In The News May 2003

Aged garlic extract (Kyolic) can potentially cut the risk of heart attack by its dramatic reduction of major risk factors for heart disease. This breakthrough that can help save lives was reported to the media in late February by the Research and Education Institute (REI) at Harbor-UCLA Medical Center, where the study took place. The report showed that daily consumption of Kyolic aged garlic extract inhibited atherosclerotic plaque formation in coronary arteries of cardiac patients and reduced blood homocysteine, another risk factor for cardiovascular disease. The study will be presented at the meetings of the Federation of the American Societies for Experimental Biology in San Diego on April 15, 2003.

The placebo-controlled, double blinded clinical trial, lead by Dr. Matthew Budoff, investigated over a year whether aged garlic extract alters the rate of plaque formation in coronary arteries of patients with heart disease, who were on cholesterol-lowering statin medication. Nineteen patients with an average age of 59 participated in the complete study. Nine ingested 4 ml/day (1200 mg/day) Kyolic aged garlic extract, while 10 ingested a placebo. Electron beam tomography (EBT), a non-invasive procedure, served to determine arthrosclerotic plaque progression by measuring calcium deposits (calcification) in coronary arteries. Increased calcification correlates with plaque build-up and indicates an active development of atherosclerotic plaques that can trigger heart attacks.

At year's end, the results were striking. Kyolic aged garlic extract reduced coronary artery plaque build-up by more than 50%, compared to placebo. The garlic extract lowered blood homocysteine, while patients on placebo showed an increase; aged garlic extract also improved high density lipoproteins (HDL, the good cholesterol).

Made from organically grown garlic, by a standardized extraction and aging process, the odorless Kyolic aged garlic extract retains garlic nutrients and is rich in antioxidants that play a role in protecting blood vessel walls from atherosclerosis. The process of extraction and aging produces healthful water-soluble organosulfur compounds, such as S-allyl cysteine, and converts harsh volatile compounds, such as allicin, to stable beneficial substances.

The UCLA study adds new critical information to the body of data showing that aged garlic extract reduces multiple risk factors associated with heart disease. These include blood thinning (by inhibiting platelet aggregation and adhesion), a lowering of blood pressure, stimulation of blood circulation in capillaries, reduction of LDL (the bad cholesterol) and triglycerides levels and inhibition of LDL oxidation (oxidized LDL promotes plaques).

Although the study was small, its striking results on coronary artery protection by aged garlic extract, even in people with heart disease, is hopeful news for those at high risk for heart attacks. Aged garlic extract can be added to other routine medications for heart disease-such as statins-without side effects, potentially enhancing treatment and helping to postpone the need for cardiac surgery. As for healthy people, the study suggest that adding aged garlic extract to the diet would provide a preventive strategy against atherosclerosis and help maintain a healthy heart.

- Carmia Borek, Ph.D.

Medical patents prove the benefits of
CoQ10 when taken with statin drugs

Millions of Americans are now taking various statin drugs such as Lipitor, Zocor, Mevacor and Pravachol to control their cholesterol. While generally considered safe and effective, statin drugs can cause side effects such as liver dysfunction, muscle myopathy, skeletal muscle myopathy and acute renal failure.1

Unfortunately what most patients and doctors do not realize is that the use of statin drugs not only blocks the production of cholesterol but also the production of CoQ10. CoQ10 is an over-the-counter dietary supplement that has been found to be essential for cellular energy production as well as for the functioning of the heart muscle. The heart requires massive amounts of energy to function optimally and CoQ10 is a key element in its energy regulation. According to Dr. Julian Whitaker, "Statin drugs have proven in clinical trials to deplete CoQ10, the 'sparkplugs' of the human body. Patients who take statin drugs without CoQ10, particularly those with a history of heart disease, are especially prone to developing complications that can have fatal consequences."

According to Dr. Whitaker, the pharmaceutical manufacturers have long been aware of the importance of CoQ10 in relation to the use of statin drugs. "The lack of CoQ10 in statin drugs can wreak havoc on patients and that simply taking this compound along with the drug would eliminate these side effects. In fact, the evidence supporting CoQ10 as the antidote to the drug's complications is so clear that in 1989 and in 1990 Merck patented the use of CoQ10 to be combined with statin drugs to both prevent and treat these complications. However, the company has neither exercised these patents nor educated physicians or patients on the necessity of taking CoQ10 along with the drugs. "I'm at a loss as to why Merck refuses to exercise these patents or, at the very least, add a warning label describing the potentially detrimental effects of not taking CoQ10 with its statin products," said Whitaker.

One of the two Merck patents concerned with the combination of statin drugs and CoQ10 states that "Since CoQ10…is of benefit in congestive heart failure patients, the combination with HMG-CoA reductase inhibitors (statin drugs) should be of value in such patients who also have the added risk of high cholesterol."2 This patent was filed by Michael S. Brown on behalf of Merck & Co on June 12, 1990. Now, thirteen years later, doctors and their patients remain ignorant of the benefits of supplementing the use of statin drugs with CoQ10. In preparation of this article numerous calls were made to Merck's press and media office to discuss its patent of the statin/CoQ10 combination and why this invention was never brought to market. Unfortunately, we were unable to obtain a response as to why all of this time, money and research had been undertaken by a leading pharmaceutical company only to let their patents sit in a file cabinet. To this day, few doctors are aware of the depletion of CoQ10 by statin drugs despite the extensive research undertaken by Merck.

In an effort to address this situation, Dr. Whitaker has petitioned the FDA to require the manufacturers of statin drugs to, at the very least, feature warning labels that explain "the need for CoQ10 supplementation with statin drug prescriptions." Dr. Whitaker, in his petition, suggests the "use of 100 to 200mg per day of supplemental CoQ10 to reduce the risk of statin-induce myopathies which include cariomyopathy and congestive heart failure."

1.Whitaker, J.M., M.D. Citizen petition before the department of health and human services Food and Drug Administration, November 24, 2002.

2. Brown, M.S. Coenzyme Q. sub. 10 with HMG-CoA reductase inhibitors. United States Patent 4,933, 165. June 12, 1990.

The importance of testing for
H. Pylori to prevent stomach cancer

Mister Rogers, 1928-2003

America is now mourning its most famous and beloved father figure, Mister Rogers. Originally, Fred Rogers studied music composition and later became an ordained Presbyterian minister. After several attempts at writing and producing children's television, his signature show, Mr. Rogers' Neighborhood was born. It became public television's longest running television program. Mister Rogers had a unique way of communicating love and trust to children everywhere. In this day and age, Mr. Rogers was a welcome respite from aggressive video games and children growing up all too quickly. Sadly, Fred Rogers died at age 74 of stomach cancer despite his disciplined life-style of not smoking, drinking or eating meat. Gastric cancer is the second most common cancer in the world, though it is much less prevalent in the United States.

One of the leading causes of stomach cancer and ulcers is infection with the bacteria Helicobacter Pylori (H. Pylori). Close to two-thirds of the world's population is infected with H. Pylori. In the U.S. older adults are most likely to carry the bacteria. Due to increased sanitation and healthier food preparation,

H. Pylori is not as common in younger adults. Researchers believe that H. Pylori is transmitted orally through the ingestion of waste tainted foods. Once in the body, the bacteria lives in the stomach protected from digestive acids by the mucous membrane. The danger of this bacterium is that there are no symptoms until it has done its damage.

The various methods of diagnosis include an endoscopy in which a biopsy is taken, a blood test that measures whether you have antibodies which stick to H. Pylori, or a breath test in which patients are given a capsule of radioactive C14-urea and asked to blow up a small balloon which will be tested for H. Pylori. Once discovered, there are numerous methods of treating H. Pylori, the most common is a course of oral antibiotics given over a two week period. Unless you complain to your doctor about recurrent stomach pain, it is unlikely that you will be tested for H. Pylori. The Life Extension Foundation urges all of its members to have an H. Pylori antibody blood test every two years. If you test positive - get treated. It could save your life.

Supplement benefit claims finally
allowed by the FDA

The March issue of Life Extension Magazine featured an in-depth report on the recent Federal Court victories in which the FDA had to finally allow certain claims for various nutrients. We are happy to report that this trend continues. On February 21, 2003, the FDA authorized the use of two claims regarding the benefit of the dietary supplement selenium against cancer. The FDA had to relent in the face of substantial scientific evidence concerning these nutrient-disease effects. The language allowed on the label will now state:

Selenium may reduce the risk of certain cancers. Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive.

Selenium may produce anticarcinogenic effects in the body. Some scientific evidence suggests that consumption of selenium may produce anticarcinogenic effects in the body. However, FDA has determined that this evidence is limited and not conclusive.

Back in 1983, the Life Extension Foundation made a similar claim about selenium based on their own research. Unfortunately, at the time, the FDA determined that Life Extension Foundation was out to harm rather than help people. As a result Life Extension had to endure the illegal seizure by the U.S. government of their selenium products which resulted in a lengthy and costly legal battle. Now years later, the government has reluctantly realized that it can no longer limit or control information that benefits the health and well being of the American public.

Days after the FDA allowed the above selenium claim, it also approved an important claim concerning the benefit of phosphatidylserine with regard to cognitive dysfunction and dementia. On February 24, 2003, the FDA agreed to allow the following statements to be placed on the labels of dietary supplements containing phosphatidylserine:

Phosphatidylserine (PS) may reduce the risk of cognitive dysfunction in the elderly. Very limited and preliminary scientific research suggests that PS may reduce the risk of cognitive dysfunction in the elderly. FDA concludes that there is little scientific evidence supporting this claim.

Phosphatidylserine (PS) may reduce the risk of dementia in the elderly. Very limited and preliminary scientific research suggests that PS may reduce the risk of dementia in the elderly. FDA concludes that there is little scientific evidence supporting this claim.

The Life Extension Foundation originally introduced phosphatidylserine and its brain-function benefits to the American public in 1988. Despite the clear-cut applications for the elderly, the FDA interceded and fought to keep this supplement off the market. On two occasions, the FDA seized Life Extension's phosphatidylserine (PS), and on both occasions Life Extension was able to win the detained product back. The FDA then made a concerted effort to incarcerate Life Extension's founders for promoting and selling a phosphatidylserine supplement. Through persistence and costly legal battles, Life Extension eventually prevailed and those who needed it the most, were able to use phosphatidylserine to alleviate one of the more devastating effects of aging. These two recent victories are an outgrowth of the legal battles that Life Extension has been fighting for the past 18 years. The right to take supplements to protect and enhance one's own health has been hard won.

1. Hulten K et al. Carotenoids, alpha-tocopherol, and retinol in plasma and breast cancer risk in northern Sweden. Cancer Causes Control 2001; 12:529:37.

2. Toniolo P et al. Serum carotenoids and breast cancer. Am J Epidemiol 2001; 153:1142-47.