There are two distinct issues at play in discussion of this document.  First
and foremost the evidence cited in the patent document *is* published, it is
published in the patent document.  As such, it is unlikely to be accepted
for publication elsewhere.  Second, although I am all in favor of pointing
out misleading and erroneous conclusions related to artificial feeding in
appropriate and scientifically valid situations, there is not compelling
evidence in this case to do so.  This document was written in standard
scientific language.  I see no evidence of efforts to mislead anyone.  In
fact, if efforts were to be made to mislead a reader, this document would
likely be the most ineffective forum, as it is read mainly by people
uninterested in the nuances of breastfeeding versus artificial feeding.
The purpose of the research conducted to pursue the patent referred to in
this case was to determine the 'efficacy' of two variations of formula
fortification *as related to standard formula*.  While the EHM group was
followed, they were not part of any of the research conclusions.  This fact
is clearly and appropriately stated throughout their document.  The standard
in researching new 'versions' of formula is, is it more dangerous than
existing formula?  This key difference in definition is crucial for
adequately understanding formula related research.
There are many issues which are worthy of clarification in this study.
First, the EHM infants are a self-selected group, which is the only ethical
way to approach this kind of research, it would be unethical to randomize an
infant whose mother had planned to provide breastmilk into one of the
artificial milk groups. As such, the EHM group in their study is not a
control group at all, but instead something of a parallel group that is an
interesting reference, but not integral to the study design. The control
group of this study is the 'standard care' group, i.e., those infants whose
mothers had already chosen to artificially feed, and were given standard
preterm formula (Similac Special Care followed by Similac Neosure). The
experimental groups were those given fortified formula differing by source
of fortificant. The goal of the study was to examine results of different
versions of fortified formula versus standard preterm formula. Randomization
of formula type only occurred after medical staff determined a 'need' for
formula supplementation.
Many factors may have made some mothers choose to pursue breastmilk feeds
with greater frequency than their formula feeding counterparts (as it seems
from the study description that indeed no participant was truly EHM),
including better initial health, better family health, less infection, etc.
It is well documented that artificial milk is hazardous to premature
infants. The question here is whether the fortified formula is in fact
'more' hazardous than its standard counterpart.  It does not appear to be,
as reflected in the infant death statistics of 6, 3, and 6 for the standard
formula, fish/fungal fortified, and egg/fish fortified respectively. Given
the sample size, the power is not sufficient to judge a statistical
difference between 6 and 3.

If one looks at Table 3 - Family Characteristics, the mothers in the EHM
group are in general at least 2 years older than any of the formula groups,
with in general at least 2 more years education, even more in the Chile
group, they are overwhelmingly less likely to be smokers during pregnancy
(4.7% versus 25.4-29.3%) as well as postnatally (9.5% versus 37-44%), they
were more likely to have gotten prenatal care during the 1st trimester, and
their intelligence scores were unlike their formula counterparts (53.2
versus 37-39). This is the crux of the issue. Regardless of the health
prognosis of the infants involved, the risk of complications was higher for
the group that ended up choosing formula than that of the EHM group.
Katherine Shealy

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