Monday, January 7, 2013

The Daffodil Study, infant formula research

I am not particularly fond of daffodils.  And I don't really know why.  They don't grow well in Florida.  In fact, I have never seen them growing in the ground in Florida, but I have seen them in pots in the grocery store around Easter.  When I think of daffodils, I think of Easter and its symbolism.  Rebirth comes to mind, spring, rising againreligious symbolism that are embedded in my psyche.  I think of the color, yellow;  when I think of daffodils.  Then my mind trips over to patents and inventions.  Yes, I never stop thinking about inventions or patents, particularly when it involves infant feeding.  Remember Golden Rice and how biotech would save the world from vitamin A deficiency 
by creating a rice with lots of vitamin A.  Do you know how they created Golden Rice?  The rice carries the gene from a daffodil;  a gene that expresses phytoene which is a key to the synthesis of beta-carotene.  The petal of the daffodil or the petal of the marigold holds the key to producing carotenoids.   Vitamins for you and me and baby makes three.  

So what has this got to do with the Daffodil Study in Indonesia, a study that has been receiving a lot of criticism from breastfeeding advocates in Indonesia as well as around the worldI don't know, if there is a connection between the symbol, the Daffodil and the study?  It seems to be just a curiosity in my head.  Does the daffodil symbolize a specific brand of infant formula?  Or the Indonesian University?  Or the Indonesian Pediatric Society?   I really don't know.  What infant formula are they testing on infants that are younger than 4 months old?  What baby formula company is involved with this study?  Is it just the Indonesian University and its Department of Pediatrics that is funding this study?  The study is called, "Effect in Using Formula Composed with Cow's Milk Fat, Enriched with Mixed Fats and Added Fosfolipid [Phospholipids] on Duration and Infection in Babies' Digestive and Respiratory System."  How does informed consent work in regard to research on babies using infant formula, particularly in countries that have high levels of poverty and high infant mortality rates?  

The BBC News Asia-Pacific (dated November 2010) reported, "In Indonesia a new law has been passed that stipulates all babies should be exclusively breastfed for the first six months of life.  From early next year [2011], anyone who stands in the way of this will be fined up to 100m rupiah (7000 pounds, $11,000) and sentenced up to a year in prison."  Researchers are under some serious obligations to see that exclusive breastfeeding is not disrupted by such studies.  Since there is a petition up on to stop this research, I wonder whether the law was revoked or been unenforceable?  For those interested in signing the petition to stop this research, this is the website:  

At the NIH clinical trials website there is 132 infant formula studies going on world-wide, most funded by various infant formula companies in various stages.  Some studies are completed, some terminated, some no longer recruiting and some actively recruiting babies.  Studies in countries such as China, Mexico, Vietnam, Indonesia (2 stated but neither is the Daffodil Study-Danone and Fonterra funded), and the USA.  Within the last decade the infant formula industry is introducing new/novel ingredients.  Most of those novel ingredients have never before been eaten by human beings.  And yes its about genetic engineering those ingredients, using genes from one species in combination with genes from other species.   A recent patent application from an employee of dupont de Nemours is called, "Carotenoid production in a recombinant oleaginous yeast."  They mention the use of genes from the petals of daffodils or marigolds to add to a recombinant host.  This is to produce/engineer not only carotenoids but also omega3/omega6 polyunsaturated fatty acids.   And yes this patent application is about using this in foods and infant formula.   So we are recombining genes and creating substances that have never been eaten before by the human species.  Should infants be a part of this experiment?  And no I don't know if the Daffodil Study has anything to do with using novel ingredients.  And I really don't know what these 132 infant formula clinical trials are testing.  Are we testing for safety?  Are parents being given informed consent about all the possiblities in these clinical trials?  And really, really should infants even be in clinical trials involving novel foods??  How do researchers protect exclusive breastfeeding doing this kind of research?  What populations are enrolled in this study?  Is this research done in poorer districts, those marginalized by society?  In the US, is this research directed at the poorer communities and/or the African American communities?  Who does the recruiting of mothers and how is it done?  

So what is the daffodil to me?  Symbolic of the ease in which genetic engineering has become part of our food industry which not only impacts adults but our most vulnerable population, infants.  The Daffodil Study may have nothing to do with the genetic engineering of ingredients of infant formula.  But it should raise questions for many around the world who are concerned about research and the problems of ethical research when it involves infants.
Copyright 2013 Valerie W. McClain 


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