Saturday, August 2, 2014
World Breastfeeding Week 2014: More patents to think about..
"More than a third of deaths in children under five happen
during the first month of life (about four million babies).
Breastfeeding within the first hours would save 22% of these
babies. That means 880,000 babies could be saved simply by
not removing them from their mothers, and by supporting
early sucking." --by Gabrelle Palmer, "The Politics of
Breastfeeding: When Breasts Are Bad for Business"
I decided to pick 3 patents from 3 different infant formula companies and share their statements about breastfeeding/breastmilk. The industry is trying to imitate human milk to create a safer infant formula. While laudible, it avoids the really tough questions. Is it possible to imitate human milk which has thousands of components (many not even known yet)? Why is the understanding of the value of breastfeeding/human milk so limited in our society? Why does it sometimes seem like the infant formula industry understands this value more than some breastfeeding advocates? Of course the value for the infant formula industry is in dollars and cents of profits. The value is in being able to market their product to be just like human milk. With the advent of genetic engineering and the lack of regulation and labeling, the industry can claim ownership of the genes of human milk. And then declare that their product is closer to human milk than ever before without the public understanding how they have done this. Dissecting human milk and trying to find that magic bullet that will create health and wellness in our babies, is a reductionist viewpoint. A huge error in the understanding of our world. We are a complex web of a variety of life forms that in many cases have symbiotic relationships. Reductionist thought creates the belief that one can extract a component from human milk, place it an artificial environment and genetically engineer it, add artificial ingredients and create a healthy food for infants. The distortion of reality means that the world begins to believe that breastmilk feeding is equivalent to breastfeeding. Yet, breastfeeding is a process not a product. Its a complex biological behavior that rests uneasily in a technological world, where human interaction is becoming more and more limited. World Breastfeeding Week is a time to celebrate the miracle of breastfeeding and committ to its very survival.
This is a patent owned by Nestec (Nestle) entitled, "Soluble toll-like receptor," patent #7230078. It was filed in 2004 and invented by Eduardo Schiffrin and Michael Affolter. It was "surprisingly" found that the transmembrane protein (soluble toll-like receptor) was found in breastmilk.
"It has been demonstrated that breast-fed newborns have a lower incidence of intestinal infections and inflammatory conditions, lower incidence of respiratory infections, and later in life, less allergic diseases. A number of human milk components may explain the protective role, among others, immunocompetent cells, antibodies transferring passive immune protection, human milk oligosaccharides, lysozyme, lactoferrin and other factors have been evoked."
Mead Johnson owns this patent filed in 2005 and invented by Erika Isolauri and Seppo Salinines. It is entitled, "Method for preventing or treating respiratory infections and acute otitis media in infants using Lactobacillus LGG and Bidfidobacterium Bb-12." patent # 7862808.
"Regardless of the cause for the differing bacterial populations [gut flora of infants], it is clear that breast milk has a measurable benefit in the treatment
or prevention of respiratory infections and AOM {Acute Otitis Media]."
and...
"In the United States, for example, 53% of lactating mothers introduce formula before their babies are a week old. By four months of age, 81% of infants receive formula on a regular basis."
and...
"Specifically, one study indicated that the feeding of many currently available infant formulas may be associated with a 3.6 fold increase in risk of infant hospitalization for respiratory infection when compared to at least four months of exclusive breastfeeding. Bachrach, V.,et al, Arch. Pediatr. Adolesc. Med 57:227-43(2003)"
Abbott filed this patent in 2011 entitled,"Nutritional formulations including human milk oligosaccharides and antioxidants and uses thereof," patent # 8703737. The inventors are Rachael Buck et al.
"Breastfeeding has been associated with enhanced development and balanced growth and maturation of the infant's respiratory, gastrointestinal and immune systems, thereby providing protection of the infant to infection and inflammatory disease.
and...
"Further, breast milk includes HMO's [Human Milk Oligosaccharides] that not only act as pathogen receptor analogues, but activate immune factors by infant intestinal epithelial cells and/or associated immune cell population. The function of these breast milk components, functioning as antioxidants and as immune modulators, include not only the protection of breast milk lipids by peroxidation, but may also assist in the regulation of inflammatory responses to infection or other injury."
The infant formula industry recognizes that their product adversely effects infants and the answer is in mimicking human milk components. The reason for making these products is because some woman can't or won't breastfeed. Yet these products in the past have created infant morbidity and mortality. Correcting the defects of a product by adding human milk components, whether real or genetically engineered is thought to create a safer infant formula. Does it? The energy, time and money that is used to create a new safer infant formula could be spent on protecting and supporting breastfeeding. Instead our society's financial investment is in a product that has known risks.
Copyright 2014 Valerie W. McClain
Friday, August 1, 2014
World Breastfeeding Week 2014: Breastfeeding: A Winning Goal--For Life
"But human milk is not simply food. It is a living tissue,
including many substances that affect not only the body's
use of nutrients but also its immune capacity. Nutrition and
immunity are inextricably interwoven in either a healthy or
vicious cycle." by Maureen Minchin, "Breastfeeding Matters:
What we need to know about infant feeding" 1985
As we celebrate another World Breastfeeding Week, I thought I would dedicate my blog this week to discussing why breastfeeding is a health care decision and not a life-style choice. I feel a cold wind blowing at my back, listening to some younger women involved in breastfeeding advocacy who seem to have forgotten the reason for breastfeeding advocacy or for the existence of the WHO Code. We have a mountain of medical literature from the 1970's onward that shows the statistical differences in health between breastfeeding (particularly the practice of exclusive breastfeeding for 6 months--only breastmilk, no other liquids including water or solid foods) and infant formula feeding. My focus today will be on 3 patents/applications that are concerned with infant diarrhea and ways to treat it. Two of those patents use human milk components to treat infant diarrhea.
The first patent I saw that triggered my writings was the following patent filed in 1995. It was called, "Anti-diarrheic product and method of treating rotavirus-associated infection, patent #5505955 owned by Senomed Inc., Cancer Research Fund of Contra Costa, and John Hopkins University School of Medicine. The inventors are Jerry A. Peterson, Robert H. Yolken and David S. Newburg. Both Yolken and Newburg have had funding at various times from Mead Johnson. The patent states the belief that gastroenteritis and diarrhea are linked to rotavirus infection. They will be using human milk fat globule to treat this problem. The patent states,
"In the US, over 200,000 children under 5 years of age are
hospitalized each year with acute diarrheal disease. This results
in nearly 880,000 in-patient hospital days, over 500 deaths, and
almost one billion dollars of in-patient costs per year."
And they go on to state,
"More recently, studies of children living in developing as well as
developed countries such as Great Britain and the U.S. have shown
that breastfed infants undergo fewer episodes of gastroenteritis than
bottlefed infants."
I discovered a patent application filed in 2006 regarding ORS (Oral Rehydration Solutions) entitled, "Oral Formulations for enteric disorders and/or rehydration." The inventors are Frank E Hagie, et al. (all are or have been employed by Ventria Bioscience). They will be using recombinantly-produced (genetically engineered) human milk proteins to prevent diarrhea and its recurrence. These inventors state,
"Breast-fed children have a lower incidence of diarrhea, as well
as other infections. Breast milk contains a number of innate
anti-microbial proteins that may play a role in the reduction of
diarrhea and in the promotion of colonization of the good intestinal
tract with health or commensal microflora that act as a deterrent
to ongoing and future diarrhea episodes."
The following patent, entitled, "Use of probiotics and fibers for diarrhea," owned by N.V Nutricia (infant formula company in the Netherlands)and filed in 2008.
This patent will use Lactobacillus rhamnosus (a probiotic derived from the human gut or urine), inulin, and soy polysaccharides to treat diarrhea. The infant formula industry does recognize the seriousness of infant diarrhea and many infant formula companies have created products specifically designed to treat infant diarrhea.
"Diarrhoea is a serious public health problem, a significant
contributor to malnutrition and associated with one-fourth of
all deaths in children less than 5 years, especially infants, in
developing countries. Each year diarrhoea causes more than
1 billion episodes of illness, with a global average of 3 episodes per
child and nearly 5 million deaths worldwide."
UNICEF more recently wrote the following in regard to breastfeeding and infant morbidity and mortality.
"The potential impact of optimal breastfeeding practices is
especially important in developing country situations with a
high burden of disease and low access to clean water and
sanitation. But non-breastfed children in industralized countries
are also at greater risk of dying--a recent study of post-neonatal
mortality in the United States found a 25% increase in mortality
among non-breastfed infants. In the UK Milennium Cohort Survey
six months of exclusive breastfeeding was associated with a 53%
decrease in hospital admissions for diarrhoea and a 27% decrease
in respiratory infections."
http://www.unicef.org/nutrition/index_24824.html
So for approximately 20-40 years, researchers and various institutions have recognized the association between diarrhea and how an infant is fed. Infant diarrhea can cause hospitalizations for dehydration and is known to cause death. Infant formula has a high solute load in comparison to breastmilk and thus contributes to rapid dehydration in the infant. Should we not inform the public of this risk? Is there a principle of the right to informed consent? Breastfeeding, particularly exclusive breastfeeding, saves infant lives. Denial of the risks, serves no purpose other than to keep the public misinformed and under the illusion that infant feeding is a balanced choice.
Copyright 2014 Valerie W. McClain
Sunday, July 27, 2014
Marketing infant formula with the magic of a coupon fairy
"No one can make you feel inferior without your consent."
--Eleanor Roosevelt
Social media, marketing, public relations and social marketing use words and images in the management of our perceptions. Our reality becomes the world of name brands, products, trinkets and toys that are coveted for the micro-second in internet time. Discarded next year for the new, improved, sleek and shiny thing of tomorrowland. Public relation campaigns are about managing the reputations of products or clients. We are managed and most of us don't even know it. But then if you knew that you were being managed and manipulated, the marketing would no longer work.
Breastfeeding advocates are currently faced with a media and marketing campaign entitled, "I Support You" spearheaded by Suzanne Barston, of The Fearless Formula Feeder blog. The implication is that breastfeeding advocates do not support infant formula feeding mothers. And that we need a media campaign to get breastfeeding advocates to treat infant formula feeding mothers more fairly. Little mention is made of how breastfeeding mothers are treated in public. How breastfeeders are often kicked out of public facilities for breastfeeding. The argument seems to be weighted on the side of the injustices suffered by infant formula feeders. Heaven forbid a breastfeeding advocate dare comment on that particular blog. In fact early on I realized it was a waste of time to make any comments in defense of breastfeeding advocacy on that blog. It either gets erased or you are personally attacked. I have watched a variety of breastfeeding advocates bullied on that blog. So I wonder how can we, breastfeeding advocates, be asked to join this media campaign? Joining the campaign means that we accept that we have made infant formula feeders feel guilt and shame. I believe that guilt or shame are emotions that are self-imposed feelings. Blaming others creates anger in the people accused and solves nothing. I call this an example of scapegoating and it is a great propaganda technique.
Recently it has come to my attention that the "I Support You" campaign is asking breastfeeding and infant formula feeding mothers to bring infant formula coupons to retail stores to give to mothers in an "I Support You" gesture. The coupon used to show as an example was a Similac coupon. The retail stores that were used as examples to go to were Walmart, CVS, and Target. The reason for giving out these coupons was for mothers who could not afford infant formula. All 3 stores mentioned offer store brand infant formulas from Perrigo which are not as expensive as name-brand formulas like Similac or Enfamil or Carnation Good Start. I found myself wondering why The Fearless Formula Feeder picked Similac as an example of the coupon to use? But then I watched one of her instructional videos on infant formula feeding at www.kidsinthehouse.com entitled, "Differences between formulas," and to my surprise she specifically mentions one particular brand of formula, Similac Advance [corrected-wrote Advanced] and no other brand. She also states that infant formula standards are regulated by the Infant Formula Council (which is made up of the various infant formula companies) and the FDA. Later I found out that prior to creating her blog, Fearless Formula Feeder, was hired with her husband to do a Pampers reality show (A Parent is Born and Welcome to Parenthood). Both reality shows were sponsored by Pampers but Welcome to Parenthood was also sponsored by Similac and Beechnut. Both shows are still available for viewing on you tube. On the internet there are offers for free Pampers and Similac Bundle of Joy Sample kits. So it would seem that Pampers (Proctor & Gamble) and Similac (Abbott) do joint marketing adventures. This infant formula association has been pointed out by other bloggers and on August 12, 2012, Suzanne Barston felt it necessary to respond (post entitled, "The startling FFF Disclosure Post." I found her response light-hearted, and sarcastic. How could anyone believe that it had any influence on her? She only became aware of the infant formula sponsorship after she had already done the series. I know that happens. We can't always control situations. Yet the coupon fairy seems to be bringing Similac coupons. And in the video discussing the differences between formulas, she specifically mentions Similac Advance [corrected-wrote Advantage] and no other name brand. Coincidence? The subtle influence of brand names?
How does the use of infant formula coupons undermine breastfeeding? One of the problems I see with this exhortation to leave infant formula coupons at stores for economically disadvantage mothers is that there is no control over who gets the coupons. Thus the pregnant mother is accidently targeted by this kind of marketing. Helping disadvantaged mothers with coupons creates a dependency on those coupons. When they stop coming, what can the disadvantaged mother do?
Should breastfeeding advocates be infant formula coupon fairies to show their support of infant formula feeding mothers? And what are the infant formula feeding mothers doing to show support of breastfeeding mothers? Somehow I have not heard that part of this very one-sided media campaign.
I was somewhat surprised that the Fearless Formula Feeder has become a CLC (Certified Lactation Consultant). Why would someone who believes foremost in the support of infant formula feeders become a Certified Lactation Consultant? How does someone who advocates for infant formula support breastfeeding? And how does someone who advocates for breastfeeding support infant formula feeding? Is it possible to do both without compromising your beliefs regarding risks; since how babies are fed is a health care decision and not a personal lifestyle choice?
I find the "I Support You" media campaign very troubling. Who in breastfeeding organizations is behind this campaign? Is this social marketing gone amuck? Why does it appear to be a totally one-sided campaign in support of infant formula feeding? Why are we to accept that breastfeeding advocates are to blame for the guilt and shame of infant formula feeders? How does handing out infant formula coupons support breastfeeding?
Copyright 2014 Valerie W. McClain
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
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