A "novel" oil

Infant formulas have "novel" oils added to them to imitate the naturally occurring DHA and ARA in breastmilk. The UK definition of novel food is "a food that is produced by a novel process, e.g. a genetically modified food product." I am not sure how the US defines "novel." Novel seems to mean "new" but also could be "genetically engineered." Let the consumer guess seems to be the FDA position on novel foods. These novel oils are added to some organic infant formulas as well as most conventional infant formulas.

The creation of ARA by novel methods means that a fungal species is used to make this oil. The fungal species that is often used is called Mortierella alpina. We can buy this species at the ATCC (American Type Culture Collection) in Rockville Maryland accession # 42430. I am not sure whether one gets the orignal species or the cloned version. Next step is to get our species to replicate. So we place our species on a growth medium--can be glucose, molasses, high fructose corn syrup, hydrolized starch, or whey permeate. Then we add a yeast extract or a peptone or tryptone or cornsyrup liquor or soy flour or hydrolized vegetable protein. Those skilled in the art of making single cell algae and/or fungal oils will know how to carefully shake and stir it and watch it grow in fermentor tanks. Next is extraction, hexane is used. Then the cloudy oil must be clarified using acetone. Foaming is a problem, so anti-foaming agents must be used. And sometimes other polar solvents must be used like ethanol or isopropyl alcohol. Yummy.....

And this is placed in infant formula and organic infant formula. (DHA is produced in a similiar manner, only using an algae species). This is called single cell protein production. It is a new way of making food but is also a way of making fuel (replacement for crude oil). Humans have never eaten such food before...hence the word novel. Algae and fungi reproduce by cloning. But natural reproduction can often be too slow for a growing industry. With genetic engineering techniques, an industry can alter genes of these single cell organisms to produce more oil in their darkened fermentor tanks. It's a challenge. But our science is meeting the challenges of food production. Too bad the consumers (babies) have little to say in regard to what they eat.

(Martek Bioscience, maker of these oils, denies that they genetically engineer their algae or fungi.)

Copyright 2008 Valerie W. McClain

HIV...patents

On April 23, 1984, Margaret Heckler, Secretary of the Department of Health, announced the discovery of the virus that was the "probable" cause of AIDS. She also announced that within the next 6 months there would be a test for blood to determine if it contained the virus. On that same day, April 23, 1984 at the US Patent & Trademark Office two patents were filed. Patent # 4647773 called "Method of continuous production of retrovirus (HTLV-III) from patients with AIDS and pre-AIDS." The inventors were Gallo and Popovic with the owner of the patent being the United States Government--Department of Health. And patent #4520113, called "Serological definition of antibodies to HTLV-III in sera of patients with AIDS and pre-AIDS condition." The patent inventors were Gallo, Popovic, and Sarngadharan and it was also owned by the United States Government. These patents have portions disclaimed. This beginning seems to represent all that is so very questionable about hiv/aids policies in the medical community and with the government. No peer review was done regarding this discovery. Government announcement of a "truth" and government ownership of the blood tests to the invention done in one day. Twenty-four years later, many people accept as fact that hiv causes aids and that testing everyone for this disease is a public health policy that is based on scientific truths.

Government ownership of medical inventions, tests for diseases, seems rather strange to me. I thought government created laws. I never realized that government could be a business...indeed a business involved in determining disease? Wow...so when laws are passed that make it mandatory for pregnant women to be tested for hiv, should we consider that the government has an unbiased opinion? They own the invention to the testing. They own the original research (although the French might dispute this--it was French researchers who sent Gallo the samples he used to proclaim that hiv=aids).

What about the "discouragement" of breastfeeding for any hiv-positive woman by the US government (Department of Health). The US Government-Department of Health owns a patent called, "Method of screening for risk of cancer using human lactoferrin." (patent # 5948613) This patent was filed in 1996 and states, "Due to its bacteriocidal, antifungal, and immunoregularory activity, administerin pharmaceutical acceptable doses of lactoferrin of the present invenion could prove an effective agent to treat patinets with AIDS or patients with neutropenia." Human lactoferrin (which is what they are discussing in this patent) is a component of human milk. It will be a recombinant, a genetically engineered version of the real component. But the patent is based on studies that show what the real component does. So when we look at the US Department of Health policy on hiv/aids and breastfeeding, are we seeing scientific facts or a business decision? Are decisions made based on patent ownership or on scientific facts?

Various companies owns patents on the use of human lactoferrin in treatments for hiv/aids.

Pharming of the Netherlands owns patent # 6333311 called "Useful properties of human lactoferrin and variants thereof." It states, "Therapeutic indications for hLF [human lactoferrin] and LF variants include use in therapy or prophylaxis of infection, including local infection, large scale (bacterial) infection, blood borne infection (sepsis) as well as inflammation resulting from infection....also used to prepare or treat organ transplant recipients or other immunosuppressed individuals (e.g. AIDS patients)."

Or Snow Brand Milk Products of Japan (now owned by Nestle of Japan) who manufactures infant formula. Their patent (#5565425) filed in 1994 states, "Recently the inventors confirmed the inhibitory effect of iron-binding proteins against infection and growth of HIV .....containing LF [lactoferrin] as an effective ingredient."

What do you believe and why? Does patent ownership effect government health policies?

Copyright 2008 Valerie W. McClain

Comments to a anonymous comment

I recently received a comment to my post on "Bone mineralization." The anonymous commentator states:

"Your reasoning is flawed, breast milk is the best nutrition for babies. However there needs to be comparable substitutes for mothers who are not producing enough milk, who have engourged breasts and those who are HIV positive. Thank God you are able to breast feed."

The only comparable substitute would be a mother's own pumped milk and in cases of low supply donor, human milk. Artificial milks have serious health consequences for all infants. Those health consequences may be obvious immediately or not so obvious-- impacting the individual when they are older (allergies, diabetes, heart disease, cancers). I do recognize that current availability of donor milk is limited . It is dependent upon where one lives, who one knows, insurance coverage, cost, etc. But mothers should know that there are health ramifications in using artificial milks.

Is low milk supply a problem that cannot be fixed? Very few women cannot fully breastfeed their infants. The medicialization of birth and breastfeeding often creates the problem of low milk supply. Low supply is often a ramification of separation of mother and baby. Separation can either be because of hospital procedures (prematurity or hospital routines). Or separation may be intiated by the mother or her family believing that separation is normal. There are various factors that can create low milk supply but almost all those factors are correctable with positive interventions.

Engorgement is another issue that can be corrected and this problem is more often than not a problem created by mother/infant separation. Engorgement is one of the more easily fixed issues in breastfeeding management. On the other hand if sore nipples are the cause of the engorgement then the problem is more complex but still fixable.

Hiv-positive mothers are actively discouraged by the CDC and the US medical community from breastfeeding. But the question is whether this is correct policy or policy driven by enormous monetary interests. Millions and billions are being spent by the US governement on universal testing and drugs. Hiv antibody testing creates a number of false-positive tests. There are a number of reasons one gets a false-positive reading from these tests. One of the reasons is pregnancy. Some US states require that all pregnant woment get a hiv antibody test. Do women understand that false-positives happen during testing? One is suppose to be retested after a positive test with a different hiv test. But all hiv tests have a certain amount of false-positives and pregnancy does create false-positives. There has been no studies which offer proof that hiv is transmitted through breastmilk. Studies have been difficult to do because components in human milk inactivate the hiv virus. There are patents on those components to inactivate hiv. Several of those patents are owned by infant formula companies. Thus, hiv-positive mothers will feed their babies formulas with genetically engineered human milk components to inactivate hiv. How ironic is that? We have studies that show that human milk components inactivate hiv but hiv-positive women are told not to breastfeed. In Africa we now know that this policy of hiv-positive women not breastfeeding has increased the mortality rates of their infants from diarrhea. Poorer nations have higher rates of infant mortality and breastfeeding has proven its ability to increase infant survival. Even in the US we have pockets of poverty where infant mortality is too high and closer to some poorer nations. In my county in Florida the white infant mortality rate is about 5% while the black infant mortality rate is about 14%. Far more infants in my state die from pneumonia, gastroenteritis, SIDS than hiv/aids in any given year. In looking at our statistics one year, there was one infant death of hiv/aids but 23 deaths from pneumonia, 17 infant deaths from intestinal infectious disease, 14 from septicemia, 139 deaths from SIDS. Human milk has protective factors for all these illnesses. A majority of the deaths were black infants. Most African American women bottlefed their infants.

The anonymous commentator wrote, "Thank God you are able to breastfed." I think this statement reflects a belief that breastfeeding is a difficult undertaking and that only by a miracle one breastfeeds. Our society, our medical communities make breastfeeding a difficult undertaking. It shouldn't be. It is the lack of understanding of what women and babies need that creates a billion dollar industry. Mothers need the right information, and the support of their communities and families. Mothers need the close contact of their babies, just as babies have a need for their mothers. Separation of mothers and babies creates the necessity of artificial feeding. Copyright 2008 Valerie W. McClain

Breastfeeding or protein factory of the future?

What happens to breastfeeding in a society when childhood is viewed as a fast-track to adulthood? What happens to breastfeeding when a society believes that the only value of an individual is based on the currency of the country. What happens when humans disconnect from their bodies and view breastfeeding with disgust? What happens to breastfeeding when men view women as an alien species whose value depends on a society's definition of attractiveness, youthfulness, and sexual availability?

We get a country where breastfeeding becomes "choice." We get large number of women who cannot breastfeed. We get many women who cannot breastfeed for any length of time and who have to leave their infants in the care of strangers. This is very strange mammalian behavior. We are mammals despite our wish to be considered better than animals. National Geographic just published an article (March 2008) on "Inside Animal Minds." The article is a fascinating look at the cognitive abilities of animals. The author, Virginia Morell writes about a cognitive psychologist named Louis Herman working with bottlenosed dolphins in the 80's. She quotes him in regard to his description of understanding the intellect of this mammal. He discusses the similarities between humans and dolphins, "That leaves social similarities--the need to establish relationships and alliances superimposed on a lengthy period of maternal care and longevity--as the likely common driving force."

"Lengthy period of maternal care," impacts intellect. Yet, our society is creating a world where lengthy period of maternal care (breastfeeding) is given up to be replaced by artificial nutrition and upbringing by strangers. We have a young generation that has no bonds, a rootless generation that is fed genetically altered foods. I feel an enormous sense of sadness for our children brought into this artificial world. How does one connect with multiple caregivers (no matter how loving these caregivers are)? How do mothers feel leaving their infants in the care of strangers? Happier? Does having more money but less time with your babies bring happiness, peacefullness? Or does it create a huge disconnect, a rootlessness, a massive disruption of human society?

I began this post with a wish to salute women who struggle to breastfeed. It is not an easy task in this alienated society. Mothers are bombarded with misinformation and multiple information. Who to believe? US society does not protect women and babies during this very vulnerable time. Instead, women are made to feel that their desire to be with their infants is unreasonable. Women feel that they must be employed to be a valued member of society. If one is poor and seeks help from the government programs (food stamps, etc) then the government demands employment of new mothers. Counterproductive in so many ways to creating a society that values the "intellect." Our society seems to believe that only the wealthy and formally educated have "intellect." Truth or fallacy? It is the wealthy and formally educated who run the country and organizations that impact our society. So they may have a vested interest in this belief.

Is our future one of disconnect from the reality of life? We are mammals, mothers and babies need time together. We need to breastfeed for the survival of our species.

Copyright 2008 Valerie W. McClain

Breastfeeding as Normal

The new mantra currently being promoted is that breastfeeding is normal. Normal to who? Normal in what context? What is normal behavior in an artificial world? What is abnormal behavior in an artificial world? We are told that there is nothing magical about breastfeeding, its just the normal way of feeding a baby. Breastfeeding is normal mammalian behavior. We are mammals. But are we living in a normal world? Do we have babies normally? How normal is birth in a hospital. Artificial light, artificial temperatures (air conditioning or central heat), plastic tubes to clear the throat, plastic bins to sleep in, drugs in our veins, injections for protection: human normalcy. The sounds of normal: TV, radio, cell phones, ipods, computers, humming machines, flickering lights. Clocks ticking away precious time...ticking, ticking, ticking. Normal time? Mama time? Baby time? Mama alone with baby and the clock keeps ticking away time. Whose time? Normal time? Lets get out. Take a drive in the car, strapped in the box, facing backwards...see how normal time travels. Hear the sounds of normal driving, radio static, beeping, beeping, creeping into baby's brain.

Carried in plastic, wrapped in plastic, soothed by plastic.....thank god...the plastic deity on the dashboard of human consciousness........

Breastfeeding....human connection...time standing still, magical, mystical moments of prolactin high. Normal? The world of normal is disconnect, noise, and the sickening sweet smell of plastic. Breastfeeding is none of those things. Normal in our biotech world of gene technology is a product in a plastic tube, patented and sold to you for many hours of labor. Magic is the human touch, the rising prolactin of love, the soulful gaze your baby gives you during the mystical moments of breastfeeding. Bah humbug to normalcy.

Copyright 2008 Valerie W. McClain

cloned milk in food? in baby formulas?

We have come a long way. The FDA has approved the use of cloned milk and meat unlabeled. It is likely that most people in the US don't understand what that means. And many of those that understand it, believe that the industry doesn't have enough transgenic cows (we also have transgenic pigs, goats, etc) to make it to our dinner table. There is also the belief that cloned milk is only destined to be pharmaceuticals. Wrong. I believe that there has been evidence since 2000 that herds of transgenic cows exist in the US, Canada, Finland, New Zealand.
And there is some evidence to suggest that some transgenic cow herds are not separated from cows who have not had their DNA manipulated.
Which would mean that there would be a strong possibility that the milk from the transgenic cows (cloned milk) would be mixed with the milk of cows who aren't transgenics. Up until the FDA approval, cloned milk and meat were not suppose to be marketed and on your dinner table. The ruling prior to approval, was that milk was to be dumped and meat destroyed. But it was not a mandatory ruling.
We might ask ourselves, why make a ruling on cloned milk and meat, if we don't have herds of transgenics? In the US alot of our food has been genetically engineered without the public's knowledge or consent. So the question would be why would cloning of milk and meat be any different? It has been since 2003 that the FDA has been trying to make a decision on cloned milk and meat. (basing this on a NY Times article by Kristoff regarding his adventure of drinking cloned milk--he states he didn't grow 3 heads).

Some environmentalists believe that cloned milk will only be used as pharmaceuticals. The mammary gland of all mammals (humans included) is considered to be a bioreactor. It can make therapeutic proteins that supposedly will be used in cancer therapies, HIV/AIDS, diseases of all sorts. The problem with using animal proteins on humans is that alot of humans have allergic reactions to the animal protein. Human proteins do not create such reactions. Of course, one might question whether human proteins made within another animal such as a cow is truly human or truly cow. No time to question or debate, onward in the quest for better drugs and greater profits.
But one of the things about our fast-paced, multi-tasking capitalist system is that why have milk you can only use for the pharmaceutical industry? The food industry has created foods that now give us better hearts, smarter brains. So now we have milk that produces human milk proteins, we certainly can claim the benefits of human milk/breastfeeding. And the uses of this cloned milk become even more profitable because they can be used in baby milks, foods, supplements, cosmetics, dental health. Pharming of the Netherlands (their herds are in Finland because not allowed in the Netherlands) has a US patent that tells us the variety of uses for lactoferrin. Patent # 5919913 filed in 1995 called, "Isolation of lactoferrin from milk."
"An advantage of transgenic animals and differential gene expression is the isolation of important proteins in large amounts, especially by economical purification methods. Such proteins are typically exogenous to the transgenic animal and may compromise pharmaceuticals, food additives, nutritional supplements, and the like."
Abbott Labs, pharmaceutical company and their Ross division, infant formula maker, has a 1995 patent. Patent # 5700671 called, "Method of making transgenic animals producing oligosaccharides and glycoproteins."

"...oligosaccharides in human milk inhibit the attachment of harmful microorganisms to the mouth and throat."

"These human oligosaccharides and specifically glycosylated proteins are absent from, or present from, or present in markedly different amounts, in bovine milk."

"As a consequence, infants fed infant formula which comprise cow's milk may be more susceptible to intestinal disturbances such as diarrhea, or their blood plasma amino acid ratios and levels may differ from breast fed infants."

Abbott Labs in another patent (# 5891698) on human milk oligosaccharides made in transgenic animals states another use for these human milk components...diagnostic kits. There is a wide range of uses for cloned milk, and not just in pharmaceutical products. For me the most upsetting part of this is that cloned milk is destined to be used in infant formulas. Infants become the guinea pigs to a new industry.
Copyright 2008 Valerie W. McClain

human milk proteins produced in plants

There are a number of ways to genetically engineer human milk proteins. One way is cloning of animals to produce the human milk component in their mammary glands. A number of companies around the world are involved in that endeavor, such as Pharming of the Netherlands. Another way to create a genetically engineered human milk protein is through cell culture. Agennix of the US is using this method to create their recombinant human lactoferrin. There is a third way, and that is to genetically engineer human milk proteins in plants. Ventria Bioscience is working on the production of human milk proteins through plants. Their field trials created quite the stir in California with Green Peace protesting their fields of genetically engineered plants. Environmentalists believe that what these specialized plants produce will be used in the pharmaceutical industry. Lets look at their patent. Their patent is called, "Expression of human milk proteins in transgenic plants," #6991824 filed in 2002.

"It would therfore be desirable to provide a plant-derived infant formula having beneficial levels of one or more proteins normally present in human milk, while largely avoiding costly recombinant protein production techniques and safety issues. More generally, it would be desirable to provide a nutritional food extract that may be readily and inexpensively obtained in large quantities, can be delivered by itself as a nutraceutical or added to processed foods, for supplying one or more human milk proteins beneficial to human health."

The intent is to provide such human milk proteins as lactoferrin, to the infant formula, supplement, and food industries. Genetically engineered lactoferrin is already in a variety of products bought by consumers: mouthwash, toothpaste, whey products, supplements. One way or another, people will get human milk. Of course it won't be through breastfeeding.