Medical Definitions for Patients, Policymakers and Prescribers

Early on, in ancient China, Confucius observed that social disorders often stemmed from failure to perceive, understand, and deal with reality. Wise man and philosopher, he attributed this to the failure to call things by the proper names. He advised his contemporary Chinese that in order to repair what is wrong in the world and administer the government properly, they had to start with “rectification of names” (literally “rectification of terms”):

• "(...) Why must there by such rectification? (...)
• If names be not correct, language is not in accordance with the truth of things.
• If language be not in accordance with the truth of things, affairs cannot be carried on to succeed.
• When affairs cannot be carried on to success, proprieties and music do not flourish.
• When proprieties and music do not flourish, punishments will not be properly awarded.
• When punishments are not properly awarded, the people do not know how to move hand or foot.

Therefore a superior man considers it necessary that the names he uses may be spoken appropriately, and also that what he speaks may be carried out appropriately. What the superior man requires is just that in his words there may be nothing incorrect.” (Analects XIII, 3, tr. Legge)(ref. 1).

My conclusion: To apply medical information properly, to communicate better with all involved parties, and to solve our problems, it is required that all patients, researchers, pharmacists, medical practitioners, and policymakers understand and accept a common language. As misinformation, corruption, nepotism, and misunderstanding are not yet the things of the past, we have to clarify some issues. The following is an attempt to define important terms that pertain to our health.

IMPORTANT DEFINITIONS AND EXPLANATIONS

“Prescribe” (Latin—praescribere), “to write before, to appoint or direct in writing.” In medicine, as per Oxford English Dictionary: “To advise or order the use of (a medicine, remedy, or treatment), with directions for the manner of applying it.”

“Prescribed”—“laid down, appointed, or fixed beforehand; ordained, appointed, set, fixed, defined.”

Comment: “Prescribed” medication does not have to be a chemical, a chemically altered, or a genetically modified drug that is “available by prescription only” due to its harshness and numerous side effects and adverse environmental impact. Prescribed medication should be the safest and the most effective product available that do the job. When a safe to the human body and environment botanical, vitamin or a natural supplement is available and proven effective, this is what should be prescribed—by writing prescription or by giving oral advice. Regrettably, most of us here, in the U.S., are unaware that natural remedies and nutritional interventions work, and that writing prescription for natural medicines is considered an integral part of doctor’s routine medical practice in Europe and throughout the world. In example, in Italy and some other European countries it is considered medical malpractice not to prescribe or advise fish oil to patients who suffer from heart disease. The other example of potentially life-saving botanical is standardized mistletoe extract (Iscador®), widely used in Europe. Being there the number one complementary cancer treatment and the key component of conventional cancer therapy for good part of 20th century, it is not available in the U.S. (as per National Cancer Institute website) (ref. 2). The third example is Silymarin, a safe and inexpensive standardized botanical extract of milk thistle. Emergency room physicians in Germany and physicians in many other countries use Silymarin, as it protects liver from many chemicals and toxins, including from alcohol toxic liver injury and from poisonous mushrooms amanita. By stimulating regeneration of liver cells, it gives poisoning victims a good chance of surviving and returning to good health. Without Silymarin, the option is often either death or liver transplant.

You probably wonder why our medicine and prescription habits are so different? The reason is simple: Here, in the U.S., natural medicines can’t be patented, and for this reason can’t generate spectacular return on investment that synthetic, genetically modified or chemically altered drugs do.

“Prescription” (Latin—praescriptionem)—“A direction or formula (usually) written by a physician for the composition and use of a medicine; a recipe; the medicine prescribed.”

Prescription is the specific recommendation or request by a physician to a pharmacist to dispense medicinal product and for the patient to follow the doctor’s instructions.

In many European countries, the medical doctor will often write a prescription for a product available also without a prescription, when such a product is the best, safest, most appropriate, and least expensive form of treatment, and use of it will give the best of outcomes. Such a product may be vitamin, mineral, botanical or a safe, time-proven synthetic remedy. A written prescription also authorizes such treatment and obligates an insurance company to provide its recipient with prescription benefits. Over-the-counter medication is often the safest, most effective and least expensive, so writing a prescription for a powerful, safe and inexpensive botanical, vitamin or other effective natural product makes sense from a medical, ethical, and economical point of view.

“By prescription only”—medication that due to its chemical composition or nature is less safe, has toxic side effects, has a narrow therapeutic window, even when used “as directed.” A request written and signed by a licensed physician is the only way to obtain these.

Newly developed synthetic medications have no established safety record, and thus are by prescription only. Some of those products will be accepted as successful and safe medicines, while others will be recalled and rejected due to accumulation of data on their long-term-use toxicity or other major side effects.

The fact that a product is “by prescription only” does not mean that the product is the proper, best, or safest choice for given condition. There are numerous botanicals, vitamins, and minerals that are far superior to their synthetic alternatives and de facto are more appropriate and safer treatment options.

The fact that many insurance companies pay for expensive prescription medications but are declining to pay for many extremely safe and extremely effective over-the-counter products, including botanical ones, is only a political or bureaucratic decision. Different rules apply in different countries. This situation of paying for patented “prescription” drugs only leads to unnecessary over-utilization of more expensive and less safe prescription drugs, when more successful, safer, standardized, high quality, less expensive natural options that are now widely available are underutilized. This is the insurance companies’ as well the consumers’ loss.

“Controlled substances”—this group includes products that are controlled by means of prescription writing. This category includes narcotic medications. Those substances fall under FDA jurisdiction.

“Controlled”—according to Webster’s Dictionary: “having the capacity to affect behavior and regulated by law with regards to possession and use (? drugs).”

“FDA-approved”—medications or medical devices that fall into the category of products that need FDA scrutiny of the manufacturer’s research data prior to allowing their use as medicines or medical devices, to assure safety of the product user, the public. In the U.S. the FDA approval usually is associated with windfall of profits for patent holder and manufacturers of the drug—for the life of the patent.

Typical FDA-approved medication is allowed for use to treat a specific, “approved” condition or disease, after FDA reviews submitted data. Regardless of this, many of FDA-approved products are used “off label”—that means for conditions other than those listed (approved) or for age groups not studied, such as children.

Manufacturers of the medications or medical devices are responsible for any study that will be submitted to the FDA for product approval. The study is frequently done by a third party, such as a team of physicians, university researchers or specialists in serving the pharmaceutical industry. Numerous research institutes recruit study subjects, as well as manage the studies. The FDA also charges substantial review fees.

There are many natural medicinal products that have been recommended for use for years in many countries and are not FDA-approved. One example is the safe and effective use of a standardized extract of valerian root, which has been used for more than 2,000 years and is widely accepted and used in Europe. This product reduces anxiety and enhances restful sleep without drowsiness or compromise of mental function caused by many synthetic products (ref. 3, 4, 5). It also enhances REM sleep, thus allowing its users to wake up well refreshed. Valerian root also helps effectively with lower back pain, by allowing effective overnight lower back muscle relaxation. Use of this product in the elderly for sleeping and anxiety control would lead to millions of dollars of savings due to dramatically reduced prescription medication costs, fewer falls related to sleeping pill and sedative use, and fewer hip fractures.

Why then does this safe product not have the official FDA stamp of approval? The reason is simple: No one has an interest or deep pocket to pay for the study. “Proving” the product effective with an FDA-required double-blind study would cost millions. As no millions would be recovered and no billions made, no one is interested in conducting the study of a product that cannot be patented. Furthermore, valerian root extract belongs to the group of extremely safe botanical remedies classified as Generally Regarded As Safe (GRAS) and as such does not need FDA scrutiny or approval.

In my opinion, the public deserves fast-track access to safe and extremely effective natural remedies. This would save our country billions, as well as help the nation in maintaining wellness. Of paramount significance is also the fact that use of natural products and botanical medicines would reduce the need for more expensive, more toxic synthetic medications, thus preventing side effect-related deaths, hospitalizations and, of course, budget distress.

Many natural medicinal products are proven by overwhelming data of high-quality medical studies to be equal or superior to the best and safest of available-by-prescription products. Many other potent and safe natural medicines are too complex to be synthesized or re-created even in the best of chemical laboratories, thus we have no synthetic versions of them. For this reason the list of essential medicines should include Valerian root and the following natural products:

· Coenzyme Q-10 for its cardio-protective and numerous other actions (ref. 6). · Silymarin (standardized extract of milk thistle) for its action as life-saving liver protectant, as well as for its ability to promote liver tissue regeneration (ref. 7). · Standardized elderberry extract for its ability to inhibit several strains of influenza viruses (ref. 8). · Selenium, the critically important supplement for prevention of virus and body cell mutations and for its ability to prevent many cancers (ref. 9). Yes, this trace mineral can make a life-or-death difference (ref. 10). · Hawthorn for its cardiac benefits that rival and exceed that of digitalis, and at the same time providing all of its benefits safely (ref. 11). · Glucosamine for its ability to relieve the pain and significantly (by about 50 percent) reduce the need for hip and knee surgery in people suffering from osteoarthritis (ref. 12).

The above list is by no means complete. There are numerous other botanicals, vitamins and minerals that have powerful beneficial actions and have no synthetic alternatives—just as there are no synthetic alternatives to water, magnesium or oxygen. Many of these natural products save lives of patients here in the U.S.A. and around the world, and their clinical use is explained in medical textbooks (ref. 13).

“Generally Regarded As Safe” (GRAS)—this term describes products that include safe nutritional supplements, minerals as well as some vitamins that have well established safety record and margin and frequently have long history of successful use as medicines.

Some of those products have been in medicinal use for more than 2,000 years. The safety of these products, when used as directed, frequently equals the safety of generally consumed foods. Congress, by creating this category, removed these extremely safe or relatively safe products from excessive, unnecessary and burdensome regulations (ref. 14).

A word of caution from the author: Although botanical medicines are in general very safe and many of them have absolutely no known side effects, they should still be used with respect and complete knowledge, as some of them have strong (albeit desirable) medicinal effects. Exercise caution: Some supplement and drug manufacturers may often hype the product’s benefits to boost its sales. For maximum safety and to assure the best possible overall benefit, patients should seek the advice of a primary prevention-oriented physician who is versed in the practice of integrative or holistic medicine (ref. 15).

One has to realize that numerous consumed foods also have health-enhancing and disease-modifying properties, and those at times equal or exceed benefits of prescription or non-prescription drugs.

“Pain”—as per Webster’s Dictionary: “localized physical suffering associated with bodily disorder (as a disease or an injury).” Also: “a basic bodily sensation induced by a noxious stimulus, received by naked nerve endings, characterized by physical discomfort (as pricking, throbbing, or aching) and typically leading to evasive action.”

Removal of a noxious stimulus may often lead to the resolution of pain. Also, a simple change of one’s diet may lead to the “cure” or pain-free state.

Example: Joint and other musculo-skeletal pain is typically and most frequently related to high levels of uric acid, which causes soft tissue irritation, and can crystallize and cause pain in great toes, knees and distal joints of fingers. The elevation of the uric acid level is the consequence and byproduct of excessive consumption of animal protein as well as poor hydration. Avoiding excessive consumption of animal protein (shrimp, other animal meats), as well as simultaneous purging of the body of urea by good water intake, will lead to elimination of uric acid from blood, joints and tissues, thus helping arthritis pain.

Is asking for a strong pain pill to “treat” the painful joint the right thing? I strongly disagree. This would be equal to keeping one’s finger in the flame—and asking for the pain pill. A much better solution is to remove the finger from the flame before irreparable damage is done.

Pain medications are here to stay, and depriving patients of them would compromise our code of ethics. Prescribing a strong pain pill has merit as it allows for comfort while waiting for a definite treatment—as in the case of hip replacement.

Nature supplied us with nerve endings and the sensation of pain to alert us of harm and to take evasive action. That may mean a vegan diet for a few days and few days’ worth of extra hydration and turmeric and ginger to “purge” uric acid out of the system and to become completely free of uric acid-dependent joint or neck pain.

“Etiology” (Latin—aetiologia)—1: “all of the causes of a disease or abnormal condition,” 2: “a branch of knowledge concerned with the causes of particular phenomena;” “A branch of medical science concerned with the causes and origins of diseases.” (As in Webster’s Ninth New Collegiate Dictionary.)

Understanding the etiology (knowing the root cause) of particular medical problem allows us, physicians, to remove offending substance or factor (e.g. known allergen), or correct nutrient deficiency. Such simple action frequently corrects the problem.

Example 1: A low magnesium level in one’s blood may lead to sudden onset of atrial fibrillation, one of the dangerous arrhythmias that are frequently complicated by stroke. A simple blood test, such as serum magnesium level, can identify this cause (etiology) of one’s arrhythmia. Administration of magnesium corrects magnesium deficiency and frequently leads to rapid resolution of atrial fibrillation. Still better is disease prevention: People can prevent arrhythmias by keeping their magnesium level well within the normal range, the higher in the normal range, the better. Caution: Treatment of any arrhythmia must be done under strict supervision of a physician. Never try to do it yourself. Prevention of arrhythmia with magnesium is safe. A low magnesium level may also be the etiology of severe psychosis (in case of severe deficiency), confusion, agitation, irritability, insomnia, muscle cramps, as well as many other conditions (ref. 16).

Example 2: Low thyroid function (hypothyroidism), sedentary lifestyle, ongoing tissue repair, and low dietary fiber intake are all common etiologies (causes) of a high cholesterol level. Correction of thyroid function, increase of activity, dietary improvements and especially an increase in consumption of water-soluble fiber, all frequently bring cholesterol levels to normal. For maximum benefit, correct as many problems as possible.

“Preventive”—(medical) “having the quality of preventing or keeping off disease; prophylactic.” (As in Oxford English Dictionary.)

Correction of a selenium deficiency, which is almost universal in the United States, is a good example of preventive action. Supplementation of selenium, an essential good health nutrient, prevents numerous cancers, including skin, breast, lung, esophagus, stomach, colon and prostate cancers. It is well known that consumption of high selenium content foods, grown in soils that are selenium-rich, is inversely proportional to the incidence of numerous cancers. The higher the selenium content of food consumed, the fewer the cancers. As there is widerpread lack of selenium in our food, the only prudent action is selenium supplementation (ref. 17, 18).

The other excellent preventive action is correction of vitamin B6, B12, and folic acid deficiencies to prevent Alzheimer’s disease, as well as other vitamin deficiency related dementias and heart conditions. Vitamin B12 deficiency is widespread among the elderly. This is due to the problems with insufficient vitamin B12 intake (supply), or absorption of this vitamin crucial for normal functioning of our brain, bones and peripheral nervous system.

On the other hand, a mammogram, the radiographic examination of breasts, should not be considered preventive action. This test is useful only in detection of cancers that are already present. The mammogram thus is the test that allows early detection of an existing disease.

“Palliative”— 1. Soothing anxieties or the intense emotions, 2. Alleviating pain and symptoms without eliminating the cause. (n.): Something that palliates, especially a medicine that treats symptoms only. (Encarta Encyclopedia.)

Disease palliation is frequently used and has merit for pain or other symptom control of conditions that have no cure. This is well understood. Palliation, though, will not serve well patients who suffer from migraines or arthritis. As migraine sufferers frequently have low blood and tissue levels of magnesium, correction of blood level of this essential nutrient frequently eliminates this condition. Advising migraine sufferers to supplement with fish oil further amplifies magnesium benefit.

Both, arthritis and gout respond well to a low animal protein diet, such as vegan, consumption of oily fish, and good hydration that purges uric acid from joint fluid. This simple dietary change essentially eliminates the pain of uric acid-related conditions in majority of people. Once you get well, you will respect and like the vegan diet. Due to the above dietary reasons, arthritis in China, as compared to the United States, is rare.

1. http://en.wikipwdia.org/wiki/Conficianism. Accessed Dec. 23, 2007.

2. National Cancer Institute. Cancer Topics. Mistletoe Extracts (PDQâ). Patient Version, Health Professional Version. Accessed 12/23/2007 at http://www.cancer.gov/cancertopics/pdq/cam/mistletoe.

3. Leathwood PD, Chauffard F. Aqueous extract of valerian reduces latency to fall asleep in man. Planta Med 1985;51:144–8.

4. Leathwood PD, Chauffard F, Heck E, Munoz-Box R. Aqueous extract of valerian root (Valeriana officinalis L) improves sleep quality in man. Pharmacol Biochem Behav 1982;17:65–71.

5. Leathwood PD, at al. Aqueous extract of valerian root (Valeriana officinalis) improves sleep quality in man. Pharmacol Biochem Behav 1982 Jul;17(1):65-71.

6. Langsjoen H, et al. Usefulness of coenzyme Q10 in clinical cardiology: a long-term study. Mol Aspects Med 1994;15 Suppl:S165-S175.

7. Ferenci P, Dragosics B, Dittrich H, Frank H, Benda L, Lochs H, Meryn S, Base W, Schneider B. Randomized controlled trial of silymarin treatment in patients with cirrhosis of the liver. J. Hepatol 1989 Jul;9(1):105-113.

8. Zakay-Rones Z, et al. Inhibition of several strains of influenza virus in vitro and reduction of symptoms by an elderberry extract (Sambucus nigra L) during an outbreak of influenza B Panama. J Altern Complement Med 1995;1(4):361-369.

9. Combs GF Jr., at al. Reduction of cancer mortality and incidence by selenium supplementation. Med Klin 1997 Sept 15;92 Suppl 3:42-45.

10. Passwater Richard A. Selenium Against Cancer and AIDS—The trace mineral that can make a life-or-death difference… and that many of us lack. Keats Publishing, Inc. New Cannon, Connecticut. 1996.

11. Weiki A, et al. Crataegus Special Extract WS 1441. Assessment of objective effectiveness in patients with heart failure. Fortschr Med 1996 Aug 30;114(24):291-296.

12. Das A Jr, Hammad TA. Efficacy of a combination of FCHG49 glucosamine hydrochloride, TRH122 low molecular weight sodium chondroitin sulfate and magnesium ascorbate in the management of knee osteoarthritis. Osteoarthritis Cartilage. 2000 Sep;8(5):343-50.

13. Jellin, J.M., Batz, F., Hitchens, K.: Pharmacist’s Letter/Prescriber’s Letter—Natural Medicines Comprehensive Database. Stockton, CA: Therapeutic Research Faculty. 1999:154-156 and 242-244.

14. In 1994 by the act of U.S. Congress, the Dietary Supplement Health and Education Act (DESHEA) was created to simplify and streamline the entry of low cost and low risk natural health enhancing products to the U.S. marketplace. Under DESHEA herbs and other botanicals, minerals, vitamins, amino acids and tissue extracts are regulated as foods and do not require testing and FDA approval. To protect the public from unscrupulous manufacturers and questionable quality of botanicals and other natural products, DSHEA gives the FDA authority to establish Good Manufacturing Practice (GMP) regulations. At present, following the GMP regulations is voluntary. Fortunately, there are numerous manufacturers that voluntarily follow and exceed recommendations of GMP regulations and produce world-class products. It is the obligation of a treating physician to educate his patients and recommend only products that are standardized, properly labeled, free of any contaminants as well as cost-effective.

15. To obtain listing of physicians who practice Integrative and Holistic Medicine in your area, you may contact American Holistic Medical Association, American Board of Holistic Medicine, as well as listing of alumni of The University of Arizona Program In Integrative Medicine, the program that is already well established and has many graduates. Please be aware that expertise and experience of physicians may vary. Although U.S. Medical Schools for years do a lot of research in the field of botany, basic cell functions and role of vitamins, it is just recently when they started to introduce some instructions in integrative medicine in residency training programs.

16. Please, read the chapter explaining role of magnesium in section on normalizers, also other chapters that explain the role of magnesium in etiology of diabetes, heart disease, Alzheimer’s disease, hypertension, diabetes and many other.

17. The dose of selenium that is appropriate for cancer prevention is very specific, and usually is 200 mcg (micrograms). Smaller dose may not be effective in some geographic areas. Due to fairly narrow therapeutic window of this nutrient, selenium is not suitable as food additive. Consult your physician for proper use.

18. Gullestad L, Dolva LO, Soyland E, Manger AT, Falch D, Kjekshus J. Oral magnesium supplementation improves metabolic variables and muscle strength in alcoholics.

Alcohol Clin Exp Res 1992 Oct;16(5):986-90