Thursday, March 31, 2016


"Disclosure rules need to go deeper than the typical financial conflict of interest rules to ensure that scientific research is conducted in an atmosphere of full disclosure.  Patent rights should not be excluded from this realm of openness.  A patent right is a finger of the private sector in the public information cookie jar, and the scientist has the social duty to let the public know.  Science and technology have important societal ramifications--for example, in genetic engineering, cloning, stem cell technology, and new drug development."
by Richard M Lebovitz, "The Duty to Disclose Patent Rights," Northwestern University School of Law, Northwestern Journal of Technology and Intellectual Property, Fall 2007 vol.6, no.1

The other day I ran across a paper written by Richard M Lebovitz, a patent attorney at the US Patent and Trademark Office, that I found to be quite interesting.  He discusses the fact that very few scientists recognize the need to disclose patent filings in their research papers.  Studies show disclosure rates to be very low in biomedical research articles (about 15-20%).  This article was written in 2007, so perhaps disclosure rates have increased.  Although I have found that in the area of human milk research, disclosure of patenting is very low and often erratic (researchers disclose in one publication but not in other publications).

For example a research paper published by PLOS ONE (an open access multidisciplinary online  journal), entitled, "Breastmilk Cell and Fat Contents Respond Similarly to Removal of Breastmilk by the Infant," by researchers: Foteini Hassiotou, Anna R Hepworth, Tracey M Willimas, Aecia-Jane Twigger, Sharon Perrelia, Ching Tat Lai, Luis Figueira, Donna T. Geddes, Peter E Hartmann; mentions funding provided by Medela and stem cell patents applications invented by Foteini (Hassiotou)Kakulas.  The first "Stem cell preparations and methods of use," was filed with the Australian patent office in April 2012. Second patent application at US patent office in April 2013.  And 3rd patent application with WIPO (international patent office) filed in April 2013.  No mention was made of the Carag AG stem cell patent-"Method for isolating cells from mammary secretion," with one of the researchers, Peter E Hartmann being a listed inventor.  Carag AG is a company that Michael Larsson, CEO of Medela, bought out and is currently on the Carag Board of Director.  Peter E. Hartmann also is inventor of a number of patents owned by Medela. Donna T. Geddes is a listed inventor to a variety of inventions owned by Medela.  And Ching  Tat Lai is a listed inventor to several patent applications owned by Medela.

I find it interesting that the PLOS ONE paper does not appear to be a paper on stem cells.  But I did skim the paper and have to take a second look.  Perhaps stem cells are more prevalent in the fat of human milk? Rather odd since all the research papers on Breastmilk Stem Cells that I have seen do not mention any patents.  In fact the papers disclose no conflict of interest by the authors.  For instance, a paper in Stem Cells entitled, "Breastmilk Is a Novel Source of Stem Cells with Multilineage Differention Potential," the many authors state no conflicts of interest.  Yet in acknowledgments state that the work was supported by an unrestricted research grant from Medela to Peter Hartmann and a scholarship and academic award to Foteini Hassiotou and various grants and awards from the US government. Then they thanked the participating mothers and the Australian Breastfeeding Association and La Leche League for support in recruiting the participants.

At the time this paper was published(October 30, 2012), Medela already had a Australian patent application #2012202353 with Foteini Hassiotou as inventor entitled,"Stem cell preparations and methods of use, " filed on April 20, 2012.  And Peter E. Hartmann was listed inventor to the Carag AG patent #7776586 on breastmilk stem cells entitled, "Method for isolating cells from mammary secretion," filed in December 2004.  From my perspective I view these patents as a conflict of interest.  But obviously, these researchers have a very different perspective.

One of the comments by Richard M Lebovitz in his article, "The Duty to Disclose Patent Rights," seems pertinent to a discussion regarding disclosure of patents,

"Even when patent rights have no personal financial value that would require their declaration in a journal article, they may still compromise the perceived or true objectivity of the publication, one of the driving forces behind the conflict-of-interest guidelines."

Lebovitz discusses the fact that companies that sponsor research may review manuscripts prior to submission and "cleanse" them of statements that may impact the companies patent position. Thus some information may be left out and impact the free-flow of scientific enquiry.

In another research paper by Professors,Hassiotou and Hartmann, published in Advances in Nutrition in 2014 entitled, "At the Dawn of a New Discovery:  The Potential of Breast Milk Stem Cells."  Hassiotou and Hartmann disclose no conflict of interest.  The article was a review of a symposium entitled, "It's Alive:  Microbes and Cells in Human Milk and Their Potential Benefits to Mother and Infant." The symposium was supported by an educational grant from Medela.

An announcement in University News of March 2014, states that Assistant Professor Foteini Hassiotou won $900,000 from Medela AG to "illuminate life-giving properties of human milk."

It appears that Medela through patenting and funding has a financial interest in Breastmilk Stem Cells.   Yet it appears to me that very few people seem to understand this interest.  Breastfeeding organizations mentioned in these research studies recruited mothers to participate in this research.  Are they unaware of the financial investment in stem cells by Medela?  Medela is a WHO Code violator for their promotion of bottle teats/nipples.  They also have funded new HMBANA milk banks.  They have easy access to human milk and a financial investment in the potential of breastmilk stem cells.  

It would seem to me that this interest should require more disclosure regarding their patenting.  Instead, I find that some breastfeeding advocates believe that respect of the scientific community means that one must not question funding of researchers.  I believe knowledge of funding is important in order to understand whether research has some built-in bias/conflict of interest.  It is not about disrespect.  It is about respect for human psychology and the understanding of how bias or conflict of interest can easily distort science.  

When researchers recruit women to donate their milk for science, I believe they have a duty to inform these mothers that the research may result in patenting and financial opportunity for those involved.  Respect goes both ways.  If researchers and scientists want respect from their community, then provide informed consent to mothers who take the time to donate their milk.  

Researchers belief that donating milk for stem cell research is far more ethical than stem cells from aborted fetuses is based on who's ethics?  And that belief seems to have absolved researchers from telling the financial interests involved.  For some mothers who donate their milk to researchers it wouldn't matter that patenting is involved.  Or it wouldn't matter that some company may make a lot of money.  But if this research leads to actual commercial use and the company reaps the financial benefit from it, some moms might question their donation.

Copyright 2016 Valerie W. McClain

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