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.

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."

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."