A Quarterly Health Update • Winter 1996 • Vol. 1 No. 1

By David Perlmutter, MD, FACN

New Study Challenges Safety of Cholesterol-Lowering Drugs
Vitamins Prevent Skin Cancer
Is Beta Carotene Safety
Book Review
Herb Corner

New Study Challenges Safety of Cholesterol-Lowering Drugs

Perhaps nowhere is the quick-fix magic-bullet mentality of modern western medicine more obvious than in the use of drugs to lower cholesterol. During the past decade, the number of prescriptions written for this type of drug has increased tenfold. In 1992 alone, more than 26 million prescriptions for cholesterol-lowering drugs were written. No doubt this trend will continue as cholesterol lowering drugs are among the most heavily promoted pharmaceutical agents.

A recent study published in the Journal of the American Medical Association (January 3, 1996) entitled "Carcinogenicity of Lipid-Lowering Drugs" called to question the safety of long-term usage of various medications designed to lower cholesterol. This study evaluated the carcinogenicity (ability to cause cancer) of various popular cholesterol drugs like Colestid, Mevacor, Pra-vachol, Zocor, Lescol and others. The authors looked at the ability of these drugs to cause cancer in rodents (rats and mice) and related these findings to the use of these drugs in humans.

The results demonstrated that these drugs almost uniformly produced cancer in the animals tested. The type of cancers produced in cluded liver cancer, thyroid cancer, lung cancer, stomach tumors, as well as various "benign" tumors. Of great concern to the authors was the fact that the studies demonstrated cancer production in the animals after a relatively short exposure when it is known that patients may be taking these drugs for 20 years or longer. As the author stated, "In this article, we call attention to evidence of experimental carcinogenicity of lipid-lowering medications. This class of drugs has come into widespread use in people who are currently healthy, but who have laboratory findings - high cholesterol levels - that place them at above-average risk for their age for the development of coronary heart disease in the future. Because the latent period between exposure to a carcinogen and the incidence of clinical cancer in humans may be 20 years or more, the absence of any controlled trials of this duration means that we do not know whether current drug treatment of hypercho-lesterolemia (high cholesterol) will lead to an increased rate of cancer in coming decades." Obviously, the authors are expressing their grave concern that while millions of Americans are taking these medicines for decades, there have been no studies to demonstrate the safety of these medications for that length of time.

Indeed, the data indicating carcinogenicity of these medicines has been published for many years and, submitted to the FDA. The authors ask, "How did it happen that cholesterol-lowering agents were approved by the FDA for long-term use in spite of their animal carcinogenicity? To address this question we obtained minutes of the Endocrinologic and Metabolic Drugs Advisory Committee meetings (under the Freedom of Information Act) at which lovastatin (Mevacor) and gemfibrozil (Lopid) were discussed... the only reported discussion of animal carcinogenicity studies at the FDA Advisory Committee meeting on lovastatin (February 19th and 20th, 1987) was by a representative of Merck, Sharpe and Dohme (makers of the Mevacor brand of lovastatin) who downplayed the importance of the studies."

At the end of this meeting, a vote was taken of the Advisory Committee concerning the safety of Lopid (gemfibrozil) and the minutes state that only "three of the nine members believed that the potential benefit of using gemfibrozil for prevention of coronary heart disease outweighed the potential risk associated with such use." Unfortunately, such votes are only "advisory" to the FDA which then decides whether to approve or deny approval of a drug based upon "other information," much of which is produced by the manufacturers of the drug in question. The FDA, despite the vote of the Advisory Committee, went ahead and approved Lopid for the prevention of coronary heart disease.

The authors conclude that, "Most cholesterol-lowering drugs cause or promote cancer in rodents. Patients to whom these drugs are prescribed, either singly or in combination, are exposed throughout many years to doses approaching those shown to be carcinogenic in animals." Does this mean that physicians should stop prescribing these cholesterol-lowering drugs? In my opinion, drugs like Pravachol still have a role in the management of patients who are at high risk for coronary heart disease. This would include patients who have already experienced an event like a myocardial infarction or severe angina from documented coronary heart disease, patients at very high risk for coronary heart disease as a consequence of a strong family history, or patients who have inherited a disease which causes an extremely high cholesterol.

Unfortunately, what we are now seeing is a gross over utilization of this group of medicines. The typical patient on a cholesterol- lowering drug has had no history of coronary artery related disease, but simply has a mild elevation of the cholesterol on laboratory testing. The unfortunate reflex response that is all to common is for the physician to simply write a prescription for a cholesterol lowering medicine and feel satisfied that he or she has "taken care of the problem".

But, the first and foremost consideration in the management of a patient with an elevated cholesterol must be attention to diet. Reducing consumption of animal products is the simplest and most effective dietary technique for reducing cholesterol and reducing risk of heart attack. Vegetarians typically have much lower cholesterol readings when compared to omnivores. Their cholesterol readings are 9% to 32% lower than meat eaters. Going on a vegetarian diet for just six weeks can reduce your cholesterol from 3 to 11 percent and lower the artery damaging bad cholesterol (LDL) by some 4 to 17 percent. These are very meaningful numbers when you consider that with every one percent drop in your total cholesterol you reduce your risk of suffering a heart attack by two percent. Other sensible steps you can take to safely lower cholesterol include discontinuation of caffeine and tobacco use, appropriate weight loss and the use of a good multivitamin containing 200 mcg of chromium and 100 mg of niacin.

Vitamins Prevent Skin Cancer

We have all seen the statistics that skin cancer is increasing in incidence at an alarming rate. No doubt, this likely represents a consequence of our increased exposure to sunlight, as well as the fact that the thinning of the ozone layers allows higher levels of cancer-causing ultraviolet radiation to reach us. Advertising executives have made sure that we all get the message to use their sunblocking creams and lotions liberally (the higher the SPF number the better). Now, a study reveals that we can actually reduce the risk of skin cancer by taking vitamins.

This study, entitled "Vitamin Supplementation and Reduced Risk of Basal Cell Carcinoma," appeared in the Journal of Clinical Epidemiology in 1994. This study looked at the incidence of basal cell carcinoma, which is the most common form of skin cancer in the United States. Typically, basal cell carcinoma is not considered to be "serious" like other forms of skin cancer such as squamous cell carcinoma and melanoma. Nevertheless, if untreated, basal cell carcinoma can cause problems.

It demonstrated that individuals taking multivitamins were 70% less likely to develop basal cell carcinoma when compared to non-users. The study suggests that vitamins A and E appear to be most protective. We know that vitamins A and E (and others) are "antioxidants." This means that they help reduce the dangerous oxidizing effect that ultraviolet radiation may have on the skin. It is felt by many researchers that the oxidizing effect of ultraviolet radiation, by producing unstable chemicals called "free radicals", increases the risk of skin cancer.

Is Beta Carotene Safe?

A new study reported in the New England Journal of Medicine (November 23, 1995) entitled "Teratogenicity of High Vitamin A Intake" indicates that there may be significant risks associated with high dietary intake of preformed vitamin A.

The study evaluated the babies born to women who took more than 10,000 IU of preformed vitamin A per day in the form of supplements. Based upon this study, the authors estimated that the risk of significant fetal malformations was one infant in 57 in the group taking vitamin A. Many animal studies have demonstrated that high levels of preformed vitamin A may be teratogenic (cause birth defects). A synthetic compound similar to vitamin A, used in the treatment of severe acne (Retin-A) is also known to cause congenital fetal anomalies. It has been estimated that the risk of malformation of fetuses exposed to Retin-A is 25 times greater than normal.

It is very important to recognize that there is a profound chemical difference between vitamin A and beta carotene. Beta carotene is a plant synthesized precursor of vitamin A. It becomes chemically transformed into vitamin A after it is absorbed from the gut. No association with teratogenicity or other significant health consequence has been described with typical usage of beta carotene. Indeed, the authors of the study report, "Our findings indicate that vitamin A is potentially teratogenic, but these findings relate solely to the preformed vitamin A and not to beta carotene, a vitamin A precursor." They further state that "... studies in animals indicate that a high intake of beta carotene is neither toxic nor teratogenic." It is estimated in the United States that approximately 25% of adults ingest supplements containing preformed vitamin A and that about 5% take supplements of vitamin A alone. Indeed, preformed vitamin A may play an important role in the actual treatment of certain illnesses, including various skin conditions, and inflammatory diseases of the bowel.

Nevertheless, my recommendation would be that women in the childbearing years avoid taking preformed vitamin A unless it is under the supervision of a physician as part of a treatment program for a specific health problem. On the other hand, there is no reason whatsoever to avoid beta carotene, even for women who are pregnant or who are considering it.

It was quite distressing to watch the evening news when this article was first published, as viewers were no doubt left with the impression that here was an important reason for women in the childbearing years to avoid taking vitamins. Unfortunately, this type of sensationalism very likely caused many women to stop taking their multivitamins altogether. I am sure this will have consequences since over the past five years it has been clearly demonstrated that women taking multivitamins, because they contain folic acid, significantly reduce their risk of having children born with developmental abnormalities of the nervous system.

The take-home message - women in the childbearing years should take a good multivitamin that contains beta carotene (not preformed vitamin A), as well as folic acid (supplying 400 mcg per day).

BOOK REVIEW

Tired of Being Tired - Overcoming Chronic Fatigue & Low Energy
by Dr. Michael A. Schmidt with Foreword by David Perlmutter, MD, FACN

ISBN 1-883319-16-1 Frog, Ltd., Berkeley, California Publisher

For the past several years, Dr. Schmidt has toured the country lecturing to health care professionals about management of patients with chronic fatigue. His personal experience in dealing with patients, as well as interactions with physicians, led him to produce a teaching guide for health professionals which evolved into a valuable guide for anyone concerned with fatigue - health care practitioner and patient alike. Dr. Schmidt provides a comprehensive overview of the subject of chronic fatigue and low vitality, exploring the various signs and symptoms associated with a particular type of illness, a deficiency state, or a consequence of toxic exposure. He carefully explains the various laboratory tests that doctors may order, why they are ordered, and how to interpret their results. In addition, he provides a list of state- of-the-art laboratory tests that many physicians may not be aware of but which, nevertheless, can prove very helpful in unraveling the mystery of chronic fatigue.

Perhaps the most useful aspect of this book is its consideration of the wide variety of causative factors which can ultimately lead to problems of energy utilization. Specific chapters deal with obesity - how those extra pounds may cause fatigue, thyroid and adrenal problems, the fitness factor - the paradox of inactivity and energy, the athlete with fatigue, infections, antibiotic overuse, cancer, heart disease, lung disease, prescription drugs that can lead to fatigue, airborne allergies, the effectiveness of light therapy, sleep disorders, psychological factors including depression and stress, motherhood and fatigue, and toxicity states.

Dr. Schmidt concludes Tired of Being Tired with "steps to improved energy" including techniques for boosting energy and restoring balance, detoxification protocols, as well as a variety of nutritional approaches for the energy-compromised patient. His last chapter offers a unique inventory of personal questions which may demonstrate a need for change in some maladaptive physiological, as well as psychological habitual patterns.

Tired of Being Tired - Overcoming Chronic Fatigue & Lower Energy by Dr. Michael A. Schmidt, North Atlantic Books, P.O. Box 12327, Berkeley, California 94712, $19.95. ISBN 1-883319-16-1 Frog, Ltd., Berkeley, California Publisher.

Herb Corner

Ginger is a common folk remedy, having its roots in ancient lore dating back to about 3000 B.C. Ancient Chinese texts describe the usefulness of ginger for menstrual cramps, arthritis and seasickness. A recent study reported in the prestigious British medical journal The Lancet, showed that ginger root was significantly better in preventing motion sickness than an over-the-counter drug, Dramamine. Other studies have shown that ginger root is effective for nausea caused by car, boat, train, and plane travel. Ginger is useful for a variety of medical problems, including menstrual cramps, colds and flu, arthritis, and even high cholesterol. Ginger ale is useful in relieving upset stomachs, as well as other digestive problems.

Available at most grocery stores, ginger root is used to make the powder in ginger capsules. The root can begrated and made into ginger tea, which is helpful for a variety of problems. It can, however, cause "heartburn" in which case the dosage should be reduced or eliminated completely. For motion sickness, take 2-4 capsules of ginger powder an hour before starting a trip. Take an additional one or two capsules every hour as needed. With colds, with congestion, try 3-4 tablespoons of fresh ginger juice in a warm bath.

To learn more about herbs and health, read The Healing Herbs by Michael Castleman (Rhodale Press, Emmaus, PA.)

"Knowing the patient is as important as knowing the illness."

Copyright © 2005-2008 Perlmutter Health Center All Rights Reserved.
Perlmutter Health Center - Commons Medical Center
800 Goodlette Road North - Suite 270 - Naples, FL 34102
Tel: (239) 649-7400 - Fax: (239) 649-6370