Friday, September 5, 2008

Medela's Human Milk Fortifier European Patent

Medela own's a European patent EP1637043 called "Human Milk Fortifiers & methods for their production." The inventors are Peter Hartmann et al. They also own a US patent application #20080187619 entitled with the same name and the inventors the same. This patent and its USA application seems to be making claims on components directly or indirectly derived from human milk. Thus Medela, well-known, respected breast pump company has now entered into the field of transforming breastmilk into an acceptable liquid for use with preterm infants. The question is will Medela manufacture this specialized human milk? Or will they license it out? Who has the facilities? Prolacta is already in that business and Medo owns a patent application on a standardized human milk for use in human milk fortification. So it seems very unlikely that Prolacta would be a part of this venture. It would seem far more likely that this venture will be licensed out to one of the infant formula companies.
While some might feel this endeavor--human milk fortification-- is supporting breastfeeding, I do not believe it is supportive of breastfeeding. We are already witnessing Medela's disregard of the WHO Code regarding bottles and bottle nipples. It would seem logical, particularly if they license this patent out to an infant formula maker (possibly more than one infant formula company) that the disregard would become even greater.
The need for a human milk fortifier for preterm infants is based on research that was mostly paid for by the infant formula industry. If a premise is based on monetary interests, might it be imperative that independent research revisit the question? Part of the problem of feeding human milk to premature infants is the plastic feeding tubes--the fat of human milk adheres to the tubing causing losses in energy, protein, etc. Nestle's answer to this problem is to add lecithin to human milk. I have a simpler answer to the problem. How about letting mothers of preterm infants breastfeed their babies? I recognize this is dependent on the stability of the premature infant and also whether the premature infant is younger than 34 weeks gestion. But the emphasis in US hospitals is to get moms pumping (important) but vastly more important is infant/mother contact through breastfeeding (or attempts at breastfeeding) in the hospital setting. When I worked in the WIC Program (1994-1998) breastfeeding mothers of preterm infants often had little to no breastfeeding within the confines of the NICU. I am hopeful that has changed. The emphasis was on pumping and it seems to me that even now the main emphasis is pumping and storing milk. Fortifiying the milk means to many moms that their own milk is not adequate. Thus the fortification of human milk in the early days, sets up the belief in the inadequacy of breastfeeding to sustain the growth of the infant once it goes home from the hospital. Is this really a truth? Or is part of the problem of preterm human milk caused by the inadequacy of feeding infants by artificial means--the plastic tubes, the bottles, the pumps?
We are poised at the beginning of a new industry, the human milk industry. What makes breastfeeding advocates believe that this endeavor will support breastfeeding? The basis of this industry is about the inadequacy of human milk. Thus this new industry will manipulate it to the tune of the infant formula research that shows that preterm human milk is inadequate. Is this the truth?
Copyright 2008 Valerie W. McClain


  1. Why do you think they would license to a formula company. Surely not likely for a company that otherwise is focused on breast milk. Isn't human milk already an acceptable liquid for use in pre-term infants, or in reading the patent have you seen methods for the production of other milks which is what you seem to suggest?

    In our NICU we fortify because it improves survival rates. Do you suggest we stop? If a mom pumps enough milk should we feed the unfortified milk to improve mom's feeling of adequacy? Will this improve her milk? I would be grateful for your advice thanks Valerie.

  2. Dear Anonymous,
    Fortification studies on preterm infants have been funded by the infant formula industry. Funding often influences outcomes in studies/research. So the question in my mind is whether there is truth to the belief that fortification of human milk improves survival rates. This issue is not resolved until we have totally independent studies. The point of my discussion is not about a "mother's feelings of adequacy." This is about a mother's right to know the truth. And not the truth as written by human milk researchers who are funded by Nestle, Abbott, Wyeth, Nutricia, etc.

    This is about seeking answers to questions regarding the science of human milk and breastfeeding. Medela is like any corporation that seeks to increase profits. The focus on "breast milk" is not a focus on breastfeeding. Fortified human milk is not equivalent to breastfeeding. What about exclusive breastfeeding, have we abandoned our belief in that value for premature infants. As far as I know Medela does not have facilities to make human milk fortifiers. The companies that do have such facilities are Prolacta, the dairy or infant formula industries. I will be posting the websites for patent offices, so readers can judge for themselves the intent of this corporation.