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Post by momofautistic on May 20, 2004 12:08:16 GMT -5
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Dietary Supplements: What Are the Risks? Consumers should not assume that "all natural" dietary supplements are always safe.
By Ricki Lewis
The average health food store is likely to display many signs claiming the benefits of various natural remedies. One sign may claim that an all-natural compound can dramatically lower cholesterol levels. Another may promise a natural way to cure cancer and even reverse the aging process. Still another may advertise a "miracle weight-loss" pill. All of these products, like drugs, contain chemicals that affect the body, yet all of them are readily available because they fit into a special category of products called dietary supplements.
Consumers often assume that these natural remedies--extracts of plants or animals, including chemicals naturally produced in the human body--are more effective and safer than drugs made in the laboratory. However, a chemical is a chemical, and one that causes harm to the body will do so whether it comes from a vegetable or a test tube. As dietary supplements gained popularity in the 1990's, some medical experts came to believe that without careful regulations, consumers could not make informed judgments about the safety and value of these products.
Why is a dietary supplement not a "drug"?
Many drugs originally came from nature. Aspirin was derived from a chemical in willow tree bark; caffeine, from coffee beans. And flowers and bark have been the source of many modern cancer drugs. To develop drugs from a natural product, chemists isolate a single active ingredient in an organism that has a medicinal effect, or they improve upon the naturally occurring chemical by making a related one in the laboratory. The synthetic, or laboratory-created, versions of the chemical are often more effective or safer than the "natural product" itself, because they are more concentrated or purer. Whether the substances chemists use to make drugs are natural products or synthesized chemicals, the Food and Drug Administration (FDA) approves them for sale in pharmacies and regulates the drug company's manufacturing process.
Dietary supplements less carefully regulated
Products known as dietary supplements, however, are less carefully regulated. The makers of dietary supplements do not need to conduct extensive research, meet specific production standards, or abide by other FDA regulations for drugs. Many dietary supplements, however, are promoted as herbal remedies and "natural drugs."
Dietary supplements are widely available in health food stores, on the Internet, in pharmacies, and from health-care practitioners. These products include vitamins, minerals, herbs, botanicals (plant products), certain hormones, amino acids, and products derived from these substances. According to the Dietary Supplement Health and Education Act of 1994, the difference between a dietary supplement and a drug depends largely on the intended use of the product. A product is considered a drug if the maker claims that the substance is intended to diagnose, prevent, treat, cure, or lessen the severity of a disease or condition of a disease. The makers of dietary supplements, on the other hand, cannot make any of these claims. Instead, they can only say that the product is intended to supplement an individual's diet. The product's label can describe the effects of the supplement on a function of the body, but it cannot claim any medicinal effect. The label on saw palmetto, for example, states that it improves urinary flow, but it does not claim that saw palmetto treats an enlarged prostate, which is a disease condition.
Dietary supplements versus drugs
This distinction between dietary supplements and drugs is important because the two categories have very different regulations. Pharmaceutical companies must conduct laboratory and animal tests on a prescription drug before it can be presented to the FDA for approval. The FDA then uses manufacturer's studies to determine whether the company can test the product in a series of clinical trials (studies with humans). Although the FDA regulates the process, it is the manufacturer's responsibility to prove that the drug is both effective and safe in treating certain conditions and that the benefit of taking the drug outweighs the risks of side effects. The FDA specifies the conditions for which a drug can be prescribed, its potency, the dosage schedule, the package labeling, a profile of the possible side effects, the method of production, and standards for purity.
In addition, the FDA closely regulates over-the-counter (OTC) drugs, drugs that can be purchased without a physician's prescription. The agency has approved about 700 active ingredients that can be used in OTC drugs, established guidelines for the recommended dosages, and issued warnings that must appear on the packages of products containing any of these ingredients. And the FDA has an extensive review process to ensure the effectiveness and safety of a product when a manufacturer wants to create an OTC version of a drug that had previously been approved only for prescription use.
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Post by momofautistic on May 20, 2004 12:11:11 GMT -5
pg 2 Picture Poison ivy The FDA also regulates homeopathic medicines, which are sold both as prescription and OTC drugs. Homeopathic treatment is based on "the law of similars." This theory, which dates to the late 1700's, suggests that the same substance that causes a disease symptom when taken in high doses will counteract this same symptom when taken in low doses. For example, poison ivy causes rashes. Homeopathic practitioners prescribe compounds with extremely low doses of poison ivy extracts to treat rashes caused by other factors. Most homeopathic remedies are so dilute, in fact, that the active ingredient cannot be detected in the final product. According to the theory of homeopathic treatment, even if the active ingredient is diluted to near nothingness, its "imprint" remains and heals. There has never been any scientific proof that homeopathic treatments are effective. However, since homeopathic remedies are so dilute, FDA regulations for the manufacturing of these products are much less stringent than are those governing conventional drugs.
Limited regulations on dietary supplements
Dietary supplements are subject to even looser standards. The 1994 dietary supplement law established that manufacturers of dietary supplements do not have to prove the effectiveness of their products. Manufacturers must only have evidence of some "substantiation" for the claims that they make about their products, though the law does not clearly define the term "substantiation." The proof for the effectiveness of a dietary supplement, for example, can be based on the results of laboratory tests even if the effect has not been proven in clinical trials on human beings.
The makers of dietary supplements also do not need to prove the safety of a product, according to the 1994 law. Instead, they must show that there is a "reasonable assurance" that the ingredients in a product do not "present a significant or unreasonable risk of illness or injury." Consequently, many dietary supplements have not undergone thorough tests, especially for the long-term effects of products or for possible harmful interactions with other drugs. Therefore, even if a dietary supplement seems to have the desired effect, a consumer does not know whether the product could prove to be dangerous if taken over a long period of time or with a combination of other supplements or drugs.
The burden of prooof on dietary supplements
The FDA must prove that a dietary supplement is unsafe before the product can be restricted or taken off the market. Furthermore, the FDA can intervene only after a number of people have reported that a supplement has caused harm. The FDA's Office of Special Nutritionals, which is responsible for monitoring complaints, does not have the resources to conduct the research itself. Consequently, the FDA must rely on the research of independent institutions to prove that the product causes a health risk. For example, the FDA began investigating the Chinese herb ma huang, or ephedra, in April 1996 after receiving reports that at least 15 people died after taking the supplement. (Ma huang is sold under brand names, such as Herbal Ecstasy, Ultimate Xphoria, and Cloud Nine, and in formulas marketed as exercise aids, such as Ripped Fuel.) Several factors complicated the process of proving the harm of the product. For instance, most of the deaths occurred after a person took more than the manufacturer's recommended dosage--a fact that makes it more difficult for the FDA to prove a significant health risk. In June 1997, the FDA issued proposed restrictions for ephedra products, and final recommendations were scheduled to be released after August.
The 1994 law also does not allow the FDA to regulate the manufacturing process or to inspect the product to make sure that it contains the correct plant or plant part. The active ingredient might be in the leaf of the plant, but to save on production costs, a manufacturer may use the whole plant, thus creating an inferior product. In some cases, plants used in dietary supplements are not harvested by specially trained botanists. On occasion, untrained harvesters have reportedly tainted dietary supplements with harmful plants and substances. In 1996, for example, seven New Yorkers fell ill from drinking herbal tea contaminated with belladonna, a poisonous plant. Three of the people who drank the tea were hospitalized with racing heartbeats, fever, dilated pupils, and flushed skin.
"Natural" does not mean "safe"
Because the manufacturing of dietary supplements is not regulated, these products may not be standardized, meaning that the amount of the active ingredient may not be consistent from bottle to bottle. In 1996, the Center for Science in the Public Interest in Washington, D.C., examined garlic supplements sold at health food stores. The researchers found that the brand with the highest concentration of garlic in the pills had 40 times more than the brand with the least amount of garlic. Such discrepancies can occur because an individual plant can have a concentration of a medicinal chemical as much as 10,000 times greater than another plant of the same variety, according to botanist James A. Duke of the U.S. Department of Agriculture. Further complicating the picture, some manufacturers combine several different plants to make a "multi-herbal" product. Given this fact--and that many people take more than one supplement at a time--concerned doctors say it is almost impossible to determine which ingredient relieves which symptoms or causes which side effects.
The lack of regulations over the labeling of dietary supplements can also present risks to consumers, according to critics of the dietary supplement law. White willow bark, for example, contains an active ingredient called salicylic acid, the same active ingredient that is synthetically produced for aspirin. The label on a bottle of aspirin warns that when a child has just had a mild viral infection, such as influenza or chicken pox, aspirin may cause Reye's syndrome, a potentially fatal disease that affects the liver and central nervous system. Manufacturers of willow bark, however, do not have to put a similar warning on the product's label even though willow bark poses the same danger to children.
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Post by momofautistic on May 20, 2004 12:13:47 GMT -5
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Watch the dosage
The absence of warning labels, as well as the assumption that "natural" always means "safe," may lead some people to assume that dietary supplements are safe in any dosage or combination. Even a product that has been used successfully to treat a particular condition can have toxic effects when taken in high dosages. One such product, which the FDA has identified as potentially dangerous, is Indian tobacco or lobelia. A 55-milligram dose of dried lobelia--less than the usual amount in a single lobelia pill--can improve breathing by causing the bronchioles (small branches of air passages in the lungs) to expand. In higher doses, however, lobelia can slow breathing, lower blood pressure, increase the heartbeat, and cause death.
The makers of chaparral, an herb sold in tea or tablet form, advertise that the product slows aging, cleanses the blood, and heals skin problems. But it also can cause liver damage if taken in large doses or over an extended period of time. The FDA has linked chaparral to at least six cases of acute nonviral hepatitis (a liver disease not caused by an infection). Yohimbe, a pill made from tree bark, supposedly enhances male athletic and sexual performance. In large doses, however, it can cause kidney failure, paralysis, seizures, and even death.
"Natural" drugs may cause harm
Even if a natural drug is safe under all circumstances, some people have put themselves at risk by relying solely on the "natural cure" promised by proponents of dietary supplements rather than continuing a doctor-advised treatment. Michael Diaz, an oncologist and hematologist (cancer and blood disorder specialist) at Mt. Sinai Medical Center in New York City, reported in May 1996 that he treated a cancer patient who grew more ill after each chemotherapy session. The doctor discovered that instead of taking the prescribed medication between chemotherapy treatments, the patient was taking shark cartilage, a dietary supplement promoted as a cancer cure.
Consumers who want to avoid the possible risks associated with taking dietary supplements have a formidable task in choosing among the estimated 20,000 products on the market. Some products can be helpful and have few or no known side effects. Pharmacog-nocists (specialists in herbal and plant medicines) Varro Tyler of Purdue University in West Lafayette, Indiana, and Norman Farns-worth of the University of Illinois in Chicago have noted the benefits of several medicinal plants that are safe for most people. For example, echinacea, an herb in the daisy family, may boost immunity by stimulating production of white blood cells. And ginger and peppermint can prevent motion-sickness and treat some nausea.
Other so-called "natural drugs" may not have such a clean bill of health. Under scrutiny were some of the most popular dietary supplements in 1997, such as melatonin, dehydroepiandrosterone (DHEA), chromium picolinate, ma huang, and shark cartilage. All of these products meet the conditions of the Dietary Supplement and Health Education Act; however, medical professionals raised questions about each of the products' effectiveness, safety, the legitimacy of health claims, and the need for long-term studies.
Melatonin
Melatonin is a hormone produced in the human pineal gland, a tiny, pea-shaped gland located in the center of the brain. The natural cycle of darkness and daylight seems to trigger the production of this hormone. At night, levels of melatonin are high, and during the day they are very low. Researchers believe that melatonin serves as a chemical messenger that tells the rest of the body that it's time to sleep. A 1993 study at the Massachusetts Institute of Technology in Cambridge, Massachusetts, suggested that small doses of melatonin could induce sleep. Further medical studies have shown that melatonin may ease the effects of jet lag (fatigue and irritability following long flights through several time zones). But no clinical studies have proved claims that melatonin helps with long-term insomnia (inability to fall asleep or remain asleep).
Although affecting short-term sleep problems is the only known benefit of the hormone, the proponents of the dietary supplement melatonin list many others. In 1996, consumers spent an estimated $200 million to $350 million on melatonin in hopes of treating cancer, heart disease, diabetes, cataracts, AIDS, Alzheimer's disease, depression, epilepsy, autism, schizophrenia, and influenza. Some of these hopes were based on inconclusive research on how melatonin functions in the body. Babies begin producing melatonin when they are about 3 months old. Production gradually increases throughout childhood and peaks just before puberty. Then it declines. By the time most people are 70 years old, melatonin production has almost ceased. Many proponents of the supplement concluded that if melatonin production decreases with age, then the dietary supplement could reverse the aging process and the cellular changes that lead to diseases such as cancer.
Miracles or myths of melatonin
The popularity of melatonin stemmed largely from claims made in books, such as The Melatonin Miracle by physicians Walter Pierpaoli and William Regelson. However, neurobiologist Fred Turek at Northwestern University in Evanston, Illinois, and other experts argued that the evidence presented in these books was based mostly on hearsay or insufficient laboratory tests. The Melatonin Miracle, for example, reported that researchers had proved that melatonin reverses the aging process in humans. However, the study on aging used to support this claim was performed on mice--not humans. When scientists switched the pineal glands of older mice with those of younger mice, the younger mice died prematurely and the older mice lived longer. Turek pointed out, however, that the pineal glands in the strain of mice used in the study do not produce melatonin. Whatever extended the lives of the mice, it was not melatonin.
Researchers at a meeting of the National Institutes of Health in August 1996 advised consumers to avoid using melatonin. They raised concerns about the long-term effects of the hormone, the proper dosage of the supplement, how the hormone interacts with other drugs, how different people react to the recommended dosage, what effects the hormone may have on reproduction, and what happens in the body when the level of one hormone is increased when the levels of other hormones are still changing with age. Also, studies have not proven that the body actually incorporates the supplement as it does the naturally produced hormone. Therefore, even if it does present no risks, it could be a waste of money.
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Post by momofautistic on May 20, 2004 12:15:51 GMT -5
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DHEA
DHEA is a hormone produced by the adrenal glands that the body converts into the sex hormones estrogen and testosterone. Like melatonin, DHEA levels decrease as people age. Research published in 1986 by Elizabeth Barrett-Connor, an epidemiologist (disease-control specialist) at the University of California, San Diego, prompted further research about the hormone. She found that of the 143 men in the study, those with naturally high DHEA levels had half the incidence of heart disease as those with low DHEA levels.
Since Barrett-Connor's study, other research has offered some promising evidence for the benefits of DHEA. But many proponents of the dietary supplement DHEA have claimed that researchers have proved that it can slow the aging process, prevent cancer and heart disease, promote weight loss without dieting, and treat Alzheimer's disease and AIDS-related conditions. According to a March 1997 report from the Center for Science in the Public Interest, many of these claims have been supported with misinterpretations of published research about the hormone. Furthermore, proponents of DHEA supplements do not mention Barrett-Connor's 1996 follow-up study that showed high DHEA levels lowered the risk of heart disease in men by only 20 percent and had no noticeable effect on the heart disease incidence among women.
Although some research ers believed that further studies would reveal the benefits of DHEA, others expressed concern over its safety. Biochemist Arthur G. Schwartz of Temple University in Philadelphia reported in 1995 that DHEA could cause liver damage in rodents. He also noted that an increased level of testosterone in older men taking DHEA supplements could make them more susceptible to prostate cancer. Also, as with melatonin, researchers are not certain if the body actually incorporates DHEA supplements.
Chromium picolinate
Chromium picolinate was another popular dietary supplement that continued to cause concern among researchers in 1997. Chromium is an essential nutrient that helps bind insulin to cell membranes and is therefore important for the metabolism of some sugars and fats. Some cases of adult-onset diabetes mellitus have been linked to a deficiency of chromium in the diet. In 1995, researchers at the Louisiana State University Agricultural Center in Baton Rouge found in animal studies that when chromium is combined with a molecule called picolinate, it appears to cause fat loss. Manufacturers of the dietary supplement chromium picolinate used this study, as well as related research, to claim that the supplement helps regulate blood sugar levels and helps dieters "lose fat and keep muscle."
Despite claims by manufacturers that chromium picolinate is "exceptionally safe," a study published in December 1995 suggested that the supplement may cause cancer. Chemists at Dartmouth College in Hanover, New Hampshire, and George Washington University Medical Center in Washington, D.C., found that chromium picolinate damages the chromosomes of cells growing in laboratory cultures, which is a sign that it might cause cancer. Researcher Steven R. Patierno explained that when chromium enters the body on its own, it works outside of cells. However, when chromium is combined with picolinate, it enters cells and disrupts chromosomes. The researchers concluded that chromium picolinate needed further study before it could be classified as a safe diet pill.
Ma huang
Chinese herbalists have reportedly used ma huang, or ephedra, for at least 2,000 years to treat respiratory problems. In the body, ephe-dra is converted into ephedrine, a powerful stimulant to the heart and central nervous system. Ephedrine and the chemically related pseudoephedrine are used in cold remedies and some asthma medications. Most manufacturers of ephedra-based dietary supplements combine the herb with caffeine to boost the effect. This combination, however, creates a greater risk of adverse reactions.
Manufacturers of workout formulas containing ma huang and caffeine claim that the products promote weight control and boost energy. Other ephedra-based dietary supplements, such as Herbal Ecstasy, are promoted as a way to get a "natural high"--a legal alternative to an illegal and chemically unrelated drug called Ecstasy. The makers promise that the product can heighten energy, inspire inner visions, boost sexual sensations, and bring on cosmic consciousness.
Public health officials have criticized the safety of this "natural high," however. Medical researchers have linked Herbal Ecstasy and similar ephedra-based supplements to liver failure, skyrocketing blood pressure, heart attack, psychosis, stroke, and death in several young people. Many states outlawed ephedra-based supplements after the March 7, 1996, death of 20-year-old college student Peter Schlendorf in Panama City, Florida. Schlendorf's heart stopped after taking twice the suggested dose of Ultimate Xphoria, which contains ephedrine, pseudoephedrine, phenylpropanolamine (an appetite suppressant), and caffeine. In June 1997, the FDA reported at least 20 deaths and 800 adverse reactions linked to the ephedra-based supplements. The FDA restrictions, scheduled for final approval after August 1997, would limit the recommended dosages of the supplements and require warning labels explaining the various risks.
Shark cartilage
The Chinese have eaten shark fin soup for centuries as an aphrodisiac (a substance that arouses sexual desire), but in the 1990's sharks were touted as a "miracle" treatment for cancer. Oncologist Judah Folkman at Harvard Medical School in Boston and his colleagues published research in 1983 showing that shark cartilage could slow the growth of the blood vessels necessary for cancerous tumors to grow. Although Folkman and the other researchers did not pursue this research any further, their study was a part of the evidence used in the book Sharks Don't Get Cancer, published in 1992. The book became the focus of media attention for its claim that the dietary supplements made from shark cartilage could cure cancer.
A shark's skeleton is made entirely of cartilage, a flexible tissue that consists of protein, calcium, phosphorus, sticky substances called mucopolysaccharides, and some unknown chemicals. The primary author of Sharks Don't Get Cancer, nutritionist and biochemist William Lane, claimed that sharks do not get cancer and attributed this to some unknown property of the shark's skeleton. Lane also conducted research with shark cartilage at cancer clinics in Cuba and Mexico. After a 1993 broadcast of the television program 60 Minutes that featured this research, sales of shark cartilage, which sells for $30 to $60 a bottle, increased rapidly in the United States.
Critics were quick to point out that, first, sharks can get cancer. Also, none of the research performed in Cuba and Mexico had been reviewed by other specialists, and no peer-reviewed research had isolated a chemical in shark cartilage that shrinks tumors. The American Cancer Society concluded that "there is no record in the medical literature of any benefit to ingesting shark cartilage." Scientists are not even sure if the body can absorb the cartilage in a pill form.
Taking chances with nature
Since the enactment of the 1994 dietary supplement law, sales of "natural drugs" rose an estimated 15 percent annually. Consumers bought millions of dollars worth of products whose long-term effects doctors, pharmacists, and other medical specialists knew little or nothing about.
Many medical professionals fear that the leniency of federal regulations, the widely held belief that any natural product is safe, and the lack of long-term clinical trials may create health risks that outweigh the potential benefits of some products. They advise that when shopping for health products, consumers should focus less on claims about the "natural" benefits of a dietary supplement and more on how rigorously each product has been tested.
The author: Ricki Lewis has a doctorate in genetics and is the author of several life science textbooks
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Post by Nolansbuddy4ever on May 21, 2004 13:43:10 GMT -5
I take Melatonin before bed, it helps me sleep.
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Post by Rebecca on Oct 10, 2005 11:22:01 GMT -5
What about High Doses of Vitamin B6 and Magnesium? I hear it works wonders. I am going to start this with Alexis today after researching it. I will let you know how it works for us. More info on this click hereAlso I am curious, has any one else here tried the Casein Free Gluten Free diet? We tried this with my daughter and it was so hard to stick too, but I didn't notice a change at all.
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Post by momofautistic on Oct 10, 2005 18:07:44 GMT -5
it was to hard for me to stick to also since the reward wasnt noticeable enough
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Post by melissa on Oct 13, 2005 11:22:34 GMT -5
We tried the B-6, mag, and also omega oils, we also tried the gluten, casien free diet. Getting the supplements down him was a nightmaire and the diet was to difficult to stick to with the other family members eating regular. We did stick to every thing for 2 weeks though with no noticable changes in any thing. The one thing we did stick to was the casien free, when we took him off all dairy products his health improved. He has had cronic ear and throat infections since a baby and omiting that from his diet has helped clear that up and also improve his behavior because he was feeling better.
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Post by momofautistic on Oct 13, 2005 18:52:05 GMT -5
yep the milk was the only thing that did have an effect on Jimmy and that we did manage to stick to.
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Post by DFGADFG on Nov 2, 2007 1:42:02 GMT -5
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