Discussion group forming on the issue of patenting of human milk components

If you are interested in discussing the patenting of human milk components, I am starting a discussion group.  Please contact me, vewickstead@yahoo.com

Nestle's seed patent application and its human milk component patent

I have received a variety of communications regarding Nestle and its financial interest in a plant called Nigella sativa (Black Cumin, Black Seed).  In fact most of the communications are about signing a petition to, "Tell Nestle to stop trying to patent a natural cure."  So I decided to look up their patent application and get an idea of what was going on.  Nestec S.A. (Nestle) has a US patent application called, "Opioid receptors stimulating compounds (Thymoquinone, Nigella Sativa) and food allergy," #20120142580 which was filed in 2010.  The abstract states, "It was found that the stimulation of opioid receptors could be used to treat or prevent food allergy." and "One of the plants containing thymoquinone is Nigella sativa (Black Cumin, Black Seed).  It has been used for centuries as a spice and medicinal plant in Southern Europe, Northern Africa, Asia Minor, and India."  They detail various methods to extract thymoquinone, although Nigella sativa is one of several plants they might use.  They mention the possibility of using Eupatorium ayapana ( white snakeroot, Philippines), Satureja montana (winter savory), or Thymus.  It kind of reminded me of the human milk component patents in which Nestle might use human, bovine, or buffalo milks.  We don't know and they aren't going to tell us.  For those interested in signing the petition,
http://action.sumofus.org/a/nestle-nigella-sativa/6/2/?akid=1576.861564.bnIsWh&rd=1&sub=fwd&t=3

I find myself somewhat baffled about this petition.  At least 3 or 4 different people or organizations sent me the information on this petition.  So I scratch my head and wonder why no one is interested in the patents (not just applications) that Nestle owns on human milk components.  We are upset about their declarations of methods to extract a component from a plant (actually plants and we know not which plants) but we aren't upset over their declarations of methods to extract a component from human milk.  Human milk has also been used for centuries to cure various ills:  eye infections, wound healing, etc.  It is human survival against the pathogens in our environment.  It is a child's true genetic inheritance. Breastfeeding is the heirloom of heirlooms.  It is a richness we should not abandon to commercialism.
     
Let us look at patent #7524815 entitled, "Osteoprotegerin in milk," owned by Nestec (Nestle).  The source of osteoprotegerin is from milk:  human, cow, and maybe buffalo.  And then maybe it will be genetically engineered.  Like the above patent we will not know what they use.  Osteoprotegerin will be used to prevent or treat "disorders associated with bone metabolism and immune function."  Surprisingly or not so surprisingly, the patent discusses very little about cow or buffalo milks.  Its all about human milk.

"In the studies leading to the present invention, it has now surprisingly been found that in addition to its presence in e.g. bone tissues, osteoprotegerin may also be found in human breast milk."  One of the advantages of human breast milk is its stability and its resistance to degradation in the gut.  It will be used in foods (infants and particularly preterm infants) and treatments or prophylaxis of bone remodeling.  

Words escape me.  Wake up, people, wake up....
Copyright 2013 Valerie W. McClain 

Suffer the little children...forced medical treatments or experiments?

This blog post is dedicated to Baby Rico Nagel Martinez and all the babies and children who have been forced to take medications/vaccinations against parental consent.  In many of these cases the infants and children have been removed from the custody of their parents or relatives because of their families' belief that the drugs or vaccinations were dangerous to the health of their children.  In some cases the children were in foster care with no voice or say in their medical care.

For an update on the hearing and interviews regarding Baby Nagel Martinez.
http://www.howpositiveareyou.com/2013/04/03/hpay061-defendingbabyrico/ 

A week or so ago I ran across a study entitled, "Human Immunodeficiency Virus Type 1 (HIV-1) gp120--Specific Antibodies in Neonates Receiving an HIV-1 Recombinant gp120 Vaccine," published in The Journal of Infectious Diseases published in 2001.  The authors were Elizabeth J. McFarland, William Borkowsky, Terry Fenton, Diane Wara, James McNamara, Pearl Samson, Minhee Kang, Lynne Mofenson, Coleen Cunningham, Anne-Marie Duliege, Faruk Sinangil, Stephen A Spector, Eleanor Jimenez, Yvonne Bryson, Sandy Burchett, Lisa M. Frnkel, Ram Yogev, Francis Gigliotti, Katherine Luzuriaga, Robert A. Livingston, and the AIDS Clinical Trials Group 230 Collaborators.  Financial support for this study was the Pediatric AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Dieseases, Pediatric/Perinatal HIV Clinical Trials Network of the National Institute of Child Health and Human Development, Chiron Corporation, General Clinical Research Center Units funded by the National Center for Research Resources.
http://jid.oxfordjournals.org/content/184/10/1331.full.pdf

According to the fine print on this study, "Informed consent was obtained from the parents and guardians of the children in this study."  Before I started reading the study, I found myself wondering what parent would allow their newborns/infants to be vaccinated with an experimental vaccine made with a recombinant (genetically engineered) protein?  (of course a parent wouldn't know what vaccine they were getting because it would be blinded and one group of infants would be getting a placebo) This study was published in 2001 but the actual clinical trial appears to have been started in 1999.  As far as I know, they have yet to come up with a safe and reliable vaccine for hiv and this is 14 years later.  So obviously this clinical trial was not successful in creating a usable vaccine.  The paper makes this statement, "The vaccine used in this study failed to induce neutralizing antibody to primary HIV isolates in sero-negative adults, a characteristic likely to be critical to protective immunity.  However our data demonstrating the capability of newborns to respond to an envelope subunit vaccine should encourage evaluation of other candidate vaccines that may be efficacious in reducing HIV-1 transmission due to peripartum exposure and to breast feeding in developing nations."

According to ClinicalTrials.gov the purpose of this particular study was, "Primary:  To determine the safety of envelope recombinant proteins rgp120/HIV-1MN (Genentech) and rgp120/HIV-1SF2 (Chiron/Biocine) in infants who are of indeterminate HIV status born to HIV-infected women.  To evaluate changes in viral load in infants proven to be infected and absolute CD4 counts in all immunized infants.  Secondary:  To evaluate the immunogenicity of these envelope recombinant proteins in infants of indeterminate HIV status born to HIV-infected women.  Only 30-50 percent of HIV-infected infants have detectable virus at birth.  Successful early sensitization to HIV envelope epitopes may help prevent infection or , alternatively, may enhance HIV-specific immune function to alter HVI replication and disease progession."

 http://clinicaltrials.gov/ct2/show/NCT00000774?term=NCT00000774&rank=1

The study chairs for this investigation were William Borkowsky of New York and Diane Ware of California.  One of the locations for this study was Incarnation Children's Center in New York.  I remembered reading about the Incarnation Children's Center.  I had to search the web and sure enough there was an expose done on this children's center entitled, "Orphans on Trial," by Liam Scheff.  He wrote in 2004 about how the National Institutes of Health (NIH) had conducted pediatric clinical trials on infants, toddlers and children.  They were forced to ingest the toxic drugs used to treat hiv/aids.  They used  g-tubes when children refused to take their meds.  Most of the children were foster children or wards of the state.  Many suffered the side effects of the drugs and some died.  How many?  Not sure they know. 

http://www.altheal.org/toxicity/orphans.htm

or see

http://www.sourcewatch.org/index.php?title=Foster_child_drug_trials


Some of these children (infants) from Incarnation Children's Center were given a recombinant hiv vaccine.  The research paper states 87 patients were randomized to receive vaccine or placebo.  ClinicalTrials.gov says they enrolled 156 newborns.  How many of these newborns were in foster care?  All the infants had to be on the hiv/aids meds, although on different dosages.  One of the challenges of the study was the presence of maternal antibody in determining a vaccine-induced antibody response.  The study states, "The traditional definition of a vaccine-induced antibody response as a 4-fold increase in titer from the baseline could not be used (because of maternal antibodies)."   The continued conundrum of maternal antibodies that circulate in newborns.  The infant infected or protected???

Let's take a look at the ethics involved in giving an experimental genetically engineered hiv vaccine to newborns who are in foster care.  The relinquishing of parental rights places newborns/children into the hands of the State.  What is the duty of the State regarding these children, particular if those children were born of "supposedly" hiv positive mothers?  Who speaks for the interests of the newborn, the child?  Particularly when the State has an interest in experimental drug and vaccine trials.  Is it in the best interest of any child to be part of a medical experiment in which the State has a vested interest in the outcome?  How is it that some of these researchers who represent the NIH, are part of an enforcement policy of hiv/aids meds on newborns and children (despite their comments that they believe enforcement is not beneficial in the long run)?  The Incarnation Children's Center situation was swept under the carpet.  And the State machine moves on without hesitation because no one is allowed to question hiv/aids.  And god forbid that you question any of it and work in the medical field...goodbye job.  And that is how you get situations like Baby Rico.  Is kidnapping too broad a term from what has happened to Baby Rico or to all the other children who have suffered through forced medication?  And where oh where is medical ethics, when we vaccinate newborns with genetically engineered hiv?  It seems that declaring a parent unfit because of refusal to medicate or vaccinate their children, makes it very easy for the State to use their children as guinea pigs.  Who speaks for these children?  What is wrong with researchers who are so blinded by their research that they cannot see the suffering they are imposing on children?
Copyright 2013 Valerie W. McClain

Toxic Drugs to eradicate hiv transmission in pregnant women and babies

"We do not have enough information about the effects of many medications when they are taken by pregnant women.  The U.S. Food and Drug Administration (FDA) regulates medications to ensure their general safety and effectiveness.  All prescription and over-the-counter medications are tested to see if they are safe and effective before they become available to the public.  Pregnant women usually are not included in these tests because of the possible risks to the unborn baby.  As a result, little information is available about the safety of most medications during pregnancy--including those available over the counter--when they first become available."
                                  CDC on "Medications and Pregnancy"
http://www.cdc.gov/pregnancy/meds/index.html 

It was and still is standard practice to discourage pregnant women from ingesting any drugs unless it is a medical necessity.  This is because of the concern about serious birth defects.  I grew up hearing about the tragedies of the mothers who took Thalamid for morning sickness and had deformed infants.  During my pregnancies in the eighties, I took no meds-prescription or non-prescription, no illegal substances, no alcohol (was ridiculed by some friends for not having just one drink) because I was concerned about birth defects.  Maybe I went to extremes, but I really don't think so.  It seems from the above CDC statement, we are in the dark about the effects of most drugs on the pregnant mother and her unborn child. So we don't know about the risks, unless pregnant mothers take the meds and give birth to infants with problems.

How does this impact pregnant women who are diagnosed with hiv in their pregnancy?  (a second pregnancy and subsequent pregnancies can create a false positive hiv test)  Obviously, the risk of birth defects is outweighed by the risk of transmission.  Yet there are studies that should have us concerned about the use of very toxic drugs in pregnancy and its impact on infants.  A study was reported in 2007 that stated "that AZT caused genetic damage to infants which may increase their risk of developing cancer in the future.."
Walker DM et al.  Transplacental carcinogenicity of 3'Azido-3'Deoxythymidine  in B6C3F1 mice and F344 rats.  Environmental and Molecular Mutagenesis 48:283-298, 2007.

What about drug safety for newborns diagnosed with hiv (testing in the newborn period is unreliable according to a Baylor College Nursing textbook on hiv/aids)?  For instance a recent safety announcement by the FDA about Kaletra oral solution used in premature babies (used in hiv treatment and the oral solution contains alcohol and propylene glycol) and newborns under 14 days states, "Because the consequences of using Kaletra oral solution in babies immediately after birth can be severe or possibly fatal, the label is being revised to include a new warning."
http://www.fda.gov/Drugs/DrugSafety/ucm246002.htm 

Of interest to readers might be this document entitled "Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States." revised 9/14/11  page 1 of over 200 page document

"The benefits of ARV drugs for a pregnant women must be weighted against the risks of adverse events to the woman, fetus, and newborn.  Combination drug regimens are considered the standard of care both for treatment of HIV infection and for prevention of perinatal transmission of HIV.  After provider counseling and discussion on ARV drug use during pregnancy, a pregnant women's informed choice on whether to take ARV drugs either for her treatment or for prevention of mother-to-child transmission or to follow other medical recommendations intended to reduce perinatal transmission of HIV should be respected.  Coercive and punitive policies are potentially counterproductive,they may undermine provider-patient trust and could discourage women from seeking prenatal care and adopting health care behavior that optimize fetal and neonatal well-being."

http://www.health.state.mn.us/divs/idepc/diseases/hiv/perinatalguideline.pdf


This document was found at the Minnesota Department of Health website and is from the US Department of Health.  It would seem that the US Department of health does not endorse coercive measures to hiv positive women and their babies.  Although they support the use of toxic drugs.  Reading some of the pages in this document about the side effects of these drugs, would make most women concerned about the well being of their babies.  About half of the authors to this report have declared fundings from various pharmaceutical industries (10 out of 28 authors).  see page 2 of the document.

I just recently listened to an abc.13 video of an interview with Dr. Mark Kline, President and Founder of Baylor International Pediatric AIDS Intiative.  see http://www.bipai.org

In which he is responding to the case of the infant supposedly cured of hiv/aids.  He does not believe that is possible. Nor is he aginst hiv drugs for pregnant women.  In fact, he seems to think that is the preventative step.  His organization is funded by the Abbott Fund and Bristol Myers Squibb Foundation (Abbott and Bristol Myers Squibb are pharmaceutical companies who have made quite a bit of money from hiv/aids drugs and test kits).  One of his executive directors, Gabriel M. Anabwani is chairperson of the Nestle Nutrition Institute Africa and on the technical expert committee for UNICEF and WHO.  Nestle does have some commercial interests in hiv/aids policies.
The last minute of Kline's comments are about the importance of not testing for hiv in newborns of mothers who did not get the hiv meds in pregnancy but were found to be hiv positive at the delivery of their babies.  His concern was about giving toxic meds to babies who were not actually hiv positive. 

There is a rush to use these medications on pregnant mothers and newborns.  That rush involves the use of Child Protective Services as a threat to make sure all mothers and babies receive these meds.  These drugs are DNA chain terminators, meaning they kill DNA.  While it would appear to some people that a pregnant mother is irrational and negligent to refuse the drugs for herself and the unborn baby/infant;  it seems to me that the irrational people are the ones who think giving toxic drugs to pregnant women and infants is the answer.  It may stop transmission but it is very questionable whether it gives hiv mothers and babies quality of life--particularly coupled with threats from Child Protective Servies.
Copyright 2013 Valerie W. McClain 

************************
For further information on the drug AZT usage in Pregnancy and in Children, I recommend, "AZT:  Unsafe at Any Dose?"
http://aras.ab.ca/azt-perinatal.html 

One of the more bothersome aspects of hiv transmission from mother to child is that prior to the recommendation of use of drugs (AZT, etc), the transmission rates were 16%-25% in the USA and Europe.  What that means to me is that 75%-84% of infants were not positive for hiv; either were born hiv negative or converted at some time during their infancy despite their mothers being hiv positive. (that is if you believe in the infallibility of hiv testing).  Yet current and past policy recommendations written by the US Government are that all babies of hiv positive mothers must take treatment.  
from the CDC, "Revised Recommendations for HIV Screening of Pregnant Women," dated April 1999.

"Before the results of the PACTG 076 trial using prenatal, intrapartum, and postpartum ZDV for perinatal prophylaxis, the risk for mother-to-child transmission ranged from 16% to 25% in studies from North America and Europe (17--19), up to 24% in Thailand (20), and 25--40% in Africa (21,22)."

Cited to a study by Dunn et al.
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5019a2.htm 

What adult would take treatment for a disease because they were in a at-risk population in which 75%-84% would not get the disease?  Particularly if the drugs have side effects like AZT?  It makes little to no sense.  Even if the drugs were "just" antibiotics, would you take them because you are in the at-risk population?  What is that famous saying about physicians?  "First do no harm?"  

  

 

Baby Rico Martinez Nagel: The collision of curent medical practices, Child Protective Services and Families

                                   
 "Modern Medicine would rather you die using its remedies than live by using what physicians call quakery."--Robert Mendelson,MD

The path we walk as parents, grandparents is difficult, treacherous, emotionally and financially draining, when we disagree with the medical treatment given to our children.  Refusing treatment (no matter how toxic and brutal) for our children is regarded in the medical community to be a red flag.  Often this means the threat of removal of our children from our homes by Child Protective Services.  It means our lives are laid bare and placed under the microscope to prove or disprove that we are not a danger to our babies and children.  Accepting the standard medical treatment often means watching our children suffer the pain of treatments that may or may not make life better for our children.  In cases such as cancer, it may destroy the quality of life and only prolong the suffering.  Often the treatment results in suppressing one cancer only to have another cancer appear years later.  

Baby Rico Martinez Nagel does not have cancer.  His health issue is that he tested positive to an hiv test given to him, after he was born.  His mother, Lindsey Nagel was adopted as an infant from Romania in 1990.  When Lindsey was brought to the US by her parents, Cheryl and Steve Nagel, she tested positive for hiv (she tested negative in Romania).  The prognosis at that time for her survival was grim, a few years at most.  She was started on AZT and progressively got sicker and sicker.  They stopped the AZT and her health gradually returned.  Steve Nagel has related in various publications that Lindsey was one of 12 children under 10 diagnosed with hiv in the state of Minnesoto and she was the only one who survived. Steve Nagel believes his daughter survived because she stopped taking AZT.  Lindsey gave birth to Rico in December of 2012. Rico was tested for hiv in the hospital and started on AZT and various other drugs (Lamivudine also known as 3TC, antifungals, antibiotics, etc).  He had feeding difficulties and ended up having a feeding tube inserted into his stomach, which leaked, creating further complications.  For a better understanding then I can give about the situation and to view the video of Rico being taken by Child Protective Services. (recent news is that Baby Rico is now on is way to his home or there already)
 http://saverico.com

As a mother, I find it heart-wrenching and heart-breaking to see a new mother have her baby taken away from her.  An infant is taken away because of a difference in opinion regarding testing and treatment of hiv.  Current policy in the USA seems to side with medical opinion over parental opinion.  I am at a loss to fully understand the situation with Baby Rico and the whys of taking a baby from a mother who has been trying to comply with the medical treatment.  So rather than writing about the situation when I don't fully have the facts, I'd rather discuss some of the issues regarding mother-to-child transmission of hiv. 

In 1994 a study reported in the New England Journal of Medicine called ACTG 076 in which AZT was reported to reduce perinatal hiv transmission.  The conclusion of the study done by the Pediatric AIDS Clinical Trials Group was, "In pregnant women with mildly symptomatic HIV disease and no prior treatment with antiretroviral drugs during the pregnancy, a regimen consisting of zidovudine [AZT] given ante partum and intra partum to the mother and to the newborn for six weeks reduces the risk of maternal infant HIV transmission by approximately two thirds." 
http://www.nejm.org/doi/full/10.1056/NEJM199411033311801 

By 1996, the NIH stated that with new data, were strongly "recommending to caregivers to offer AZT therapy to all pregnant HIV-infected women, regardless of the stage of disease."
http://www.nih.gov/news/pr/nov96/niaid-27.htm 

AZT was manufactured by Glaxo Wellcome (now GlaxoSmithKline).  There are side effects to this drug.  This is a drug that originally was intended to be used in cancer treatment but was considered too toxic and shelved until hiv/aids appeared.  Side effects listed in the 2010 HIV Nursing Curriculum by Baylor College of Medicine state that a common side effect is hematologic toxicity (anemia due to bone marrow suppresion or hemolysis, leukopenia, and thrombocytopenia), and other side effects as myopathy (muscle disease/muscular weakness), myositis (inflammation of the muscles--weakness, swelling, and pain), and liver toxicity.  
http://www.bipai.org/WorkArea/DownloadAsset.aspx?id=137 

In a book written in 2001 by Eleni Papadopulos-Eleopulos et al. entitled, "Mother to Child Transmission of HIV and it's Prevention with AZT and Nevirapine,"  the authors state, "However, the presently available data indicate that treatment with AZT increases, not decreases, morbidity and mortality in children."

So the study that changed what seemed to be standard medical protocol regarding pregnant mothers and hiv/aids meds was the ACTG 076 study.  And the reason was because the fear of transmission superceded the fears of toxicity.  Last night, I found myself looking at the authors of the ACTG 076 study.  While this study appears to have funding from the NIH (National Institute of Health)and NIAID (National Institute of Allergy and Infectious Diseases), many of the authors have had funding now or when the study came out from various pharmaceutical companies.  Some of the researchers have had GlaxoSmithKline funding (Glaxo Wellcome).  And one of the authors, Robert Coombs, is employed by GlaxoSmithKline as a Validation Analyst. Some of the authors have worked for or been funded by MedImmune, AstraZeneca, Bristol Myers, Abbott, Pfizer, Roche.  All of these pharmaceutical companies have a stakehold in hiv/aids medications or infant formula or hiv test kits.  And so how do we judge this study?  Do we dismiss how researchers are funded as irrevelant to the truth in medical science?

Technically the ACTG 076 study was funded by the NIH.  The NIH, like so many other US governmental agencies has public-private partnerships.  One of those partnerships is called the Grand Challenges for Global Health.  The NIH initiative is supported by the Bill and Melinda Gates Foundation, the Wellcome Trust (a trust derived from the company Glaxo Wellcome which is now GlaxoSmithKline), and the Canadian Institutes of Health Research.  Was this partnership in place at the time of the ACTG 076?  And how might this kind of partnership impact medical policy and practice?
http://ppp.od.nih.gov/pppinfo/examples.asp 

Finally, most importantly how accurate is hiv testing in newborns, when newborns carry maternal antibodies for 18 months or longer?  Standard practice according to the Baylor text book, entitled, "HIV Nursing Curriculum," and dated 2010 states the following on page 20, "In countries in which pediatric ARV therapy and infant formula are readily available and resources permit multiple tests, infants of HIV-positive mothers are tested at 14-21 days, 1-2 months, and 4-6 months."  I believe the reason there is a delay in testing is because testing in the newborn period is so unreliable.  In 2001, PCR testing for newborns was started at one month.  Further testing has to be done because of the problem of maternal antibodies.  PCR testing was never intended to be used as a diagnostic for hiv infection. 

Baby Rico was tested within the first 24-48 hours of life.  This appears to be contrary to the medical protocol put out by Secure the Future/Bristol Myers Squibb/Baylor College of Medicine text book.  Their approach shows a much more cautious approach to a presumption of hiv transmission in the newborn period.  The disregard to caution by authorities seems brought on by fear, panic and certainly some degree of arrogance about the rightness of calling in Child Protection Services.
Copyright 2013 Valerie W. McClain