keeping the silence

"Method for stimulating the functional attributes of human milk oligosaccharides in formula-fed infants."

A recent title to a new patent at the US Patent & Trademark Office, patent # 7572474 owned by Mead Johnson Nutrtionals. Inventors of the formula are Bryon W. Petschow et al. Some of the inventors are from Great Britain and Finland. Petschow is the Director of External Affairs for Bristol Myers Squibb (Mead Johnson is part of Bristol Myers Squibb, the pharmaceutical company).

Some statements of interest in the patent:

"Bifidobacterium spp. are also associated with resistance to gastrointestinal (GI) tract and respiratory infection as well as enhanced immune function in children and infants."

"Because cow's milk and commercially available infant formulas that are based on cow's milk provide only trace amounts of oliogosaccharides..."

"Briefly, therefore the present invention is directed to a novel method for stimulating the functional attributes of human milk oligosaccharides in a formula-fed infant, the method comprising administering a therapeutically effective amount of polydextrose (PDX) to the infant."

So why should we care about this patent? What does the infant formula industry know? They know their product is deficient and that they will have to "therapeutically" change their product in order to create a product that is resistant to diseases that effect the GI tract and the respiratory system of the infant. Sounds to me like we are talking about a pharmaceutical use of a food product. What will be their advertising slogans to get mothers to buy this product? And exactly why do we still believe that infant formula is a safe product in developed countries, when formula companies have to continue to improve their product in order to "try" to make it safer?

Of course, safety is not mentioned in this patent. But if resistance to infections is not the same in formula-fed infants, then it would seem logical to assume that formula-fed infants are sicker and their mortality rates are higher than breastfed infants. Why else "try" to imitate human milk?

I had correspondence some years ago with an MD regarding the safety of infant formula in the USA. This MD was not happy with my stance (not safe and never has been and never will be). I believe that this MD's belief was that because everyone had access to the greatest medical system in the world, any problems with formula could be rectified medically. Access....access to doctors and hospitals? Hm...how many people uninsured now in the USA? Sometimes even with the best of care, infants die...like the elderly they are our most vulnerable population. But the silence continues regarding the safety of infant formula because it is politically unacceptable to offend the infant formula industry (other than Nestle).

Copyright 2009 Valerie W. McClain

Silencing other views, more patents

It seems to be a common response to alternative ideas on medicine, science, politics, even lactation consulting to respond in ways to silence those opposing views. This is done to protect one's reality, one's income, and one's ego. This response is so rampant in our society that I have come to believe that we, humans, are not very democratic. We treasure our reality and heaven forbid someone burst the bubble of our reality. How dare they think differently, see reality differently! Why can't they be nice and shut up? Yes, even I have succumbed to this ego-mania. Every once and awhile, I get stopped in my tracks and realize that reality is a composite of individual realities. No one has all the knowledge, all the answers. By shutting people out or up, one becomes lost in a fantasy of one's own making. Solving the difficulties of life, becomes impossible when one's mind is not open to other possibilities, other realities. Of course, that doesn't mean one let's other people bulldoze your reality. These last 10 years have opened my eyes to the difficulties in any profession in which "niceness" is the priority (mostly a woman issue). Being nice, means not openly telling the truth as you see it. Instead we beez nice and play nice....and maybe we getz a cookie for niceness. Actually niceness gets us to be speakers at Conferences, niceness gets us friends with the right pull, niceness gets us contracts with the government, niceness gets us jobs. Nice people gets to keep all the un-nice people out of sight and mind. Of course, the question is how do we define "un-nice." I leave it to the nice people in the world to define the "un-nice." My version is that niceness often involves having the right education and the right neighborhood. Having the right education (the Cornell, Harvard, Hopkins, etc higher institutions of niceness) means that one is automatically assumed to do no wrong. Heck, people with ivy league paper diplomas never lie, steal, or cheat. Just one of those American truisms that leds us "gently" around the world diplomatically telling the "unnice" people what to do. Breastfeeding advocacy is about being nice. Our niceness means that we do not discuss patents on human milk, human milk researchers who are funded by the infant formula industry (almost all of them) and the pharmaceutical industry, and never discuss any other formula company other than bad, bad Nestle. So we believe and encourage human milk researchers to speak at Conferences in which they do not have to publicly disclose their affiliations with the infant formula industry, nor disclose their patents they own. We don't know the names of the "other" infant formula companies because they aren't important. And we don't care to discuss the implications or even the facts about human milk component patenting. Nor do we discuss companies like Medela or Pigeon or Lansinoh because we are the nice people and it doesn't matter if these companies have easy access to breastfeeding advocacy organizations and their BODs.

Before I totally show my "un-niceness" I wanted to write about few patents that might interest some people.

In 1997 a patent was published at the US Patent & Trademark Office owned by Boehringer Ingelheim called "Human lysozyme" (patent # 5618712). Boehringer Ingelheim is a huge pharmaceutical company that has developed alot of hiv/aids drugs.

"Up til now, human milk and human placenta have been the only commercial sources for obtaining human lysozyme." Okay...so human milk was sold commercially to the pharmaceutical industry prior to 1997. Interesting, something I have been saying for some time and been disbelieved. Patents are legal documents, so I would suppose that they aren't lying about it.

They go on to say in this patent that since the availability of human milk and placentas was limited, they have had to develop a synthetic version (a gmo version). Why bother with human lysozyme? because, "The therapeutically effective use of lysozyme is possible in the treatment of various bacterial and virus infections (Zona, Herpes Zoster), in colitis, various types of pain, in allergies, inflammation and in paediatric (the conversion of cow's milk into a form suitable for infants by the addition of lysozyme)." Treatment of allergies? Who to believe? Kramer?? a pharmaceutical company???

Another patent called "Method for expressing phosphorylated recombinant human.beta.-casein in a bacterial system," (patent # 5807702) owned by Abbott Labs (drug and infant formula company) published at the US Patent & Trademark Office in 1998. This infant formula company states, "Efforts have been made to develop infant milk formulas that have some of the advantageous properties of human milk and avoid the disadvantages associated with bovine milk based infant formulas such as allergic reactions and incomplete digestion by the infant."

Abbott Labs believes that human milk is "less likely to cause allergic reactions." Maybe they should talk to Kramer and not bother genetically engineering human milk .beta.-casein. "Hansson et al. demonstrated that recombinant human .beta.-casein was expressed in the yeast, S. cerevisiae using the pYes 2.0 vector (Invitrogen Corp., San Diego, Calif)."

Of course, I can hear people saying that they don't genetically engineer human milk components for infant formula. Maybe not. But published some 11 years ago (filed in 1995), so they could do it years ago. What would stop them from putting it into formulas now? The FDA?? Hm...I wouldn't answer that rhetorical question....signing off as one un-nice person...

Copyright 2009 Valerie W. McClain

Infant formula patents and allergies

What to believe? Breastfeeding does or does not prevent allergies? Why would Kramer et al in the recent PROBIT study on allergies see no difference in allergies between infants whose moms were encouraged to breastfeed longer and exclusively and infants whose moms were not encouraged. Maybe because the differences between the two groups was minimal? Differences would be subtle because essentially all mothers were doing both breastfeeding and bottlefeeding-some more breastfeeding, some less. I thought it might be of interest to quote from some patents regarding allergy and infant feeding.

Patent #5591446 published at the US Patent & Trademark Office in 1997 is called, "Methods & agents for the prophylaxis of atopy." owned by Beiersdorf AG (a multinational company in Denmark that produces and sells cosmetics-Nivea-and personal care, wound care items).

"By the 1920"s, it was recognized that early childhood nutrition plays an important role in preventative medicine. R.S. Zeiger et al; in "Journal of Allergy and Clinical Immunology," 78 (1 Part2):224-238 (1986) stated that breastfeeding in combination with a delay in supply of solid nutrients is suitable to alleviate atopic dermatitis and food allergies in early childhood."

But that is a cosmetic company and maybe they don't understand the recent science in which breastfeeding has no effect on allergies? Hm...Let's look at a Nestle patent (#7230078) published in 2007 called "Soluble toll-like receptor," by inventors Eduardo Schifferin. They have claims on a human milk component (soluble toll-like receptor). "Their" human milk component will, "provide for prophylaxis, prevention, treatment or therapy of inflammatory conditions or allergic reactions in a mammal..." Mammals, I guess that would include us, humans. Nestle is using a human milk component against allergies....confusing, eh? How can that be?

Patent Application 20080125346 called "Infant Formula" by Beermann et al, owned by NV Nutricia (European infant formula company) pulbished in 2008. They state, " The present nutritional composition is particularly suited for feeding infants as it mimics the protective effects of human milk, in particular against allergies and infections." Both Nutricia and Nestle seem to think that human milk has some sort of protective effect.

Patent Application 20080139499 called, "Beta-Serum Dairy Products, Neutral Lipid-Depleted and/or Polar Lipid-Enriched Dairy Products, and Processes for Their Production," invented by Katrina Fletcher et al and owned by Fonterra Cooperative Group/New Zealand (Dairy company that was touched by the melamine scandal in China)

They say, "Research over the last 5-10 years has shown that increasing phospholipid and (glyco) sphingolipid levels in infant formulations to levels found in human milk may lead to enhanced gut maturation thereby reducing the risk of infection; prevention of infections by modifying gut intestinal flora and competitively binding antigens, prevention of allergies, and optimal neural development."

It looks like the infant formula industry is trying to imitate human milk in order to reduce the risk of allergy. Rather odd considering the media's reporting of Kramer's studies in which we are to believe that breastfeeding does not make a difference in allergies. What does the public prefer to believe? It would seem odd that patents are saying one thing but media reports on research says something different.

In April of 2008, "a symposium at the American Society for Nutritions' annual meeting at Experimental Biology was held in which noted scientists discussed new infant feeding studies..."

http://www.medicalnewstoday.com/printerfriendlynews.php?newsid=103695

Kramer presented his evidence regarding the PROBIT study and obesity--breastfeeding had no effect. Not surprising that the finding showed no effect--same data from the original PROBIT study where all babies did breastfeed and bottlefeed (some breastfeed exclusively and longer but by 6 months of age all babies seemed to be bottlefeeding more than breastfeeding)

The conference was sponsored by the IFC (international formula council) which includes Abbott, Mead Johnson, Nestle, and Wyeth. PR by Kellen Communications.

So what do you believe and why???????

Copyright 2009 Valerie W. McClain, IBCLC

The PROBIT studies by Michael S. Kramer

Anyone else been following Lactnet and the Michael Kramer thread? Me, me, me, me......I even sent an email to the Lactnet listmothers, asking them if they would consider my comments worthy of sharing with Lactnet subscribers...NOT. Of course, I think my comments might further clarify the PROBIT (Promotion of Breastfeeding Intervention Trial) studies. But clarity and other viewpoints seem to be illusive in our world. I wrote the following email to Lactnet.

from the email:
Dear Lactnet Listmothers:
I have been following the thread on Lactnet regarding Canadian researcher, Michael S. Kramer and was hopeful that my comments were worth sharing with Lactnet subscribers. The PROBIT study by Michael S. Kramer et al. was published in JAMA in 2001. It showed a very positive view of breastfeeding and particularly showed that with positive breastfeeding interventions, more women would breastfeed longer and exclusively. (WHO defintion of exclusive breastfeeding). And it seemed to show the positive health benefits to infants when mothers exclusively breastfeed. In the 2001 JAMA paper it stated that "Atopic eczema was reduced by 46%." This paper stated, "In addition the prevalence of exclusive breastfeeding was seven fold higher in the experimental group [interventions to encourage exclusive breastfeeding and longer duration of breastfeeding] at 3 months (43.3% vs. 6.4%) although low in both groups at 6 months (7.9% vs 0.06%)." Looking at the data, the prevalent mode of feeding was MIXED FEEDING not exclusive breastfeeding. Health benefits to infants were visible despite the fact that a majority of infants were not exclusively breastfed.
http://jama.ama-assn.org/cgi/content/full/285/4/413

In 2007, the BMJ published another study using PROBIT participants who were now children, again lead by researcher Michael Kramer entitled, "Effect of prolonged & exclusive breastfeeding on risk of allergy & asthma..." This study shows no benefit of lengthy or exclusive breastfeeding regarding allergy or asthma. They used skin prick tests (for dust mites, cat, birth pollen, mixed northern grasses, and Alternaria) on the children. The majority of PROBIT infants were not exclusively breastfeed. How do we come to a clear understanding of the relationship between how one is fed as infant and health effects, if one is fed not only breastmilk but other milks?
http://www.bmj.com/cgi/content/full/335/7624/815

Of interest regarding the BMJ paper, is that the list of authors to this paper are different than the JAMA study. Last author to the BMJ paper is a Bruce Mazer. While he is also a Canadian researcher from McGill University, he also has represented the drug company, Fujisawa Healthcare, inc. see
http://www.wvdhhr.org/bms/sPharmacy/PDL/Mtg_agenda_minutes/bms_pdl_20030122minutes.pdf
Interestingly this drug company sells Protopic Ointment for atopic dermatitis. In 2001 the FDA issued a warning letter to this company for this ointment because their TV ads were determined to be misleading.

The PROBIT study was funded by the Canadian Institute of Health Research (Canadian government). While researchers may do research at the universities or through various government agencies, they also maybe funded by various industries. Does this negate the sicience? Possibly. When I look at studies/papers I look at not only the first author of the study but the last author. Often the last author is of more importance to the study--gathering the funding, guiding the particular research. It looks to me like Mazer in the BMJ study is of importance, particularly when one is refuting the original work of the study in which your data is based.

Should we believe that the 2001 study was defective in regard to allergy and asthma? Does the newer study gave [give] us better science? Or is this paper a reflection of a change in authors? Bruce Mazer is paid by a drug company that specifically markets meds to alleviate atopic dermatitis. How is the drug market effected when we believe that exclusive and lengthy breastfeeding does not impact allergies or asthma? Or how is it impacted when we have one study that says one thing and another the reverse? Confusion...maybe less reason to support breastfeeding, more media stories that say that health effects of breastfeeding are minimal...

It would seem to me that it would be highly improbable that Michael Kramer did not know of Mazer's association with Fujisawa Healthcare Inc. and the drugs designed by this company against allergy. This is something that should have been disclosed before publication. These two studies give us a good view of how changing the author can reverse the original findings. The problem with the original study and this follow-up on allergy and asthma is that one cannot use mixed feeding of infants to determine health effects. One needs to examine exclusive breastfeeding versus exclusive formula feeding to get the real picture. The original paper gave us a real understanding of how positive interventions (BFHI) will increase the duration and exclusivity of breastfeeding. The second paper muddies the waters of our understanding about health effects and breastfeeding because a majority of the infants were not exclusively breastfed.

Sincerely,
Valerie W. McClain, IBCLC"

These further comments were not sent. According to one report read on the internet, "Canada's patent holding pharmaceutical companies have teamed with the CIHR (Canadian Institute of Health Research) to create the not-for-profit R & D Health Research Foundation." PROBIT studies were funded by the CIHR. Do pharmaceutical companies partnered with government give us better studies or more studies supportive of pharmaceutical objectives? The CDC has its own foundation, too, in which the pharmaceutical and infant formula industries support. So how much of science funded by government is a science seeking the truth and how much is science seeking customers? Should we allow our health care professionals to understand how much their "evidence-based" medicine is owned by the pharmaceutical and infant formula industry? Yes, silence wins again.
Copyright 2009 Valerie W. McClain

stormy weather....genetic engineering risks

How much of infant formula ingredients are genetically engineered? 2 per cent? 10 per cent? 50 per cent? 75 per cent? 99.9 per cent? Your guess is as good as mine. Read the ingredient list? I can barely prounounce the ingredients and I supposedly learned English in US schools. OK? What about cow's milk? We know that recombinant bovine growth hormone is in cow's milk (unlabeled). Recombinant means that it is was man-created not naturally created. If the product is soy, we know that 80% of US soy crops are genetically engineered. That means that the genes and specifically DNA has been manipulated by someone in some lab. We are told by those who produce this new food that we shouldn't worry, it's safe. And we are told to save the world from famine that it is necessary to use this technology. (Tell this to India, where farmers are committing suicide in large numbers because of crop failures and the necessity of buying genetically engineered seeds--no saving seeds, the farmer must buy from the company store--Monsanto) Genetic engineering seems to be requiring the use of more and more pesticides and herbicides putting farmers at risk financially. And we need to factor in the risks to human health from handling, spraying such chemicals onto your land where you have to breath, drink, and eat.

There is a long list of ingredients in formulas. Do parents who buy this product for their babies know how these ingredients are made/created? Formulas have added vitamins and minerals because the food is highly processed and is devoid of nutrients. Many of those vitamins and minerals are not absorbed well and manufacturing processes often overload the vitamins because of shelf life (18 months).

Many of those vitamins are derived from corn (vitamin c--60% of US corn crop is genetically engineered) or soy. The oils are derived from crops that are often genetically engineered. So who knows what this mix means for infants and their future health.

According to the Union of Concerned Scientists genetically engineered foods have a potential of harm to health and the environment.

http://www.ucsusa.org/food_and_agriculture/science_and_impacts_genetic_engineering?risks-of-genetic-engineering.html

Dr. John Fagan, a molecular biologist at the NIH for some years, states that there are risks to eating genetically engineered foods. He mentions an increase in allergies. The potential of toxins in foods--specifically mentioning the L-tryptophan disaster in which 37 people died and 1500 people were permanently disabled around the world. L-tryptophan was genetically engineered. It was a supplement and it took a while before anyone understood what had happened. It was called a manufacturing error. Another risk he mentions is reduced nutritional quality.

http://www.psrast.org/jfassess.htm

We face a society in which we learn after the fact that our food is being changed at the molecular level. Food no longer tastes the same, children are sicker and fatter. And we point the finger at parents being too indulgent. Yet food has changed to met the supposed needs of a society that is into fast living, fast food eating. Our foods are laden with salt and sugar and bet ya just can't eat one potato chip ya eat the whole bag. We have become a society addicted to our fast food and fast living. We have to medicate ourselves to survive our food. We feel like crap and we are miserable. We are drawing in the poisonous nature of our food, digesting a world of pesticide, herbicides and now genetically engineered organisms. Our science is mixing human genes with bacteria, fungi, yeast, and animals, and we wonder why we have this new disease called H1N1-swine flu. How is it that diseases are now quickly jumping the species barrier? The government called it a "novel" flu. Novel, great word--we call DHA novel. What does the government mean when they use the word novel, new? What does the future hold for all these babies who are being fed this novel food we call infant formula? We believe that infant formula must have a place in our society. Shouldn't it matter what the choice may mean for the long term health of these childern? Stormy weather ahead....is life about greater profits and making money? Does money take priority over truth, health and the well-being of our next generation?

Copyright 2009 Valerie W. McClain

DHA farming or mutant manufacturing 101

Let's go to the DHA farm. How do ya grow DHA? DHA is naturally present in human milk. DHA stands for docosahexaenoic acid. If you can prounouce it, go to the head of the class. I think that is why we call it DHA, much easier to say. Its an omega-3 oil and people usually obtain their omega-3's from fish oil or a vegetarian source is flax oil. Martek Bioscience, an offshoot of the Martin Marietta space program, devised a way to produce DHA through algae (single cell oil production). Originally, the direction of this new food science, was to solve the problem of growing food in space. A great deal of creativity and innovation went into solving the problem. But Martin Marietta divested itself of this research and a new company was born in the eighties, Martek Bioscience.
About nine years ago, I happened across a couple of their patents, and wrote about it in Lactnet.
I stated that the patents talked about the use of recombinants in production of DHA. In my mind when we start talking about recombinants we are talking genetic modification (the DNA is not a natural combination, but a man-made mutation). So I stated that I believed that Martek's oils were genetically engineered. Not long after that statement, I received an email from the company's medical director which stated that their product was not genetically engineered and that if I persisted with stating the products were gmo their would be consequences. I didn't know what consequences but I certainly could envision some pretty dire happenings. So, I started using the word "novel" because that is what the FDA used to describe the DHA and ARA sold by Martek. In genetic engineering terminology novel can mean something new but also can mean genetically engineered. Certainly, one can create this oil with the natural or as they state in their patent "wild" type organism. But there are also some problems with manufacturing on a large scale. These oils are farmed in tanks. The algae is not harvested from the ocean or other bodies of water. It may have at one time been harvested from its natural environment but it is grown in a lab, petri dish. For a price at the ATCC (American Type Culture Collection) you can buy some of Martek's algae. Feed it and it will multiply. Anyway, on a large scale, Martek ran into problems making enough of the oil from the algae (and they were experimenting on various algae to see which one's produced more of the oil). They believed that genetically engineering the algae could resolve some of their production problems.
Patents are legal documents and as such one would assume that how something is worded is critical--critical for possible future litigation and critical for an understanding of the technical nature of the patent that makes it innovative. In August 13, 1992 Martek Bioscience filed a patent called, "Infant formula and baby food containing docosahexaenoic acid obtained from dinoflagellates." (patent # 5397591) The inventors, David J. Kyle et al, state:
"Accordingly wild type and recombinant microorganisms designed to produce single cell oil containing DHA are an aspect of this invention. Such recombinant organisms would include those designed to produce greater quantities of DHA in the single cell oil, greater quantities of total oil, or both, as compared to the quantitites produced by the same wild type microorganism, when provided with the same substrates."
This patent does not say "wild type or recombinant" nor does it say "wild type and/or recombinant." So we have a patent written in 1992 that states the use of recombinant microorganisms. We also know through documents that Martek Bioscience was having a hard time keeping up with the production of DHA. ARA oil, is derived from fungi, which is produced at DSM (Dutch State Mine, a Netherland food company that was once an oil company) and shipped to Martek. This novel farming of food is being used in organic products. I am not sure how one would perceive this kind of farming to be organic?? But I guess if you have enough good PR and enough scientific studies about the value of omega-3, then regulating bodies fall sway to the power of belief. Funny how that belief does not support the promotion of breastfeeding. Rather the belief is that the effort, money most go into making a better infant formula. It would seem to me that in giving infants alternatives to breastfeeding, it would be critical that we have a better understanding of novel or gmo products and their effects on our most vulnerable populations.
Copyright 2009 Valerie W. McClain

a patent application

Cheshire Cat, all-knowing tree-cat...looking down, seeing what? knowing what?

Lactation consultants might be interested in a patent application owned by Medela. It's called "Method of assessing breastfeeding," patent application 20080108882. It's about a "method of assessing the health of a breastfeeding relationship." I didn't know that assessments are something you could patent. I have this vision of various LCs patenting their method of assessment. Heaven forbid, you use someone's patented assessment without paying a fee. In this case the fee will go to Medela and maybe the inventor will get some bucks for it (Catherine Peta Garbin). Reminds me of Monsanto and the use of their gmo seeds. Everything on this earth is ownable (a word??). Of course one has to have the money to file for patents and pay their yearly fees. So of course that lets me off the hook. I'll just have to invent my own assessment in my head and never talk about it because someone might patent my idea. I envision court cases where LCs will be accused of using the Medela assessment without paying their fees. Or what about the possibility of the infant formula industry getting into patenting of breastfeeding assessment? I could just see Nestle owning patents on breastfeeding assessment. I can also envision companies accusing LC's of using their patented assessments without paying for it. How to make lawyers happy and wealthy and corporations all-powerful! Don't worry, be happy.....

Copyright 2009 Valerie W. McClain