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.

River of denial...patenting of human milk

One would suppose that the lactation profession would have more than a passing interest in the patenting of human milk components. I have written about patenting and human milk since 2000 and find that some members of the lactation profession believe that patents are about the future and possibly they will be interested in this area sometime in the future. (comments made to me by various members of our profession). Patents in many minds are just "inventions" that may or may not happen. The lack of interest and in some cases downright hostility seems so odd to me. Of course, there are some people who are very interested. But they seem to be vastly outnumbered by people who view patenting as rather boring and not relevant to their profession.

Yet human milk patenting reveals research and the direction in which our science is taking us. The interest in human milk components by the infant formula, pharmaceutical, and supplement industries should serve as an early warning system. These industries have the money and power to control not only the media but to influence governments. They do so on a regular basis. Thus our knowledge of human milk and its amazing capabilities is not reaching the profession who most needs to know it. It is not reaching the parents who need to know that infant formula is the grand experiment with their infants the guinea pigs for future improvements of this product. If industry, academia, and government hold the patents, the secrets of what human milk can do to diagnose and treat disease; then artificial baby milks are a part of the economic underpinning of a profitable society. Institutions teach and prepare a society to use infant formula. Breastfeeding becomes impossible on a variety of levels because institutions have no clue of the value of breastfeeding.

Formula feeding is a direct route to all sorts of health problems from infancy into adulthood. Formula fed infants are immune deficient. They are at risk for all sorts of diseases. A company called Agresearch Limited of New Zealand has a patent called "Processes for production of immunoglobulin A in milk," (patent # 6616927) filed in 2000 by inventors Hodgkinson et al.

They state that IgG is the major immunoglobulin in ruminant mammary secretions, but IgA is the predominant immunoglobulin in human milk.

"Immunoglobulin A (IgA) participates in the clearance of pathogenic bacterial, viral or parasitical organisms and a variety of ingested or inhaled antigens from the mucosal surfaces by nertralizing toxins and viral particles, inhibiting adherence of bacterial pathogens and preventing olonization and penetration of mucosal surfaces by pathogenic microorganisms."

and

"Formulations containg high levels of IgA specific for infants is one application. Infants are often very susceptible to enteric gastric disorders. Special formulations containing anti-cryptosporidiosis IgA for protection against cryptosporidiosis infection in HIV and AIDS patients..."

Thus instead of preserving, protecting breastfeeding, our society will create the IgA for infant formula (genetically engineered of course). My water bill has often included a warning about their inability to inactivate cryptosporidium, thus those who are immune deficient...like HIV/AIDS patients and formula-fed infants are advised against using tap water. Supporting breastfeeding is about helping humans build an immune system. But we have created medical protocol that often sabotages babies from building a proper immune system. And instead we create products that imitate human milk components. One system is costly to the consumer but enriches industries. The decision to use a more costly and questionable science (the science of genetic engineering) is based on patenting, on secrecy. And the people who should be aware of what is happening, float on the river of denial.

HIV, human milk...infant formula part 2

My interest in HIV and breastfeeding began during my employment with the WIC Program (1994-1998). A referral was made to me regarding a young mother who was hiv positive because of her wish to breastfeed her newborn son. My response to her was inadequate. All I knew at the time was that the CDC did not recommend that hiv positive women breastfeed. And that is what I told her. I found myself uneasy over my response to her and my own ignorance. I started wondering about the science behind the recommendation. In 1999 I was no longer employed by the WIC Program. I had received a computer as a gift from my Dad and while surfing the web ran across a reference to a human milk patent by a researcher from LaTrobe University. John May, the researcher, in response to my query regarding the patent, sent me a website page with the announcement of a John Hopkins patent on HMFG (human milk fat globule). I read the patent and was fascinated by several things. The patent called, "Antidiarrheic product and method of treating rotavirus-associated infection." (patent # 5505955). Invented by Jerry A. Peterson, Robert H. Yolken (a researcher often funded by Mead Johnson) and David S. Newburg. The patent was owned by Senomed, Inc., Cancer Research Fund of Contra Costa, and John Hopkins University School of Medicine with a statement that the US Government may have certain rights to the patent because it was funded in part through grants by the NIH (National Institute of Health). The patent states, "...the present invention provides an effective and potent agent for the treatment of gastroenteritis, and/or diarrhea, associated with a variety of conditions linked to rotavirus infection such as infantile gastroenteritis and some types of diarrhea prevalent in nursing homes and day care centers, and afflicting travelers and adults exposed to sick children and patients subjected to bone marrow transplant, persons with genetic immune deficiencies, those afflicted with acquired immune deficient diseases such as AIDS, and those who's immune systems are suppressed by drug administration and immunodeficient patients in general."

I was intrigued because a top medical school in the USA partially owned a patent that would use a human milk component to treat AIDS patients for diarrhea. Diarrhea is a common cause of mortality in infants around the world. Infants fed artificial formulas, particularly those infants living in poverty, are at high risk for developing diarrhea. How curious to create health care policy which tells hiv positive mothers not to breastfeed, "to discourage" them from breastfeeding. Yet the treatment for hiv positive mothers and babies if they got diarrhea would be a derivative (real or synthetic-gmo) of human milk.

Another troubling aspect of the patent was that they used donor milk from a HMBANA (Human Milk Banking Association of North America-a non-profit) milk bank. "Human milk was obtained from 30 healthy, lactating women donors to the Central Massachusetts Regional Milk Bank, Worcester, Massachusetts." Did the milk donors know that their milk donations went to researchers who "invented" these patents? Did they believe that their milk went to sick or premature infants? What were they told? I suspect nothing. In contacting HMBANA by email, I was told that this particular milk bank had recently closed down and that the paperwork I requested could not be found. At this particular time, I happened to be corresponding with a documentary film maker (doing films on alternative theories of hiv/aids) who had an interview with David S. Newburg (one of the inventors to this patent and well-known human milk researcher). One of her questions to him was in regard to these patents. According to her, he denied they existed. I have felt over the years since that time, that the common thread to the patenting of human milk components is denial. to be continued...

HIV, human milk....infant formula

An infant formula company in Japan, Snow Brand Milk Products Co., filed a patent in 1994 with the US Patent Office. It was patent # 5,565,425 called, "Viral infection and proliferation inhibitor," by inventors Yamamoto et al. A few years ago Snow Brand Milk Products merged with Nestle of Japan. This patent stated:

"Recently, the inventors confirmed the inhibitory effect of iron-binding proteins against infection and growth of HIV and accomplished an invention of HIV infection and growth inhibitor containing LF (lactoferrin) as an effective ingredient (Japanese Patent Application No. 220635 (1992)."

In a more recent patent application owned by Agennix (biotech company that produces recombinant lactoferrin) and invented by Varadhachary et al. called "Use of lactoferrin in prophylaxis against infection and or inflammation in immune suppressed subjects," filed in 2004, it is stated,

"Lactoferrin has also been recognized as a potent inhibitor of various viruses. (Matthews et al., Hansen et al., 1995; Marchetti et al., 1998, Ikeda et al., 1999)."

and,

"For instance Inoue et al. have reported that orally administered natural human lactoferrin significantly reduces GVDH (graft versus host disease) ..."

Agennix has many patents at the US Patent Office. They also have a patent called, "Composition of lactoferrin, related peptides and uses thereof," filed in 2005. They are creating the recombinant lactoferrin to make a pharmaceutical composition to treat infectious diseases. (hiv/aids being one of those diseases).

If human lactoferrin is considered a potent inhibitor of hiv/aids by infant formula companies and biotech pharmaceutical companies, why is breastfeeding discouraged by the medical profession?

Human milk has more lactoferrin than cow's milk (trace amounts). Infant formula has no natural lactoferrin in it. What lactoferrin it has must be genetically engineered. What do these companies know about human milk components that is not being made public? The use of infant formula to decrease the spread of hiv/aids is premised on the belief that hiv positive mothers pass the virus through breastmilk. But the proof of this is rather dubious. Some human milk researchers say that when the hiv virus is placed in human milk, anti-viral factors kill the organism. So why have we been so quick to believe that hiv is transmitted through breastmilk? to be continued...

Short gut syndrome

"For example, in newborn pigs who are nursed by the mother, there is substantial growth, approximately eight to ten inches of intestines of the infant within the first few days after birth. In a large number of human newborns who are not nursed by the mother but are placed on an infant's formula, this growth of the gastrointestinal tract during the first few days may not occur."

Written in 1987, this patent owned by Baylor College of Medicine created a furor in Europe. It was called the Pharm Woman patent by those opposed to its conception. It is a patent on life--making claim to lactoferrin that is made in the mammary gland of a woman. The patent at the European Patent Office was never approved because of the efforts of the Green Party. But the patent was approved in the USA and in Australia. The USA patent is #4977137 called "Lactoferrin as a dietary ingredient promoting the growth of the gastrointestinal tract," with inventors Buford Nichols et al. It also states:

"Studies in the pig, dog, and rat indicate that the gastrointestinal tract matures more rapidly if the newborn animal is suckled."

"Mammary secretion from goats, sheep, cows, and humans have been found to stimulate the proliferation of various cell lines growing in culture."

In more recent patent applications by a company called GroPep in Australia called, "Growth Promoting Agent," they state a study by M. Klagsbrun, "Human milk stimulates DNA synthesis and cell proliferation in cultural fibroblasts." (Proc. Nat'l Acad. Sci USA, 75, 5057, 1978)

In a patent owned by Abbott (a pharmaceutical company but also the infant formula company, Ross) entitled, "Method for reducing the incidence of necrotizing enterocolitis, " invented by Carlson et al. A study is quoted by Kosloski, "..NEC is rare among infants fed only breastmilk, In humans breastmilk plays a role in passive immunization of the neonatal intestine, and contains factors that promote the growth of Bifdobacterium in the intestinal flora. It is also reported that the beneficial contents of human milk may be adversely affected by freezing, pasteruization, or storage." patent # 6080787

Patent #6682744 mentions the use of Bifdobacteria and Lactobacilli to reduce the occurrence of NEC in preterm infants. They state, "Human milk populates the intestines with Bifidobacteria and Lactobacilli, generating a very different gut flora than seen after formula feeding."

One patent uses oral glutamine in the prevention of neonatal necrotizing entercolitis and other gastrointestinal mucosal damage. This patent states that the glutamate content of human milk protein is very high. "...high glutamate and glutamine content is advantageous for the developing small intestine."

Patent application 20070161541 invented by Marian L. Kruzel et al called "Insult induced immune dissonance," mentions not only the Nichols patent from 1987 but a study by Brock called "Lactoferrin in human milk its role in iron absorption and protection against enteric infection in newborn infants." ArchDisChild. 1980; 55, 417-421.

There are a number of other patents on short gut/short bowel syndrome using human milk components to treat or prevent this problem. It would seem to be advantageous that infants and in particular preterm infants get the real thing, their own mother's milk--fresh not frozen or pasteurized according to some patents. We are acquiring meds, supplements and infant formula based on what human milk properties can do to prevent or treat short gut syndrome and NEC.

Yet, I think there are many health care professionals and parents who haven't a clue that human milk builds and protects the intestinal tract. Good food, good medicine.

shelf stability of ready-to-feed infant formula

The current recommendation for newborns/premature infants not breastfed is to use sterile infant formula (not powdered) due to the threat of e.sakazakii. An interesting patent filed in 1999 states some of the problems with sterilized infant formula. Hopefully, these problems have been corrected. Patent # 6039985 called, "Refrigeration-shelf-stable ultra-pasteurized or pasteurized infant formula invented by Kamarei and owned by Princeton Nutritionals. "Since sterilized products are designed to have up to one and a half (1 1/2) year of room temperature shelf-life, such products will have a different actual content of degradable micro nutrients (vitamins) in the early part of its shelf-life as compared to the latter part. Thus an infant will obtain a different and unknown amount of vitamins depending on when the sterilized product is consumed." "To account for degradation manufacturers of sterilized infant formulas often include up to 50% to 70% more of a given viatmin." The problem with that according to the patent is that it changes the taste of the product and is costly to the manufacturer. My question would be what about the fat soluble vitamins? Vitamin D--overdose possiblities?? What about DHA and ARA?

RSV protection/

Patent # 5506209 owned by Abbott (Ross) uses a native or recombinant human milk component (beta-casein) to inhibit RSV infection. The patent is called, "Product for inhibition of infection of mammalian cells by respiratory syncytial virus," invented by Mukerji et al. It states:

"...a study which confirms that human milk may contain RSV-neutralizing activity of a non-immunoglobulin nature as well as RSV-specific antibody."

Human milk was obtained from Symbicom AB of Sweden. This was filed in 1994. How many parents know that human milk components can inhibit RSV? How many parents know that human milk has the ability to inhibit a variety of viruses (HIV for example) besides bacterium? Why is this knowledge so well-hidden that even many medical care providers don't know it?

The gold rush,mining for human milk components

Human milk is considered the "gold standard" for creating artificial baby milk. The infant formula industry funds and studies human milk in order to create a better infant formula. What is created by this need to constantly improve infant formula is a system in which human milk researchers and the infant formula industry are bound together by mutual interests. The researcher wants to make a living and the industry wants to sell a product, particularly a new improved product.

Breastfeeding organizations assume that human milk research will make breastfeeding more acceptable to the medical and scientific community. Yet, the driving force of research in a capitalist society is to make a profit, to make products, to patent, to monopolize those products or ideas. It is not to create a breastfeeding society, unless there is a profit to be made in creating such a society.

The infant formula industry isn't the only industry interested in the properties of human milk components. The pharmaceutical, food , and supplement industries are also interested. This interest has been driven by our gene revolution. Scientists in these industries believe they can imitate life, recreate it, and improve it. They can study human genes and recreate, recombine, and make products that improve upon nature.

How do these scientists of industry obtain human milk? Who sells it? Who gives it away? The early human milk component patents obtained their human milk from donor milk banks. A HMBANA milk bank (not for profit) is mentioned in one of the first human milk component patents I read. Some patents mention obtaining human milk from medical universities lactation labs (Baylor College of Medicine). Some patents mention a company named Sigma. In writing Sigma about where they obtain their human milk, I was told that it was proprietary information.

Women give it away and industry trades and sells it (although Sigma states that their products are for research purposes only). They patent off it and hope to make a profit. Yet women still devalue their milk. In fact it is so devalued by some women, that they won't even breastfeed. They must spend their money on the artificial product. They enrich an industry because they cannot breastfeed. This same industry keeps the knowledge of human milk components (their gold mine) a secret. Patenting is about secrets and monopolies. The industry makes a profit and the consumer becomes a little poorer.

Diabetes...adding insulin to infant formula

The relationship between type I diabetes and infant formula is mentioned in this patent invented by Naim Shahadeh called "Insulin supplemented infant formula," patent # 6365177 filed in the year 2000. The assignee is Isotech of Maabarot, Israel. Maabarot is a kibbutz that is known for the manufacturing of Materna, an infant formula. It also has two pharmaceutical plants. "Many studies show that type I diabetes is related to cow's milk consumption and neonatal feeding practice. In the case-control studies (including a study conducted in the Juvenile Diabetes Unit of the Rambam Medical Center, Haifa, Israel), patients with type I diabetes were more likely to have been breast-fed for less than 3 months and to have been exposed to cow's milk protein before 3 months of age." The answer to this dilemna is adding insulin to infant formula--recombinant insulin. One might wonder whether infant formula with added insulin is a drug rather than a food product? While mothers in the USA must get a prescription from a physician for donor milk from a human milk bank, infant formula is readily available in stores. No warnings to mothers about the risk of diabetes....no advisory of whether the ingredients are genetically engineered. Parents are left in the dark about this "convenience" food for infants. Convenience is an interesting word. Many infant formula patents state that the reason they must produce infant formula is partly because mothers find breastfeeding "inconvenient," and "difficult." In a patent invented by Julian Cooper et al called ".alpha-lactalbumin gene constructs," patent # 5852224 assigned to PPL Therapeutics (made famous for the cloned sheep. Dolly), they state: "Human milk has been shown to be superior over other milk types, notably cow, sheep, camel and goat milk, for human nutrition. However many mothers find breast feeding [two words] difficult or inconvenient. Moreover, in countries where infant food supplements are in great demand, it would be highly desirable to be able supply a milk product with the nutritional benefits of human milk." Who has created the demand for this product? What is convenient about fixing formula versus the simplicity of putting a baby to the breast? Why is breastfeeding considered difficult? How much of the difficulty is living in a society where the bottle signifies infant feeding and the breast signifies sexuality. How does a woman in this society understand how much consumerism has shaped her behavior, her feelings about motherhood? If a woman embraces feminism, must she abandon her infant to daycare to fit the role society wishes her to play? If a woman instead embraces motherhood, must she consider herself enslaved to her children? And what about the many women who have no choice in the matter, it is economic survival? What kind of society fails to protect its young? What kind of society fails to protect mothers so that they can protect their young? The answer seems to be the society that fails to protect mothers and infants, is the consumerist-oriented society.

will infant formula's be able to inhibit bacteria?

Bristol Myers Squibb (Mead Johnson) has a patent application that is called "Methods for inhibiting the growth of bacteria." It is application number 20070191264 and the inventors are Robert J. McMahon et al. It was filed in 2005. They plan to add bovine lactoferrin to infant formula. Since cow's have little or no lactoferrin, we might ask what exactly are they adding to infant formula? We can get human lactoferrin from transgenic cows (cloned milk). Cloned milk and meat have been accepted by the FDA for use in the marketplace. The FDA does not accept the word bovine lactoferrin and instead calls it milk lactoferrin. So one might come to the conclusion that this company has the intention of using a cloned product to inhibit bacteria--e.coli. This pending patent states: "Diarrhea is a particularly dangerous disease for children and infants. It is the leading cause of death in children under 5 years of age, accounting for 3-4 million deaths each year worldwide." "Multiple studies have shown that exclusive breastfeeding and to a lesser extent, partial breastfeeding, can protect against acute & persistant diarrhea." "As a means for protecting children younger than 5 years of age against various diarrheal diseases breastfeeding has been identified as the most effective intervention." What can one say? Breastfeeding has been identified as the most effective intervention against diarrhea in children under 5 years of age. Thank you Mead Johnson...now if we could only hear this publicly.

Nestle, a human milk component patent for infant formula

"The present invention is based on the surprising discovery of a molecular component of human breast milk, which shows high homology with the extracellular domain of TLR molecules, and more specifically with TLR-2."

TLRs according to this Nestle patent "play a crucial role in regulation of immune responses, especially of immune responses against bacterial conserved molecules present in the intestinal tracts of mammals."

This is US Patent # 7,230,078 called, "Soluble toll-like receptor," filed in 2002 by inventors Schiffrin et al. and assigned to Nestec (Nestle).

They patented from human milk obtained in Santa Cruz, California. I wonder if the woman or women knew that their milk was the basis for a patent by Nestle? If it were me, I wouldn't be too happy about it. One would think that Nestle owed these mothers some kind of financial compensation. But we don't compensate dairy cows for their donations of milk. So I guess why would we think that some huge corporation that makes millions of dollars from dissuading women from breastfeeding would compensate the lactating mother? Just think lactating mothers are supporting the infant formula industry. Ironic. Anyway on this fine day let's quote the Nestle patent:

"It has been demonstrated that breast-fed newborns have a lower incidence of intestinal infections, intestinal inflammatory conditions, lower incidence of respiratory infections, and, later in life, less allergic disease."

Genes, breastfeeding, and IQ

The media and the Human Genome Science community are determined to spread the belief that some specific gene is the trigger for higher IQ. We are to believe that one specific gene called the FADS2 gene (which stands for Fatty Acid Desaturase 2) raises IQ by 7 points, if one is breastfed. They found that 90% of the babies studied had this gene. But 10% had a different version of the gene and did not have their IQ raised despite breastfeeding. Hm...This discovery is based on two studies. One done in New Zealnad in 1972 and 1973. And the other study done in the UK in 1994 and 1995. They say breastfeeding status was assessed. Okay I am at a disadvantage I haven't seen these studies but the most important question is how was breastfeeding defined? Without proper definition, studies on infant feeding are mostly worthless. I would suggest that exclusive breastfeeding is rarely practiced. So to determine the health impact of infant feeding with babies who are mixed feed or given water, or anything but breastmilk is a fruitless task. Were the babies that were breastfed but showed little or no raising of IQ exclusively breastfed?? Without the studies, one can only speculate, but it will be of interest to see the data.

More relevant to my interests is the commercial aspects os FADS2. If we want to produce Gamma linolenic acid (GLA) this enzyme will help us make the conversion. Oh yes, there is a commercial aspect to this enzyme. Abbott Labs has a series of patents on the desaturase genes and uses. And of course, the use of this gene would be included in the production of infant formula besides nutritional supplements, other foods, etc. Desaturases are considered critical in the production of long-chain polyunsaturated fatty acids. The Abbott patents are about using recombinant methods to produce these enzymes. (patent # 7241619, inventor Mukerji et al.)

DuPont de Nemours owns a patent that would creat GLA for placement in various foods and yes, infant formula. This patent states that formation of long chain PUFAs are rate limited by delta-6 desaturation (my understanding is that FADS2 is equivalent to delta-6 desaturase). "Many physiological conditions suach as aging, stress, diabetes, eczema, and some infections depress the delta-6 desaturation step." and "GLA is readily catabolized from the oxidation and rapid cell division associated with certain disorders, e.g.,cancer or inflammation." [patent application 200702378776 called "Production of Very Long Chain Polyunsaturated Fatty Acids in Oilseed Plants," invented by Kinney et al.

This is speculation. But maybe the study that shows an increase in IQ for 90% of breastfed infants by the FADS2 gene is also showing the "environmental" damage done by mixed feeding to those whose IQ was not increased. We do know that genetic integrity maybe modified by environment--for example radiation's damaging effect on genes. We know from several patents that infant formula causes inflammatory health effects in the body. It would seem possible that enzymes/the genes might be damaged by mixed feeding. An infant might have the normal gene at birth but the initiation of an artificial food in the newborn period might damage that normal gene. Speculation, I know. But let me conclude this post with an interesting patent application called. "Method of improving learning & memory in mammals." The inventor is Robert J. McMahon and the application number is 2006247153 dated 2005. No assignee but McMahon is a senior principle researcher for Mead Johnson. This patent states:

"Among the recongized benefits of breastfeeding is optimal mental development." and "Specific components unique to human milk have the potential to support rapid brain growth."

The component that is of interest to this patent is from the sialic acid family, part of the oligosaccharides called N-acetylneuramic acid (NANA)---a component of human milk.

If genes are responsible for our intellgience, then the infant formula companies are not responsible for lowered IQs of babies fed their products. Who will question some of this thinking? Breastfeeding advocates celebrate these kind of headlines in the media but I can only shake my head and think about how easily people can be mislead.

New and improved infant formulas

I thought I would devote more time to patents owned by infant formula companies. They are quite eye-opening. One patent of interest is owned by Abbott/Ross and called "Nutritional formulations containing Lacto-N-neo Tetraose," invented by Prieto, et al. [Lacto-N--neo Tetraose is a component in human milk) filed in 1999. "The growth of Bifidobacterium in the intestine of a baby is believed to be promoted by the physicochemical properties of human milk, particularly its high lactose content, which is a substrate for Bifidobacterium, its low protein content, and its low buffering capacity. Unfortuately, infant formula is believed to have a high buffering capacity which is not favorable for the growth of Bifidobacterium." Bifidobacterium is believed to help inactivate pathogens and microbes. There is a patent application this year by inventors Atul Singhal and Alan Lucas owned by the University College of London called, "newborn infant formulas and feeding methods." application number 20070254062 "We have found from our long term infant studies that rapid early growth, achieved in large part from nutrient enriched feedings from conventional infant formulas, may result in long term adverse health effects in individuals later in life, particularly with regard to long-term vascular health relevant to the development of atherosclerosis and to the later propensity to insulin resistance and non-insulin dependent diabetes mellitus (NIDDM), while slow growth in newborn infants achieved in part from feeding human milk or formula with a modified carbohydrate, fat and protein caloric distributions (e.g., higher protein, lower caloric density), can have a beneficial effect in the form or reduced occurrence of markers of adult morbidity." Hm...so now we know that "conventional infant formula has long-term health consequences." What is stunning to me is that for years the infant formula growth charts have been used to badger breastfeeding women into starting formula...because their babies didn't gain weight in a similiar pattern to those infants fed formulas. And now we are witnessing the realization by the scientific research community that that was a mistake. One of the inventors--Alan Lucas owns another patent on infant formula from the late 80's owned by Farley's. What is troubling regarding these patents is that the research community on infant feeding thinks that somehow man can eventually create a safe substitute for mother's milk. The premise of making a safer and better infant formula is laid on a foundation made of sand. We have something that is known to be safe and of great benefit to the baby and the mother. Shouldn't our investment be in creating an environment supportive of breastfeeding? Instead our research community is investing in the continuous creation of the new and improved infant formulas.

Infant formula patents and patent applications

Infant formula patents should be of vital interest to those of us involved in promoting breastfeeding. These patents tell us more than the label on the can. If we believe in the safety of infant formula perhaps reading some of the 1400 infant formula patents and applications might make us a little leery of declaring that infant formula is the safe alternative. The patents tell a history of constant improvements to fix the health problems created by the older formulas. The infant formula companies are working hard to improve the problems of infant formula.

For example: a patent application #20060233762 invented by Robert J. McMahon et al. (McMahon happens to be a senior principle researcher for Mead Johnson) called, "Method for treating or preventing systemic inflammation in formula-fed infants," states:

"Because the microflora of formula-fed infants is so unstable and the gut microflor largely participate in stimulation of gut immunity, formula-fed infants are more likely to develop inflammatory illnesses. Many of the major illnesses that affect infants, including chronic lung disease, periventricular leukomalacia, neonatal meningitis, neonatal hepatitis, sepsis, and necrotizing enterocolitis are inflammatory in nature."

Patent # 6849268 invented by John B. Lasekan et al. and assigned to [owned by] Abbott [Ross]called, "Method for improving bone mineralization," states:

"Infants consuming formula containing palm olein oil had lower rates of calcium absorption."

Patent # 6656903 invented by Sawatzki et al. and assigned to N. V. Nutricia (formula company in the Netherlands) called, "Baby food stimulatory growth of thymus," states:

"The thymus thereby plays a very important role for maturation particularly of the T-lymphocytes." " Children who are nourished with mother milk exhibit a significantly larger thymus than children who are fed with formula food. Moreover it is known that babies nourished with mothers milk respond to vaccination during the first year of life with higher antibody production than it is the case with children fed formula foods."

Patent application 20070104700 invented by C. Garcia-Rodenas et al (Garcia-Rodenas is employed by the Nestle Research Center) called, "Nutritional formula for optimal gut barrier function," states:

"During the postnatal development , the newborn intestine experiences a process of maturation that ends by the establishment of a functional barrier to macromolecules and pathogenic bacteria. This phenomenon is called gut closure and appears to be affected by the diet."

"...the maturation of the barrier is faster in breast-fed than in formula-fed newborns. This could explain the higher prevalence of allergy and infection in infants fed formula than those fed with mother milk."

Eye-opening comments from the industry researchers themselves regarding infant formula. We have the printed word from these researchers who are patenting substances to correct these problems like slow gut closure, poor calcium mineralization, poor antibody response, inflammatory diseases, etc. This is just a small sample of what is written regarding the health risks of infant formula within patents and patent applications. Yet, we can't have a US Breastfeeding Ad Campaign that states alot of these health risks because there is no evidence???

the "only safe alternative"

A comment was made by Anonymous to my last post that "infant formula is a relatively safe alternative-the only safe alternative, I might add-to breast milk."

What studies show us that this is a true statement? Yes, there are studies but the studies are done by the very industry who sells the product. So for example, the safety of DHA, genetically engineered algae and ARA, genetically engineered fungus is determined by Martek Bioscience. The FDA GRAS system is now a process whereby the industry determines its safety not the FDA. The FDA has opted out of a determination of safety. So safety of these products is not based on independent testing but rather by the consumer. If enough people get sick and die, then the product isn't safe and it will be taken off the market.

If infant mortality was tracked by feeding method (exclusive breastfeeding, mixed feeding, and exclusive formula feeding), we might get a better picture of infant mortality in the USA. In my county in Florida infant mortality for white infants is around 5% but for African American infants it is close to 14%. According to Florida Vital Statistics infant deaths were mostly due to pneumonia, gastroenteritis, and SIDS. It is known that breastfeeding, particularly exclusive breastfeeding has a preventative effect against pneumonia, gastroenteritis, and SIDS. African American babies are the least likely to be breastfed. They are also the least likely to have easy access to the health care system.

Safety of infant formula is based on the illusion that since we don't see infants drop dead after ingesting formula, then it must be safe. We don't see the long-term ramifications of artificial feeding because we are not looking at that issue. We are looking at short-term effects, and even that is smoke-screened because we do not track infant mortality by feeding method.
We do know that some babies have been damaged and die because their infant formula was contaminated with e. sakazakii. Shouldn't we question the safety of infant formula? Like tobacco smoking, the long-term damage takes years to see. And the industry will do everything in its power to load the dice so that consumers are kept ignorant.

The only safe alternative to breastfeeding is the use of donor milk not infant formula. Choice is an illusion. Artificial baby milks have levels of risk, and for some infants the risk is death. A physician once told me that infant formula was safe in the USA because of our excellent health care system. Access to health care in the USA is predicated on your income. Thus poverty, lack of access to health care, and bottle-feeding creates high levels of infant mortality around the world.

A Slogan of Illusion

Why do we use the slogan, "the risks of not breastfeeding?" What does that mean? If there are risks of not breastfeeding, then there must be risks of breastfeeding. Relatively speaking the biological use of our bodies does create some risks. We use our legs and can walk. Therefore we risk falling down and getting hurt or dying. We can walk into traffic and die. Ultimately, walking isn't really risky. Nor is it really a choice, although we can refuse to walk and we can die while walking. Would we discuss, "the risks of not walking?" There is no need to discuss it. Walking is our normal biology. Likewise, breastfeeding is our normal biology.

What is the strategy behind the slogan of "the risks of not breastfeeding?" We avoid the real discussion of the risks of artificial baby milks/infant formula. Avoidance of issues, reminds me of the codependent behavior of families who are dealing with addictive behavior. Codependent behavior avoids the discussion of the reality of addiction. Daddy wasn't drunk last night, he was just sleepy. Mommy isn't addicted to painkillers, she just popps them alot because she is in so much pain. It is the refusal to see the reality and the refusal to talk about that reality. Aren't we, the lactation profession, dealing with an addiction? Aren't the dealers the infant formula industry? The freebies to get ya started, just one bottle. Society blames the victim/the mother for weakness, for giving into the one bottle. And there sits the dealer/the industry wealthier and more powerful than ever. And there sits the victim, poorer and powerless. She feels "guilty" because society would rather blame the victim than speak "truth to power."

The issue is quite simply, "the risks of artificial baby milks/infant formula. "
Infant feeding becomes a choice because industry is creating that illusion for a purpose, for a society of their choosing. The patents on human milk components shows that the illusion is to support the ownership and monopolization of infant feeding by the corporate world. Infant formula feeding is the risk.

Imitating human milk, genetic equivalency?

How does one imitate life? Can we make infant formula genetically equivalent to human milk? Will the industry find every component of human milk to engineer? And will industry create the research and the policy to make each component required substances in baby milks? Seems like they are already moving down that road. DHA, genetically engineered is a good example of funding the research, creating support through breastfeeding organizations, and then persuading governmental institutions to rubberstamp its necessity.

How for example is a genetically engineered amino acid like L-glutamic acid equivalent to the L-glutamic acid in human milk? How can we suppose that a fermented and mutant bacteria can create the same substance as human milk? Just as we seem to suppose that DHA made by some fermented mutant algae can create health. Or a fermented mutant yeast can create the ARA of human milk?

The new, improved infant formulas created to imitate human milk is beneficial to who? If human milk is the gold standard, then the race by industry is to imitate it and "improve" it.
But maybe the premise of industry is the ultimate illusion. The reality is that humanmilk is more than its components. The complexity and the synergy of breastfeeding is that the system creates health for the giver and the receiver. It creates a physical need, the presence of both mother and infant. One cannot easily imitate such a system.

Should human milk be the gold standard of baby milks? Isn't the reality that nothing can be created by man that imitates this system? The reality is that all baby milks are risky. Mothers and babies risk their health by buying into the industry's illusion that somehow man can create an imitation of a system that meant the survival of babies but also the survival of mothers.

L-tryptophan tragedy 1980's

In 1989, a variety of persons around the world became very sick with severe muscle pain and high white blood counts (eosinophiles). Some people died but the exact number of people affected was never certain. At the time no one knew exactly what the disease was or how it spread. Eventually it was traced to L-tryptophan supplements. It was called eosinophilia myalgia syndrome. Contamination of the supplement was traced to one manufacturing company. I remember reading about it but I never saw anything written that discussed the fact that L-tryptophan was being genetically engineered. It was traced to a company that had genetically engineered the bacteria to produce greater amounts of L-tryptophan. In "Seeds of Deception," Jefferey Smith devotes a chapter to this tragedy.

One cannot help but wonder if the contamination of powdered infant formula with e.sakazakii is related to the genetic engineering of L-glutamic acid or other amino acids. I read another patent owned by Archer Daniels Midland Co. called "Production of tryptophan by microorganisms" patent # 5939295 filed in 1996 in which the suggested mutated microbes included enterbacter. How do we know if the production of L-glutamic acid or L-tryptophan through mutated bacteria is safe? Safe for adults? Safe for children? Safe for infants? Safe for preterm infants? Many of the specialty formulas are used on preterm infants. For instance Neocate is an amino acid based formula. If all your amino acids are genetically engineered, what bacterias are being used in production. Is it possible that the mix of these amino acids might in some cases produce a more potent bacteria, resistant to antibiotics? How do we know they are stable? How do we know that the gut doesn't absorb them? Where are the studies? Are we presuming the safety of these components without testing? We are certainly presuming that the consumer or should I say the buyer of the product should remain clueless to the contents.

e.sakazakii, intrinsic contamination?

Manufacturing amino acids is done through the use of mutated organisms, genetic engineering. L-tryptophan and L-glutamic acid are produced through these methods. One company in Japan, called Ajinomoto has a US Patent called "L-glutamic acid-producing bacterium and method for producing L-glutamic acid," #6331419, filed in 1999. This particular patent discusses the use of bacterium from the genus Enterobacter, including enterobacter sakazakii, in the production of L-glutamic acid. Ajinomoto supplies amino acids for the infant formula industry(they have a US office in North Carolina).

How stable are these mutated organisms? Is stability dependent on whether they are within a powdered form or liquid form? According to Jefferey Smith's book, "Seeds of Deception" :

"Scientists who genetically modified yeast to increase its fermentation were shocked to discover that it also increased levels of naturally occurring toxin by 40-200 times."

Is anyone studying this situation?