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HEALTH
EXPERTS URGE FDA TO DENY
SOY PROTEIN / CANCER PREVENTION
HEALTH CLAIM
Scientists say Solae petition omits many studies
indicating soy may cause cancer
July 5, 2004,
WASHINGTON, DC: Researchers at a non-profit nutrition education
foundation in Washington, DC are urging the Food and Drug Administration
to deny a petition that would clear the way for soy products to
claim they prevent cancer. The Weston A. Price Foundation says a
petition by Solae, a manufacturer of soy protein and other processed
soy products, for a FDA health claim is based on misleading research.
Approved health
claims can be used in product labeling and packaging to influence
consumers in making dietary choices. The FDA will make a decision
later this year.
Kayla T. Daniel,
PhD, author of The Whole Soy Story (to be released Fall 2004), noted
that "Solae was highly selective in its choice of evidence
and biased in its interpretations. It omitted many studies that
show soy to be ineffective in preventing cancer, emphasized favorable
outcome in studies when results were mixed and excused results of
a few unfavorable studies that they included to give the illusion
of balance. Most seriously, Solae omitted many well-designed studies
that have suggested that soy protein can contribute to, cause and
accelerate the growth of cancer."
Solae, a joint
venture of Dupont and Bunge, applied for a Soy Protein and Cancer
Health Claim in March 2004. Sally Fallon, President of the Weston
A. Price Foundation, points out that Solae has a strong financial
interest in winning a cancer health claim. "In their petition,"
notes Fallon, "Solae states that since the FDA authorized the
Soy Protein and Coronary Heart Disease Health Claim, per capita
consumption of soy protein increased from 0.78 g/day in 1998 to
2.23 g/day in 2002. Solae predicts that consumption of soy protein
will double with a cancer health claim. Solae stands to reap tremendous
financial gain at the expense of the public."
"Numerous
experts including scientists from the FDA's own National
Laboratory for Toxicological Research have warned of soy
protein's carcinogenic potential and of the health dangers of excess
soy-food consumption," says Bill Sanda, Director of Public
Affairs for the Weston A. Price Foundation. "Yet in its petition,
Solae contends that their data 'establish that there is scientific
agreement among experts qualified by scientific training and experience
to evaluate such claims regarding the relationship between soy protein
products and a reduced risk of cancers.' No such consensus exists.
The British Committee on Toxicity (COT) reviewed much of the evidence
and found the results to be both 'inconsistent and contradictory.'"
The British
Committee on Toxicity (COT) has stated that "the epidemiological
data on soy intake and prostate cancer are inconsistent" and
that concentrations used in animal experiments are "very high
compared with the likely dietary exposure levels in humans."
These studies not only show that soy foods are not protective against
prostate cancer or less effective than other dietary agents, but
also that soy protein and its constituent isoflavones
have been linked to increased prostate cancer risk. In addition,
they have caused undesirable side effects, including changes to
the brain.
According to
the Weston A. Price Foundation, Solae also failed to present theories
about why soy might be protective against the development of prostate
cancer. "Prostate cancer is generally thought to be dependent
on exposure to male reproductive hormone. If soy confers protection,
it does so by altering endogenous hormone concentrations
by decreasing testosterone and androgen levels and feminizing men,"
said Fallon. "While this might have valid pharmaceutical applications
for cancer treatment, it seems inadvisable as a preventive treatment
for our entire population of men and boys."
Solae's claim
that soy protein prevents gastrointestinal cancer is contradicted
by numerous studies, including one that links soy protein with a
lowered risk of stomach cancer but a higher risk of colorectal cancer.
Dr. Daniel adds that "Solae also omitted key studies that link
the soy lectin a component of soy protein to precancerous
conditions in the small intestines, including shortened villi, a
diminished capacity for digestion and absorption, cell proliferation
in the crypt cells, interference with hormone and growth factor
signaling and unfavorable population shifts among the microbial
flora."
Solae states
that "the totality" of the evidence supports a soy protein/cancer
claim, a conclusion that Solae's consultants were able to reach
only through a series of statistical studies known as meta-analyses.
"Meta-analyses serve researchers and their industry
sponsors when they wish to draw specific conclusions,"
explains Fallon. "Meta-analysts have been criticized by many
in the scientific and statistical communities for making faulty
assumptions, indulging in creative accounting and for leaving out
studies that contradict or dilute the conclusions desired. Solae
has left out many such studies."
Experts were
also concerned about Solae's summaries of the body of evidence concerning
soy and other cancers. Solae chose to minimize a large-scale study
linking soy protein to bladder cancer and it omitted evidence linking
soy protein to thyroid and pancreatic cancers and to childhood leukemia.
Solae also failed to address soy protein's well-documented risks
to the digestive, immune and neuroendocrine systems of the body,
including strong evidence that dietary soy has contributed to rising
rates of infertility and hypothyroidism. Soy is also highly allergenic.
Most experts now place soy protein among the top eight allergens,
and some rate it in the top six or even top four. Allergic reactions
to soy range from mild to life threatening and fatalities have been
reported in medical journals.
A Note
About this article from Health101.org:
Like
many health educators, this article contains examples of educators
who have some spot-on, accurate info, but also teach some incorrect
info. For example, Health101.org does not endorse the Weston A.
Price organizaion because in my opinion they have the same issue;
some accurate and some inaccurate info about the diet all humans
are best suited to eat (they promote a high animal fat diet).
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