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

Mary, Mary quite contrary how does your garden grow?

What is a woman? Saint or sinner? Virgin? Slut? How do men view women? Can't say I know cause I ain't a man. But over the years I have felt the ominous weight of a male-centered society. Young people's greatest insult to a girl is to call her a slut. Sexual liberation? Who got liberated? Not women. I once had a date with a fella who couldn't believe I had a mind. He must have had a vision of women as feeble-minded. Actually, I couldn't figure out how someone could get to this age in life (50's) and think that all women are ignorant simpletons. Well, what has this got to do with patenting of human milk? Alot and a little.

We, woman are supposedly liberated. We are free, free at last. Yet, we still call women sluts? What do we call men who sleep around? Yes, we call them: politicians, men of the cloth, lawyers, doctors, neighbors, husbands, and fathers. But what's the word for it? Honestly can't think of the word. Slut isn't the word because that is only directed at the female gender. Interesting...

The dichotomous view of women is reflected in society's strange views on breastfeeding and the biotech industries interest in human milk. Our society believes that women should have choice regarding infant feeding. The male corporate society seems to think that all female biology is a choice. Periods? Who needs them? Breastfeeding, who needs that? Babies, if ya don't want it, we have choice. Menopause, you don't have to have that. Liberation from biology is choice. But does man want to be liberated from his biology? Let me see, erections, who needs that? What an inconvenience, lets offer a choice. Men don't have to be liberated from their biology, because why?

Women reject their biology. Men embrace their biology. But the biotech man not only embraces his biology, he wants to own and control the biology of women. Like the pimp who controls and makes money off his prostitutes, biotech man is making claims on the cells of the mammary gland. Slavery is not just rooted in the physical chains that bind a human to a place, but the mental chains that control the mind. Biology is slavery if you are a female, or so our culture dictates through the media. Behind the chains of slavery is always the economic advantage of owning a resource without paying for it. Behind the chains of slavery is the mind control, that make the victim believe that they have chosen their chains.

Stem cells are in breastmilk. So, woman, why are you accepting the slavery of choice? Mary, Mary quite contrary, how does your garden grow?
Copyright 2010 Valerie W. McClain

"Breastfeeding is an example of allogenic stem cell therapy"

Dr. Satish Patki and Dr. Ramesh Bhonde of India said,

"Breastfeeding is an example of allogenic stem cell therapy where the child receives mesenchymal stem cells from the mother as a natural gift."

http://www.indianexpress.com/news/project-to-treat-babies-with-stem-cells-from-human-milk/623267/0

There is a pilot study underway where breastmilk stem cells will be given to sick babies. Of course, I would argue that the mother's own breastmilk should be what a sick baby should get but the argument will be that women don't or can't breastfeed. The article on this research has an interesting statement that might be worth letting mothers and fathers know. (wait a minute I forgot we can't tell mother's the benefits of breastfeeding because breastfeeding is normal--maybe this once we can tell them about stem cells?)
"According to Patki, stem cell number in the colostrums contains about 50,000 cells per ml while mature milk contains hardly 50-100 cells per ml. Hence in the first five days the baby gets 5 million stem cells per kg body weight per day."
These scientists see a use for these stem cells in effective treatment for neonatal sepsis, neonatal respiratory diseases. I can see what will happen...mothers wouldn't be allowed to breastfeed sick babies but they will pay for stem cells from other mothers' breastmilk to treat their baby.
On another note, we should congratulate inventors Mark Cregan and Peter Hartmann because their patent application was accepted as a patent at the US Patent & Trademark Office. It's called, "Method of isolating cells from mammary secretion," patent #7776586. They have developed a method of isolating the stem cells from breast milk. The patent is owned By Carag AG of Switzerland. Never heard of this company? Neither had I, but I did go to their website and learn that in 1999 Michael Larsson bought the company. I believe Michael Larsson is part of the family that owns Medela. He is on Carag's board of directors. Carag has joint ventures with a variety of universities (University of Zurich, University of Western Australia, University of Gothenburg, University of Belgrade) and Medela and Swissimplant AG.

So there are stem cells in that there breastmilk made by women. The image of a modern day Colombus, planting a Swiss flag or is it an Australian flag on mothers' donated milk. "I claim thee in the name of the Corporation, Father, Son, and Holy Ghost...."
Copyright 2010 Valerie W. McClain

Breastfeeding: The Tree of Life, an endangered species

From the milk cells clustered like leaves, to the branches of the milk ducts, the human mammary gland stands as a tree of life. It's function is to sustain human life and it does this quite simply, yet elegantly. It is food security and food sovereignty for a people. It represents independence: a freedom from corporate ownership, secrecy, and profit. It is traditional knowledge, passed from mother to daughter, within a community. It is genetic diversity, species specific, a food system rooted in immunology. Yet this tree, this tree of life is an endangered species. Like so many indigenous traditions, the knowledge is being lost. The global corporate worldview is destroying it like the rain forests in the Amazon.

With stealth and secrecy the corporate world of pharmaceuticals and food technology, acquires human milk to study and make claims, patenting as much of it as possible. These corporate giants prey upon the ignorance of the people. Donate your milk for research...not telling the donor that the plan is to plunder and profit from what is freely given. Like the indigenous people in the rain forest, women watch as the corporate world destroys a natural resource. We watch as the earth becomes bare from deforestation. We watch our natural resource dry up, as the robber destroys our safety and peace. We become dependent on their system, on their products to survive. The knowledge of breastfeeding is destroyed, replaced by the medical-industrial jargon, incomprehensible and destructive. Secrecy of the value of breastfeeding is part of the system. Breastfeeding is put on a pedestal of impossibilities, used as a whip to judge women, and denied to those who need to breastfeed.

Dripping words of encouragement, the authorities talk of poisoned breastmilk, toxic breastmilk, infectious breastmilk. The wondrous tree of life, full of milk becomes a barren, empty vessel. It's role relegated to sexual enticements. Women condemned by society to show their empty breasts while denying their infants its treasures. Women scorned, keepers of the tree of life. I weep for a world gone mad.
Copyright 2010 Valerie W. McClain

make it so....we are a breastfeeding culture

The magical words, "make it so," and it happens. This is a common authoritarian, militaristic viewpoint. We will just "power-through" and people will do what we want them to do. And if they won't, then we make them. Our society uses the soft approach when it comes to making people behave. First we use PR campaigns through educational institutions and or advertising. The internet and blogs work great for creating new mind sets. The CDC devotes some millions of dollars to blogging and bloggers so that the public understands health and disease as viewed by those in power.

The current spin in breastfeeding advocacy is that breastfeeding is normal. How does that statement impact women who struggle with breastfeeding or those who can't or refuse to breastfeed? As a mother who struggled with breastfeeding her first baby, and as an IBCLC working with mothers who had problems breastfeeding, I find the statement unsettling, upsetting. No qualifications, no elaborations are made regarding this statement. Thus, if breastfeeding is normal, then often the conclusion some would make is that formula feeding is abnormal. To be judged, perceived as abnormal in a culture is upsetting. It creates the image of the blame game on individuals rather than on a society that creates enormous obstacles to breastfeed.

The cry that breastfeeding is normal is a reaction to the discrimination of breastfeeding in our society. But the answer is not in reversing that discrimination and making those who bottlefed feel the weight of public judgment. The answer is in placing the blame on the infant formula industry for its PR campaigns, its circumventing of the WHO Code, and on a society that places profit first before the welfare of its people.

Years ago, I struggled with breastfeeding my first baby. She was born at home in a very simple birth. Birthing was easy in comparison to figuring out how to breastfeed her without enormous pain. I called La Leche League and tried to follow their suggestions but got no where. Finally, in so much pain, I started formula feeding my baby. I felt devastated, a failure. Despite people telling me it didn't matter, it did matter to me. And I felt an anger inside that people could be so ignorant of the feelings that mothers have when breastfeeding doesn't work out. The only saving grace in the midst of this situation, was the belief that I would go back to breastfeeding when I healed. Most of my family and friends thought I was done with breastfeeding--quit and that's it. But I started reading everything I could about relactation and adoptive nursing. And back in 1982 there wasn't much to read. I read and reread the chapter on relactation in You Can Breastfeed...Even in Special Circumstances. I was afraid it would hurt again and I was afraid that maybe I was just one of those people who couldn't do it. But I had alot of support from my husband. He believed that it would work and his statements were all positive. It was about a month after quitting breastfeeding that I breastfed her for a few minutes. It didn't hurt and I gradually over time increased breastfeeding while decreasing the infant formula. At a certain point, I was down to giving only a few ounces of formula. I found my fear of not having it as a back up stalling my ability to fully breastfeed. Going to La Leche League meeting inspired me to quit all the way, and fully breastfeed her. This experience was the inspiration for being a La Leche League leader and for becoming an IBCLC. I saw the value of support (husband and La Leche League) and information (knowing that relactation is possible). Struggling with breastfeeding, using infant formula has made me more aware of how abnormal our society is regarding infant feeding. Certainly, breastfeeding is the biological norm. But culturally breastfeeding is a lost practice. For many breastfeeding in a society that thinks breasts are obscene, just sexual appendages, means that many women struggle to bring breastfeeding into their lives.

I do not think my experience was abnormal. In fact after working as an IBCLC for some years, I would say that many women struggle with breastfeeding physically and emotionally. Why? Because we live in a culture that sets up enormous barriers. Perhaps the reason I feel so revolted by the words, "breastfeeding is normal," is because of my struggles with breastfeeding and seeing others struggle with it. Breastfeeding would be normal, if we lived in a society that protected and supported breastfeeding mothers and babies. But that is not the situation. And making statements as if there is normalcy when there isn't is just bad PR.
Copyright 2010 Valerie W. McClain

Selling Breastfeeding as "normal"

Breastfeeding advocacy has changed its strategy. Instead of describing breastfeeding as "best," "free," and listing "benefits," we are now told that breastfeeding is to be described as just normal. There are numerous problems with this strategy in promoting breastfeeding to the public. Normalcy is defined in communities by the majority. Does the majority in US communities perceive breastfeeding as normal? Despite many women attempting to breastfeed, initiation rates climbing to 70-80% in the last few years, continuation rates drop drastically by 3 months. I see relatively few women breastfeeding in public. We hear constant media stories of women harassed for nursing in public areas, despite laws to protect breastfeeding.

Yes, breastfeeding is the biological norm but it is not the cultural norm in the US. We may wish it to be a cultural norm, but just saying it does not make it so. In fact the reactions to statements like this may cause more harm than good. Is it formula feeding that is abnormal? Or is it our society that is abnormal? When the public hears the statement breastfeeding is normal, how do they perceive that statement? Do they wonder about the reality behind that statement?

If we read about words that sell a product or a concept, would we use "normal?" Reading on the web about words that sell, I do not see "normal." I do see the word, "free." But breastfeeding advocates have been told not to use the word, "free," because it implies cheap. Yet in all the marketing websites I looked at, free was one of the words that sells(one website states that it is the top selling words of all time). Benefits was another selling word. Yet again we told not to talk about benefits of breastfeeding. Instead I have read articles by breastfeeding advocates that state that there are no "benefits" to breastfeeding because breastfeeding is just normal.
Yet marketing pros, use the word benefits. Why bother breastfeeding, if there are no benefits?

Are those who write about effective marketing wrong? Will describing breastfeeding as normal promote breastfeeding? Already the infant formula industry in Australia and New Zealand has embraced the words, breastfeeding is normal. Why? One would suspect that they like "breastfeeding is normal," because it sells more infant formula.
Copyright 2010 Valerie W. McClain

just add a little lye....manufacturing DHA

Rereading patents sometimes gives you a new perspective. I never noticed a statement made in a Martek Bioscience patent called, "Infant formula and baby food containing docosahexaenoic acid obtained from dinoflagellates," patent # 5397591 filed in 1992.

Part of the process of manufacturing microbial oils is to add sodium hydroxide or caustic potash to neutralize any free fatty acid.

"A base, such as KOH or NaOH is used to adjust the media prior to inoculation." [ KOH=caustic potash, NaOH=sodium hydroxide, lye]

How do we get sodium hydroxide or caustic potash? These substances are listed as hazardous. A process that is used is called the Castner-Kellner process which is a mercury cell process invented in 1892. This process uses electrolysis to create sodium hydroxide. The mercury cell process is gradually being phased out because the plant operations release mercury into the environment. Does sodium hydroxide have residual mercury that could contaminate the food that is being neutralized?

Martek Bioscience has another patent called, "Solventless extraction process," patent # 7781193 filed in 2007. Once again they are still using sodium hydroxide in the manufacture of their microbial oils. Their solventless extraction method does leave some trace metals: lead, arsenic, iron, mercury..all less than 0.02, and less than 3 ppm of hexane. I wonder the amounts of metals left with the hexane extraction method that has been in use until they invented this solventless method?

Mercury must be in caustic soda (sodium hydroxide) and caustic potash because there are standard test methods for determining the amount of mercury present in these substances.
see http://www.astm.org/Standards/E538.htm

It is hard to fathom that a food, particularly a food/supplement given to infants, children, and pregnant women would be processed with something so hazardous. I guess a little lye wouldn't hurt us.
Copyright 2010 Valerie W. McClain

Mercury, autism, and infant formula?

"Algae eat up mercury in Chinese lake," a title of an article in Geotimes of March 2008. "Nutrient enrichment from agricultural runoff and sewage into lake ecosystems can produce large seasonal increases in algae, called algae blooms..." Algae scavenge arsenic and mercury in the water. The algae are eaten by fish, and we eat the fish. Thus, we are eating our pollution and suffering the health consequences of metal contamination. Mercury is toxic and can cause brain and neurological injury. It is especially dangerous for pregnant women and young children. Mercury, besides occurring naturally, is the product of coal burning factories and electric power plants. It becomes airborne and then falls into our lakes, rivers, and oceans.
Martek Bioscience is using algae to produce the DHA in baby formulas. I find myself wondering about the availability of non-polluted waters for generating large quantities of DHASCO (the oil produced by the algae).
Fermentation tanks for algae must have water. Where does the water come from--tap water? Is the water tested for toxins everytime a new batch of algae is produced? Who monitors the situation, since algae is known to scavenge heavy metals? Two of Martek's production plants are located in areas near coal burning power plants (Winchester, Kentucky and Kingstree, South Carolina). Kingstree is in the Pee Dee region of South Carolina known to have particularly high contamination of mercury. So how does industry keep an eye on this situation, particularly since this substance is going into infant formulas for premature infants, babies, and as a supplement for pregnant women? How does the US government monitor the situation? Forty percent of mercury emissions in the US are caused by coal burning power plants. Eastern coals have a high chlorine content. This high level of chlorine makes mercury more water soluble.
"Grown in Martek's labs in 130-gallon vats of water surrounded by fluorescent bulbs [broken fluorescent bulbs leak mercury] and injected with a mix of nitrates, potassium, phosphates, carbon dioxide, and other elements."
and
"Of the 10,000 to 30,000 strains of algae believed to exist by 1988, Martek's scientists had worked with 50-100 purified strains, manipulating the cells' manufacture of fats, proteins, and other products to yield food colors, nutritional supplements, lubricants, and chemicals for use in medical diagnoses."
a company profile-history
http://www.referenceforbusiness.com/history2/8/Martek-Bioscience...
Note the words, "Manipulating the cells' manufacture..." does that mean genetic engineering? Martek Bioscience states they do not genetically engineer DHASCO. The rise of autism in children has coincided with the rise in vaccinations for infants, but also with the use of infant formulas containing these manipulated oils. Many parents believe that it was vaccinations that caused their child's autism. Yet no one questions the use of a manufactured food for infants as a cause of autism. Well, except a father called Mike, who wrote me over a year ago asking questions about these oils and giving me references/research regarding his concerns. He has written the FDA, the NIH, wanting answers to the cause of autism, driven by his own son's autism. I always believed it was the vaccines (having had children who had mild to severe reactions to vaccinations). So it was quite easy to believe that the mercury in vaccinations is causing the rise of autism. But Mike and his questions and his references to studies got me wondering about whether autism might be caused by our infant formula with its new space-age oils.
Do these oils cause oxidative stress in the body? Do they cause mitochondrial dysfunction which causes autism?
Mike sent these references which I would like to share with readers on studies regarding of DHA as a potential inducer of neuronal cell death.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2659540/pdf/nihms-94427.pdf

http://www.hriptc.org/pdfs/Autism%20Phenotype%20Brain%20Tissue%200108.pdf

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2459249/

Most babies in the US have had infant formula at one time or another (there is not much exclusive breastfeeding due to interventions in hospitals where babies are born or by lack of understanding of its importance by parents). Many parents use the powdered infant formula because it is less expensive than ready-to-feed or concentrate. So the water source when using powder is important. How free of heavy metal contamination is the water used by parents for mixing infant formula?
Recently an article linked jaundice in newborns to autism. Is it the jaundice? Or is it the use of infant formula to treat the jaundice? Breastfed babies are often taken off the breast and given infant formula to bring down the levels of jaundice. Many of those babies never go back to the breast (in part because their is an implication that the jaundice was caused by breastfeeding) Premature infants are also more likely to be autistic. Most premature infants get some form of infant formula. In fact infant formula with Martek oils was first given to premature infants.
I believe that autism could be caused by a variety of causes: a genetically predisposed infant, vaccinations, infant formula, a mother who was exposed to heavy metal contamination. All these factors could be linked to autism. I believe that we need to take a harder look at infant formula and these novel oils to determine whether our new food technology is creating autism. For too long the public has assumed the safety of infant formula.
Copyright 2010 Valerie W. McClain

Autism, infant formula with Martek's oils

Awhile ago, a father whose son was autistic contacted me. He believes there is a relationship between his son's autism and the infant formula his son consumed. In particular, his concerns were about the DHA and ARA oils manufactured by Martek that are placed in almost all infant formulas on the market. He has written the FDA, various government agencies, and researchers looking for answers. And more importantly to register his belief that his son was injured by these additives that are used in over 90% of all formulas manufactured. When he first contacted me, I was set in my thinking that autism was related to vaccine damage. And I haven't changed that belief, yet his concerns, his questions made me start to question what I thought I knew. According to Wikipedia the steep rise in cases of autism began in the years 1996 thru 2007. What changed during those years besides vaccinations? What about infant formula? And particularly infant formula with the added Martek "novel"oils? When was Martek's oils introduced into infant formula? According to Martek's company history, the first preterm infant formula with these oils was on the market in 1994 and the first term infant formula in 1997.
http://www.martek.com/About/History.aspx
In 2001 Martek declared that the oils were GRAS and the FDA affirmed that position. The FDA GRAS system is no longer an approval system but rather an affirmation system. Still people assume the safety of the oils since the FDA had no questions regarding Martek's declaration. The safety of new ingredients in this system are learned after the fact (meaning the consumer is the guinea pig) and only by consumer complaint or a massive incident with injuries and deaths (Chinese infant formula contamination tragedy). With infant formula it is up to the parent or caregiver to make the complaint. The US FDA system is dependent upon a highly literate/articulate and computer savy parent/consumer. The industry does its own safety evaluation and that is like allowing a student who is taking a test to score his/her own paper. Some students will be honest. Similiarly some manufacturers will be honest in the GRAS process and some won't be.
There is a current belief in some research circles that "substances released in the gut give rise to autism." There has been a recognition that autistic children seems to have "metabolic abnormalities and gastrointestinal problems--gut pain and diarrhea."
The New Scientist, "Gut bacteria may contribute to autism" by Linda Geddes June 2010
The recognition that bacteria in feces of children with autism is different than children without autism has created a new diagnostic test for autism. The belief is that the gut bacteria is creating a toxin that interferes with brain development. In particular researchers are looking at the clostridium bacteria. A study done in 2002 in Clin Infect Dis 2002 by Finegold et al. called "Gastrointestinal microflora studies in late-onset autism states, "The number of clostridial spores found in stools of children with autism was greater than in stools of control children." In the 1980's research linked clostridium difficile with SIDS and with the possibility of an association to infant formula feeding. "Infants fed formula were nearly four times more likely to carry C. difficile than were those exclusively breast-fed (62 versus 16%). whereas breastfed infants also receiving formula or solids had an intermediate rate of colonization (35%)."
Pediatrics, "Clostridium difficile in Normal Infants and Sudden Infant Death Syndrome: An association with Infant Formula Feeding" by Cooperstock et al. vol 70 no1 July 1982, p.91-95
What we know, "Human milk populates the intestine's with Bifidobacteria and Lactobacilli, generating a very different gut flora than that seen after formula feeding." US Patent #6682744
There are many patents on harvesting bacteria from breastfed infants poop or the sugars of human milk to create prebiotics and probiotics.
What is Clostridium difficile? Its a bacteria that some people get after taking antibiotics, it causes a very severe diarrhea. Human milk has factors that are active against C. difficile (in vitro): secretory IgA, Carbohydrate, free secretory component, and unidentified factors.
Research shows us that the stools of the breastfed infant and the formula-fed infant are very different. More formula fed infants have the bacteria clostridium difficile in their stools. Researchers believe that this bacteria creates a toxin (possibly causing death from SIDS-research in the 80's). The bacteria is now implicated in autism. And we know that more infant formula infants have this bacteria in their feces than exclusively breastfed infants. Is there a relationship between this bacteria/toxin and autism? Is exclusive breastfeeding protective against autism? Are there toxins created by ingesting Martek's DHA/ARA oils in baby formulas, foods? What do novel ingredients,these oils, do to the gut of the newborn? Create a leaky gut? A gut susceptible to bacterial invasion? One would suspect that mammals who ingest the milks of other mammals rather than their own species have damage done to their intestines. The Pharm Woman patent owned by Baylor College of Medicine, states that the growth of the gut (activation of the DNA) occurs when mammals are feed their own species milk. Short gut syndrome is caused by the use of infant formula--which means digestion is impaired. We do unknown damage to newborn mammals--particularly the human mammal when artificial milks are used. Damage to the gut, damage to the brain from the intestines inability to colonize the good bacteria. A gut colonized by an overgrowth of the wrong bacteria creates sickness and death and perhaps even autism?
Copyright 2010 Valerie W. McClain

A Dance of the Sugar Plum Fairies

It's not Christmas. It's just bake day at the lab, creating food for the hungry people of the world. Petri dish and microbes sitting on the bench. See them dancing? Come on look in your microscope. Hear the music? It's the dance of the sugar plum fairies. Little cloned algae twirling and swirling, swooping through the carbon. See how they dance? Time for a glucose break, and more dancing.

Hey look over there, cloned fungi, filamenting (microbiology term for flamingo dancing) It's wild, it's crazy, it's micro-food technology, feeding the world's hungry. Tell little Johnny that his food doesn't come from the land or the sea, it comes from a petri dish. Men of science, can make life happen. They are the new chefs, directors of the Dance, the dance of the sugar plum fairy. And, we believe, we believe that the Nutcracker knows what he is doing. Yes, he is saving the world from hunger, because hunger is about not growing enough food for the people. Forget the politics of food. Farmers just cannot grow enough food, so we will make it for you in the lab. We offer you cleaned up microbes, the gene spliced option to food from the earth or sea. They can live on anything, they love petroleum. What's a little oil in your food, paraffin-smaraffin. Come on. Babies need our formula ingredients, just like breastmilk. Yeah even tastes like it. Same benefits. Get this in your head, we can't grow enough food for everyone and women can't or won't breastfeed. That is the first lesson. And my god we have learned our first lesson well. Farmers can't or won't grow enough food. (liberation from the land) Fishermen can't or won't catch enough seafood.

(liberation from the sea) Women can't or won't breastfeed (liberation from the body)

Hunger isn't about injustice, the haves and the have-nots. It's only about farming. (funny how an oil company that started the food from oil process, massively pollutes the land and oceans with little remorse and lots of PR--now ya gotta eat our petri dish paraffin microbial foods). And so the dance goes on and on and the people believe their Nutcracker.

"Sugar plum receipe from the Lab"

tap water

mortierella alpina

potato dextrose medium

stir and agitate

freeze and dry

extract with hexane

or:

artificial sea water

concentrated yeast

glucose syrup

C. cohnii

agitate and add

glucose syrup

freeze and dry

add hexane

Sorry guys, ya have to have a white coat and a lab to be a chef today.

Copyright 2010 Valerie W. McClain

BP + Martek Bioscience=fuel + food

"BP and Martek Biosciences Enter a Joint Development Agreement to Deliver Advanced Biodiesels" BP Global Press Release August 11, 2009. This is about the development of sugars into a biodiesel fuel using microbial fermentation. Fascinating, particularly when you know the history of both companies. BP, the oil company, developed in the 1960's a "protein-from-oil process" (single cell protein)to create food.

http://en.wikipedia.org/wiki/Single_cell_protein

Yeast was fed by n-paraffins, a petroleum product. This product's intended use was in animal feed. By the 80's there was manufacturing plants in France, Japan, Italy, Russia, UK and USA. Microbes that were used in this manufacturing process were yeasts, bacteria, fungi, and algae. Spirulina, toprina, pruteen, torutein were some of the products. (Quorn is a food that is made by this technology--I have eaten it, tastes like chicken) There was some concerns about product safety. "High concentraion of nucleic acids, elevates serum uric acid levels and results in kidney stone formation, skin reactions to foreign protein, and gastrointestinal reactions.

http://ayushveda.com/blogs/education/single-cell-protein

The reasoning behind this new process was the "prediction" of future protein shortages, particularly in developing countries. Some of these manufacturing plants used hydrocarbons to feed their microbes and some used other substances such as bagasse, citrus wastes, sulphite waste liquor, molasses, animal manure, whey, starch, sewage. etc.

-Professor Cleanthis J. Israelidis, "Nutrition-single cell protein, twenty years later"

One of the more successful single cell protein manufacturing companies is Martek Bioscience. Their algae (DHASCO) and fungi (ARASCO) use the technology of single cell protein production. Their product is in infant formula, supplements, animal feed, and variety of human foods. The assumption by consumers is that the algae is harvested from the oceans (fishermen) and the fungi harvested by farm workers. The algae and fungi actually originate from cloned cultures in Martek's research lab. Although you, too, can buy the Crypthecodinium cohnii that Martek uses for its DHASCO at the ATCC (ATCC Number 40750 for a mere $205 per frozen ampule) ATCC states in their notice and disclaimer section, "ATCC products are intended for laboratory research purposes only, unless noted otherwise. They are not intended for use in humans." Of course this algae is intended for human use--baby use. And the ATCC references this algae to the Martek patents on use for infant formula, baby food, pharmaceutical and dietary supplements.

Over the years I have noticed that many oil industry executives are involved directly or indirectly with biotech industries (genetic engineering being the prime focus). The alliance of BP with Martek in creating a biofuel is fascinating in that you have a company that is making a food, also making a fuel. In regard to creating this biofuel, Martek readily admits to genetic engineering techniques. But in regard to creating its food for babies and adults, they only admit to the single cell protein process. Maybe, just maybe, this alliance with BP will create a sugar fuel that not only we can put into our cars but we can also drink. "Yep, I am just going down to the 24-hour jiffy store for a gas-up for me and my truck--just one spigot for both of "us." Man and machine, have you noticed how much everyone looks like their car/truck. We are one.....OM.........I look like my silver toyota tacoma--curvy, silver-grey, with battery charged, idling at the red light.......waiting for the green.....v....r...oom and she's off and running.

stay tuned for more exciting news about DHASCO and ARASCO, our fine single oiled proteins

copyright 2010 Valerie W. McClain

the smell of things to come, creating a better infant formula

The sizzling aroma of bacon frying in the great outdoors assaults my nostrils. Despite being a vegetarian for many adult years I feel hungry, my stomach rumbles and grumbles. Give me bacon. Yet at the same time I feel great sorrow for the animal that has been sacrificed. My body betrays my philosophical views about life and living on this planet. No, I don't eat the bacon. Yet, I feel repulsed by how easily the odor penetrates belief. Why aren't I repulsed by the smell of cooking flesh? Does the odor remind me of my childhood; the good memories of our family camping? We remember our past by odors. Sometimes a certain smell reminds me of a memory long forgotten. There is often pleasure in that memory, sometimes saddness, sometimes wistfullness for those now gone. Lately, the odors of perfumes in a crowded mall or at my job, bother me, choke me with their strange scents. I feel assaulted by their foreign presence. It isn't a pleasurable smell but a smell that repells me; that makes me want to run to the ocean to breath in the sea and the air.

So it is with great curiosity that I recently found a patent application called, "INFANT FORMULA CONTAINING AN AROMA COMPOSITION FOR USE AS FRAGRANCE." (patent application #20100129312 at the US Patent & Trademark Office) The inventor is Andrea Buttner (German scientist at Fraunhofer Gesellschaft working in sensory analytics). Her name is also spelled Buettner. Fraunhofer Gesellschaft is a applied research company in Germany that is funded mostly by industry and about 1/3 of funding comes from the German government.

The patent application is of interest to me because it states, "babies prefer the odor attributes of human milk compared to those of artificial infant formula or milk products based on milk compositions of animal origin..." The intent of using this aroma is to "improve baby or newborns acceptance of a nutraceutical composition, especially infant formula." It will be used in such products as pacifiers, pillows, toys, breast comfort aids, clothing, incubators, medical equipment, cream, ointment, etc. Wow. So researchers study the odor of human milk, a complex job because the odor is not the same from one feed to the next. The odor dependent on the mother and the food she eats and her chemical contact. So I am fascinated by industry...we will recreate the odor that babies prefer and use it to entice the next generation to accept man-made products.

If that isn't curious enough, this particular researcher was part of a couple of researchers who studied the changes of aroma on stored human milk. From an article in Gas Chromatography in Jan 4, 2010 on their research on the aroma of stored human milk, "The pressures of modern living can limit the opportunities for mothers to breastfeed their babies, directly, but there is always the option of expressing milk for storage and consumption at a later date." The study showed that the odor of stored human milk was very different from the odor of fresh human milk. ("fresh milk to be low in overall odour intensity," "thawed stored milk was strikingly different...dominated by metallic and fishy odours") The study showed that while mothers found the stored human milk distasteful, babies did not seem to be bothered and drank the stored human milk. It would appear that this study was beneficial to breastfeeding and a greater understanding of storage issues of human milk. Since one of the scientists involved in that study is the inventor to this patent application on using a fragrance in infant formula, I start to wonder about the real intent of studying human milk. And then I wonder about the women who donated their milk for this study, that will in all liklihood benefit the infant formula industry. And then I wonder about breastfeeding advocacy organizations and how blinded they seem from the reality of human milk research. Who benefits from human milk research? And do mothers who donate their human milk understand that the research benefits the infant formula industry?

Copyright 2010 Valerie W. McClain

"It was the winter of despair...."-Charles Dickens

"It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, it was the epoch of incredulity, it was the season of Light, it was the season of Darkness, it was the spring of hope, it was the winter of despair, we had everything before us, we had nothing before us, we were all going direct to Heaven, we were all going direct the other way....."

Charles Dickens, A Tale of Two Cities

It has been the winter of my despair for quite some time. Humanity has entered into a season of Darkness. Our science has brought us to great heights. Yesterday I heard the shuttle go up. I live about an hour north of the Cape. The ground shakes and vibrates in waves. I had forgotten that this was the last shuttle trip. I went outside to see the white plume trail. Ah, how many pounds of rocket fuel vented today. A respiratory therapist told her mother (a friend of mine) that after a shuttle launch, the ER has a significant rise in asthma attacks/breathing difficulties. Anecdotal information not worthy of serious consideration?

Will someone investigate it? Not when the job situation in this area is so bad, stop the space program-you have to be kidding!!! I see that white plume and remember the Challenger. I didn't go outside that day-babies napping. Just saw it replayed over and over again on TV-embedded in my brain like the 9-11 plane hitting the World Trade Center. Traumatized by those images, can't forget, never will forget. How the media impacts our lives....not the same as seeing it happen, yet emotionally I feel I was there. Lives lost. Why?

The pursuit of knowledge is the quest for truth. Truth is on who's side? Is there a side? Is the infant formula industry truthful? Are breastfeeding advocates truthful? Is truth relative? Is truth dependent on what side of the fence you live on? Is honesty ditched because your side is the right side? What is the right side? What is academic scholarship? What is intellectual honesty? Where be thee? Is publication a game of roulette? What does it mean, when publication becomes a means to an end, not pursuit of truth. How can we depend on publication, if it can be changed at the whim of the researcher/publisher/editor? I mull this over this morning, wondering if I will ever bother reading online journals again. Despite it being "the spring of hope," I feel winter has not left us.

Copyright 2010 Valerie W. McClain