To be added to Petition Docket # FDA-2009-P-0425-0001
Dear HHS Director Sebelius, FDA Commissioner Hamburg, Drs. Silverman, and Schneeman,
If you will take a moment to review Wikipedia internet encyclopedia definitions of soy, it also confirms the existing massive evidence proving soy's many toxic effects, largely developmental toxic effects-
Wikipedia confirms Soy;
"Genistein- Is one of several known isoflavones...many isoflavones have been shown to interact with animal and human estrogenic receptors, causing effects in the body similar to those caused by the hormone estrogen. Isoflavones also produce non-hormonal effects. Genistein influences several targets in living cells that leads to many, frequently exclusive or paradoxical conclusions-
1. Inhibition of several tyrosine kinases- ...implicated in almost all cell growth and proliferation signal cascades. Tyrosine kinases function in a variety of processes, pathways, and actions and is responsible for key events in the body. Cellular growth and reproduction may rely in some part on tyrosine kinase. Tyrosine kinase function serves to physically stabilize DNA.
2. Inhibition of topoisomerase- enzymes that unwind and wind DNA in order for DNA to control the synthesis of proteins and to facilitate DNA replication. The enzyme is necessary due to inherent problems caused by the DNA's double helix. Topoisomerases catalyze and guide the unknotting or unkinking of DNA.
(Several studies report inhibition of topoisomerase as a cause of infantile leukemia Hengstler JG et al 2002, Ross JA 1996, Ross JA 1998, JA Ross 2000, Strick R et al 2000, Ivanova T et al 2001, Grandage VL et al 2005, Brownson et al 2002, Cohen Y et al, 2009, and more).
3. Stimulation of autophagy- In some situations, it (autophagy) may actually contribute to the development of a disease.
4. Activation of estrogen receptor beta- (or activation of the sex hormone estrogen ERb expressed by many tissues throughout the body and is found throughout the brain at different concentrations in different neurn clusters). Estrogen receptor beta has been shown to interact with: Estrogen receptor alpha, NCOA3, NCOA6, MAD2L1, RBM39, and Src.
5. Inhibition of the mammalian hexose transporter GLUTI- De Vivo Disease is an autosomal dominant developmental disorder associated with a deficiency of GLUTI also known as Glucose transpoerter type 1 deficiency syndrome. De Vivo disease is characterized by deceleration of head growth ....mental and motor developmental delays, infantile seizures refractory to anticonvulsants, ataxia, dystonia, dysarthria, opsoclonus, spasticity, and other paroxysmal neurologic phenomena. Typically, seizures begin between one and four months in 90% of cases with abnormal eye movements and apneic episodes preceding the onset of seizures in some cases. Developmental delays are often global and include receptive and expressive language dysfunction.
6. Contraction of several types of smooth muscles- smooth muscle is an involuntary non-striated muscle found within the walls of blood vessels. Smooth muscle is also found in lymphatic vessels, urinary bladder, uterus, male and female reproductive tracts, gastrointestinal tract, respiratory tract, arrector pili of skin, ciliary muscle, iris of the eye, and glomeruli of the kidneys.
7. Modulation of CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) channel, potentiating its opening at low concentration and inhibiting it a higher doses. CFTR is the protein product of the gene defective in cystic fibrosis the most common lethal genetic disease among caucasians. (Multiple studies, as example, DC Gadsby and AC Nairn, Physiological Review, Vol 70, Jan 1999 confirms: "Kinase inhibiting concentrations of genistein have been demonstrated to increase CFTR channel activity in all cells tested).
Genistein was found to increase the rate of proliferation of estrogen-dependent breast cancer when not cotreated with an estrogen antagonist (Ju YH et al 2006, Chen WF and MS Wong 2004, Yang X et al 2010). It was also found to decrease efficiency of tamoxifen and letrozole drugs commonly used in breast cancer therapy (Helfenrich, WG et al 2008, Tonetti DA et al 2007). Genistein was found to inhibit immune response towards cancer cells allowing their survival (Jiang, X et al, 2008. Many more studies exist).
(Soy) Isoflavones can act like estrogen, stimulating development and maintenance of female characteristics, or they can block cells from using cousins of estrogen."
Wikipedia continues with;
"Daidzein- many (soy) isoflavones have been shown to interact with animal and human estrogen receptors, and are therefore known as phytoestrogens. Isoflavones can act like estrogen in stimulating development and maintenance of female characteristics or they can block cells from using other forms of estrogen. Isoflavones also have been found to have aniangiogenic effects (blocking formation of new blood vessels).....Laboratory studies using animal models have show that both soy and isoflavones might stimulate response to cancer causing chemicals when given during fetal development or when circulating levels of estrogen are low. Daidzein...has not been tested in clinical trials to make sure that it is both safe and effective for treating any disease."
Wikipedia continues;
"(Soy) Glycitein is a phytoestrogen with weak estrogenic activity comparable to that of other soy isoflaovnes."
(Multiple studies report the same as this study), "Song TT et al, 1999, 'These data indicated that glycitein has weak estrogenic activity, comparable to that of the other soy isoflavones but much lower than that of DES and 17beta-estradiol.'"
Wikipedia continues-
"Chemically it is the 7-O-beta-D-glucoside form of genistein 99% of the isoflavonoid compounds in soy are present as their glucosides. When ingested along the diet, genistin is readily converted to its aglycone form, genistein...the form responsible for the biological activities of the isoflavone. The digestive metabolism was first demonstrated in 2002 that the gut microflora played a large role in the conversion of genistin to genistein.
It was late found that enzymes present in the human small intestine and liver also have the ability to convert the isoflavone...oncegenistin is ingested conversion begins in the mouth and then continues in the small intestine. Genistin like genistein is a phytoestrogen as it was shown to stimulate estrogen dependent breast cancer cell growth in vivo. At a concentration of 1200ppm genistin caused significant increase of growth of breast tumors, cellular proliferation and estrogen responsive pS2 gene expression in mice. Removal of genistin or genistein from the diet caused tumors to regress, (Allred CD et al, 2001).
Genistin and other isoflavones are demonstrated to be bioactive within the neonatal intestine (Donovan SM et al 2009). The presence of genistein or genistin in the tissue culture caused a significant increase in alkaline phosphatase activity, DNA, and calcium contents."
("Significant increase") of the above mentioned is clearly proven as especially damaging during fetal, infant, and child development.
As with the massive study evidence in your files, along with further available information from Wikipedia internet encyclopedia when will you dutifully disclose the repeatedly proven high health risks for developmental adverse effects proven as caused by soy's toxic components to once healthy fetus, infant, and child?
Have you reviewed the many, many MedWatch reports from parents reporting observed soy toxicity of their child(ren)?
Have you reviewed the 2010 NTP Brief, that repeatedly concludes "Clear Evidence of Adverse Effects?"
With such overwhelming scientific study evidence all proving extensive developmental soy toxicity, it is past due to enforce developmental soy WARNING labels, and to WITHDRAW soy formulas of which infant's dietary intake can reach a most frightening 100%, while even minimal soy infant toxicity is largely proven as physiologically, reproductive, and neurologically damaging to once healthy fetus, infant, and child.
Allow truthful public disclosure of developmental soy toxicity, until a day comes that soy; phyto-estrogens, phytic acid, inhibition of several essential enzymes, and multiple heavy metals can by proven as safe for fetal, infant, and child consumption.
I will appreciate and look forward to your reply.
Sincerely,
Gail Elbek
380 N. San Marcos Road
Santa Barbara, CA 93111
gaelbek@yahoo.com
