Institute of Medicine (IOM)...independent scientists?

I read the DHA/ARA Report by the Cornucopia Institute when it came out a few months ago. I was somewhat astounded to read that they believe that a "panel of independent scientists was convened by the Institute of Medicine to take a critical look at tests performed for new ingredients in infant formula." Certainly, they convened a committee to "evaluate the addition of ingredients new to infant formula." In fact this was back in early 2002. I wrote the Institute of Medicine to complain about their selection of committee members. I stated in my letter, "Should the decision of safety of infant formula be given to people from the very industries and universities that will benefit from the decision?" My letter was 4 pages long with 14 references to the connections between the committee members and the new industries that would gain from the inclusion of new or novel ingredients. The committee members were changed, but the chairman of the committee stayed the same. Dr. Richard Deckelbaum was the chairman and had been funded over the years by Nestle, Mead Johnson, and the National Dairy Promotion and Research Board. Many of the new committee members had associations with Mead Johnson (they funded alot of the original DHA research). In fact one committee member, George L. Baker, was the retired Vice president of Mead Johnson. William C. Franke, another committee member, was employed by Unilever at that time. Unilever at that time had Loder's infant formula (Europe) and they were working on a human milk fat replacer similiar to Betapol.

Representatives of Monsanto and major pharmaceutical companies have been on the IOM Board over the years. How do these representatives of these industries make "independent" policy decisions regarding issues that impact the companies they represent? Currently the Food Forum participants at the IOM are from Coca-Cola, ConAgra, Kellogg, Ross Products (infant formula company), McDonalds, General Mills, Mead Johnson, Cargill, Monsanto, Kraft, and Mars. Scattered among these participants are some people representing universities and government (FDA, NIH)...about 5 representatives.

I would think in regard to safety issues regarding products that effect our most vulnerable populations, like infants, there would be a stricter definition of the word "independent." But such is life in the USA. By the way Martek, recently announced that they had just hired Dr. Norman Salem, Jr. as vp and chief scientific officer. Dr. Salem worked at the NIH for 30 years as the government expert on DHA and the function of polyunsaturated fatty acids and lipids.
Some people call this the "revolving door" of employment between government researchers and industry. Why would we begrudge scientists the chance to make more money? And yet, there is something troubling about this situation.
Copyright 2008 Valerie W. McClain

Genetically engineered...truth or dare?

Martek, maker of microbial oils by single cell protein production, states that their oils are not genetically engineered. Since the company began in 1985 they have always stated that genetic engineering is a possibility but that would be sometime in the future. Their first few patents were filed in 1992-1995. They now have many more patents but the original patents were from that time period.

Genetic engineering went commercial in 1985 when companies were able to manipulate enzymes. This was not public knowledge. Most consumers are unaware of how much of our food is genetically modified. I have helped run a small local organic food coop since 1985, and in the nineties came to the realization that almost all USA cheese is made with a genetically engineered enzyme that imitates cow or pig rennet (chymosin). Our coop in order to get cheese without this genetically engineered enzyme had to order cheese from Europe. Since that was prohibitively expensive, most members were resigned to eating American cheese or none at all. How many US consumers realize this fact. Do we know if this is safe technology? How do we know that this is safe? Previously we were dependent on the slaughter of veal calves or cows or pigs for our cheese. We are now dependent on genetically engineered E.coli, Kluyveromyces lactis, and Aspergillus niger to make our rennet. (from "An Introduction to Genetic Engineering," by Desmond S. T. Nicholl, second edition, Cambridge University Press, p.186)

Martek Bioscience is a spinoff company from Martin Marietta and the NASA space program. Providing food for people in space is a complex problem. Remember Tang, the orange breakfast drink? This drink was the result of the NASA space program. Teflon is also another product that has its roots in the space program. The space program creates consumer products that are in the marketplace.

On March 29, 1995 Henry Linsert, Chairman and CEO of Martek Biosciences (Steve Durbin is the current CEO) testified before the House Judiciary Committee subcommittee on courts and intellectual property. He was testifying on behalf of BIO (Biotechnology Industry Organization). His testimony was about the enormous capital needed to bring a biotech product to market. He stated that Genzyme raised $328 million and Amgen had to raise $406 million. He spoke about the "critical synergy between intellectual property protection and capital formation." He quoted A Dr. Austin who states that patents are a way to attract investment capital. Henry Linsert states in this testimony, "Since genetic engineering is the only commercially feasible method for manufacturing human proteins, a patent on the recombinant manufacturing process can be tantamount to a product patent." Later he states, "Thus a patent on the method of making a protein by using a host cell would produce a basis for an infringement action under section 271(g) of tile 35, United States Code."

see http://judiciary.house.gov/Legacy/457.htm

In a report written in June 2001 in Science (http://www.sciencemag.org/ volume 292 15 June 2001 page 2073) called "Trophic Conversion of an Obligate Photoautotrophic Organism Through Metabolic Engineering," scientists from Martek and the Carnegie Institution of Washington, detail how to genetically engineer a microalgae, Phaeodactylum tricornutum to thrive on glucose in the absence of light. This abstract states, "This also represents progress toward the use of fermentation technology for large scale commercial exploitation of algae by reducing limitations associated with light dependent growth."

In an article in the Asia Food Journal written by Leontien Braakman dated January 1, 2005 it states, "An American firm, Martek Bioscience has used genetic modification to convert algae that need light to grow, to the their energy instead from sugar." and "But the strain of algae has become a genetically modified organism (GMO) as a result consumers may not like this and reject products made with it." What strain are they talking about, since Martek denies genetically engineering the algae used for infant formula? Does Martek have separate fermenting tanks? How is this separation maintained during processing? Does the FDA inspect the facilities to ensure that no gmo strain accidently contaminates the algae not genetically engineered? Anyone know?

SemBioSys Genetics, Inc. has an agreement with Martek Bioscience that was amended in 2007. In a press release by BioSpace it states, "Martek has decided it is important to have the flexibility to pursue a traditional commodity crop as well as specialty crops, like safflower, as a source of DHA-rich plant oil. Regardless of the crop used by Martek as a source of DHA-rich oil, under the amended agreement, SemBioSys will receive a royalty on gross margin of DHA-rich plant oil product sales." SemBioSys is a biotech company that is developing commerical products using genetic engineering (in this case the plant,safflower, to create DHA).

http://www.biospace.com/news_story.aspx?NewsEntityID=42297

So Martek is not adverse to using other biotech company's genetically engineered oils but does not genetically engineer its own oils. Will the consumer know whether the DHA is from algae or safflower or a mixture? Afterall, it's rocket science, and your guess is as good as mine. Rock, paper, scissors: who wins?

Copyright 2008 Valerie W. McClain

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