Tuesday, December 31, 2013
"Recognizing further that inappropriate feeding
practices lead to infant malnutrition, morbidity
and mortality in all countries, and that improper
practices in the marketing of breast-milk
substitutes and related products can contribute
to these major public health problems."
--International Code of Marketing of Breast-Milk Substitutes
Should we whisper this quote or yell it in the mountains, letting it echo and steep into our consciousness. All countries not just developing nations are impacted by inappropriate infant feeding practices. What world is this that controls, regulates advertising of cigarettes, yet sees no reason to control a product that causes death and disease in our most vulnerable population, our future? What world is this where medical establishments, researchers, and health care professionals turn a blind eye to corporate funding and influence? What world is this where the media tells the story and we are suppose to believe it?
What is reality in a world where the truth lies in a heap in the closet door of our dreams? And will we ever know the truth? Whose reality do you accept? The reality the PR players tell you? What happens when you find that you cannot believe what anyone is saying? Well, here I sit and wonder at my desk, scratch my head and mumble to myself. The little bit of me that is the scientist says I need the truth to understand my world and how I should act in it. The truth in our society seems to have gone into that Louisiana fracking sinkhole. Yep now ya see a glimmer of the truth and oops there it goes, all oiled-up and draining into the depths of the earth, never to be seen again.
So I want to tell the "story" about the AAP (American Academy of Pediatrics), and the Mead Johnson gift bags for breastfeeding mothers which have the AAP logo on them because I think parts of the story are being left out.
This website shows the gift bag and its contents. http://motherbabysummit.com/?page_id=263
The booklet on breastfeeding included in the gift bag is entitled "New Mother's Breastfeeding Essentials," was adapted from at least one AAP book and pamphlets. The AAP book that the booklet was adapted from is "New Mother's Guide to Breastfeeding" (second edition) edited by Dr. Joan Y. Meek, (also an IBCLC). One can obtain AAP books and pamphlets from the website healthychildren.org which features the AAP logo and is sponsored by various companies like Coca-cola, Kelloggs and even a company called Perrigo--maker of store brand infant formulas.
It all sounded so familar to me, like something from the past calling to me. Oh yes, I remember now. Back in 2002, the first edition of the AAP's "New Mother's Guide to Breastfeeding" edited by Dr. Joan Y. Meek, IBCLC was bought by Ross (infant formula company, a division of Abbott). Ross put their name and teddy bear logo on 300,000 copies of the book.
So one would suppose that since this has happened before, that steps would be taken by AAP members involved in breastfeeding support to see that it would not happen again. Yet here we go again. Funny how this little fact seems to be lost in the accusations of AAP hypocrisy. What happened? How could this happen again? There should be explanations and so far as I can tell there seems to be a epidemic of amnesia among breastfeeding advocates.
One of the things that happened after the 2002 absconding of the book edited by Dr. Meek was that some IBCLCs (not me) noticed that Dr. Meek had been doing speaking engagements funded by Mead Johnson. In June 2003, Dr. Meek shared a letter she wrote to Karen Lundgren, MS, RD of Mead Johnson to the Lactnet community that she would no longer be doing any future pediatric grand rounds, CME programs, or other speaking engagements which were sponsored by or associated with Mead Johnson.
So we seem to have come full-circle and are back at square one. And nothing seems to have been learned. Will there ever be any explanations of what happened? Will we be able to believe any of the explanations? This is somewhat as baffling a situation as the IBLCE (International Board of Lactation Consultant Examiners) eliminating the IBCLC duty to protect, promote and support by "complying with the International Code of Marketing of Breast-milk Substitutes and subsequent relevant World Health Assembly resolutions." (accessed 2008) In 2012, the Scope of Practice no longer includes this provision. Hm, who in the IBLCE decided this? In the FAQ, there is some kind of answer regarding the WHO Code and a duty to adhere to the principles and aim of the Code. But it's not part of the Scope of Practice nor in the body of the Code of Professional Conduct. And the question is asked whether an IBCLC can work for an infant formula company. And the answer is that the IBLCE cannot prohibit it. I find that odd. Particularly since I just learned that some companies in the USA have a morals clause. So a company can make individuals comply with a morals or ethics clause; but an institution that regulates the lactation consultant profession feels they cannot make it a duty for its certificate holders to adhere to the WHO Code nor can they stop that professional from working for the competition (the infant formula industry). All mighty strange to me and I believe it requires some answers.
As for Dr. Meek, she has done a lot for breastfeeding advocacy. This is why it is such a painful situation. She has served on the boards of many breastfeeding organizations: US Breastfeeding Committee, Academy of Breastfeeding Medicine, the International Board of Lactation Consultant Examiners, Florida Mothers Milk Bank, to name a few.
Who ultimately has control of what you edit or write...the AAP or Mead Johnson? What about copyright? Does the AAP own the copyright to the book she edited? How could this happen a second time? I don't know what happened and I don't understand how it has happened again. But it has and I get the feeling that the wheel will keep on spinning in the same place until this Pandora's Box is nailed shut and buried.
Copyright 2013 Valerie W. McClain
Sunday, December 29, 2013
NOTHING GOLD CAN STAY by ROBERT FROST
"Nature's first green is gold.
Her hardest hue to hold.
Her early leaf's a flower;
But only so an hour.
Then leaf subsides to leaf.
So Eden sank to grief,
So dawn goes down to day.
Nothing gold can stay."
Remember the story of Pandora's box? According to Greek mythology, Pandora was given a beautiful jar (the box) and told not to open it under any circumstances. Pandora opened it and all evil escaped onto the earth. Pandora expected that Zeus would be angry over her disobedience. But Zeus was not angry because he knew what she would do with the box. Yes, she was set-up by Zeus. (women in religion and myth seem to bare the responsibility for evil on earth)
We have our own modern day Pandora's box. It is exemplified in the hospital gift bags given to new breastfeeding mothers in which infant formula is part of the gift. A new mother intending to breastfeed her baby takes home this gift and is "expected" to not use it. Like Pandora it is a set-up. There really is no expectation by the gift-giver (Mead Johnson or any other infant formula company) that the gift will not be opened. And like the Greek myth of Pandora, the woman is blamed for "giving-in" and succumbing to the temptation of using infant formula. Yet someone set her up and it wasn't Zeus. Obviously the set up was staged by the infant formula industry. But this recent event also has a more repugnant aspect to it in that these gift bags have the AAP (American Academy of Pediatrics) logo. Thus the implication is that this gift is endorsed by American pediatricians. Likewise the receiving of a gift by a medical facility implies endorsement of a product. Of course, mothers ought to ask themselves what other products does the hospital give out free? Not much--ask for a band-aid or a sanitary pad in a hospital--and then look at your itemized hospital bill. Yeah sticker shock. So giving out free formula from a hospital must mean that they think ya really need it cause nothing is free in American hospitals. In fact I remember a teen mom I worked with to help her with breastfeeding. She assumed that the case of free formula she was given meant that the medical staff believed that she "needed" it. In fact it was the reason for my lactation visit--she thought she had to use the formula--like it was a prescription from the medical staff/hospital.
I was glad to read that the Academy of Breastfeeding Medicine wrote an email to Dr. Thomas K. McInerny, President of the Amercian Academy of Pediatrics. The Academy of Breastfeeding Medicine is composed of physicians supportive of breastfeeding. They urged that AAP discontinue its relationship with Mead Johnson. Hm....think that might be a little difficult since Dr. Thomas K McInerny, President of the AAP is the Editorial Advisory Board Chair for Pediatric Care Online sponsored by Mead Johnson.
There is a belief by some people that formula gift bags in the hospital do not impact breastfeeding. I hear this on formula feeding blogs and there seems to be some resistance by hospitals to discontinue this practice. In a very interesting research paper entitled, "Marketing Breastfeeding--Reversing Corporate Influence on Infant Feeding Practices," by Deborah L. Kaplan and Kristina M. Graff published in 2008 by the Journal of Urban Health: Bulletin of the New York Academy of Medicine; the authors state, "In 11 studies selected for review by the US Government Accountability Office (GAO), seven found that for at least one point in time, breastfeeding rates were lower among women who received formula company-produced discharge packs and/or formula or formula coupons from hospitals, as compared to women who received non commerical packs or no packs at all."
The research paper also states "Adequate food and nutrition are basic human rights. The widespread promotion of infant formula, which provides suboptimal infant nourishment, and lack of community, institutional, and government support for breastfeeding, all undermine this right."
Pandora's box sits on the hospital bed waiting to be taken home by the new breastfeeding mother. Will she open it or not? What do you expect she will do? Zeus knows.
Copyright 2013 Valerie W. McClain
Thursday, December 26, 2013
I am not a poet but just felt the need to write this. I have other writing projects but am troubled by the direction breastfeeding advocacy is taking. So instead of writing about the real issues of breastfeeding advocacy, instead I dance away from those issues. So this is a break from what has to be written and I realize I am stalling. But also sometimes things just play in my mind, like this "poem." And I have to write it on paper. Usually I don't share my "poems." But this is close to my heart, our world/my country seems to have embraced inhumanity, hate, and violence. And that colors our world of mothering and children. We forget the needs of our newest members to this world at great risk to the survival of our future. The needs of the new child born into this world are the same needs of all children in the past. The need for the closeness of one's mother, her warmth, her milk, and her touch. That need subverted by our technology and psychological game-playing will create a high price on humanity and its survival. May all mothers be surrounded by loving kindness, words of strength and belief in her and the biological wisdom of breastfeeding. May our society open its eyes to the enormous damage we do when we separate mothers and babies. May our society find ways to help mothers and babies be together.
The Candle Light Vigil or A Breastfeeding Requiem by Valerie McClain
Put a candle in the window for what we have lost.
The experts,the industry expound and exhort.
Encouraging and separating mothers and babies.
Into the cribs of micro-chipped strangers.
All homage to the reality show of parental dangers.
Welcome baby, welcome baby, to the world of molded plastic: the bottles, the nipples, and pacifiers galore.
Welcome mother, welcome mother, to the world of molded plastic: the breastpumps, the nipple-shields, and bottles galore.
Put a candle in the window to guide the young mom,
For the list of necessities in parenting abound.
The mother, the baby, living miles apart.
In a society of violence, death, and disease.
All hail the drones of technology spreading hate and war.
Welcome baby, welcome baby, to the world of molded plastic: the bottles, the nipples, and pacifiers galore.
Welcome mother, welcome mother, to the world of molded plastic: the breastpumps, the nipple-shields, and bottles galore.
Put a candle in the window in memory of the past.
The human gift of loving gazes, body warmth, and tender touch.
The mother, the baby, together as one.
In a society that treasured people over money and gold.
All hail to a mother and baby breastfeeding.
Welcome baby, welcome baby, into the arms of your mother.
Welcome mother, welcome mother, into a treasured world of breastfeeding.
Copyright 2013 Valerie W. McClain
Wednesday, December 11, 2013
"Legal and moral justification, however, are not identical, and it is possible for a legal decision to be immoral although consistent with legal precedent and procedure. Thus it is not surprising that the emerging legal consensus on human gene patents had not significantly allayed doubts about their morality." --Annabelle Lever, PhD, "Ethics and the Patenting of Human Genes"
Sometimes I feel like a broken record. (for those who are too young to remember polyvinyl record albums, broken record refers to, "one who continually repeats the same statement with little variation, the term was derived from polyvinyl record albums which kept skipping back and repeating and repeating a song--the Urban Dictionary) A tune runs through my mind as I reread something I wrote on September 7, 2001 to Lactnet under the title "Milk Harvesting." It is rather disconcerting to read something I wrote over 12 years ago and realize that I am still writing the same thing. Meaning I am stuck, stuck, stuck and either I need to change the record or find something else to do. But I thought maybe passing it on again to the readers of my blog might make people understand that these issues that I wrote about in 2001 are not going away but only getting worse. Although I suppose it depends on what side of the fence you live or where you are employed.
Post to Lactnet:
"We are now witnessing the beginning of a new industry whose impact on breastfeeding may be profound. The commercialization of human milk will impact the breastfeeding community significantly. As Elena Taggart Medo raises funds to launch her company Prolacta Bioscience Inc., breastfeeding advocates will need to rethink alot of issues. One of which is making our communities aware of the benefits of direct breastfeeding. Canned human milk is obviously an outgrowth of a society that has made an investment in "things" rather than people. Breastmilk has become a commodity to be bought and sold. If we accept this idea and if we invest in this business, than[then] ultimately we are self-destructing.
It is also important to find out whether Prolacta Bioscience is getting funding from the infant formula industry. I suspect this is the case. Therefore if breastfeeding advocates join forces with this business, they are aligning themselves with the infant formula industry.
In the past Ms. Medo secured contracts with Abbott ($1.1million) for her company White River Concepts. And according to her biography, in April 2001 she has 'filed patents on the creation of a gammglobulin[gammaglobulin] replacement made from 100% human milk products and lactoferrin from human milk, a pharmaceutical cure for e.coli.' So one might suspect that women who kindly donate their milk will be helping Ms. Medo and her company profit from something they are willing to give freely.....
We need to reflect on the value of breastfeeding, the actual physical contact of mothers and babies. Our society seems bound and determined to value the commodity rather than the relationship. And maybe that is because our society has made the decision that value has everything to do with the capacity to generate 'money' and that human relationships are secondary or unimportant."
This was in 2001. I am not sure when it was announced that Prolacta and Abbott had partnered (2011?) but predictably it happened. I wasn't surprised but I was surprised that the FDA in 2010 did not even know that Prolacta existed. And frankly I would not describe what they are doing as human milk banking. They are a business making a preterm and term infant formula from components of human milk.
Spending over a decade like a broken record is massively depressing. I find the game playing of social marketing (propaganda?) that is used by breastfeeding organizations to be disturbing. How does one find the truth amidst all this marketing? Whose reality do you accept? The one promoted by both the donor milk banks (non-profit and profit) and the infant formula industry that women won't and can't breastfeed. So we have to develop a product that is safer than in the past. No one questions that for the past 100 years scientists have yet to develop a safe substitute/product that will replace breastfeeding. If we make an infant formula with human milk components, will it be safer? And to make human milk into a product, how many women do you need to pump their milk (meaning less time for their babies and less breastfeeding)? The real issue is not that women can't breastfeed but what happens at most American births and afterwards: the mother-infant separations, the poor help for breastfeeding, the marketing of infant formula, the bottle-feeding of breastmilk. The fix is not just in developing a safer product. The major fix is to make breastfeeding the priority in health care facilities, in society at large.
Copyright 2013 Valerie W. McClain
Tuesday, December 10, 2013
"Propaganda becomes ineffective the moment we are aware of it."
The definition of social marketing at a CDC website is, "the application of commercial marketing technologies to analysis, planning, execution, and evaluation of programs designed to influence voluntary behavior of target audiences in order to imporve their personal welfare and that of society." The CDC should know the definition since they budget and employ people to influence people to vaccinate, use condoms, get tested for hiv/aids, etc. They enlist mommy bloggers, just like the infant formula industry enlists mommy bloggers to market their products.
Propaganda is defined, "as the deliberate, systemic attempt to shape perceptions, manipulate cognitions, and direct behavior to achieve a response that furthers the desired intent of the propagandist." by Jowett & O'Donnell
It seems we are living in times, where every health organization and many non-profits employ media specialists to socially market their interests or their products. I remember back in the 1990s attending a breastfeeding conference and one of the sessions was on socially marketing breastfeeding. I walked out about half-way. I probably should have stayed and listened but I couldn't get past the thought that what they were really talking about was propaganda. It's the only time I have ever walked out of a session in a Conference. I look back and think who would have believed that so many organizations have embraced social marketing/social media. The concerns I had back then have not changed. The major concern was that social marketing is governed by the supposed truths of an organization. Organizations are run by individuals who don't necessarily have a direct line to the "truth." In fact no one has a direct line to the truth because we are human. We, humans, often have no idea how others live, their cultures, their needs. We, humans, can only see our needs. Improving someone else's welfare is a tricky business and often social marketing does not account for the many factors of why people do what they do. Social marketing is dependent on who runs the organizations and their agendas, and this does not necessarily equate to the common good.
Over the years, I have watched the social marketing of donor milk banking and been rather perturbed over it. The number of not-for-profit milk banks in the USA and globally has expanded. We even have two for-profit milk banks in the USA (although the person who founded Prolacta also started Medolac). This expansion of donor milk banking has coincided with the growth of the breast pump/bottle industry. One sort of piggy-backing on the other. More and more women believing that breastfeeding requires the purchase of pumps and bottles. Many women trying to breastfeed but finding it next to impossible to maintain. Of course it also coincides with more and more women with young babies in the workplace (with little time-off or social/financial support for staying home). In the USA, we are witnessing an increase of preterm birth and better survival of these tiny babies.
This merging of events seems to have created a steady need for more and more donor milk. The not-for-profit milk banks in the past have complained about Prolacta Bioscience (the for profit milk bank)competing against them and impacting donations to their not-for profit banks. In more recent times HMBANA has publicly complained about informal milk sharing on the internet. The target seems to be Eats on Feets and strangely enough not the other internet milk sharing service called HM4HB (Human Milk for Human Babies). Not sure why one organization is the target, because it appears to me that some of the same people that are involved with the one organization are also involved in the other organization. But maybe I misread the internet stories and news, and maybe a lot of it is the masks and mirrors of social marketing.
As I have written before HMBANA has wanted regulation of "informal milk sharing on the internet." This was stated in 1999 on Lactnet by Mary Rose Tully who at that time was the Chair of HMBANA, when it appeared that there was a web page milk exchange going on. In 2000 she met with the FDA and again expressed her concern about "informal milk sharing on the internet." Knowing this, makes it very surprising that HM4HB seemed so willing to advertise the need for donor milk by non-profit milk banks on their websites. But then maybe these groups did not understand that since 1999, HMBANA has wanted internet milk sharing stopped. Back in 2010, I was concerned that HM4HB was not really a grassroots organization but astroturf (from Sourcewatch-astroturf refers to apparently grassroots-based citizen groups or coalitions that are primarily conceived, created, or funded by corporations, industry trade associations, political interests or public relations firms). I was told by their 300 or so administrators that I was totally wrong about my concerns.http://vwmcclain.blogspot.com/2011/07/is-hm4hb-grassroots-organization-or.html
I find myself once again wondering about internet milk sharing organizations. Why is their petition on the web only directed at the one bill and not at the bill regarding licensing of milk banks? The bill on licensing milk banks appears to be directed at anyone who attempts a milk banking service (which in my mind means it is directed at stopping internet service organizations like Eats on Feets and HM4HB) Why would a petition signed by people of all different countries make NJ legislators rethink this bill? Legislators mostly care about their constituents (voters in New Jersey) and wouldn't really care what someone from another country thinks. Its rather amazing to watch how many people signed this petition within a short period of time.
It will be interesting to see what happens next in the world of social media. One would think that the NJ Department of Health would be more interested in stopping internet milk selling rather than internet milk sharing. Obviously people selling human milk are not going to report it on their income tax. But you know the reality is that we don't know the actual statistics of how much human milk is being shared or sold on the internet. So we have to believe in the truth of the internet, that this has become a booming business/service in need of curtailing. Funny thing is I just read an abstract from the JHL entitled, "Donor Human Milk Bank Data Collection in North America," by Brownell, et al. (10-28-13). The study concluded (according to the abstract), "Without standardized data across all HMBANA sites, the creation of a centralized data repository is not yet feasible. Lack of standardization and transparency may deter implementation of donor milk programs in the neonatal intensive care unit setting and hinder benchmarking, research, and quality improvement initiatives." I kind of laughed because I was amazed they got any data from HMBANA milk banks (only 8 out of 13 sites consented to participate). Basically we don't know donor demographics to milk banks. We don't know some basic information about donor milk banking or internet milk sharing or internet milk selling. And yet, here we are creating bills with little background information on how much of this is really going on nor do we know the demographics of women who donate to non-profit milk banks.
Copyright 2013 Valerie W. McClain
*In December 2010 the FDA Working Group held meetings on Banked Human Milk. I was amazed that the FDA stated that they just had been made aware of a large scale human milk company, Prolacta Bioscience. The company was launched in 2001. So we have a company that is making human milk products for preterm infants, and the FDA in 2010 just became aware of it. Fascinating.
Sunday, December 8, 2013
Indeed, who shall control a world's natural resource, human milk? Women? The US Department of Health? HMBANA (the North American non-profit milk banking organization)? Prolacta Bioscience or Medolac (the US for-profit milk banks)? And what about the global internet milk sharing organizations like Eats on Feets or HM4HB (Human Milk for Human Babies)? What role does the internet milk sharing organizations play in the battle for human milk? Are women selling their milk through the internet (which is not what the internet milk sharing organizations are about)? And how is this struggle for control tied to the social marketing of donor milk?
I cannot answer all these questions because sometimes we don't know the truth of a matter until much later in time. Events aren't always clear as they are happening. And even when we have the grace of retrospection, we can be blind by our own prejudices. In a society governed by the profit motive and the need to own and control a resource, there is a blindness to the reality that nothing ultimately can really be owned. That natural resources are a gift to all the people on this earth. They are here to be shared not to be squandered, pillaged, and raped by corporate or individual greed.
Recently, it has come to my attention that New Jersey Assemblywoman, Pamela R. Lampitt has introduced two bills to the New Jersey Assembly. Assembly Bill 3703 which provides licensure of human milk banks and Assembly Bill 3702 which establishes a "public awareness campaign advising pregnant women, new parents, and women who are breastfeeding about dangers of casual milk sharing." (November 25, 2013 reported out of Committee, 2nd reading)
Part of the proposed bill is on licensure of human milk banks, "Any person who operates a human milk bank that does not have a license, or who has used fraud or misrepresentation in obtaining a license or in the subsequent operation of a human milk bank, or who offers, advertise, or provides any service not authorized by a valid license, or who violates any other provision of this act shall be subject to a penalty of not less than $100 or more than $1000..." I was told that this penalty is not directed at mothers sharing human milk but directed at human milk banks. Curious to me. Since I don't think too many people or persons are starting up human milk banks in New Jersey. And having recently read a slew of media reports on how the "booming demand for donated breast milk raises safety issues," with interviews of people involved with HMBANA and people involved with internet milk sharing organizations; I found myself rather curious about the reason for this legislation. So how is human milk banking defined in this legislation? It is defined as, "an organized service for the selection of a donor and the collection, processing, storage, and distribution of donated human breast milk to a hospital for use by low birth weight babies or new mothers with delayed lactation, or directly to a parent, with a physician's prescription order, who is unable to nurse, or is in need of additional breast milk to feed, the parent's child." Is it possible that this definition might encompass the services of internet milk sharing organizations? A recent article in the New Jersey spotlight entitled, "Websites for sharing breast milk raise concerns about health risks by Andrew Kitchenman (December 2, 2013) interviews Dr. Sharon Mass, chairwoman of the New Jersey chapter of the American Congress of Obstetricians and Gynecologists. The author writes, "However Mass said, women should use milk from licensed milk banks instead of using the unregulated milk-sharing sites. 'if it's not regulated and it's not licensed, then we have no idea about the quality or safety of that milk,' said Mass, ACOG's representative to the United States Breastfeeding Committee.
Kim Updegrove, President of HMBANA, "would like the government to simply, outlaw the internet milk trade. This would steer would-be donors to the milk banks..." This was stated in an interview on NPR, All Things Considered, November 27, 2013. There has been this amazing amount of articles in November (from various places in the USA) reporting on the one study done in which "bought" human milk over the internet was "supposedly" contaminated with bacteria. This study was done by at least one researcher from the HMBANA organization. Which one might be concerned that there might be a level of bias in this particular study. HMBANA has since the year 2000 (letter to FDA) stated that they want internet milk sharing/selling to be stopped. I had not realized that there was internet milk sharing/selling back in the year 2000--other than some men having a fetish for human milk and wanting to buy some. I also know that human milk researchers advertise in the media for human milk and pay for it. But some human milk researchers (who are often funded by the infant formula industry) get donor milk from HMBANA (one of the organization's mission statements is promotion of research of human milk). In years past HMBANA's advisory board was often human milk researchers who were funded by the infant formula industry. I brought this up a number of times to breastfeeding advocates and the response was a lack of concern or the ever-endearing dead silence. I think having researchers who are funded by the infant formula industry sitting in advisory boards to human milk banks is mighty short-sighted. But I guess I am the only one who feels that way since there has never been a protest over this common practice.
I think it is a rather sorry state of affairs when donor milk banks feel the need to use the media to broadcast research that is dubious, that donor milk is disease-ridden, etc. It plays quite nicely into the hands of the infant formula industry. And is very destructive to creating a breastfeeding society. On the other hand I cannot support internet milk sharing organizations because the internet is just not community. I support milk sharing with mothers who live in close proximity to each other. Sharing locally or even selling locally makes more sense to me than believing that we truly know someone over the internet. So I stand in the middle of what I perceive to be a war over a resource, human milk. We have over 2000 US patents and applications on human milk components (some owned by the US Department of Health). Many of those patents are owned by the infant formula industry, some by medical colleges who will license their inventions to companies, some by for-profit milk banks, and some by the pharmaceutical industry. Is this really about the danger of a substance in the hands of private citizens? Or is this about a battle over the ownership of a natural resource? Frankly, I saw this coming back some years ago, I pleaded to be listened to, that something needed to be done. Silence and more silence has been the overall response. If this bill passes and becomes law, we will have a social marketing campaign by the NJ Department of Health telling mothers how disease-ridden and toxic donor milk is if shared or purchased by anyone but the State regulated milk banks. How will we ever get women to breastfeed once they believe that the milk they produce and are willing to share freely is just some diseased and toxic substance, unworthy of consumption? The fact is that human milk contains many treasured substances, one being stem cells with supposedly magical properties, magic bullets (as male researchers like to say because they target organs without damaging them--very important in cancer therapies). Is this a legal battle of keeping the public safe? Or is this about control of a natural resource?
Copyright 2013 Valerie W. McClain
Thursday, November 21, 2013
I woke up this morning to the gentle sound of rain, another day in paradise. So I turned to the internet for my morning entertainment. Lo and behold, there before my early morning blurry eyes is a story from channel 9 news in Orlando. The headline is, "9 Investigates black market breast milk sales." What a way to wake up, when ya live in the land of Disney. Hm, I didn't know it was illegal to share human milk. A black market would mean something illegal was going on, right? When I think of black market, I think of criminal activity, usually involving drugs or weapons. The article is worth reading to understand how the media is used to socially market new concepts to the public.
I never knew we had a black market in human milk until now and right here in Paradise--Orlando no less. Our reporter, just back from her maternity leave has an interest in this topic. Not sure how she found out about it but knowing that Orlando just opened its first not-for profit milk bank makes me think that maybe that news lead to this. Anyway she buys some breast milk through the internet. It is selling for $1 or $2 per ounce. She buys 110 ounces from 4 different persons. Then she mails it to researchers at Boston College in Massachusetts to have it tested. It just so happens she has had contact with the reseacher Dr. Sarah Keim who just did a study on "unregulated black market human milk... which had high levels of bacteria or certain disease-causing bacteria like the kind you find in human waste." Surprisingly, the samples the Orlando reporter sent to Boston College had similar findings.
Of interest to my readers is that it just so happens that the researcher they contacted from Boston College is Dr. David Newburg. He was described as a biology professor and director of the Glyco-biology program at Boston College. Funny how they neglected to tell readers that he is also a co-inventor to over 10 US human milk component patents and applications, co-founder of a company called Glycosyn LLC. This company was founded by 2 other researchers, Ardythe Morrow of Cincinnati Children's Research Foundation, and Guillermo Ruiz-Palacios of the Instituto Nacional de Ciencias Medicas y Nutricion of Mexico. All 3 are co-inventors to several patents like patent #8314061 entitled, "Adiponectin for treatment of various disorders." Which may be used in infant formula.
The very first human milk component patent I ever saw was one in which Newburg co-invented. It was filed in 1995 and was about human milk fat globule which would be used to treat diarrhea particularly diarrhea in immune-compromised patients like those with hiv/aids. There is a second one filed in 1996 and these patents are co-owned by John Hopkins Medical School.
This research has been funded by the NIH (National Institute of Health). The Cinncinati Children's Hospital Medical Center, the University of Massachusetts Medical School, and the Instituto Nacional de Ciencias Medicas y Nutricion licensed this technology to Glycosyn. The company offers 6 different products.http://www.glycosyninc.com/products,3.html
They are also collaborating with Grameen to "introduce, manufacture and distribute Glycosyn's products for the prevention and treatment of diarrhea throughout Bangladesh.
Dr. David S. Newburgh is also on the Board at a HMBANA milk bank, Mothers Milk Bank Northeast. He has many accomplishments. But I have numerous questions about this investigation by channel 9 news in Orlando. Who paid for the milk (and the shipping and the testing?) that was bought through this so-called black market? The reporter? The news agency? Dr. David S. Newburgh who was the recipient of this milk? What was done with this milk? Thrown out after checking for bacteria? Used in research? Interesting the timing of this article and how it supposedly confirms the recent study done by Dr. Sarah Keim.
Glycosyn states that it was founded to commercialize discoveries in which it was found that "natural, anti-infective components (glycans) in human breast milk demonstrate significant protection against diarrhea." This is a biotech company and almost all the patents are about genetically engineering the human milk component. Will more babies breastfed? Or will we committ more money and resources to sell products that interfere with breastfeeding. While we can genetically engineer them, does the public understand how these products are made? I remember when I first became an IBCLC and learned this statistic: approximately 1.5 million infants die around the world (including the US) because they are not breastfed. They die from diarrhea and dehydration. And that statistic has not changed. Do we need more products to treat the problem which is lack of breastfeeding? Or do we need more nations investing in actively supporting mothers to breastfeed?
What do the donor milk banks want? Quite simply they seem to want women donating their milk to their milk banks only. In the contest for a natural resource, what will be done or said? Who wins? No one wins in this situation. Who owns your breast milk? Why are moms giving it away at $1 or $2 an ounce? And who wins when the public starts to believe there is a black market in human milk? Will the real black market please stand up? And I'll tell ya now it ain't mom and pop selling it in Orlando.
Copyright 2013 Valerie W. McClain
Monday, November 11, 2013
I wrote a position paper for AnotherLook entitled "Patents, Breastfeeding and HIV," in 2001. http://www.anotherlook.org/papers/c/english.pdf It was all about the patents at the US Patent Office that were using various human milk components to inactivate hiv. The infant formula, food, supplement, drug and vaccine industries, educational and governmental institutions have patented various human milk components to treat or inactivate hiv. Those components have been: Lactoferrin, HMFG (Human Milk Fat Globule), HMO (Human Milk Oligosaccharides), etc. So now they have found this Tenascin C and hope to create a drug (according to this particular article). In Health News the lead author of this study, Dr. Sallie Permar says they hope to create
a vaccine to "eliminate mother-to-child transmission."
I found myself reading the articles and shaking my head. This is what Dr. Sallie Permar says according to Health News regarding the statement, "But only one in 10 HIV-infected nursing mothers is known to pass the virus to their infants." She says, "That is remarkable, because nursing children are exposed multiple times each day during their first year of life." Now the other article from the Smithsonian states that, "Only 10-20 percent of infants who are breastfed by infected mothers catch the virus."
Here it is 2013 and the statistics for transmission of hiv through breastmilk still vary enormously depending on the article you read. So some 80-90% of supposedly infected mothers do not transmit hiv through breastfeeding, right?? And some scientists have known that various components of human milk prevent or inactivate hiv. The CDC does not recomment breastfeeding for hiv-positive mothers because "baby formula is a safe alternative for U.S.-born infants." (article from healthcanal.com-health news). Tell that to moms in the USA whose babies died from Enterobacter sakazakii that had contaminated infant formula in 2011.
What were the studies on hiv transmission that health authorities accept? Over and over again it has been a study submitted to the Lancet in 1992 by Dunn et al. in which it is estimated that hiv transmission through breastfeeding is 14%. This study set public health policy. And paved the way for world-wide policies of encouraging the use of infant formula and discouraging breastfeeding. Although I would say that discouragement may not be the proper term. It was far more drastic in the US in that it became a forced policy in which Child Protective Services were used to enforce compliance of infant formula feeding. What happened during these years is that slowly world health officials began to recognize in developing nations that babies of hiv positive mothers were dying not from hiv/aids but from the risks of infant formula (diarrhea/dehydration, unsanitary conditions in which to prepare infant formula, lack of ability to pay for infant formula--watering it down, feeding other unsuitable foods). It became a public health disaster http://www.cfr.org/world/garrett-botswanas-infant-formula-debacle/p14050
There is the belief that in some areas of the US, the conditions of poverty are close to some areas in developing nations. When I worked for the WIC Program from 1994-1998, I worked with women and their babies who lived in their cars, or lived with relatives in small cramped trailers with little sanitation. What happens when utilities are turned off for lack of payment--no way to heat that bottle of formula, no way to clean those bottles. So I have never understood this two-prong policy, this magical belief that in the US, that everyone here has access to electricity and clean water and medical care. And at the rate the politicians are currently pushing everyone into poverty, the numbers of disadvantaged in the US will continue to grow. We have a two-pronged policy in which the WHO encourages exclusive breastfeeding for hiv positive mothers based on a criteria called, AFASS http://motherchildnutrition.org/info/afass-principles.html
So we have a two-pronged policy on hiv transmission through breastfeeding in which depending on the country you live in, will depend on whether you are encouraged or "discouraged from breastfeeding."
But what if the studies on hiv transmission through breastfeeding are incorrect? I invite my readers who are interested in a different viewpoint to read a paper written by David Crowe, George Kent, Pamela Morrison, and Ted Greiner entitled, "Commentary: Revisiting the Risk of HIV Infection from Breastfeeding." It is on AnotherLook website and worth reading and considering. http://www.anotherlook.org/papers/g/english.pdf
I frankly think that hiv transmission rates through breastfeeding need to be revisited by the scientific community. I think there were serious mistakes made back during the time because of the panic and need to solve a situation quickly. But also from my perspective, I see that this policy was an enormous boost to profits for the infant formula industry.
The infant formula industry has financially benefited by these health care policies. And not just from stopping hiv-positive women from breastfeeding but from the spill-over effect of such policies. Not only does infant formula feeding become more common in various communities but a new notion appears in the media. Breastfeeding known as a protector of infant life is now thought to be a carrier of infection, disease, and death. How much of this policy was driven by narrow views, inadequate understanding of breastfeeding, and mostly the need for profit?
Copyright 2013 Valerie W. McClain
Saturday, November 9, 2013
This morning I thought about what the future will be offering infants. I am sure it won't be the breast. It will be a choice of " a standardized Human Milk" or "a Dairy Substitute." Society seems to be gearing up for a very technological world in which breastfeeding has no place. Our current world seems ensnarled in its technology. People have phones stuck to their heads and hands. Try to contact a business or an organization, and ya get voice mail. No one is there. I ask on the phone, may I speak to a real person please. Oh sure, hold....my digital clock quietly moves the numbers, no tick tock in this world. If I became a mother now (yes a biological miracle), I don't think I would have time to connect with a baby. I'd be too busy looking at my emails or Facebook, browsing websites, looking at photos. And of course I wouldn't be home, I'd be in the workplace, making a living or is it a dying? Thank god, I had my children before I had a computer. I knew things were getting strange even when my kids were little--that people were disconnected. I'd go to a party and someone would be videotaping the party. Fine. But then before the party would end, everyone would have to watch the videotape of the party. So the experience of the party became a movie and the movie was the experience of the party. It became this narcissistic event of watching yourself and your friends. So rather than spending time talking with each other, dancing, or sharing a meal, we passively watch ourselves party. I found that strange then and realize it was the beginning of our current cultural journey of disconnection.
I found myself reading a Prolacta patent, entitled "Human Milk compositions and methods of making and using same." (patent # 8545920) And my sense of disconnection increases and weariness falls heavily on my shoulders. Inventing human milk concoctions appears to be very complex. Interestingly, we are told (like all the infant formula patents), "Not every mother, however, can or will breastfeed her baby..." We learn about screening donors through interviews and biological sample processing.We are informed that "each donor's milk is sampled for genetic markers, e.g. DNA markers, to guarantee that the milk is truly from the registered donor." Genetically screened by PCR (polymerase chain reaction) for contaminants. Then the milk is filtered, and heat treated. Then the cream of the milk is separated from the skim by centrifuge. This may be done twice. Then once this is done, the cream is added back and further filtration occurs which concentrates the nutrients by filtering out the water. The water obtained from this process is called permeate. There are various processes depending on whether they are making a fortifier or standardized human milk. Some of those processes are freezing and then thawing, adding minerals or extra cream. After certain steps then pasteruization happens. The vitamins and minerals that may be added to the various inventions are: "vitamin A, vitamin B1, vitamin B2, vitamin B6, vitmain B12, vitamin C, vitamin D, vitamin E, vitamin K, biotin, Folic acid, pantothenic acid, niacin, m-inositol, calcium, phosphorus, magnesium, zinc, manganese, coper, sodium, potassium, chloride, iron, and selenium. The compositions can also be supplemented with chromium, molybdenum, iodine, taurine, carnitine and choline may also require supplementation." DHA and ARA, fatty acids may also be added depending on the product. Depending on their source for these fatty acids, most are genetically engineered. The list of added vitamins and minerals reads like the ingredient list on infant formula. I suppose their suppliers for these added nutrients are the same ones that the infant formula industry uses.
The processing of donor milk at Prolacta seems very complex with many steps. How does this kind of milk resemble the milk that infants drink at the human breast? Is part of the reason for fortification (besides the fact that most of this goes to premature infants) because this has become highly processed which means nutrients are lost? And then what are the ethics behind women donating their milk so that this company can make a profit?
I do see this as the future of infant feeding. With the ability to filter out various components of human milk, the components can be sold to the infant formula industry who will add it into their products. Already Abbott has 7 or 8 patent applications in which Human Milk Oligosaccharides will be used in their infant formula and the way the patent is worded makes me wonder whether they will be using the real component or the gmo version. Abbott is partnered with Prolacta, so it isn't farfetched to believe that this might be the direction they are going. Or maybe not. What will be the direction of infant formula in the future? What is Prolacta's place in that future? Who would have thought that people would accept standardized human milk products? Who would have thought women would donate their milk to that endeavor? Seems like science fiction. What will the future bring?
Copyright 2013 Valerie W. McClain
Tuesday, November 5, 2013
Well folks lets get to the real story, not my life of baby tomatoes, kale, red sail lettuce, raccoons, possums, wrens, and that cocky blue jay. Let's talk about this mornings amusing adventure at the US Patent Office. I found a very interesting patent because it changed my perspective about a product, infant formula. The patent has nothing to do with human milk which I usually write about. The patent created this light bulb effect in my brain. And so I now have a new definition for the product we call infant formula. And since this is not an original thought, I must give credit where credit is due. The patent is called, "Manufacturing execution system for use in manufacturing baby formula," patent # 8498729 owned by SMP Logic Systems LLC (a drug manufacturing software company). It is a system which performs validation and quality assurance for baby formula manufacturers to "achieve data and product integrity." This patent classifies infant formula as a dairy substitute. People buy dairy substitutes and they are products like imitation cream, coffee whiteners, cheese, and ice cream. As one definition states these foods are "similar in taste, and texture to genuine dairy products." [my emphasis] In fact I learned that Dairy Substitutes are made by blending fats, proteins, and carbohydrates using the same technology and equipment used to manufacture real dairy products." Good to know, good to know. So infant formula, a dairy substitute, is almost like a real dairy product. Today I learned something new and just wanted to share it with my readers. The patent also stated that, "many consumers are under the mistaken impression that the FDA closely and carefully monitors infant formula."
Just the morning coffee news. Maybe it will startle some people because it is a new perspective and then again maybe I am the only one fascinated by infant formula, the dairy substitute. Just a quick story about my experience with a cheese substitute (am allergic to dairy but really miss cheese). I was buying these vegan cheese slices, all wrapped in wonderful plastic wrap. I went on a road trip--7 days back and forth from Florida to the Boston area to visit relatives. I put those cheese slices (thinking it would be a good snack) in a soft nylon cooler, along with some ice packs. I put them in a zippered portion of the cooler and promptly forgot about them. Ate the fresh cut fruit I brought but totally forgot about those cheese slices. Got back to Florida emptied the cooler (by then ice packs no longer frozen) but again forgot about the cheese slices. One week later, I just happened to go through the zippered pockets and lo and behold there was the cheese slices. No mold! They looked exactly like they did when I put them in the cooler, only now warm imitation cheese slices. How do you create a food that doesn't rot? My parents bought this imitation ice cream. They gave some to their dog and she didn't want it and it sat out all day (Florida) and it didn't melt. It didn't melt!!! Send that stuff to the polar ice caps to save the world from global warming!! Needless to say my parents quit eating that particular brand of ice cream and I have quit those vegan imitation cheese slices. So the dairy substitute, infant formula, is fake real food...and we have it because....I know, I know, women can't or won't breastfeed. I think I will go outside and play in the garden.
Copyright 2013 Valerie W. McClain
Friday, October 25, 2013
A river of denial cuts through our digital world. What do we believe? And why do we believe it? Nestle, on their website, denies they are "trying to patent human breast milk." They state, "We have filed patents to protect the use of a protein called osteoprotegerin in food and granted two patents in the US. This particular protein is found in many types of milk and may be used to help treat bone disorders and regulate immune responses."
Yes, a protein and where is it found? The first sentence in their patent abstract (patent #7749960, one of two on osteoprotegerin), "The present invention pertains to osteoprotegerin obtainable from milk sources, in particular human and bovine milk." The rest of the patent is centered on human milk, a Western blot analysis of human milk franctions, a RT-PCR analysis of human breast milk cells, cloning the protein in yeast, and human mammary gland epithelial cells. I see no mention of an analysis of bovine milk or Western blots on bovine milk fractions or PC analysis. Maybe I missed it?
I particularly enjoyed reading from the patent these statements, "In the studies leading to the present invention, it has now surpisingly been found that in addition to its presence in e.g. the bone tissues, osteoprotegerin may also be found in human breast milk. In consequence, during breast feeding the mother is obviously supplying the newborn with this bioactive substance in a form that is capable of surviving the child's gastro-intestinal tract. From this it follows that the OPG [osteoprotegerin] produced by mammary gland cells obviously differs from OPG isolated from other sources as regards its stability and/or resistance to degradation."
So here is a substance in human milk that can be used to treat bone disorders. A substance to treat bone loss caused by calcium or hormonal deficiencies. Whether Nestle will use this substance or some cloned, genetically engineered version, or the bovine protein is unknown. I tend to view these statements as interesting even if this patent does not become a product. The standard medical belief in regard to human milk is that it is deficient in calcium for preterm infants. So preterm infants must be supplemented. Hm, yet there is a substance in human milk that cures bone loss caused by calcium or hormonal deficiency and it resists degradation in the gut of the infant. Interesting and if it were up to me I would want to revisit the issue of the need of supplementation of preterm infants in regard to calcium. And I would like to see research done on how these synthetic vitamins and minerals added to human milk improve the substance. Or might these synthetic substances nullify the effects of human milk? But I doubt that these questions will be asked.
Nestle has these two patents on osteoprotegerin and I suppose we will continue to debate about what they are actually patenting--human or bovine milks. But they have more patents on various human milk components (of course, all state various mammal milks might be used). For instance, patent # 8394370 entitled, "Nutritional formula for optimal gut barrier function." One of the options they state is a "Human Milk Oligosaccharide such as Sialyllactose." Or patent #8524658 entitled, "Lactoferrin and brain health and development in infants." The source for this patent is a milk or whey source: bovine, human, goat, camel, horse or donkey milks. And they state that colostrum may be used. In fact they state, "Human colostrum has a relatively high concentration of lactoferrin followed by human milk, then cow milk." Or we could look at patent #7230078 entitled, "Soluble toll-like receptor." This patent states, "The present invention is based on the surprising discovery of a molecular component of human breast milk..." and "...the present invention may be obtained from human milk; especially during the early stages of lactation."
Yes, that river of denial. "No. We have not patented human breast milk, nor are we trying to." I swear I am living in George Orwell's novel, "1984." But then maybe its just that I am living next to that river of denial waiting for the dawn.
Valerie W McClain copyright 2013
Monday, September 23, 2013
Infant formula is breast-milk. George Orwell did not say that but we are 1984. We are living in a time of illusion, a time of "spin." Social marketing has brought us back into the future of Orwell's 1984. Everything has a price and anything can be sold in the marketplace of earthly desire. Human cells, stem cells, proteins, DNA, RNA; it's all for sale. Truth, where be thee? Not on this planet of avarice and greed. Lie, steal, and cheat: it doesn't matter, just repeat and repeat. Welcome to planet earth, where everything has a price and illusions are guaranteed.
So what new illusions have arrived from the inventors of human milk components? Inventors who play with their magic molecules, magic bullets, and mumbo-jumbo science. A whisper of words about preserving exclusive breastfeeding. A joke? Must be a joke cause its a Nestle patent. A patent designed for the breast-fed infant or pet. Are ya laughing yet? So some Nestle inventors create a patent that will benefit the exclusively breast-fed infant or pet. The captive mammal in artificial environments finds it difficult to exclusively breastfeed. But there is a company that will save all mammal babies by promoting a product, a nutritional supplement for those breast-fed infants...be they human or animal. Nope, I am not making this up. It's there at the US Patent & Trademark Office, a patent application entitled, "NUTRITIONAL COMPOSITION FOR BREAST-FED INFANTS OR PETS WITH PROBIOTICS AND SELECTED NUTRIENTS." application # 20120121562 and owned by Nestec (Nestle)
"...even in the cases where the mother exclusively breastfeeds an infant, the mother's milk may still be lacking in certain important nutrients..."
One could give the mother a supplement. No, no that won't work--"difficult to restore by supplementation of the mother diet during lactation."
"It has now been found that by supplementing the breast milk itself, without having to resort to traditional infant formulas. a number of advantages can be derived for the infant and the mother."
I can't help but wonder about the next step regarding supplementing the exclusively breastfed infant or pet with a nutrient (DHA, alpha-linolenic acid, carotenoids, calcium iron, zinc, copper...) plus probiotics. Let me see. Make everyone believe that there is a deficiency (so easy to do regarding breastmilk), get the medical community to back the need for supplementation of all breastfed infants(that worked with vitamin D supplementation), and blanket the pediatric journals with articles about the wonders of probiotics and deficiencies in human milk. Of course we won't let parents know that breastmilk already contains probiotics. And that studies on deficiencies in breastmilk have always been funded by the infant formula industry. Nor will we tell parents how these ingredients are created, mostly through genetic engineering. Nor do we have long-term studies on this experiment on our most vulnerable population-babies.
I can visualize the marketing of these products. The doubts about breastfeeding already exist but these kind of products will increase the level of doubt. No mother will feel like she has an adequate diet and this kind of "science" states that mother's cannot make up for their inadequate diet. Only a Nestle product given to the "exclusively" breastfed infant can make up for the improper diets of mothers. Meanwhile, at another part of the US Patent Office, some inventors own a patent entitled, "Human milk peptides," patent # 8518894. They are creating novel peptides derived from human milk to combat oxidative stress, build immunity, stop inflammatory responses, combat pathogens. Oh wait, at least one of the inventors to this patent has been funded by Danone, and Heinz, James Friel. In an interview of the other inventor, Apollinaire Tsopmo, "...Tsopmo discovered mother's breast milk also contains antioxidants that can be incredibly valuable for premature infants." and
"Tsopmo says formula milk on the market tries its best to "mimic" breast milk. Since there will never be enough breast milk to feed the entire infant population, the food industry will always be striving to find beneficial molecules within it..."(article from a blogger from Carleton University)
So we have on the one hand Nestle who is convinced that mother's milk needs fixing and they can do it!! But also we know from other Nestle patents that they are also staking claims on components of human milk. How strange... Then we have other inventors involved with various infant formula companies who are staking claims on the magical properties of human milk. Do they really believe that there will never be enough breast milk to feed the entire infant population? Or is it that an industry has created a belief system that there is not enough breast milk in the world and never will be. And that there will always be women who reject breastfeeding and there will always be breastfeeding failure. No where does the industry perceive that they are part of the problem. One way breastfeeding fails is by early and frequent supplementation of infant formula. Another way is to have women believe in the inadequacy of their milk and the nutritional superiority of man-made artificial baby formulas. The marketing of infant formula has spread persistent doubts about breastfeeding. Yet while these doubts are spread through advertising, the industry is busy making claims on human milk components. Rather odd, don't ya think?
What would be a way to stop this craziness, this subverting of breastfeeding and creating a world that thinks, "Infant formula is breast-milk."? There is the WHO Code for marketing breast-milk substitutes, under-utilized or virtually unknown in the US. The purpose of the Code: "Recognized further that inappropriate feeding practices lead to infant malnutrition, morbidity and mortality in all countries, and that improper practices in the marketing of breast-milk substitutes and related products can contribute to these major public health problems." The Code recognized the importance of stopping the direct marketing of infant formula to parents/the public. It is a health issue in which infants suffer the consequences of such marketing through parental misconceptions of infant feeding.
The intent was not to stop the manufacture of infant formula or complementary foods. The WHO Code states, "Considering that, when mothers do not breast-feed, or only do so partially there is a legitimate market for infant formula...and that they should not be marketed or distributed in ways that may interfere with the protection and promotion of breast-feeding."
Will we continue to let our society sink into a dystopia of half-truths, slogans that compromise the health and well-being of infants and mothers? Or will we take another look at the possibility of regulating the marketing of breast-milk substitutes so that mothers and babies have better health?
Valerie W. McClain copyright 2013