As a nutritional epidemiologist (PhD Cornell, MHS Johns Hopkins University)
who worked for CDC and Emory University before becoming a lactation
consultant, I have to say I am more than a little shocked that someone from
CDC could make a statement that a study designed with a totally inadequate
sample size is sufficient to make the statement that the "fortified formula
is apparently not more hazardous than the standard formula" to try to
paraphrase Katherine Shealy's interpretation of the results. This study is
completely inadequate in its design to make any claims about the safety of
the "new improved formula" and that is what should be demanded for any
human, let alone some of the most vulnerable infants.

It is very basic epidemiology to know that you need to have an even greater
sample size when you are trying to prove that something is safe,
particularly when dealing with rare events such as death and with crucial
issues such as the health of premature infants. Any basic epidemiology text
will cover this topic.  Since I have a bad cold and don't feel like
searching around for my dissertation advisor's best work on the topic, I
can refer to an article I wrote that includes a discussion of how to look
at studies Burger SE, Haas JD, and Habicht J-P.  Testing the effects of
nutrient deficiencies on behavioral performance. American Journal of
Clinical Nutrition. 1993; 57(2S):295S-302S. I'm sure with a minmal amount
of searching any one of you can find far better and more specific
references out there about appropriate study designs for determining risk.

Furthermore, just because a document is written in "standard scientific
writing" does not mean that it is clear.  I did NOT find the descriptionsof
the study groups clear, I'm still confused, and I've been reading
scientific articles for over 20 years. I may be a little fuzzy headed
because of the cold, but I'm not brain dead yet.

Katherine Shealy is completely correct that the sampling of the EHM infants
makes this group completely irrelevant to the study findings and results.
Therefore, I find it completely unethical that a group of infants is
included in the study when the information collected from these infants
served no useful purpose.

Finally, just because something is "published" does not mean that it is
peer-reviewed and even peer-reviewed articles are not always free of bias,
bad design, or faulty conclusions.

Sincerely,

Susan Burger, PhD, MHS, IBCLC, RLC

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