Biopharming with human milk proteins

Fields of rice growing in the heartland of the USA. Just rice? Or genetically engineered rice with human milk proteins to create a better infant formula, oral rehydration solutions, foods for adults, or antibiotics?
Don't believe it? Yeah, who would believe that standing in the farmer's field is our distant relative, call her, HuRice or HuBarley or HuMilkie or HuBucks($$$$). Ventria Bioscience is a company that believes in the science of creation. As the magician can pull a rabbit out of his hat, Ventria will pull human milk proteins from rice or barley or wheat or oats or rye or corn or millet or triticale or sorghum (all mentioned in their patents as possibilities). For now its just rice, growing in Kansas. The NIH (National Institute of Health) awarded Ventria a Phase II SBIR competitive grant of $724,628. Kansas Bioscience kicked in $144,744 as a partial match for the federal funding. I guess this is one way of our government supporting human milk feeding, just a little sarcasm. In reading government documents from about 10-20 years ago, one understands that US governmental research on human milk was driven by the idea of creating an infant formula as good as breastmilk or better than breastmilk. How would this be done? Genetic engineering.
There was alot of faith in our new science back then. That faith has became institutionalized and heaven forbid anyone question the safety of genetic engineering. Heaven help the scientist who shows that genetic engineering creates health problems in animals and ultimately with humans. Those scientists have lost their jobs, and the cone of silence descends on their work and their names.

Onward soldiers of fortune. Some women don't want to breastfeed. Don't ask why. Some women can't breastfeed. Hm...how many really can't physically produce milk? C-section rates are approaching 50-75% in some hospitals. We modern women are losing our biological ability to birth naturally. Can't birth without medical intervention and can't breastfeed either. So we must develop an infant formula as good or better than human milk. How do you do that? Well, genetic engineering. We can recreate human milk proteins, and in this case the creation is in rice (some are creating those proteins in yeast cells, and some through transgenics of cows, goats, rabbits, mice).

Ventria's patent is called, "Expression of human milk proteins in transgenic plants," #7718851 with inventors: Ning Huang, Raymond L. Rodriguez, and Frank E. Hagie. The patent discusses various human milk proteins. One is lysozyme, which is a human milk protein and an enzyme. Just a reminder this enzyme would be inactivated in the pasteurization of donor human milk.


"Lysozyme also exhibits antiviral activity, as exemplified by the significant reduction in recurrent occurrences of genital and labial herpes after oral treatment of patients with lysozyme (Jolles, 1996). More recently, lysozyme from chicken egg whites, human milk and human neutrophils has been shown to inhibit the growth of HIV-1 in an in vitro assay (Lee-Huang et al., 1999). In addition, an anti-fungal activity has been demonstrated for lysozymes using oral isolates of Candida albicans (the most common fungal causative agent of oropharyngeal infection in humans; (Samaranayake et al., 1997). In this capacity, lysozyme can function as a broad spectrum antimicrobial agent. "

Hm, again we see a human milk component patent that "inhibits" (some patents say inactivates) hiv. Yet, we have no questions regarding Department of Health regulations that coerce hiv positive women to bottle feed their babies. Most of those babies will be African American babies. Interesting how an infectious disease impacts mostly one race. Doesn't make sense to me. One would think that an infectious disease would spread throughout various races and not be mostly confined to one race or another.

According to this patent, lysozyme is the most abundant protein in human milk. The patent also states that, "... lactoferrin and lysozyme are present in relatively high amounts in human milk but in only low or trace amounts in cow's milk." Ventria manufactures Lactiva(TM) and Lysomin(TM), both recombinants of the human milk components lactoferrin and lysozyme respectively. Dr. Bo Lonnerdal states in an article in Redorbit News, "Ventria's Lactiva and Lysomin have been shown to have identical functional and biological activity as their breast milk counterparts." According to Redorbit News, Bo Lonnerdal, PhD was presenting his paper on this at the Nestle Nutrition Workshop Series in Ho Chi Minh City Vietnam in November 2005. Dr. Bo Lonnerdal is part of "Our Network" for Ventria Bioscience. He is among other Ventria Network scientists such as: Dr. Roger Beachy, member of US National Academy of Sciences, President of Donald Danforth Plant Science Center [Monsanto-funded institution], Dr. Eric Conn, member of National Academy of Sciences, Dr. Gurdev Khush, member of the US National Academy, Dr. Ray Rodriguez, patent owner and founder of Ventria, NIH postdoctoral fellow in the lab of Herbert Boyer, and Dr. Diter von Wettstein, also member of US National Academy of Sciences.
http://www.ventria.com/aboutus/ournetwork.asp

"The idea of improving oral electrolyte therapy with the addition of proteins naturally found in breast milk is a novel and important concept and is potentially a major advancement in this therapy, which impacts the health of children globally."
Ron Kleinman, MD, Acting Chief of Pediatrics and Chief of Pediatric Gastroenterology, MassGeneral Hospital for Children, January 2007
http://www.ventria.com/www/Comments.asp

Who wouldn't want to support a therapy that would save lives? But how many of the dehydrated children are dehydrated because they are being formula-fed? Genetic engineering may try to imitate our genetic blueprint but can we manufacture an identical substance to human milk components? I believe it is a recognized fact that genetic engineering does not duplicate identically. What about mixing human genes with rice? We are opening up the species barrier between humans and plants What are the ramifications? What pathogens that only infects plants will now be able to cross over the broken barrier to infect humans? Where is common sense? Yes, common sense went into the stock market never to be found again.
Copyright 2010 Valerie W. McClain

Processed and altered humanmilk

Pasteurization sterilizes liquids. It kills, inactivates pathogens. Donor milk banking processes their donor milk by pasteurization. Mothers who are hiv-positive in Africa and want to breastfeed are encouraged to pasteurize their breastmilk. Safety is supposedly the issue. We do this with mass production of cow milk, wines/beer, etc. And few people think twice about it. The US is a germ-phobic society. We have anti-bacterial soaps. In fact its hard to find a soap that isn't anti-bacterial. The belief is centered on all bacteria being bad, dangerous. We are just beginning to understand that not all bacteria is bad, that we need certain bacteria in our guts to protect us. Babies born by c-section in sterile environments and bottlefed are more at risk for infections. Life is not sterile. Sterile is dead. Humanity would not have survived this long, if we could only survive in a sterile environment. Yet the reality is that people die of infections and that some pathogens can and do overwhelm the human body. Why? Is health a matter of keeping clean and using antibacterial soaps in our pockets? Aren't hospitals the cleanest places in town? Or they should be. Yet we knew that they are the repositories of some of the more virulent pathogens. So why are hospitals so full of germs despite their use of antibacterials and sterilization procedures? I don't want to go to a hospital that is sloppy in its procedures to prevent disease. I appreciate the health care professional who washes his/her hands before coming near me but isn't the situation in hospitals very different? Hospitals are not homes. We seem safest living in our own germs.

Besides pathogens, pasteurization of milk kills enzymes. In human milk one enzyme of enormous interest is bile salt-activated lipase (only found in humans, gorillas, cats and dogs not cows) "The test for successful pasteurization is absence of enzymes." It denatures milk proteins and alters amino acids. It promotes rancidity of unsaturated fatty acids and destruction of vitamins.
dairying and cheesemaking of goat milk/pasteurization
http://fiascofarm.com/dairy/rawmilk.htm

What is lost through heat treatment (Flash pasteurization and the Holding Method) and refrigeration/freezing of human milk is shown in a wonderful website at LaTrobe University by Dr. John T. May-retired. The percentage of activity remaining for various antimicrobial factors in human milk is presented in chart form. There is some loss in heating with Secretory IgA but not with refrigeration/freezing. Only 40 percent activity remains for lactoferrin using the Holding method of pasteurization. The lipases show major destruction of activity using heat treatment and even refrigeration and freezing shows a major reduction in activity.
http://www.latrobe.edu.au/microbiology/table7.html

Infants have lower levels of digestive enzymes than children or adults. An infant's pancreas is not fully functioning. The enzymes in breastmilk compensates for this problem. The infant's gut is immature making the infant very vulnerable to pathogens that can penetrate the epithelium, risking infection and allergies. Raw human milk/breastfeeding has the enzymes and the IgA to offer more protection than pasteurized human milk.

In 1987, a patent was filed called, "Dietary compositions and methods using bile salt-activated lipase," # 4944944. Inventors are Jordon Tang and Chi-Sun Wang and the owner of this patent is Oklahoma Medical Research Foundation. From the abstract, "Dietary compositions, especially cow's milk-based infant formulas, are fortified with bile salt-activated lipase. Methods are provided for feeding newborn and premature infants which include administration of bile salt-activated lipase to increase fat digestion and therefore growth rate."

These inventors want to use a human milk component, an enzyme to promote growth and increase fat digestion in formula-fed and preterm infants. The inventors have a later patent using a recombinant human bile salt-activated lipase. This critical enzyme is killed in pasteurization of donor milk. So I am sure at some point we will have to add this back. Kinda like the refinement of grains. We take the bran and the germ out of flour to make it more acceptable and then have to add it back (adding vitamins and nutrients). AstraZeneca AB of Sweden also has a patent on human bile salt-stimulated lipase obtained from transgenic sheep for "improvement of the utilization of dietary lipids in preterm born infants." It is called, "Expression methods," patent #6525241 by inventors Dalrymple et al filed in 1999. I am not sure if any of these US patents became actual products. But I am fascinated by the adulteration of human milk. We have to tinker with everything because what nature provides isn't good enough. So we process the food, the fluid and components are destroyed. But industry always finds a way to add it back into the product. Although it isn't quite the original component and currently the rage is to genetically engineer everything. Refining a food brings a whole host of new problems. How realistic are our fears regarding raw human milk? Raw goat's milk is difficult if not impossible to obtain in many parts of the USA. Many seekers of better health maintain that raw goat's milk is better for you because the enzymes are not destroyed. We seem to be following the same path with human milk because of our fear of disease. Who is right and who is wrong? Is the answer far more complex than believing raw human milk is always safe or believing that raw human milk is always unsafe?
Copyright 2010 Valerie W. McClain

The MilkMan cometh....

Okay, here she comes, walking into your living room via the Internet. Looking for donations and maybe she will even pay ya for your freezer-full of humanmilk. She has such a sad story of babies in need, desperate for humanmilk. You feel the need to help, its your civic duty. Generosity is often in the souls of many women, often unrecognized. Babies call to us. I melt every time I see a baby. I remember my babies: their adoring eyes, their sweet breastmilk breath, their soft skin, their vulnerability. I'll donate, I'll relactate, I want to save babies. Wait, is the story for real....its the Internet, The Virtual, prime dreamworld of a world on self-destruct. It could be true, I want it to be true, but some things are just too good to be true.

As a lactation consultant, who no longer practices her profession, but remembers trying to preserve and protect a mother's milk supply; I value the idea of access to donor milk. If only a mother who has breastfeeding difficulties could easily access donor milk rather than infant formula (a costly product with known and unknown risks). But does the introduction of donor milk create risks for mothers who are having difficulties breastfeeding? How will the mother introduce this donor milk to her infant? By bottle?? By a SNS/Lactaid-devices to keep infants on the breast while getting extra milk? The introduction of bottles or breastfeeding devices is not without risk to the breastfeeding relationship. The LC/health professional has to understand the risks and educate the mother (time intensive). The mother has to incorporate new ideas and behavior at a time when she maybe stressed beyond her abilities to cope with something new. Will introducing "a product," human milk, make us a breastfeeding society? Or should our society's investment be in creating better childbirth environments in which breastfeeding is normalized. Should we invest in better financial support for mother's of new babies? Why should women, particularly women who are resource poor, be forced into employment two weeks postpartum (it's two months postpartum in Florida but mothers are often scared of losing their jobs or benefits and rush to get back) by US public health systems? We will give you food stamps or WIC but you must be employed? So a women in poverty must abandon her newborn to some daycare provider, a boyfriend, a relative who has less investment in protecting her newborn than the mother. One reads on a regular basis news stories of infants beaten, abused by boyfriends who are babysitting. The story often reads that the baby cried too much (missing mommy) and the boyfriend couldn't take it. How many families are destroyed because we believe that babies aren't really human beings in need of comfort and care of their mommies? Is this a rejection of feminism? No. It's a step towards building love and humanity into our child-rearing practices.

We now have breastmilk sharing at Facebook/ Internet called Eats on Feets. I like the idea, yet I am troubled by it. Part of the troubling aspect, is just the fact of the Virtual. We are dealing with the unknown, mothers will be dealing with the unknown. Is the person really a mother needing breastmilk? Or might this mother be faking it in order to sell the milk to Prolacta or researchers in various industries? Interestingly, Prolacta has a new patent application (several in fact) filed in March 2010. Called, "Method for collecting, testing and distributing milk," patent application 20100268658. The inventors are Elena Medo, Martin Lee, and David Rechtman. The abstract states, "The disclosure is related generally to a method for facilitating the collection and distribution of milk over a computer nextwork (I think they mean network) among a milk provider, a milk company and a milk distribution center." Interestingly, Elena Medo is now the CEO for a company called Neolac, Inc. It's listed as a private company in California under fluid milk, Dairy Products.

I think this is all getting rather confusing to me. We have a void of knowledge about the financial value of humanmilk. And into this void steps industry and a global organization dedicated to helping mothers connect with other mothers for breastmilk. We have HMBANA (nonprofit milk banks) who is collaborating with the FDA and has in the past given donor milk to researchers who have patented. Is there transparency in these organizations? Shouldn't regulations demand transparency, so that mothers recognize when they are truly gifting their milk and when donating is actually enriching corporations?
Copyright 2010 Valerie W. McClain

The destruction of a natural resource, breastfeeding

"Human lactoferrin was prepared from human milk using a heparin-sepharose CL6B column. "

Patent #5725864 assigned/owned by Snow Brand Milk Products Co. Ltd of Japan (infant formula maker) which collaborates or was bought out by Nestle of Japan. It's called "Composition for suppressing infection and growth of human immunodeficiency virus." Filed in 1994. How does an infant formula company obtain samples of human milk? I have been told that corporations get human milk through advertising in newspapers, etc (maybe the internet).
In a market economy, competitors closely guard their products. The creation of these products are often a guarded secret and to steal company secrets has legal ramifications.

Breastfeeding/human milk is the competition to infant formula. Yet, the infant formula industry has easy access to human milk. So here is an infant formula company, studying a component of human milk for use in suppressing hiv. "In the course of further study on the anti-virus activity of lactoferrin the present inventors have found that iron-binding proteins such as lactoferrin also exhibit a strong effect of preventing infection of HIV." How curious that an infant formula maker believes that a human milk component can prevent hiv infection? Of course the file date is 1994, so readers probably believe its just one of those corporate whimsical patents that is just invention not evidence-based. Frankly, I don't know whether this is whimsy, wishful thinking, or evidence. But I really start to wonder, particularly when a more recent patent (2007) called "Peptides based on the sequence of human lactoferrin and their use," assigned to PharmaSurgics AB of Sweden (Patent # 7803757) with inventors Lars A. Hanson et al. state, "The peptides or medicinal products and methods according to the invention are particularly well suited for the treatment and/or prevention of urinary tract infection and colitis, but several other inflammatory and infectious diseases are also treatable according to the present invention, such as inflammatory bowel diseases, rheumatoid arthritis, conditions caused by the virus HIV-1, conditions caused by the virus CMV, and conditions caused by the fungi Candida albicans, Candida krusei, and Cryptococcus neoformans." Lars A. Hanson is a human milk researcher who in 2004 received the Nutricia Foundation award (Nutricia is an infant formula company in Europe). He is also on the scientific advisory board of Prolacta Bioscience (the for-profit milk bank). This patent states that it relates to food stuff, infant formula food. Of course we also have the US Government patent on human lactoferrin for use in treatment of hiv/aids (wrote about in my previous post to this blog). What is known? How will hiv positive mothers feel when denied breastfeeding but end up using components of human milk to treat their babies or themselves? I know I'd be pretty angry. Particularly if I understood the studies that were done that supposedly determined the hiv was transmitted through breastfeeding are flawed. The studies that determined this were based on women who mixed breastfeeding with formula feeding. How can one determine a cause when mothers are feeding at the breast and giving infant formula, too? The mammary gland is a marvelous antibody factory. How does one determine through our genetically engineered hiv antibody test kits whether we are seeing actual disease or the body's natural immune defense (meaning the person is not sick but has a healthy immune system that has created antibodies). Add to the confusion is that infants carry maternal antibodies for 18 months or longer. So is the infant infected or protected??
In my mind, hiv is an infectious medical-industrial disease. Hiv/aids research has been a corporate race to create antibody test kits (whose accuracy is questionable due to the genetic engineering of hiv so you are not being tested against the actual disease but rather a gmo), drugs, and an opportunity for the infant formula industry to create a demand for infant formula. It has also is a driving force in the donor milk industry, nearly crippling donor milk banks initially in the 80's. But now used by the US for-profit milk bank industry as a rallying cry to save the "hiv-positive" babies in Africa. Infectious political diseases (like the recent H1N1 flu hysteria) have common themes. Number one is the medical-industrial complex belief that the public is too dumb to understand the research, therefore we have to take the "experts" at their word. No questions should be asked about the connections between research and corporation profit-making. No questions should be asked about government patents, investments in this infectious political disease. First comes the media headlines creating fear and panic. Death and disease is upon us, unless all populations get tested, get vaccinated, take the drugs, and by god don't breastfeed. And if the US population refuses to comply to the fear-mongering, then they just use the legal system and make it compulsory to be tested, get vaccinated, take the drugs, and use infant formula.
Copyright 2010 Valerie W. McClain

Milksharing, milkbanking, the media, and what isn't part of the debate

"The story of Bangladesh
Is an ancient one again made fresh
By blind men who carry out commands
Which flow out of the laws upon which nation stands
Which is to sacrifice a people for a land."
-"Bangladesh" by Joan Baez

A powerful voice and lyrics that strike to the soul of the listener. Although in my mind it is no longer about lands but about sacrificing people for their blood, for their cells, for their milk. Patenting of life, our cells, animal cells, plant cells, is the new territory in which men and women of science can claim ownership. Our science believes it can play with genes and be the Creator. They will control nature by controlling, manipulating genes. They will own a piece of nature and sell it back to those who lost that bit of nature. Of course it won't be in the same condition as it was found. Kinda like the white man taking the lands of the indigenous peoples. We claim it, we own it, we can do with it what we want-pollute it, blow it up-and you can't have it or do anything about it

The patenting of human milk components is not part of the discussion of milksharing and milkbanking. Why? a) nobody has heard about it, b) it's not the issue, c) people are too ignorant to understand, d) information is being suppressed, e) it's not important, not relevant. Why are women interested in milksharing rather than milkbanking? Is the only reason the limited availability of donor milk through milkbanks? Would more women use milkbanks, if it were more readily available? Would they choose private milk sharing over milkbanks, if availability was not the problem?

Its rather fascinating that there is this level of silence regarding the patenting and commercialization of human milk components. Sh.......! Let's not make this public because women don't need to know about the Mammary Gold Mines. Instead lets keep talking about choice in infant feeding, and lets get women pumping, storing their milk, giving it away. We need alternatives to breastfeeding because we have a society that must separate its babies from their mothers (war-like cultures encourage separation--think of the Spartans of Greece). And well breastfeeding is very difficult, so we need alternatives. It has nothing to do with our medicalized birthing practices, or the drive to medicalize breastfeeding?

Ten years ago when I first read about two human milk component patents, I thought it was information that should be shared among breastfeeding advocates. As time went along. I realized there was a lot more patents than just those two patents. And now patents and applications on human milk components are some 2000 or more. (I am tired of counting). And I am still waiting for a public discussion of this issue because it has enormous repercussions politically, medically, and legally. But silence surrounds this issue.

Human milk research and its patenting is not creating a breastfeeding society. It is creating a milksharing and milkbanking society. Human milk research is the lifeblood of the infant formula industry. To dare to mention that human milk researchers are funded by this industry is to risk the wrath of breastfeeding organizations.

Sidetracked again. I wanted to share an interesting patent for those who are worried about the "infectious" nature of human milk.
It's called, "Antiviral and antibacterial activity of fatty acids and monoglycerides" patent #4997851. The inventors are Charles E. Isaacs, Halldor Thomar, Kwang S. Kim, William C. Heird. Filed in 1987 it states at one point,
"Human milk becomes antiviral not only upon storage but also in the stomach of infants within one hour of feeding."
The storage discussed in this patent was freezing not heating. Fascinating when considering hiv and the standard recommendation/enforcement of formula feeding in the USA. In this patent there is a discussion of the medium chain fatty acids in human milk. Remember 1987, yet standard medical thought (even now) is that human milk doesn't have medium chain fatty acids. Therefore, infants with such medical problems as Chylothorax are given skimmed human milk with added MCT oil or specialized infant formula. So you take the fat off human milk and add your genetically engineered MCT oil. Huh??? Mind-blowing.
Charles E Isaacs, one of the inventors to the above patent, has a more recent research paper presented at the 2005 Symposim on Innate Immunity and Human milk entitled, "Human Milk Inactivates Pathogens Individually, Additively, and Synergistically." "This Symposium was sponsored by the American Society for Nutritional Sciences and the International Society for Research on Human Milk and Lactation , and in part by the Baby Care Global Business Unit of The Proctor & Gamble Company, Mead-Johnson Nutritionals, Nestle, Ross Products Division of Abbott Laboratories Inc., and Wyeth Nutrition." He states, "The lipids in human milk do not initially have antimicrobial activity but become antiviral, antibacterial, and antiprotozoal in vivo after digestion in the gastrointestinal tract."
http://jn.nutrition.org/content/135/5/1286.full

Isaacs still believes in his research. Wonder what the sponsors of this symposium think of it? And what will they invent to duplicate what human milk can do? And women will heat their milk, skim it, add some genetically engineered oil to it to make it acceptable...."sacrificing a people for a land."
Copyright 2010 Valerie W. McClain

River of Gold, white blood, life's treasure

"FDA-Industry collaboration at Stake in November?"
Concerns expressed in a published article dated April 2004 by the Medical device and diagnostic industry explain the FDA's new view on "collaboration."
"The agency's current attitude toward collaboration, Philips said, represents a significant shift in its approach to regulation. He contrasted this new posture to the agency's previous practice of maintaining what he called 'a certain distance from the industry it regulated.'
http://www.mddionline.com/print/889

Fascinating that we now believe that a regulatory government agency can now collaborate with industry as well as with non-profit and educational institutions. How is it that we believe a regulatory body can regulate while collaborating? Now let me see, the FDA collaborates with HMBANA milk banks. Does it collaborate with Prolacta? And if it doesn't, wouldn't Prolacta be angry that HMBANA has an "in" with the government but they don't? Does the FDA collaborate with the infant formula industry, too? Is the collaboration that HMBANA gets the same as the collaboration that the infant formula industry gets? And when the FDA helps write the guidelines for HMBANA, then it appears to me that HMBANA is no longer an independent non-profit organization but rather an off-shoot of the FDA. When we mix relationships up between the government and industry, educational institutions, and non-profits, what are we creating?? Will independent thought survive in this atmosphere? I noticed in the build-up to the invasion of Iraq, there became this political undertone among US LC's on Lactnet. It was the silencing of any comments on war and its effect on breastfeeding. It was the American flag plastered on websites. It was a level of craziness that I still do not understand. I like the American flag, I support democracy, democratic principles. Yet, I am troubled by a theme of "My country right or wrong." So if your country tells you to jump off the cliff, would you jump? When non-profits become entangled with the federal government, they entangle us all in the political atmosphere of government interests. Which is often not the interests of everyday people but the interests of people of power and wealth. When government and professions get enmeshed, then your politics determines your acceptability. Democracy? Freedom of thought? Freedom of Inquiry? Where goes science, the search for truth, when government and institutions and corporations melt into one massive bureaucracy? I am fascinated, like I am fascinated with watching a rattlesnake, or a hawk catch its prey.
One of the first patents I read some years ago, which led me down this insane road of reading human milk component patents is called "Anti-diarrheic product and method of treating rotavirus-associated infection," (#5505955) and "Anti-viral composition & kit and use for treating rotavirus infection and diarrhea." (#5667797). The inventors were Jerry A. Peterson, Robert H. Yolken and David S. Newburg and the patents are owned by Senmed Inc, Cancer Research of Contra Costa, and John Hopkins University School of Medicine. These patents state where they got their human milk--a HMBANA milk bank of Worcester Mass. That milk bank is no longer in existence. Interestingly, it was soon after I started questioning that milk bank and HMBANA that the milk bank folded. Not that I am saying there is a connection, just another strange coincidence. I asked for paperwork from that milkbank regarding how these researchers got HMBANA donor milk. I was told that there was no paperwork.

from Patent #5505955 and 5667797

"Example 1: Source of Human Milk

Human milk was obtained from 30 healthy, lactating women donors to the Central Massachusetts Regional Milk Bank, Worcester, Mass. The donors were chosen to represent a wide range of maternal ages ranging from 20 to 37 years (average: 28.+-.4 years), parity: 9 primiparous, 13 secundiparous, 5 tertiparous, 3 quadriparous with a 0 to 14 months lactation period (average:6.0.+-.3.8 months postpartum). The milk was generally expressed in the morning by means of a mechanical pump, pooled and used to isolate the human milk components utilized below. "

Breastfeeding mothers are concerned about donating to Prolacta because they state that they may patent off the milk (actually they don't state "patenting," the donor waives her rights to any commercialization that may happen). What assurances does the donor have regarding HMBANA milk banks?
Copyright 2010 Valerie W. McClain

Collaboration between the FDA and HMBANA

In the year 2000, a proposal for collaboration between the FDA and HMBANA was written by Mary Rose Tully, MPH, IBCLC.

http://www.fda.gov/ohrms/dockets/dockets/00n0001/ts00019.pdf

"There appears to be an increasing need for federal oversight of donor human milk banking, as witnessed by current concern expressed at USDA over use of donor human milk for WIC recipients, and a few random attempts by breastfeeding mothers to give away or sell their milk locally or via the Internet."

"FDA staff have regularly given input into the development and updating of the Guidelines (HMBANA guidelines) since 1987."

**"Dr. Wallingford [FDA staff member at that time, later became VP Government Affairs Liason and Market Compliance for Wyeth--infant formula maker] even found funding for testing of the milk processing procedure to ascertain that it would destroy HIV while minimizing damage to the unique immunologic and nutritional properties of the milk."

My understanding is that infectious HIV has never been found in breastmilk. They have used recombinant HIV to see what happens but the properties of human milk inactivate the "virus."
Wonder where he got the funding? Yes, I know don't ask.......

The FDA has a website under Science & Research, "Use of Donor Human Milk." The FDA's recommendation (updated 11/30/10) states,

"The choice to feed a baby human milk from a source other than the baby's mother should be made in consultation with the baby's health care provider..."

Try that where I live....the recommendation will be to go to the grocery store and buy infant formula.

"FDA recommends against feeding your baby breast milk acquired directly from individuals or through the Internet."

The last paragraph is contact information for HMBANA.
http://www.fda.gov/ScienceResearch/SpecialTopics/PediatricTherapeuticsResearch/ucm235203.htm

Fascinating.
Copyright 2010 Valerie W. McClain

**Dr. Wallingford is now employed by Medolac, the second for-profit milk bank founded by Elena Medo
http://www.prnewswire.com/news-releases/john-wallingford-retained-by-medolac-laboratories-as-worldwide-regulatory-affairs-advisor-254542031.html

The FDA, Milkbanks, Milksharing, and Regulation

The FDA, part of the US Department of Health and Human Services is having their Pediatric Advisory Committee meet to discuss "donor and banked human milk: current practices and potential benefits and risks..."
The meeting is scheduled for December 6, 2010 (8am-6pm). The Committee's job is to provide advice and recommendations to the FDA. The public can submit electronic comments to http://www.regulations.gov
Written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. I did the email comment and it was a challenge (timed). I also plan to write something more substantive. Comments will be taken until January 6, 2011.
So here we are at the Edge of new beginnings. A new organization of mothers dedicated to helping mothers share breastmilk called Eats on Feet blossoms on the internet through the use of the social networking site, Facebook. Suddenly, the FDA picks up its head and decides to have a meeting about potential benefits and risks of donor, banked milk. "Topics will include infectious disease risks, State regulations, and current practices in donor and human milk banking." The HMBANA milk banks had been working on creating a collaboration with the FDA since about the year 2000. I suppose to legitimize their operations. I am not sure what happened with their proposed collaboration with the FDA (document to the FDA). What I find fascinating is that for the past year I have been seeing comments by various HMBANA milk banks about the "dangers" of private milk sharing going on through the internet. And now their dream has come true with the birth of Eats on Feet. Be careful what you wish for?? Now the FDA will sit up and take notice. Yep they did sit up and take notice. First topic on their agenda is the infectious disease risk.
Readers may wonder what side of the fence am I, particularly when I write about industry patenting/claiming human milk components (mostly the gene constructs). I really am not on either side. I see the value of private milk sharing but I would rather see what we use to call "wet nursing." We are mammals, we need human contact. Yet I do recognize that this "modern" era seems predisposed to viewing all milks in a bottle. I see the value of milk banks in hospitals. I would like to see hospitals that have a maternity unit have a milk bank. But that milk should only go to infants or sick people. Seeing some patents where researchers got their breastmilk from HMBANA milk banks angers me. Looking at HMBANA Conferences in which researchers who patent are featured speakers angers me. But heck, we live in a world where everything is for sale--life itself. So from my viewpoint, I want the milk banks to be regulated in how they dispense their donor milk. At the very least, donors should be informed that their milk will be going to researchers who may patent off their milk. There should be a statement given to donors of how much of their donated milk goes to babies and sick adults, how much is thrown out and or given to researchers. Prolacta Bioscience, a for profit milk bank fortifies and pasteurizes their donor milk. The fortification is what makes this a different product and is directed at preterm infants--making the milk more "acceptable" to the medical community.
Within the mix of milkbanking and milksharing, the FDA will supposedly come to the rescue of the consumer. They supposedly regulate the infant formula industry. Although some people would call regulation of the infant formula industry debatable.

The first topic on the FDA agenda is about infectious disease risks. I am sure this will be a discussion of hiv/aids and the belief that it is transmitted through breastmilk. I wish to share with readers a patent owned by The United States of America as represented by the Department of Health. The FDA answers to the US Department of Health. It's called, "Method of screening for risk of cancer using human lactoferrin DNA probe or prime," patent #5948613. The inventors are Teng et al and this patent was filed in 1996 and publishes in 1999.
Within the body of this patent is this statement.


"Another embodiment of the present invention relates to a method of treating a condition in a patient characterized by a deficiency in lactoferrin by administering to the patient an amount of human lactoferrin according to the present invention in sufficient quantities to eliminate the deficiency. The conditions include neutropenia, AIDS, skin infection, gastrointestinal bacterial overgrowth syndrome, vaginal infection and septic shock."


AIDS is considered a deficiency of human lactoferrin, a component of human milk. Interesting that the US Department of Health has a patent like this. Human lactoferrin will also be used to diagnose cancers. Of course there are various industries who have similar patents. The human lactoferrin will be genetically engineered. Life is curious...we believe human milk is diseased but we take away some its components to treat that disease and of course we tell women not to breastfeed and donor milk is dangerous because it is diseased. Of course this is about making money. All makes sense to the powers that be but strikes me as totally, "Brave New World."
Copyright 2010 Valerie W. McClain