Wednesday, January 7, 2015

Commercialization of Human Milk--Part 2

"Indigenous  peoples worldwide are now at the forefront of a new wave of scientific investigation:  the quest for monopoly control of genetic resources that will be useful in new pharmaceuticals, nutriceuticals and other bio-engineered products."  by Debra Harry, Executive Director of the Indigenous People's Council on Biocolonialism, in 2001.


In 1990 Dr. Ivan Casas (who would later become Research Director of BioGaia of Sweden/USA- a company that markets and sells probiotics) went looking for a strain of Lactobacillus reuteri (L. reuteri) that could be commercialized.  It is quite probable that the interest in L. reuteri derived from the observation that this bacterium produced a substance called reuterin,a broad-spectrum antibiotic. With increasing antibiotic resistance, a natural occurring antibiotic, would be a great discovery, as well as of great financial interest.  In Peru he found the strain he was looking for in the breastmilk of Indians from villages high in the Andes.  He had examined breast milk from mothers in the USA as well as South American mothers in Lima Peru and had not found this particular strain.  Whether these Indian mothers from the Andes were direct descendents of the Inca or Arawak, I do not know.  But who would have believed that the milk that these women donated would contain a bacteria that would become very popular as a supplement for infants and children, as well as adults.  It would also become known as Lactobacillus reuteri Protectis, and BioGaia in 2012 would sell the rights of its patent for use in infant formula to Nestle.  "BioGaia received EUR 40 million up-front and a commitment to a further EUR 10.8 million during the period 2014 to 2017 upon achievement of certain milestones."

Initially this strain of bacteria from human milk was deposited at the American Type Culture Collection (ATCC) as Lactobacillus reuteri SD 2112 but later given the number ATCC 55730In 2007 it was replaced and became Lactobacillus reuteri DSM 17938.  According to Biogaia literature, the strains ATCC 55730 and DSM 17938 are "considered comparable in all aspects of probiotic function."  The only difference is that DSM 17938 no longer carries the two plasmids that carried resistance to tetracycline and lincomycin.  The original ATTC 55730 had these plasmids that carried antibiotic resistance.

According to the ATCC the Lactobacillus reuteri that was isolated from human milk is connected to patent #7344867,  This patent is entitled, "Selection and use of lactic acid bacteria for reducing inflammation in mammals." filed in 2005, invented by Eamonn Connolly who was the Senior VP for Research at BioGaia, and patent inventor to quite a few other patents owned by BioGaia.  Eamonn Connolly is now Head of Research and Development at Infant Bacterial Therapeutics AB of Sweden, a subsidiary of BioGaia.  He also is one of the authors of a recent paper published in The American Journal of Tropical Medicine and Hygiene entitled, "A Phase One Safety Study of Lactobaciluus reuteri Conducted in the Peruvian Amazon:  Observations from the Field,"  published 2/10/2014.  The was a phase one trial under the FDA Investigative New Drug program.  Forty-five healthy adults received either L.reuteri DSM 17938 or a placebo.

Thus the bacterium from the breastmilk of Peruvian Indian mothers of the Andes lives on and on.   And breastfeeding mothers and infant formula feeding mothers around the world will use and benefit from the donated milk/bacterium of Peruvian Indian mothers.  And a few companies will financially benefit from "their invention."  And people will continue to believe that the commericalization of human milk has not happened yet.  I find it fascinating that one of those industries that benefits from this kind of invention is the infant formula industry and particularly that it is Nestle.  If moms make the choice to not breastfeed, then industry will make sure moms get the human milk component equivalent to the real thing.   Don't ask questions about these kind of inventions.  Don't ask about ethics regarding donating human milk (breastmilk is often called white blood-the collection of white or red blood is often about collecting DNA) for research. But the next time you dose your infant or child with this particular probiotic or give the infant formula with Lactobacillus reuteri Protectis, say a little prayer of thanks to the Indian women of the Andes!
Copyright 2015 Valerie W. McClain

1 comment:

  1. Great post, Valerie. However, it's doubtful indeed that in that dehydrated powder mix with its other inevitable microbes any strain is going to work as it did in the milk of women in their natural environment. In fact, it may interact with those other microbes and even become harmful over time. These things are marketing tools, not genuine advances, or so the evidence to date suggests: any benefit is pretty marginal. Breastmilk's hundreds of different microbes are all interacting to produce protection. No one knows how deliberately adding bacteria to formula will work out in the long run.