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could remain so over a long period, is another matter. The researchers noted that the children vomited "occasionally", usual- ly after finishing a meal; that over half suffered from periods of moderate diarrhoea; that some had upper respiratory infections; and that others suffered from rash and fever. It should be noted that the researchers did not dare to use soy products to help the children recover from malnutrition, and were obliged to supplement the soy-sugar mixture with nutrients large- ly absent in soy products—notably, vitamins A, D and B12, iron, iodine and zinc. could remain so over a long period, is another matter. The clinical studies on the same subject. Use of meta-analyses to researchers noted that the children vomited "occasionally", usual- draw general conclusions has come under sharp criticism by ly after finishing a meal; that over half suffered from periods of | members of the scientific community. "Researchers substituting moderate diarrhoea; that some had upper respiratory infections; meta-analysis for more rigorous trials risk making faulty assump- and that others suffered from rash and fever. tions and indulging in creative accounting," says Sir John Scott, It should be noted that the researchers did not dare to use soy President of the Royal Society of New Zealand. "Like is not products to help the children recover from malnutrition, and were being lumped with like. Little lumps and big lumps of data are obliged to supplement the soy-sugar mixture with nutrients large- being gathered together by various groups."* ly absent in soy products—notably, vitamins A, D and B12, iron, There is the added temptation for researchers, particularly iodine and zinc. researchers funded by a company like Protein Technologies International, to leave out studies that would prevent the desired FDA HEALTH CLAIM CHALLENGED conclusions. Dr Anderson discarded eight studies for various rea- The best marketing strategy for a product that is inherently sons, leaving a remainder of twenty-nine. The published report unhealthy is, of course, a health claim. suggested that individuals with cholesterol levels over 250 mg/dl "The road to FDA approval," writes a soy apologist, "was long __ would experience a "significant" reduction of 7 to 20 per cent in and demanding, consisting of a detailed review of human clinical levels of serum cholesterol if they substituted soy protein for ani- data collected from more than 40 scientific studies conducted over mal protein. Cholesterol reduction was insignificant for individu- the last 20 years. Soy protein was found to be one of the rare als whose cholesterol was lower than 250 mg/dl. foods that had sufficient scientific evidence not only to qualify for In other words, for most of us, giving up steak and eating an FDA health claim proposal but to ultimate- vegieburgers instead will not bring down blood ly pass the rigorous approval process."” cholesterol levels. The health claim that the The "long and demanding" road to FDA FDA approved "after detailed review of human approval actually took a few unexpected turns. Thousands of women clinical data" fails to inform the consumer about The original petition, submitted by Protein re now consumin these important details. Technology International, requested a health 9 I ond g soy Research that ties soy to positive effects on claim for isoflavones, the oestrogen-like com- in the belief that it cholesterol levels is "incredibly immature", said pounds found plentifully in soybeans, based on protects them against Ronald M. Krauss, MD, head of the Molecular assertions that "only soy protein that has been breast cancer. Medical Research Program and Lawrence processed in a manner in which isoflavones Berkeley National Laboratory.* He might have are retained will result in cholesterol lower- added that studies in which cholesterol levels ing". In 1998, the FDA made the unprecedent- Yet, in 1996, were lowered through either diet or drugs have ed move of rewriting on petition, removing researchers found that consistently resulted in a greater Humber of any reference to the phytoestrogens an . leaths in the treatment groups than in con- substituting a claim for soy protein—a women consuming soy trols—deaths from stroke, cancer, intesti- move that was in direct contradiction to protein isolate had an nal disorders, accident and suicide. *° the agency s regulations. the FDA i increased incidence of Fete ee0 tia in tne RS authorised to make rulings only on sub- P . . ave fuelled a illion per year choles- stances presented by petition. epithelial hyperplasia, a terol-lowering industry, but have not saved condition that presages malignancies. The abrupt change in direction was no us from the ravages of heart disease. doubt due to the fact that a number of researchers, including scientists employed by the US Government, submitted docu- ments indicating that isoflavones are toxic. The FDA had also received, early in SOY CONSUMPTION & CANCER The new FDA ruling does not allow any claims about cancer prevention on food packages, but that has not restrained the industry and its marketeers from making 1998, the final British Government report on phytoestrogens, them in their promotional literature. which failed to find much evidence of benefit and warned against "In addition to protecting the heart," says a vitamin company potential adverse effects.” brochure, "soy has demonstrated powerful anticancer Even with the change to soy protein isolate, FDA bureaucrats benefits...the Japanese, who eat 30 times as much soy as North engaged in the "rigorous approval process" were forced to deal Americans, have a lower incidence of cancers of the breast, uterus nimbly with concerns about mineral blocking effects, enzyme and prostate."”” inhibitors, goitrogenicity, endocrine disruption, reproductive Indeed they do. But the Japanese, and Asians in general, have problems and increased allergic reactions from consumption of much higher rates of other types of cancer, particularly cancer of soy products.” the oesophagus, stomach, pancreas and liver.* Asians throughout One of the strongest letters of protest came from Dr Dan the world also have high rates of thyroid cancer.” The logic that Sheehan and Dr Daniel Doerge, government researchers at the links low rates of reproductive cancers to soy consumption National Center for Toxicological Research.” Their pleas for requires attribution of high rates of thyroid and digestive cancers warning labels were dismissed as unwarranted. to the same foods, particularly as soy causes these types of can- "Sufficient scientific evidence” of soy's cholesterol-lowering cers in laboratory rats. properties is drawn largely from a 1995 meta-analysis by Dr Just how much soy do Asians eat? A 1998 survey found that James Anderson, sponsored by Protein Technologies International the average daily amount of soy protein consumed in Japan was and published in the New England Journal of Medicine.* about eight grams for men and seven for women—less than two 40 A meta-analysis is a review and summary of the results of many teaspoons.” The famous Cornell China Study, conducted by Thousands of women are now consuming soy in the belief that it protects them against breast cancer. Yet, in 1996, researchers found that women consuming soy protein isolate had an increased incidence of epithelial hyperplasia, a condition that presages malignancies. 22 - NEXUS APRIL — MAY 2000