Tuesday, November 27, 2007

River of denial...patenting of human milk


(photo by Jesse McClain, 2007)
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.

Monday, November 26, 2007

HIV, human milk...infant formula part 2


(photo by Jesse McClain, 2007)
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...

Saturday, November 24, 2007

HIV, human milk....infant formula

(photo by Jesse McClain, 2007)
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...

Wednesday, November 21, 2007

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.

Monday, November 19, 2007

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?

Sunday, November 18, 2007

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.

Wednesday, November 14, 2007

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.

Monday, November 12, 2007

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.

Thursday, November 8, 2007

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."

Wednesday, November 7, 2007

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.

Tuesday, November 6, 2007

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.

Thursday, November 1, 2007

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.