Sunday, February 27, 2011
Yesterday's blog shared a patent invented by human milk researchers Ardythe L. Morrow, David S. Newburg, and Guillermo M. Ruiz-Palacios. Their research on human milk resulted in creating an invention that could be an ingredient in infant formula as well as a nutritional composition, a rehydration solution, etc. The Children's Hospital Medical Center (Cincinnati Ohio), Instituto Nacional De Ciencias Medicas Y Nutricion (Mexico D.F. Mexico), and the University of Massachusetts (Boston, Masschusetts) are the owners of the patent. I kept thinking about this and realized there is more to this than meets the eye. According to a document from the Cincinnati Children's (not-for-profit hospital and research center),
"Cincinnati Children's Hospital Medical Center is a collection site for the Mother's Milk Bank of Ohio, located in Columbus, Ohio [a HMBANA milk bank]... In 2006 the Center for Breastfeeding Medicine received a grant from the Ronald McDonald House Charities to cover the start of costs of becoming a depot site..." Cincinnati Children's have maintained the facilities since that start-up.
In a paper written by SR Geraghty et al. (as well as Ardythe Morrow) in the Journal of Human Lactation 2005 Feb;219101:59-66 entitled, "The development of a research human milk bank." They state in their abstract: "Donation [human milk] to the Cincinnati Children's Research Human Milk Bank are accepted within the context of ongoing, hypothesis-driven research or on an ad hoc basis. Donors must give informed consent, and scientists wishing to use the samples must have Institutional review board approval for their use."
I have alot of questions about this. But having dealt with HMBANA before, I realize that they are not going to answer any of my emails. I emailed various directors and the executive director years ago (about the year 2000). They answered some of my questions but then refused to answer any further questions--they didn't like my "tone" of questions.
The Institutional review board obviously approved the use of human milk for these researchers to create a patent for use in infant formula, as well as other food stuffs. What organization do these reviewers come from? The hospital itself? Obviously milk donated for the HMBANA milk bank in Columbus is kept separate from that which is donated to the research milk bank. How does this work? What steps are done to keep this separate? Does the consent form that donors sign for research on their milk, state the possibility of patenting and that the patenting may enrich the infant formula industry? Don't think I will get my answers but it is just good to write them down and mull it over in my mind.
I guess the serendipitous moment was running across a recent article on "Eats on Feets," the organization that connects through social-networking mothers who have extra breastmilk with mothers who need it for their infants. In this article published in February 21, 2011, they interview Dr. Sheela R. Geraghty, the medical director of the Center for Breastfeeding Medicine at Cincinnati Children's Hospital Medical Center. Yes, the same author of the article in the Journal of Human Lactation (2005 Feb;21(1) called, "The development of a research human milk bank." I suppose the interview is to give a "balanced" view of the concept of Eats on Feets. Dr. Geraghty states in this article, "People ask me all the time about sharing (breast) milk. I unfortunately have to say we're not there yet in saying it's OK." The previous statement in this article before the doctor's comment was that health professionals are warning of the risks of sharing breastmilk via the internet.
Hm...the irony...I am left without a word to describe this situation. I wrote warnings about this 10 years ago. No one liked my "tone." There is a real truth to the fact that we silence our messengers.
We cannot know the intentions of the receipient of that donor milk. It is the essence of human nature, that some people will deceive us by either not telling us the whole truth or they will outright lie to us. We become a nation of many rules because truth is often destroyed in the interest of getting ahead financially or professionally.
Copyright 2011 Valerie McClain
Saturday, February 26, 2011
"The deeper you can manipulate living structures the more you can control food and medicine."
--Dr. Vandana Shiva
The more we pursue the dream of the magic bullet to cure all ills, the more illusive the dream. Science pursues knowledge of the mammary gland and tears apart each living component. There must be one thing in human milk that is the cure. Through microfiltration and powerful microscopes we probe and prod to find the one magical component that controls health and well-being. Reductionism is a scientific illusion of understanding because ultimately nature is a matrix of multiple actions and reactions. Change one small thing and sometimes a monster of a problem is created. So our science thinks it can work at the molecular level without ramification. We are brave and reckless explorers of the inner realm of cell life. Even far worse for life on this planet, is that this science has become part of the corporate world of profit and monopolization. I feel what Dr. Vandana Shiva writes in regard to India and the monopolization of seed and the threat to human diversity is also what is happening with the monopolization of human milk components. It is a threat to the survival of breastfeeding. Human milk is as diverse as the people of this planet. It is the rightful genetic inheritance of each child. Yet we are willing to let our scientists grab it, manipulate it, and pronounce discovery. Yes, discovery, what the heck is that? Women have known for thousands of years, that breastfeeding was survival of their infants. Mother to daughter through generations of diverse cultures, have taught what now seems unteachable: the art, faith, and value of breastfeeding. The infant formula industry spreads doubt, injects its "scientific" understanding of its products, in a power grab for more customers. Human milk research has become the foundation of the infant formula industry. Breastfeeding advocacy will go no where without understanding how seriously undermined breastfeeding has become because human milk is now a commodity of interest to the medical, food, and infant formula industries.
There is a new patent called, "Oligosaccharide compositions and use thereof in the treatment of infection," patent # 7893041, filed in 2004, just published by the US Patent and Trademark Office (February 22, 2011). The inventors are Ardythe L. Morrow, David S. Newburg, and Guillermo M. Ruiz-Palacios and the patent is owned by the Children's Hospital Medical Center (Cincinnati, Ohio), Instituto Nacional De Ciencias Medicas Y Nutricion (Mexico), and the University of Massachusetts. Human milk banks are great providers for research.
"The oligosaccharides agents can also be added to other compositions. For example they can be added to infant formula, a nutritional composition, a rehydration solution, a dietary maintenance or supplement for elderly individuals or immunocompromised individuals."
Human milk was studied and they found: "Thus specific combinations of oligosaccharides are expected to be effective in treating and preventing cholera, Campylobacter diarrhea, calicivirus diarrhea, Candida albicans infection, HIV infection, and other disorders."
and, "Human milk may be considered a natural and efficacious 'nutriceutical,' ie., a model food that conveys immunologic benefits."
They aren't using real human milk oligosaccharides. They will genetically engineer them by using yeast, or some pathogen (e.coli). So because human milk is known to treat and prevent these diseases (gee to bad the CDC doesn't know this, maybe policy would be changed regarding HIV positive mothers being "allowed" to breastfeed), our scientists jump to the conclusion that using a component(s) of human milk genetically engineered will do the identical thing. Yeah, good luck on that.
So here we are, a public misinformed regarding infant feeding. And here are human milk researchers creating gmo human milk components for the infant formula industry and the pharmaceutical industry. The patent states in the beginning:
"Consumption of human milk is one of the most cost-effective strategies known to medicine for protecting infants against morbidity and mortality due to infectious disease."
Consumption of human milk...what is that? Not breastfeeding, welcome to the 21st century!
Copyright 2011 Valerie W. McClain
Sunday, February 20, 2011
In the still of the night, amidst wakeful thoughts and drifting dreams, I reflect on the black and white mentality that pervades current thought. The world spins according to the spinners, the media. We are a world of players, on a stage set for self-destruct. Who can argue against the values that are directed by those in power? The men and women, who use spin to make logic stand on its head. We are directed to dance to the tune of the corporate melody, a melody so sweet, so sickeningly sweet that our minds rush from the sugar high. We crash, as all good things must come to an end. In the dim, swirling fog of twilight thought, I realize the world is not within the grasp of those who shy away from the sunlight of curious thought. The music is not so sweet. It is the wild and open field of human endeavor. Variations and more variations, always changing. Never one melody and one beat. It is millions of heartbeats and thoughts, intertwined and woven. We are a human race of many thoughts and many visions. Stop one thought, stop one vision, and the river of life becomes a river of death. And this is my dream of where we are going, when we refuse to listen to the beating of the many hearts and minds of the world. This is where we are going, when the only heartbeat is the dance of the corporate world. The world of dreams is spinning and spinning, its sweetness turning into sourness, our world upside-down. The twilight dreaming becomes a nightmare turned into reality.
The sun has risen on a new day and still I see the patents, unending. Reading, reading, and staring at the world of intellectual property rights. Property, who would think that word had so much meaning? Onward dear readers, onward to the valley of invention and property rights and profits. There is another US patent to look at, and it's called, "Method for preventing or treating respiratory infections and acute otitis media in infants using Lactobacillus rhamnosus LGG and Bifidobacterium lactis Bb-12," patent # 7862808. It is owned by Mead Johnson Nutrition Company, filed in 2005, with inventors Erika Isolauri and Seppo Salminen of Finland.
"In a meta-analysis of data from multiple studies, results indicate that breastfeeding may have a positive effect on the frequency of both infant respiratory infection and AOM [allergic otitis media]. Specifically, one study indicated that the feeding of many currently available infant formulas may be associated with a 3.6-fold increase in risk of infant hospitalization for respiratory infection when compared to at least four months of exclusive breastfeeding. Bachrach, V., et al., Arch. Pediatr. Adolesc. Med. 57:237-43 (2003). Additionally, infants who are breastfed have been shown to have significantly fewer (about 50%) episodes of AOM than do infants who are exclusively formula-fed. Duffy, et al., Pediatr. 100(4):E7 (1997). These differences may be attributed to the fact that human milk promotes the growth of beneficial bacteria such as Lactobacilli and Bifidobacteria. Duffy, et al., Dig. Dis. Sci. 44(8):1499-1505 (1999).
So there was a 3.6-fold increase in hospitalization for respiratory infection if an infant is formula fed. Parents know about this? Nope. Is it on a label on the can that the parents buy? Nope. Uninformed public. Let me see, if a product is known to cause an increase in hospitalization, one would think there would be more regulation of the product, possibly making it a prescription only product since it is a serious risk for infants? Nope. This patent also state that "in the US, 53% of lactating mothers introduce formula before babies are 1 week old." Of course this was filed in 2005, so old statistic but wonder if there has been much change in this statistic? The patent also states that, "by 4 months of age [breastfed infants] 81% receive formula on a regular basis." And that fewer that 5% of infants are being breastfed at 12 months of age." All this data on infant formula regarding breastfeeding. Interesting.
This patent mentions another patent (patent # 6613549) called, "Probiotic therapy for newborns," owned by Urex Biotech of Canada. Mead Johnson mention it because this patent uses probiotics in a different way, for treating intestinal infections specifically. Again, breastfeeding gives infants natural, live probiotic elements, unlike infant formula.
"Bifidobacteria have been shown to effectively treat intestinal infections in Chernobyl patients in Russia, where the intestine has been damaged by exposure to radiation (unpublished data)."
"In studies of acute diarrhea (bacterial and rotaviral) in children 6 to 36 months of age, a Lactobacillus reuteri probiotic was given at 10e10 and 10e11 colony-forming units daily for 5 days and found to significantly reduce the duration of watery diarrhea compared with placebo (Shornikova et al. J. Pediatr. Gastroenterol. Nutr. 1997, 24: 399-404; and Shornikova et al. Peediatr. Infect. Dis. 1997, 16: 1103-1107)."
And of interest may be the patent called, "Method of enhancing cognitive ability in infant fed DHA containing baby-food compositions," patent # 7413759, owned by Beech Nut Nutrition Corporation with inventors Eileen E. Birch et al (long list which includes Dennis R Hoffman and Richard C. Theuer). I believe it was Birch's research that got the bandwagon rolling to get DHA included in formulas. By the way this patent was developed by a grant from the NIH (grant # HD22380). " Thus the US Government may have certain rights in this invention." If one goes to the Beechnut website, one will note that they are partnered or collaborating with Similiac (infant formula company--Abbott). Of interest is that this patent seems directed at breastfeeding,
"Evidence indicates that breast-fed infants have a long-term advantage in cognitive development over formula-fed infants."
"In various embodiments, feeding an infant a composition of the present teaching can commence as early as an infant will ingest semi-solid food, which can be, in non-limiting example, as early as about 4 months of age, about 5 months of age, or about 6 months of age."
"In various aspects a composition can be fed to an infant as a supplement to breastfeeding or as a substitute for breastfeeding."
It would seem that the baby formula/food industry is targeting breastfeeding by some of their comments in the patents. In the still of the night, the fog-shrouded dream is of mothers dancing to the tune of an industry. Dancing without knowing that the spiraling staircase to heaven has been spliced and glued with a new genetic blueprint.
Copyright 2011 Valerie W. McClain
Tuesday, February 15, 2011
Headlines made around the world, "Breastfeeding study raises doubts over guidelines." From Malaysia to Tehran to Pakistan to Australia, to the USA; we, the people, read online or in newspapers that exclusive breastfeeding is a doubtful practice.
Well, my God, it was written in the BMJ (British Medical Journal) and it must be so. Poof, the experts are now doubtful about exclusive breastfeeding. Funny how it is that this research makes news around the world. Yeah, not so funny to those of us who have preached exclusive breastfeeding to mothers and fathers. Many of us who have worked with breastfeeding mothers and know how the introduction of foods and lots of food replaces a perfect food for infants with substances more processed, less nutritious. It often short circuits breastfeeding and leads to early or untimely weaning.
Let's dig a little deeper, who are these researchers and what did they research? The authors are Mary Fewtrell, David C Wilson, Ian Booth, and Alan Lucas and they wrote an "Analysis" in the BMJ. According to the BMJ in its instructions for authors, "analysis papers are narrative articles in which we [the BMJ] seek to inform and promote debate on important contentious medical, scientific and health policy issues." Yes, I love a good debate, clears the head of cobwebs and can often led to better understanding. So these authors determined (as well as the BMJ) that exclusive breastfeeding is debatable, a contentious issue in health care policy. Well, they sure stirred up a hornet's nest, when this narrative article hit the press world-wide. I am sure it made the baby food industry delighted. "Let there be Doubt."
Is the practice of exclusive breastfeeding harmful? No, my understanding is that exclusive breastfeeding is beneficial to mothers and babies and society at large. Mothers who are resource poor, do not have to depend on buying other foods, saving them money. Mothers who exclusively breastfeed also are able to suppress ovulation for longer times, thus preventing untimely pregnancies. The only harm that is quite obvious to me is that exclusive breastfeeding if practiced world-wide would impact the profits of the baby food/formula industry. Is this debate about health or about economics?
How can I say this? One of the authors, Alan Lucas of the UK is listed as an inventor in a US patent and a US patent application. The patent dates back to 1987 called, "Infant foods," patent # 4753926 and is owned by Farley (a baby food company in the UK). The other is a patent application called, "Baby feeding formula and system," application #20090175979 filed in 2009. this application is assigned to/owned by the University College London. It is a baby formula that reduces the long term adverse health effects of previous formulas. Supposedly it will reduce the occurrence of insulin resistance, obesity and atherosclerosis in later life.
I think it is most interesting that this researcher believes that exclusive breastfeeding is debatable. And that a university owns this particular patent application.
An interesting statistic I came upon the other day was an article from 2003 (about then) that stated that "annual patent licensing revenues forecast for that year in the USA were $500 billion. Maybe we ought to read about inventor success stories.
Patenting is an enormous business and may be the driving force of why some research makes headlines and some research is buried. We risk much as a community, a global society when we allow the Beast to devour our institutions, our research communities, our journals, our media.
Copyright 2011 Valerie W. McClain
Sunday, February 13, 2011
"Men have become the tools of their tools."
Henry David Thoreau
I should stay away from Lactnet (a professional listserve for lactation consultants and breastfeeding advocates). The discussion is on Medela and the WHO Code. Its a very nice discussion, nice being the operative word. Yes, in my opinion a very bland, good-girl conversation. Let's not get heated, upset over the issues of the marketing of artificial nipples by Medela and their thumbing their noses at the WHO Code. Let's wring our hands and wonder how could this possibly happen to a company that has supported breastfeeding all these years.
First question I would ask to breastfeeding advocates, what do you mean supportive of breastfeeding. Define your words. Breastfeeding? Or is the correct terminology breastmilkfeeding? Supportive? What support are we talking about? The gifting, the donations this company gave in the early days to LCs, to Conferences, and to breastfeeding organizations, ie. La Leche League International?. I remember those early days. As an LC, I was a pump rental station (for a few years). I had Ameda Egnell pumps to rent and decided to also provide Medela pumps (because the local hospitals were only giving out Medela pump kits which were not compatible with Ameda's pumps). The Medela representative came to my house and gave me over $100 worth of equipment as a "gift" for opening up a rental station. Wow--Ameda Egnell didn't give me gifts for opening a rental station but then again their rental to me wasn't as expensive as Medela's.
We had local breastfeeding conferences and Medela readily gave money to help out on our organizations expenses. I was so very grateful as a LLL leader to have the special Medela pump program for mother's who could not afford breastpumps or other breastfeeding equipment. It helped a number of moms in this area (one of the economically poorer counties of Florida). I thought it was generous of the company and I felt very positively about the company. Do gifts come with strings attached, those invisible strings that pull at our hearts? Back then, I would have said that Medela was supportive of breastfeeding. But was the reasoning because the company was supportive of breastfeeding? Or because the gifts swayed me to believe that this gift-giving was a symbol of their altruism? Overtime, as the pump rentals got more and more expensive and their other products, too; I found myself disenchanted. Although it wasn't just the price of the pumps, but that it seemed that the more breastfeeding equipment we had at our disposal, the less breastfeeding happened. I gave up the pump rental station when I began to question my own motives regarding pumps. Survival as a business meant keeping those pumps rented. So when a mom came to me with a request for a pump, my thoughts were a jumble of contradictions. "I need to rent this pump to keep the business afloat but the mom doesn't really need a pump." What to do? Let her rent it because she thinks this is the answer? How do you dissuade someone who has been convinced by the medical profession that this is the answer to all her breastfeeding problems? I found that the only answer for me was to get out of the pump rental business. I often wonder if I was the only LC who found this so difficult? I saw the usefulness of pumps for a small set of breastfeeding problems. Many of the moms I saw did not need a pump but needed intensive coaching regarding the reality of babies: the need for closeness and nursing often. cluster feeding, the total intensity of mothering. Pumping in my opinion is a risk factor for early weaning from the breast when instituted for the wrong reasons. Over time as an LC, I noticed that more and more women with newborn babies had breastpumps (some horrible pumps and some incredibly expensive pumps). So instead of discussing breastfeeding with these mothers, I had to spend more time going over pumping, storage, etc. Often these moms were not going back to work right away neither did they have any particular problem with breastfeeding, in fact many had purchased pumps during their pregnancy. So it was their "just in case" product, similiar to breastfeeding mothers who purchase infant formula...just in case. Doubt is already built-in to new mothers regarding breastfeeding. More and more pregnant mothers told me in exactly the same words, "I am going to try to breastfeed." Huh? Do we say that we are going to try and walk today but if it's too difficult we won't be walking? Or do we tell our boyfriends/husbands "I am going to try to have sex." But if it doesn't work....like if its painful or whatever, I'll just opt out of that part of my biology? Interesting what we are willing to do and not do dependent on our belief system.
This is what is not brought up in discussions on Lactnet regarding Medela and the WHO Code and its marketing of artificial nipples. Medela has patent applications and patents that are worth looking at to get a better understanding of the company. First they do have a patent on an "Artificial nipple." Is it the same one they are marketing in violation of the WHO Code. I am not sure but the inventor is Brian H. Silver and it was published in 2010 (filed in 2003). Patent # 7712617. The patent reminds me of the way infant formula patents reads--the praise of human milk/breastfeeding and then of course the reality of our world where so many women don't or can't breastfeeding. "For various reasons, however, exclusive breastfeeding is not always possible. An example of this would be where a nursing mother cannot produce enough breast milk to feed her infant." That is a common thread in all infant formula patents--nursing mothers who cannot produce enough milk. This theme irritates me because almost all women can produce milk for their infants. The factors that cause a woman to not produce enough milk are: their lack of seeing breastfeeding within their own families and within their culture, medical interventions, drug interventions, separation of mothers and babies, birthing practices/drugs, lack of lactation support from family and the community.
Okay, lets look at a patent application owned by Medela with inventors Peter Edwin Hartmann, et al. It's called, "Human Milk Fortifiers and Methods for Their Production," patent application 2008187619 filed in 2005. Their first claim on their application. It appears to be a claim on a human milk component for use in making human milk fortifiers. I have no legal training, so that may not be what they are claiming. But it is odd that part of this patent is on methods of claim but some of it seems to verge on making claims on an unnamed component or components of human milk.
"1. Human milk fortifier comprising at least one human component based on a product directly or indirectly derived from human mammary secretion during at least one of the following periods: non-pregnant period, pregnant period, lactating period, involuting period."
The question we must ask ourselves is what happens when companies create human milk fortifiers. This is a good thing--we know this as breastfeeding advocates. But I can't help but believe that once we make products from human milk than the necessity of breastfeeding becomes less apparent. What happens to companies who market fortifiers (like the infant formula companies)? The market has to expand to more customers because of the monies invested in a product. That means that fortifiers for premature babies go home with them and are not just in use in the NICU.
Peter Hartmann, researcher for Medela, also is a listed inventor to other patent applications at the US Patent & Trademark Office: "Treatment of mother's milk, "Method for Analysing & Treating Human Milk and System Thereof." It appears that research is directed towards better pasteruization methods, better fat content, etc. All very praiseworthy attempts in regards to helping premature babies survive. Yet I am troubled by this, too. What do we really know about human milk and why are we so willing to tinker with it? Oh it has too little fat? Not enough of this component or that component...so we think we know better than nature? And will all this tinkering only happen with premature babies or will we expand these manipulations to all babies?
Okay, what about the patent called, "Method for isolating cells from mammary secretion," patent # 7776586? Owned by Carag AG-Michael Larsson of the family who owns Medela bought the company in 1999 and the company is involved in joint ventures with Medela among several Universities-University of Western Australia, University of Zurich, University of Gotherburg, University of Belgrade. The inventors are Mark Derek Cregan and Peter Edwin Hartmann. This patent is about a method for isolating progenitor cells [stem cells] from breastmilk. Stem cells have enormous value in the medical market. The patent was filed in 2004 and in 2010 was finally published. This patent isn't about ownership but a method to collect stem cells from breastmilk. Should we be troubled by this? I have alot of reservations about a company that ignores the WHO Code and understands very deeply the value of human milk (note I am not saying breastfeeding). Most of the infant formula companies in their patents state the awesome nature of human milk. Yet their business is to create products that compete against breastfeeding. The infant formula industry wants to create a safer, better infant formula. Likewise Medela wants to create a better, safer human milk (fortifier). Where goes this thinking? Its so right but so wrong.
Copyright 2011 Valerie W. McClain
Wednesday, February 9, 2011
"Good Food, Good Life," good grief another message from Nestle to consumers around the world. The bluebirds are nesting under the eaves of our house and creating "our" shared values. My eyes glaze over reading about my shared values with a multi-national corporation that provides the world with food products for the young and old. This is a corporation that espouses the creation of shared values promoted by Mark Kramer of Harvard University. How does a multi-national corporation share its values? Well, in the USA, Nestle [besides ConAgra, Food Lion, General Mills, Kellogg, Kraft, Kroger, Pepsi, WalMart, etc] is partnered with Feeding America, a leading organization that feeds the hungry. Yeah, there are actually hungry people in the USA. Government spending on bombs and bullets, leaves very little left in the budget for food. So we rely on multi-national corporations to feed our poor. Yeah its a tax write-off, too. But don't let your mind drift away from the value of gift-giving, of sharing values.
Nestle also gives farmers free training and assistance, some 594,233 farmers (according to the US Nestle website). They also have an "Adopt-A-School" program to share their values with the school systems. And a program called Healthy Steps for Healthy Lives which offers teachers tools to "educate" students.
Since Nestle is so willing to share their values, might they be interested in sharing their patents on human milk components? Their current slogan says it all, "Nothing else is breast milk. Nothing else is Good Start.
Nestle isn't the only multi-national corporation sharing its values to the world. Mead Johnson has a mission: to nourish the world's children for the best start in life." Their project, "Feeding Hope," in the Philipines is giving infants and children the best start in life. Of course, if one understands the value of breastfeeding, one might want to debate this with this company. In the USA, Mead Johnson gave a gift of $250,00 donation to Zeeland Community Hospital [home of a Mead Johnson manufacturing facility] to create family-oriented, home-like patient rooms.
Abbott Nutritionals is "committed to helping give every baby the very strongest beginning." Their motto is "Strong Moms." They also are sharing their values world wide.
And PBM (now acquired by Perrigo for $808 million) maker of store brand infant formulas shares its values around the world. It's owners gave $5 million to diabetes research. They donated products for Hurricane Katrina survivors, and some $250,00 of infant formula for Tsunami Relief.
When infant formula corporations share their values world-wide, whose values are shared? Family values? Community values? National values? Business values? How can we be surprised that the world seems to value the artificial, the store bought items over what use to be normal human behavior such as breastfeeding?
Copyright 2011 Valerie W. McClain