cloned milk in food? in baby formulas?

We have come a long way. The FDA has approved the use of cloned milk and meat unlabeled. It is likely that most people in the US don't understand what that means. And many of those that understand it, believe that the industry doesn't have enough transgenic cows (we also have transgenic pigs, goats, etc) to make it to our dinner table. There is also the belief that cloned milk is only destined to be pharmaceuticals. Wrong. I believe that there has been evidence since 2000 that herds of transgenic cows exist in the US, Canada, Finland, New Zealand.
And there is some evidence to suggest that some transgenic cow herds are not separated from cows who have not had their DNA manipulated.
Which would mean that there would be a strong possibility that the milk from the transgenic cows (cloned milk) would be mixed with the milk of cows who aren't transgenics. Up until the FDA approval, cloned milk and meat were not suppose to be marketed and on your dinner table. The ruling prior to approval, was that milk was to be dumped and meat destroyed. But it was not a mandatory ruling.
We might ask ourselves, why make a ruling on cloned milk and meat, if we don't have herds of transgenics? In the US alot of our food has been genetically engineered without the public's knowledge or consent. So the question would be why would cloning of milk and meat be any different? It has been since 2003 that the FDA has been trying to make a decision on cloned milk and meat. (basing this on a NY Times article by Kristoff regarding his adventure of drinking cloned milk--he states he didn't grow 3 heads).

Some environmentalists believe that cloned milk will only be used as pharmaceuticals. The mammary gland of all mammals (humans included) is considered to be a bioreactor. It can make therapeutic proteins that supposedly will be used in cancer therapies, HIV/AIDS, diseases of all sorts. The problem with using animal proteins on humans is that alot of humans have allergic reactions to the animal protein. Human proteins do not create such reactions. Of course, one might question whether human proteins made within another animal such as a cow is truly human or truly cow. No time to question or debate, onward in the quest for better drugs and greater profits.
But one of the things about our fast-paced, multi-tasking capitalist system is that why have milk you can only use for the pharmaceutical industry? The food industry has created foods that now give us better hearts, smarter brains. So now we have milk that produces human milk proteins, we certainly can claim the benefits of human milk/breastfeeding. And the uses of this cloned milk become even more profitable because they can be used in baby milks, foods, supplements, cosmetics, dental health. Pharming of the Netherlands (their herds are in Finland because not allowed in the Netherlands) has a US patent that tells us the variety of uses for lactoferrin. Patent # 5919913 filed in 1995 called, "Isolation of lactoferrin from milk."
"An advantage of transgenic animals and differential gene expression is the isolation of important proteins in large amounts, especially by economical purification methods. Such proteins are typically exogenous to the transgenic animal and may compromise pharmaceuticals, food additives, nutritional supplements, and the like."
Abbott Labs, pharmaceutical company and their Ross division, infant formula maker, has a 1995 patent. Patent # 5700671 called, "Method of making transgenic animals producing oligosaccharides and glycoproteins."

"...oligosaccharides in human milk inhibit the attachment of harmful microorganisms to the mouth and throat."

"These human oligosaccharides and specifically glycosylated proteins are absent from, or present from, or present in markedly different amounts, in bovine milk."

"As a consequence, infants fed infant formula which comprise cow's milk may be more susceptible to intestinal disturbances such as diarrhea, or their blood plasma amino acid ratios and levels may differ from breast fed infants."

Abbott Labs in another patent (# 5891698) on human milk oligosaccharides made in transgenic animals states another use for these human milk components...diagnostic kits. There is a wide range of uses for cloned milk, and not just in pharmaceutical products. For me the most upsetting part of this is that cloned milk is destined to be used in infant formulas. Infants become the guinea pigs to a new industry.
Copyright 2008 Valerie W. McClain

human milk proteins produced in plants

There are a number of ways to genetically engineer human milk proteins. One way is cloning of animals to produce the human milk component in their mammary glands. A number of companies around the world are involved in that endeavor, such as Pharming of the Netherlands. Another way to create a genetically engineered human milk protein is through cell culture. Agennix of the US is using this method to create their recombinant human lactoferrin. There is a third way, and that is to genetically engineer human milk proteins in plants. Ventria Bioscience is working on the production of human milk proteins through plants. Their field trials created quite the stir in California with Green Peace protesting their fields of genetically engineered plants. Environmentalists believe that what these specialized plants produce will be used in the pharmaceutical industry. Lets look at their patent. Their patent is called, "Expression of human milk proteins in transgenic plants," #6991824 filed in 2002.

"It would therfore be desirable to provide a plant-derived infant formula having beneficial levels of one or more proteins normally present in human milk, while largely avoiding costly recombinant protein production techniques and safety issues. More generally, it would be desirable to provide a nutritional food extract that may be readily and inexpensively obtained in large quantities, can be delivered by itself as a nutraceutical or added to processed foods, for supplying one or more human milk proteins beneficial to human health."

The intent is to provide such human milk proteins as lactoferrin, to the infant formula, supplement, and food industries. Genetically engineered lactoferrin is already in a variety of products bought by consumers: mouthwash, toothpaste, whey products, supplements. One way or another, people will get human milk. Of course it won't be through breastfeeding.

formula for brain development

There is a patent application, #20080003330, Called "Infant formulas for early brain development."  The owner of the patent is Ross/Abbott, an infant formula company.  I am fascinated by the direction the infant formula industry is taking, when it feels the obligation to create a substance to make our babies smarter.  Perhaps, that may backfire on them?  Are they taking responsibility for those children who were fed infant formulas that did not help develop the brain?  Could a teenager who scores poorly on the SATs, blame the poor scores on the fact that he was fed that formula that didn't have the components that increased early brain development?  Or better yet, could a teenager put the blame on his/her not being breastfed, as a cause for a poor score?  Could he/she sue and win in court?  Would we hear, "I could have been a nuclear physicist but my mom gave me infant formula, and so I did poorly in school." Or, "I could have been a doctor or a lawyer but my mom choose the wrong infant formula." Simplistic thinking, but in a world of reductionist science and law it might happen.  Maybe not.

The reason I found myself fascinated by this patent application is because of the following statements:

"...commercial infant formulas are still not identical, in either composition or function, to human milk. Almost 200 different compounds have been identified in human milk, over 100 of which are still not typically found in significant amounts, or at all, in commercial formulas...Many of these materials are unique to human milk or are otherwise present in only minor concentrations in cow's milk or other protein sources used in preparing a commercial infant formula."

This patent application would add the human milk components (gangliosides, phospholipids, sialic acid) to create the infant formulas that would promote brain development. Of course we are not talking about the real components, we are talking genetic engineering of the components. How this makes it equivalent to the real thing is beyond my imagination.

milk banks, not for profit

Do non-profit milk banks only provide donor milk for babies and sick adults? My understanding from looking at the HMBANA website and from my emails to the head of that organization is that some donated milk goes for research. Which researcher and how much is decided by the director of the particular milk bank. HMBANA milk banks have provided donor milk for researchers that have patented human milk components. Although it seems to be only 3 times (and there are some 2000 human milk component patents and applications), all 3 times involve patenting of the real component as well as the gene construct of the component. All 3 patents have the possibility of being used in artificial baby milks. The components were HMFG (Human Milk Fat Globule and leptin). The HMFG patents are owned by John Hopkins Medical School (along with two other companies) and the leptin patent is owned by the Nemours Foundation (Dupont). What guarantee does the milk donor have that their milk will not be given/sold to researchers who plan to patent discoveries? One of the purposes of HMBANA is to support research of human milk. Therefore it would be extremely difficult to control whether a researcher will patent or not.

Some of the advisers to the HMBANA Board of Directors have been heavily funded by the infant formula industry. Does it effect policy and the direction of this non-profit organization? Maybe and maybe not. One of the questions I posed in my emails to HMBANA was how much of their donated milk went to babies and sick adults and how much went to researchers. The response was that a small amount went to researchers.

HMBANA is opposed to the selling of human milk for profit. HMBANA milk banks have had an increase in milk donations as well as an increase in distribution of its donor milk since the emergence of Prolacta Bioscience. It would seem that Prolacta has created more public awareness of human milk banking and both Prolacta and HMBANA are benefitting from the media exposure. It would seem logical that HMBANA might consider selling its donor milk to Prolacta. Many non-profit tissue and organ organizations sell their tissues and organs to for-profit companies (helps keep the non-profit economically afloat). I have been told by various members of the lactation community that HMBANA does not give/sell its donor milk to Prolacta.

HMBANA had a Conference a year or two ago with one of their main speakers being Catharine Svanborg, human milk researcher. She owns 5 patents on human milk components (HAMLET real and gmo). I wrote HMBANA, hoping that she disclosed this fact to her audience. I got no response from HMBANA. And since I did not go to this conference, I have no way of knowing what she did or did not disclose. Does HMBANA oppose patenting of human milk components? It doesn't seem like it.