"FDA-Industry collaboration at Stake in November?"
Concerns expressed in a published article dated April 2004 by the Medical device and diagnostic industry explain the FDA's new view on "collaboration."
"The agency's current attitude toward collaboration, Philips said, represents a significant shift in its approach to regulation. He contrasted this new posture to the agency's previous practice of maintaining what he called 'a certain distance from the industry it regulated.'
http://www.mddionline.com/print/889
Fascinating that we now believe that a regulatory government agency can now collaborate with industry as well as with non-profit and educational institutions. How is it that we believe a regulatory body can regulate while collaborating? Now let me see, the FDA collaborates with HMBANA milk banks. Does it collaborate with Prolacta? And if it doesn't, wouldn't Prolacta be angry that HMBANA has an "in" with the government but they don't? Does the FDA collaborate with the infant formula industry, too? Is the collaboration that HMBANA gets the same as the collaboration that the infant formula industry gets? And when the FDA helps write the guidelines for HMBANA, then it appears to me that HMBANA is no longer an independent non-profit organization but rather an off-shoot of the FDA. When we mix relationships up between the government and industry, educational institutions, and non-profits, what are we creating?? Will independent thought survive in this atmosphere? I noticed in the build-up to the invasion of Iraq, there became this political undertone among US LC's on Lactnet. It was the silencing of any comments on war and its effect on breastfeeding. It was the American flag plastered on websites. It was a level of craziness that I still do not understand. I like the American flag, I support democracy, democratic principles. Yet, I am troubled by a theme of "My country right or wrong." So if your country tells you to jump off the cliff, would you jump? When non-profits become entangled with the federal government, they entangle us all in the political atmosphere of government interests. Which is often not the interests of everyday people but the interests of people of power and wealth. When government and professions get enmeshed, then your politics determines your acceptability. Democracy? Freedom of thought? Freedom of Inquiry? Where goes science, the search for truth, when government and institutions and corporations melt into one massive bureaucracy? I am fascinated, like I am fascinated with watching a rattlesnake, or a hawk catch its prey.
One of the first patents I read some years ago, which led me down this insane road of reading human milk component patents is called "Anti-diarrheic product and method of treating rotavirus-associated infection," (#5505955) and "Anti-viral composition & kit and use for treating rotavirus infection and diarrhea." (#5667797). The inventors were Jerry A. Peterson, Robert H. Yolken and David S. Newburg and the patents are owned by Senmed Inc, Cancer Research of Contra Costa, and John Hopkins University School of Medicine. These patents state where they got their human milk--a HMBANA milk bank of Worcester Mass. That milk bank is no longer in existence. Interestingly, it was soon after I started questioning that milk bank and HMBANA that the milk bank folded. Not that I am saying there is a connection, just another strange coincidence. I asked for paperwork from that milkbank regarding how these researchers got HMBANA donor milk. I was told that there was no paperwork.
from Patent #5505955 and 5667797
"Example 1: Source of Human Milk
Human milk was obtained from 30 healthy, lactating women donors to the Central Massachusetts Regional Milk Bank, Worcester, Mass. The donors were chosen to represent a wide range of maternal ages ranging from 20 to 37 years (average: 28.+-.4 years), parity: 9 primiparous, 13 secundiparous, 5 tertiparous, 3 quadriparous with a 0 to 14 months lactation period (average:6.0.+-.3.8 months postpartum). The milk was generally expressed in the morning by means of a mechanical pump, pooled and used to isolate the human milk components utilized below. "
Breastfeeding mothers are concerned about donating to Prolacta because they state that they may patent off the milk (actually they don't state "patenting," the donor waives her rights to any commercialization that may happen). What assurances does the donor have regarding HMBANA milk banks?
Copyright 2010 Valerie W. McClain
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