth of stock back in the spring of 2007.
3) 2 drug trials in the past 13 months show no health benefit of lowering LDL cholesterol. (ENHANCE and Torcetrapib)
Dr Steven Nissen, cardiologist at Cleveland Clinic, said this of the Merck Enhance-Vytorin data, ” ENHANCE results were a big surprise and a big disappointment. The data show no benefit for ezetimibe (Zetia) on top of simvastatin (Zocor). In fact, the data on both the rate of progression of atherosclerosis and cardiovascular events are trending in the wrong direction. This is a pretty clear failure. Physicians should now stop using ezetimibe or Vytorin except as a last resort. The drug doesn’t work”.
The results of the ENHANCE had to be released because now all trials must be pre-registered with the government because of new FDA rules Sept 2007. In the old days it would have been buried. (22B)
The following quote about Vytorin-Enhance from Bill Sardi is illuminating:(18
)
From Bill Sardi: "The revelation that statin cholesterol drugs may be of little or no benefit, as revealed in a lengthy cover story in January 28 issue of Business Week (BW) magazine, begs the question: how did this misdirection go on for so long?
As the BW article pointed out, statin drugs "are the best-selling medicines in history, used by more than 13 million Americans and an additional 12 million patients around the world, producing $27.8 billion in sales in 2006."
How can anyone question the benefits of such a drug, asks BW, when they are "thought to be so essential that, according to the official government guidelines from the National Cholesterol Education Program (NCEP), 40 million Americans should be taking them. Some researchers have even suggested – half-jokingly – that the medications should be put in the water supply, like fluoride for teeth. And it's almost impossible to avoid reminders from the industry that the drugs are vital. A current TV and newspaper campaign for one statin drug, as endorsed by Dr. Robert Jarvik, artificial heart inventor, proclaims that this drug ‘reduces the risk of heart attack by 36%...in patients with multiple risk factors for heart disease’."
Statin drug ruse revealed:
But the cholesterol/statin drug ruse finally unraveled when, after two years of foot dragging delays to release data from a large study involving Zetia, a cholesterol-lowering drug that inhibits cholesterol absorption from foods, and Vytorin, which is a combination of Zetia plus Zocor, the latter a statin drug that inhibits formation of cholesterol in the liver, revealed no health benefits.
Even though this drug combo lowered circulating cholesterol numbers better than either drug alone, it did not reduce plaque formation in arteries and did not confer a projected reduction in mortality.
In fact, an earlier review published last year in the British journal Lancet by Drs. John Abramson of Harvard Medical School and James M. Wright MD of the University of British Columbia, could find no evidence for a reduction in cardiac mortality in a combined review of all published statin drug studies. [The Lancet 2007; 369:168–169]
Falsifying the numbers:
The Business Week report says statin drugs benefit only 1 in 100 users, but they claim to reduce the risk of a non-mortal heart attack by 36%. But that figure is a relative number, not a hard one. About 3% of patients taking an inactive placebo pill will experience a heart attack compared to 2% taking a statin drug, which produces the so-called 30-plus percent risk reduction. But in hard numbers, this is only a 1% reduced risk. This type of misleading advertising wouldn’t pass Federal Trade Commission guidelines. But public health agencies, serving as free publicity agents for the statin drug manufacturers, repeat the claim to give it a ring of credibility."
endquote from Bill Sardi.
More on the Merck Vytorin/Enhance Scandal: America Fooled Again(19) (20)
Merck ran these two TV ads over the course of about a year spending 100 million dollars, allowing a windfall of 1-2 billion dollars on the sale of Vytorin. All the time they knew that the ENHANCE study showed that Vytorin didn't work. Take at look at the TV ads that fooled a nation.
(Vytorin Ad #1 video) 30 sec, Humorous clothes which look like the food. (21)
(Vytorin Ad Video #2) More Food colored tro match the clothes. (22
)
Wall Street Journal, Congress Investigates Vytorin Ads
Posted by Anna Wilde Mathews: Splash ads for your drug across every TV screen and magazine in the land, and there’s a good chance you’ll hear some static about them if the drugs start to take heat.(22A)
Editorials: Mandatory disclosure of trial results for drugs and devices New US law will require public posting of all the main results and data on harms.
Last week the drug industry was shown, twice, to have suppressed trial results that were commercially unfavourable—an all too familiar tale. But from September 2008, a new US law will mandate the public disclosure of such results, and it will no longer be left to investigative journalists and other researchers to dig out the findings of trials.
Vytorin Ad Shame Taints Entire Marketing Industry Cholesterol Drug's Ad Campaign Turns Into PR Nightmare, Fanning Flames of Public Mistrust of DTC By Rich Thomaselli Published: January 21, 2008 (22C) "Reports that Merck & Co. and Schering-Plough Corp. kept under wraps for more than a year findings that Vytorin does not deliver results it spent more than $100 million advertising to consumers is much more than a PR disaster for the drug's co-marketers.
Coming on the heels of a New York Times story that Pfizer's $2 billion drug Lyrica treats a condition, fibromyalgia, that a lot of doctors don't think exists, the Vytorin news is fanning the flames of public mistrust for the $5 billion direct-to-consumer drug industry -- and the ad business in general. " end quote
Lipitor and the Dracula of Medical Technology
My previous Newsletter, (Lipitor and the Dracula of Medical Technology), discussed the Robert Jarvik -Lipitor celebrity ads.
In a new development, John Dingell’s House Committee on Energy and Commerce has issued Subpoenas to Pfizer CEO, Jeffrey B Kindler, asking for information about the Jarvik-Lipitor Ad Materials: Here is the letter:(22)
Among other things, Chairman John Dingell wants to know why Jarvik takes Lipitor, and why Jarvik impersonates a doctor in the Ads, yet has never actually been licensed to practiced medicine.
Robert Jarvik, MD, Inventor of the Jarvik Heart
Here is coverage of the letter in the Wall street Journal:(23)
Here is a Lipitor Ad (Video) with Robert Jarvik 60 seconds. (24)
What's Next? Could this be the END of the Lipitor Era? Stay Tuned.
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References
(1) The new cholesterol guidelines, Applying them in clinical practice Brian L. Pearlman, MD, FACP VOL 112 / NO 2 / AUGUST 2002 / POSTGRADUATE MEDICINE
(2) The new cholesterol guidelines
(3) USA Today, 2004, Cholesterol guidelines become a morality play the Associated Press
(4) Mary Enig, Cholesterol and Heart Disease-- A Phony Issue
(5) Questioning the benefits of statins Eddie Vos and Colin P. Rose , CMAJ • November 8, 2005; 173 (10). doi:10.1503/cmaj.1050120.
(6) Dangers of Statin Drugs: What You Haven’t Been Told About Popular Cholesterol-Lowering Medicines By Sally Fallon and Mary G. Enig, PhD
(7) 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.
(8) Drug Treatment of Hyperlipidemia in Women Judith M. E. Walsh, MD, MPH; Michael Pignone, MD, MPH
JAMA. 2004;291:2243-2252.
(8A) BMJ 2007;334:983 (12 May), doi:10.1136/bmj.39202.397488.AD
Should women be offered cholesterol lowering drugs to prevent cardiovascular disease? No Malcolm Kendrick, general practitioner
(9) Women's Health Activist May/ June 2007: Exploring Statins: What Does the Evidence Say? By Electra Kaczorowski, National Women’s Health Network
(10) 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
(11) Evidence for Caution: Women and statin use By Harriet Rosenberg Danielle Allard Women and Health Protection June 2007
(12) LETTER TO THE EDITOR: Statins for women, elderly: Malpractice? Nutrition, Metabolism & Cardiovascular Diseases (2007) 17, e19ee20 Eddie Vos 127 Courser Rd, Sutton (Qc),
(13)
Who Will Tell the People? It Isn't Cholesterol! by Bill Sardi
(14) Lancet: Vol 369 January 20, 2007 Are lipid-lowering guidelines evidence-based? J Abramson and JM Wright
(15)"The Hidden Truth About Cholesterol-Lowering Drugs! ", by Shane Ellison, MS, Organic Chemistry
(16)"New Questions on Treating Cholesterol", By ALEX BERENSON, New York Times January 17, 2008
(18
) Government Health Agencies Complicit in Cholesterol Ruse
by Bill Sardi
(19) Zetia Enhance trial
(20)January 14, 2008, 9:11 am Zetia Doesn’t Enhance Zocor Posted by Shirley S. Wang Wall Street Journal
(21) Vytorin video AD 30 sec, Humorous clothes which look like the food.
(22) Letter from John Dingel Mich to CEO of Pfizer asking for records on Jarvik and Lipitor, celebrity endorsement of Lipitor Ads.
(22A) Wall Street Journal January 16, 2008, 3:44 pm Congress Investigates Vytorin Ads Posted by Anna Wilde Mathews
(23) January 7, 2008, Wall Street Journal, Congress to Pfizer: Why is Robert Jarvik the Lipitor Man? Posted by Shirley S. Wang
(24) Lipitor Ad with Robert Jarvik 60 seconds
(25)
New Questions on Treating Cholesterol
By ALEX BERENSONPublished: January 17, 2008
For decades, the theory that lowering cholesterol is always beneficial has been a core principle of cardiology. It has been accepted by doctors and used by drug makers to win quick approval for new medicines to reduce cholesterol.
Study Reveals Doubt on Drug for Cholesterol (January 15, 2008) Times Health Guide: Cholesterol
But now some prominent cardiologists say the results of two recent clinical trials have raised serious questions about that theory — and the value of two widely used cholesterol-lowering medicines, Zetia and its sister drug, Vytorin. Other new cholesterol-fighting drugs, including one that Merck hopes to begin selling this year, may also require closer scrutiny, they say.
“The idea that you’re just going to lower LDL and people are going to get better, that’s too simplistic, much too simplistic,” said Dr. Eric J. Topol, a cardiologist and director of the Scripps Translational Science Institute in La Jolla, Calif. LDL, or low-density lipoprotein, is the so-called bad cholesterol, in contrast to high-density lipoprotein, or HDL.
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Jeffrey Dach MD
4700 Sheridan Suite T
Hollywood FL 33021
954 983-1443
Jeffrey Dach, M.D.
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All after tax profits from TrueMedMD clinic operations are donated to charity.
(c) 2007-2008 all rights reserved jeffrey dach md
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Jeffrey Dach, M.D. TrueMedMD
Catalog of NewsLetters
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(1)
My Vitamins Are Killing Me by Jeffrey Dach MD !!!
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Stroke Prevention and Vitamin C by Jeffrey Dach MD
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(9) Orthomolecular Medicine Meeting in Toronto 2007 by Jeffrey Dach MD
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(12) Vitamin D Deficiency by Jeffrey Dach MD
(13) Andrew Weil AARP, and Human Growth Hormone HGH by Jeffrey Dach MD
(14) Michael Moore's SICKO by Jeffrey Dach MD
(15) Blood Pressure Pills for Hypertension, When to Treat? by Jeffrey Dach MD
(16) Low Dose Naltrexone (LDN) by Jeffrey Dach MD
(17) Protect Your Family From Bad Drugs by Jeffrey Dach MD
(18) Roger Federer, Race Horses and Pulsed ElectroMagnetic Devices by Jeffrey Dach MD
(19) Vaccination, Autism Link, Real or Imagined? by Jeffrey Dach MD
(21) The Importance of the Pelvic Sonogram by Jeffrey Dach MD
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Catalog of Articles Published on Hank Barnes World,
You Bet Your Life, by Jeffrey Dach MD
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(1)
Lipitor and "The Dracula of Modern Technology" by Jeffrey Dach MD
(2)
Osteoporosis, Bisphosphonate Drugs and Toulouse Lautrec by Jeffrey Dach MD
(3)
Prozac, Paxil and SSRI Drugs - Part One by Jeffrey Dach MD
(4)
Prozac, Paxil and SSRI Drugs - Part Two by Jeffrey Dach MD
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The Origins of HIV by Jeffrey Dach MD
A Medical Article that I Published in 1980:
(7)
Dach J, Patel N, Patel S, Petasnick J. Peritoneal mesothelioma: CT, sonography, and gallium-67 scan. AJR Am J Roentgenol. 1980 Sep;135(3):614
Jeffrey Dach, M.D.
Member of the Board of the American Academy of Anti-Aging Medicine
Board Certified by the American Board of Radiology
4700 Sheridan, Suite T
Hollywood Fl 33021
office phone 954-983-1443
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Jeffrey Dach, M.D.
4700 Sheridan Suite T.
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954-983-1443
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Dr. Dach is Board Certified by the American Board of Radiology and a
member of the Board of the American Academy of Anti-Aging Medicine. He has 25 years experience in the Memorial Hospital System as an interventional radiologist. His current practice focuses on Bio-identical hormone supplementation for men and women, menopause, andropause, HGH, testosterone, natural thyroid and the use of natural substances rather than drugs in the appropriate setting.
All after-tax profits from TrueMedMD office operations (including nutritional supplement sales) are donated to charity.
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