National Women's Health Network
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 In a Phase II trial, the drug is given to people with the condition or disease to be treated; it supplies some preliminary data on whether the treatment works and supplements the safety data of the Phase I trial. Phase II trials may or may not use a control group.
A Phase III trial assesses efficacy, safety, and dosage, compared with standard treatments or a placebo. Phase III trials are usually randomized and controlled.
Phase I, II, and III trials are usually performed as part of an IND (an investigational new drug application to the FDA). |
Ruth Winter
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 COPPER SALTS • Used as nutrient supplements in animal feed. Copper itself is nontoxic, but soluble copper salts, notably copper sulfate, are highly irritating to the skin and mucous membranes, and when ingested cause serious vomiting. Copper salts include copper carbonate, chloride, gluconate, hydroxide, orthophos-phate, oxide, pyrophosphate, and sulfate. The final report to the FDA of the Select Committee on GRAS Substances stated in 1980 that it should continue its GRAS status with no limitations other than good manufacturing practices. |
David Brownstein
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 Progesterone and Provera There are two types of progesterone supplements available—natural progesterone and synthetic progesterone. Synthetic progesterone, such as Provera, resembles natural progesterone but has been chemically altered in order to be
Figure 7: A Comparison of a Natural Hormone (Natural Progesterone) and a Synthetic Hormone
(Provera)
Provera CH3
The difference between the natural hormone, progesterone, and the synthetic version, Provera, is illustrated in this diagram. The arrows in the Provera illustration point out the additional side chains added to progesterone. |
Marion Nestle
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 As a result of this tragedy, the FDA appointed an internal task force to recommend ways in which it could "improve" (translation: strengthen) its regulatory methods for supplements. While the committee review was under way, the FDA was dealing with the 6,000 or so comments that had been filed on its 1990 proposals for health claims—many of which argued for less restrictive scientific standards. |
| The Times characterized the FDA as opposed to the idea that supplements "can be effective, whether or not they are backed by science." It reported protests to the FDA action, among them a press conference at which celebrities urged the public to "start screaming at Congress and the White House not to let the F.D.A. take our vitamins away" and editorials demanding that "if there is any plausible excuse for the Gestapo-like tactics ... it had better be forthcoming and fast. |
| In demanding only semantic restrictions on what marketers can claim about health benefits, Congress weakened not only the FDA's ability to protect the public from supplements that are in fact hazardous but also its ability to control the inappropriate marketing of foods, food additives, and even drugs. This achievement was hailed as a tremendous victory by the supplement industry. As one of its lobbyists gloated, "DSHEA stands for the unusual precedent that the FDA was wrong. . . . |
| The makers of conventional foods, watching sales of supplements increase at a greater rate than they themselves can achieve, also are demanding—and getting—the same kinds of loose regulations for foods. It is difficult to believe that this situation is in the best interest of public health.
Although the supplement industry has always couched its political efforts in terms of health benefits or "freedom to choose," its more immediate rationale was and is economic. Supplement makers do not want to have to conduct lengthy, expensive clinical trials to prove that their products are safe or useful. |
| Companies in this $3 billion annual industry sold vitamins to makers of supplements, fortified foods, or animal feeds (the heaviest user). With sales of $1.4 billion per year, Roche was the largest supplier, but its prices did not seem to vary from those of its competitors. According to investigators, senior executives of the wholesalers—constituting what they called "Vitamin, Inc."—met in secret every fall for a decade to set production quotas, prices, and distribution for the global market. |
| On the other hand, Congress, annoyed with the FDA's strict regulatory approach to drugs and tobacco as well as to supplements, has reduced the agency's autonomy and funding levels to the point where its resources are demonstrably inadequate for the work it is expected to perform. Although the FDA's budget was about a billion dollars in 2001, Congress had earmarked most of that amount for specific programs, and its entire allocation for dietary supplement regulation included just $6 million and fewer than five full-time employees. |
John Robbins
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 For vegan women who are pregnant or nursing, B-12 supplements are indispensable.
Sometimes people say, well, if a vegan diet is a healthful one, and if it's in keeping with our natural relationship to the Earth, how come vitamin B-12, which is necessary for health, is only found in animal products? It's a good question, and the answer is simple.
Animal products have vitamin B-12 because animals ingest plants and/or drink water that are carrying the microorganisms that produce the vitamin. Vitamin B-12 is constantly being produced throughout the environment by bacteria. |
| It was also found to be independent of smoking, alcohol consumption, exercise, body mass index, and the use of vitamin E and other supplements. My friend, always scrupulously careful not to make claims that aren't entirely supported by the data, wrote, "This study suggests support for the hypothesis that there might be an association between nut consumption and a possible reduction in heart disease risk."33
My friend, as you can see, tends to speak in the typically restrained fashion of scientists. I love him dearly, but I think there are times to leave such language behind. |
| One company, NOW Foods of Bloomingdale, Illinois, has begun to augment its vitamin line with non-GMO supplements. "The challenge," said James Roza, the company's director of quality assurance, "is enormous. Not only do we have to worry about the contamination of raw materials like corn and soy, but ... all of the genetically engineered processing aids used to make vitamins as well."1,
I wish I could tell you the name of a particular brand of vitamins that you could purchase knowing they were guaranteed to be free from GMOs. But I can't. |
| But the lack of labeling makes it very difficult to choose foods and supplements that don't contain genetically altered substances.
]y[ilk from Drugged Cows
For some time, bovine growth hormone (BGH) has been used to stimulate milk production in cows. The hormone was too expensive for widespread use, however, until Monsanto came up with a genetically altered hormone, called rBGH (recombinant bovine growth hormone), sold under the brand name Posilac. This genetically engineered hormone is now injected into about a quarter of the cows in U.S. dairies. |
Leo Galland
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 Magnesium supplements can build resistance to the effects of stress.
Personality has an effect on this cycle. Students who must take an exam while being distracted with noise may also lower their magnesium levels. |
Robyn Landis
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 They are whole and complete, not isolated substances like drugs (except when their active ingredients are concentrated into standardized supplements, a topic we will cover later on).
Herbs fall somewhere in the middle of the spectrum between food and drugs. Some herbs actually are nutritive, the way food is, and can be used the way food is used—consumed because it is healthy and makes you feel good. |
Ruth Winter
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| No food additive regulation authorizing use of menadione in prenatal supplements or any other food products has been issued. However, menadione is permitted as a nutritional supplement in chicken and turkey feed for prevention of vitamin K-deficiency and in swine feed. Used as a preservative in emollients. A synthetic with properties of vitamin K. Bright yellow crystals that are insoluble in water are used medically to prevent blood clotting and in food to prevent souring of milk products. Can be irritating to mucous membranes, respiratory passages, and the skin. |
James A. Duke, Ph.D.
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 Although I prefer to recommend that you get your vitamins and minerals from foods rather than supplements, deficiencies of folate (the naturally occurring form of folic acid) are quite common, and you might need a folic acid supplement. The average American consumes only 61 percent of the Daily Value of 400 micrograms of folate. Whether or not you take a supplement, however, don't neglect good food sources such as spinach, pinto beans, asparagus, broccoli, okra and brussels sprouts.
V Wheatgrass (Agropyron, various species) and other grasses. |
Larry Trivieri, Jr.
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 Lactobacilli, Bifidobacteria, and Streptococci are the bacteria most commonly found in probiotic supplements. Other beneficial species that may be included are L. casei,
L. plantarum, L. sporogenes, L. brevis, and Saccharomyces boulardii. Without bacteria like acidophilus, you would be unable to properly digest your food and absorb vitamins and other nutrients. But digestion is only the beginning of the health benefits probiotics can provide. Other benefits include:
• The manufacture of certain B vitamins, including niacin (B3), pyridoxine (B6), folic acid, and biotin. |
National Women's Health Network
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| Vitamin D supplements reduce hip and other nonvertebral fractures.
• Bisphosphonates (alendronate, etidronate, risedronate) increase bone mineral density at the spine and hip and reduce the risk of vertebral fractures. Alendronate and risedronate reduce the risk of subsequent nonvertebral fractures.
• HRT decreases the risk of vertebral and nonvertebral fractures. Observational studies show reduced risk of hip fracture, but the HERS trial indicated no reduction in hip fracture after four years. |
Cheryle R. Hart, M.D. Mary Kay Grossman, R.D.
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 Excessive doses of any of these supplements could be toxic, so talk to your physician about the right dosage for your needs.
Helen—When Helen came to see us, she was despondent. She was forty-five years old and had been battling her weight for most of her life. She even remembered going to a doctor for "diet pills " when she was twelve years old. Her whole family seems to have had some type of overweight problem. Her father had diabetes and died of a heart attack at age fifty-seven. Her mother has high blood pressure besides being overweight. |
National Women's Health Network
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| Most health care providers do not prescribe these supplements.
• There is a dearth of scientific evidence from clinical trials about osteoporosis and the benefits of drugs for women over age seventy-five. It is these women who are most at risk for hip fracture, but drugs have not been adequately tested for safety or efficacy in this age group.
• Most of the drugs for treatment and prevention of osteoporosis are too new to have a long-term record on safety or efficacy. ERT and HRT have the longest record, but these drugs are not risk-free. limit their activities. |
Cheryle R. Hart, M.D. Mary Kay Grossman, R.D.
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| We'll discuss more about antioxidants later in this chapter under "Other Foods and supplements." Fruits also provide folic acid, which you need for building new cells. Not getting enough folic acid causes anemia and can cause birth defects in a developing fetus during pregnancy. Often, when people learn that fruits are high in carbohydrates, they avoid them or limit them too much. Don't be tempted to do this. Include at least two servings of fruits each day. Just be careful not to eat too much fruit or fruit juice at any one time and be sure to link them with protein. |
National Women's Health Network
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| For example:
• A case-control study that compared food choices of 200 Chinese women in Singapore who had breast cancer with 420 matched controls found that soy product intake had a protective effect in omen should be wary of phytoestrogen supplements proliferating on drugstore shelves, because they may have very different efects than adding tofu to meals. premenopausal women but no effect on postmenopausal women.15
• Another case-control study of premenopausal and postmenopausal women in China did not find a protective effect in either group. |
| Four studies have looked at whether supplementing the diet with phytoestrogens resulted in estrogenic changes
Food or supplements?
Soy foods have been a staple in Asian cuisine for thousands of years and can be presumed safe, at least for those raised on it. There is some interesting evidence that phytoestrogen consumption during puberty, when breasts develop, could be the most critical period for its intake. Beans are safe; the recent availability of purified isoflavone, mixed-phytoestrogen, or nonfood phytoestrogen pills like red clover, however, is worrisome. |
Ralph W. Moss, Ph.D.
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 They also advise their patients to eat large amounts of fresh fruits and vegetables, in part to make up for the loss of animal protein and in part for the other enzymes and nutrients that these foods contain. supplements are often given in the form of Wobe Mugos, which contain enzymes from pancreas, calf thymus, peas, lentils, and papaya (Wolf and Ransberger, 1972). |
| For cancer patients -not taking supplements this figure ranges from around 0 to 10 milligrams. But of six patients whose urine was tested, two excreted over 550 milligrams; the other four excreted an unspecified amount less than this. Thus, of the controls, a third of those tested excreted amounts ten to one-hundred times greater than normal.
Moertel stated that one of these patients was diabetic and that this may have led to the discrepancy. |
James A. Duke, Ph.D.
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| On returning home, after two weeks without the supplements, he began taking them again, and his rash cleared up again. That made a believer of him.
Allow me to tell you one more story before we get to the herbs. A videog-rapher who worked with me in the Amazon developed a strange and very itchy eczema while in the rain forest. A shamanistic healer I knew suggested that she apply a poultice of crushed petals of Peruvian red hibiscus. |
| Few marketers of herbs or supplements have that kind of spending money. Drug companies, which do have the money, can justify the expense because once they get a new drug approved, they usually have a patent entitling them to exclusive marketing rights for many years. During that time they can recoup many times over the investment made in the approval process. But who in their right mind would spend hundreds of millions to prove that prune juice is a good laxative? (It is.) You can't patent prunes, so you could never make your money back. |
| Until quite recently, the Food and Drug Administration and most physicians told us that supplements, including calcium, were a waste of time and money. Now, very belatedly, they tell us that we're not getting enough calcium. According to the 1995 National Institutes of Health (NIH) Consensus Development Panel on Optimal Calcium Intake, Americans (especially women) should get 1,000 to 1,500 milligrams a day. Unfortunately, most get much less than that, and many don't get even half that amount. |
David Brownstein
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| Also the following supplements are helpful: Vitamin C 3000mg/day, Vitamin D 400 I.U./day, Calcium Citrate 1500mg/day and Magnesium Chelate 400mg/day.
*Most soy products in the United States are the non-fermented soy products. These products should be used sparingly, as they may inhibit thyroid function.
1 Documenta Geigy, Scientific Tables sixth edition; pg 493.
2 Lee, John. IBID, 40
3 Lemon, H.M., et al. 1966 Reduced estriol excretion in patients with breast cancer prior to endocrine therapy. JAMA 196:1128-1136
4 Follingstad, Alvin. Estriol, the forgotten Estrogen? JAMA 1/2/78 Vol. |
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