Wednesday

The FDA, Milkbanks, Milksharing, and Regulation


The FDA, part of the US Department of Health and Human Services is having their Pediatric Advisory Committee meet to discuss "donor and banked human milk: current practices and potential benefits and risks..."
The meeting is scheduled for December 6, 2010 (8am-6pm). The Committee's job is to provide advice and recommendations to the FDA. The public can submit electronic comments to http://www.regulations.gov
Written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. I did the email comment and it was a challenge (timed). I also plan to write something more substantive. Comments will be taken until January 6, 2011.
So here we are at the Edge of new beginnings. A new organization of mothers dedicated to helping mothers share breastmilk called Eats on Feet blossoms on the internet through the use of the social networking site, Facebook. Suddenly, the FDA picks up its head and decides to have a meeting about potential benefits and risks of donor, banked milk. "Topics will include infectious disease risks, State regulations, and current practices in donor and human milk banking." The HMBANA milk banks had been working on creating a collaboration with the FDA since about the year 2000. I suppose to legitimize their operations. I am not sure what happened with their proposed collaboration with the FDA (document to the FDA). What I find fascinating is that for the past year I have been seeing comments by various HMBANA milk banks about the "dangers" of private milk sharing going on through the internet. And now their dream has come true with the birth of Eats on Feet. Be careful what you wish for?? Now the FDA will sit up and take notice. Yep they did sit up and take notice. First topic on their agenda is the infectious disease risk.
Readers may wonder what side of the fence am I, particularly when I write about industry patenting/claiming human milk components (mostly the gene constructs). I really am not on either side. I see the value of private milk sharing but I would rather see what we use to call "wet nursing." We are mammals, we need human contact. Yet I do recognize that this "modern" era seems predisposed to viewing all milks in a bottle. I see the value of milk banks in hospitals. I would like to see hospitals that have a maternity unit have a milk bank. But that milk should only go to infants or sick people. Seeing some patents where researchers got their breastmilk from HMBANA milk banks angers me. Looking at HMBANA Conferences in which researchers who patent are featured speakers angers me. But heck, we live in a world where everything is for sale--life itself. So from my viewpoint, I want the milk banks to be regulated in how they dispense their donor milk. At the very least, donors should be informed that their milk will be going to researchers who may patent off their milk. There should be a statement given to donors of how much of their donated milk goes to babies and sick adults, how much is thrown out and or given to researchers. Prolacta Bioscience, a for profit milk bank fortifies and pasteurizes their donor milk. The fortification is what makes this a different product and is directed at preterm infants--making the milk more "acceptable" to the medical community.
Within the mix of milkbanking and milksharing, the FDA will supposedly come to the rescue of the consumer. They supposedly regulate the infant formula industry. Although some people would call regulation of the infant formula industry debatable.

The first topic on the FDA agenda is about infectious disease risks. I am sure this will be a discussion of hiv/aids and the belief that it is transmitted through breastmilk. I wish to share with readers a patent owned by The United States of America as represented by the Department of Health. The FDA answers to the US Department of Health. It's called, "Method of screening for risk of cancer using human lactoferrin DNA probe or prime," patent #5948613. The inventors are Teng et al and this patent was filed in 1996 and publishes in 1999.
Within the body of this patent is this statement.


"Another embodiment of the present invention relates to a method of treating a condition in a patient characterized by a deficiency in lactoferrin by administering to the patient an amount of human lactoferrin according to the present invention in sufficient quantities to eliminate the deficiency. The conditions include neutropenia, AIDS, skin infection, gastrointestinal bacterial overgrowth syndrome, vaginal infection and septic shock."


AIDS is considered a deficiency of human lactoferrin, a component of human milk. Interesting that the US Department of Health has a patent like this. Human lactoferrin will also be used to diagnose cancers. Of course there are various industries who have similar patents. The human lactoferrin will be genetically engineered. Life is curious...we believe human milk is diseased but we take away some its components to treat that disease and of course we tell women not to breastfeed and donor milk is dangerous because it is diseased. Of course this is about making money. All makes sense to the powers that be but strikes me as totally, "Brave New World."
Copyright 2010 Valerie W. McClain

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