Friday, April 18, 2008

DHA Research Trail of Funding

The International Formula Council (IFC) in response to the DHA/ARA Report written by the Cornucopia Institute stated their position on their website.
They state, "The decision to supplement formulas with these nutritional long-chain polyunsaturated fatty acids (LCPUFAs) was made following years of research studying the clinical effects of both DHA and ARA in infants." And then they state a list of respected institutions or organizations that support the inclusion of DHA and ARA in formulas, such as the FDA, Child Health Foundation (a non-profit partly funded by Martek maker of DHA and ARA for infant formulas around the world), the National Academy of Science, the World Health Organization, the Codex Alimentarius Commission, etc.
But how long has researchers and industry been studying the effects of these oils on infants? In particular, how long have they been studying the effects of new or novel microbial oils on infants? It would seem that research on the need for LCPUFAs started in the 80's. But research on the microbial oils only began in the 90's. Not a very long time to know the health ramifications of something new. Martek Bioscience declared their oils were GRAS, and the FDA had no questions regarding this declaration. The IFC statement that the "FDA agreed that oils containing DHA and ARA are generally recognized as safe for use in infant formula," is a slippery slope comment. I would believe that the FDA might be somewhat unhappy with this statement. The FDA system is no longer an approval system but a notification system. Thus, the FDA only publicly registers that they have no questions regarding the company's belief that their substance is GRAS. In 1999, Wyeth tried to get the FDA to declare that Martek oils were GRAS. This was prior to the changing of the GRAS system from approval to notification. In 1999 the FDA refused GRAS approval to Wyeth for Martek oils because of independent studies that showed abnormalities in rats given these oils.
In the references to research on LCPUFAs in the IFC statement, one researcher's name is prominent, Berthold Koletzko or B. Koletzko of Munich, Germany. This particular researcher is on the scientific advisory board of the Nutricia Research Foundation (which "acts completely independent of the commercial activities of the related company" and "the capital of the Foundation was generously donated by Nutricia and its successor Royal Numico")
Most of the research on DHA/ARA has been either sponsored by the infant formula industry or Martek Bioscience. Mead Johnson was the first infant formula company to place DHA and ARA in their infant formula. They funded a researcher named Eileen E. Birch (EE Birch) who is a co-inventor to several pending patents on DHA and ARA (patent applicaition # 20040048926 called "DHA and ARA to enhance visual development of term infants breast-fed up to age 6 months," assigned to Mead Johnson and the Retina Foundation of the Southwest--Birch is employed with this foundation--and patent application # 20040091599 assigned to Beechnut and the Retina Foundation of the Southwest regarding the placement of these oils in baby food)
Eileen Birch received a grant from Mead Johnson of $1,460,000 for the years 2003-2008.  

[This link no longer works, 10/1/12--Dr. Birch along with Dennis R. Hoffman, Julia Anne Boettcher, Deborah Ann Schade are inventors to patent application 20040048926 entitled, "Use of docosahexaenoic acid and arachidonic acid to enhance the visual development of term infants breast-fed up to the age of six months."  filed in March of 2003.  According to the application, "the U.S. Government has a paid-up license in this invention and the right in limited circumstances to require the patent owner to license others on reasonable terms as provided for by terms of Grant No HD22380 awarded by the National Institute of Health."]

Dennis R. Hoffman is a co-inventor to these pending patents with Eileen Birth. His research is often cited regarding the need for DHA and ARA. Deborah Schade [ now known as Deborah A. Diersen-Schade, Director of Global Scientific Affairs at Mead Johnson] is a researcher on DHA and ARA with Mead Johnson and inventor to several patents. In an article on her and her research at Mead Johnson in the Courier & Press of Evanville she states, "We work very closely with some of the best nutritional scientists around the world," The article then states that those scientists are from institutions such as Harvard, Baylor College of Medicine, and Cincinnati Children's Hospital.
The article also states that, "Collaboration between the company and academic institutions is important to both. Mead Johnson researchers can contribute information that assists them in publication."
Another well-known researcher on LCPUFAs for infants is Susan Carlson. She has been funded by Mead Johnson for various research projects. But holds a patent with the assignee being Abbott (parent company to Ross, infant formula) called "Method of reducing the incidence of necrotizing enterocolitis," patent # 6080787. She has co-authored studies with John Columbo, another well-known researcher on DHA and ARA. He happens to be a consultant for the US Tuna Foundation, Fonterra Brands, Mead Johnson, Ross Labs, New Zealand Milk, and Martek.
The IFC references a new study (2008) by Koletzko et al. in the Journal of Perinatal Medicine
entitled, "The roles of long-chain polyunsaturated fatty acids in pregnancy, lactation and infancy: review of current knowledge and consensus recommendations." In small print above the abstract on medscape it states: "Developed under the direction and sponsorship of Martek."
Are we basing our understanding of LCPUFAs on several industrys' need for greater profits. Martek became cash flow positive in 2006 (first time) in a statement made to investors. There infant formula revenue increased 27% to $241 million. Breastfeeding rates according to many LCs is down. Is there a relationship between increasing profits of these industries and the slow slide downward of breastfeeding intiation and duration?
The IFC states they support breastfeeding...that breastfeeding is the "ideal," but some mothers cannot or choose not to breastfeed. How much of the "cannot" and "choice" resides on the ability of powerful industries to influence the academic world through funding? How much of the "cannot" and "choice" resides on what gets published in our medical journals and is believed to be unbiased? I suppose there are some people who believe that how one is funded does not matter or whether patenting (a monopoly on a product) exists has no factor in influencing medical policy decisions by our institutions. I guess I am not one of those people.
Copyright 2008 Valerie W. McClain

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