Standardized human milk patent-pending

photo by Jessie McClain

Welcome to the Brave New World. One has to be brave to read and digest this patent application # 20080124430 called "Human Milk Compositions and Methods of Making and Using Same." This is a patent application on the invention of a human milk fortifier and standardized human milk (whatever that means--read the patent application).

http://www.uspto.gov/patft/

Invented by Elena Medo et al and various employees of Prolacta Bioscience. So the question is what are they claiming to own?? There seems to be some slippery slope language in this application. What is standardized human milk? Is this a claim to ownership of a "standardized" human milk from donors? And aren't we charting new territory with this patent? Should we be outraged over this? It was inevitable but there are some ethical questions regarding the patenting of a "standardardized human milk." It would seem to me that the language used in this patent application is careful but still creates some ethical dilemnas. How will my profession respond to this patent application? I would think that it should at the very least bring up some needed debate/discussion but I am not holding my breath on that. Who really cares? So what if a few people of a corporation own a pending patent claiming ownership to a standardized human milk? What does it matter that there are over 2000 human milk component patents? Stem cells in human milk? We just discovered (cough-cough) stem cells in human milk. Of course, we won't tell people that old text books on human milk state that there are stem cells in human milk. Picture a mother donating her milk to save a preterm infant or sick adult. Does she realize that her milk is an invention created by an industry? Her milk is the raw ingredient. A corporation will standardize it and sell it. Sounds like the dairy industry to me. Enslavement in the 21st century under the auspices of doing good. Human milk is not an invention, nor any version/variation that some group of people dream up!!!!!!!!!!!!!! Breastfeeding is the value. Human milk is valuable but it should not be a commodity nor is it an invention. Brave New World, I never thought I'd live to see this day.

Copyright 2008 Valerie W. McClain

patents regarding neonatal jaundice and breastfeeding

photo by Jessie McClain

Filed in 2001 is patent # 6627213 called, "Inhibition of neonatal hyperbilirubinemia in breast fed infants." The inventors of this patent Glenn R. Gourley and Bill L Kreamer have written studies in Pediatrics on the use of various substances to lower bilirubin in breastfed infants. The patent is assigned to the Wisconsin Alumni Research Foundation but the patent specifically mentions Nutramigen (Mead Johnson) as a particular formula of interest for this patent. The US Government has interests in this patent (so they get to make money off it too) Both Gourley and Kreamer received funding for their research through Mead Johnson. The L-aspartic acid they suggest will lower bilirubin is in all probability genetically engineered. This invention will of course have ramifications for mothers who plan to "exclusively" breastfeed their newborns. Rather fascinating how the infant formula industry can target breastfeeding for remedies...yes, yes...remember the golden role of choice in infant feeding: breastfeeding always is questionable and therefore the default of choice is infant formula or some kind of intervention so that breastfeeding can be fixed. Of course, industry just knows that fixing breastfeeding is the basis of infant formula sales. The world calls it choice....

The illusion of "choice"

photo by Jessie McClain

As women, we have been liberated from our biology. Infant feeding is declared a choice. Breast or bottle?? Spin the bottle and the bottle lands on breast. So mom "tries" breast. She survives THE BIRTH (and nowadays that is a miracle--another stomping ground of "choice") and has a try at this thing called breastfeeding. She has difficulties...sore nipples, engorgement, feelings of being overwhelmed but she thinks she has it all under control. Oops, she goes to the two week pediatric check and finds that her baby has not gained enough weight. Sorry, the medical staff say you must supplement with the "BOTTLE." So where did choice go? Mother chooses breast, the medical staff declare it ain't working. So choice defaults to BOTTLE. Breastfeeding mothers find that choice always defaults to bottle...no matter what. Does bottle ever default to breast? Sorry mother, bottlefeeding isn't working for you, you will have to breastfeed your baby? Your baby hasn't gained sufficient weight on the bottle, so you must go to breast. Your baby has gotten diarrhea for the second time on that formula, so you must go to breast. Any mother ever ever heard those words out of a medical professional. No because the medical rule is that "Breast always defaults to bottle never bottle to breast." Yet as a lactation consultant I know that women can and do relactate. (relactated myself and know it is possible)So it isn't something that is biologically impossible. It is just a mental leap that cannot be circumvented in the medical community. So exactly how is choice in infant feeding an equivalent choice? Isn't this a token choice to make women feel like they can be freed from their biology?

The offer of choice dissolves when a mother tests positive for hiv. Fascinating in that a number of infant formula companies, pharmaceutical companies, medical institutions, and the US Department of Health own patents on various human milk components to inactivate or treat hiv/aids. A hiv positive mother goes against medical protocol in the USA, if she breastfeeds. While our multi-national corporations, medical institutions, and the US government have "faith" as documented by their patenting in human milk components, a hiv-positive mother loses her faith in breastfeeding. Choice, what is that when you test positive for hiv? Doesn't exist....an illusion.

Breastfeeding is often terminated when a mother is ill or when the infant is ill. And often it is not the choice of the mother but the choice of the mother's health care provider. Why? What evidence do they use? How are pediatricians trained? What sales people visit their offices, take them on cruises, leave their gifts? Yes, we all know, the formula representative like the pharmaceutical rep spends alot of time at medical offices and institutions providing their "free" gifts. How was the pediatrician trained? Did he or she know that the professor that taught them infant nutrition moonlights at Nestle or Wyeth? Probably not, young students think the world of their professors, source of all knowledge, giver of A's and B's. While they are paying the institution to be "educated," often that institution is funded by the corporate world. Capitalism at its finest moment. Education becomes the corporate reality without the student ever being aware of where their "knowledge" comes from and at what cost to a society, to the world. The view of infant nutrition is the Nestle/Wyeth/Mead Johnson/Abbott/PBM-WalMart illusion. Let the babies eat almost organic, almost real baby milk...recombinant/cloned human milk components. Preserved in plastic, grown in plastic...fungi and algae from god-knows where??? Out of the depths of the vent holes from hell...the very best....the very best. Spin the bottle and it lands on disease and disaster and lots of money...the mother of all jack pots. Thank the multi-national corporations for giving us a choice and liberating us from our bodies, our health, and our money.

Copyright 2008 Valerie W. McClain

"There is a desire..." bacteria, food, & breastfeeding

 

Patent # 5902743 says, "There is a desire to provide women with the option to replace human breastmilk with manufactured formula/foods."

Patent #590274 is called, "Probiotic bifidobacterium strain, filed in 1998 by Luchansky et al and owned by the Wisconsin Alumni Research Association. Luchansky was a professor at the University of Wisconsin and is now a research microbiologist for the USDA (for the Microbial Food Safety Research Unit). In this patent, it is stated that breastmilk appears to be prebiotic and a Bifido strain is isolated, cultured, and deposited with The Amercian Type Culture Collection (ATCC)--Bifidobacterium longum JBL. The isolate was derived from the feces of a breastfed infant. The uses for this bacteria are very specific--Carnation Good Start and Gerber baby foods as well as food and drinks for adults. The bacteria derived from the feces of the breastfed infant is probiotic.

Surprised? No, you shouldn't be.

 

There is a patent from 1976 called, "Fermented milk containing viable bifidobacterium." Patents inventors are Masahiko Hutai et al. and the patent is owned by a Japanese company called Kabushiki Kaisha Yakult Honsha. They state, "Bifidobacteria are well-known as dominant bacteria in the intestinal fora of a breast-fed infant." The new strain they discovered was from the feces of the breastfed infant. A patent #4756913, called Sour milk product,: filed in 1987 by Russian inventors Khorkova eet al. says, "A disbalance in an infant's intestinal microflora due to lack of human milk, dysbacteriosis, antibiotic therapy or intestinal infection results in sudden decrease in the number of bifidbacteria conductive to pathogenesis of prolonged disfuntions and metabolic failures and very often causes severe chronical diseases in children."

 

More interesting are the patents owned by the infant formula industry. Patent # 6083934 called "Nutritional formulations containing Lacto-N-neoTetraose," by Prieto et al, filed in 1999, and owned by Abbott states that Lacto-N-neoTetraose was isolated from pooled human milk and that it also can be made synthetically. This Abbott patent states, "Lacto-N-neoTetraose stimulates growth and/or metabolic activity of Bifidobacteria inhibiting bacterial infections caused by Bacteroides, Clostridium, and E.coli." And then we also have a patent by Wyeth by inventor Jeffrey L. Wilson called, "Nutritional formulation containing prebiotic substances." (patent #6630452) It states, "A nutritional composition is provided which comprise oligofructose and sialyllactose." The oligofructose will be derived from chicory. The sialyllactose is a human milk component. "Sialyllactoses are oligosaccharides which occur naturally in human milk as well as milk of other mammals....present in noticeably higher concentrations in human milk." The combination of chicory and silayllactose produces a prebiotic effect...increasing bifidobacteria. 

 

Last but not least is a patent owned by Nestec (Nestle) called "Lactic acid bacteria for the treatment and/or prophylaxis of giardiasis." (patent # 7229616) It has many references but of interest to many of us who are IBCLCs is the reference to a study, "Reiner et al. "Human Milk Kills Giardia lamblia by Generating Toxic Liploytic Products" The Journal of Infections Diseases vol 154.no.5, 1986, pp 832-835."

This Nestle patent used a novel lactic acid bacteria and bifidobacteria. Yes, there is a desire to provide women with options to feeding their infants. Choice, the bedrock of infant feeding and women's liberation. While the industry liberates human milk components from women or the results of human milk feeding from babies, it tells us there is a desire. Desire....

Copyright 2008 Valerie W. McClain

Children prohibited from receiving human milk feeding

photo by Jessie McClain

In a patent filed in 1996 called, "Use of indigestible oligosaccharides to prevent gastrointestinal infections and reduce duration of diarrhea in humans," (patent #5827526) the inventors Dohnalek et al. mention that the children were prohibited from receiving human milk feeding. This was a study on children (10-24 months of age) who were attending day care. All these "children" (I would call them infants) were on various formulas none were breastfed. Yet the inventors of this patent that is owned by Abbott, felt the need to prohibit these infants from getting any human milk feeding. This is a study on daycare and diarrhea in infants. We know that human milk feeding would alleviate gastrointestinal infections and diarrhea. We knew this in 1996 and I am sure that Abbott knew it, too. How ethical is it to deny infants/children something you know will help them when they are ill? The only reason to deny these infants this medicinal fluid is because you know it will mess up your study. Many questions but who will ask them? Who is actually monitoring infant formula studies?

Copyright 2008 Valerie W. McClain

Allergies and exclusive breastfeeding studies

photo by Jessie McClain

I have been following a Lactnet discussion of a Finnish study by M. Pesonen et al. published in 2006 on exclusive breastfeeding and atopy. Since I cannot join in on the discussion, I thought I'd use this blog to share my thoughts on this particular study and how this does relate to the patenting of human milk components. One of the first things I usually do when reading a research paper on "exclusive" breastfeeding is to see how the authors define exclusive. In this study exclusive breastfeeding included the use of water supplementation and vitamins. From my perspective (and I believe there are other IBCLCs who feel likewise) that would mean that these infants were not truly "exclusively" breastfed. Water and vitamins means that substances other than human milk were given to these babies. The CDC has changed their definition of exclusive breastfeeding within the past two years. They no longer consider exclusive breastfeeding to include water supplementation. Depending on the brand, vitamins may have dairy, soy, or other allergens in them. Is this a valid study regarding exclusive breastfeeding, particularly when we know that the newborn gut is effected by very small amounts of foreign proteins and/or chemicals? It doesn't take much to change the gut flora of the newborn and therefore change the dynamics of health and illness. Of interest is a statement made in this study, "when supplemented human milk had been needed twice, exclusive breastfeeding was considered terminated, and the child was gradually weaned to cow's milk-based formula (Tutteli, Valio, Helsinki Finland)." Exclusive breastfeeding mothers who needed supplemental human milk more than twice had their infants weaned to a specific infant formula. Interesting. Why a specific infant formula? Why not a choice of infant formulas? This was from a study in the early 1980's. Did the authors get their data from Valio?

I find it difficult to understand the lactation profession's reluctance to believe in human milk, to understand the dynamics of the infant formula industry in its quest for more consumers. Prebiotics and probiotics are seen as the answer to allergies. These micro-organisms are being put into infant formulas to help infants tolerate the gut damage done by ingestion of foreign proteins. Human milk is prebiotic and probiotic. Was this study in anyway funded by Valio? Nothing states this and yet it looks like they only used a specific formula manufactured by Valio.

I find it interesting that Ciba-Geigy Corporation owns a series of the same patent called, "Polypeptide factors from colostrum." (one in 1986, 1992, 1994--patents are held for 20 years and many companies and inventors will have a series of the same patent in order to hold down the patent for extra time). They are patenting on a method to extract IgE-BS from human colostrum (human not cow). Why? as a treatment for allergy. Ciba-Geigy became part of Novartis (Gerber use to be part of Novartis) and in 1997 they filed for a patent called, "Methods and kits for determining the levels of IgE-BS." The 1986 Ciba-Geigy patent states, "Recent prospective studies further indicate that exclusive breast-feeding protects the high risk infants against allergic disease." So in 1986 a huge corporation was willing to own a patent that uses IgE from human colostrum to treat allergy. But the lactation profession is still debating the allergy issue??

Agennix, a company that makes recombinant human lactoferrin (use of this genetically engineered human milk component is based on human milk research) has a patent called, "Oral lactoferrin in the treatment of respiratory disorders." The patent was filed 2003 and will be a treatment for asthma. In 2004 Agennix received a SBIR (Small Business Innovative Research) grant from the National Institute of Allergy & Infectious Disease. Agennix's strategic partners are Baylor College of Medicine (who helped create this company), John Hopkins, University of Texas, Avecia, DSM--maker of ARA oils for Martek Bioscience, University of Texas MD Anderson Cancer Center.

What do these institutions and corporations know that the lactation profession seems to not know? Agennix's patent states, "lactoferin is an essential growth factor for both B & T lymnphocytes." Sounds like the definition of stem cells. Oh yes, I forgot that can't be because we just discovered that human milk has stem cells in it.

So the debate rages on. Meanwhile your friendly multi-national corporations continue to patent human milk components for a wide variety of diseases, cancers, and yes...allergies.

Copyright 2008 Valerie W. McClain

John S. O'Brien

John S. OBrien discovered the genetic cause of Tay-Sachs disease and developed the screening tests. He also was inventor to two patents regarding prosaposin. Prosaposin, according to the patent is in human milk, cerebrospinal fluid, and seminal plasma. Patent # 5700909 is called "Prosaposin and cytokine-derived peptides," and was filed in 1994. It is owned by The Regents of the University of California. He is co-inventor to another patent on prosaposin filed in 1995 but owned by Myelos Neuroscience Corporation. The 1994 patent states that, "Prosaposin increases nerve cell mylination ex vivo." This invention has "significant therapeutic applications in promoting functional recovery after toxic, traumatic, ischemic degenerative and inherited lesions to the peripheral and central nervous system." The patent also states that the invention has use as laboratory reagents and components of cell growth media in order to better enable growth of cells in vitro." Another substance in human milk that creates cell growth. Stem cells?? No, we didn't discovery stem cells until 2008.

Copyright 2008 Valerie W. McClain