Thursday, March 31, 2016
"Disclosure rules need to go deeper than the typical financial conflict of interest rules to ensure that scientific research is conducted in an atmosphere of full disclosure. Patent rights should not be excluded from this realm of openness. A patent right is a finger of the private sector in the public information cookie jar, and the scientist has the social duty to let the public know. Science and technology have important societal ramifications--for example, in genetic engineering, cloning, stem cell technology, and new drug development."
by Richard M Lebovitz, "The Duty to Disclose Patent Rights," Northwestern University School of Law, Northwestern Journal of Technology and Intellectual Property, Fall 2007 vol.6, no.1
The other day I ran across a paper written by Richard M Lebovitz, a patent attorney at the US Patent and Trademark Office, that I found to be quite interesting. He discusses the fact that very few scientists recognize the need to disclose patent filings in their research papers. Studies show disclosure rates to be very low in biomedical research articles (about 15-20%). This article was written in 2007, so perhaps disclosure rates have increased. Although I have found that in the area of human milk research, disclosure of patenting is very low and often erratic (researchers disclose in one publication but not in other publications).
For example a research paper published by PLOS ONE (an open access multidisciplinary online journal), entitled, "Breastmilk Cell and Fat Contents Respond Similarly to Removal of Breastmilk by the Infant," by researchers: Foteini Hassiotou, Anna R Hepworth, Tracey M Willimas, Aecia-Jane Twigger, Sharon Perrelia, Ching Tat Lai, Luis Figueira, Donna T. Geddes, Peter E Hartmann; mentions funding provided by Medela and stem cell patents applications invented by Foteini (Hassiotou)Kakulas. The first "Stem cell preparations and methods of use," was filed with the Australian patent office in April 2012. Second patent application at US patent office in April 2013. And 3rd patent application with WIPO (international patent office) filed in April 2013. No mention was made of the Carag AG stem cell patent-"Method for isolating cells from mammary secretion," with one of the researchers, Peter E Hartmann being a listed inventor. Carag AG is a company that Michael Larsson, CEO of Medela, bought out and is currently on the Carag Board of Director. Peter E. Hartmann also is inventor of a number of patents owned by Medela. Donna T. Geddes is a listed inventor to a variety of inventions owned by Medela. And Ching Tat Lai is a listed inventor to several patent applications owned by Medela.
I find it interesting that the PLOS ONE paper does not appear to be a paper on stem cells. But I did skim the paper and have to take a second look. Perhaps stem cells are more prevalent in the fat of human milk? Rather odd since all the research papers on Breastmilk Stem Cells that I have seen do not mention any patents. In fact the papers disclose no conflict of interest by the authors. For instance, a paper in Stem Cells entitled, "Breastmilk Is a Novel Source of Stem Cells with Multilineage Differention Potential," the many authors state no conflicts of interest. Yet in acknowledgments state that the work was supported by an unrestricted research grant from Medela to Peter Hartmann and a scholarship and academic award to Foteini Hassiotou and various grants and awards from the US government. Then they thanked the participating mothers and the Australian Breastfeeding Association and La Leche League for support in recruiting the participants.
At the time this paper was published(October 30, 2012), Medela already had a Australian patent application #2012202353 with Foteini Hassiotou as inventor entitled,"Stem cell preparations and methods of use, " filed on April 20, 2012. And Peter E. Hartmann was listed inventor to the Carag AG patent #7776586 on breastmilk stem cells entitled, "Method for isolating cells from mammary secretion," filed in December 2004. From my perspective I view these patents as a conflict of interest. But obviously, these researchers have a very different perspective.
One of the comments by Richard M Lebovitz in his article, "The Duty to Disclose Patent Rights," seems pertinent to a discussion regarding disclosure of patents,
"Even when patent rights have no personal financial value that would require their declaration in a journal article, they may still compromise the perceived or true objectivity of the publication, one of the driving forces behind the conflict-of-interest guidelines."
Lebovitz discusses the fact that companies that sponsor research may review manuscripts prior to submission and "cleanse" them of statements that may impact the companies patent position. Thus some information may be left out and impact the free-flow of scientific enquiry.
In another research paper by Professors,Hassiotou and Hartmann, published in Advances in Nutrition in 2014 entitled, "At the Dawn of a New Discovery: The Potential of Breast Milk Stem Cells." Hassiotou and Hartmann disclose no conflict of interest. The article was a review of a symposium entitled, "It's Alive: Microbes and Cells in Human Milk and Their Potential Benefits to Mother and Infant." The symposium was supported by an educational grant from Medela.
An announcement in University News of March 2014, states that Assistant Professor Foteini Hassiotou won $900,000 from Medela AG to "illuminate life-giving properties of human milk."
It appears that Medela through patenting and funding has a financial interest in Breastmilk Stem Cells. Yet it appears to me that very few people seem to understand this interest. Breastfeeding organizations mentioned in these research studies recruited mothers to participate in this research. Are they unaware of the financial investment in stem cells by Medela? Medela is a WHO Code violator for their promotion of bottle teats/nipples. They also have funded new HMBANA milk banks. They have easy access to human milk and a financial investment in the potential of breastmilk stem cells.
It would seem to me that this interest should require more disclosure regarding their patenting. Instead, I find that some breastfeeding advocates believe that respect of the scientific community means that one must not question funding of researchers. I believe knowledge of funding is important in order to understand whether research has some built-in bias/conflict of interest. It is not about disrespect. It is about respect for human psychology and the understanding of how bias or conflict of interest can easily distort science.
When researchers recruit women to donate their milk for science, I believe they have a duty to inform these mothers that the research may result in patenting and financial opportunity for those involved. Respect goes both ways. If researchers and scientists want respect from their community, then provide informed consent to mothers who take the time to donate their milk.
Researchers belief that donating milk for stem cell research is far more ethical than stem cells from aborted fetuses is based on who's ethics? And that belief seems to have absolved researchers from telling the financial interests involved. For some mothers who donate their milk to researchers it wouldn't matter that patenting is involved. Or it wouldn't matter that some company may make a lot of money. But if this research leads to actual commercial use and the company reaps the financial benefit from it, some moms might question their donation.
Copyright 2016 Valerie W. McClain
Saturday, March 5, 2016
"Colostrum is thick and creamy yellow, as compared with mature milk, which is thin and bluish-white in color." --"Breastfeeding and Human Lactation," by Riordan and Auerbach, Second Edition
Without air conditioning, Florida heat in early September sucks the energy out of you. It covers you in a blanket of moisture and fogs your brain. It was in the early morning hours of September that I gave birth at home to my first child. Those early days are memories of joy and pain. Breastfeeding in comparison to birthing was more difficult and demanding. I struggled with breastfeeding for 11 days and then quit. I learned to use infant formula. But emotionally I spiraled into a dark abyss of depressive thoughts. I felt this yawning gap between my baby and myself. And with each day not breastfeeding, the gap became larger and larger. When my baby cried, my ability to respond to her had slowed. I felt detached and the memories of the closeness we had had when she was first born weighed upon me. During that time I read and reread everything on breastfeeding and focused on relactation. Intuitively I knew that I needed breastfeeding. Infant formula satisfied my baby's hunger, but it did not physically and emotionally satisfy that closeness I remembered from the early days of breastfeeding. If I had not breastfed in the beginning, I would never have known what I had missed.
I remember the day, I went back to breastfeeding. The sunlight streamed through the window and the curtains gently danced in the sea breeze. There was a smell of fall in the air. I sat on the bed and stared at my smiling, calm baby. She had just had a bottle of formula and I decided to see if she would breastfeed. She immediately started breastfeeding as if we had never stopped. The sun seemed to shine brighter, the breeze more embracing and my heart skipped a few beats in joy.
Many weeks later, after some trial and error; we were breastfeeding exclusively. I did not use a pump or all the gadgets that are now suggested by lactation professionals to relactate. I gradually lowered the amount of formula and increased the breastfeeding. There are many obstacles to relactating and many of those obstacles had to do with my ignorance of babies. I thought breastfeeding was only about feeding a baby. When I stopped viewing breastfeeding as a food system with set times and limits, the obstacles started to disappear. And as I learned that crying is an infant's last resort to communicate the need for food or comfort at the breast, I became more in sync with my baby. Knowing those cues and responding to those cues made mothering my baby so much easier.
Over the years I have wondered whether so many untimely weanings from the breast have more to do with our preconceived notions of babies. Whether so many generations of bottlefeeding have distorted and extinguished our mothering wisdom. If I had pumped and bottled my breastmilk, would I have gone back to exclusive breastfeeding? Would seeing the amounts and color of my milk, helped me over the obstacles to breastfeed? Or would I have started to question my milk because its color was not quite the colors mentioned in articles on the subject? Or would I have doubted my milk supply because I could only pump a few ounces? Would I have spent more time pumping and bottling my milk than actually breastfeeding?
I saw an article on Facebook that triggered this journey of serendipity. It was entitled, "Mom's Baby is Sick, Then She Looks At Her Bag of Breast Milk and..." written by Barbara Diamond.
The article was about a mom who was breastfeeding and pumping and noticed that after her baby got sick her milk was an orange color resembling colostrum. There was a picture of her pumped milk before the baby got sick (white color) and after the baby was sick (orange color). The first thing I noticed was the storage bags had the company name, Lansinoh. And then the other picture I noticed was her Evenflo pump. Both companies are known violators of the WHO Code. I thought to myself that it was a strange article because I had never heard that milk would revert to the colostrum color (the orange color that is representative of carotene levels). As a lactation consultant I had only seen the orange colored milk in moms with newborns. And because I never pumped during the newborn days of my babies, I never saw the color of my colostrum. That doesn't mean that I disbelieve that this could happen, but that I had never seen it as a LLL leader for 10 years and IBCLC for 20 years. And it intrigued me and troubled me at the same time. The article seemed to be implying that this was proof that, "Mom's body will actually change the milk's immunological composition, tailoring it to the baby's particular pathogens by producing customized antibodies."
My understanding of the color of colostrum is rather limited. I found myself revisiting some of my text books on human lactation. And wondering about carotene in milk that supposedly is responsible for the orange color of colostrum. Cow colostrum also has an orange-yellow color and is related to a cow's grass-fed diet. Carotene gives grass that green color. But humans are not cows. We get our carotene, a fat soluble orange to red pigment from various veggies, like carrots. Carotene is considered an antioxidant in plants, a precursor to vitamin A in humans. So what is the color of immunoglobulins? Secretory IgA (a major human milk immunoglobulin) is closely associated with the human milk fat globule. So the color may have something to do with the amount of fat in the milk. As volume of milk decreases the concentration of immunoglobulins increase. So the color change in the article may represent the fact that a sick infant nurses more frequently and pumping besides increased nursing would mean that the volume of milk had decreased significantly. If the volume decreased then the infant would get more protection through a concentrated dose of immunoglobulins. Of course this is just a theory in my head because I have not seen what this author documents. And then I start thinking why do we have to "see" a visible change in the milk? How does this help women breastfeed? Will women who pump and don't see this color change presume that something is wrong with their milk. Even though text books on human lactation say that the dose of immunoglobulins throughout lactation is the same, independent of volume. I could imagine that some mothers would never see a color change. Of course that is dependent on the veracity of this article.
The article also discussed, "that when a baby nurses, it creates a vacuum in which the infant's saliva sneaks into the mother's nipple." Then the article mentions "baby spit backwash." I remember reading this in a blog or was it a journal article? And I guess I am feeling my age but "baby spit backwash" sounds so revolting to me that I don't know whether to cry or laugh. In our germ phobic society I am not sure how this term is really helpful in promoting breastfeeding. It does not seem like an apt description of breastfeeding or maybe it is just an unnecessary description. Or maybe I am just a romantic about my own breastfeeding experience.
The importance of color in human milk is predicated on a breast pumping society. It is rather sad that this is the direction in which our society is headed. If one is exclusive breastfeeding, one does not have to be concerned about the color or volume of milk. Your body knows what it is doing and that understanding creates a base of belief in mothering though breastfeeding. When the milk becomes the prime importance, then we look to the milk as the arbitrator of our reality.
That reality will be governed by various industries involved with the collection and distribution of human milk. It will be breast pump companies and milk banks that will determine our mothering or lack of mothering. And it will be these companies that determine whether breastfeeding will survive.
Patent # 7914822, "Method of producing nutritional products from human milk tissue and compositions thereof," owned by Prolacta Bioscience, inventor Elena Maria Medo, filed in 2009
"Colostrum contains high levels of immunoglobulins, a vital defense mechanism that protects the newly born. sIgA [secretory Iga-an abundant immunoglobulin in human milk closely associated with the milk fat globule] provides immediate protection to the infant by lining the gastrointestinal system and providing a first defense against dangerous pathogens like E. coli and other devasting disease organisms. The invention discloses concentrated, processed sIgA for use as a prevention or therapeutic for gut disorders in patients of all ages."
Copyright 2016 Valerie W. McClain