I believe last year I posted about the patent on insulin to be used in infant
formula. So I guess I am surprised that others are surprised.  Discoveries
about human milk properties in research are not resulting in promoting
breastfeeding.  Their discovery (invention) is for use in the infant formula and drug
industry.  Every bit and piece of human milk proteins are being genetically
engineered and proclaimed to be the solution to some health problem or to improve
infant formula. (700 human milk component patents with 200 in the application
stage)  Meanwhile breastfeeding is proclaimed to be "the most toxic food on
earth" or human milk is considered to be infected by this virus or that virus.
I am not sure why breastfeeding advocates refuse to see the big picture.
Maybe people just don't want to believe that science could be so tied to
industry.  Or maybe the picture just isn't clear enough. Maybe it is believed that if
we genetically engineer human milk proteins some how that makes it better than
human milk--cleaner, purer, whiter, brighter....If insulin is put in infant
formula, then by god this substance better be regulated as a DRUG and by
PRESCRIPTION ONLY.
Valerie W. McClain, IBCLC

patent #6399090
"Insulin supplemented infant formula"  Inventor:  Naim Shehadeh

"According to a preferred embodiment of the present invention, the insulin is
selected from the following insulin types: recombinant insulin, synthetic
insulin, purified natural insulin, biologically active insulin and insulin having
an amino acid sequence of human insulin (e.g., human insulin). Some of these
types are overlapping and therefore the insulin of choice may be categorized
to more than a single type of the types listed. Human recombinant insulin is
available in a pure form from Eli Lilly & Co, USA. Human natural purified
insulin is available in a pure form from Novo Nordisk, Denmark. Crude extracts may
also be useful, depending on the method of their manufacturing. Synthetic
insulin may be manufactured using commercially available building units for Boc and
Fmoc chemistry peptide synthesis, as well known in the art.

According to another preferred embodiment of the present invention the
concentration of the insulin in the solution is similar to the concentration in
human milk. Thus, according to a preferred embodiment the insulin concentration is
in the range of about 25000-75000 .mu.U per 100 grams of the powder (which is
diluted about 7.5 fold to form the solution) or 3000-10000 .mu.U per 100
milliliters of the solution, preferably 3000-6000, optimally about 4200 .mu.U per
100 milliliters of the solution.

EXAMPLES

Reference is now made to the following examples, which together with the
above descriptions, illustrate the invention in a non limiting fashion.

Materials and Methods

Milk Samples and Insulin Measurements

Human breast milk samples were collected from mothers between the second and
the 30th day after delivery of full term pregnancies. Cow milk samples were
taken from pooled fresh commercially available milk. Cow milk formulas were
prepared according to manufacturer instructions. All samples were stored in
polypropylene tubes at -20.degree. C. Fat-free infranatant were obtained by diluting
the milk samples with PBS (10 mM KH.sub.2 PO.sub.4, 0.15 M NaCl, pH 7.4) and
centrifuged at 100,000 g for 60 min. Clear infranatant were aspirated and
stored at -20.degree. C. Insulin concentrations were determined by
radioimmunoassay with commercial kit (Bio Data, Sorin) using human insulin as standard.

Experimental Results

As shown in Table 1 below, insulin concentration is significantly higher in
human milk (about 42 .mu.U/ml) compared with commercial fresh cow milk (about
17 .mu.U/ml) and infant formulas (about 4-12 .mu.U/ml). Insulin levels in
infant formulas is very low and is similar to the levels recorded for negative
control solution (0.5% bovine serum albumin solution, about 6 .mu.U/ml). "



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