Tuesday, August 30, 2011

A human milk product for treatment of immune deficiency (hiv/aids)

"At the center of this invention, is the intent to solve the worldwide shortage of gamma globulin."  patent #7914822

Presenting another Prolacta Bioscience patent, invented by Elena Medo dated this March 29, 2011.  This patent is called, "Method of producing nutritional products from human milk tissue and compositions thereof."

Supposedly gamma globulin injections treat immune deficiency diseases, such as agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, B-cell chronic lymphocytic leukemia, bone marrow transplant, and hiv/aidsIntravenous gamma globulin has been given to children with symptomatic hiv infection while receiving Zidovudine.  Clinical trials through the National Institute of Allergy and Infectious Diseases (NIAID) were done for for hiv-infected children ages 3 months to 12 years of age who were receiving oral AZT with intravenous gamma globulin or placebo.  The researchers believed that the rate of bacterial infection would be reduced in hiv-infected children given gamma globulin,an immunoglobulin derived from blood plasma proteinsI do not know what the outcome of this trial was but I can imagine that none of these children were breastfed because of US policy that has pushed infant formula feeding for infants diagnosed with hiv/aids.  Thus, some of these children got injected with antibodies derived from blood plasma to combat bacterial infections.  I look at that as rather scary situation in comparision with getting natural antibodies through breastfeeding. Injecting antibodies into the blood stream is not without some risk.  But, yes this is science and research.
Now we have a company, Prolacta Bioscience, who would like to provide a more natural treatment for immune deficiency.  Although it isn't breastfeeding but, "The present invention discloses a prophetic inclination, based upon a 15-year study of human milk, that a new form of gammaglobulin referred to here
in as 'panaglobulin,' 'mammaglobulin,' or 'lactopanaglobulin' may replace the current gamma globulin."

"Because higher levels of IgA and IgM are present in human milk and colostrums, and a more diverse form of IgG as well, panaglobulins may provide protection beyond the scope of current gamma globulin therapy."

One of the more interesting connections that I see between Prolacta's interest in providing gamma globulin from human milk is that many of the BOD of Prolacta as well as their executive management have worked at Baxter, a manufacturer of intravenous immune globulin (from blood plasma) among many other healthcare products.  The CEO of Prolacta, Scott Elster worked for Baxter for 13 years in the plasma products area.  Scott Eaker, VP, Quality, is also from Baxter, having worked with Baxter's first recombinant Factor VIII manufacturing facility.  Joseph Fournell, VP, Operations for Prolacta,  worked as a director of global logistics for Baxter.  David Rechtman, Chief Medical Offider, also worked for Baxter responsible for prodcut safety.  He helped start an AIDS care team at SUNY-Health Science Center at Brooklyn.  John Bacich Jr., chairman of the Board of Prolacta was also employed by Baxter.  So Medo's patent for Prolacta does not seem like some far-fetched inventor's dream.
I am curious about our so-called knowledge of immune deficiencies.  We institute policy in which women who are hiv positive are not allowed to breastfeed their babies.  Yet, we will create a product made from the human milk to treat those babies.  What do we really know about building immunity?  Is denial of breastfeeding circumventing health for these infants?  What makes us believe that hiv/aids is transmitted through breastfeeding?  Wouldn't proof of transmission through breastfeeding require that infants be exclusively breastfed?  If given formula or foods or water, where is the proof that breastfeeding transmits this "virus?"  None of the studies done on transmission back years ago defined breastfeeding.  So now mothers will pay for a product to help her infant's immune system.  And no one questions the original studies done on transmission through breastfeeding.  No one questions the tragic twist of fate in which an infant will be denied breastfeeding but will need the milk of other mother's to build an immune system.  I guess we can applaud the ingenuity of men in a capitalist system in which we can be convinced that the natural development of immunity must not happen and we can readily replace it with injections of products "donated" from other mothers.  
Copyright 2011 Valerie W. McClain

Friday, August 26, 2011

IBCLC, concerns about a profession...

The IBCLC Code of Ethics  will be changed to a Code of Professional Conduct effective November 1, 2011.  I guess I shouldn't be concerned since at that date I will no longer be an IBCLC.  It's kind of ironic to see this proposed document and realize it coincides with my departure in the profession.  It makes me more at peace with my decision.  IBCLCs will no longer be obligated to follow the WHO Code, they will only be "encouraged."  So we are witnessing a profound change in a profession whose job was to promote, protect, and encourage breastfeeding.  It should make industry, particularly the infant formula industry happy.  And it lets human milk researchers (who sometimes are IBCLCs) off the hook.  They can happily continue doing human milk research for the infant formula industry and feel not a twinge of guilt.  For an understanding of the direction the IBCLC profession is going, I'd encourage readers to access the IBLCE website.  (http://www.ibcle.org)  I can't seem to access it anymore (it must be down right now-guess cause of the impending hurricane--Irene?  or IBCLCs?).  If one looks at the history of the IBLCE Board members, one is struck by the backgrounds of previous and current board members.  Many are nurses, doctors, and human milk researchers.  One year, I remember looking at the list and almost all board members were human milk researchers.  Does that present a problem?  Maybe.  It could explain the direction in which the profession is headed.  Non-medical educated people need not apply unless they want to get medical training.  I knew this was coming back in 1985.  I was told at a Florida LLL Conference that eventually the profession would not be easily accessible to LLL leaders and now was the time for LLL leaders to get this credential.  So I am surprised by other IBCLCs who are surprised by these "new" requirements.  This was the intended direction from the get-go by the leadership then and now.
What amuses me (sorry, in a cynical, sarcastic way) about the IBLCE's new Code is that they watered-down an IBCLCs obligation to the WHO Code but they did not change "respect for intellectual property rights" (which includes copyrights, trademarks, service and certification marks-certification marks was not on the old Code of Ethics), and patents.  This obligation is still there.  Why?  The IBCLC certification is a trademark, yeah a certification trademark.  But listed in the US Patent & Trademark Office.
Serial # 74631001  Registration # 2042667
Typed Drawing

Word Mark IBCLC
Goods and Services IC B . US B . G & S: independent lactation consultant services. FIRST USE: 19850308. FIRST USE IN COMMERCE: 19850308
Mark Drawing Code (1) TYPED DRAWING
Serial Number 74631001
Filing Date November 23, 1994
Current Filing Basis 1A
Original Filing Basis 1A
Published for Opposition December 17, 1996
Registration Number 2042667
Registration Date March 11, 1997
Owner (REGISTRANT) International Board of Lactation Consultant Examiners CORPORATION VIRGINIA 7245 Arlington Blvd. #200 Falls Church VIRGINIA 22042
Attorney of Record PAUL E. HODGES
Affidavit Text SECT 15. SECT 8 (6-YR). SECTION 8(10-YR) 20070427.
Renewal 1ST RENEWAL 20070427
Other Data The certification mark, as used by persons authorized by applicant, certifies the quality of the services performed by those approved by the certifier.
Live/Dead Indicator LIVE

So, I suppose if your profession depends on a trademark for credentialing purposes, then it is imperative that we "respect" ownership of a credential.  Luckily I don't have to worry about my BA credential.  Its bought and paid for a long time ago and I will never lose it.  But the IBCLC credential trademark is just a rental property.  I suspect there is more to the IBCLC respecting intellectual property rights than just the fact that IBCLC is a trademark, albeit a certification trademark.  I believe that having had alot of human milk researchers on the IBLCE Board may have influenced the views of the Board on patents and patenting issues.  The direction the profession goes is important.  It looks like the direction is headed down the road to hell but who am I to say anything?

Here's another patent that we can thank human milk researchers for, in particular Alan Lucas.

Patent # 7998501, "Newborn infant formulas and feeding method"
Inventors:  Atul Singhal and  Alan Lucas
Assigned to University College London (Cambridge, GB)

"It has been observed, however, that formula-fed newborn infants might benefit from a feeding having a lower energy density, and perhaps more importantly from a feeding that provides fewer calories during the initial weeks or months of life than would otherwise be provided from a feeding with a conventional infant formula.  We have found from our long term infant studies that rapid early growth achieved in large part from nutrient enriched feedings from conventional infant formulas,  may result in long term adverse health effects in individuals later in life, particularly with regard to long-term vascular health relevant to the development of atherosclerosis and to the later propensity to insulin resistance and non-insulin dependent diabetes mellitus (NIDDM)..."
The patent mentions that slower growth achieved by human milk (note:  breastfeeding? where be thee?) and a modified infant formula had better results regarding these diseases that cause adult morbidity.
And the patenting goes on and on.  And you, IBCLCs, are obligated to respect the business of patenting of human milk.  I call that an ethics dilemma that the profession has chosen to avoid.
Copyright 2011 Valerie W. McClain

Friday, August 19, 2011

Breastfeeding: the new morality play

Breastfeeding advocates are enthused by an article in Psychology Today called, "Breastmilk Wipes Out Formula:  Responses to Critical Comments." I am not so enthused.  In fact, I am deeply troubled by this article.  The author writes about her students and herself presenting a series of blog posts on breastfeeding vs. formula.   The article reads like the current one-mind set PR program from the US Health Department.  So we have a associate professor of psychology from Notre Dame (a Catholic University) and her psych students posting on a blog (blogs?) learning how to create just the right piece of evidence to convince readers about "breastfeeding."  Wait...wait....is it to convince readers about breastfeeding or breastmilk?  How does the public like having a psych professor and her students using their research knowledge of the human mind to "share" information on blogs?  Did they identify themselves as researchers to blog readers?  Interestingly, psych professors are being hired by the US Government (CDC) to write blogs, to attack alternative viewpoints on health (from hiv/aids to vaccinations).  The author, Darcia Narvaez, PhD is a researcher on teaching moral character has received funding at various times from the Department of Health in Minnesota (when she lived there) and is applying for grants from the NIH.  Does funding from US government agencies influence what you say and don't say?  Why is this article in Psychology Today focused on breastmilk?  In bold letters the article states, "We must face the fact that there is no comparability between breastmilk and formula."  Where is breastfeeding?  Words are important, we aren't talking about breastfeeding in this article.  This article is a promotion of breastmilk by a researcher who is often funded by the US government.  This article was written under the title, Moral Landscapes.  So I find myself wondering, are we going to make infant feeding a morality decision?  I thought breastfeeding was biology:  like walking or giving birth.  Oh yes, we aren't writing about breastfeeding.  It is breastmilk, a product that this article is promoting.  The author quotes Jim Akre writing that "milk sharing, a longstanding practice in human history is taking off through the internet."  What????  Wet nursing was and is a long standing practice not milk sharing.  Are we piggybacking another article to promote milk sharing over the internet?
This article states that the next step (in bold) is "establishing breast milk banks and milk sharing opportunities."  Yes, lets get women to share their milk as the US government, medical research institutions, the infant formula industry continue to patent human milk components.  Lets make it a moral, ethical imperative for women to "donate" their milk.  Anyone else think that there is something basicly unethical in promoting breastmilk sharing while keeping silent about patenting of human milk components?  Is anyone else troubled by the fact that a psych professor and students are writing to blogs, influencing the content, researching responses to content so that they can influence readers?  
I have gotten the impression over the years that various blogs are just propaganda efforts and some commentators to various blogs are part of various industries, infant formula in many cases involved with infant feeding.  Maybe psych professors need to study the influence of industry on blogs and blogging.  Or better yet, how the US Government influences content on the Virtual.  How many of those wonderful bloggers out there are really paid by the CDC to promote a viewpoint that sells vaccinations, pharm drugs, condoms to the public--now breastmilk feeding?  Yeah, all is fair in love and war....so the moral imperative is breastmilk feeding...God, what a world.
Copyright 2011 Valerie W McClain 

Wednesday, August 10, 2011

Mining human milk components

I really don't get it.  I really, really don't get it.  I don't get the lack of understanding or concern regarding the "mining" of human milk components?  Wake up?  Anyone there?  The media has a stranglehold on the reality of milksharing. So this is dedicated to my friends.



It's a news article from the Dairy Reporter on Danisco and Arla and their "project to develop human milk components-oligasaccharides for use in infant formula.  Read it.  Then ask how does the infant formula industry acquire human milk?  How?  Yes, maybe they advertise in newspapers and mothers get money in exchange for donating for a scientific cause.  Do mothers really not care that their breastmilk helps the infant formula industry make money??  Oh yes, I forgot, the world is a business arrangement and people will do anything for money.  But what about the mommies who donate their milk to those non-profits, who also believe that research of human milk is part of their mission?  Yeah, I know close your eyes, ears, and mouth because this is what human existence is about, BUSINESS.

Let's get to business.  How about buying some human breast milk (raw colostrum) from a company that sells human and animal proteins for research.

Or better yet let's learn about available technology for licensing on Human Milk Oligosaccharides.

Okay and now tell me why donor milk banks and milksharing organizations do not mention this possibility to mothers and fathers.  Informed consent?  Does it exist regarding human milk donations? 
Copyright 2011 Valerie W. McClain