"You cannot insert a gene you took from a bacteria into a seed and call it LIFE. You have not created life, instead you have only polluted it."--Vandana Shiva
BIFIDOBACTERIA
Likewise I would add to Dr. Vandana Shiva's statement that scientists cannot rearrange genes within a bacteria and call it a probiotic. Probiotics are live microorganisms that are suppose to create health benefits by improving the gut flora of an individual. There is a history of safe use of Bifidobacteria in the food industry. But historically the safe use was based on a natural microorganism not on a genetically engineered microorganism. For instance Nestle has had concerns about Bifidobacteria used in creating probiotics. In patent #8071353 entitled, "Genetic Remodeling in Bifidobacteria," filed in 2007.
"Use of any bacterium that possesses or has acquired antibiotic resistance in food processing or agricultural production poses a potential, theoretical risk of transfer of the resistance fostering genes to other bacteria in the food, the gastrointestinal tract (GIT) of a person or animal after consumption of the food, or the environment, at some point before or after consumption. Examples of such a bacterium can be found among the Bifidobacterium spp., for example, Bifidobacterium animalis such as Bifidobacterium animalis subsp. lactis (also referred to as Bifidobacterium animalis subsp. lactis subsp. nov., previously regarded as Bifidobacterium lactis and sometimes referred to herein as such). One such strain, B. animalis subsp. lactis strain NCC 2818, CNCM I-3446, is commercially available, has been used for over 20 years as an additive to food products and is generally regarded as safeIt has recently been discovered that this bacterium, in common with certain other gram(-) and gram(+) bacteria of human and animal origin has a tetracycline-resistance gene, tetW, present. Although tetracycline resistance transference is theoretically possible, it has so far not been possible to demonstrate this even under laboratory conditions. It is, however, known from cloning experiments that tetW from this strain is active in gram(+) bacteria although not in gram(-) bacteria."
According to the patent the use of genetic engineering techniques will disrupt or delete the tetracycline-resistance gene. The patent also states the following:
"The above-described method may also be practiced on Bifidobacterium cells of the species B. longum."
and
"Thus, in a preferred embodiment, the Bifidobacterium cell according to this aspect of the invention is substantially lacking the nucleic sequence for the tetW gene. In one embodiment the coding sequence is at least substantially deleted. Alternatively, one or more noncoding sequences related to the predetermined functional gene may also be deleted."
Sometimes they cannot totally eliminate or disrupt the tetW gene, nor can they always substantially eliminate or disrupt the gene. And it appears that some supposedly noncoding sequences are sometimes deleted. Hm, reading this should give people pause to wonder about the accuracy of genetic engineering. And should a genetically engineered microorganism be treated the same as microorganisms that have not been genetically engineered? We know that antibiotic-resistance is creating a health crisis. Is this the only antibiotic resistant gene in bacteria that is harvested for the probiotic industry?
In 2014 a preterm infant died in a US hospital NICU from a fungal infection of the gastrointestinal tract. The infant was given a probiotic supplement that was marketed for infants and children. Are probiotics safe for preterm infants, full term infants, children?
https://www.forbes.com/sites/davidkroll/2014/12/17/infant-death-triggers-fda-health-provider-warning-on-probiotic-risks/#2e1c88041835
Which leads me to questions about a probiotic being marketed internationally at breastfeeding mothers. The probiotic is Bifidobacteria longum, subsp. infantis and sold by a company called Evolve Biosystems and their probiotic product is called Evivo.
The company was founded in 2011 in California, USA. The founders are David Mills, Bruce German, Samara Freeman, Carlito Lebrilla, Daniella Barile. All 5 founders are co-inventors to various Evolve US patent applications and/or patents. They are also co-inventors to patents and patent applications owned by the Regents of the University of California.
https://www.evolvebiosystems.com/founders
Bruce German was employed by Nestle and has been funded by other infant formula industries. He has also collaborated with Prolacta Biosciences (the for-profit milk bank that makes human milk-based infant formula for NICUs).
Some issues that are of concern regarding the company Evolve Biosystems
1. The company states that they have FDA GRAS. Yet the FDA GRAS inventory list of ingredients appears to have nothing listed for the company, Evolve Biosystems. There are 4 Bifidobacteria ingredients listed in this 17-page inventory list. One is from Nestle and the FDA had no questions, FDA GRAS #49. One is from Morinaga Milk Industry Co., Japan, FDA GRAS 268. Another one was from a Canadian company, Lallemand Health Solutions-FDA GRAS #758-one of 3 bacterial species to be used together. And the Korean company Bifico Co. #813 FDA GRAS which is still pending. Perhaps the FDA has not published the Evolve's FDA GRAS request?
2. At this point in time the clinical trial that proves its safety was funded by the company. And at least 2 of the authors of the paper on that clinical trial have been funded by Evolve. The lead author, Jennifer T. Smilowitz is a private consultant for Evolve. Mark Underwood, another author, has received funding from Evolve.
3. Evolve's World Patent Application states the following,
"The composition of any one of claims 1-15, wherein the Bifidobacterium is B. longum, B. breve, B. bifidum or B. pseudocaternulatum."
Are all these Bifidobacteria species equivalent and are safety studies done on each possible bacteria? Consumers may presume that the one specific bacteria is being used. Shouldn't people who buy this product have accurate information?
4. Evolve's World Patent Application states the use of oligosaccharides (some are gmo) with Bifidobacterium longum.
"0004] The instant invention provides compositions comprising isolated
complex oligosaccharide fractions from mammalian milk sources,
optionally supplemented with purified fucosylated/sialylated
oligosaccharides. The mammalian milk may be from human or bovine
sources, and including but not limited to, the bovine source is from
bovine colostrum. The fucosylated oligosaccharide(s) may comprise
synthetically produced and purified 2'- fucosyllactose,
3-fucosyllactose, difucosyllactose, or lacto-N-fucosylpentose."
5. Evolve's World Patent Application states the use of flow agents,
"[0039] Any of the compositions described herein can further comprise a
secondary metabolite. The secondary metabolite can be a short chain
fatty acid, such as acetate, lactate, or combinations thereof. The
compositions described herein can further comprise a stabilizer, such as
a flow agent. Flow agents may include starch, silicon dioxide,
tricalcium phosphate, powdered cellulose, magnesium stearate, sodium
bicarbonate, sodium ferrocyanide, potassium ferrocyanide, calcium
ferrocyanide, bone phosphate, sodium silicate, calcium silicate,
magnesium trisilicate, talcum powder, sodium aluminosilicate, potassium
aluminum silicate, calcium aluminosilicate, bentonite, aluminum
silicate, stearic acid, and polydimethylsiloxane. The stabilizer can be a
milk protein or another suitable pharmaceutical grade or infant formula
grade diluent (e.g., lactose). The milk protein can comprise a protein
fraction of non-fat dry milk."
6. Evolve's World Patent Application seems to imply genetic modification,
"[0031] In various embodiments, the bifidobacteria encodes gene clusters
containing ATP-binding cassette (ABC) transporters and glycosyl
hydrolases involved in HMO utilization, typically including one or more
genes coding for a fucosidase. In some embodiments, the bifidobacteria
contains a gene coding for a complex oligosaccharide transporter. In
some embodiments, the bifidobacteria contains a gene coding for a fucose
transporter. In some
embodiments, the bifidobacteria contains a gene coding for a fucose or
sialic acid transporter. In many embodiments, the genes encoding these
components are upregulated or expressed. The genes may be constitutively
upregulated or induced."
7. Recent patents on Bifidobacterium longum, subsp. infantis use genetic engineering to create an improved product (Nestle and Proctor & Gamble US patents). Evolve has stated in their US patent application that their source for the bacteria is either the International Milk Bank or from the ATCC (American Type Culture Collection).
8. Evolve has many patent applications around the world. They have a World Patent WO/2016/065324 entitled "Activated Bifidobacteria and Methods of Use Thereof." This same patent application is also filed in Mexico, USA, China, Singapore, Australia, Brazil, and the European Union.
9. Since 2014 Evolve has received some $70 million in funding, $20 million was from the Bill Gates Foundation/Li Ka Shing Foundation
10. Evolve has stated that it has received Health Canada approval for its product, Evivo.
CONCLUSION
It seems to me that safety questions need to be asked regarding the use of probiotics for infants (especially preterm and newborn) and children. Especially when there is limited independent research and so much investment in IPR's (Intellectual Property Rights). Does probiotics impact exclusive breastfeeding? The infant's gut will change by a company's design, by their understanding or misunderstanding of breastfeeding. Should infant's be guinea pigs to a new growth industry without independent evidence? What do we really know about the use of genetic engineering of probiotics for infants and children? Will exclusive breastfeeding survive? Are we jeopardizing the next generation by manipulating gut bacteria?
Copyright 2019 Valerie W. McClain
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