Monday, April 21, 2014

Human milk stem cells: a mother of an invention

                 "Humanity is acquiring all the right technology for all
                  the wrong reasons." --R. Buckminster Fuller

There is a belief that the use and extraction of stem cells from human milk is more ethical than the use and extraction of stem cells from human embryos.  I agree that this seems to be less destructive of life, since embryos are destroyed in order to harvest stem cells.  I find the collecting of embryos rather upsetting and their destruction more upsetting.  Yet I realize that many others feel comfortable with this situation because they believe in the ultimate goal of saving lives or creating life through the use of stem cells.  There stands our Lady Justice balancing the needs and wants of our civilization.  How do we determine what is morally, ethically important to humanity?  

So I who really feel that the use of embryos for harvesting of stem cells is repugnant, should feel joyous about our men and women of science turning towards another source, human milk.  But I don't feel joyous about the use of human milk to provide stem cells.  I feel dread and dismay.  It's like watching the clear cutting of the Amazon rain forest.  At first it is just a few trees that disappear into the hands of industry.  But eventually a natural resource, in the desire for increasing profits, is destroyed.  Where once there was a large and varied land, full of life;  there now stands a stubbled and dead land devoid of its life and variety.  A heritage,a world is left in ruins in order that a few corporations can make more profits.  Likewise, human milk will be torn apart, in order to get to the gold, the stem cell.  The cellular landscape of human milk will no longer be what it once was, replaced with laboratory chemicals, made uniform, genetically injected with genes and chemical matter.  The inheritance of humanity, a mother's gift to her baby, will be nothing more than a substance owned by the corporate world to make a profit.

What is the price we are willing to pay in order that men and women of science can collect human milk to create their marvelous medicines?  It seems that in order to extract this marvelous commodity, we must have women believe in a breastmilk society.  No, not a breastfeeding society.  The breastpump is becoming the symbol of breastfeeding.  More women than ever before believe that having a breast pump is an essential baby shower gift, like the essential gift of nipples, bottles, and pacifiers.  I have watched how this ideology has overtaken the breastfeeding community.  I have watched as the breast pump companies invade the hearts and minds of IBCLCs, LLL leaders, and to my dismay even my own outlook on breastfeeding.  We question docs and their ties to the pharmaceutical industry but never question the ties between breast pump companies and the lactation consultant profession, milk banks (both for-profit and not-for-profit), and breastfeeding organizations.  It is so easy to judge other professions and other organizations and not see that human nature is easily manipulated by gifts and well-trained sales men and women.  Maybe we should forgive the docs who let the drug rep persuade her/him that their drug is the best drug.  Forgive them for not understanding market forces and marketing.  Forgive them for accepting gifts and benefits, for helping them with their education.  Yet, in the end it is the people who least benefit from a health care system based on the profit motive.  How can they forgive us for accepting that human milk is a commodity?

I mull these thoughts over because I read a new patent application at the US Patent & Trademark Office on human milk stem cells.  Now a patent application means that it has yet to be approved by the Patent Office.  Should we be concerned about a patent application?  We now have a patent application (#20140086882) entitled, "Stem Cell Preparations and methods of use," invented by Foteini Hassiotou and owned by Medela Holding Company filed in April of 2013. The abstract states, "The invention has been developed primarily as a method for preparing and culturing BSC [Breastmilk Stem Cells]."  There are 34 claims and it appears to me that 28 claims are on methods of preparing and culturing stem cells.  But 6 claims sandwiched between the methods claims appear to be on breastmilk stem cells. Is that claims on life?  Or a claim on their creation of breastmilk stem cells?  As this is a patent application, a patent examiner will study it and those claims could be cancelled and it could become a patent.  Or the examiner may believe that human milk stem cells are invention and the claims may stay. Or it may never become a patent. Who knows?  But we are witnessing the intentions of industry and whether or not it becomes a patent should give some of us a pause of concern.

The patent application came from the inventor's research which appears to be from a study entitled, "Breastmilk Is A Novel Source of Stem Cells with Multilineage Differentiation Potential."  It was published in the journal, "Stem Cells" in October of 2012.  The 11 authors of this article acknowledge that their work was supported by an unrestricted grant from Medela, a Women and Infants Research Foundation Scholarship, and grants from the US National Institute of Health (NIH).  The also expressed their thanks to all the mothers who participated and to the Australian Breastfeeding Association and the US La Leche League for support in recruiting the mothers.  What greatly intrigued me and has made me believe that this study is connected to the patent application is that the research paper states the following under "Material and Methods"/ "Breastmilk Sample Collection,"

"The study was approved by the Human Research Ethics Committee of The University of Western Australia and the institutional review board of the University of North Carolina at Chapel Hill, and all participants provided informed written consent.  Healthy breastfeeding women (>70) were recruited in Australia and USA, coverin a wide range of lactation stages, from month 1 to year 5, through one or multiple children.  Pump-expressed mature breastmilk (5-200ml) was obtained from each participant and was transported to the laboratory immediately unpon expression under aseptic conditions."

Almost verbatim, the same paragraph was used in the patent application under Material and Methods/Breatmilk Sample Collection.  So I must assume that the application came about because of this particular research paper.  I guess I feel somewhat taken aback that the Australian Breastfeeding Association and La Leche League in the USA did the recruiting of mothers for research funded in part by Medela  (a WHO Code violater) and which eventually is the basis for a US Patent Application.  And I guess I wonder about the exact wording of the informed consent these mothers signed.  I am amazed that women are so willing to give away their own milk in order that an industry may profit.  I am amazed that breastfeeding organizations are so willing to do the recruitment of mothers for this industry.  But then again as I said in my blog post of July 26, 2012 entitled, "Protecting Breastfeeding from the Human Milk Industry,"  

"Obviously, the US is way ahead of the game of monopolies and using women for greater gain.  I am shaking my head and wondering when will breastfeeding advocates stop imploring women to donate their milk and at the very least question what is going on?  I guess when hell freezes over." 

I guess the answer is that some breastfeeding organizations will never stop imploring women to donate their milk.   I guess I just look at life differently.  I fully support the gifting of mother's milk to babies and adults in need.  But why do women feel that gifting it to research by industry is of benefit to our society? 
Copyright 2014 Valerie W. McClain

Wednesday, April 9, 2014

The Biopiracy of Human Milk

                         "The present invention provides for novel peptides
                           derived from human milk...the peptides of the in-
                           vention may be used in food supplements, milk
                           substitutions, infant formula, mother's milk,
                           parenteral nutrition solutions, cell/tissue/organ
                           storage and perfusion solutions and pharmaceutical
                           formulations."--US Patent # 8518894 "Human Milk Peptides"

Where is the outrage?  Hidden somewhere inside this woman, who feels useless against the growing tide of control, arrogance, and profit seeking by men and women living in the Ivory Tower of Knowledge.  Where is the legal system when biotech companies, researchers and government institutions declare their monopolies, their right to a substance made by women that was and is responsible for the survival of our species?  How do we call this invention?

For thousands of years, women passed down to each new generation the knowledge and the art of breastfeeding.  This knowledge meant survival for its babies and children.  They recognized the food value as well as the medicinal properties of the substance that flowed from their breasts.  They did not call it invention or exclude others from this knowledge.  

But now we live in a world, where men and women of science, believe that nature can be owned.  From the seeds that blow in the wind to the human cells in our bodies, the belief is that life can be owned, monopolized, and made profitable.  Is not ownership of life, slavery?  Our plant seeds have become the workhorse of companies like Monsanto.  Our cells have become the foundation of profits for the pharmaceutical industry.  Likewise human milk, its components, are ensnared by a system of corporate greed.  The system creates a reason for this form of enslavement by deceit.  Donate your milk for science (so we can prove that human milk is better than infant formula--already known by scientists for at least 40 years).  Donate your milk for sick and premature babies--don't ask why these babies aren't getting their own mother's milk or being breastfed.  Yes, dear reader, I know that some women can't breastfeed and that some women won't breastfeed.  And I know that some women can't pump their milk and that some women won't pump.  But the question is why has this happened?  How much of our society is invested in the idea that women can't or won't breastfeed?  The investment is in the industries that promote and market their wares because of this ideology of can't and won't breastfeed.   The investment is not in empowering women to breastfeed.  It is in psychologically conditioning through social marketing the idea that society cannot be changed.  Women have to adapt to a man's world. A society ruled by mostly men whose core value is profit.   A world where babies and children must be separated from their mothers (and fathers).  We live in a world where not earning a paycheck is looked down upon.  An odd idea, since the economic downturn that is still upon us has thrown so many onto the streets without a hope for employment.

Dear reader, please explain to me why the above patent called, "Human milk peptides," is legal in our US patent system?  This is a relatively new patent dated August 27, 2013 in which the  Canadian inventors propose that there is,  "a need for new compounds derived from mother's milk that provide antioxidant advantages and may be used as ingredients to mothers' milk substitutes."  They state in their patent, "the present invention relates to novel peptides that are derived from human milk."  They may genetically engineer those peptides but they may use the real peptides.  They obtained their human milk samples from "volunteer mothers whose milk was expressed."  Where did they find these volunteer mothers and were the mothers given informed consent regarding the possibility of patents and financial profits?  

What is biopiracy?  A dictionary defines it as, "the commercial exploitation or monopolization of biological or genetic material usually without compensation to indigenous peoples or countries."  So is the patenting of human milk biopiracy?  It is certainly the commercial exploitation of a biological or genetic material without compensation.  It is destructive to the biodiversity of human milk.  Donor milk is a pooled substance that is pasteurized.  Thus circumventing the value of human milk as not only a species specific milk but a milk that is genetically specific for the mother's baby.  Pooled human milk would be better than the dairy substitute we call infant formula but it defeats the purpose of the protective/antibody system.  A system that responds to the mother's immediate environment protecting the infant from the specific pathogens and chemicals the mother encounters.

The patents and patent applications on human milk components are stating the desire to use human milk components in the production of infant formula.  So essentially this means that mothers who refuse to breastfeed will get a product that has the genetic material of various human milk components.  Those components will have to be sterile, without life.  Or those components will be genetically engineered, an experiment.  There is no public discussion, this will just happen because men and women of science can declare that they have invented a human milk component and it will lower the risk of the infant formula that they plan to manufacture.  Regulation of infant formula is in the hands of various government institutions.  Will it be regulated?  Do these government institutions even know what is going on?  And if they know, why isn't their public discussions?

Like dairy cows, women will donate they milk and let industries make their fortunes.  Women don't know or they don't understand the value of the milk they are providing.  They give it away or are given minimal compensation.  Profits will be made on a natural resource.  Breastfeeding is food security for the impoverished.  It is food security for those trapped in natural and man-made disasters.  Breastfeeding is freedom from dependency. 

This situation is a reminder of what happened to John Moore and Henrietta Lacks whose cells were taken from them to make enormous profits.  Henrietta Lacks was an African American tobacco farmer who was diagnosed in 1951 with a malignant tumor of the cervix.  Her cells were used to develop the polio vaccine and have been used world-wide in research:  cloning, gene mapping and in vitro fertilization.  The HeLa cells is well know in research.  There was no informed consent when those cells were taken and Henrietta Lacks died that same year. Her grandchildren and great-grandchildren only learned about those cells and its profitability about 15 years ago.

John Moore had his spleen removed in 1976 because of hairy cell-leukemia.  A cell line was created by his doctor and was very profitable.  Informed consent was not provided at the time and John Moore became suspicious of the doctor's motives because of the many office visits to donate blood, tissues, etc.  He sued and the case went all the way up to the California Supreme Court in a case called Moore v. Regents of the University of California in 1990.  He lost that decision.  The Court determined that Moore, "had no right to any share of the profits from commericalization."

There is a very interesting NY times article entitled, "Taking the Least of You" on the tissue-industrial complex (human milk is considered a tissue and state regulated in California, NY, Maryland, and Texas). Although not about human milk, is relevant to an understanding of the issues of collecting human tissues. It discusses how "researchers have become entrepreneurs."  And it explains the Moore case as well as other cases.

How many women who donate they milk are given informed consent?  How much of the donor milk given to non-profits like HMBANA goes to researchers who patent or who are connected to the infant formula and drug companies?  What should be the ethical obligations of non-profits and for-profit milk banks?  Why isn't this a public discussion?  Why are most breastfeeding organizations reluctant to address these issues?  Is this what women want for the future?  Or should not the commitment be to creating a world where breastfeeding is promoted, protected through the law, and supported by society?
 Copyright 2014 Valerie W. McClain

"The deeper you can manipulate living structures the more you can control food and medicine."--Vandana Shiva