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 becomeing 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