Saturday, December 6, 2014
"Despite conflicting clinical trials, highly variable products, and lack of FDA approval, probiotic supplements containing Lactobacillus and/or Bifidobacterium species have been increasingly used in neonatal intensive care units to prevent death due to necrotizing enterocolitis (NEC), a disease of premature infants where the intestinal wall becomes inflamed and bacteria invade the bowel wall."
--Forbes, "Children's Probiotic Supplement Contaminated with Disease-Causing Fungus," by David Kroll, 11/18/2014
A very premature infant died from gastrointestinal mucormycosis. The cause of this infection was determined to be from a fungus called Rhizopus oryzae, which had contaminated a product called ABC Dophilus Powder, distributed by Solgar Inc. of Leonia, New Jersey. Three lots of this product were believed to be contaminated with the fungus. The product is distributed in 29 states in the USA, as well as Puerto Rico. Internationally, it is sold in the UK and Israel. It is a product that has been available through the internet.
Probiotics have in recent years been promoted for use in the prevention of NEC (necrotizing enterocolitis), in preterm infants. What is the medical evidence for use of probiotics in the preterm infant? A recent Cochrane Summary of the evidence states, "There is insufficient data with regard to the benefits and potential adverse effects in the most at risk infants weighing less than 1000 grams at birth." http://summaries.cochrane.org/CD005496/NEONATAL_probiotics-for-prevention-of-necrotizing-enterocolitis-in-preterm-infants
Probiotics seem to have side effects that often are not discussed widely. Side effects noted in adults as well as children. Some studies have shown an increased sensitivity to allergies, in the Dutch Pancreatitis Study Group the death rates of those treated with probiotics increased, and it has been known to cause lactobacillus septicaemia in immune-compromised patients.
What interests me is that my research on patents and human milk components, found a number of patents and patent applications that used various human milk components (human lactoferrin, Human Milk Oligosaccharides for example) to prevent and treat NEC in preterm infants. A Cochrane Summary on studies of the use of formula milk versus donor breast milk states, "This review of nine randomized controlled trials suggests that feeding formula increases short-term growth rates, but is associated with a higher risk of developing the severe gut disorder called 'necrotizing enterocolitis.'"
The American Academy of Pediatrics states in their policy statements in the document "Breastfeeding and the Use of Human Milk" dated 2012, "Meta-analysis of 4 randomized clinical trials performed over the period 1983 to 2005 support the conclusion that feeding infants human milk is associated with a significant reduction (58%) in the incidence of necrotizing enterocolitis (NEC). A more recent study of preterm infants fed an exclusive human milk diet compared with those fed human milk supplemented with cow-milk-based infant formula products noted a 77% reduction in NEC."
It appears that we have medical evidence that human milk/breastfeeding protects against NEC, particularly exclusive human milk feeding/breastfeeding. What is the basis for using probiotics in preterm infants? We have insufficient data. So why are NICUs (Neonatal Intensive Care Units) using probiotics? And how many NICUs are encouraging exclusive human milk feeding/breastfeeding in their NICUs?
One of the fascinating facts I recently learned about probiotics is that of a scientist named Henry Tissier of the Pasteur Institute in France in the 1900's. He isolated a microorganism from the intestinal flora of breastfed infants, called Bifidobacterium. Throughout his life he promoted the therapeutic use of this bacterium to prevent diarrhea. (breastfed infants are protected against diarrhea). Thus it is rather ironic in my opinion to give a breastfed infant a product off the shelf that has Bifidobacterium because breastfeeding provides this protective bacterium. We now consider Bifidobacterium a probiotic ("for life") and it is being added to all kinds of products: infant formula, yogurts, cereal, sports drinks, cereal, nutritional bars, etc. Some how consumers now believe that adding probiotics to their foods somehow makes it healthier. Yet consumers and medical professionals have very different feelings about human milk and its components. The medical evidence for these probiotic products are not confirmed by studies. We have a confusion regarding what probiotic bacterial strain is really in these products. How do these substances survive packaging? And some experts are concerned that some bacterial strains are toxic to humans. In the USA we have no governmental regulation regarding labeling of those probiotics that are genetically engineered.
Frightening is the fact that the Rhizopus oryaze is used by food manufacturers to create lactic acid (which is used to create probiotics). And this fungus can be genetically engineered. A patent (# 6849444) filed in 2002 and owned by Archer Daniels Midland Company (a well-known food company) entitled, "Strains of Rhizopus oryzae and uses thereof," states the following:
"The strains of the invention are temperature-resistant and convert a carbon source to lactic acid at high temperatures." and, "If desired, a Rhizopus strain of the invention can be transformed with a genetically engineered vector to express a coding sequence."
So I wonder about the contamination of a product with Rhizopus oryaze. Is this a simple case of contamination of probiotic product? Or a result of the use of this fungus in the genetic engineering of lactic acid cultures? What do we really know, as consumers, about the products we buy that are considered foods or supplements? And why are hospitals using these products without clear medical evidence? Particularly when it appears to me that we have clear evidence that exclusive human milk feeding or breastfeeding, is protective against NEC. Human milk/breastfeeding contain what we now call probiotics. This has been known since the early 1900s. The food and supplement industries are basing their probiotic products on the studies of human milk bacterium. These industries are creating these products through the use of synthetic materials and/or gene technology. Consumers have become part of a experiment that enriches industry without being fully informed of the risks.
Copyright 2014 Valerie W. McClain
Wednesday, November 12, 2014
"With the prevailing attitudes in this culture that birth is unsafe, that women aren't physiologically or psychologically designed to have babies anyway, and that the total management of labor and delivery is essential, it is no wonder that women find their instincts blocked, their hormones confused, their confidence disintegrating, their dignity stripped. We are part of one big obstetrical disgrace. One mammoth maternity mess." --Nancy Wainer Cohen, "Open Season: Survival Guide for Natural Childbirth and VBAC in the 90s"
[This post is not about patents and human milk components or infant formula. This post is about witnessing a birth in a hospital in the USA. It's about my need to document how inhumane birth has become under the driving force of technology and supposed safety concerns. It comes from my heart and soul as a mother and grandmother. It's about witnessing the insanity of confining a active, healthy woman to a bed to give birth. And about medical staff spending more time and attention with their technological gadgets than the laboring mother. It is no wonder that the c-section rate in the USA has skyrocketed to a ridiculous level. Website showing c-section rates in USA.
c-section rate in Florida by hospital
Last weekend was cold and blustery for Florida. Unusual weather for this time of year in a southern state known for its warmth and sunshine. The weather wasn't the only change arriving into my life. My daughter's husband called to tell me that my daughter was in the early stages of labor. Since my daughter had asked me to be with her during labor and delivery, I felt a wave of excitement and apprehension. All my babies had been born at home with midwives from a free-standing birth center. After the home birth of my first baby, I volunteered with the birth center. As a volunteer I answered the phone,filed papers and did pregnancy tests. I attended some home births as the babysitter for the birthing mother's children. I was not a midwife nor did I have an interest in becoming a midwife. I volunteered out of gratitude to the midwives for the services they offered to me and other women in the community. They helped educate me and many other women in our community about birth and breastfeeding. Office visits were often an hour long with the midwives giving of their time and attention to a pregnant woman's concerns. The individual attention given by midwives is in stark contrast to what the medical profession offers pregnant and laboring mothers. The Birth Center eventually closed down in 1985, largely due to the inability to get physician backup. I never witnessed a birth in a hospital. Although I had mothers tell me their hospital birth stories and was often appalled by what women think is normal procedures in birth. I wasn't sure what to expect with my daughter's labor nor was I very up-to-date on what the birthing situation was like nowadays. I pictured in my mind that I would hold her hand and give her the support that all women need during birth. I have never forgotten the midwife who held my hand during my first birth. She helped me weather the storm of contractions that birthed my baby. That baby, now an adult, was now having her own baby.
My daughter had had a c-section with her first baby because the baby was breech despite several attempts to turn the baby head down by external version. With this second baby she wanted to have a VBAC (Vaginal Birth After Cesarean Section). Only certain hospitals do VBACs. Women who want a VBAC are considered by the medical profession to be high risk without consideration to individual health and circumstances of previous c-section. Her local hospital did not do VBACs despite the fact that they did her first cesarean. So she had to go to a major teaching hospital some 40 minutes away.
My daughter handled early labor beautifully. She walked, she rested, she ate lightly, drank fluids, and was very, very positive. Her lower back was bothering her, so she went to her chiropractor and had an adjustment. The back pain disappeared making her more comfortable. Her contractions eased up and were intermittent. She was able to sleep the night. The next morning the contractions started up again, stronger but she was rested and feeling confident. By early afternoon, she became concerned because she hadn't felt the baby kick but once or twice some hours earlier. She called the hospital and they told her to come in to be checked. So we left for the hospital. At the hospital they hooked her up to the fetal monitor. And there it was the thumping beat of the baby's heart. Relief, the baby is okay. They then did an internal check and she was 3-4 cm dilated and 70% effaced. She decided to be admitted to the hospital. Since this was a teaching hospital, I overheard one of the nurses stating to what I gathered was a student nurse that since my daughter wanted a VBAC the hospital offered a trial of labor. The way in which it was said gave me the shivers. A TRIAL of LABOR, the words kept running around in my head. A trial?? Like a criminal trial, where it is decided whether you are guilty or innocent? A trial? Like an athletic event, where there are winners or losers? The Merriam Webster dictionary defines "trial" in several ways:
"A formal meeting in a court in which evidence about crimes, disagreements, etc. is presented to a judge and often a jury so that decisions can be made according to law."
or, "A test of the quality, value or usefulness of something."
or, "A test of someone's ability to do something that is used to see if he or she could join a team, perform in a play, etc."
These words that the medical community use have meaning and a psychological impact on mothers and their families. This was a test of labor to see if they would let the mother birth vaginally. How many pass the test to birth vaginally? How many at this particular hospital passed their tests? What were their tests? This whole idea of a trial/test in birthing is a very foreign concept in my mind. Particularly if you believe like I do that the deck is stacked against the laboring mother.
While my home-birth mind ran through these words, trial of labor, over and over again, a nurse came in to put in an IV into my daughter's arm. The nurse botched the insertion and then played with it to get it to work. I had seen botched IVs done to both my parents when they were hospitalized. And seen the consequences of botched IVs--swollen hands, arms, bruising, numbness. If this was a Hollywood movie, then this botched IV would have been the ominous sign of worse things to come. Almost all women are given IVs in hospital births. This never use to be a standard of practice for birthing moms. It limits mobility as well as having other risks.
Part of the admittance to labor and delivery was the medical staff asking my daughter about whether she wanted an epidural, pitocin, etc. My daughter said no to pain meds, pitocin, and the epidural. But she added that her decision was flexible. She was willing to reconsider based on how her labor progressed. Her refusal of the epidural seemed to surprise the staff or was it surprise? I was overwhelmed by this feeling that in this trial of labor, my daughter did not give the right answers to these people.
It seems the fetal monitor straps that they had put on her belly to hear the baby's heart beat and monitor contractions were to be kept on throughout labor. They did offer what they called a remote fetal monitor, so that she could walk during labor rather than being confined to the bed. She gladly accepted the remote because walking or standing during a contraction felt much better than being in bed.
What we noticed right from the beginning was that the straps to the fetal monitor seemed to loosen over time and that effected the machine's ability to record a heartbeat and/or contractions. This technical problem of a man-made machine caused the nurses to constantly show up in the room and peer at the monitor and its paper trail spewing onto the floor. Then the nurse would rearrange the straps of the fetal monitor on my daughter's belly. The monitor was showing decelerations of the baby's heartbeat. Were the decelerations (lowered heart beat showing that the baby is in stress)really happening or was this just a problem caused by a strap system that loosens when a mother walks or moves in bed? Strangely enough, even though the nurses were fiddling with the straps every time they walked into the room, they always presumed that the reading of decelerations was correct. We realized after a time that the paper trail made by this machine was the medical profession's only reality. My daughter at one point angrily stated that she hated the machine. Watching the straps slipping and sliding around her belly, I found myself hard pressed to believe in the accuracy of the machine. The cold and cruel reality is that this is the evidence that the medical staff used to create the next set of interventions.
We were pretty much left alone through the rest of the day and throughout the night, other than the staff peering at the machine and readjusting the straps to the monitor. In the morning of the next day, a doc suggested pitocin to get things going, since she was "still" 3 cm dilated. That recommendation meant that my daughter would be confined to bed and taken off the remote fetal monitor. As the remote got bagged up, the nurse dropped the machine on the floor. This was the hospital's relatively new remote machine. I wondered whether something got damaged by the fall? Was this the first time that this machine had fallen to the floor? From now on my daughter would be directly hooked to the machine sitting by her bed that spewed the paper trail of zig-zag graphs recording heartbeats and contractions. And she would be getting pitocin without pain relief. Something I would never be brave enough to do because I had heard so many stories about pitocin and its ability to create painful and multiple contractions.
My daughter's labor seemed little changed by the introduction of pitocin and she handled the contractions quite well. At some point they said my daughter needed to be on oxygen for the baby's sake. So they strapped on a mask that was tethered to a wall outlet of oxygen. But about an hour later they stopped the pitocin because they said the baby was not appearing to cope well with the pitocin. As time went on, leading into the afternoon of the third day that my daughter had been in labor, I could see that she was tired from lack of sleep and the continued contractions. And at some point they decided to restart the pitocin and her contractions became more fierce. Being stuck in a bed while having contractions is a very difficult thing to handle. She had not been allowed food or water all this time, although ice chips were allowed. Suddenly, a new doctor and more nurses came into the room. The doctor stated that what was needed is an internal monitor of her contractions as well as an internal fetal monitor. He stated that this would increase her contractions but would speed up the delivery. He never presented the risks, the drawbacks to this procedure. He wasn't really asking her whether she wanted to do it but rather telling her that this was what needed to be done. She agreed to it. And my heart took a nosedive. Breaking her water would make the contractions even more difficult to withstand and an internal fetal monitor is so invasive (they screw the wires into the baby's scalp--I had seen the result of this on some of the breastfeeding babies I had worked with). The medical staff flattened out the bed so the doc could break the amniotic sac that protects the baby from the contractions and infections. She was still 3 cm dilated when they did this procedure and had had no pain medications. The water broke and there seemed to be a ton of water pouring out onto the bed. Then the doc tried to put the fetal monitor into the baby's head. It was at this point that my daughter started to scream and cry. The doc said he was sorry but he couldn't get the internal fetal monitor in place. He left the room. He never made another attempt at placing the internal fetal monitor. I am not sure why he gave up but I was thankful that he stopped. Did he put that screw into my daughter's cervix rather than the baby? What happened? Meanwhile the contractions became more and more vicious, one on top of the other; and my daughter was losing her ability to breathe through the contractions. At this point in time, she began to complain about her arm, where the IV was located. It had become painful to her and I noticed that the hand and the arm were swollen until the hospital bands looked like they were cutting off circulation. She yelled at the nurse to change the IV to the other arm because she was losing feeling in her arm. The nurse proceeded to try to insert another IV in the other arm. The nurse couldn't do it. And in the mean time the contractions keep rolling onwards, doubling and tripling. They asked my daughter if she wanted an epidural for the pain and at first she said yes. But as each painful contraction came one on top of the other and with them trying to change the IV to the other arm, my daughter decided that she couldn't take it anymore and told them she wanted a c-section. They asked her if she was sure about it cause they could do an epidural. She could continue on with this trial of labor. Of course they wouldn't know how much longer she would be in labor. After 3 days in labor, confinement to a uncomfortable bed, little sleep, no food or water: the decision was made.
As they wheeled my daughter out of the room for surgery, I turned to one of the nurses and asked who was the surgeon who would be doing the c-section. The nurse said his name and he was the doctor who had just broken her water and botched the internal fetal monitor. I went numb inside. So the same doctor who does the invasive procedures that lead to this c-section is also the doctor who does the c-section? Isn't that a conflict of interest? I felt fear grip me. He obviously screwed up the internal fetal monitor. Would he screw up the surgery?
I felt the tears in my eyes and in my heart. How do woman give birth like this? I who had home births. I had listened and was nearby at other home births and never seen these kinds of invasive procedures or the level of pain generated from these procedures. I feel so naive and old. What I witnessed in my daughter's birth I cannot easily forget. Do women have any civil liberties while giving birth? Do they even have the freedom to reject any procedure? Are they told clearly the risks of each procedure? Is all the machinery and gadgetry a test for how much pain a women can withstand? And can any women withstand the amount of pain that the American hospital way of birth inflicts? I know I couldn't do it. I'd be begging for a c-section. Not allowing a woman to walk, eat or drink during labor is torture. The medical profession is fixed on the belief that their machines and interventions save babies. The profession seems to have lost the ability to care for the laboring mother. They care more for the machine, the paper strips of supposed proof of the ability to birth. They trust the machine over the mother and consequently destroy rather than empower women to give birth. (recent Florida news report on woman being forced to have a c-section)
If this system of birth, this trial of labor created less morbidity and mortality in women and babies, I would believe that maybe all these inhumane, painful, and torturous procedures might be worth the better outcomes. But the reality is that in 2010 the US ranked 50th in the world for maternal mortality.
"An estimated 11,300 newborn babies die each year in the United States on the day they are born. This is 50% more first-day deaths than all the other industrialized countries combined."
I have had young women say to me that they thought I had a lot of courage to have had my babies at home. They don't know how I withstood the pain. And all I could say is that young women who go into hospitals to have their babies have much more courage than I. When it comes to pain, I am a wimp. I am too afraid of the pain, to have a tattoo In a dentist chair, I want as much pain relief as possible. There is something seriously wrong with birthing in the USA. Why do we accept that these Trials of Labor (because every woman is on trial) are normal? It appears to me to be so abnormal that for days after my daughter's labor and c-section I had tears in my eyes. I am weeping for my daughters. I am weeping for a whole generation of young women who have no real chance at a normal birth. The deck is stacked against them because the medical community has determined that birth has to be tested and controlled through technology.
Copyright 2014 Valerie W. McClain
My daughter and her baby are home and doing well. I am grateful they survived all the interventions. I am not grateful about her treatment, her trial of labor in the hospital. I think many of the interventions were unnecessary and subjected her to pain that could have been prevented.
I also found myself reflecting on the midwives that helped me during my labors some 30 years ago. They will always be held in my heart with the highest esteem for the kind of care they gave me and my babies. They gave so much to all the mothers that they had in their care.
I think that medical people who are involved with laboring mothers should have to spend a day in a hospital bed having simulated contractions. They would be tethered to a machine. Humans would come and go to check the miracle machine but pay no attention to them. They would not be allowed to get up and walk around to relieve their pain, no food or drink. I would also like these people to witness a number of home births. Without the knowledge of normal birth, how can you give quality care to laboring women?
Thursday, September 11, 2014
"The question is whether any civilization can wage relentless
war on life without destroying itself, and without losing the
right to be called civilized." --Rachel Carson
Where do parents get their information on breastfeeding? Who should parents trust for accurate and non-biased information on breastfeeding? Why should parents question the source of information on breastfeeding?
It is obvious to most parents that information from the infant formula industry on breastfeeding is often misinformation that benefits the industry. As adults we understand the concept of "follow the money." Although sometimes the slanted information is so subtle that it is difficult to see. But most of us understand advertising. And breastfeeding information from the infant formula industry is a form of advertising. Surprisingly most of us think we are not influenced by advertising. Yet studies show that advertising works. So more of us are actually influenced by advertising while believing that we aren't influenced. I guess we could call it denial. And we all in some degree of denial about how influenced we are by advertising.
I happened to browse a few infant formula websites on "tips on breastfeeding." I didn't realize that Abbott has a "commitment to breastfeeding education." (information for health professionals). And Mead Johnson can educate mothers on expressing breast milk, "expressing breast milk is a great way to catch a break, get some sleep or let dad or another caregiver have a hand in feeding. It gets your baby used to the idea of a bottle, and of getting nutrition from someone other than you." I am vaguely amused by an infant formula company's commitment to breastfeeding education. It has this Orwellian feel. The reality is that breastfeeding is the competitor to the infant formula industry (and to the human milk industry). Breastfeeding education in the hands of the infant formula industry is for lack of a better word, crazy. Almost as good as having fast food companies give us nutritional education. Oh yeah, that also is being done in the US. We have to hope that consumers are educated enough to question this kind of education that benefits industries. Mead Johnson's education on expressing breast milk as a great way to catch a break is some kind of American male fantasy. Pumping is work and time away from the baby, another chore added on to the many chores that women seem stuck doing (as household chores seem to still be mostly relegated by whether you are male or female). Why is babyhood a commitment to the idea of getting babies used to a bottle not the breast? Why are man more interested in feeding the baby a bottle than doing household chores so that mom can breastfeed her baby? Oh yeah, household chores seem to still be women's work--at least in most American households. And oh how quickly men lose interest in feeding the baby a bottle after they have done it a number of times. Yes, I get it, babies are cute and men envy women's ability to nourish a baby. Mammary-envy is alive and well. Breastfeeding, nourishing a human being, is a powerful gift. In our male-dominated society it seems to be an imperative to disturb or destroy that relationship. In a society governed by industry, profits, its needs and wants; the disruption or destruction of breastfeeding will be a part of our reality.
But it is not even the infant formula industry who is trying to guide breastfeeding education in our society. We now have milk banks who financially need mothers to make a commitment beyond breastfeeding to breast milk feeding. Prolacta,who calls itself a for-profit milk bank, offers its breastfeeding tips for an increased milk supply.
First on their list is to, "drink lots of water to avoid dehydration." Huh? Say what? The principle of increasing milk production is to breastfeed more often. Or use a pump, if a baby is refusing to nurse. Drinking extra water does not increase a milk supply. Mothers do need to be aware of the need for more water during exercise or when temperatures are high. But increasing water consumption does not increase milk production.
Second suggestion from Prolacta is "Healthy Choices." They suggest eating lots of fruits, vegetables, and whole grains. They also suggest a calorie range. Eating healthy foods is a good idea but it does not increase a mother's milk supply. Breastfeeding more frequently or pumping when infant's absolutely refuse to breastfeed increases a milk supply.
Third on the list is "Eat Frequently." They suggest 3 small meals with healthy snacks. And again having a healthy diet and eating frequently does not increase a milk supply. Breastfeeding more frequently or pumping increase a milk supply. Eating healthy meals and snacks is something all people should be doing. Good nutrition makes people feel better and benefits the immune system. Eating well may improve the quality of the milk but it doesn't increase a mother's milk supply. Only breastfeeding more often or pumping if the baby refuses to nurse more often will increase a milk supply.
The fourth breastfeeding tip for an increased supply is to, "Pump Often." They state, "Breast milk is produced on a supply and demand basis, so if you pump more often, your body will naturally make more milk." Hm....now they finally have gotten to the principle of increasing milk production. But dear reader is this really a breastfeeding tip or a breast milk pumping tip to increase milk production?
When working with moms who needed to increase their milk supply, my first suggestion would be to increase breastfeeding time. Pumping was not one of my suggestions unless the baby was refusing to breastfeed. Adding pumping to a mother's life with baby, puts the mother's supply out of sync with the baby's needs. When moms have an oversupply, they are often at risk for engorgement and/or mastitis. Breastfeeding exclusively is a balanced system. Adding pumping to a balanced system is a risk.
There are 16 Breastfeeding tips. Not surprisingly the fifth suggestion is to "Get in a Routine." Pumping requires a routine, scheduling. Breastfeeding is not so easily made into a routine because it is about human behavior and the needs of a baby. Routine usually means a clock approach to life. Now its time to eat, now its time to sleep, and now its time to play. Babies don't know clock time. And breastfeeding, while about feeding is not solely about feeding. It is about comfort and connection. How do we schedule the human need for love and connection? If it is needed and denied, do we perceive the crying of the infant to only be about hunger or indigestion? When the reality is that the need for love and comfort is as strong as the need for food.
Prolacta obviously has confused breastfeeding tips with breast milk pumping tips. Their suggestions are not geared for mothers who are exclusively breastfeeding and not pumping. Yet Prolacta, like the infant formula industry has chosen to educate parents on breastfeeding. Yet their suggestions are not about breastfeeding but about breast milk feeding. Breast milk feeding benefits their industry. Their tips are about obtaining an optimal supply of donor milk.
Breastfeeding is not breast milk feeding. And while it takes enormous dedication to pump milk instead of breastfeeding, it does not make them equivalent actions. Are we moving towards a breastfeeding society or to a breast milk feeding society? Do babies benefit or does an industry benefit, when breastfeeding and breast milk feeding are considered one and the same thing? Should the human milk industry educate us on breastfeeding?
Time for a patent or two!! Just happens to be Prolacta's patents. Both patents are entitled, "Compositions of human lipids and methods of making and using same." Both patents (#8377445, #8821878), are owned by Prolacta and invented by Elena M. Medo and Scott Eaker, filed in 2007 and 2013 respectively.
Elena Medo is no longer with Prolacta and has formed another company called Medolac (for profit milk bank). She established a company called Neolac in 2009 when she left Prolacta.
Both patents appear to be one and the same, just filed on different dates (patents are for 20 years based on the filing date--so having filed another same or similar patent extends a monopoly). The patents state,
"The disclosure features methods of making compositions that include a human lipid. The methods can include: obtaining whole human milk; separating the milk into a cream portion and a skim portion; processing the cream portion; and pasteurizing the processed cream portion."
"Nutritional support can be administered to the patients in need of it, e.g., enterally or parenterally (e.g., by a process called total parenteral nutrition [TNP])."
Science Daily just had an article entitled, "Human milk fat improves growth in premature infants." (dated Augsut 15, 2014)
"Researchers at the USDA/ARS Chidren's Nutrition Research Center at Baylor College of Medicine and Texas Children's Hospital have now successfully incorporated a cream supplement into premature infants' diets that improved their growth outcomes in the NICU. The report appears in the Journal of Pediatrics."
And while some people would call this article news, I would call it advertising.
This article never mentions that two of the authors of this report in the Journal of Pediatrics are employed by Prolacta (Martin L. Lee and David J. Rechtman) and two other authors (Amy Hair and Cynthia Blanco) received financial support and speaker honoraria from Prolacta. The study was funded by the USDA, ARS, and the National Center for Research Resources General Clinical Research. Prolacta provided the product. None of the authors of this study are inventors to the Prolacta patents. But the study does not mention the patents.
From my perspective, I do not understand the ethics of an industry that makes profits from women who donate (some compensation is offered--breast pump or $1 per ounce of milk provided)? I also don't understand the enthusiasm of some breastfeeding advocates for this endeavor. Interestingly at Fearless Formula Feeder's website, their seems to be a lot of enthusiasm for the recent product of Prolacta, human milk-based infant formula. I don't understand that either, since many of the people supportive of fearless formula feeding don't believe that infant formula has any risks at all--unless you live in some undeveloped nation. So why would this group be enthused about an infant formula made from human milk? If we believe that infant feeding choices are equivalent choices, then who needs human milk infant formula? In the context of public relations and social media I understand the game playing. As long as we continue to believe that breastfeeding and breast milk feeding are the same and can be used interchangeably, industries will continue to profit. Breastfeeding is not just a method of giving nutrition, but about how human beings learn to love and connect to one another. The sad thing is that this understanding of breastfeeding is lost by industries trying to educate the public about breastfeeding. And the reality is that both the infant formula and human milk industries survival is based on breastfeeding not surviving.
Copyright 2014 Valerie W. McClain
Monday, August 25, 2014
"Globalized industrialized food is not cheap: it is
costly for the Earth, for the farmers, for our health.
The Earth can no longer carry the burden of ground-
water mining, pesticide pollution, disappearance of
species and destabilization of the climate."
I recently read, "Supporting Formula-Feeding Moms During World Breastfeeding Week," by Suzanne Barston (Fearless Formula Feeder blogger) published at the Huffingtonpost website on August 6, 2014. Suzanne Barston is an advocate for formula feeding familes. Yet, recently she became a Certified Lactation Consultant (CLC). How exactly does one adequately advocate for both infant formula feeding and breastfeeding families? Isn't it possible that some families may get short-changed by this middle-of-the-road approach? I remember from my childhood a biblical verse that seems to address this concern about a middle-of-the-road approach. From Matthew 6:24, "No one can serve two masters. Either you will hate the one and love the other, or you will be devoted to the one and despise the other."
Suzanne Barston states that World Breastfeeding Week, "is the perfect time to spread our own message about self-care, individuality and confidence." Timing of social media messages is critical. Why pick the same week as World Breastfeeding Week? What message does this send out to the world? Hm, if infant formula feeding is about self-care, individuality and confidence then breastfeeding is not about self-care, individuality and confidence.
I feel a sense of competitiveness, why else pick the same week as World Breastfeeding Week to celebrate infant formula feeding families? Why not pick another month or another week? From the beginning Barston writes about failure--playing at soccer, losing the game because as a goalie she failed to block a shot by the opposing team. Then being yelled at by her teammates and feeling like a failure. This is the author's issue. Should this issue be the basis of running a social media campaign that in essence sabotages a time to celebrate breastfeeding?
The author writes, "What's best for the masses isn't always best for the individual." One has to conclude from the article that infant formula feeding is about individualism and by implication that breastfeeding is what everyone is doing. Yet that isn't even true. Most women do either a mixture of breastfeeding and infant formula feeding or exclusive formula feeding. The message of individualism speaks to who? This is a subtle media message, a Republican ideology, stemming from Herbert Hoover days who coined the term "rugged individualism". Hoover believed that the federal government should not interfere with the American people during the Great Depression. He also said, "After all, the chief business of the American people is business." Business is the priority of our society. Infant formula is a billion dollar business that thrives when women believe that choice is an individual, rational decision not governed by advertising or social media campaigns.
The author writes, "Breastfeeding is one part of a complex puzzle that makes up child health." She states, "Public health messaging is about public health, not individual health." Say what? This statement is bizarre in the extreme. I won't even comment because it is beyond rationality.
The author to prove that bottlefeeding is wonderful and that bonding does not require breasts, let's readers click on a link to a picture of a mother bottlefeeding her baby. Where has the author been for the past few decades? There are bottlefeeding pictures everywhere, glorifying bottlefeeding--just look at infant formula advertising on the internet. What we don't get to see so much is breastfeeding pictures. Even Facebook up until recently was taking down pictures of breastfeeding. We don't need more bottlefeeding pictures. And the fact is that glorifying pictures of bottlefeeding will definitely sell more cans of infant formula. This makes me question how someone who advocates for infant formula feeding (families) can also serve breastfeeding clients well if at all.
I think the biggest problem I have with this media campaign is that all these messages play into an industry that stands to gain in more people using infant formula to express their individuality. And actually this campaign seems to create an even bigger divide between breastfeeding mothers and infant formula feeding mothers with its focus on how infant formula feeding mothers are made to feel like failures (by who else breastfeeding mothers). The reality is that feelings of failure are self-induced and to blame someone else for feelings of failure in a public venue is scapegoating, a well-known propaganda technique.
From my perspective, Huffington Post is unsupportive of breastfeeding, otherwise it would not have published this kind of article, particularly on World Breastfeeding Week!
Another patent...regarding irradiation of infant formula...
Patent # 88902018 entitled, "Apparatus and method for radiation processing of fluent food products," by inventors Shekhar Patel and Laurence J. Kiely and owned by Nestec (Nestle). Filed in 2006. The invention uses e-beams to reduce levels of Enterobacter sakazakii.
"Figure 9 is a flowchart depicting a method of irradiating powder infant formula according to an embodiment of the present invention."
"In most scientific literature it is assumed that on an average E. sakazakii contaminated infant formula has approximately 36 cells/10Kg of product. If an infant formula contaminated at this level is processed by e-beam at a dose level of 3.4 KgY, it will bring down the microbial load to 0.36 cells/10 Kg (almost impossible to detect using current microbial testing procedures)."
Food irradiation has some health risks. Vitamin E and C levels are reduced which can be compounded by longer storage times of irradiated foods. By-products are created by irradiation, one chemical is known to cause DNA damage in rat colon cells at high doses. "Food irradiation does not inactivate dangerous toxins which have already been produced by bacteria prior to irradiation." from Position Statement of The Food Commission-July 2002
I don't know if infant formula is irradiated in the USA or in other countries. Interesting that Nestle owns a patent on irradiating infant formula and I wonder whether this technology is used and in what countries.
Copyright 2014 Valerie W. McClain
Sunday, August 24, 2014
"A nation that continues year after year to spend more
money on military defense than on programs of social
uplift is approaching spiritual doom."
--Martin Luther King, Jr.
We are a visually-impaired country. We are a violent country. We are a society that is racist as well as sexist. And actually racism exists in almost any country in the world. But the US is one of the more dominant violent countries of the world. We have the bombs and the bullets and we use them to suit the business needs of our corporations. Its about power, profits and wealth. As the old bumper sticker states, "He who dies with the most toys wins." Somehow we believe that in the afterlife, that those who made a "killing" on the stock market or in business will be rewarded.
Ferguson, Missouri, a suburb of St. Louis Missouri, home to the Monsanto Corporation, is currently faced with massive protests regarding a white policeman shooting to death an unarmed young black man, Michael Brown. His body left on the street for hours, without the dignity of a shroud. He is one of many young black males to die in the US in confrontations with police. How many will die before our society says enough is enough? Will there be justice for Michael Brown? Was there justice for Trayvon Martin? There is an utter senselessness to these killings. And then when the community stands up against this injustice, they face tear gas and guns pointed in their faces? Why? Is protest now a crime?
I never heard of Ferguson, Missouri before this happened. But I certainly knew that St. Louis, Missouri is the home of Monsanto. It seemed ironic that a company so hated by environmentalists because of its poisoning of the earth and its people, seems smack dab in the middle of racist turmoil. Although, one might consider that environmental degradation is not only poisonous to the health of people but poisonous to the poorer communities, particularly poor black communities. Monsanto, is known for its manufacturing of DDT, aspartame, glyphosate herbicides-"Round Up," Agent Orange/Dioxin, PCBs, genetically modified seeds, aspirin, saccharin, caffeine, vanillin and assisted in the development of our first nuclear weapons. Monsanto is also known for its political influence in Congress, the FDA, the USDA, the EPA, the Courts-including the Supreme Court. Monsanto has the power to influence the nation; to make the populace accept the poisoning and pollution of our land. So should we be surprised that racism seems to be embedded in the roots of a city that Monsanto calls home? Is Monsanto still as racist as their 1950's ad, "It's Plastics Picking Time Down South, depicting blacks picking cotton? see
Or is the racism more subtle? For example, there has been a 98% decline in black farm ownership. Part of the reason for this decline is Monsanto's monopolies on seeds and its curtailing of saving seeds. The saving of seeds has been farmers economic lifeline; without that ability, farmers are put into greater and greater debt.
Who has suffered the most from unemployment (latest statistic from New Pittsburgh Courier/August 2014 jobless rate-4.9% white males, 11.4% black males, 4.9% white females, 10.1% black females)? Who is last to be hired and first to be fired? What neighborhoods have the worst schools with high drop out rates? Racism impacts jobs and education. It impacts medical care. Infant mortality rates for black infants is 2-3 times higher than white infants in the USA. Infant mortality is a barometer of economic well-being of a people. High rates of infant mortality shows us that the well being of the black community is in jeopardy. Black infants have the lowest breastfeeding rates. Racism has a lot to do with a community's access to knowledge about breastfeeding and the risks of infant formula.
When I was a young girl in the fifties I remember watching the television and seeing Southern police and their dogs attack civil rights protestors. I didn't understand that kind of cruelty then and I don't understand it now. I didn't understand why black people had to sit in the back of the bus? Or why they couldn't eat at lunch counters with white people? Or why there were bathrooms for white people only? Or why there were white hospitals and black hospitals? A black person who got into a car accident and was critically hurt near a white hospital would not be allowed in the white hospital and would have to travel to the black hospital (that is if there was a black ambulance). While desegregation has happened, the poisonous nature of racism still exists. It exists in laws that are applied unequally, in whether you can obtain a job or an education or where you can live.
Recently UN human rights official, Navi Pillay's commented to US authorities "urging the US authorities to investigate allegations of brutality and examine the 'root causes' of racial discrimination in America." She further stated, "..privately I was thinking that there are many parts of the United States where apartheid is flourishing." and, "Apartheid is also where law turns a blind eye to racism."(Reuters, Aug 20, 2014, "Missouri racial violence recalls apartheid, UN rights chief says," by Stephanie Nebehay)
As Pillay states in this article racism breeds conflict and violence. Martin Luther King, Jr. stated many years ago, "Discrimination is a hellhound that gnaws at Negroes in every waking moment of their lives to remind them that the lie of their inferiority is accepted as truth in the society dominating them." We seem to be stuck in the continuous tragedy of racism and violence. The US is the number one arms dealer of the world. We also export our crowd control weapons: tear gas, flash bang grenades, and rubber bullets. All this violence we have exported, only to have the police use it on our own streets.
I realize this is not my usual kind of post for my blog. Violence in our society is a huge problem that creates a common state of fear and anger, an exportation of wars across the globe, and violence in our streets. Violence towards one race, towards women and children, is self-perpetuating. It will never end unless more people demand an end to violence, racism, and sexism. This is the time for justice. A time to realize that violence only begets more violence.
Copyright 2014 Valerie W. McClain
"In the end, we will remember not the words of our enemies, but the silence of our friends." --Martin Luther King, Jr.
Wednesday, August 13, 2014
as the savior of the planet. Through the green economy
an attempt is being made to technologise, financialise,
privatise and commodify all of the earth's resources and
living processes."--Vandana Shiva
Breastfeeding is normal or so they say. Yes, biologically, humans are mammals. And mammals feed their young with their mammary glands. So yes-yes, breastfeeding is normal. But I started playing this game in my head and you, too can play the game. If breastfeeding is normal, the question of how a mom is going to feed her baby would not be asked. The assumption would be that you would breastfeed cause that is the biological norm. If breastfeeding is normal, a bottle would not be a baby shower gift. If breastfeeding is normal, a healthy newborn would be at the breast within the first hour after birth. The assumption would be that breastfeeding after childbirth is normal. If breastfeeding is normal, no birthing mom would get a free "6-pack" of infant formula in the hospital. The assumption would be that moms breastfeed their babies. If breastfeeding is normal, moms would breastfeed whenever and wherever they needed to, no stalling for a suitable location. If breastfeeding is normal, moms breastfeeding in public would be unnoticed because it was so normal as to be unremarkable. If breastfeeding is normal, a symbol of babyhood would be a breast not a bottle. If breastfeeding is normal, infant formula would be by prescription only (instead of human milk being by prescription only). If breastfeeding is normal, mothers would be given plenty of time to establish breastfeeding and/or family leave from their employers. If breastfeeding is normal, our stories, our art would be full of written and visual imagery of breastfeeding. If breastfeeding is normal, nursing bras wouldn't cost so much. They would be standard items in every department store and they would include all sizes. If breastfeeding is normal.....(your turn dear reader to play the game!)
Breastfeeding is normal biological behavior in mammals (humans being mammals). But breastfeeding is not normal in our society. If and when breastfeeding ever becomes normal in our society, we wouldn't need to talk about the normalcy of breastfeeding. Yesterday I read this interesting article in NUTRA ingredients.com. The article was entitled, "Breast is best: Punjab gov sets new infant formula labelling rules," by Annie-Rose Harrison-Dunn, dated August 4, 2014. This article is what triggered my thoughts on the game-playing, if breastfeeding was normal...
"Labelling of infant formula sold in the Pakistani department of Punjab must now include the warning, 'mother's milk is the best food for your baby and helps in preventing diarrhoea and other illnesses,' according to new prohibition and guidance rules released by the region's government."
I am all for warning labels on infant formula, which should have a long list of risks for parents to read. And maybe this article is an English translation problem. But to me a warning label should not include a statement about mother's milk/breastfeeding is the best food. A warning label is about the risks of the product, breastfeeding is not the risk. If breastfeeding is normal, a can of infant formula would not have to warn parents that mother's milk is the best food. The assumption would be that breastfeeding is the normal way to feed a baby and that feeding anything else is a risk. But you see we don't live in a world where breastfeeding is normal.
Patent # 8754126 entitled, "Methods for improving tolerance, digestion, and lipid soluble nutrient absorption in an infant, toddler, or child," filed in 2011.
Invented by Chron-Si Lai et al. and owned by Abbott Laboratories.
"Unfortunately, a small percentage of infant formula fed newborns can experience gastrointestinal (GI) intolerance problems, including loose stools, gas, necrotizing enterocolitis, colic, and the like."
"Presumably newborn infants are deficient in lipase, and thus, they do not digest and absorb fat as well as breast fed infants who receive lipase in the mother's milk."
Patent # 8785163 entitled, "Desaturases and methods for producing polyunsaturated fatty acids in transgenic organisms," filed in 2008. Inventors are Toralf Senger and Jorg Bauer and owned by BASF Plant Science GmbH. This about using genetic engineering to produce polyunsaturated fatty acids. BASF is the largest chemical company in the world. It has worked with Monsanto in biotechnology of products.
"Thus, for example, polyunsaturated fatty acids such as docosahexaenoic acid (=DHA, C22:6.sup..DELTA. 4,7,10,13,16,19) or eicosapentaenoic acid (=EPA, C20:5.sup..DELTA. 5,8,11,14,17) are added to infant formula to improve the nutrional value. The unstaurated fatty acid DHA is said to a positive effect on the development and maintenance of brain function."
"The present invention relates to polynucleotides from Helobdella robusta, Laccaria bicolor, Lottia gigantea, Microcoleus chthonoplastes, Monosiga brevicollis, Mycosphaerella fijiensis, Mycospaerella graminicola, Naegleria gruberi, Nectria haematococca, Nematostella vectensis, Phycomyces blakesleeanus, Trichoderma resii, Physcomitrella patens, Postia placenta, Selaginella moellendorffii, and Microdochium nivale, which code for desturases and which can be employed for the recombinant production of polyunsaturated fatty acids."
Patent # 8795750 entitled, "Method for manufacturing low-phosphorus whey," filed in 2010. The inventors are Nobuo Seki et al. and the patent is owned by Morinaga Milk Industry Co., Ltd. (Japan). Cheese whey is the raw material fo infant formula. It was discovered that over-ingestion of phosphorus from foods exerted an adverse effect on bone metabolism. (Morinaga Milk Industry produces infant formual).
"However, when whey is used as a raw material for infant formula, because the whey includes large amounts of minerals, there are limitations to the potential applications of the resulting formula."
Telling moms that breastfeeding is normal when the reality that moms see is that it is not normal creates distrust. Normal is defined as the "usual, expected or standard state." While breastfeeding is upheld as the standard by experts around the world, a mom's reality (brought to you by the infant formula industry control of the media) is that it is not really expected of her to breastfeed. The expectation is that she can't or won't breastfeed (a statement made over and over again in human milk component patents and infant formula patents) and there is a belief that that will never change.
Copyright 2014 Valerie W. McClain
Sunday, August 10, 2014
"Advertising is the art of convincing people to spend money
they don't have for something they don't need."
Well, US News and World Report, you have truly breached the gap between news and advertising. When advertising becomes a news article, do we laugh or cry? Should I be surprised? Me, who only reads newspapers to figure out what the government wants us to believe. No, I am not surprised. Well dear reader how about taking a look at this news article.
"But sometimes, breast-feeding just isn't in the cards..."
Let us believe in fickle fate, luck of the draw, or tarot cards in determining how we feed our babies. Let's not question how hospital birthing policies and practices, lack of support and correct information, and advertising dressed up as news influences the roulette wheel of infant feeding choices.
"[Read: Is Breast-feeding Always Best for Babies?]"
Subtle, eh? I read it, didn't like it. But I am sure that you can convince a number of readers in the validity of choosing the right formula rather than choosing breastfeeding.
"U.S. News, in partnership with Pharmacy Times, conducted a survey of 2,490 pharmacists to see which health products they recommend most often. When it came to infant formula, 49 percent of pharmacists recommend Enfamil as the brand of choice. Similac came in a distant second place with 21 percent of the votes, and PediaSure came in third with 17 percent."
Okay Mead Johnson (manufactures Enfamil) wins the contest...but pharmacists are recommending PediaSure (Abbott manufactures this product as well as Similac) for infants??? Hold on, PediaSure is not an infant formula!! Package brochure states for children 1-13 years old not recommended for children under 1 years of age and states consult a health professional for children under 2 years of age. Obviously consulting a pharmacist about infant formula might not be the wisest thing to do, if some of them are recommending PediaSure as an infant formula.
"Formula isn't the place to look for a bargain."
"Generic companies don't put as much research into their products..."
"Don't splurge on organic."
No, splurge on name brand formulas. Wow if I was Perrigo, manufacturer of store-brand infant formulas I would not be happy with this news article. Perrigo won a lawsuit regarding Mead Johnson's false advertising in 2011.
Hm...here we go again the accusations regarding store brand formulas. Oh wait this isn't advertising...its news!!!!!! God save me from this crazy, messed up world. Orwellian? You bet.
Here's some more patents to enjoy...
Patent # 7893041 entitled, "Oligosaccharide compositions and use thereof in the treatment of infection," filed in 2004. The inventors are Ardythe L. Morrow, David S. Newburg, and Guillermo M. Ruiz-Palacios and owned by the Children's Hospital Medical Center (Cincinnati Ohio), Instituto Nacional De Ciencias Medicas Y Nutricion(Mexico, D.F.,MX), and University of Massachusetts (Boston, MS).
"Significantly enhanced immunologic protection by breastfeeding has been demonstrated for diarrheal diseases, respiratory tract illnesses, bacteremia, meningitis, and necrotizing enterocolitis."
Patent # 8715769 entitled, "Preventing diseases in infants delivered via caesarean section," filed in 2006. The inventors are Joachim Schmitt et al., and the owner is N.V. Nutricia (Netherlands). The believe that C-sectioned infants have different intestinal flora than vaginally-born infants. The C-sectioned infants have less Bifidobacterium and less diverse Bifidobacterium.
"Human milk contains non-digestible oligosaccharides which specifically stimulate the growth of lactic acid producing bacteria, such as species belonging to the genus Bifidobacterium and Lactobacillus and prevent the growth and/or adhesion to the intestinal wall of other (pathogenic) bacteria. Hence, when an infant receives human milk, the infant's intestinal flora develops into a healthy flora rich in lactic acid producing bacteria. The presence of a healthy intestinal flora improves gut barrier maturation and/or gut barrier integrity, stimulates the formulation of mucus, inhibits pathogenic bacteria and stimulates the immune system."
Patent #8637297 entitled, "Isolation, identification and characterization of strains with probiotic activity, from faeces of infants fed exclusively with breast milk," filed in 2010. The inventors are Jose Maria Vieites Fernandez et al., and owned by Hero AG (infant formula company in Europe).
""The general objective of this study is to isolate probiotic microorganisms for a subsequent use in the food and pharmaceutical industry, especially for using them in infant formula milk."
"..the French microbiologist Tissier observed that the fecal microbiota of breast-feeding newborns have more bacteria from the genus Bifidobacterium than the fecal microbiota of children who have received artificial milk and acknowledged the beneficial role of this microorganism."
Henri Tissier discovered Bifidobacterium in the 1900's. He called it Bacillus bifidus communis but it is now called Bifidobacterium bifidum Ti. (Encyclopedia of Food Microbiology, ed. by Carl A. Batt). The health of breastfeed infants was believed to be caused by this substance. So do breastfed infants need probiotics? No, they get it naturally through breastfeeding. The infant formula industry will use this bacteria (derived from the feces of exclusively breastfeed infants) to imitate human milk's beneficial attributes. Of course the question is how does one manufacture such substance and consider it equivalent?
Copyright 2014 Valerie W. McClain