Life Extension Magazine®

Issue: Nov 2004

FDA Permits New Fish Oil Health Claim

When Bill Clinton underwent quadruple bypass surgery, the news media focused on the former president’s high cholesterol level. Life Extension looks at the many factors (in addition to cholesterol) responsible for America’s heart attack epidemic, including those that might have contributed to the severe blockage found in Bill Clinton’s coronary arteries.

By William Faloon.

LE Magazine November 2004

What the News Media Did Not Reveal About Bill Clinton's Heart Problem
 
William Faloon

When a celebrity develops a serious illness, the news media reports not only on the famous person, but also on the disease itself. The media conducts interviews with physicians and discusses what may have caused the celebrity’s ailment.

We have long argued that medical ignorance is the leading cause of death in the US. We thus believe that the news media provides a partial public service by revealing intimate details about a celebrity’s disorder, and information about what average people can do to reduce their risk of contracting the same disease.

In early September, former President Bill Clinton underwent quadruple coronary artery bypass surgery. This operation was performed after Clinton went to his doctor complaining of chest pains and shortness of breath. An angiogram revealed significant (90%) atherosclerotic occlusion in the major arteries feeding his heart. Immediate bypass surgery was prescribed to prevent the 58-year-old former president from suffering a major heart attack.

The news media did a good job of educating the public about coronary artery disease, how it is diagnosed, and what happens during bypass surgery. There was also a lot of reporting on what may have caused the apparently robust former president to develop such a severe case of coronary artery occlusion.

Bill Clinton’s penchant for eating artery-clogging fast food was noted, along with his mild hypertension. If these news media reports motivate some Americans to alter their food choices and maintain optimal blood pressure levels, then Clinton’s ordeal will have provided some benefit to the public.

Regrettably, the news media spent so much time focusing on Clinton’s cholesterol level that people could have been misled into believing that keeping cholesterol low is all it takes prevent coronary artery occlusion. While cholesterol (especially the more dangerous low-density lipoprotein, or LDL) facilitates arterial blockage, it represents only part of the reason why heart attacks continue to strike Americans at epidemic levels.

Misconceptions About Atherosclerosis
Atherosclerosis is the underlying cause of most heart attacks and strokes, yet doctors remain confused as to how this artery-blocking process occurs. Most cardiologists overlook specific mechanisms that inflict arterial wall damage and the ensuing progression to occlusive atherosclerotic disease. The usual result is that only a few of the factors that accelerate arterial blockage (such as elevated LDL) are addressed in today’s clinical setting.

Most doctors think of an ath-erosclerotic lesion as a “clog” consisting of fat, cholesterol, and platelets that have accumulated on an inner arterial wall. As a result, they tell their patients to eat less fat, take a statin drug (if cholesterol levels are high), and use a baby aspirin to prevent arterial platelet aggregation. The problem with these approaches is that while they may postpone a heart attack or stroke, they fail to correct the underlying pathologies that cause atherosclerotic lesions to form and progress.

If people are to live long lives free of the ravages of atherosclerosis, these lethal misconceptions must be cleared up. Otherwise, there will be an epidemic of aging people receiving coronary stents, undergoing bypass surgeries, and dropping dead from sudden heart attacks.

In reporting on Bill Clinton’s coronary bypass surgery, the news media stated that over 300,000 of these “routine” procedures are performed every year. Considering the miserable adverse consequences these operations can inflict, coronary bypass surgery should be considered only as a last resort rather than as a “routine” procedure.

BILL CLINTON’S CHOLESTEROL, LDL, AND BLOOD PRESSURE

One of the unique aspects of being president of the United States is that details of your medical history are made public every year. According to the results of the last exam performed before he left the White House, Bill Clinton’s total cholesterol was 233 mg/dL, which is not outrageously high. Since optimal cholesterol levels are now considered below 200 mg/dL,1 the news media made a big deal over the fact that Clinton’s cholesterol was too high.

A more significant problem that the news media only touched on was that the former president’s LDL level was a dangerous 177 mg/dL. New guidelines call for LDL to be below 100 mg/dL, and some doctors want LDL to be below 70 mg/dL in those suffering from coronary artery disease.2 The Life Extension Foundation was first to advocate that LDL levels should be below 100 mg/dL. Until recently, most mainstream doctors believed that an LDL of 130 mg/dL was all right.

Clinton’s blood pressure of 136/84 used to be considered acceptable, but conventional medicine has finally realized that blood pressure over 119/79 exposes one to greater risks of coronary artery disease, stroke, kidney failure, and other diseases.3 One of the drawbacks of being president is that you get free health care provided by government doctors who are not always up to date on new disease risk factors.

Interestingly, Clinton was prescribed cholesterol-lowering medication before he left the White House, but decided on his own to stop taking the drug after losing some weight. Without first verifying that LDL and cholesterol levels are in safe ranges using a simple blood test, discontinuing any lipid-lowering therapy is a risky strategy. Regrettably, side effects from cholesterol-lowering drugs cause some patients to stop taking them without informing their doctors.4

Why Arteries Clog as We Age
The aging process damages blood vessels, even when conventional risk factors such as cholesterol and blood pressure are within normal ranges.

For the past 35 years, the standard treatment for coronary ath-erosclerosis has been to bypass the blocked arteries. Recuperation from this procedure can take months, and some patients are afflicted with lifetime impairments such as chronic inflammation, memory loss, and depression.5-15

A review of the scientific literature reveals that atherosclerosis is associated with high blood levels of homocysteine,16-24 fibrinogen,25-28 C-reactive protein,29-36 glucose,37,38 cholesterol,39-43 insulin,44-47 iron,48-51 LDL,39-43 and triglycerides,52-54 along with low levels of HDL55-57 and testosterone.45,58-64 Optimizing blood levels of these substances can dramatically reduce heart attack and stroke risk.

Despite thousands of studies validating that atherosclerosis is a multifactorial process, today’s doctors often prescribe a statin drug as the sole therapy to prevent and treat coronary atherosclerosis. Mainstream cardiologists fail to appreciate that coronary atherosclerosis is a sign of systemic arterial dysfunction requiring aggressive therapy to correct it. Conventional medicine’s failure became self-evident when the news media interviewed cardiologists about Bill Clinton’s diseased arteries. The doctors focused on his elevated cholesterol as the cause of his problem.

Life Extension members, on the other hand, have grown inpatient with doctors who fail to translate research findings into improved therapies. More than ever before, health-conscious people are taking responsibility for the health of their arteries by correcting as many of the known risk factors as possible.

Cross-section of an artery demonstrating plaque.

Anatomy of the Artery
Arteries are the blood vessels that bear the full force of each heartbeat. Most people think of arteries as flexible tubes whose only function is to carry blood that flows continuously throughout the body. In fact, arteries are dynamic, functioning muscular structures that, when healthy, expand and contract to facilitate circulation and maintain optimal blood pressure.

The outer layer of the artery comprises mostly connective tissue and provides structural containment for the two layers beneath. The middle area comprises elastic smooth muscle that provides the contractile strength to make possible the artery’s expansion and contraction with each heartbeat. The inner layer, known as the endothelium, comprises a thin area of endothelial cells whose integrity is crucial if atherosclerosis is to be prevented.

Poor health habits and normal aging result in endothelial dysfunction, a process in which the endothelium boundary is broken, arterial flexibility is diminished, abnormal platelet aggregation occurs, and atherosclerotic lesions form in response to arterial wall (endothelium) injuries.

Folic acid,65-71 vitamin C,72-76 fish oil,77-79 and lipoic acid80-84 are just a few of the nutrients that help maintain healthy endothelial function. It is no coincidence that these same nutrients have been shown to reduce cardiovascular incidence in both animals and people.85-94 Agents that suppress chronic inflammation also help protect the endothelium.95-133

LE Magazine November 2004

What the News Media Did Not Reveal About Bill Clinton's Heart Problem

How Atherosclerosis Develops
At least one of every two Americans over the age of 65 has atherosclerosis.134 It is so common in older people that some experts used to think that it was part of the normal aging process.

Atherosclerosis begins with changes in endothelial cell function that cause white blood cells moving through the blood to stick to the endothelium (inner arterial wall) instead of flowing by normally. The endothelium then becomes weakened. This allows blood cells and toxic substances circulating in the blood to pass through the endothelium and enter the artery’s sub-endothelial compartment. Lipid or fat-cell-like substances such as LDL and triglycerides in the blood then accumulate in this area.

The lipids that accumulate in the broken endothelium become oxidized, causing the smooth muscle cells to try to “repair” the damaged endothelium. The result of this repair process is smooth muscle cell infiltration into the endothelium causing the formation of the initial atherosclerotic lesion. Depending on an individual’s risk factors—such as poor diet, lack of exercise, smoking, high blood pressure, and the aging process itself—fat accumulation continues and the atherosclerotic process accelerates.

Immune cells called macro-phages then invade the damaged arterial area to digest the fat. But smooth muscle cells that have migrated to the area have already changed their nature to scavenge fat. These fat-laden white blood cells and smooth muscle cells are called “foam cells,” and provoke a chronic inflammatory attack by various immune components.

Smooth muscle cells try to curtail the injury to the endothelium by producing collagen, which forms a cap over the injury site. Calcium then accumulates over the injury site to form a material resembling bone. This is why atherosclerosis used to be referred to as “hardening of the arteries.”

This complex array of foam cells, calcification, and lipid accumulation is called an atherosclerotic plaque. The plaque grows, and if it becomes unstable, it is vulnerable to acute rupture that exposes the contents of the plaque to blood. Platelets can then rapidly accumulate around this ruptured plaque, resulting in an acute blockage (or blood clot) on the inner surface of the blood vessel wall. This clot can become very large and occlude the vessel. Even small plaques, if they rupture, can interfere with blood flow and cause an acute heart attack.

A 3-D spiral CT scan of carotid atherosclerosis. Inset: Plaque attached to the wall of left internal carotid artery. This angiogram was taken with a helicoidal scanner.

Alternatively, atherosclerotic plaques can grow to such a degree as to restrict blood flow severely, as was the case with former President Clinton. When blood flow within an artery is gravely compromised by a large plaque or blood clot, the cells of tissues that depend on blood flow from that artery become damaged or die. Coronary atherosclerosis cuts off the heart’s blood supply by occluding the heart’s arteries, thus stopping the oxygen supply to the heart and causing a heart attack. A stroke results when atherosclerotic processes cut off the oxygen supply to a portion of the brain.

As you can see, therefore, much more is involved in the development of atherosclerosis than just high cholesterol and LDL. We must emphasize, however, that maintaining optimal LDL and cholesterol levels is an important component of an atherosclerosis-prevention program.

Protecting Your Arterial Walls
High blood pressure,135-140 elevated LDL-cholesterol-triglycerides,141-146 low HDL,147 smoking148-151, diabetes,152-157 obesity,158-161 and lack of exercise162-166 contribute to endothelial dysfunction and the subsequent development of atherosclerosis.

Other significant artery-damaging factors are high-normal levels of glucose, insulin, iron, homocysteine,16-24 and fibrinogen,25-28 and any level of C-reactive protein29-36 that is higher than optimal.

Homocysteine is particularly dangerous because it can induce the initial atherosclerotic injury to the endothelium, then facilitate the oxidation of the fat and LDL that accumulate beneath the damaged endothelium, and finally contribute to the abnormal accumulation of blood components around the atherosclerotic plaque.

Fibrinogen is a clotting factor that accumulates at the site of the endothelial lesion. Fibrinogen contributes to plaque buildup and can participate in the arterial blockage after an unstable atherosclerotic plaque ruptures.

Glucose at high-normal levels may accelerate the glycation process that causes arterial stiffening, while high-normal fasting insulin inflicts direct damage to the endothelium. High levels of iron promote oxidation of LDL in the damaged endothelium, while low levels of testosterone (in men) appear to interfere with normal endothelial function.

C-reactive protein is an inflammatory marker and directly damages the endothelium. Chronic inflammation, as evidenced by persistent high levels of C-reactive protein, not only creates initial injuries to the endothelium, but also accelerates the progression of existing atherosclerotic lesions.

In response to a large number of published studies, enlightened people are taking charge of the health of their arteries. They are eating better, exercising regularly, and undergoing regular blood testing to identify the specific drugs, hormones, and dietary supplements they need to reduce their atherosclerotic risk factors.

The News Media Can Endanger Your Arteries
At the age of 46, Bill Clinton became the third-youngest man to be elected president of the US. Clinton projected an energetic image and was seen as someone who took physical fitness seriously, despite his admittedly poor diet.

We do not want any of our members to become victims of news media hype about what may have caused Clinton’s arteries to clog. We suspect the former president’s heart problems were due to many of the atherogenic factors discussed in this editorial. Sad to say, most cardiologists are not even familiar with the multiple heart-attack risk factors that were long ago identified by the Life Extension Foundation.

In this issue of Life Extension, we examine the pros and cons of statin drugs and provide rational strategies for using these drugs if natural approaches fail. We know that many Life Extension members with elevated LDL or cholesterol levels refuse to take statin drugs because of concern about side effects. The good news is that a patented dietary supplement has been developed that has shown remarkable effects in reducing LDL and cholesterol without side effects. For members who have excess LDL or cholesterol, this new supplement could help lower these artery-clogging factors to safe levels.

For longer life,
image

William Faloon

FDA Permits New Fish Oil Health Claim

LE Magazine November 2004

What the News Media Did Not Reveal About Bill Clinton's Heart Problem
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LE Magazine November 2004
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FDA Permits New Fish Oil Health Claim

It was long ago established that consumption of cold-water fish reduces the risk of heart attack.1 In fact, just two to three servings of fish a week may protect against many diseases, including arthritis, stroke, certain cancers, and a host of inflammation-related disorders.2-9

When scientists sought to discover which components of fish are responsible for preventing heart attacks, they found that the oil plays a critical role. Cold-water fish oil is high in omega-3 fatty acids that function in multiple ways to reduce cardiovascular disease risk.10

Based on the published scientific evidence about fish oil, a lawsuit was filed against the FDA in 1994 by Durk Pearson and Sandy Shaw, seeking to force the agency to allow the following health claim on fish oil supplement labels:

“Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease.”

The FDA rejected this one-sentence claim and a multi-year litigation battle ensued.

In their lawsuit, Durk and Sandy pointed out that consumers would benefit by learning of the value of fish oil in protecting against heart disease. They also argued that the FDA lacked the constitutional authority to ban this truthful health claim.

The FDA contended that this health claim was not adequately backed by scientific studies and that the agency had the legal authority to ban these kinds of health claims.

Seven years of extensive litigation ensued as the FDA asserted that it had the sole authority to dictate what Americans could read on the label of fish oil supplements. After an onslaught of irrefutable scientific evidence was presented, including articles published in the most prestigious scientific journals in the world, the FDA capitulated and said it would permit the following claim:

“Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease. FDA evaluated the data and determined that although there is scientific evidence supporting the claim, the evidence is not conclusive.”

Life Extension Challenges FDA On Fish Oil Health Claim
The FDA’s compromise health claim that the evidence was “not conclusive” did not satisfy The Life Extension Foundation. The scientific literature provided overwhelming validation that consuming cold-water fish or fish oils dramatically lowers heart attack risk.

The Life Extension Foundation Buyers Club, Inc., and Wellness Lifestyles, Inc., filed a health claim petition against the FDA on June 23, 2003. The petition urged the FDA to reconsider its permitted health claim for omega-3 fatty acids and coronary heart disease risk, and to allow the following revised claim:

“Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease.”

To substantiate this position, a massive document enumerating the scientific studies backing the benefits of omega-3 fatty acids was filed, along with legal arguments supporting the constitutional right to disseminate this truthful information.

Also included in the petition was a calculation of how many American lives were needlessly being lost because of the FDA’s restriction of this simple health claim. Epidemiological data were presented showing that if all Americans regularly took fish oil supplements or ate about two cold-water fish meals a week, it would prevent about 150,000 deaths a year. Life Extension further argued that during the seven years it took to litigate this case against the FDA, Americans suffered over 1 million preventable sudden-death heart attacks.

The Political Battle Over What Americans Eat
Junk food is big business in the United States. Processed food companies have historically used their political clout to persuade the federal government to defend the safety of dangerous food products. The cost of treating diseases caused by poor diet has become so staggering, however, that the government is recommending that Americans eat healthier.

For nearly two decades, the FDA protected the economic interests of companies selling high-fat and high-cholesterol foods by making it illegal to promote a healthy diet as a way of preventing heart disease. Heart attack rates were three times higher in the 1950s than in the 1990s. The FDA’s censorship of healthy dietary information caused tens of millions of Americans to unnecessarily succumb to cardiovascular and other diseases.

FDA Capitulates To Scientific Reality
On September 8, 2004, the FDA announced that it would allow an expanded health claim on products containing the omega-3 fatty acids eiscosopentaenoic acid (EPA) and docosahexaenoic acid (DHA).

According to Acting FDA Commissioner Dr. Lester M. Crawford, “Coronary heart disease is a significant health problem that causes 500,000 deaths annually in the United States. This new qualified health claim for omega-3 fatty acids should help consumers as they work to improve their health by identifying foods that contain these important compounds (EPA and DHA).”

The FDA now permits the following statement to be printed on the label of fish oil supplements:

“Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”

Jonathan Emord

The FDA went on to recommend that consumers not exceed more than 3 grams per day of EPA and DHA omega-3 fatty acids, with no more than 2 grams per day derived from a dietary supplement. Life Extension argues that many scientific studies show that higher amounts of EPA and DHA are often needed to obtain optimal benefits, such as reduction of triglycerides and prevention of restenosis (re-occlusion of a blocked artery).11

This battle over what can be stated about fish oil began back in 1994. While the FDA’s announcement of a broader health claim represents a significant legal victory, Life Extension is still not satisfied with the FDA’s latest health claim on fish oil supplements. We reiterate our position that evidence from peer-reviewed scientific publications supporting the benefit of EPA and DHA supplements in reducing heart attack risk is conclusive and not merely “supportive” as the FDA contends.

Life Extension congratulates attorney Jonathan Emord for the hundreds of hours of productive work he has put into this case over the past ten years. Jonathan filed the initial lawsuit against the FDA on behalf of Durk Pearson and Sandy Shaw that resulted in a precedent-setting legal victory against FDA censorship. Jonathan then prepared the petition on behalf of Life Extension and Wellness Lifestyles that resulted in the FDA allowing this new expanded health claim to be made about the protective effect of fish oils against cardiovascular disease.

It is unfortunate that Bill Clinton, as president in 1994, did not take actions he had the authority to take. President Clinton could have ordered the FDA to allow truthful, non-misleading health claims on dietary supplements. If Bill Clinton personally followed the scientifically-based diet and supplement program that the FDA was suppressing at that time, perhaps he could have avoided his recent coronary bypass surgery.

References

1. FTC Press Release, November 29, 2000. “FTC Reaches Record Price-fixing Settlement to Settle Charges of Price-fixing in Generic Drug Market.”

2. Price quoted by Hollywood Discount Pharmacy in Hollywood, Florida on Jan 15, 2002.

3. Associated Press, October 4, 2001. “Drugmaker to pay $875 million fine.”

4. Robert Pear (New York Times News Service). “Health spending jumps 6.9%—Main factors: hospitals and drug costs, managed care resistance, The Herald, Tuesday, January 8, 2002.

5. Faloon William, “Dying from Deficiency,” Life Extension magazine, October 2001.

6. National Vital Statistics Reports, Vol. 48, No.11.

7. Wall Street Journal, December 24, 2001, pp- A3, “Schering Fines Could Total $500 Million.”

8. http://www.cnn.com/HEALTH/9804/14/drug.reaction/Chicago CNN. “Study: Drug reactions kill an estimated 100,000 a year,” April 14, 1998.

9. David Willman, “The Rise and Fall of the Killer Drug Rezulin,” Life Extension magazine,
September 2000.

10. http://news.ft.com/ft/gx.cgi/ftc?pagename= View&c=Article&cid=FT3HZ3AFMWC &live=true&tagid=IXLHT5GTICC&subheading=heal By David Firn in London, “More deaths linked to Bayer’s Lipobay,” January 18, 2002. 19:44 | Last Updated: January 18 2002 19:48

11. Calder PC. n-3 fatty acids and cardiovascular disease: evidence explained and mechanisms explored. Clin Sci (Lond). 2004 Jul;107(1):1-11.