January 17, 20007 -- Recent weeks have witnessed a collapse of the drugs and technology which form the present back bone of cardiology’s assault on the coronary artery disease epidemic. Is this a dark shadow over our cardiac health or could it be a time to rejoice?
Pfizer, in late December 2006 announced its long hoped for block- buster new drug Torcetrapib was killing more people in its test run than were dying in the control group. Pfizer had spent 800 million in developing this drug to raise HDL, “good” cholesterol and had openly forecast it would reap billions for the company once it came into production. But the research trial was clear and unequivocal with its results. Among 15,000 patients, 82 died taking Torcetrapib and 51 died taking a standard drug to lower cholesterol Additionally the Torcetrapib group experienced a greater number of cardiac events such as angina, heart failure, and a need for angioplasty. The independent monitoring group advised Pfizer to halt the trial and they complied. The unfathomable mysteries of human metabolism could not tolerate the assault of this drug. It was making vascular disease worse not better.
The double whammy for cardiology also developed in the second half of 2006. Reports from Europe in September 2006 indicated that patients utilizing the new drug eluting stents were suddenly having heart attacks and some were dying. While the number was small (0.5%), it was disturbing to cardiologists and remains frightening for patients.
When an artery to the heart is severely narrowed and causing symptoms cardiologists insert a balloon tipped catheter to the area of blockage and expand the balloon to widen the constriction. The benefit of this angioplasty is lost in 50% of patients because of recurrent constriction in 6 months. Placing a metal scaffold or stent improves the results to only 10% to 20% recurrent narrowing. Starting in 2003, stents were coated with a drug which diminished the rate of recurrent blockage after angioplasty. However, it is essential to maintain patients on an anti clotting drug for 6-12 months to prevent the stent from developing a clot or thrombosis. It now appears that after stopping the anti-clotting drug 1 in 200 or 0.5%or 5,000 nationwide and 10,000 persons worldwide will have a heart attack and 50% of these will die when the stent fails. These results have so upset cardiologists and the Federal Drug Administration that a national conference was called in December 2006 to review this disturbing news. Watching intently and participating were the stent manufacturers Johnson and Johnson and Boston Scientific. Billions of dollars are at stake.
Following testimony, experts contend that for patients with uncomplicated disease the benefits of the drug-coated stents outweighs the risks. For patients with more advanced or complicated disease patterns the outlook is less clear and more research data is required. What is clear is that everyone feels it may be necessary to prolong the period requiring the anti-clotting drug: Plavix from months to years or indefinitely. However Plavix is not without complications. It promotes bleeding, which may mean a gastrointestinal hemorrhage as well as easy bruising. The most desperate situations occur when a patient taking Plavix must stop it for dental work, hip or other major surgery and colonoscopy. Will they have a heart attack or die from a stent clot when Plavix is stopped? This scenario has occurred and is continuously encountered. It is as if a therapy for one disease now is painting patients into a corner from which they can not escape when other illnesses require surgical therapy.
This Gordian knot has lead leading cardiologists to question stent therapy.
Dr. Eric Topol, a member of the conference panel stated, “There’s a much more liberal use of angioplasty and stenting than there needs to be.”
The head cardiologist at Kaiser Permanente, Dr. Calvin L. Weisberger added, “A large pool of angioplasties and by pass surgery are being done with out scientific evidence.”
The hard science, which seems not to be prominent in all these discussions is that it is not the major blockages which are treated by angioplasty and stents which account for heart attacks. The small unstable juvenile arterial plaques are prone to rupture and cause over 85% of heart attacks, and they are not treated by angioplasty or by-pass surgery. Then why do cardiologists treat the blockages unlikely to cause the heart attacks? There is a lingering belief that somehow the patient will be improved by widening the opening, and there is the unspoken force of money – huge guaranteed money from doing these procedures.
Then there is the harshest critic of all- scientific research. Study after study indicates for most patients undergoing angioplasties and stents, there is no increase in survival and no decrease in heart attacks.
Why might this be a time to rejoice? The morbidity, mortality, expense and transient benefits of a high technology approach toward the coronary disease epidemic, has failed. It is time to realize that the answer to a faulty lifestyle epidemic is not drugs and technology – it is lifestyle. The epidemiologic evidence that coronary artery disease does not exist in cultures consuming plant-based nutrition is robust and overwhelming. There is clear evidence that cultures which switch from a plant based culture to a western diet develop an epidemic of coronary heart disease. Lewis Kuller, Professor of Medicine at the University of Pittsburg School of Public Health, based on his 10 year cardiovascular health study states “all males 65 years of age or older who have been exposed to the traditional western diet have cardiovascular disease and should be treated as such.
This toxic diet with its burden of animal protein, dairy, processed oils, white flour, sugar, and excess saturated and trans fats and free radicals marinates in our bodies injuring our delicate cellular matrix with every bite at every meal. Science shows us how this occurs. We depend mightily on the capacity of our endothelial cells, which comprise the single cell layer lining our arteries, to manufacture nitric oxide. Nitric oxide is the strongest vasodilator in the body. It causes blood vessels to enlarge, prevents blood flow from being sticky or sluggish, and inhibits arterial plaque formation.
The brachial artery tourniquet test quantifies the endothelial responses. The test requires an ultrasound measure of the diameter of the brachial artery below the elbow before and after an upper arm tourniquet stops blood flow to the forearm for 5 minutes. Normally when the cuff is released and the brachial artery ultrasound measurement is repeated the artery dilates or widens. This occurs from a healthy out pouring of nitric oxide from the endothelium. When volunteers consume cornflakes their brachial artery tourniquet test is normal. If they consume sausage, olive oil, or saturated fat they fail the test. The ingested fat so injures the endothelium that it cannot produce nitric oxide. Regular consumption of the toxic western menu is a cardiovascular disaster. The time is long overdue to challenge the failure of drugs and technology to stop the coronary disease epidemic.
The natural next question is can patients who have severe coronary artery disease arrest and reverse this disease by consuming a totally plant based diet?
Dr. Dean Ornish and this author have investigated this question through scientific peer reviewed study. Dr. Ornish reported his results at one year and again at 5 years. This author reported results at 5 years, 12 years and most recently at 21 years in a book for the public, Prevent and Reverse Heart Disease, Avery /Penguin, February 2007. These studies indicate that fully compliant patients decrease the episodes of angina or eliminate them, decrease their cholesterol, decrease their weight, increase their exercise capacity, and arrest and selectively reverse their disease on follow up x-rays of the coronary arteries. Seeing these patients thrive beyond 20 years of initiating their plant-base therapy is the most powerful reason for wanting the cardiology community to embrace and utilize plant- based nutrition. There is no morbidity, mortality or added expense with plant-based nutrition and benefits endure and improve with the passage of time. Cardiologists say they doubt that patients will follow such a nutritional change. My experience in counseling hundreds of these patients indicates this concern is flatly not true. As a matter of fact, patients rejoice in the knowledge that they have become the locus of control over the disease that was destroying them and are distraught they were never told of this option by their cardiologist.
In summary, the dark shadow cast over cardiology, through failure of its miracle drug and the melt down of drug eluting stents with unforeseen clotting resulting in heart attacks and death should motivate us to look more closely at a proven therapy which is effective and endures and has the potential to eliminate the coronary heart disease epidemic, as well as other chronic western illness such as strokes, hypertension, adult onset diabetes, obesity, impotence and dementia.
Caldwell Esseltyn MD is a preventive cardiology consultant in the Department of General Surgery Cleveland Clinic Foundation, Cleveland, Ohio, and the author of the forthcoming, “Prevent and Reverse Heart Disease” due out February 1, 2007.