Thursday, November 21, 2013

Will the real black market please stand up!

I woke up this morning to the gentle sound of rain, another day in paradise.  So I turned to the internet for my morning entertainment.  Lo and behold, there before my early morning blurry eyes is a story from channel 9 news in Orlando.  The headline is, "9 Investigates black market breast milk sales."  What a way to wake up, when ya live in the land of Disney.  Hm, I didn't know it was illegal to share human milk.  A black market would mean something illegal was going on, right?  When I think of black market, I think of criminal activity, usually involving drugs or weapons.  The article is worth reading to understand how the media is used to socially market new concepts to the public.

I never knew we had a black market in human milk until now and right here in Paradise--Orlando no less.   Our reporter, just back from her maternity leave has an interest in this topic.  Not sure how she found out about it but knowing that Orlando just opened its first not-for profit milk bank makes me think that maybe that news lead to this.  Anyway she buys some breast milk through the internet.   It is selling for $1 or $2 per ounce.  She buys 110 ounces from 4 different persons.  Then she mails it to researchers at Boston College in Massachusetts to have it tested.  It just so happens she has had contact with the reseacher Dr. Sarah Keim who just did a study on "unregulated black market human milk... which had high levels of bacteria or certain disease-causing bacteria like the kind you find in human waste."  Surprisingly, the samples the Orlando reporter sent to Boston College had similar findings.

Of interest to my readers is that it just so happens that the researcher they contacted from Boston College is Dr. David Newburg.  He was described as a biology professor and director of the Glyco-biology program at Boston College.  Funny how they neglected to tell readers that he is also a co-inventor to over 10 US human milk component patents and applications, co-founder of a company called Glycosyn LLC.  This company was founded by 2 other researchers, Ardythe Morrow of Cincinnati Children's Research Foundation, and Guillermo Ruiz-Palacios of the Instituto Nacional de Ciencias Medicas y Nutricion of Mexico.  All 3 are co-inventors to several patents like patent #8314061 entitled, "Adiponectin for treatment of various disorders."  Which may be used in infant formula.

The very first human milk component patent I ever saw was one in which Newburg co-invented.  It was filed in 1995 and was about human milk fat globule which would be used to treat diarrhea particularly diarrhea in immune-compromised patients like those with hiv/aids.  There is a second one filed in 1996 and these patents are co-owned by John Hopkins Medical School.

This research has been funded by the NIH (National Institute of Health). The Cinncinati Children's Hospital Medical Center, the University of Massachusetts Medical School, and the Instituto Nacional de Ciencias Medicas y Nutricion licensed this technology to Glycosyn.  The company offers 6 different products.,3.html

They are also collaborating with Grameen to "introduce, manufacture and distribute Glycosyn's products for the prevention and treatment of diarrhea throughout Bangladesh.

Dr. David S. Newburgh is also on the Board at a HMBANA milk bank, Mothers Milk Bank Northeast.  He has many accomplishments. But I have numerous questions about this investigation by channel 9 news in Orlando.  Who paid for the milk (and the shipping and the testing?) that was bought through this so-called black market?  The reporter?  The news agency?  Dr. David S. Newburgh who was the recipient of this milk?  What was done with this milk?  Thrown out after checking for bacteria?  Used in research?  Interesting the timing of this article and how it supposedly confirms the recent study done by Dr. Sarah Keim.

Glycosyn states that it was founded to commercialize discoveries in which it was found that "natural, anti-infective components (glycans) in human breast milk demonstrate significant protection against diarrhea."  This is a biotech company and almost all the patents are about genetically engineering the human milk component.  Will more babies breastfed?  Or will we committ more money and resources to sell products that interfere with breastfeeding.  While we can genetically engineer them, does the public understand how these products are made?  I remember when I first became an IBCLC and learned this statistic: approximately 1.5 million infants die around the world (including the US) because they are not breastfed.  They die from diarrhea and dehydration. And that statistic has not changed.  Do we need more products to treat the problem which is lack of breastfeeding?  Or do we need more nations investing in actively supporting mothers to breastfeed? 

What do the donor milk banks want?  Quite simply they seem to want women donating their milk to their milk banks only.  In the contest for a natural resource, what will be done or said?  Who wins?  No one wins in this situation.   Who owns your breast milk?  Why are moms giving it away at $1 or $2 an ounce?  And who wins when the public starts to believe there is a black market in human milk?  Will the real black market please stand up?  And I'll tell ya now it ain't mom and pop selling it in Orlando.
Copyright 2013 Valerie W. McClain

Monday, November 11, 2013

Infected or Protected? HIV & Breastfeeding

I just read, "Discovered:  A Natural Protein in Breast Milk that Fights HIV."  It was written in the Smithsonian magazine blog under Surprising Science.  I like surprises, don't you??  Except this wasn't much of a surprise for me.  Although, I honestly had not heard of this particular human milk protein called Tenascin C.  But then again maybe I just don't remember, getting older and my memory sometimes short-circuits.

I wrote a position paper for AnotherLook  entitled "Patents, Breastfeeding and HIV," in 2001.  It was all about the patents at the US Patent Office that were using various human milk components to inactivate hiv.  The infant formula, food, supplement, drug and vaccine industries, educational and governmental institutions have patented various human milk components to treat or inactivate hiv.  Those components have been:  Lactoferrin, HMFG (Human Milk Fat Globule), HMO (Human Milk Oligosaccharides), etc. So now they have found this Tenascin C and hope to create a drug (according to this particular article).    In Health News the lead author of this study, Dr. Sallie Permar says they hope to create
a vaccine to "eliminate mother-to-child transmission."

I found myself reading the articles and shaking my head.  This is what Dr. Sallie Permar says according to Health News regarding the statement, "But only one in 10 HIV-infected nursing mothers is known to pass the virus to their infants."  She says, "That is remarkable, because nursing children are exposed multiple times each day during their first year of life."  Now the other article from the Smithsonian states that, "Only 10-20 percent of infants who are breastfed by infected mothers catch the virus."

Here it is 2013 and the statistics for transmission of hiv through breastmilk still vary enormously depending on the article you read.  So some 80-90% of supposedly infected mothers do not transmit hiv through breastfeeding, right??  And some scientists have known that various components of human milk prevent or inactivate hiv.  The CDC does not recomment breastfeeding for hiv-positive mothers because "baby formula is a safe alternative for U.S.-born infants." (article from news).  Tell that to moms in the USA whose babies died from Enterobacter sakazakii that had contaminated infant formula in 2011.

What were the studies on hiv transmission that health authorities accept?  Over and over again it has been a study submitted to the Lancet in 1992 by Dunn et al. in which it is estimated that hiv transmission through breastfeeding is 14%.  This study set public health policy.  And paved the way for world-wide policies of encouraging the use of infant formula and discouraging breastfeeding.  Although I would say that discouragement may not be the proper term.  It was far more drastic in the US in that it became a forced policy in which Child Protective Services were used to enforce compliance of infant formula feeding.  What happened during these years is that slowly world health officials began to recognize in developing nations that babies of hiv positive mothers were dying not from hiv/aids but from the risks of infant formula (diarrhea/dehydration, unsanitary conditions in which to prepare infant formula, lack of ability to pay for infant formula--watering it down, feeding other unsuitable foods).  It became a public health disaster

There is the belief that in some areas of the US, the conditions of poverty are close to some areas in developing nations.  When I worked for the WIC Program from 1994-1998, I worked with women and their babies who lived in their cars, or lived with relatives in small cramped trailers with little sanitation.  What happens when utilities are turned off for lack of payment--no way to heat that bottle of formula, no way to clean those bottles.  So I have never understood this two-prong policy, this magical belief that in the US, that everyone here has access to electricity and clean water and medical care.  And at the rate the politicians are currently pushing everyone into poverty, the numbers of disadvantaged in the US will continue to grow.  We have a two-pronged policy in which the WHO encourages exclusive breastfeeding for hiv positive mothers based on a criteria  called, AFASS

So we have a two-pronged policy on hiv transmission through breastfeeding in which depending on the country you live in,  will depend on whether you are encouraged or "discouraged from breastfeeding."
But what if the studies on hiv transmission through breastfeeding are incorrect?  I invite my readers who are interested in a different viewpoint to read a paper written by David Crowe, George Kent, Pamela Morrison, and Ted Greiner entitled, "Commentary:  Revisiting the Risk of HIV Infection from Breastfeeding."  It is on AnotherLook website and worth reading and considering.

I frankly think that hiv transmission rates through breastfeeding need to be revisited by the scientific community.  I think there were serious mistakes made back during the time because of the panic and need to solve a situation quickly.  But also from my perspective, I see that this policy was an enormous boost to profits for the infant formula industry.

The infant formula industry has financially benefited by these health care policies.  And not just from stopping hiv-positive women from breastfeeding but from the spill-over effect of such policies.  Not only does infant formula feeding become more common in various communities but a new notion appears in the media.  Breastfeeding known as a protector of infant life is now thought to be a carrier of infection, disease, and death.  How much of this policy was driven by narrow views, inadequate understanding of breastfeeding, and mostly the need for profit?
Copyright 2013 Valerie W. McClain

Saturday, November 9, 2013

Standardized human milk or a dairy substitute?

What will the future bring?  I never thought I'd live past 30, so it is quite the surprise to look in the mirror and see a wrinkled face peeking at me.  My belief that I wouldn't make it past 30 was not based on having a deadly disease or cancer.  It was just I never planned for this aging business.   In my mind I am still 18 or even 20 but the reality of looking in the mirror tells me something happened overnight.  Time travel?  Things have changed.  Just yesterday--30 years ago-the ocean was full of fish.   The dirt road I lived on 30 years ago is paved and all the woods are gone.  And the fireflies have disappeared with the woods.  The cranky old neighbors who didn't want families moving into the block are long gone.  And now I am the cranky old neighbor.  Waves of change to my world.   Slowly like the grains of sand, I am worn down by thoughts of what the future will bring.  Will there be a future?  Fukishima, a living nightmare for the Japanese people and the World, is never far from my thoughts.  We have taken the World to the brink and we are teeter tottering on the edge.   I never considered the future in my youth, why now?

 This morning I thought about what the future will be offering infants.  I am sure it won't be the breast.  It will be a choice of " a standardized Human Milk" or "a Dairy Substitute."  Society seems to be gearing up for a very technological world in which breastfeeding has no place.  Our current world seems ensnarled in its technology.   People have phones stuck to their heads and hands.  Try to contact a business or an organization, and ya get voice mail.  No one is there.  I ask on the phone, may I speak to a real person please.  Oh sure, digital clock quietly moves the numbers, no tick tock in this world.  If I became a mother now (yes a biological miracle), I don't think I would have time to connect with a baby.  I'd be too busy looking at my emails or Facebook, browsing websites, looking at photos.  And of course I wouldn't be home, I'd be in the workplace, making a living or is it a dying?  Thank god, I had my children before I had a computer.  I knew things were getting strange even when my kids were little--that people were disconnected.  I'd go to a party and someone would be videotaping the party.  Fine.  But then before the party would end, everyone would have to watch the videotape of the party.  So the experience of the party became a movie and the movie was the experience of the party.   It became this narcissistic event of watching yourself and your friends.   So rather than spending time talking with each other, dancing, or sharing a meal, we passively watch ourselves party.  I found that strange then and realize it was the beginning of our current cultural journey of disconnection.

I found myself reading a Prolacta patent, entitled "Human Milk compositions and methods of making and using same." (patent # 8545920) And my sense of disconnection increases and weariness falls heavily on my shoulders.  Inventing human milk concoctions appears to be very complex.  Interestingly, we are told (like all the infant formula patents), "Not every mother, however, can or will breastfeed her baby..."  We learn about screening donors through interviews and biological sample processing.We are informed that "each donor's milk is sampled for genetic markers, e.g. DNA markers, to guarantee that the milk is truly from the registered donor."  Genetically screened by PCR (polymerase chain reaction) for contaminants.  Then the milk is filtered, and heat treated.  Then the cream of the milk is separated from the skim by centrifuge.  This may be done twice.  Then once this is done, the cream is added back and further filtration occurs which concentrates the nutrients by filtering out the water.  The water obtained from this process is called permeate.  There are various processes depending on whether they are making a fortifier or standardized human milk.  Some of those processes are freezing and then thawing, adding minerals or extra cream.  After certain steps then pasteruization happens.  The vitamins and minerals that may be added to the various inventions are:  "vitamin A, vitamin B1, vitamin B2, vitamin B6, vitmain B12, vitamin C, vitamin D, vitamin E, vitamin K, biotin, Folic acid, pantothenic acid, niacin, m-inositol, calcium, phosphorus, magnesium, zinc, manganese, coper, sodium, potassium, chloride, iron, and selenium.  The compositions can also be supplemented with chromium, molybdenum, iodine, taurine, carnitine and choline may also require supplementation."  DHA and ARA, fatty acids may also be added depending on the product.  Depending on their source for these fatty acids, most are genetically engineered.  The list of added vitamins and minerals reads like the ingredient list on infant formula.  I suppose their suppliers for these added nutrients are the same ones that the infant formula industry uses.

The processing of donor milk at Prolacta seems very complex with many steps.  How does this kind of milk resemble the milk that infants drink at the human breast?  Is part of the reason for fortification (besides the fact that most of this goes to premature infants) because this has become highly processed which means nutrients are lost?  And then what are the ethics behind women donating their milk so that this company can make a profit?

 I do see this as the future of infant feeding.  With the ability to filter out various components of human milk, the components can be sold to the infant formula industry who will add it into their products.  Already Abbott has 7 or 8 patent applications in which Human Milk Oligosaccharides will be used in their infant formula and the way the patent is worded makes me wonder whether they will be using the real component or the gmo version.   Abbott is partnered with Prolacta, so it isn't farfetched to believe that this might be the direction they are going.  Or maybe not.  What will be the direction of infant formula in the future?  What is Prolacta's place in that future?  Who would have thought that people would accept standardized human milk products?  Who would have thought women would donate their milk to that endeavor?  Seems like science fiction.  What will the future bring?
Copyright 2013 Valerie W. McClain

Tuesday, November 5, 2013

Infant formula: A Dairy Substitute

A stormy day in Paradise in which the winds are howling;  setting off the dogs to barking and the neighbors to fighting.   But this time it almost seems like the outside storm is creating the inner storms of humans and dogs.  No wonder I like the dawn of a new day, blessed quiet.  No dogs, no humans making noise, just the wind blowing persistently against the house.  Enveloping the house in the breathe of Mother Earth.  Tired, sick, and old she is but she can still howl.  What foolishness we have created by our greed for trinkets and toys.  A throw-away world, a midden of our broken desires.  We are this veiled world of games, and I am oh so tired of it.  I don't know how to play and the only solace seems to be my dream garden.  My little tomato babies sitting next to the dormant broccoli embryos.  I am learning to outwit the raccoons and that little rat possum that think they own the land.  But do I own the land? I pay taxes on that land.  But am I not, the housekeeper of this little plot of land?  Actually I haven't outwitted the raccoons yet nor that little ratty bedraggled possum.  I kinda like having them around, more than I like my neighbors or other people's dogs. I am at the bargaining table and they, arrogant creatures don't even know there is a table.  So who is the fool?  Ah, nothing like an old fool except a young fool.

Well folks lets get to the real story, not my life of baby tomatoes, kale, red sail lettuce, raccoons, possums, wrens, and that cocky blue jay.  Let's talk about this mornings amusing adventure at the US Patent Office.  I found a very interesting patent because it changed my perspective about a product, infant formula.  The patent has nothing to do with human milk which I usually write about.  The patent created this light bulb effect in my brain.  And so I now have a new definition for the product we call infant formula.  And since this is not an original thought, I must give credit where credit is due.   The patent is called, "Manufacturing execution system for use in manufacturing baby formula,"  patent # 8498729 owned by SMP Logic Systems LLC (a drug manufacturing software company).  It is a system which performs validation and quality assurance for baby formula manufacturers to "achieve data and product integrity."    This patent classifies infant formula as a dairy substitute.  People buy dairy substitutes and they are products like imitation cream, coffee whiteners, cheese, and ice cream.  As one definition states these foods are "similar in taste, and texture to genuine dairy products." [my emphasis]  In fact I learned that Dairy Substitutes are made by blending fats, proteins, and carbohydrates using the same technology and equipment used to manufacture real dairy products."  Good to know, good to know.  So infant formula, a dairy substitute, is almost like a real dairy product.  Today I learned something new and just wanted to share it with my readers.  The patent also stated that, "many consumers are under the mistaken impression that the FDA closely and carefully monitors infant formula."

Just the morning coffee news.  Maybe it will startle some people because it is a new perspective and then again maybe I am the only one fascinated by infant formula, the dairy substitute.  Just a quick story about my experience with a cheese substitute (am allergic to dairy but really miss cheese).  I was buying these vegan cheese slices, all wrapped in wonderful plastic wrap.  I went on a road trip--7 days back and forth from Florida to the Boston area to visit relatives.  I put those cheese slices (thinking it would be a good snack) in a soft nylon cooler, along with some ice packs.  I put them in a zippered portion of the cooler and promptly forgot about them.  Ate the fresh cut fruit I brought but totally forgot about those cheese slices.  Got back to Florida emptied the cooler (by then ice packs no longer frozen) but again forgot about the cheese slices.  One week later, I just happened to go through the zippered pockets and lo and behold there was the cheese slices.  No mold!  They looked exactly like they did when I put them in the cooler, only now warm imitation cheese slices.  How do you create a food that doesn't rot?  My parents bought this imitation ice cream.  They gave some to their dog and she didn't want it and it sat out all day (Florida) and it didn't melt.  It didn't melt!!!  Send that stuff to the polar ice caps to save the world from global warming!!  Needless to say my parents quit eating that particular brand of ice cream and I have quit those vegan imitation cheese slices.  So the dairy substitute, infant formula, is fake real food...and we have it because....I know, I know,  women can't or won't breastfeed.  I think I will go outside and play in the garden.
Copyright 2013 Valerie W. McClain