Sunday, June 22, 2014

The FDA's 2014 Final Rules and Guidance to the Infant Formula Act


               "The lack of appreciation for the breast reflects a lack of 
                appreciation of the female as a person.  When the fluid 
                responsible for sustaining human life is seen as essentially
                identical to a canned powder produced in a factory, it is easy
                to see how the appreciation of the breast (and with it, the
                female body) has been lost."  Milk, Money, and Madness:
                The Culture and Politics of Breastfeeding by Naomi Baumslag,
                M.D., M.P.H. and Dia L. Michels

In 1978-1979 an infant formula company eliminated chloride from some of the formulas they manufactured.  Infants fed those formulas were later diagnosed with metabolic alkalosis.  During the 1970's, there was concern about salt intake and its relationship with the development of high blood pressure.  Thus some manufacturers of infant formula decided to lower and even eliminate salt in their baby formulas.  Over 100 US infants were known to have acquired this deficiency disease caused by manipulations of their baby formula.  Metabolic alkalosis causes diarrhea, vomiting, dehydration, failure-to-thrive, kidney problems, and developmental delays.  One wonders how many infants died before the situation was recognized by the medical community.  Because of this incident, the Infant Formula Act of 1980 was passed to prevent such tragic outcomes because of the lack of regulation of the infant formula industry.
http://www.cdc.gov/mmwr/preview/mmwrhtml/00044475.htm   

Over the years the FDA has worked on revising this law. This is the 2014 rules and guidelines to manufacturers of infant formula.
 https://www.federalregister.gov/articles/2014/06/10/2014-13384/current-good-manufacturing-practices-quality-control-procedures-quality-factors-notification#h-51

There has been other tragic incidents in the years prior to and after the Infant Formula Act of 1980 and as recently as 2011.  Unlike the manufacturing of a adulterated infant formula, it has involved contamination of powdered infant formula by various organisms:  Salmonella, Enterobacter sakazakii (now called Cronobacter sakazakii).  Powdered infant formula is not a sterile substance and it has been known since 1958 to be sporadically contaminated with these organisms causing brain damage and death.  In the US in 2011, there was 13 cases of infants who were infected by E. sakazakii (1 death was recorded and other infants suffered the damaging effects of the infection).  In the past year there have been two court cases: one lawsuit against Mead Johnson (death of an infant) and also a lawsuit against Abbott (brain damage of an infant).  Neither family won their lawsuits.  

The CDC has issued guidelines for safer preparation of powdered infant formula with recommendations that newborns or young infants be given liquid infant formulas rather than the powdered.  If powdered, the recommendation is to boil the water used to make the formula to 158 degrees F./70 degrees C.  Then cooling to serve safely to infant. Similar to the World Health Organization's guidelines.  The FDA's recommendation is to boil the water for 1 minute and cool.

http://www.cdc.gov/Features/Cronobacter/ 

These suspected contamination situations may have pushed the FDA to finalize their revisions of the Infant Formula Act.  Although it has been a process of 8 years.  One might suspect that the infant formula industry may have put considerable pressure on the FDA to delay the finalization of these rules.  Of particular interest to me was a recent letter written by the Chairman of the Committee on Energy and Commerce, Fred Upton (House of Representatives, Republican legislator from Michigan) in May of this year to Margaret Hamburg, Commissioner of the FDA asking that the "FDA postpone the implementation date until the agency engages in a meaningful dialogue with Congress and industry about the need for--and the science and data behind--the changes proposed, and the feasibility of their implementation."
http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/letters/20140522FDA.pdf 

Congressman Fred Upton, according to the Center for Responsible Politics website receives campaign funds for the year 2013-2014 from the Pharmaceutical/Health Industries, Health Professionals, Electric, Oil & Gas, lawyers and law firms.  The company Abbott (Ross, a division of this company and well-know infant formula maker) mentions in their Campaign Finance website that Fred Upton was one of their top recipients of contributions through their PAC ($52,150).  Barack Obama was at the top of the recipients ($149,353).http://influenceexplorer.com/organization/abbott-laboratories/5f5e9875e0c64328baf13e6f5e83814c 

The FDA receives some of its funding through the Reagan-Udall Foundation not just from US taxpayers.  The Regan-Udall Foundation is "an independent 501(c)(3) not-for-profit organization created by Congress to advance the mission of the FDA by advancing regulatory science and research."   
http://www.reaganudall.org/ 

Some of the donations to this foundation from 2009 until now are from organizations like the National Business Group on Health*, Susan G. Komen for the Cure, Booz & Company (less than $30,00 per donor organization).  Some donations from PhRMA Foundation ($150,000-general donation, $400,000 medical evidence and surveillance program) and Bill & Melinda Gates Foundation $1,000,000 for project on TB drug regimens.  Donations from PhRMA are donations from the pharmaceutical industry which often includes the infant formula industry, for example Abbott Labs/Ross or Bristol Myers Squibb/Mead Johnson.

Will this new FDA ruling and guidance documents on infant formula safeguard our infants?  It remains to be seen.  Foremost, is the fact that "the FDA does not approve infant formulas before they can be marketed."  Thus their surveillance system, while better than nothing, is an after-the-fact system in which our infants are the guinea pigs.  While it is wonderful that these documents are available for all to read, they are difficult for the average person to understand their implications.  It is ominous that some Congressional leaders believe more in safeguarding the profits of industry over safeguarding the lives and health of our infants.  The saddest statement from my perspective is the FDA's comment , "...most infants in the US rely on infant formula for some portion of their nutrition.  An estimated 1 million infants in the US are fed formula from birth and by the time they are 3 months old, about 2.7 million rely on formula for at least part of their nutrition." 
http://www.fda.gov/forconsumers/consumerupdates/ucm048694.htm

We live in a society that supports infant formula feeding despite the risks.   We believe that there are no risks to infant formula feeding in the USA.  But that belief is predicated on the rapid availability of medical help, antibiotics, and safe water.  It is also predicated on the ability of families to pay for it or the tax payers to subsidize it (through the WIC Program).  None of this appears to be cognizant of the growing instability of our financial systems particular in regard to the growing dissolution of the middle classes and growing numbers of families put into poverty.  Nor is there awareness of our growing destruction of our environment-contamination of water through oil spills and fracking, pesticides and herbicides, radioactivity spreading globally (Fukishima).  What about our growing antibiotic resistance?  Will a nation with greater numbers of chronically unemployed be able to subsidize the costs of medical care for infants fed suboptimally?  Not being breastfeed, is a huge financial burden on parents, on a nation.  We have been blinded to the health risks of infant formula.  Reading these documents, should be a wake up call for our country about the risks of infant formula and how politicians and industry have delayed some remedies to make a safer infant formula.
Copyright 2014 Valerie W. McClain  
 
*The National Business Group on Health is "the national voice of large employers dedicated to finding innovative and forward thinking solutions to the nations most important health care issues." (mission statement)  There are many large corporations in this Group.  Some of the members are: Nestle, Kellogg Company, Pepsi, Tyson Foods, CVS Caremark, Wal-mart stores, Target, AT&T, Verizon, Delta, JetBlue, BP, Shell Oil, Marriott, Walt Disney Company, Coca-Cola, CongAgra Foods, Hershey, Heinz, Chrysler, Abbott Labs, Bristol-Myers Squibb, Pfizer, Genentech, Home Depot, Gap, Publix, etc.  Note that companies like CVS, Wal-mart, Target, Publix sell their own store-brand infant formulas manufactured by Perrigo Nutritionals.
http://www.businessgrouphealth.org/join/members.cfm

According to their website under public policy, "The National Business Group on Health's public policy activities provide members with the latest information and analysis of federal legislation and regulatory developments in health care that impacts employers.  As the national voice of large employers, the Business Group also educates and informs policy makers about the perspective and practices of large employers on key health care issues."


                  

Saturday, May 31, 2014

Collecting DNA thru donor milk


                     "We live in a society exquisitely dependent on science
                       and technology, in which hardly anyone knows anything
                       about science and technology."--Carl Sagan

According to the ACLU (American Civil Liberties Union), "The DNA of virtually every newborn in the United States is collected and tested soon after birth." Many states do not require parents' express permission to collect the DNA. Collecting the DNA is done through a newborn heel prick and part of the screening is for genetic disorders as well as serious health conditions that may impact the health of the infant.  This screening in the past was destroyed.  But in many states in the US these samples are held for years, or even indefinitely.

In 2010 CNN wrote an article entitled, "The government has your baby's DNA."  The article tells how some parents in Texas and Minnesota have filed lawsuits.  In the state I live in, Florida, babies DNA is stored indefinitely.  The article states, "Scientists have heralded this enormous collection of DNA samples as a "gold mine' for doing research.."  Concerned parents worry how this storage of DNA may impact their child's future, getting a job or health insurance.
http://www.cnn.com/2010/HEALTH/02/04/baby.dna.government/

A year ago, the US Supreme Court in a 5-4 decision authorized the collection of DNA by the police.  They consider it a valuable tool for investigating unsolved crimes but also it can be used to identify the suspect in custody.  The dissenting judges to this ruling cited the Fourth Amendment which "forbids searches without reasonable suspicion to gather evidence about an unrelated crime."
Justice Scalia in his dissent stated, "Solving crimes is a noble objective, but it occupies a lower place in the American pantheon of noble objectives than the protection of our people from suspicion-less law enforcement searches.
NY Times article 6/4/13  "Justices Allow DNA Collection After an Arrest" by Adam Liptak

Collecting DNA seems to generate a lot of debate.  There are concerns about privacy and concerns regarding our civil liberties.  What is DNA?  DNA is an abbreviation for deoxyribonucleic acid which is a double-stranded nucleic acid present in nearly every living cell.  RNA is usually a single-stranded nucleic acid.  It is the carrier of our genetic information.  DNA can be obtained from blood, a cheek swap, a finger print--anything you touched, hair, etc.  DNA is the blueprint of life.  It is the prized possession of researchers, particularly of interest to those who wish to make claims and patent upon parts of our DNA.  While DNA cannot be claimed on patents (recent US Supreme Court decision), cDNA is allowed.  Complementary DNA is derived from mRNA (messenger RNA) with the use of an enzyme called reverse transcriptase.  Biological information goes from DNA to RNA to protein and at times it goes from RNA to DNA.  Thus cDNA is derived from DNA but is created through a man-made enzymatic process.  I think of DNA as the starting material in the recipe to make cDNA.  And like any food recipe, there can be thousands of recipes to make cDNA.  The collection of DNA has become of great importance and financial profit for the biotech industry.

Of interest to breastfeeding advocates is that DNA is being collected in human milk (which is often called white blood).  Prolacta Bioscience has 3 patents, all are entitled, "Methods for testing milk."  patents 7943315, 8278046, 8628921.  The first was filed in 2008, second patent in 2011, and third patent in 2012.  Inventors are the same for all 3 patents:  Elena Medo, Martin Lee, and David Rechtman.  The abstract is the same for all three patents.  But the number of claims of each patent differ, as well as length of each patent document.  Testing of the donor milk is to establish or confirm the identity of the donor.  They will use identity markers, such as genes, alleles, loci, antigens, polypeptides or peptides or combinations.  They will be using DNA to profile the donated milk.

I have questions about private corporations or for that matter non-profit institutions collecting DNA from human milk. Were women given informed consent about the collection of DNA?  How long will they hold onto the DNA?  How will it be used? Privacy? It is interesting that there has been an uproar over the government collecting of DNA.  And now we have private industry collecting DNA through human milk.  This very same company is making a human milk infant formula.  Seems that there should be some kind of public discourse on this.  But I guess the social marketing of donating human milk is far more important. 
Copyright 2014 Valerie W. McClain

Saturday, May 17, 2014

Human Milk Infant Formula


                  "It is difficult to get a man to understand something when his
                   salary depends upon his not understanding it."--Upton Sinclair

Upton Sinclair wrote a book called, "The Jungle."  I was taught in public school that this was a book about the horrors of the meatpacking industry during the early 1900s.  It was a driving force in major reforms in the US meatpacking industry according to my school text book.  I recently read that Upton Sinclair's point of the book was not the meatpacking industry but rather the tragedy of working class poverty.  Sinclair felt that Americans were more concerned about what they ate than social injustice.  I never read the book.  Perhaps I will read it this year to get a better understanding of why people refuse to see the obvious and why people stay silent in the face of injustice rather than speak out. 

The other day I ran across a news release from Prolacta BioScience, maker of standardized human milk products.  They were announcing their first premature infant formula made from human milk.  In the news release they state they will "meet the needs of hospitals that wish to provide exclusive human milk nutrition in the NICUs."  They also mentioned the 2012 AAP (American Academy of Pediatrics policy statement that recommends, "all preterm infants receive human milk, whether their mother's own milk or, if mother's milk was unavailable pasteurized donor breast milk."
http://www.prolacta.com/preview/wp-content/uploads/press_release_pdf/2014-02-20_Prolacta_Announces_the_First_Premature_Infant_Formula_Made_from_Human_Milk.pdf

Well this makes some people happy.  We now have a safer infant formula because it is made from human milk.  I wonder how many people in our breastfeeding advocacy organizations feel this is a step in the right direction?  The belief seems to be that it must be safer because it is made from human milk.  And who will question this premise?  Will there be clinical trials of this new infant formula?  Or are we believing that since it comes from donor milks, there is no need to trial this new kind of formula?  I call that belief system faith-based not science.  We can call it a human milk product, but it is not the same substance that an infant gets at his/her mother's breast.  Prolacta emphasizes that they are offering "standardized" human milk products.  Human milk is not standardized.  It is a unique substance that changes from hour to hour, day to day, month to month.  Its life saving properties tied to a mammary gland that responds to the mother's local environment by creating antibodies to the pathogens in that environment.  It is a dynamic, live substance.  Do we think that human milk in a can will have these live substances in it, after it has been frozen and refrozen, pasteurized, and filled with additives?  Is processed, convenience foods ever equivalent to a food that is fresh?

Okay how will the human milk industry that makes human milk in a can or aseptic box find enough donor human milk to create this infant formula?  Well yes, they are just starting out and its only for preterm infants, so they won't need that much donor milk.  Interesting that this new endeavor by Prolacta coincides with the HMBANA public relation campaign to stop mother-to-mother milk sharing.  Mothers should only donate their milk to milk banks, preferably non-profit milk banks.  Although HMBANA milk banks give/sell their donor milk to human milk researchers who patent and sometimes are connected to the infant formula industry.  It also coincides with another public relation campaign entitled,"Milk Stroll" in the USA and Canada to raise funds for HMBANA milk banks and to encourage mothers to donate breast milk."  The news articles also like Prolacta's news release mention the AAP statement regarding the recommendation that all preterm infants should receive human milk.  

So what we have in the US and Canada is a huge public relation campaign to get mothers to donate their milk.  Meanwhile Prolacta will be selling a human milk infant formula.  Is there a connection between these events?  It would appear that there is no connection.  Yet there is what I would call a spill over effect of a public relation campaign.  Mothers become more aware of donating their milk but they may not be aware of the differences in the various milk banks.  Thus, a mom may donate her milk to a Prolacta milk bank because she is not aware of the differences between what Prolacta does and that of a non-profit milk bank.  She has heard the message of donating milk loud and clear.  And she has heard the message that it is dangerous to share milk with other mothers.  Thus the human milk industry gains more ground because of the spill over effect of the non-profit human milk industries PR campaigns. 

Are mothers who donate their breastmilk being given informed consent in regard to patenting of their milk?  Do mothers know that some milk banks in the US and Canada are collecting donor milk to manufacture an infant formula? There are ethical and moral issues regarding donor milk banking that are not being addressed publicly.  Silence has worked for many years regarding the patenting of human milk components. Continued silence means acceptance.  There needs to be a public dialogue about the ethical and moral implications of creating a human milk products industry, patenting, and why silence is an unacceptable response.
Copyright 2014 Valerie W. McClain 

Tuesday, May 13, 2014

Word games: Breastfeeding? Breast Milk Feeding? Human Milk? Human Milk Feeding? Human Milk Products?


                      "No two hemispheres of any learned professor's brain
                       are equal to two healthy mammary glands in the
                       production of a satisfactory food for infants."
                                           --Oliver Wendell Holmes

Mothers willingly sacrifice themselves, their time or their money to give their infants a healthier life. Some mothers breastfeed their infants.  Some mothers pump their breasts to feed their infants.  Some mothers use infant formula.  They make these decisions based sometimes on instinct, sometimes on literature given out by breastfeeding organizations, or the influence of infant formula marketing.  Some mothers make their choices based on spousal or family pressures.  Sometimes their choices are based on seeing others who have breastfed their babies, or bottle fed their breast milk and/or formula fed. 
How much of this decision process is based on truth and how much is based on societal pressures and marketing of products?  What happens when marketing pressures distort our reality of the differences between these choices? What happens when medical authorities are afraid to speak honestly to mothers about the differences between exclusively breastfeeding and providing breast milk exclusively?

I have witnessed the rise in the use of breast pumps.  In fact, like the bottle, it has fast become the standard baby shower gift.  When I was employed as an IBCLC, I began to notice that more and more mothers believed that breastfeeding could not happen without a breast pump.  Women with little to no financial resources bought the cheapest pumps they could find (some second-hand) and many quite useless products.  Did this rise in the buying of breast pumps, increase breastfeeding rates?  Well, initiation rates certainly have increased.  But duration rates are still quite low...meaning in general terms that all these breast pumps may not be sustaining long term pumping or creating more breastfeeding.  Interestingly the categories for statistics on breastfeeding initiation and duration do not include the categories breast milk feeding or exclusive breast milk feeding.  A mother who is pumping will be listed as a breastfeeding mother.  Which is not a problem unless we truly want to come to understanding about whether pumping impacts breastfeeding or whether more moms are pumping than actually breastfeeding.  Are there differences in health effects between exclusively breastfeeding and providing breast milk exclusively?  I suspect there are differences.  Infants being fed pumped milk will have greater exposures to plastics (chemicals considered endocrine disruptors).  If infants fed pumped milk are in daycare settings, they will be exposed to more infections/diseases. Will the question of these differences be researched?  Or will these differences be muted because of the mistaken belief that breastfeeding is the same as human milk feeding.  Thus exclusive breastfeeding will appear less protective and exclusive breast milk feeding will appear more protective?  Should we care about this issue?  Won't we offend mothers who are pumping their milk?  Is the truth important or not?  

The rise of the human milk industry (Prolacta and Medolac) is already creating a lot of confusion.  The hiring of people from the infant formula industry and the partnership of Prolacta with Abbott (infant formula company) creates a merging of mutual interests and beliefs.  Does the creation of human milk products for use in human milk fortifiers, preterm and term milks mean that infant formula will in the future contain human milk components (or maybe already has these components or their genetically engineered versions)?  Or is this all a word game played out by a new industry and an old industry desires to make a profit?  Don't we want a safer infant formula?  And doesn't that mean that human milk components or its genetic equivalent needs to be a part of the newer, safer infant formula?
  
Lately I have noticed that the words, breastfeeding and breast milk feeding (or human milk feeding), seem to be used as one and the same.  I have read various articles not only in the media but in medical literature that use the word breastfeeding when they mean breast milk feeding. These articles and professional papers perpetuate a confusion between a behavior that nutritionally sustains an infant through physical contact and a behavior that produces a product to nutritionally sustain an infant.  Why are these words being used as, if they are synonymous? What is the purpose in this distortion of reality?  Is there a purpose in using words incorrectly or is it just simply a misunderstanding of the impact of words in creating a reality?  Or has the merging of a human milk industry with the infant formula industry created the need to create a language of distortion?

Will breastfeeding organizations ask these questions?  Certainly the infant formula and human milk industries will not question the distortion of our language.  And certainly the breast pump industry has no financial incentive to question the use of breast milk feeding as synonymous with breastfeeding.  So onward we go with the infant formula industry mimicking the properties of human milk, even to the point of genetically engineering human milk components.

Three patents:
Patent #8114441 entitled, "Immune stimulatory infant nutrition," filed in 2005 by N.V. Nutricia (infant formula company).  The patent explains that whey dominant formulas create, "suboptimal intestinal flora."  They believe that whey dominant formulas do not protect against infection like human milk and their new formula will reduce the risks of feeding whey dominant infant formula. The patent states that human milk protects against infections and allergies.  They will be adding oligosaccharides (galactooligosaccharides (GOS) and fructooligosaccharides (FOS).

Patent #8445429 entitled, "Lactoferrin & neuronal health and development in the infant gut," filed in 2010 by Nestec (Nestle).  The patent describes how lactoferrin exhibits antimicrobial activity and is part of the innate defense system.  "Lactoferrin improves neuron density and neuron survival."  and "It protects neuronal cells and delays neuronal cell death."  High concentrations are found in human colostrum, human milk, then cow's milk (debatable whether very much in cow's milk:  some researchers state their is little to no lactoferrin in cow's milk).  They state their source for lactoferrin may be a "milk or whey source: bovine milk, human milk, goat milk, camel milk, horse or donkey milk."  "Colostrum may be used as well."

Patent #8703737 entitled, "Nutritional formulations including human milk oligosaccharides and antioxidants and uses thereof," filed in 2011 by Abbott.  The patent's purpose is to reduce inflammation and the incidence of inflammatory diseases.  The patent states, "...these breast milk components, function as antioxidants and as immune modulators, includes not only protection of breast milk lipids by peroxidation, but may also assist in the regulation of inflammatory response to infection and other injury."  and " HMOs [Human Milk Oligosaccharide's] act in a synergistic manner against respiratory viruses, including RSV when combined with a long chain polyunsaturated fatty acid and/or a carotenoid."  and "The HMO or HMOs may be isolated or enriched from mik(s) secreted by mammals including but not limited to human, bovine, ovine, porcine, or caprine species."  Not sure how one can have a human oligosaccharide from another species of animal--unless genetically engineered.  They also mention that HMOs may be produced by "microbial fermentation, enzymatic processes, chemical sytheses or combinations thereof."

So let confusion rein upon our lives.  What is in that can of infant formula?  Human Milk components?  Genetically manipulated human milk components?  Is a mother breastfeeding or is she breast milk feeding?  Will we understand whether there are differences in health effects from each form of feeding?  Or will marketing make the public believe that all is one and the same?  It's a strange world.

Copyright 2014 Valerie W. McClain


Interesting article entitled, "Formula Ingredients for Infant Health" published in Nutritional Outlook" submitted by rgardner.  It states, "With two-earner households now the norm, millions of moms will continue to opt for the convenience of formula.  This opens enormous opportunity for suppliers of nutritional ingredients, while at the same time placing great responsibility on their shoulders."  http://www.nutritionaloutlook.com/print/18067





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."
http://onlinelibrary.wiley.com/doi/10.1002/stem.1188/full

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." 
http://vwmcclain.blogspot.com/2012_07_01_archive.html 

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.
http://www.nytimes.com/2006/04/16/magazine/16tissue.html?pagewanted=all&_r=1&

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

Sunday, March 16, 2014

"I support you" campaign: public health risks vs. lifestyle choices


                                      "Jarvisalo et al. (2009) have concluded that adult
                            men who have been breastfed have better brachial 
                            endothelial function compared to men who have
                            been formula fed." --Nestle patent application #
                            20140044830 entitled, "Infant Formula for use in the
                            Prevention of Cardiovascular Diseases."

There is a public relation campaign entitled, "I support you."  This campaign is about infant feeding and the belief that all mothers need support.  I agree with supporting others during parenting trials and tribulations because mothering/parenting is a tough job.  It has its moments of sheer joy, fun and love.  It has its serious moments like staying up all night with a sick baby or child.  It has its moments of wonder, when a child shows us that our world is pretty amazing.  The new eyes of the child and their enthusiasm for everything uplifts us.  Their never-ending energy tires us beyond belief.  Parenting needs support.

But do we need a public relation campaign to support both breastfeeding and infant formula feeding? Infant formula blogs state that breastfeeding advocates are creating guilt and shame in formula feeding mothers.  These blogs state that formula feeding mothers are being bullied by health care professionals to breastfeed.  So they believe that we need a public campaign to support all mothers.  I would suggest that "all" really means that the support they are asking for is for infant formula feeding mothers.  I read one infant formula feeding blogger who voiced her depression and upset over World Breastfeeding Week.  I suppose that no longer having World Breastfeeding Week would show our support of all women? 

So I have a number of questions.  Is breastfeeding a health care decision that impacts the health and well-being of infants and mothers?  Or is this just a life-style choice?  The premise of this PR campaign seems to be that how we feed our babies is a life-style choice.  It is a choice of equal value and without risks.  Therefore it is important to protect the feelings of mothers who choose or cannot breastfeed.  

Is shame and guilt caused by others?  Can individuals control how others perceive life?  Feelings come and go, should we blame others for our grief, shame, guilt, sadness, depression.  Can other people fix our grief or our shame or guilt?  Or are these feelings resolved when a person accepts that emotions are self-generated and often fleeting.  Or the realization of the importance of building personal boundaries in which feelings of others do not control our personhood. 

If breastfeeding is a health care choice of great importance to the health and well-being of infants and mothers, then should we accept a PR campaign that essentially mutes the dangers of infant formula?  Would the PR campaign for stopping cigarette smoking include a "I support you," organization?  Or wouldn't we consider that absurd?  Or the PR health campaigns for "healthy eating" or "exercising" include "I support you," campaigns.  Is support about hiding the truth about health risks in order to make people feel better or is real love about telling the truth about health risks?  How will mothers feel in the future, when they realize that health care professionals kept quiet about the risks of infant formula in order to protect them from feeling bad about their decision?  

The patents and patent applications by the infant formula industry admit that their product is inferior.  Not just inferior but a substance that causes adverse effects in babies.  The patents and applications are about fixing the health problems that infant formula feeding causes.  So far they are still patenting because they can't eliminate the risks of artificial feeding.  The industry is trying to fix their product through genetic engineering (which has its unknown risks on a vulnerable population).

Nestle is busy patenting infant formulas to prevent obesity,heart disease, infections, etc.  And of course so are the other infant formula companies creating patents to prevent or treat the very health problems that artificial feeding causes in babies.  The real prevention is breastfeeding. 

Nestle's latest patent application on infant formula is about preventing cardiovascular diseases (associated with high blood pressure).  So they are changing the protein and lipid content of their formulas.  They believe that their invention will prevent "coronary heart disease, heart failure, peripheral arterial disease, hypertensive retinopathy, hypertensive encephalopathy, stroke, and kidney failure," in patients later in life.  So one must question whether Nestle has research that shows that before this invention, infant formula was the cause of all these health problems involving the heart.  Is one of the risks of infant formula, heart disease in adulthood???  Kidney failure?  Stroke?

Should the issue of health risks be about "feelings?"  Would health care organizations invest in PR campaigns to "Stand Up For Smokers?"  Smoking causes heart disease besides lung cancer and other cancers.  Not being breastfed puts an infant at higher risk for heart disease as well as various cancers.  Not being breastfed impacts the infant into adulthood.  

In "The Politics of Breastfeeding," Gabrielle Palmer states, "I know that stating these facts can be painful or even enraging to some women who have not breastfed their children, but the continued denial of the risks of not breastfeeding [I prefer the term risks of infant formula] and the value of breastmilk, supposedly to spare women's feelings, is a patronising deception."  and, "No women need feel guilty for 'failing' to breastfeed, though she has the right to feel angry or sad for being denied support and information when she needed it."  

How can we be so stuck on this theme of "shame and guilt?"  I think its time to let go of this "elephant in the room." The risks of infant formula are real and the patents and applications by the industry are the legal proof.  The truth has to be spoken and the consequences of speaking the truth means that some mothers will feel guilt or shame, sadness, and anger.  
Copyright 2014 Valerie W. McClain