Wednesday, September 30, 2009

CDC does not recommend nasal flu vaccine for pregnant women



The CDC does not recommend that pregnant women get the nasal flu vaccine. They recommend the inactivated virus vaccine shot. see
http://www.cdc.gov/h1n1flu/vaccination/pregnant_qa.htm

One patent application (20090081255) on a flu virus vaccine at the US Patent & Trademark Office owned by Sanofi Pasteur (French pharmaceutical company) discusses the use of vectors such as plasmids (usually used in genetic engineering). It also mentions the use of artificial chromosomes. It would seem highly likely that any inactivated virus flu vaccine will be genetically engineered. Currently there are no studies on H1N1 flu vaccine and pregnancy but studies will be starting soon. Interesting way of doing medical research....put out the product then test to see if its safe. It used to be the other way around but in this busy world we don't have the time.

I just finished reading a document entitled, "Legal Immunity for Pharmaceutical Industry" in which they state, "So far, neither the WHO nor the CDC or any other scientific body has demonstrated required scientific proof for the existence of the alleged H1N1 Influenza A new virus." Sounding more and more like hiv/aids. The existence of hiv is debatable and the PR campaign was about a massive epidemic--which never materialized (in Africa all statistics are debatable--testing unavailable, number of cases estimates only).

PhRMA (pharmaceutical industry group) had a press release dated 4-28-09 entitled, "PhRMA Applauds Kathleen Sebelius Confirmation as HHS Secretary." An interesting comment written in this April 2009 press release, "It's equally important for Congress to act rapidly to put a full-time Commissioner in place to head the Food & Drug Administration (FDA). Consumers count on the FDA to help assure the safety of a myriad of products--including the life-saving anti-virals contained within the Strategic National Stockpile which could be deployed in the event of an influenza pandemic." Gee whizz, those pharmaceutical people are sure amazing. They had that premonition that we were headed for an influenza pandemic. I guess one might call that fortune-telling....
Copyright 2009 Valerie W. McClain

Genetically engineered vaccine



The H1N1 flu vaccine created by Medimmune is patented. Two patents by this company are described at the US Patent & Trademark Office. There is patent # 6843996 called "Recombinant PB2 variant influenza virus," and patent # 6974686 called, "Recombinant tryptophan mutants of influenza." Both patents use genetic engineering to create the vaccine.
http://patft.uspto.gov/ patent number search

What do we know about genetically engineered vaccines? I don't know much about it. Who does?? How stable is a live genetically engineered vaccine? Meaning will it mutate into something else, something more virulent than its design? Why is a supposedly democratic society limiting choices in health care? Is there an epidemic emmergency? Why should we believe that this is some different flu that requires massive immunization of our population? Rather odd that there is no longer any legal recourse for people damaged by immunization. I suppose that suggests that the US Government and the pharmaceutical industry believe that vaccines are absolutely safe for all people? Or does it mean that these people-government officials and industry refuse to take responsibility for their decisions?

People my age (50's) remember very clearly the swine flu disaster of 1976. Perhaps this is why the government has chosen not to call it the swine flu. Instead it is just a bunch of letters and numbers. But the people are still calling it swine flu--easier to remember. In conversations with a variety of people close to my age, who regularly go to their doctors, get vaccines, I am fascinated by their response to this particular vaccine. Most people seem to have a wait and see approach. They aren't particularly moved by the view that there is a massive epidemic. But then most people in my area are more concerned about the massive epidemic of unemployment. Survival in this cruel democratic nation without a job is far more scary than getting sick and dying. In fact, dying might be a relief.
Copyright 2009 Valerie W. McClain

Tuesday, September 29, 2009

Marketing Swine Flu


Many have forgotten the 1976 CDC campaign to get the public vaccinated against swine flu. Many who will be impacted by the current hysterics regarding the "novel" swine flu, have no idea that health care is marketed to manipulate people towards consumption of certain health care products. Some Americans will never forget the 1976 swine flu vaccine campaign because they or their relatives died or were maimed (Guillain-Barre Syndrome) by the 1976 vaccine. In 1979, 60 Minutes did an expose on the swine flu vaccine of 1976. I watched the 30-year-old video in which it is revealed that there was 300 death claims from the 1976 swine flu vaccine but only one death from the actual flu. Claims against the US Government amounted to 3 1/2 billion dollars.
http://www.examiner.com/ article by Fred Burks dated 7/10/09
Thirty years later we must be much more advanced in our medical technology. It couldn't happen again? Or could it? The reality is that the only thing that can't happen again is that victims of vaccine injury or death can file lawsuits. Happily for the pharmaceutical industry, new laws have been created so that consumers have no legal recourse for vaccine deaths and injuries.
Who are the targeted groups for this "novel" swine flu vaccine (H1N1 ---novel in a genetic engineering dictionary usually means genetically engineered--so is this flu an escapee, a man-made flu not a natural mutation of flu?)? The targeted groups for this vaccine are: pregnant women, persons who provide care for infants, heath care providers/EMTs, persons 6 months -24 years old, persons 25-64 who have serious medical conditions.
The novel H1N1 vaccine was given an EUA (Emergency Use Authorization issued by the FDA to "allow either the use of an unapproved medical product or an unapproved use of an approved medical product during certain types of emergencies with specifed agents.").
Our Secretary of Health,Kathleen Sebelius, declares an emergency and the FDA Commissioner, Margaret A. Hamburg may authorize an emergency after consultation with the NIH and CDC.
The first batch of vaccines for our novel flu is a MedImmune/AstraZeneca-parent company product. It is an intranasal live vaccine. Adverse reactions as declared by MedImmune are runny nose or nasal congestion, for children from 2-6 years old fever greater than 100 degrees F, and sore throat in adults. MedImmune states that the "safety of this vaccine has not been studied in pregnant women or nursing mothers." It is not approved for use in children under 24 months of age, nor approved for use in individuals 50-64 years old. MedImmune states it may not protect all individuals. They have a caution to nursing mothers and pregnant mothers--only use if clearly needed (not sure how that is decided). This vaccine has not been evaluated for carcinogenic, mutagenic potentials or its potential to impair fertility. see
After reading various articles on the internet regarding the need for vaccinating pregnant women with the H1N1 vaccine, I find myself deeply troubled. There is an obvious media campaign going on to get pregnant women vaccinated. Yet this particular vaccine being brought out first by the US Government has some troubling statements in its product insert of the vaccine. What consumer will read the product insert? Pregnant women are being targeted--yet this vaccine because of "OUR EMMERGENCY" was approved for use without the usual safety reviews. This particular vaccine states that children under 24 months of age should not get this vaccine, yet the CDC target population is from 6 months of age an up to 24 years old.
Pregnant women and their families should look at the CDC MMWR regarding the three pregnant women that got the H1N1 flu. In this May 12th report, one woman died from acute repiratory distress syndrome but her speciman could not be confirmed as the novel influenza A (H1N1) virus. One pregnant mother fully recovered, and one pregnant woman (not tested for this flu) remained asymptomatic after being given oseltamivir (tamiflu). Supposedly the CDC will add to these cases (April-May 2009). Although I haven't seen anything else at the CDC website other than these 3 cases. These 3 cases prove what?? I don't get it? Is this the leading edge of the epidemic--where cases cannot even be confirmed to be this novel H1N1 flu? Scientific? Yikes.
What is behind the panic? And why does the CDC socially market pharmaceutical products? One can guess. One can wonder about the relationship between the current Commissioner of the FDA (who approved the rapid deployment of this vaccine without the normal chain of safety reviews) and her past directorship of the Henry Schein Inc. (medical and dental supply company). "Henry Schein can source practically all forms of vaccines.." (mentioned are MedImmune, Merck, SmithKline Beecham. Wyeth)
In a SEC filing dated 5/22/09 by Margaret A. Hamburg she divested some of her stock in Henry Schein before being sworn in May 22, 2009 as Commissioner of the FDA. But it appears that she also kept some of that stock. The company is also the distributor of Tamiflu. Nasdaq shares of Henry Schein were down 1.8 percent at $51.51 in early trade in August 4, 2009. I am sure that with flu season upon us, shares are going up for Henry Schein. One of our past Commissioners of the FDA, Jane E. Henney is on the BOD of AstraZeneca and also Director of Cigna. It never ceases, the flow between industry and government. Obviously, these people have expertise but is that expertise helpful to Jane the Pregnant Lady down the block? Or is health care policy about the Nasdaq?
Copyright 2009 Valerie W. McClain

Wednesday, August 12, 2009

keeping the silence


"Method for stimulating the functional attributes of human milk oligosaccharides in formula-fed infants."
A recent title to a new patent at the US Patent & Trademark Office, patent # 7572474 owned by Mead Johnson Nutrtionals. Inventors of the formula are Bryon W. Petschow et al. Some of the inventors are from Great Britain and Finland. Petschow is the Director of External Affairs for Bristol Myers Squibb (Mead Johnson is part of Bristol Myers Squibb, the pharmaceutical company).
Some statements of interest in the patent:
"Bifidobacterium spp. are also associated with resistance to gastrointestinal (GI) tract and respiratory infection as well as enhanced immune function in children and infants."
"Because cow's milk and commercially available infant formulas that are based on cow's milk provide only trace amounts of oliogosaccharides..."
"Briefly, therefore the present invention is directed to a novel method for stimulating the functional attributes of human milk oligosaccharides in a formula-fed infant, the method comprising administering a therapeutically effective amount of polydextrose (PDX) to the infant."
So why should we care about this patent? What does the infant formula industry know? They know their product is deficient and that they will have to "therapeutically" change their product in order to create a product that is resistant to diseases that effect the GI tract and the respiratory system of the infant. Sounds to me like we are talking about a pharmaceutical use of a food product. What will be their advertising slogans to get mothers to buy this product? And exactly why do we still believe that infant formula is a safe product in developed countries, when formula companies have to continue to improve their product in order to "try" to make it safer?
Of course, safety is not mentioned in this patent. But if resistance to infections is not the same in formula-fed infants, then it would seem logical to assume that formula-fed infants are sicker and their mortality rates are higher than breastfed infants. Why else "try" to imitate human milk?
I had correspondence some years ago with an MD regarding the safety of infant formula in the USA. This MD was not happy with my stance (not safe and never has been and never will be). I believe that this MD's belief was that because everyone had access to the greatest medical system in the world, any problems with formula could be rectified medically. Access....access to doctors and hospitals? Hm...how many people uninsured now in the USA? Sometimes even with the best of care, infants die...like the elderly they are our most vulnerable population. But the silence continues regarding the safety of infant formula because it is politically unacceptable to offend the infant formula industry (other than Nestle).
Copyright 2009 Valerie W. McClain

Thursday, August 6, 2009

Silencing other views, more patents


It seems to be a common response to alternative ideas on medicine, science, politics, even lactation consulting to respond in ways to silence those opposing views. This is done to protect one's reality, one's income, and one's ego. This response is so rampant in our society that I have come to believe that we, humans, are not very democratic. We treasure our reality and heaven forbid someone burst the bubble of our reality. How dare they think differently, see reality differently! Why can't they be nice and shut up? Yes, even I have succumbed to this ego-mania. Every once and awhile, I get stopped in my tracks and realize that reality is a composite of individual realities. No one has all the knowledge, all the answers. By shutting people out or up, one becomes lost in a fantasy of one's own making. Solving the difficulties of life, becomes impossible when one's mind is not open to other possibilities, other realities. Of course, that doesn't mean one let's other people bulldoze your reality. These last 10 years have opened my eyes to the difficulties in any profession in which "niceness" is the priority (mostly a woman issue). Being nice, means not openly telling the truth as you see it. Instead we beez nice and play nice....and maybe we getz a cookie for niceness. Actually niceness gets us to be speakers at Conferences, niceness gets us friends with the right pull, niceness gets us contracts with the government, niceness gets us jobs. Nice people gets to keep all the un-nice people out of sight and mind. Of course, the question is how do we define "un-nice." I leave it to the nice people in the world to define the "un-nice." My version is that niceness often involves having the right education and the right neighborhood. Having the right education (the Cornell, Harvard, Hopkins, etc higher institutions of niceness) means that one is automatically assumed to do no wrong. Heck, people with ivy league paper diplomas never lie, steal, or cheat. Just one of those American truisms that leds us "gently" around the world diplomatically telling the "unnice" people what to do. Breastfeeding advocacy is about being nice. Our niceness means that we do not discuss patents on human milk, human milk researchers who are funded by the infant formula industry (almost all of them) and the pharmaceutical industry, and never discuss any other formula company other than bad, bad Nestle. So we believe and encourage human milk researchers to speak at Conferences in which they do not have to publicly disclose their affiliations with the infant formula industry, nor disclose their patents they own. We don't know the names of the "other" infant formula companies because they aren't important. And we don't care to discuss the implications or even the facts about human milk component patenting. Nor do we discuss companies like Medela or Pigeon or Lansinoh because we are the nice people and it doesn't matter if these companies have easy access to breastfeeding advocacy organizations and their BODs.
Before I totally show my "un-niceness" I wanted to write about few patents that might interest some people.
In 1997 a patent was published at the US Patent & Trademark Office owned by Boehringer Ingelheim called "Human lysozyme" (patent # 5618712). Boehringer Ingelheim is a huge pharmaceutical company that has developed alot of hiv/aids drugs.
"Up til now, human milk and human placenta have been the only commercial sources for obtaining human lysozyme." Okay...so human milk was sold commercially to the pharmaceutical industry prior to 1997. Interesting, something I have been saying for some time and been disbelieved. Patents are legal documents, so I would suppose that they aren't lying about it.
They go on to say in this patent that since the availability of human milk and placentas was limited, they have had to develop a synthetic version (a gmo version). Why bother with human lysozyme? because, "The therapeutically effective use of lysozyme is possible in the treatment of various bacterial and virus infections (Zona, Herpes Zoster), in colitis, various types of pain, in allergies, inflammation and in paediatric (the conversion of cow's milk into a form suitable for infants by the addition of lysozyme)." Treatment of allergies? Who to believe? Kramer?? a pharmaceutical company???
Another patent called "Method for expressing phosphorylated recombinant human.beta.-casein in a bacterial system," (patent # 5807702) owned by Abbott Labs (drug and infant formula company) published at the US Patent & Trademark Office in 1998. This infant formula company states, "Efforts have been made to develop infant milk formulas that have some of the advantageous properties of human milk and avoid the disadvantages associated with bovine milk based infant formulas such as allergic reactions and incomplete digestion by the infant."
Abbott Labs believes that human milk is "less likely to cause allergic reactions." Maybe they should talk to Kramer and not bother genetically engineering human milk .beta.-casein. "Hansson et al. demonstrated that recombinant human .beta.-casein was expressed in the yeast, S. cerevisiae using the pYes 2.0 vector (Invitrogen Corp., San Diego, Calif)."
Of course, I can hear people saying that they don't genetically engineer human milk components for infant formula. Maybe not. But published some 11 years ago (filed in 1995), so they could do it years ago. What would stop them from putting it into formulas now? The FDA?? Hm...I wouldn't answer that rhetorical question....signing off as one un-nice person...
Copyright 2009 Valerie W. McClain

Wednesday, August 5, 2009

Infant formula patents and allergies


What to believe? Breastfeeding does or does not prevent allergies? Why would Kramer et al in the recent PROBIT study on allergies see no difference in allergies between infants whose moms were encouraged to breastfeed longer and exclusively and infants whose moms were not encouraged. Maybe because the differences between the two groups was minimal? Differences would be subtle because essentially all mothers were doing both breastfeeding and bottlefeeding-some more breastfeeding, some less. I thought it might be of interest to quote from some patents regarding allergy and infant feeding.
Patent #5591446 published at the US Patent & Trademark Office in 1997 is called, "Methods & agents for the prophylaxis of atopy." owned by Beiersdorf AG (a multinational company in Denmark that produces and sells cosmetics-Nivea-and personal care, wound care items).
"By the 1920"s, it was recognized that early childhood nutrition plays an important role in preventative medicine. R.S. Zeiger et al; in "Journal of Allergy and Clinical Immunology," 78 (1 Part2):224-238 (1986) stated that breastfeeding in combination with a delay in supply of solid nutrients is suitable to alleviate atopic dermatitis and food allergies in early childhood."
But that is a cosmetic company and maybe they don't understand the recent science in which breastfeeding has no effect on allergies? Hm...Let's look at a Nestle patent (#7230078) published in 2007 called "Soluble toll-like receptor," by inventors Eduardo Schifferin. They have claims on a human milk component (soluble toll-like receptor). "Their" human milk component will, "provide for prophylaxis, prevention, treatment or therapy of inflammatory conditions or allergic reactions in a mammal..." Mammals, I guess that would include us, humans. Nestle is using a human milk component against allergies....confusing, eh? How can that be?
Patent Application 20080125346 called "Infant Formula" by Beermann et al, owned by NV Nutricia (European infant formula company) pulbished in 2008. They state, " The present nutritional composition is particularly suited for feeding infants as it mimics the protective effects of human milk, in particular against allergies and infections." Both Nutricia and Nestle seem to think that human milk has some sort of protective effect.
Patent Application 20080139499 called, "Beta-Serum Dairy Products, Neutral Lipid-Depleted and/or Polar Lipid-Enriched Dairy Products, and Processes for Their Production," invented by Katrina Fletcher et al and owned by Fonterra Cooperative Group/New Zealand (Dairy company that was touched by the melamine scandal in China)
They say, "Research over the last 5-10 years has shown that increasing phospholipid and (glyco) sphingolipid levels in infant formulations to levels found in human milk may lead to enhanced gut maturation thereby reducing the risk of infection; prevention of infections by modifying gut intestinal flora and competitively binding antigens, prevention of allergies, and optimal neural development."
It looks like the infant formula industry is trying to imitate human milk in order to reduce the risk of allergy. Rather odd considering the media's reporting of Kramer's studies in which we are to believe that breastfeeding does not make a difference in allergies. What does the public prefer to believe? It would seem odd that patents are saying one thing but media reports on research says something different.
In April of 2008, "a symposium at the American Society for Nutritions' annual meeting at Experimental Biology was held in which noted scientists discussed new infant feeding studies..."
Kramer presented his evidence regarding the PROBIT study and obesity--breastfeeding had no effect. Not surprising that the finding showed no effect--same data from the original PROBIT study where all babies did breastfeed and bottlefeed (some breastfeed exclusively and longer but by 6 months of age all babies seemed to be bottlefeeding more than breastfeeding)
The conference was sponsored by the IFC (international formula council) which includes Abbott, Mead Johnson, Nestle, and Wyeth. PR by Kellen Communications.
So what do you believe and why???????
Copyright 2009 Valerie W. McClain, IBCLC

Tuesday, August 4, 2009

The PROBIT studies by Michael S. Kramer



Anyone else been following Lactnet and the Michael Kramer thread? Me, me, me, me......I even sent an email to the Lactnet listmothers, asking them if they would consider my comments worthy of sharing with Lactnet subscribers...NOT. Of course, I think my comments might further clarify the PROBIT (Promotion of Breastfeeding Intervention Trial) studies. But clarity and other viewpoints seem to be illusive in our world. I wrote the following email to Lactnet.

from the email:
Dear Lactnet Listmothers:
I have been following the thread on Lactnet regarding Canadian researcher, Michael S. Kramer and was hopeful that my comments were worth sharing with Lactnet subscribers. The PROBIT study by Michael S. Kramer et al. was published in JAMA in 2001. It showed a very positive view of breastfeeding and particularly showed that with positive breastfeeding interventions, more women would breastfeed longer and exclusively. (WHO defintion of exclusive breastfeeding). And it seemed to show the positive health benefits to infants when mothers exclusively breastfeed. In the 2001 JAMA paper it stated that "Atopic eczema was reduced by 46%." This paper stated, "In addition the prevalence of exclusive breastfeeding was seven fold higher in the experimental group [interventions to encourage exclusive breastfeeding and longer duration of breastfeeding] at 3 months (43.3% vs. 6.4%) although low in both groups at 6 months (7.9% vs 0.06%)." Looking at the data, the prevalent mode of feeding was MIXED FEEDING not exclusive breastfeeding. Health benefits to infants were visible despite the fact that a majority of infants were not exclusively breastfed.
http://jama.ama-assn.org/cgi/content/full/285/4/413

In 2007, the BMJ published another study using PROBIT participants who were now children, again lead by researcher Michael Kramer entitled, "Effect of prolonged & exclusive breastfeeding on risk of allergy & asthma..." This study shows no benefit of lengthy or exclusive breastfeeding regarding allergy or asthma. They used skin prick tests (for dust mites, cat, birth pollen, mixed northern grasses, and Alternaria) on the children. The majority of PROBIT infants were not exclusively breastfeed. How do we come to a clear understanding of the relationship between how one is fed as infant and health effects, if one is fed not only breastmilk but other milks?
http://www.bmj.com/cgi/content/full/335/7624/815

Of interest regarding the BMJ paper, is that the list of authors to this paper are different than the JAMA study. Last author to the BMJ paper is a Bruce Mazer. While he is also a Canadian researcher from McGill University, he also has represented the drug company, Fujisawa Healthcare, inc. see
http://www.wvdhhr.org/bms/sPharmacy/PDL/Mtg_agenda_minutes/bms_pdl_20030122minutes.pdf
Interestingly this drug company sells Protopic Ointment for atopic dermatitis. In 2001 the FDA issued a warning letter to this company for this ointment because their TV ads were determined to be misleading.

The PROBIT study was funded by the Canadian Institute of Health Research (Canadian government). While researchers may do research at the universities or through various government agencies, they also maybe funded by various industries. Does this negate the sicience? Possibly. When I look at studies/papers I look at not only the first author of the study but the last author. Often the last author is of more importance to the study--gathering the funding, guiding the particular research. It looks to me like Mazer in the BMJ study is of importance, particularly when one is refuting the original work of the study in which your data is based.

Should we believe that the 2001 study was defective in regard to allergy and asthma? Does the newer study gave [give] us better science? Or is this paper a reflection of a change in authors? Bruce Mazer is paid by a drug company that specifically markets meds to alleviate atopic dermatitis. How is the drug market effected when we believe that exclusive and lengthy breastfeeding does not impact allergies or asthma? Or how is it impacted when we have one study that says one thing and another the reverse? Confusion...maybe less reason to support breastfeeding, more media stories that say that health effects of breastfeeding are minimal...

It would seem to me that it would be highly improbable that Michael Kramer did not know of Mazer's association with Fujisawa Healthcare Inc. and the drugs designed by this company against allergy. This is something that should have been disclosed before publication. These two studies give us a good view of how changing the author can reverse the original findings. The problem with the original study and this follow-up on allergy and asthma is that one cannot use mixed feeding of infants to determine health effects. One needs to examine exclusive breastfeeding versus exclusive formula feeding to get the real picture. The original paper gave us a real understanding of how positive interventions (BFHI) will increase the duration and exclusivity of breastfeeding. The second paper muddies the waters of our understanding about health effects and breastfeeding because a majority of the infants were not exclusively breastfed.

Sincerely,
Valerie W. McClain, IBCLC"

These further comments were not sent. According to one report read on the internet, "Canada's patent holding pharmaceutical companies have teamed with the CIHR (Canadian Institute of Health Research) to create the not-for-profit R & D Health Research Foundation." PROBIT studies were funded by the CIHR. Do pharmaceutical companies partnered with government give us better studies or more studies supportive of pharmaceutical objectives? The CDC has its own foundation, too, in which the pharmaceutical and infant formula industries support. So how much of science funded by government is a science seeking the truth and how much is science seeking customers? Should we allow our health care professionals to understand how much their "evidence-based" medicine is owned by the pharmaceutical and infant formula industry? Yes, silence wins again.
Copyright 2009 Valerie W. McClain