Since I haven't seen the protocol myself, I can't comment on the specifics
of the protocol, but I've served on the IRB for almost 2 years and have
taken courses in clinical trials, so I have some background in evaluating
these.

With the exception of the potential for misleading marketing and the
source of funding, which may possibly have dictated which outcomes the
researchers chose to focus on (i.e., choosing ones that may be less
clinically relevant but that they think will demonstrate the point that
they want to make), it sounds like the study is a valid one, and does not
violate any ethical tenets.  The standard by which we make decisions is
equipoise, so a general uncertainty as to which treatment is the "best."

Babies do not appear to be randomized to breastfeeding or not (which would
be a clear violation of equipoise), but only babies who would otherwise be
on formula are being randomized to one of two formulas.  There does appear
to be uncertainty as to whether hypoallergenic formula does appreciably
reduce risk, and there is also uncertainty as to whether the drawbacks of
the hypoallergenic formula (expense, taste, others) is outweighed by the
potential benefits.  They could have randomized between soy formula and
hypoallergenic, but I'm not sure that would have been any better, and
possibly less useful as a comparison.

The study may (will?) demonstrate that the breastfed cohort does better
than either of the formula fed cohorts, and that will be good.  The study
may also answer the question of which formula to use in babies that are
not breastfed, for whatever reason (mother's choice, bad BFing advice,
primary failure), to minimize their risk of disease.

It will be a long time before we can demonstrate the value and cost-
effectiveness of human milk to all people, overcome some people's
objection to donor milk, expand the use of human milk banks, improve
breastfeeding support to meet a gold standard at all locations, and even
then there will be some people who will, for whatever reason that I may
totally disagree with, not give their babies breastmilk.  I'd rather at
least know the data on how to choose between the lesser of two evils.

Shannon McElearney, MD
University of Virginia

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