Customers at the hospital or at the doc's office

In the US, we have witnessed a change of view regarding health care. We are no longer considered "patients," although that is what we have to have in order to get through the medical maze. We are now considered "customers." Meaning we are entering a business relationship when we enter the hospital or go to doctor's office. We present our credit cards or cash (quick care clinics do not take checks) and we may get two or three minutes of undivided attention for our medical problems. As customers, the motto is "let the buyer beware." But the problem is as customers we don't know the language of the seller, nor does the system seemingly allow the buyer any negotiating power. The customer is often in a powerless position of pain and fear. Sometimes the customer is a child or a baby. A child or a baby is even more powerless than an adult upon entering our health care system. Sometimes the child or baby is caught between the medical system of "knowing best" and the parent who believes they know the "best." Add to this mix, our health care system which is now powered by "business" principles. Customers, or patients as they use to be called, believe they have entered a system of care. The reality is they have entered the marketplace. But not a marketplace of choices. Your healthcare professional speaks Greek to you and has a fixed gaze upon his or her watch--you have 15 minutes. Your chart they hold, looks like a Webster's Dictionary that seems to have the answers entombed within the pages. Solutions seem fixed upon drugs, vaccinations, and surgical procedures. You may spend hours in the waiting room. In fact it has the feel of the hours you spent at the auto dealers negotiating for a car. You feel trapped by their time warp. They give you minutes but hold you for ransom in their offices for hours. A pathetic system disabling to all, encluding the health care profession.

I suppose many think that this health care bill will be enabling to all of us, "customers." Instead I fear, that it will be more of the same, only worse. If we are perceived as customers in healthcare then it would seem imperative that we have full disclosure of how the people in healthcare and their institutions receive funding. If we are customers, then we should have more choices not less. Yet the healthcare system creates a helpless customer. How can the buyer beware at the doctor's office or at the hospital, when the buyer does not understand the language nor the rules? We call it Healthcare but it is just another business.

Copyright 2009 Valerie W. McClain

Job Fair--wanted infant formula or breast pump reps

I just happened to run across an advertisement for a job at JOBcentral entitled, "neonatal academic sales associate" for Mead Johnson. The job requirements eliminate me. It would not be a job I would ever consider, nor would the infant formula industry want me. I would be a poor sales person--I don't schmooze very well. Anyway the requirements are a BA/BS degree--got that!! Minimum 2 years medical sales--nope, not even successful selling lemonade on a hot day. They are looking for a neonatal dietician, RD, Pharm D or NICU RN preferred. I think I'd make a good neonatal dietician--breastfeed, breastfeed, breastfeed. Wait a minute I don't think that's what they want?? Besides they prefer a NICU RN. In the job description it says, "develope and cultivate business relationships with a wide range of key decision makers and targeted customers within the Hospital setting." WOW...schmoozing 101. Not my style...yeah my style is to irritate the hell out of friends and enemies alike.

Another statement, "Build profitable business in the NICU and Academic Hospital Community which will maximize long term revenue goals, increase sales, and market share growth for nutritional and pharmaceutical products."

Here's another job description statement, "Understand the role of Professional Services and network with appropriate HCP's (healthcare professionals) to grow attendance at Mead Johnson Nutrition's national and regional sponsored events." So......this explains to me why NICU babies don't breastfeed. Oh yes need I forget, they do sometimes human milk feed. (yes I know there are many wonderful people out there working to help moms breastfeed their premmie babies--but they are out-gunned by industry). Medela (breast pump company) recently announced their "Virtual Human Milk Collection Campaign Awards." Medela donates $20,000 in Neonatal Human Milk Support Products to Neonatal Intensive Care Units in Mississippi, Oklahoma, Pennsylvania and New Mexico. Human milk support products, human milk support products, human milk support products, human milk support products---think they mean bras??? Oh yeah I sure am silly this morning, I guess they are talking about all the gadgets to "help" the medical staff or maybe mothers humanmilkfeed babies. Don't need products to breastfeed, no not really although we have created a culture of women who believe they need "products." Sounds to me like the NICU is the target of a vast sea of industries selling their wares--how the heck do medical people get their work done. Oh yeah, the target is the power brokers in the hospital. I would be interested in seeing data on breastfeeding rates (initiation, duration) of NICU babies. By breastfeeding I do not mean humanmilkfeeding. Funny, I use to think hospitals were about saving people from medical disasters. I never ever thought about the sales force behind the decision making of products in the hospital. What drug you get, what bandage you receive, what infant formula or humanmilk supplement your baby gets is dependent on what industry has the best sales force. Ever met an infant formula rep or breast pump rep? They all are good-looking, well-dressed, and very intelligent and they know how to schmooze.

Yep, I can't look at a hospital without seeing the legends of sales men and women waltzing through the doors. I can't look at a doctor without thinking about who is her or his favorite sales person. That does not negate that their are life-saving products. Just that we should be aware that health care is an industry like any other industry. Let the buyer beware.

Copyright 2009 Valerie W. McClain

World Health Organization: hiv and breastfeeding

In November of 2009, the WHO (World Health Organization) issued a document called, "HIV and infant feeding: Revised Prinicples & Recommendations." There was alot of jubilation from breastfeeding advocates who believe this is a breakthrough document encouraging hiv positive mothers to breastfeed exclusively. Well..................yes, the recommendation is, "mothers known to be HIV infected (and whose infants are HIV uninfected or of unknown status) should exclusively breastfeed their infants for the first 6 months of life, introducing appropriated complementary foods thereafter, and contine breastfeeding for the first 12 months of life." But the recommendations also state that "HIV infected mothers to either breastfeed and receive ARV interventions or avoid all breastfeeding." This recommendation is not directed at developed nations like the US. In fact there is a scary comment regarding "highly resourced countries." "In some of these countries (highly resourced) infants have been removed from mothers who have wanted to breastfeed despite being HIV infected and even being on ARV treatment. In these settings, the pursuit of breastfeeding in the presence of safe and effective alternatives may be considered to constitute abuse or neglect." So if you are a hiv-infected mother living in Africa you can breastfeed your baby as long as you take meds. If you are a hiv-infected mother in the USA, you will be considered abusive or neglectful if you breastfeed your baby. Geography is the key to recommendations regarding breastfeeding and hiv. Does this make any logical sense? Does this clarify the situation? One way or another, this issue makes enormous profits for the pharmaceutical and infant formula industry (which often are one and the same companies). For information on studies regarding the safety of these drugs for mothers and babies readers may want to go to the website of Alberta Reappraising AIDS Society:

http://aras.ab.ca/art-perinatal.html

and

http://aras.ab.ca/haart-perinatal.html

I would highly encourage breastfeeding advocates to read the beginning of this document regarding the declared interests of the writers of this document.

http://www.who.int-child_adolescent_health/documents/hiv_if_principles_recommendations_112009.pdf

The writers and researchers have financial ties to: Nutriset, Bristol Myers (infant formula and pharm company), Centoceor, Johnson & Johnson, Ortho Biotech, Ortho-McNell Janssen, Purdue Pharma, Roche, Sanofi-Aventis, Schering Plough. But boldly they state, "The Group unanimously agreed that none of the declared interests were likely to influence the discussions of the meeting." So by making this statement the readers are to believe that how one is funded makes no difference? Years ago, I believe no one could have gotten away with such statements. But now one can make such statements and the document gets hailed as a breakthrough because it recommends that hiv positive women in resource-poor nations breastfeed. Of course they can only do so as long as they take meds. And now we have an international document that states that hiv-infected mothers in resource rich nations are abusive if they breastfeed. I call this a serious step backwards and one that needs to be questioned. Why should we believe that this decision was not influenced by the pharmaceutical and infant formula industries?

Copyright 2009 Valerie W. McClain

Dr. Luc Montagnier, human milk, and oxidative stress

"Immunotec Congratulates 2008 Nobel Prize Winner in Medicine, Dr. Luc Montagnier." He won the prize for his 1984 discovery of hiv. Immunotec is a company that sells a product called Immunocal, which is a protein isolated from whey. see

http://www.healthy-is-wealthy.com/nobelprize.html

In this long advertisement, they mention that Montagnier (along with two others) edited a book called, "Oxidative Stress in Cancer, AIDS and Neurodegenerative Diseases," (1997) A chapter in this book is called, "Nutriceutical Modulation of Glutathione with a Humanized Native Milk Serum Protein Isolate." Humanized native milk??? Hm.....methinks they are talking about human milk proteins (made by a cow)? Cloned milk? One way to get human milk proteins is to genetically engineer the embryo of a dairy cow to produce such substances as lactoferrin, alpha-lactalbumin, etc. Normal cows make very little lactoferrin or alpha lactablumin. One biotech fix for that is to create a cow that makes human proteins.

So we have a nobel prize winner in medicine, whose name is being used by a company to support the use of whey proteins in the treatment of hiv/aids. Hm.......so exactly why aren't hiv positive mothers allowed to breastfeed in the USA? Oh yeah, I forgot, we have a man-made genetically engineered whey protein that imitates human milk proteins to treat hiv/aids. The belief is that breastfeeding transmits disease? The scientists say that the mammary gland manufactures proteins to prevent or treat disease. Yet somehow when it comes to hiv/aids that system doesn't work and instead we should buy the imitation human milk proteins. Fascinating how we debunk nature/breastfeeding and place our beliefs on the altar of our science gods. So we go out and buy us some denatured whey protein but we spurn breastfeeding.

Copyright 2009 Valerie W. McClain

Pregnancy, Florida law, hiv tests, and informed consent

Florida Statute 381.004

Back in 2005 the Florida legislature created a law in which informed consent for testing of sexually transmitted diseases (hiv in particular) is not a requirement. This was not directed at all people in Florida but at certain people. First on the list was "persons convicted of prostitution or procuring another to committ prostitution, then inmates, and then pregnant women. Also mentioned was that a medical examiner did not need informed consent for autopsies or investigations. Thus in the land of Disney World, a paradise of sand & sun, tropical flowers and fruits, pregnant women are denied informed consent along with convicts and prostitutes. What does that say about Florida legislators and their belief systems? Do we believe that pregnant women are not deserving of informed consent because they need to be controlled like convicts and prostitutes? If you carry another human being in your body, the state feels you have no legal right to informed consent? Is pregnancy a deviant behavior--since the list includes people who break the law? What were these legislators thinking? Shouldn't a pregnant woman be informed that because she is pregnant she is more likely to have a false positive hiv test? If you break the law and are convicted, it is understandable that you would lose your civil liberties for a time. But how does a pregnant women fall into this category of law-breakers?

Copyright 2009 Valerie W. McClain

What's wrong with patenting human milk components?

Why should we be concerned about the patenting and commodification of human milk components? It's a good thing, right? It shows that at least the scientific community as well as big business and government finally get that human milk is of value. Well, yes they get it. But no they don't get it. Current "popular" scientific inquiry is based on reductionism not holism. Thus, scientists are looking for "a" magic bullet to create health or fight disease. Most scientists are looking for a human milk component not looking at human milk as a whole or even more appropriately looking at breastfeeding. Their viewpoint narrowed by a perspective that does not represent the reality of our bodies and its relationship to the environment. Reality is multi-faceted. The immunology of the body is barely understood because so many factors are involved in creating a healthy immune system. Looking at an organism under a microscope tells us some things. But that organism is part of a bigger world than the view we see with the microscope.

Investors and the corporate world view human milk components as investment property. They aren't concerned or interested in breastfeeding, other than how it will impact their investment.

Patenting is ownership and it is monopolization. It is also involves a degree of secrecy so that the competition stays behind in the race for fortunes. Why do we believe that a corporation has the right to own something made by the body? If the corporation owns it, what does that mean legally? Can they like Monsanto in its patented seed monopoly, demand tribute for its use by individuals? That wouldn't happen, you say? Maybe not. But Monsanto is a prime example of patenting and monopolization using the legal system to defeat the small farmer in the US and farmers in developing countries (India, patented seed causing massive financial failure for the small farmer and because of it massive suicides). We think this will never happen. Maybe not but certainly when it comes to making money, ethics often gets overrun by the robber baron mentality. Secrecy, how many people realize that human milk components are being used as the "new" antibiotics or in vaccines or in test kits for disease? Do you know where the bacteria came from in your yogurt, infant formula, or supplements?

The transgenics of cows, goats, sheep, and mice is based on the biology of the mammary gland. We can make human proteins to fight disease in the mammary gland of another species. But let's not explain to people that the proteins in the human mammary gland fight disease--like hiv/aids or the popular H1N1 flu. Can't say that because scientists know that it is just "one" concentrated component that fights disease--and that component is man-made, genetically engineered. What is in our food and supplements is becoming a state secret. Knowledge is becoming difficult, if not impossible to obtain.

Breastfeeding advocates enthused about the patenting of human milk components, might want

to reflect on how this will encourage, protect, and promote breastfeeding. Patenting has gone on since the 80's and is increasing daily. Recently, the CDC website on H1N1 flu was encouraging breastfeeding mothers to separate from their babies if they got that particular flu.

How safe a recommendation is that? Scientists believe that human lactoferrin, a component in breastmilk is our new antibiotic and is also an antiviral. What about Nestle declaring ownership in human lactoferrin to be used against hiv/aids? Even the US Government in its patent on human lactoferrin declares that it inactivates hiv/aids. Yet women are told to stop breastfeeding and use infant formula. Yes, use that infant formula that has that genetically engineered human milk protein to inactivate hiv/aids. Essentially society believes in the yuck factor of breastfeeding. The belief is that something that yucky must carry disease. Something made in a "sterile" lab by men in whitecoats and genetically manipulated is good for us.

The mammary gland is about survival of the next generation. The gland is a manufacturing plant that fights all sorts of pathogens that the mother encounters in her environment. Those pathogens are bacteria, viruses, fungi, and parasites. We distrust this biological system at great risk to future generations. Ownership and monopolizing human milk components does not support breastfeeding. It supports the belief system that one magic bullet will save us from a disease and that breastfeeding is just a personal lifestyle, like having a Gucchi handbag.

Copyright 2009 Valerie W. McClain

The "catch-22" of probiotics/prebiotics in breastfed infants

As breastfeeding mothers madly dash for the probiotic drops for their colicky infants, they might want to rethink this supplement, especially if they are trying to exclusively breastfeed. And as lactation consultants and the assortment of health care professionals start making this recommendation, they might want to review some very crucial issues.

A recent study in the 2009 Acta Paediatr (98:321-323) called "Cow's milk allergic children can present sensitization to probiotics," by FM Bruni et al. Colick in some breastfed infants is a result of having a cow's milk allergy (either to cow's milk proteins in mother's milk, or to not being exclusively breastfed). So giving probiotics to an infant already sensitized to cow's milk may create a worse situation.

How is probiotics created? Does the consumer understand where the bacteria comes from that creates the supplements and foods that is suppose to create a healthy gut? Lets take for example BioGaia's liquid drops probiotics. According to advertisements for their drops, L.Reuteri is cultured from human breast milk.

http://www.feelgoodnatural.com/product.27.php?Code=FER288100

A paper in Applied & Environmental Microbiology confirms that ATCC 5570 L.Reuteri is a strain isolated from human breast milk by the company Biogaia of Sweden. The paper is called "Genomic & Genetic Characterization of the Respnse of Probiotic Lactobacillus reuteri ATCC 55730" by Kristi Whitehead et al. This study shows the genetic manipulations being done on human milk bacteria. This same bacteria from Biogaia (ATCC 5570 LReuteri) was used for the study on colic and probiotics in Pediatrics and also is a patent (#5837238) see

http://pediatrics.aapublications.org/cgi/reprint/119/1/e124.pdf

So we are to believe that it is far better to give a breastfed infant L.Reuteri bacteria made from some other mother. The bacteria is cloned for use in the food and supplement industry. How is this bacteria the same bacteria that a breastfed infant receives naturally from its mother? Can't be even close to the same because it's survival in the petri dish is dependent on various chemicals. And how do we know whether the bacteria is genetically engineered or not, since in the USA no one has to label their genetically engineered products? Is the bacteria stable? The concern in one paper I read was that there are antibiotic resistant genes in LReuteri and they were working on a process to eliminate those genes. Should we say hurray, hurray??

Isn't their a high level of irony in telling a mother to use a product that at one time was another mother's human milk bacteria? We get the breastfeeding mother to buy a product, therefore she contributes to the growth of the economy. But some breastfeeding mothers contributed to the economy by giving their milk to some smart businessman. Who is now selling it back to them? Brilliant capitalistic game. Have to admire the audacity of our current businessmen who rob from Mary and they make her and others like her buy it back from them. All in the name of health and holism? These products are for support of gut health and based on research on human milk. How come we don't believe that a mother's exclusive breastfeeding supports gut health? We, consumers and health professionals, prefer to believe that something made in a laboratory by a corporation will promote gut health. Breastfeeding mothers are the blood, sweat, and tears of the corporation. Who profits when we have lost our faith in one of humanity's greatest natural resource?

Copyright 2009 Valerie W. McClain

CDC does not recommend nasal flu vaccine for pregnant women

The CDC does not recommend that pregnant women get the nasal flu vaccine. They recommend the inactivated virus vaccine shot. see
http://www.cdc.gov/h1n1flu/vaccination/pregnant_qa.htm

One patent application (20090081255) on a flu virus vaccine at the US Patent & Trademark Office owned by Sanofi Pasteur (French pharmaceutical company) discusses the use of vectors such as plasmids (usually used in genetic engineering). It also mentions the use of artificial chromosomes. It would seem highly likely that any inactivated virus flu vaccine will be genetically engineered. Currently there are no studies on H1N1 flu vaccine and pregnancy but studies will be starting soon. Interesting way of doing medical research....put out the product then test to see if its safe. It used to be the other way around but in this busy world we don't have the time.

I just finished reading a document entitled, "Legal Immunity for Pharmaceutical Industry" in which they state, "So far, neither the WHO nor the CDC or any other scientific body has demonstrated required scientific proof for the existence of the alleged H1N1 Influenza A new virus." Sounding more and more like hiv/aids. The existence of hiv is debatable and the PR campaign was about a massive epidemic--which never materialized (in Africa all statistics are debatable--testing unavailable, number of cases estimates only).

PhRMA (pharmaceutical industry group) had a press release dated 4-28-09 entitled, "PhRMA Applauds Kathleen Sebelius Confirmation as HHS Secretary." An interesting comment written in this April 2009 press release, "It's equally important for Congress to act rapidly to put a full-time Commissioner in place to head the Food & Drug Administration (FDA). Consumers count on the FDA to help assure the safety of a myriad of products--including the life-saving anti-virals contained within the Strategic National Stockpile which could be deployed in the event of an influenza pandemic." Gee whizz, those pharmaceutical people are sure amazing. They had that premonition that we were headed for an influenza pandemic. I guess one might call that fortune-telling....
Copyright 2009 Valerie W. McClain

Genetically engineered vaccine

The H1N1 flu vaccine created by Medimmune is patented. Two patents by this company are described at the US Patent & Trademark Office. There is patent # 6843996 called "Recombinant PB2 variant influenza virus," and patent # 6974686 called, "Recombinant tryptophan mutants of influenza." Both patents use genetic engineering to create the vaccine.
http://patft.uspto.gov/ patent number search

What do we know about genetically engineered vaccines? I don't know much about it. Who does?? How stable is a live genetically engineered vaccine? Meaning will it mutate into something else, something more virulent than its design? Why is a supposedly democratic society limiting choices in health care? Is there an epidemic emmergency? Why should we believe that this is some different flu that requires massive immunization of our population? Rather odd that there is no longer any legal recourse for people damaged by immunization. I suppose that suggests that the US Government and the pharmaceutical industry believe that vaccines are absolutely safe for all people? Or does it mean that these people-government officials and industry refuse to take responsibility for their decisions?

People my age (50's) remember very clearly the swine flu disaster of 1976. Perhaps this is why the government has chosen not to call it the swine flu. Instead it is just a bunch of letters and numbers. But the people are still calling it swine flu--easier to remember. In conversations with a variety of people close to my age, who regularly go to their doctors, get vaccines, I am fascinated by their response to this particular vaccine. Most people seem to have a wait and see approach. They aren't particularly moved by the view that there is a massive epidemic. But then most people in my area are more concerned about the massive epidemic of unemployment. Survival in this cruel democratic nation without a job is far more scary than getting sick and dying. In fact, dying might be a relief.
Copyright 2009 Valerie W. McClain

Marketing Swine Flu

Many have forgotten the 1976 CDC campaign to get the public vaccinated against swine flu. Many who will be impacted by the current hysterics regarding the "novel" swine flu, have no idea that health care is marketed to manipulate people towards consumption of certain health care products. Some Americans will never forget the 1976 swine flu vaccine campaign because they or their relatives died or were maimed (Guillain-Barre Syndrome) by the 1976 vaccine. In 1979, 60 Minutes did an expose on the swine flu vaccine of 1976. I watched the 30-year-old video in which it is revealed that there was 300 death claims from the 1976 swine flu vaccine but only one death from the actual flu. Claims against the US Government amounted to 3 1/2 billion dollars.

http://www.examiner.com/ article by Fred Burks dated 7/10/09

Thirty years later we must be much more advanced in our medical technology. It couldn't happen again? Or could it? The reality is that the only thing that can't happen again is that victims of vaccine injury or death can file lawsuits. Happily for the pharmaceutical industry, new laws have been created so that consumers have no legal recourse for vaccine deaths and injuries.

Who are the targeted groups for this "novel" swine flu vaccine (H1N1 ---novel in a genetic engineering dictionary usually means genetically engineered--so is this flu an escapee, a man-made flu not a natural mutation of flu?)? The targeted groups for this vaccine are: pregnant women, persons who provide care for infants, heath care providers/EMTs, persons 6 months -24 years old, persons 25-64 who have serious medical conditions.

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr58e0821a1.htm

The novel H1N1 vaccine was given an EUA (Emergency Use Authorization issued by the FDA to "allow either the use of an unapproved medical product or an unapproved use of an approved medical product during certain types of emergencies with specifed agents.").

http://www.cdc.gov/h1n1flu/eua/qa.htm

Our Secretary of Health,Kathleen Sebelius, declares an emergency and the FDA Commissioner, Margaret A. Hamburg may authorize an emergency after consultation with the NIH and CDC.

The first batch of vaccines for our novel flu is a MedImmune/AstraZeneca-parent company product. It is an intranasal live vaccine. Adverse reactions as declared by MedImmune are runny nose or nasal congestion, for children from 2-6 years old fever greater than 100 degrees F, and sore throat in adults. MedImmune states that the "safety of this vaccine has not been studied in pregnant women or nursing mothers." It is not approved for use in children under 24 months of age, nor approved for use in individuals 50-64 years old. MedImmune states it may not protect all individuals. They have a caution to nursing mothers and pregnant mothers--only use if clearly needed (not sure how that is decided). This vaccine has not been evaluated for carcinogenic, mutagenic potentials or its potential to impair fertility. see

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182406.pdf

After reading various articles on the internet regarding the need for vaccinating pregnant women with the H1N1 vaccine, I find myself deeply troubled. There is an obvious media campaign going on to get pregnant women vaccinated. Yet this particular vaccine being brought out first by the US Government has some troubling statements in its product insert of the vaccine. What consumer will read the product insert? Pregnant women are being targeted--yet this vaccine because of "OUR EMMERGENCY" was approved for use without the usual safety reviews. This particular vaccine states that children under 24 months of age should not get this vaccine, yet the CDC target population is from 6 months of age an up to 24 years old.

Pregnant women and their families should look at the CDC MMWR regarding the three pregnant women that got the H1N1 flu. In this May 12th report, one woman died from acute repiratory distress syndrome but her speciman could not be confirmed as the novel influenza A (H1N1) virus. One pregnant mother fully recovered, and one pregnant woman (not tested for this flu) remained asymptomatic after being given oseltamivir (tamiflu). Supposedly the CDC will add to these cases (April-May 2009). Although I haven't seen anything else at the CDC website other than these 3 cases. These 3 cases prove what?? I don't get it? Is this the leading edge of the epidemic--where cases cannot even be confirmed to be this novel H1N1 flu? Scientific? Yikes.

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5818a3.htm

What is behind the panic? And why does the CDC socially market pharmaceutical products? One can guess. One can wonder about the relationship between the current Commissioner of the FDA (who approved the rapid deployment of this vaccine without the normal chain of safety reviews) and her past directorship of the Henry Schein Inc. (medical and dental supply company). "Henry Schein can source practically all forms of vaccines.." (mentioned are MedImmune, Merck, SmithKline Beecham. Wyeth)

http://www.henryschein.com/medical-vaccines.aspx

In a SEC filing dated 5/22/09 by Margaret A. Hamburg she divested some of her stock in Henry Schein before being sworn in May 22, 2009 as Commissioner of the FDA. But it appears that she also kept some of that stock. The company is also the distributor of Tamiflu. Nasdaq shares of Henry Schein were down 1.8 percent at $51.51 in early trade in August 4, 2009. I am sure that with flu season upon us, shares are going up for Henry Schein. One of our past Commissioners of the FDA, Jane E. Henney is on the BOD of AstraZeneca and also Director of Cigna. It never ceases, the flow between industry and government. Obviously, these people have expertise but is that expertise helpful to Jane the Pregnant Lady down the block? Or is health care policy about the Nasdaq?

Copyright 2009 Valerie W. McClain

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

who owns that company?

The other day I happened to find out through browsing the internet that a company called, Weston Presidio-a private equity firm-owns the company Evenflo.
http://www.westonpresidio.com/
They own quite a few companies. Now, Evenflo bought Ameda, the breast pump company. Interesting, eh? But gets even more interesting. Ameda sells on its website Lansinoh Lanolin under their products and accessories page calling it Ameda Lansinoh Lanolin. And Lansinoh pump parts are interchangeable with Ameda Purely Yours. So is Ameda a distributor of Lansinoh products? Are they partners? Now Lansinoh is owned by Pigeon Company (Japan). So things are getting downright complicated in my mind. Was Hollister (I believe they owned Ameda at one time) bought by Pigeon, too? Their website reminds me of Pigeon (the red theme). So who really owns these companies? And what does it mean to be owned by a private equity firm?
Prolacta seems to be financed (owned?) by several venture capital companies. And it seems that Elena Medo is no longer publicly mentioned at their website. Have these venture capitalists eased her out? The BOD seems to be made up of ex-Baxter employees and venture capitalists.
I feel very ignorant about venture capitalists and private equity firms. Where do they get all their millions/billions? Playing the stock market? Who owns these companies? Would the WHO Code mean anything to these companies? Is the bottom line, profit and profit only? We have become an international community through the buying and selling of corporations. So when US political parties take donations from corporations are they taking money from within the country or are outside interests massaging the political process? Who would really know since the ownership of corporations/companies has become so convoluted? Are we becoming "One World" under the guidance of the corporate giants? And what is their politics? What do they want and what are they willing to do to get what they want?
Copyright 2009 Valerie W. McClain

Human Papilloma Virus (HPV) and breastmilk

Like drinking coffee in the morning, I have this addiction to reading Lactnet, a listserve for lactation consultants. Although I still maintain my credentials as an IBCLC, I no longer practice this profession. Lactnet becomes a way of staying in touch with the issues of my profession. Which I guess means I really haven't quit the profession, maybe I am just on hold. One of the issues recently brought up was whether a mother should breastfeed when her milk tests positive for HPV. I am extremely fascinated by testing breastmilk because I think testing for the presence of a disease in human milk can give you a false impression. Since the mammary gland is an antibody factory, a living and dynamic production line designed to build the immune system of the next generation, it would seem logical to assume that one would find various bateria, viruses, fungi, etc. Does that mean that the breastmilk is contaminated? Infant formula would be considered to be contaminated, if it had pathogens in it. But why would we presume to believe that human milk is the same kind of substance as the dead food substance we call, infant formula?

Some years back a research paper was published in the New England Journal of Medicine called, "Treaatment of Skin Papillomas with Topical Alpha-lactalbumin-Oleic Acid. It was a paper co-authored by Catharina Svamborg.

http://content.nejm.org/cgi/content/full/350/26/2663

Svamborg has a number of patents on the human milk component, alpha-lactalbumin (HAMLET) at the US Patent & Trademark Office. These patents are owned by various pharmaceutical companies (Swedish, Danish companies). One patent in particular is about the use of the component to treat HPV. There are numerous articles on the web regarding the use of this human milk component to "destroy warts and fight cancer."

http://www.skane.com/cmarter/cmarter.asp?doc=1021

or

http://www.newvision.co.ug/PA/9/34/493830

It would seem that some health care professionals will be treating HPV with a human milk component. And some health care professionals will be recommending that babies be removed from the breast because of the detection HPV in the breastmilk of the mother. Thus we will harvest human milk for the component to treat HPV but we will discourage women from breastfeeding. It seems to make sense to the health care community but from my perspective is just more nonsense. This is what was done regarding HIV. There are numerous patents on the use of various human milk components to treat HIV/AIDS owned by the infant formula industry (Nestle and Nutricia) and even the US Department of Health. So the belief seems to be that "one" human milk component (protein) can cure a disease but breastfeeding can only mildly protect an infant from pathogens. Of course, this has nothing to do with making money, does it? This is about science and health. I have been told by various people in the breastfeeding community that patents have nothing to do with reality. We don't need to discuss it because it is not about present day reality. So the blinders stay on, women are continually discouraged from breastfeeding because of one reason or another. Meanwhile, the corporate world quietly, legally is planting their "flags" on various proteins made by the human mammary gland. Should we be surprised that fewer women are breastfeeding or breastfeeding exclusively? I guess so. Heaven forbid we open the door to the forbidden topic of patents, and ownership of human milk and its components. Odd this world....

Copyright 2009 Valerie W. McClain

There is a Pigeon in the house...

Life is beautiful. Life is complex. Look at the daisy and we see the beauty, the complexity of life. If only one were a flower like the daisy, life would be so simple. No need to think about life, just be life. Just reach to the sun and unfold, feel the rain, the heat of the moment. Feel the wasp gently tickle our petals as she moves and feeds. Feel the wind, gently move us or on some days pull us down to the ground. We are one with the earth, we make no judgments about the flowers next to us. We don't feel prettier or uglier than the flower next to us. We aren't richer than the rose. We aren't dumber than the ivy who climbs to the top of the house. We just are here. We can relax into living until our time is up. Sigh....oh humanity where is our souls? Lost in the maze of getting ahead of our neighbor--being richer, smarter, better-looking, having the power to move others to do our bidding. We are truly lost in a world that could be at one with life, with mother earth.

How does one gently, kindly make criticisms to people you care about, love. I am not sure there is an easy way to do it. Should one remain silent, so that the people you care about are not hurt by your thoughts? Should one remain silent because the situation is too painful to look at, too hurtful. Should one remain silent, because criticism invites ostracism? Should one remain silent because that criticism impacts how people make a living?

There are people outside breastfeeding advocacy that will not understand what I am writing about and I apologize ahead of time. But for those who have been following discussions on Lactnet regarding Lansinoh and the WHO Code, this particular post to my blog might be of interest. We, in the breastfeeding community have over the years been upset over the connections that the medical establishment has with the infant formula industry. We become angry about the way in which infant formula is marketed. Yet, we are blind to the insidious way in which various companies have gained favor in our breastfeeding organizations. Take for instance Lansinoh. Back some years ago, Lansinoh became the first company that La Leche League endorsed. As a La Leche League leader back then, I felt the need to write letters to the BOD of La Leche League stating my disapproval of this event. In response, I got a hand written note from one of La Leche League founders, Betty Wagner Spandikow. Her letter stated her agreement with my disapproval of endorsements by La Leche League but that the majority of the BOD had approved the endorsement. This was before I had a personal computer (1980 something) and I had typed letters sent by snail mail to every board member and every founding mother. I kept Betty's letter to me for some years but at this point I have no idea if it is still around. I was impressed that one of the founders took the time to hand write a letter to me. Not long after that I attended a Breastfeeding Conference and who should sit down next to me but Sue Huml, IBCLC who was an employee of Lansinoh (last I read she was the Director of Education & member of the Breastfeeding Advisory Board at Lansinoh). Sue Huml was a former executive director of LLLI and Exhibit Manager for LLLI. We both looked at each others badges and I realized that this was my golden opportunity to ask her a few questions. But someone I knew started talking to me and when I turned again I found that she had moved to the other side of the room. Lost opportunities. Anyway, I was not pleased with La Leche League's endorsement of Lansinoh but I lived with it and mostly forgot about it. Then a few years back I bought a newer edition of the Womanly Art of Breastfeeding because my old edition was ratty. One day I was trying to find a quote from the book and happened upon a sentence in the book where it was basicly an endorsement of Lansinoh for sore nipples. I just sat in my chair and couldn't believe it. I don't think this endorsement was in previous editions of the Womanly Art. I had never seen it before. I felt an enormous sense of anger that La Leche League would use this book to advertise for Lansinoh. I felt shock then but that was some time ago and nothing much shocks me anymore. We are living in mighty strange times. As most breastfeeding advocates now know, Pigeon Company of Japan bought Lansinoh. Pigeon is considered a WHO Code violator. Lansinoh, despite the fact that it is owned by Pigeon, has advertised in the JHL and allowed to have booths at breastfeeding conferences (although Medela is no longer given such privileges). The stance by ILCA, according to Liz Brooks, IBCLC (ILCA board member) is that there is a firewall between Pigeon company and Lansinoh--that the same people that ran the company before the Pigeon takeover are still the people running it now. According to the information I saw on the web the president of Lansinoh is now Shigeru Yamashita, Chief Director of Overseas Business for Pigeon. Reshed Hagen is listed on the website as "Founder." How much control she has over decisions is difficult to know. Lansinoh's breastfeeding advisory board is James Sears, MD (son of William Sears), medical advisor. Rubina Mason, RN, IBCLC is also a medical advisor to Lansinoh. And Gina Ciagne, CLC is director of Breastfeeding Relations and Outreach at Lansinoh. Gina Ciagne at one time was employed by the Office on Women's Health in the US Department of Health and Human Services and she was involved with the Breastfeeding Ad Campaign (a campaign that failed for a number of reasons). The difficulty that the medical profession has with extricating itself from relationships with the infant formula and pharmaceutical industries is similiar to this situation. Endorsements carry obligations to both parties. It is so easy to be critical of the cozy relationships between medical societies and the infant formula industry. But when the Pigeon is in our house, what do we do? Do we walk the walk, talk the talk? Or do we give excuses for our cozy relationships? The Pigeon in our house belongs outside. We are no different then the people we criticize, if we accept this situation.

Copyright 2009 Valerie W. McClain

The International Conference on Lactoferrin, probiotics and Medela in Africa

photo by Jessie McClain

The concluding remarks of Dr. Tony Schryvers at the 8th Conference on Lactoferrin, "Finally with bovine lactoferrin widely available through the dairy industry of a number of countries and with human lactoferrin available from transgenic rice, transgenic cows and fungal expression interest in its application is growing rapidly."

According to Bo Lonnerdal, who has organized the Lactoferrin Conferences, bovines (cows) have little to no lactoferrin. At least that is what he stated to the media some years ago. The FDA does not recognize the term "bovine lactoferrin" instead calling it "milk lactoferrin." So one finds oneself wondering how they are producing all this "bovine lactoferrin?" From the statements made at this Conference, human lactoferrin is genetically engineered through various approaches all involving genetic modifications. At this Conference they all state, "Recently, lactoferrin has been introduced into infant formula because of its potential health effects as we know." The belief seems to be that the real component is identical or somewhat identical to their genetically modified versions. So does the public understand that within infant formula are genetically modified human milk components? Obviously acceptable by the FDA and no need to let the public know what's in that can of infant formula. The Lactoferrin Conference was sponsored in 2007 by Biopole, DMV, Four Leaf, Pharming, Tatua, Armor proteines, Belgo-milk, Friesland Foods, Jarrow, Morinaga, etc. see
http://www.lactoferrin.conference.com/

Next conference in Beijing, China.

Dated October 19, 2004; "Fonterra taps into Asia's appetite for lactoferrin
"Lactoferrin will be to the dairy industry what aspirin has been to the pharmaceutical industry..."

"Lactoferrin is in demand because of its nutritional and immune-enhancing properties as an ingredient in a range of products. These include infant formula, yoghurts and speciality nutritional formulations. It can even be used as an additive in fresh milk to extend shelf life."
http://www.ap-foodtechnology.com/content/view/print/35194

Long live lactoferrin!!! What women make, men take.....

In February 2006, Nutraingredients.com, "Puleva Biotech's human milk probiotic debuts in Spain." Lactobacillus gasseri from human milk. "Results suggest that bacteria in breast milk could be a natural probiotic for newborns. Moreover there is a strong possibility that the strains could be used in products aimed at adults." "The probiotics market could increase as much as threefold this decade, to be worth $137.9 million in Europe in 2010 and $394 million in the US."
http://www.nutraingredients.com/content/view/print/182626

Long live probiotics!!! What women make, men take....

Last but not least, let's discuss Medela (the breast pump company) in Africa. A foundation called "Working to Advance African Women," is partnered with Medela. Partnered might not be the right word, but Medela breast pump products are sold to help finance the foundation. I gather it is somewhat similiar to how La Leche League got involved with Medela years ago. Of course, I am not sure I understand how well the selling of the breast pump culture to African nations will be beneficial. It kinda of reminds me of the infant formula industry in Africa. How do poor women in Africa benefit from this technology? How do you clean a pump, or refrigerate your milk when you live in poverty? Even in the USA, this is an issue. When I worked in the WIC Program I worked with moms who lived in their cars. They had difficulties taking a shower and keeping their babies clean. So exactly how would a pump help them??? Breastfeeding, actually keeping the baby at the breast, was the safest solution. Technology transferred into areas of poverty often does not work. Yet Medela is poised to enter into areas of extreme poverty and high infant mortality rates with their solutions. Is this a solution for women in Africa, particularly in areas of poverty? Does economic survival for women and their babies depend upon separation? Is it dependent upon the technology of pumps, the commodification of human milk? Why are we exporting this kind of culture to Africa?
http://www.waawfoundation.org/contactus.htm

Why are women in the dark about the value of breastfeeding? Is it because men of industry, men of science have mammary envy? Why imitate the mammary gland, why use the cells in cultures, in cloning, in genetic engineering? Our esteemed men of science called the first sheep cloned, Dolly. Why? Because they used a mammary cell in cloning the sheep and it reminded them of a well-known human female known for her mammary cells (Dolly Parton). I read this in a news article...those research scientists have a sense of humor.....depending on your perspective.
Copyright 2009 Valerie W. McClain

$$$stem cells and other medicinal properties of breastmilk

photo by Jessie McClain

"Research shows that breastfeeding provides multiple lifelong biologic advantages to children, including increased survival and improved neurocognitive and immune functioning."

James A. McGregor MD CM and Lisa J. Rogo

Their article in the JHL (Journal of Human Lactation) states, "We propose that maternal stem cells secreted in milk and suckled by the infant may be an important but so far unappreciated live, functional component of breast milk."

Several years later, an article in ScienceAlert states, "He [Dr. Mark Cregan] believes that it [breast milk] not only meets all the nutritional needs of a growing infant but contains key markers that guide his or her development into adulthood."

In Current Science of March 2001 the discovery of "Leukaemic inhibitory factor [LIF] in human milk," is announced by D. Kaul and Jogender Singh from the Department of Experimental Medicine and Biotchnology in Chandigarh, India. "LIF plays a major role in the host response to inflammation, tissue injury and septic shock."

In an article in Behind the Medical Headlines called, "Hamlet, breast milk and viral warts," Dr. EC Benton discusses the human milk component, alpha-lactalbumin (AL) which is in breastmilk and protects infants from infection. She discusses several researchers and their work with AL. She writes that in 2000 Svensson et al "suggest that in addition to its well recognised anti-microbial activities, breast milk might also contribute to mucosal immunity by a process of immune surveillance of the infant's immature epithelium protecting it against both infection and cancer."

Her last statement in this article states, "Optimum mode of in vivo delivery to tumours may still pose challenges, as might the supply of sufficient quantities of human breast milk, but there seems little doubt that HAMLET promises to be a major player on the stage of cancer therapeutics."

http://behindthemedicalheadlines.com/articles/hamlet-breast-milk-and-viral-warts

This article also discusses the use of topical alpha lactalbumin-oleic acid (from breast milk) as a treatment for skin papillomas.

Dr. Mark Cregan discussed earlier regarding stem cells, is also co-inventor to a patent application #2007005922 called "Method for isolating cells from mammary secretion." Which is about harvesting stem cells from breastmilk. While it is about a "method" there seems to be some questionable claims that would make those of us without a legal background wonder whether an actual claim is being made on stem cells. The article in sciencealert states that harvesting stem cells from breastmilk would be entirely ethical in comparison to the harvesting of cells from embryos. Yes, that is true to a degree. It circumvents the need for aborted fetuses. But there are still ethical issues involved in harvesting stem cells from breastmilk. First, would mothers be informed that the intent of the researchers was to harvest stem cells?? We have reason to doubt that mothers would be fully informed of this intent. Should mothers who provide their breastmilk for stem cell research have a financial share in any economic windfall of that research? Will this interest of stem cells increase breastfeeding promotion? Or will the need for secrecy (patenting requires a degree of secrecy) create a media atmosphere in which breastfeeding is devalued?

HAMLET is already patented (about 5 patents) by researcher Catherine Svanborg and owned by a pharmaceutical company. HAMLET's proposed use is for cancer and HPV (human papilloma virus). Yet mother's are bombarded by articles that question the validity of breastfeeding as a public health measure (The Case Against Breastfeeding by Rosin in The Atlantic). The media has played an enormous role in presenting breastfeeding as a lifestyle choice, when the reality is that breastfeeding is a public health issue. How does a consumer make a health decision when evidence of the value of breastfeeding and the risks of infant formula are surpressed. Even breastfeeding advocates seem to be unaware of the increasing commodification of human milk components (genetically engineered), its use in foods, infant formula, supplements, and most importantly in the pharmaceutical industry.

Copyright 2009 Valerie W. McClain