Donating breastmilk during the gold rush

Creating a supportive environment for breastfeeding becomes problematic, when that environment is directed towards the commercialization of human milk components. Donating milk is one issue in which commercialization is impacting lactating women. Currently mothers are being encouraged to donate their milk either through the for-profit milk bank, Prolacta Bioscience, or through the non-profit milk banking system (HMBANA-Human Milk Banking Association of North America). The medical system and the US Health Department discourage private sharing of human milk (through the internet, etc) or wet nursing. The concerns are in regard to the transmission of diseases, legal, and illegal drugs to the baby; when screening is not done. But is this concern the only reason for discouraging private milk sharing or wet nursing? When we know that the US Department of Health and various medical institutions (such as John Hopkins and Baylor College of Medicine) own human milk component patents, we might wonder about whether the issue might also be in regard to the monopolization of a resource (human milk). Discouraging private sharing, means more human milk will go to the institutions and industries that stand to profit from that resource. By discouraging private sharing, a monopolization of a resource is created.

In May of this year (2007), Prolacta Bioscience received over $12 million in private funding. Prolacta sells the "first and only human milk fortifier, made from 100% human milk for use in the NICU.

http://www.genengnews.com/news/bnitem.aspx?name=17899759

Prolacta describes itself as a for-profit donor milk bank system. Yet how is fortified human milk equivalent to human milk? Is Prolacta creating a human milk dairying system? In the dairy industry, the cow is just a resource. Her offspring will get some of her colostrum, because calves die without that protective milk. But her offspring will never get her presence as a mother. Because her value is in the product she produces, not in her ability to nurture her own offspring.

The cow's milk we buy from the grocery store does not resemble that which is milked from the cow--it is pasteurized and fortified. It's properties rearranged to suit an industry that needs to transport it miles away from the source. It must have a certain amount of shelf-life, because it is no longer fresh but old. It is pasteurized because it is so easily contaminated because it is handled so many times. The dairy industry promotes the health-giving properties of cow's milk but those health-providing properties were based on research of fresh raw milk. Advertising has convinced Americans that cow's milk is a basic nutritional requirement. The infant formula industry along with our medical institutions has convinced mothers that they are not capable of safely making breastmilk substitutes. Only an industry can safely do so (although the industry when they make a mistake injures or causes death to many infants). Human milk is an absolute health requirement for human infants and children. Making artificial baby milk is always a risk whether by an industry or by one mom in her home. Pasteurizing and fortifying human milk does not make it the same healthy food as breastmilk. Nor does giving a product in a bottle/cup satisfy the need all mammal babies have for sucking and physical contact with the mother.

Prolacta has a consent form for donating mothers. The donor is informed that they "will not be compensated for their donation of breastmilk." And, "the donation will be used to provide nutrition for premature and critically ill infants..." Two paragraphs later, they state, "As a volunteer donor, you hereby waive any and all interests in any proprietary technology that may result from your donation." How many people read consent forms carefully or fully comprehend what they are consenting to? This consent form "skirts" the issue of Prolacta's dual intentions. Yes, they want the use of donor human milk for a premie "formula." But it seems they are also doing a little mining of milk for components of proprietary interest. The donor is relinquishing any rights to what they donated. Thus, Prolacta owns your donated milk. Thus, if Prolacta makes a million on your donated milk (because it has some unique property that can be used in the pharmaceutical, formula, supplement, health care industries), you are agreeing that you don't wish to have some of that wealth. Lactating women might say what are the odds of that happening? But of course, many women do not know that the patenting of human milk components is growing every year and that some of this patenting has resulted in products on your market shelves (from mouth washes, bandages, toothpaste to supplements, yogurts, infant formula, etc). The consent form also releases Prolacta from "any and all liability for discomfort or injury you sustain while participating as a donor." to see consent form

http://asp.prolacta.com/interviews/consent.php

So heck maybe, women should turn to the non-profit milk banking system? to be continued...

Bone mineralization

In a document called Ross Infant Formula Applications of September 2006, a statement is made about the bioavailability of calcium from breastmilk versus infant formulas.

"The calcium bioavailability for infant formulas was assumed to be about 38% versus 58% for breastmilk (Foman & Nelson, 1993). Consequently higher levels of calcium was added to infant formula....to compensate for lower bioavailability."

"The high bioavailability of calcium from human milk can be partly ascribed to the molecular structure of triacylglycerides (TG)..."

http://abbottnutrition.com/resources/en-US/nutrition/ImMainDocument.pdf

They also state, "there is now a body of clinical data that shows palm olein or oil (PO) as the predominant fat in infant formula decreases fat and calcium absorption, and resultant bone accretion. A recent meta-analysis (Koo et al 2006) study revealed six controlled clinical studies (Carnielli et al. 1995, 1996; Lucas et al. 1997; Nelson et al. 1996; Ostrom et al. 2002; Tomarelli et al. 1968) showing lowered calcium/or fat absorption, and thre clinical studies (Kennedy et al. 1999; Koo et al 2003, Specker et al. 1997) showing lowered BMC and BMD in infants (age range birth to 192 days) fed PO predominant formulas."

Now, Abbott/Ross has a patent # 6620427 called "Method for improving bone mineralization," filed in 2001. That patent states, "Infants consuming formula containing plam olein oil had lower rates of calcium absorption." Thus the body of research they have at their disposal, shows them that past formulas decreased fat and calcium absorption. One can wonder how many children on those formulas as infants had higher rates of bone fractures or health problems?? Won't know, not a question we ask because infant formula is rarely questioned. Of course breastmilk/breastfeeding is thoroughly questioned. Currently, the premise regarding preterm infants and breastmilk is that there isn't enough calcium. This is partly the basis for fortification of breastmilk for preterm infants. Yet in looking at the various studies, most if not all studies are funded by the infant formula industry (some of the researchers in these studies are the inventors to patents in the infant formula industry). Should we question this research?

One of the problems of feeding premature infants is that these babies are often fed through plastic tubing not at the breast. We know that alot of the fat content of human milk will stick to that tubing. How much of the problem of weight gain, bone mineralization (bioavailibility of calcium dependent on certain fats) in preterms fed breastmilk is in the way they are fed? Many of the moms of preterm babies that I worked with in the WIC Program, never actually put their baby to the breast until they were at home. Their babies had gotten pumped breastmilk and supplements. Many of these moms never did get the baby to the breast at home. Some continued to pump but most found pumping and making up special formulas too overwhelming. This was between 1994-1998 and I can only hope that things are better than 10 years ago.

The question, though, is whether medical protocol based on research funded by the infant formula industry is based in truth/reality. We have a body of research supporting the supplementation of the preterm infant fed breastmilk. Yet, it seems rather strange that we are trying to make infant formula just like breastmilk. How logical is our belief system when it is based on the wants and wishes of an industry?

Industry sets reality of infant feeding

In a book called, "Mother and Child Nutrition in the Tropics and Subtropics," author Professor Gj Ebrahim (London School of Hygiene & Tropical Medicine) states, "Lactoferrin, lysozyme, and secretory immunolglobulin A (sIgA) are specific human whey proteins involved in host defense. Because these host-defense proteins resist proteolytic digestion, they are capable of a first line of defense by lining the gastrointestinal tract. The three host defense proteins are essentially absent in cow's milk." This book is online at http://www.oxfordjournals.org/tropej/online/mcnts_chap5.pdf So when consumers buy their cow colostrum supplements for support of their immune system, what are they buying? When hiv/aids patients buy whey nutritional supplements, what do they believe they are ingesting? What is the cow lactoferrin, lysozyme on the ingredient list? If these proteins are essentially absent from cow's milk, how does the dairy, supplement, and infant formula industries create them? What does the consumer believe? And what is the truth? It would seem highly likely that lactoferrin, lysozyme, et al. are created through genetic engineering. And the patents seem to support that theory. Where does the consumer put her or his faith? Why is our faith fixated on the belief that a man-made product will create health? But our faith wavers and often fails to believe that breastfeeding is the first step in creating a healthy immune system. We go without human colostrum and our health is severely jeopardized. Yet we are a culture that believes that we have a choice in infant feeding. Do we really think a woman fully informed of this kind of choice would prefer to have a sick child? If mother's knew that industries were copying and owning the genetic code to human milk proteins (components) in order to make claims of healthier products, would they make the choice of artificial foods and beverages for their babies? Has industries created the image of choice to women? We make choices about products and services based on price, advertising, and consumer knowledge. Why do women continue to make the choice of infant formula? Reality is set by industries through advertising. Formula marketing does not show the consumer the real risks of picking their products. We assume because the government lets them advertise on the web, TV, in magazines, that the product must be safe. We believe the government monitors the industry. We have hospitals and medical professions who give out free samples and if the medical community does this there is a presumption of recommendation. Our reality is set by an industry that has enormous power and presence in government, medical institutions, medical schools, and in research. We believe what we believe because our reality is set up. We see the plump, glowing formula fed baby and think we can buy health in a can. We believe this because we are told it. We see the pictures and our reality envisions a freedom from biology and we call it choice. We only see what the industries want us to see. We seem to be walking though a fog of promotion of consumer choice.

the Power of Belief

Many years ago, a bamboo curtain on my kitchen window, had become a source of argument with my husband (now ex) and myself. I believed that since I could not see out the bamboo curtain to my backyard that no one could see inside. We argued for some time over this. I had my belief and I was sticking to it. Finally, in a moment of frustration, my husband grabbed my arm and took me outside. It was dark outside and to my surprise the bamboo curtain did not exist. I saw every detail of my kitchen. My curtain that blocked a view of the inside during the day, was at night no curtain at all. I had to see it before I could believe it. How often are our beliefs about our reality faulty? What do we believe about our world? And why do we believe it? Do we test our beliefs? Or do we make assumptions? Is our set of beliefs based on reality? Whose reality? How do people understand reality? If our society projects normality as bottlefeeding and detached parenting, then how do we change that reality? So often when I worked as an LC the problem was not a physical problem in breastfeeding but a problem of what the mother believed. Her belief was standing in the way of her ability to nurture her infant. She believed that nursing her baby had to be fixed on a time schedule and that schedule was based on the clock on the wall. Baby can't be hungry again, cause its been 5 minutes (10 minutes, 1 hour, pick the time) since she last nursed. Her reality of babies and her intereaction with her infant was that it is some fixed time. Breastfeeding is mealtime and nothing more. Our culture's view is that babies sleep alot and eat at times that are convenient to the adult world. Heaven forbid you have the baby that seems to have not been programmed correctly. And of course that means that there is something wrong physically with breastfeeding or the baby. Her reality, her beliefs about babies is like my bamboo curtain. She believes without truly knowing. What we believe to be true effects our abilities to function as mothers. What we think we know effects whether "we" decide to breastfeed and it often impacts our ability to breastfeed.

HMEC, immortal cell lines

In 1979 a project called the "Characterization of Human Mammary Cells," was started by Dr. Margaret R. Stampfer at the Lawrence Berkeley National Laboratory. Over the years, funding was provided by the Department of Energy: Office of Health and Environmental Research and from the National Institutes of Health (NIH). They collected human milk in order to obtain the epithelial cells called Human Milk Epithelial Cells (HMEC). These cells were also obtained from "reduction mammoplasties, biopsies, gynecomastias, and mastectomies." in 1985 Dr. Stampfer filed a patent with the United States of America (Department of Energy) becoming the assignee (owner). Patent # 4808532 is called, "Continuous human cell lines." It states, "The invention relates generally to human cell lines useful for testing potentially mutagenic or carcinogenic agents, and in particular relates to continous cell lines developed from human mammary epithelial cells." The US government owns these cells lines. We owe a debt of gratitude to the women who donated their milk and in many cases their mammary tissue so that the government could test toxins in our environment. Margaret Stampfer donated much time and these cell lines to various researchers around the country. But I often wonder if the fixation on the environment and breast milk has more to do with having these cell lines. If you have easy access to testing toxins with a particular immortal cell line, then your view is narrowed to those cells, that particular organ. Of course the question might be did the donors realize that patenting would occur, that the government would own their cells? And while this for sure benefits our knowledge about toxins in the environment, it also seems to make us fixated on toxins in breastmilk. Instead of a broad picture of toxins, we have narrowed our view.

I just recently ran across another human cell line owned by the US Government and Nestle. Now that is interesting. The US Government as represented by the Department of Health filed in 1992 a patent called "Immortalized human cell lines containing exogenous cytochrome P450." (patent # 5356806). This cell line is of the bronchial epithelial cell, nothing to do with human milk cell lines. But fascinating that a patent on immortal cell lines would be owned by the US Department of Health and Nestle. "Show me the money." Are partnerships between a government and industry a good deal for the consumer and for a democratic society? Seems like we think its a good idea. We seem to take these things for granted. But then we have to understand why breastfeeding takes a back seat to the infant formula industry...

infant formula and transgenics

In 1995 a patent was filed by Abbott Labs (infant formula company, Ross) called "Oligosaccharides and glycoproteins produced in the milk of transgenic non-human mammals." (patent # 5801698) They state, "Before they can be incorporated into commercial nutritional product, a practical method for obtaining large amounts of glycosylated human milk proteins and oligosaccharides must be devised." Must be devised. The commercialization of human milk components is the intent of the infant formula and pharmaceutical industry. The uses of these human milk proteins are "in preparation of pharmaceuticals, diagnostic kits, nutritional products and the like." In this patent, Abbott was interested in the human milk proteins: "secretary immunoglobulins, lysozyme, lactoferrin, kappo-casein, alpha lactalbumin, beta-lactalbumin, lactoperoxidase and bile salt stimulating lipase. The solution to obtaining large scale human milk proteins is transgenic animals. Splicing the human milk protein gene into the embryo of a cow (goat or other mammal) and creating an animal that makes the human milk protein in their milk. This is what we call, cloned milk. Last year cloned milk and meat was approved by the FDA for public consumption....unlabeled. A transgenic cow looks like a regular cow, but its DNA has been changed to fit the needs of industries. There is a belief by many people that transgenic herds of dairy cows do not exist yet. But the question must be is why the FDA gave approval for the selling of cloned milk and meat last year? Of course, maybe we can believe that the FDA is preparing us for the "future commercialization of cloned milk and meat. The cloning of cows began in 1990. Maybe its that we want to believe that this hasn't happened yet.

"Treasure Them Like Gold," Wyeth Gold

I have read and heard that human milk is the gold standard. The Wyeth website(maker of infant formula around the world--except in the USA) has a slogan on one web page, "Treasure Them Like Gold." They are writing about "their" alpha protein. They state, "One of the golden ingredients that makes a mother's milk so special is something called Alpha-lactalbumin, also known as alpha-protein." It is the major whey protein in human milk. Cow's have very little of this protein. They have a high level of whey protein called beta-lactoglobulin. They state that beta-lactoglobulin "may be a potential trigger for allergic reactions in children."

At one time PPL Therapeutics had a contract with Wyeth to produce "Alpha-Lac." PPL Therapeutics is known for "Dolly, the cloned sheep." So the alpha-lac they produced was cloned using transgenic techniques. One of the purposes of the contract with Wyeth was to produce "two new nutritional proteins." One was to be used for pediatric and geriatric uses. The other was to be used in PKU treatment.

http://www.pkunews.org/research/alpha.htm

Whey Protein Concentrate (WPC) has become a popular nutritional supplement. There is a popular bovine (cow) WPC that seems to have alpha-lactalbumin in it called Immunocal. It is a "pharmaceutical grade undenatured whey protein concentrate" used in treatment for HIV and cancer. Articles on this product quote a book edited by Luc Montagnier (co-discoverer of the hiv virus) in which a whole chapter is devoted to this product. ("Nutriceutical Modulation of Glutathione with a Humanized Native Milk Serum Protein Isolate Application in Cancer and AIDS. If one goes to the website of Immunocal, one sees a breastfeeding mother with her infant as well as other healthy looking people. But how often do we see breastfeeding publicly by a company selling supplements? I applaud their promotion of breastfeeding...although I am curious about their "humanized native milk serum protein."

http://www.immunocal.com/

The researcher, Gustavo Bounous (who seems to be part of the company called Immunotech that produces the product Immunocal) has a patent called"Method of treatment of HIV-seropositive individuals with dietary whey proteins." (patent # 5456924) filed in 1992. He also did a study in 1998 using Immunocal for treatment in cancer and AIDS with another well-known HIV/AIDS researcher Mark Wainberg.

It is interesting where our science seems to take us. Hiv-positive mothers shouldn't breastfeed according to the CDC, but we will give them and their babies nutritional products that mimic human milk. Is it because breastfeeding does not create profits, products to sell? We are more accepting of that which is manipulated and made by man than letting a hiv positive woman put her baby to her breast. "Treasure them like gold." Treasure the human milk proteins, but by golly lets not let too many women know that we own their proteins and we will be treasuring them. The word bio-piracy comes to mind, except the victims don't even know they have been robbed.