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.