Ginger and Merrie have informed us of the formula companies' efforts to
influence health care providers through grand rounds and conference presentations
on DHA/ARA additives in formula. Valerie has given us a wonderful post on
background and lots of food for thought on this topic. If we take a look at what is
happening on the breastfeeding horizon we can see that much of the companies'
work is to peddle the new product as safe, project a benign helpful image,
and essentially buy the loyalty of physicians and nurses to their formula
products.

The following breastfeeding events are happening this year which means that
the companies must act proactively in order to avoid losing money or market
shares of their products:
1. The Child Nutrition Act is up for reauthorization in 2003. This act
contains the WIC funding guidelines. Industry wants to make sure that it maintains a
cozy relationship with the federal government within this program.

2. The $40 million breastfeeding promotion campaign from the Office on
Women's Health kicks off in October. More women breastfeeding means less money for
formula companies. This is why they push so hard for breastfeeding women to
supplement. It extends their market to breastfeeding mothers.

3. World Breastfeeding Week

4. The Quintessence Breastfeeding Challenge 2003: Canada and the US. On
October 4 at 11:00am local time at many sites across Canada and the US there will
occur a nurse-in! The challenge is to see how many women can be breastfeeding
at the same time at the site. You can be a site organizer for this fun way to
really get media attention for breastfeeding by registering as a site organizer
at www.babyfriendly.ca

5. The September release of a report by the Institute of Medicine on the
safety of the mechanisms used to get the DHA/ARA formulas on the market for term
infants

6. The numerous meetings that the federal government has conducted on formula
and the basis for adding and monitoring the outcomes of the use of these new
additives

7. The FDA's proposed rulemaking regarding good manufacturing practices for
formula makers to: avoid contamination with such nasties as Enterobacter
sakazakii, the formula companies wish to add bacterial strains to formula
(remembering that powdered infant formula is not sterile), the proposed changes in the
equipment used in formula manufacturing (which will cost them money), the
"preposterous" idea that formula companies should actually conduct clinical studies
when they add new ingredients!, etc. You can obtain more information on this
and send your comments to the FDA by accessing the Federal Register, Vol 68,
No. 81, Monday April 28, 2003, p22341

My bet is that the formula companies are lobbying the federal government
heavily and targeting any of the government programs that remotely deal with
infant and child nutrition so that they can counteract all the government programs
and initiatives that pour money into breastfeeding. The companies must also
target physicians and nurses who function as their front line salesmen. The
flurry of in-services, grand rounds, dinners, and conferences are designed to
promote their products while distorting or omitting the risk of their use. Notice
who is giving grand rounds at Ginger's hospital - the Vice President of
Medical and REGULATORY Affairs. Regulatory affairs means lobbying. Companies
pressure the federal government to NOT regulate their industry and usually manage to
water down most efforts into what are called guidelines or recommendations,
rather that regulations!

Questions to ask at these gatherings, in addition to the other comments are:
1. why were so many babies dropped from the clinical trials of the formulas.
There appears to be up to a 10% attrition rate from some of these studies with
little to no mention of why they did not complete the study. Could it be they
were having adverse reactions to the formula which the studies did not bother
reporting? If half of the 4 million babies born each year in the US receive
this formula and 10% react to it, 10% of 2 million is 200,000 babies. That's a
lot of diarrhea!

2. many babies are experiencing side effects from these formulas--explosive
stools and diarrhea, abdominal cramping, foul smelling gas. Could this mean
that some of the babies are having a reaction? If so, why doesn't the label on
the formula can state that babies could experience these particular side
effects. Also, does this type of diarrhea mean that the baby is also losing fat
soluble vitamins and other nutrients through the stool? One of the side effects of
the microalgae used to make DHA is steatorrhea, fat loss through the stool

3. are they going to discontinue making the standard formula so that parents
are forced to pay 30% more for the formula in order to pay for the food and
lobbying

4. some of these offerings in hospitals come very close to violating the
federal anti-kickback statute. You should check with your hospital's corporate
compliance officer to see if all the money the hospital takes constitutes a bribe
because it causes the physicians and nurses to recommend to mothers that they
buy the house brand of formula

5. these formulas are under what the FDA calls post market surveillance. Ask
what formal studies are being conducted and by whom regarding post market
surveillance. Post market surveillance means the FDA had no questions about the
new formulas, they did not approve them, but expect the formulas be given to
babies and just see what happens. This constitutes an uncontrolled experiment
where parents are not told of the potential side effects and essentially bypasses
informed consent.

Hopefully these questions will spark a little conversation. Let us all know
what happens.

Marsha Walker, RN, IBCLC
Weston, MA

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