The Holes: TDaP with every pregnancy

TDaP in every pregnancy has been a new recommendation  (in the US) since February 2013. Now we are pushing this in Canada too, and if you ask me, this is being done BEFORE the evidence even exists that this is a safe and effective vaccine in pregnancy. Some evidence to this effect:

First off - Package insert -> Adacel and Boosterix both have the same statements, which say:
USE IN SPECIFIC POPULATIONS------------
-> Safety and effectiveness of Adacel vaccine have not been established in pregnant women. (8.1)

-> Pregnancy Surveillance Registry: contact Sanofi Pasteur Inc. at

1-800-822-2463 (1-800-VACCINE). (8.1)

https://www.vaccineshoppe.com/image.cfm?doc_id=10437&image_type=product_pdf

IMO - They they made this recommendation (to get a TDaP with every pregancy) in February of 2013 without any evidence, and are only now starting to test these theories. (Wreckless if you ask me...)

A current clinical trial testing the claim they are making about safety and efficacy in pregnancy. In this stufy, they are actively seeking volunteers who have had recent TDaP injections because they don't even know if TDaP every pregnancy is safe. http://clinicaltrials.gov/ct2/show/study/NCT02209623?term=TDaP+Pregnancy&rank=5

Here's another current clinical trial that has been ongoing since 2007! "The purpose of this study is to assess whether immunization against pertussis in the mid third trimester of pregnancy provides passive protection to the infant by transfer of IgG transplacentally and by transfer of secretory IgA (and possibly IgG) in breast milk, sufficient to protect the infant against pertussis disease in the critical neonatal period, without suppressing the infant's immune response to active immunization and disease" Again, they have no clue if vaccinating moms in pregancy has risks.

http://clinicaltrials.gov/ct2/show/NCT00553228?term=TDaP+Pregnancy&rank=4

There are a couple completed clinical trials as well, but shocker - one of them is nothing to do with safety and effecacy, but rather on TDaP and how to promote the vaccine to increase the likelihood that a mother will take them during pregnancy (WTFF??):http://clinicaltrials.gov/ct2/show/NCT01761799?term=TDaP+Pregnancy&rank=6

And this completed clinical trial, that compares pregnant woman receiving TDaP to non-pregnant woman receiving TDaP. http://clinicaltrials.gov/ct2/show/NCT00707148?term=TDaP+Pregnancy&rank=8

The thing that really rubs me the wrong way in this trial is the study design. They have 48 pregnant and 32 non-pregnant, 32 of the pregnant woman woman receive TDaP during pregnancy, and a saline placebo post pardum, and 16 pregnant woman receive the saline placebo in pregnancy and the TDaP post pardum. The 32 non-pregnant woman receive just the vaccine. So they are ALL getting the vaccine. The reserach paper from this stufy concludes "Further research is needed to provide definitive evidence of the safety and efficacy of Tdap immunization during pregnancy." http://www.ncbi.nlm.nih.gov/pubmed/24794369?dopt=Abstract

The holes in healthcare: The importance of fever

With "flu season" on the way, the topic of fevers often comes up. We have been taught to fear fever, but this need not be the case. In fact reducing fever can be detrimental, and recent mainstream health resources back this. When you read between the lines and think critically and logically, it even appears that reducing fevers could be the cause of complications from disease!!

From the National Library of Medicine:

• Fever is the temporary increase in the body's temperature in response to some disease or illness.
• Fever is an important part of the body's defence against infection. 
• Most bacteria and viruses that cause infections in people thrive best at 98.6°F. 
• Many infants and children develop high fevers with minor viral illnesses. 
• Although a fever signals that a battle might be going on in the body, the fever is fighting for the person, not against.]
• Brain damage from a fever generally will not occur unless the fever is over 107.6°F
• Untreated fevers caused by infection will seldom go over 105°F unless the child is overdressed or trapped in a hot place
• Almost any infection can cause a fever.

http://www.nlm.nih.gov/medlineplus/ency/article/003090.htm

To sum up the above in less words: Fever is a normal and important part of the body's defence against infection from bacteria and viruses. Fever must be allowed to occur at levels above 98.7°F to be sufficient in battling bacteria and viruses, and fevers even up 105°F - 107°F degrees generally still do not cause brain damage.

And not only does the fever kill bacteria and virus, research is also showing it actually helps to activate parts of the immune system that are capable of destroying infected cells!

"Recent studies have begun to support the notion that elevated body temperature helps certain types of immune cells to work better."... "To test this, researchers injected two groups of mice with an antigen, and examined the activation of T-cells following the interaction with antigen presenting cells. Body temperature in half of the mice was raised by 2 degrees centigrade, while the other half maintained a normal core body temperature. In the warmed mice, results showed a greater number of the type of CD8 T-cells capable of destroying infected cells" http://www.worldhealth.net/news/fever-plays-key-role-fighting-infection/

Back in the day (1948) they had no idea of the importance of fever: "The significance of fever is not sufficiently appreciated today." (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1933808/pdf/bullnyacadmed00550-0069.pdf) 

At a time when disease prevalence was skyrocketing, so was the research and use of analgesics for reducing fever. http://www.tylenolliverdamages.com/timeline.html. Puts a new spin on why people were dying of basic diseases too doesn't it? Diseases such as measles, mumps, polio even? Of course if these viruses are allowed to persist, they will cause more damage, become aseptic and cause meningitis!!

Now we know: "Usually a fever goes away within a few days. A number of over-the-counter medications lower a fever, but sometimes it's better left untreated. Fever seems to play a key role in helping your body fight off a number of infections." http://www.mayoclinic.com/health/fever/DS00077 (2011)

"... having a fever is part of an effective immune response. We had previously thought that the microbes that infect us simply can't replicate as well when we have fevers, but this new work also suggests that the immune system might be temporarily enhanced functionally when our temperatures rise with fever. Although very high body temperatures are dangerous and should be controlled, this study shows that we may need to reconsider how and when we treat most mild fevers." http://www.infectioncontroltoday.com/news/2011/11/fever-plays-vital-role-in-immune-response.aspx (2011)

I could go on and on, but I think the point is fevers are ok, good even, and should be allowed to occur. We need only be concerned when fevers reach such high levels that they begin to affect cognitive function (lethargy), and in those time there are still ways to reduce fever naturally (being outside, cool clothes, cool baths, etc).

The holes: using VPD's (vaccine preventable diseases) to cure cancer!

So how spooky is this. Researchers are now looking at using vaccine preventable diseases (including measles, mumps, rubella, polio and more) to treat cancer! "Hold on now", you say. "I thought viruses were bad, nay terrible evil beings whose sole purpose in life is to seek out and destroy the human race?" Alas the holes in the story. "Measles KILLS! Measles CURES!"

So far I have found measles being used to treat ovarian cancer "Scientists...engineered the measles virus to attack tumor cells and leave healthy cells unharmed, and then tested the new strain in cancer patients in a phase I clinical trial, which showed the treatment to be safe and well-tolerated." (benchmarks.cancer.gov/2011/06/measl...) 

Measles being known to cure cancer "“The cancer-killing properties of measles virus have previously been reported by researchers at the Mayo Clinic,” says Dr. Richardson, professor of microbiology & immunology and paediatrics with Dal and the IWK Health Centre." (www.dal.ca/news/2011/09/01/an-unexp...)


Use of attenuated paramyxoviruses for cancer therapy. "virotherapy in combination with immunosuppressive drugs (cyclophosphamide); retargeting of viruses to specific tumor types or tumor vasculature; using infected cell carriers to protect and deliver the virus to tumors; and genetic manipulation of the virus to increase viral spread and/or express transgenes during viral replication. Transgenes have enabled noninvasive imaging or tracking of viral gene expression and enhancement of tumor destruction. www.medify.com/insights/article/210...

And a paper that says "Under the right circumstances, viruses are capable of targeting and destroying cancer cells in human cancer patients....With the advent of genetic engineering and biotechnology, a wide range of viruses are being manipulated and evaluated in various types of cancers. "(www.givetolife.org/mike/Presentatio...)

So the "healing" properties of these viruses are only "acceptable" when they have been genetically modified? Are we really expected to believe this? Or do we simply have a case of nature yet again being manipulated for proprietary gain?!!? We have diseases being eradicated, cancer rising, and then those same diseases used to cure cancer?! Is this not friggin nuts?? Viruses cause cancer. Oh, no, wait, they kill cancer. So which is it? Can't have both. And its just far too convenient that these viruses will only prevent disease (or treat it) when they have been manipulated, to otherwise make it patentable. (AKA Profitable.)

Isn't it ironic that most vaccine preventable diseases are now being used or studied to cure cancer? I find this to be far too coincidental and for me, further evidence that nature knows best, and viruses, bacteria, germs and dis-ease all serve a purpose. They knew in the 1970's what was happening, but didn't do any further studies for 20 years! 


"In the 1970s, measles infections were observed to cause regression of pre-existing cancer tumors in children. This information was noted, but nothing was done to study this phenomenon until the late 1990s, when under the direction of Stephen Russell, M.D., Ph.D., Mayo Clinic Cancer Center's Molecular Medicine Program began looking into it, resulting in the current study and other related projects." psychcentral.com/news/archives/2006...

"In the 1970s, it was reported that natural infection with the measles virus (MV) led to spontaneous regression of hematologic cancers in African children. This and other, similar reports led to investigations of the oncolytic, or cancer-fighting, properties of MV and other viruses and their potential in cancer treatment."www.mayoclinic.org/medicalprofs/mea... 

"As early as the 1970s, spontaneous clinical remissions were observed in patients suffering from hematological cancers after natural infection with wild-type (wt) MV" www.mdpi.com/2079-7737/2/2/587/pdf


Why? Because of limitations on technology? Or because no corporation is interested in studying (and investing in) something that occurs naturally and therefore cannot be "owned" as intellectucal property.

Some more sources:

"RNA viruses as virotherapy agents.
Further refinement and optimization of these oncolytic agents can be achieved through virus engineering. This article provides a summary of the current status of oncolytic virotherapy efforts for seven different RNA viruses, namely, mumps, Newcastle disease virus, measles virus, vesicular stomatitis virus, influenza, reovirus, and poliovirus. " www.medify.com/insights/article/125...

My mind has just been officially blown. So why are we not looking at the importance of these diseases then? Instead we call them all dangerous and deadly, when with most of them (80% to 95%) don't even present symptoms, depending on the virus and the person. Why? Because there is no money to be made in children growing into cancer free adults because of something nature does on its own. You can't patent something that is not novel or innovative (meaning new or modified). 

In nature, there is always an important symbiosis that we generally have no clue about until it is too late! Here is an analogy that could illustrate this cancer/virus connection:

~ Some family friends bought a house with some nasty basement spiders

~ They decided to exterminate the spiders

~ Two years later they discover termites are destrying the house!!!!

~ So they BRING BACK the spiders, to eliminate the termites.

~ The spiders were only an inconveinence, but when removed, the house could have EASILY been destroyed in a matter of time. So they brought them back. Sounds a lot more like an analogy to this VPDs to cure cancer...

SYMBIOTIC relationships exist and serve a purpose, and what evidence do we really have to suggest that there ISN'T a purpose to contracting disease - including avoiding cancer. I can't imagine thinking I know better than nature....

One final source:

(Year 1994) "The human mumps virus (which is related to the avian NDV) was reported to have an oncolytic effect on sarcomas in rats (75). Subsequently, in an uncontrolled trial, inoculation of wild-type live mumps virus into 90 terminally ill cancer patients reportedly produced a "very good" or "good" response in 79 of the patients, without causing ill effects (5). In addition, some association between measles infection and remission of human leukemia has been reported (6). However, rigorously controlled trials using on- colytic viruses to treat specific human tumors have not been performed." jnci.oxfordjournals.org/content/86/...


I can't emphasize this enough. They knew for 20 years! Why no controlled trials?? That's the biggest hole of them all...

The holes in formaldehyde safety research (in vaccines)

"FDA study reinforces no safety concerns from residual formaldehyde in some infant vaccines"

 http://www.fda.gov/biologicsbloodvaccines/scienceresearch/ucm349473.htm

Ripping this thing apart!! My comments in red :)

The amount of formaldehyde present in some infant vaccines is so small compared to the concentration that occurs naturally in the body that it does not pose a safety concern, according to a study using a mathematical model developed by scientists at the U.S. Food and Drug Administration (FDA). (NOTE: using a mathematical model, not using any real tests! They are presuming! I hate this aspect of "science") 


Formaldehyde has a long history of safe use in the manufacture of certain viral and bacterial vaccines. (Interestingly, I just learned, from Paul Offit's course even, that "safe" in medical terms means "the benefits outweigh the risks. Not that there is no risk. In this case, the risk to benefits are the risk of using formaldehyde versus not using it in a vaccine. Well not using it means the virus isn't attenuated or that the vaccine isn't antibacterial. So ya the risk to benefit ratio of formaldehyde use in a vaccine versus not is pretty obvious! But that doesn't mean that formaldehyde is actually safe. It is safer to use it in a vaccine then to not use it. Tricky wording huh?)

It is used to inactivate viruses so that they don't cause disease (e.g., polio virus used to make polio vaccine) and to detoxify bacterial toxins (e.g., the toxin used to make diphtheria vaccine). Formaldehyde is diluted during the vaccine manufacturing process, but residual quantities of formaldehyde may be found in some current vaccines. 

Formaldehyde is also produced naturally in the human body. It is essential for the production of some basic biological materials, such as certain amino acids. Amino acids are necessary for important life processes as they are the building blocks of proteins in the body. (Guess what is also produced in the body - viruses! In fact they cannot survive without a body. But they are "bad", so why are ingredients like formaldehyde automatically ok when they are produced in the body?) 

Formaldehyde is also found in the environment. For example, it is used in the manufacture of building materials, as a preservative for specimens in labs and to make many household products. (Oh well that must make it ok then, right?)

The latest research has shown that the highest risk of harmful effects from formaldehyde is from breathing it, and this occurs more frequently in people who routinely use formaldehyde in their jobs. (Oh so breathing it is bad, but injecting it is totally ok? Seems to me like they really just don't know. http://www.inchem.org/documents/iarc/vol62/formal.html "Studies in which formaldehyde was applied to the skin or injected subcutaneously were inadequate for evaluation.") 

Exposure to formaldehyde from vaccines differs from environmental exposure because the small amount of formaldehyde via injection with a vaccine occurs briefly and only occasionally. (Except they haven't looked much at injecting formaldehyde versus other modes of exposure. So how can they say this conclusively????) 

When the body breaks down formaldehyde it does not distinguish between formaldehyde from vaccines and that which is naturally produced or environmental. (This is true. What it DOES distinguish is in the route of administration. http://jem.rupress.org/content/6/4-6/487.abstract "8. The injection of formalin into the muscles produces myositis. 13. Pneumonia and bronchitis are found in all animals after the injection of formalin. 15. Formalin is, directly or indirectly, chemiotactic (it tells the cells which direction to move) for leucocytes (white blood cells).

 The tissues which are not infiltrated with leucocytes after the injection of formalin are those which have been so injured by the chemical that an inflammatory reaction is impossible. (In other words, formaldehyde damages the tissue so much that leucocytes can't even go in to repair the damage). 


Using modeling, the FDA scientists assessed the concentrations of formaldehyde in the blood and total body water of a hypothetical 2-month-old infant following injection of formaldehyde containing vaccines into the muscle at a single medical visit. They compared this estimate with the natural levels of formaldehyde that occur in the body. The model considered the natural reactions in the body that process formaldehyde and how long it would take for these processes to occur. (They assume that injected formaldehyde is processed the same as naturally occuring formaldehyde. But injecting isn't natural is it?) 

To ensure that the model did not underestimate the amount of formaldehyde the infant was exposed to, the FDA scientists assumed that the hypothetical 2-month old infant was in the 10^th percentile for age-weight relationship for the United States. Such an infant would receive the highest maximum exposure to vaccine formaldehyde relative to its weight.(Again the words assume and hypothetical. This is a friggin guess!! How is allowed to be accepted as conclusive??)

 Based on a maximal level of 200 micrograms of formaldehyde exposure from vaccination,the FDA model showed that the majority of the formaldehyde is essentially (?) completely removed from the injection site within 30 minutes. (Essentially? in a fundamental or basic way. http://www.thefreedictionary.com/essentially basically, primarily, at heart, intrinsically, at bottom virtually, fundamentally, in effect, substantially) So not totally! But my question is how do they know this when it is a computer model making the assumption? They are using the natural levels of formaldehyde in the body as a base line for how it breaks down from the injection site, but as we KNOW this is not one in the same!!! Gosh this frustrates me!!) 

The majority of the formaldehyde is broken down (metabolized) in the muscle and any remaining formaldehyde enters the bloodstream and body water. The model showed that at its highest concentration this remaining formaldehyde is less than 1% of the existing, naturally occurring level of formaldehyde in the body. (Ya because it gets converted to formic acid in the body. But formic acid is also casrcinogenic!! http://en.wikipedia.org/wiki/Formic_acid Not to mention that formadelhyde enters the body via the bloodstream, so concentrations are NOT the same, therefore matabolization cannot be the same.)

The FDA scientists note that the natural level of formaldehyde in the body is more than 100 times higher than that found in vaccines. Moreover, there are no known adverse health affects from this naturally occurring formaldehyde. They concluded that the temporary presence of a very small amount of additional formaldehyde contributed by vaccination would pose no safety concerns. (Concluded based on presumptions that naturally occuring formaldehyde is the same as injected formaldehyde. Whatever the case may be, injected formaldehyde is 100%. So say 200ug/kg of ingested formaldehyde is harmless, it is going to be a fraction of that for injectable. I'm going to make an educated guess of at least 5 times the "strength" when injected, so 200ug would be 1000ug injected! According to this table, for intramuscular administration, only 0.5ml of a substance is required versus 5ml when gavaged (ie forcefed/ingested) so that is 10 times the amount! Which translates to 2000ug/kg of formaldehyde when injected. "Intramuscular administration of substances is a common parenteral route in large animals and humans but often is avoided in smaller species because of the reduced muscle mass. Generally, intramuscular injections result in uniform and rapid absorption of substances, because of the rich vascular supply (Figure 3). Smaller volumes are administered intramuscularly than for subcutaneous delivery (Table 1).  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3189662/  

This study is part of a rigorous and ongoing evaluation of the safety of biological products for which FDA has oversight." Ya, right. Rigorous. If it were rigorous, we could EASILY find info on injecting formaldehyde. Not just computer models...

And just to add one final thing, check out this paper that says "formaldehyde may act as a cofactor in carcinogenesis." http://www.nj.gov/dep/watersupply/pdf/append-b-section-i.pdf  In otherwords, its not JUST the formaldehyde that is carcinogenic, but that it is a co-factor. IE: injecting someone with formaldehyde ALONG with other carcinogenic substances (like SV-40 perhaps?) are more likely to produce carcinoma. So is it just me, or are these HUGE holes in the science?

~ Dayna B.