The Weston A. Price Foundation
 Contact:  Sally Fallon, President
Washington, DC
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PRESS RELEASE

             Experts Dispute Study Conclusions
Urge Caution on Soy Infant Formula

        Experts dispute the findings of a recent study on soy infant
formula, published in the Journal of the American Medical Association,
August 15, 2001 and widely reported in the press as a vindication of soy
formula. The research team, headed by Dr. Brian L. Strom, called the results
"reassuring" but other scientists disagree with this conclusion.
        Dr. Mary Enig, President of the Maryland Nutritionists Association,
points out that the researchers found higher rates of reproductive
disorders, asthma and allergies in those who had received soy formula as
infants.  "This is in line with a number of reports in the scientific
literature," said Dr. Enig.  "The research team glossed over negative
findings and omitted them from the Abstract and Conclusions, noting only
that women who had been fed soy formula reported slightly longer duration of
menstrual bleeding and greater discomfort with menstruation."
        Other gynecological problems, which were omitted from the main body
of the report, included higher rates of cervical cancer, polycystic ovarian
syndrome, blocked fallopian tubes, pelvic inflammatory disease and hormonal
disorders. In addition, although the study did not specifically determine
thyroid function, soy-fed females reported higher rates of sedentary
activity and use of weight-loss medicines, thus adding new evidence to
numerous scientific reports of soy-induced thyroid problems.
        Experts were also critical of the design of the study, in which
researchers conducted telephone interviews with 282 adults fed soy formula
and 563 adults fed milk formula  during  controlled feeding studies at the
University of Iowa between 1965-1978.  "Data derived from telephone
interviews, particularly interviews that ask a lot of embarrassing
questions, cannot be used to draw any meaningful conclusions," said Dr.
Naomi Baumslag, Professor of Pediatrics at Georgetown University.  She noted
that the study provided no information on dose length or quantity, nor on
the ages at which ingestion ended, all vital in a study on toxicity.  The
amount of phytoestrogens in soy formula can vary as much as tenfold,
depending on the way it is processed.
        "The question we should be asking is why are so many of our babies
on soy?" said Dr. Baumslag. "It can only be because of the advertising
efforts of the soy industry, because there is a great deal of scientific
evidence that soy formula can be damaging to newborns."
        The soy formula study was funded by the National Institutes of
Health and the International Formula Council and carried out under the
auspices of the Fomon Infant Nutrition Unit at the University of Iowa.  The
Fomon Infant Nutrition Unit is supported by the major formula manufacturers
Ross Products Division of Abbot Laboratories, Nestle, and Mead Johnson
Nutritionals.  Dr. Samuel Fomon played an important role in the development
of soy infant formula.  Early promotional efforts for soy formula described
it as "better than breast milk."
        The questions were geared to assess reproductive disorders and age
of maturation.  The average age of maturation for both sexes was the same
for both groups; however raw data that would show whether there was abnormal
clustering for early or late maturation was not given.  Women were not asked
about the age of first appearance of breasts or pubic hair.  Age of first
wearing a bra was given as a proxy measure for age of breast development and
education level attained as a proxy measure for intelligence.  Trade school,
college and post college were lumped together as one category.  No questions
were asked about digestive disorders.
        Many of the negative findings for the soy-fed group were not
"statistically significant."  But critics point out that the group of 282
soy-fed individuals was too small for statistical significance to be
achieved.  "With so many infants now receiving soy formula, the small
differences noted in the study can affect thousands of individuals," said
Dr. Enig.
        In the US, an estimated 750,000 infants per year receive soy
formula.  Consumer groups have voiced concern about  adverse effects
reported in the scientific literature, including thyroid disorders, asthma,
digestive disorders, calcium deficiencies leading to rickets, high manganese
levels leading to brain damage and endocrine disruption.  A 1986 study in
Puerto Rico found that use of soy formula was strongly correlated with
premature maturation in girls. Anecdotal reports of other adverse effects
include extreme emotional behavior, learning difficulties,  immune system
problems, irritable bowel syndrome, depression and disrupted sexual
development in boys.
          US scientists who have warned about potential dangers in the use
of soy for infants include phytoestrogen researcher Dr. Kenneth Setchell,
Professor of Pediatrics at the University of Cincinnati, and Dr. Daniel
Sheehan, Director of the US Food and Drug Administration National Center for
Toxicological Research.  Setchell determined that babies on soy formula
receive a daily exposure to isoflavones (plant-based estrogens) that is  6
to 11 times higher on a body weight basis than the dose that has undesirable
hormonal effects in adults consuming soy foods.  His research showed that
serum isoflavone levels in soy-fed infants were 13,000 to 22,000 times
higher than those of infants fed milk-based formula.  According to Dr. Mike
Fitzpatrick, a New Zealand toxicologist,  babies fed exclusively on soy
formula receive the estrogenic equivalent of at least five birth control
pills per day.
        Noting the adverse effects of similar high levels of isoflavones
when given to young animals, Sheehan warned of key imprinting events
affecting the development of many physical, physiological and behavioral
characteristics in the human infant.  Because of this evidence, both the
British and New Zealand governments have issued warnings on the use of soy
infant formula.
        Lynn Goldman, MD, MPH, Professor of Environmental Health Science,
Johns Hopkins University Bloomberg School of Public Health, also voiced
concerns. In a letter to the Washington Post dated August 28, 2001, she was
critical of press reports about the study and stated that "there are ample
reasons to begin to question the safety of soy proteins in the diets of
infants.  There are several major limitations to this study."
        The study follows a June 1, 2001 report published in Cancer Research
which found that genistein, one of the isoflavones in soy, was more
carcinogenic (dose adjusted for estrogen potency) than the synthetic
estrogen DES (routinely given to pregnant women to prevent miscarriage) when
exposure occurred during "critical periods of differentiation," such as
during infancy.  Medical professionals insisted that DES was safe for
pregnant women until they discovered that many years later, women whose
mothers took DES suffered from very high rates of cervical cancer.  The
authors of the Cancer Research study concluded that ". . . the use of
soy-based infant formulas in the absence of medical necessity and the
marketing of soy products designed to appeal to children should be closely
examined."
        "Because the risks are so great, soy formula should only be used as
a last resort," said Dr. Enig.  "There are many alternatives available for
babies who have difficulties with ready-mixed milk-based formula."

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