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Showing posts with label routine medical interventions. Show all posts
Showing posts with label routine medical interventions. Show all posts

The Science Behind the Anti-Antibacterial Movement

Let me first start with this fundamental key:
 
One Bizarre Theory Replaces Another
 
In the early 19th century, a few scientists extrapolated a new and bizarre theory: that disease was caused by tiny organisms and each illness had a corresponding germ.
 
After a few years of examining sterile cultures slides and a bit of playing around with vaccines, these scientists were able to convince the world that their germ theory of disease was, indeed, true.
 
This outlook was convenient (and perhaps, perfectly poised to take root at this time in history during America’s industrialization) because it was methodical and specialized in its approach to understanding both the cause and treatment of disease. It allowed us to breakdown, the cause of an ailment to one small, fundamental unit which provided us a simpler way to understand a disease (ex. one germ for each disease). [*]
 
A treatment was then established based on this approach allowing generalized (‘one size fits all’) and massive quantities to be produced at an industrious scale. This approach was able to keep cost and time at a minimum while treating an increasing population. [*]
 
However, this mechanical approach to health is now diminishing…
 
Some biologists have even begun to speculate a new theory (I imagine just as absurd as germ theory was originally thought of back in the early 19th century): that humans are not individual entities, but rather complete ecosystems dependent on billions (100 trillion +) of bacteria and viruses (quadrillion +) to establish, maintain and actively influence health.[*][*]
 
Much of this information would have Pasteur rolling over in his grave…. who would think that viruses would be shown to help keep people disease free?[*][*]
 

Enter the field of Microbiomics.
 
If you have not heard of the human microbiome or microbiomics then, with great reverence, let me provide some mind blowing information for you to digest (no pun intended).
 
 
 

Microbiomics (….and why it’s absolutely mind blowing)
 
 
The ‘specific causes’ of diseases that revolutionized medicine a century ago is going through a conceptual evolution (time to get on board) – the way scientists think about disease and normal physiology is transforming. [*]
 
When I was in 7th grade, I remember the Human Genome Project being the next biggest and greatest thing science had going on…. now that it has been completed, however, a new phase has emerged: the Human Microbiome Project (HMP)….and it is changing everything. [*]
 
The HMP is an initiative to sequence the genomes of all the microbiological flora for a variety of body sites which play a “vital and interactive role” with our human DNA, immunity and disease. As bacteria, microbes and viruses in our bodies are modified under environmental pressure (ex. antibiotics and cesarean section birth), so is the regulation and replication of our genes (yes, our DNA). The two are intimately connected. [*] 
 

Far from being the ‘master molecule’ in our physiology, our DNA is demoted to simply another set of cellular genomes jostling for influence within us, reacting to and being regulated by, a set of microbial genomes that outnumber our own 10 to 1. [*]
 
 
Try to think of the bacteria, microbes and viruses that reside in our bodies as it’s own sensory motor organ which reacts much like our own nervous or immune system.[*]
 
Our microbiome encodes physiological traits that we were able to bypass in evolution; for example, the ability to “harvest certain nutrients and energy from food that would otherwise be lost because we lack the necessary digestive enzymes”. [*]
 
 
The Death of Germ Theory
 
The major conceptual doctrine of Pasteur’s germ theory is the role of causal pathogenic agents in disease. For example, diseases are separable from the patient and bacteria or virus in a human host equals disease. [*]
 
Even before the study of Microbiomics, it was clear that many individuals harbor dangerous bacteria (even at in large quantities) and suffer no ill effects.[*]
 
Certain diseases, such as herpes virus infection, which seem to fit neatly in the germ theory framework began to reveal a beneficial relationship that conferred immune advantages:

 

After clearance of acute infection, latent herpesvirus confers resistance to bacterial infection. To be specific, protection correlated with 100-fold reduction in bacterial burden in the spleen and liver.
 

2007 Nature [*]
 

“We now demonstrate that herpesvirus infection triggers systemic, PROFOUND IMMUNE MODULATION, with the potential to alter significantly the kinetics and nature of host response to foreign antigens.
 

Thus, whereas the immune evasion capabilities and lifelong persistence of herpesviruses are commonly viewed as solely pathogenic, our data suggest that latency is a SYMBIOTIC RELATIONSHIP with immune benefits for the host.”
 
 
So long we’ve swallowed the metaphor of an endless “war” on infectious diseases which involved a search for the microbial ‘cause’ of each and every disease  (of course, followed by the anti-microbial cure). This ideal has served its purpose and now we can no longer allow it to be our sole guide in medicine. [*]


 

“A new paradigm is needed that incorporates a more realistic and detailed picture of the dynamic interaction among and between host organisms and their diverse populations of microbes, only a fraction of which act as pathogens.” (Forum on Microbial Threats, 2006) [*]
 
 
A New Understanding of Disease

 

Quick Personal Backstory: My recent “antibiotic debacle”


About a month ago, my two year old was sent home from daycare for pink eye. I was expected to get a prescription for antibiotics for her to return. I was hesitant to say the least, my daughter has never received antibiotics and I wasn’t certain that all cases of conjunctivitis were caused by a bacteria. When we visited the nurse, she instructed me that only bacteria cause pink eye and my concern on delaying antibiotics was not sound. She went ahead and prescribed antibiotic eye drops.

 

Within 10 minutes of doing my own research once I returned home, I found this to be completely untrue. In fact, the majority of conjunctivitis cases are caused by a virus (NOT BACTERIA). Not to mention, the data very clearly illustrates that antibiotics for conjunctivitis is a complete over kill and often times does more harm than good.[*][*]
 

I made a deal with my husband, let’s wait one day before we administer the medication. We waited and her condition improved on its own. I suspect if we used the antibiotics, we would attribute her recovery to the drugs – luckily, we waited.
 

Medication we use via the ocular route (via eye drops) is just as important to research as ingested or injected drugs. Eye drop medication enters the bloodstream via mucous membranes lining the surface of the eye, the tear drainage system, and the nose. Once in the bloodstream, the medication can cause side effects in other parts of the body, including slow heart rate, dizziness and headaches.[*]

 

The outdated, traditional interpretation of disease correlates health as a matter of being “clean” and in order to obtain and maintain health we are advised to completely obliterate anything that’s not a human cell. [*]
 
Now, of course, microbiomics does not suggest health is all rainbows, ponies and singing kumbayah - our bacteria ecosystem can (and does) go awry. Certain species within us can overpopulate, resources decline, diversity is reduced (via antibiotics) and the interdependent processes can collapse.[*]
 
A new metaphor replaces the old – an understanding of ‘balance’ and ‘harmony’ supersedes the traditional thought of specific causation (one germ for each disease). Rather, human health is a matter of “having ones physiological process and predispositions aligned to promote homeostasis”. [*]
 

“It may turn out that diseases caused by microbial pathogens are best seen not so much as an invasion by a hostile organism, but rather as a kind of holistic dysfunction of the microbiome.” [*]
 

Simply revolutionary.
 
The greatest benefit to the health and wellness of a human body is not sterility, but rather “on maintenance of the symbiotic relationship between the host and the intestinal microbiotia”.[*]
 
This model, based on the latest science has to offer, suggests there are no diseases that exist separate from ourselves (ex. viruses floating around getting people sick) – only sick people whose processes within the body are not in balance. Recovering our health, therefor, is a matter of controlling the forces that influence the homeostasis within us.  Our health becomes a matter of our own responsibility. [*]
 
 
Antibiotics –Use with Extreme Caution (better yet, don’t use at all)
 
Our internal bacteria (particularly those located in the intestines) are essential to our health and “play an active role in nutrition, development, metabolism, pathogen resistance, and regulation of immune responses”. Antibiotic use, even for a short duration, has been “shown to disrupt these coevolved interactions leading to acute or chronic disease”.[*]
 
For every one human cell, there resides 10 bacteria cells within the human body (with viral particles expected to be a hundred times greater). Science, research and data continue to reaffirm that they play an active role in not only maintaining our normal physiology but also protecting us from: [*][*][*]
 
-respiratory infections
-acute intestinal infections
-allergies
-autism
-obesity
-type II diabetes
-cardiovascular diseases
-several forms of cancer
 

In addition to being numerous, our microbes are also “enormously varied” – with over 1,000 bacterial species residing within us. [*]

In fact, all plants and animals can be considered superorganisms; composed of a variety of species – bacterial and viral. [*] 

 
This variation in species is critical to health and is why antibiotics have been shown (repeatedly) to be permanently harmful (especially to children).
 

2007 The ISME Journal, Multidisciplinary Journal of Microbial Ecology
 

Long-term and persistent impact on human intestinal microbiota is a direct response from antibiotic exposure which never return to its original composition (during the 2 years of the study period). [*]
 
 
Antibiotics use in Children and Immune-mediated Disease
 
Antibiotics hold the possibility to be useful in some cases, but must be used with caution to protect long term health.
 
If you take anything away from reading this collection of data, please:
 

Several studies of antibiotic treatment has shown that the gut microbiota is profoundly and persistently altered by broad-spectrum antibiotic therapy. Data has shown that bacteria communities do not return to their initial state even after antibiotic treatment is withdrawn. [*]
 
During infancy and childhood, appropriate microbial stimulation and colonization is required for the development of a healthy, functional immune system. [*]
 
It is “well known that early life events occurring during critical windows of immune development can have long-term impact on immune-mediated disease. Antibiotic use in children has been shown, with significance, to increase such diseases as: diabetes, inflammatory bowel disease, asthma (requiring the use of inhaled corticosteroids), eczema. [*][*][*][*][*][*][*][*][*]
 
Antibiotic use must be critically evaluated, not just for ourselves but especially for children.  Each time we administer antibiotic medication it results in a ten-fold reduction in the amount of beneficial intestinal bacterial present. [*] 
 
With the use of antibiotic drugs,significant alternations are seen in the expression of pro-inflammatory cytokines” and Th1 immune maturation which has profound effects on our immune system. [*][*]
 
 
Take Care of Your Health by Giving Your Microbiome Some Love

 
My preference is to eat and drink foods that promote a healthy flora (versus relying on supplements) while being mindful of the lifestyle choices that can hurt me (moderation is key, of course)….
 
Focus on Prebiotics
-Foods with prebiotics are garlic, onions, almonds and asparagus.
-Foods with the fiber inulin promote beneficial flora: bananas, high-fiber veggies like peas and beans.
 
Avoid Sugar (especially artificial sugar)
-Sugar and starch promote the growth of harmful bacteria in the body
-Yogurt may have probiotics, but they are often LOADED with sugar. Be careful!
 
Eat more Fermented Foods (just a quarter to a half cup per day will do ‘ya)
-Homemade sauerkraut, kefir (watch the sugar here too), kombucha, miso soup
 
Lifestyle
-Smoking, caffeine, alcohol, consuming heavily-processed foods

 
 
Conclusion
 
It may go completely against what we all have been taught in high school biology class, to think that bacteria and viruses make our immune system function better, but the science is becoming evident: A healthy, mature immune system depends on the constant intervention of beneficial bacteria.[*]
 
Humans (all mammals, in fact) have co-evolved over millions of years to establish a dynamic, complex check-&-balance system with our microbiota. It shouldn’t be all that surprising that our immune system (particularly our mucosal immune system) has developed an intricate connection that mediates the balance between health and disease.[*][*]
 

Both innate and adaptive immune function has evolved to require microbial interactions during their development. [*]
 

The microbiota provides critical signals that promote maturation of immune cells and tissues, leading to protection from infections by pathogens. [*]
 
We must become more aware of our symbiotic relationship with the bacteria within the body (especially our children’s). This starts with not stereotyping all bacteria as bad. In fact, although a few may be problematic, these account for far less than 1% that exist in our body.[*]

Take care of your ecosystem – it sure takes care of you!

 

You can't learn everything from the laboratory, that's what he used to say. The whole is more than the sum of its parts, he told us. The whole behaves differently from the parts, and has different properties. That's what he taught us, and he was right. It's out of fashion to say these days, when we spend our time scrutinizing the interactions of eukaryotic microbes, but it's true, nevertheless. It's still true.

(M. Drabble, The Sea Lady, 140–1)

Neglected Research and the Administration of Tdap During Pregnancy

 
On October 24 of last year (2012), the ACIP voted 14 to 1 in the recommendation of administering a pertussis booster (Adacel or Boostrix) during every pregnancy regardless of vaccination history, preferably after 20 weeks gestation.[*][*][*]
 
This over ruled the earlier suggestion of the administration of just one booster during the first pregnancy because antibody levels were found to wane substantially during the first year after vaccination. Hence, leading the ACIP to conclude a single dose of Tdap at one pregnancy would be insufficient to provide protection for subsequent pregnancies.[*]
 
In the post below, I will provide published literature as to why this particular approach is not well-founded on actual science or research. I will also provide some information on the relevant risks of pertussis during infancy, the safety concerns of administering Tdap during pregnancy and the modification of pertussis epidemiology due to the current vaccination program.
 
 
Problematic Ambitions in Administering Tdap During Pregnancy
 
The underlining goal in this particular vaccination strategy (according to the CDC) is twofold:[*]
 
Mainly (1) “reduce the burden of pertussis in infants by providing some protection until they are old enough to be vaccinated themselves” [*]
 
Secondly (2) “protect the mother from pertussis around the time of delivery, making her less likely to become infected and transmit pertussis to her infant.” [*]
 
Let us address these individually with published data…
 
 
Reducing the burden of pertussis in infants
 
The goal of reducing pertussis infection within the infant population via vaccination is ambitious and nothing new (Clinical Infectious Diseases 1990).[*][*][*] 
 
Decades of research examining newborn vaccination against pertussis has been amassed; none of which has been enough to implement a national recommendation from the ACIP…until now, with a twist.
 
The CDC now feels strongly that this particular new approach, vaccinating women late term during pregnancy, will provide the protection they are hoping for.
 
Unfortunately, relying on transplacental antibodies to provide protection against pertussis in infants is not based on published evidence.
 
In fact, the very board that recommended Tdap during pregnancy (ACIP) states the effectiveness of maternal anti-pertussis antibodies in preventing infant pertussis is not yet known (ACIP 2011, CDC 2011).[*][*]
 
This is one of two major concerns the ACIP voiced, acknowledging the complete “lack of evidence evaluating that transplacental maternal antibodies induced by Tdap in the protection of infants against pertussis” (Journal of Perinatology 2010).[*]
 
Even if data reflects an increase in infant antibodies to pertussis via maternal vaccination, because there is currently no correlate of protection in pertussis infection, it is uncertain whether this increase could be considered clinically protective (The Pediatric Infectious Disease Journal 2011).[*]
 
This is significant since the transfer of antibodies against pertussis to the offspring is influenced by various factors and determining a benchmark for correlation would aid in establishing if any protection is conferred. (Current known factors that influence transplacental antibodies: the age of women at delivery, mothers’ vaccination history, mothers’ immune response and ability to generate IgG immunoglobulins).[*- Tdap in risk groups 2012]
 
In fact, it is becoming more evident that the (aP) pertussis vaccines do not yield any correlation between antibody levels and protection against pertussis.[* source 17]
 
Currently, I am aware of two completed published studies (as mentioned by the CDC in 2011) providing data that evaluates antibody levels in newborns whose mothers received tdap during pregnancy, neither produce confirmation of protection against infection.[*][*][*]
 
What is certain is the evident “need for larger studies with longer follow-up to help understand the immunologic responses in pregnant women and the consequences on neonatal immunity” (Clinical Infectious Diseases 2013).[*]
 
 
Interference with Infant Immune Response to Primary DTaP Vaccination
(also known as blunting)
 
Data to consider, several studies have suggested that maternal pertussis antibodies can inhibit active pertussis-specific antibody production after administration of DTaP vaccine to infants of mothers vaccinated with Tdap during pregnancy, referred to as blunting (CDC 2011).[*] 
 
In fact, the ACIP states that this phenomenon known as blunting could result in an increase in pertussis susceptibility to children under 12 months (Journal of Perinatology 2010).[*] 
 
The ACIP assumes that maternal pertussis antibodies might reduce an infant's risk for  infection in the first few months of life, but neglects to apply actual data illustrating an increase in risk for disease after receipt of primary DTaP doses (CDC 2011).[*]
 
Instead, the ACIP applies data used in naturally acquired maternal pertussis-specific antibodies, stating that one study completed shows little or no interference between naturally acquired transplacental antibodies and the DTaP series (Clinical Infectious Diseases 2012).[*] 
 
No published literature is available yet for review examining vaccine-induced transplacental antibodies.
 
Based on data that has been completed, blunting does occur, we just don’t know to what degree and what the effects may be.
 
The theorized benefit of vaccinating pregnant mothers is a decline in risk for disease and death in infants aged <3 months, but the trade-off is a potential increase in the occurrence of pertussis in older infants (CDC 2011).[*]
 
According to the ACIP, the potential benefit of protection from maternal antibodies in newborns outweigh the potential risk for shifting disease burden to later in infancy (CDC 2011, The Pediatric Infectious Disease Journal 2011).[*][*]
 
Worth noting, two clinical trials are currently underway (one in Canada, the other in the USA) to evaluate the assess the immune response of infants receiving DTaP immunization at ages 2, 4, and 6 months whose mothers received Tdap during the third trimester of pregnancy (Vaccine 2012).[*][*- Tdap in risk groups 2012]
 
It is unfortunate (and, in my opinion, inappropriate) that this data was not completed prior to recommendation .
 
 
Evidence for Safety
 
Although in prelicensure evaluations, the safety of administering a booster dose of Tdap to pregnant women was not studied. The ACIP Pertussis Vaccines Work Group declares safety and expresses it as well established (CDC 2011).[*]
 

What does ‘well established’ mean exactly….
 
The data that is used to established safety which resulted in the ACIP’s recommendation was collected from:

Vaccine Adverse Event Reporting System (VAERS)

Sanofi Pasteur pregnancy registry

GlaxoSmithKline pregnancy registry
 
 
The ACIP asserts that no data collected suggests any elevated frequency or unusual patterns of adverse events in pregnant women who received Tdap (CDC 2011, Can Fam Physician. 2013).[*][*]
 
It is worth noting, all three are passive surveillance programs which have several limitations which include: unverified reports, underreporting, inconsistent data quality and absence of an unvaccinated control group (Drug Safety 2008).[*] 
 
 
Data Evaluated From VAERS:
 

-Only 130 reports met safety research criteria (AJOG 2012).   [*] 
 

-The data was collected before Tdap was routinely recommended in pregnancy (AJOG 2012). [*]
 

-Only 3% of women were administered the vaccine in the recommended third trimester (77% in the first trimester, 19% second trimester, 3% third trimester) (AJOG 2012). [*] 
 

The most frequent pregnancy-specific adverse event was spontaneous abortion occurring in 16% of reports (AJOG 2012). [*] 
 
 
GlaxoSmithKline Registry:


From GSK pregnancy registry: “The safety of Boostrix (tdap) during pregnancy has not been established, and no adequate human studies have been performed. [*]


None of these products, except RETROVIR® (zidovudine, AZT) after the first trimester, is approved for use during pregnancy.”[*] 
 
 
Sanofi Pasteur Registry:
 

From the Sanofi Pasteur pregnancy registry: “This is a company-run, passive, pregnancy surveillance system designed to collect and analyze the outcome of vaccination.” [*]


“There are no adequate and well-controlled studies of Adacel in pregnant women and data are limited. Sanofi Pasteur does not recommend the use of Adacel vaccine in any manner other than that described in the package insert.”[*][*][*]
 
 
From a safety perspective, ACIP adds that administration of Tdap after 20 weeks' gestation is preferred in the hope to minimize the risk for any low-frequency adverse event and the possibility that any spurious association might appear causative.[*]
 
 
Risk of pertussis infection


In all honesty, when it comes down to it – expecting mothers are going to make the decision to get the Tdap booster if the perceived benefits outweigh any risk.
 
One could read 30 peer reviewed publication arguing for (and against) Tdap during pregnancy, but it always comes down to perceived risk.
 
To estimate risk and the potential impact of Tdap administered during pregnancy, let us evaluate the data and statistics from 2010-2011.
 
Using the National Notifiable Diseases Surveillance System during 2000–2011, the annual mean of pertussis cases in infants aged <12 months was 2,746 cases - with deaths equaling to 18.[*]
 
Using the 2010 birth rate (4,007,000 live births) and this data, we can determine the following risk assessment for 2010:[*]


Without Vaccination:

Risk pertussis infection under 12 months = 0.007%

Risk of death = 0.000004%

 

With Vaccination:

Risk of pertussis infection under 12 months = 0.005%

Risk of death = 0.000002%
 
 
Not to make light of pertussis infection, but more people died of being struck by lightning (count = 29)  then babies dying of pertussis infection in 2010.[*]
 
Yet, I’m pretty sure mothers perceive the risk of pertussis as more glaring then being struck by lightning.
 



Changing epidemiology due to vaccination and the increased risk to infants
 
 
Everyone is quick to  proclaim the benefits of herd immunity when vaccinating, yet not so many are so swift as to declare its faults (such as protecting some while placing others at greater risk).
 
The implementation of a vaccine against pertussis infection, with decreasing natural boosting,  has changed the epidemiology of infection to the disease.[*]
 
The resurgence of pertussis in the post-vaccination era has been widely documented. In fact, it is the chief reason for the ACIP recommendation in vaccinating pregnant mothers. 


The overall incidence of pertussis has been increasing steadily
 since 2007 and has now surpassed peak rates observed
 during 2004-2005. source


Yet, a shift of cases from school-age children to adolescents, adults and children under 1 year of age has been described in the last decade. As a consequence, pertussis circulating in these new populations is considered  being the source of infection for infants and newborns (The Pediatric Infectious Disease Journal 2011, BMC Infectious Diseases 2013). [*][*]
 
One study that examined the increase of pertussis in California between 2006 and 2011, demonstrated decaying protection against pertussis during 5 years after a child’s fifth dose of the Tdap booster. The authors state this waning might be one of the causes of reported increased infection in adolescents which increases the risk of transmission to infants (Can Fam Physician 2013).[*]

source here - CDC
 
The solution for a severely limited booster vaccine? Cocooning.
 
Unfortunately, this strategy of cocooning (vaccinating pregnant women immediately postpartum and all other close contacts of infants with Tdap) to reduce the risk for transmission of pertussis to infants is an insufficient strategy (CDC 2011).[*]
 
The ACIP recognizes this as well as the CDC(CDC 2011).[*]
 
The solution for this latest failing strategy and inadequate vaccine? Simply, vaccinate during pregnancy. 


 

Which to choose
 
If you still regard the risk of pertussis infection to outweigh any known and unknown risks of vaccinating during pregnancy, then consider this: Please request the Adacel vaccine.
 
The Adacel vaccine contains antigens that intend to elicit antibodies against fimbriae (types 2 and 3) which play a critical role in the attachment of the bacteria to the respiratory cells (which would, in theory, make a mother less likely to transmit the disease to her child).[*][*][*]
 
Boostrix contains mainly antigens that intend to modify and lessen symptoms of disease, which would make a mother more likely to become an asymptomatic carrier of the disease, which places her child more at risk.[* sources 3-8]
 
Information on Tdap boosters:


Boostrix contains: pertussis antigens (inactivated pertussis toxin [PT] 361 and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin). also  - contains aluminum hydroxide as adjuvant (not more than 0.39 mg aluminum by assay), 4.5 mg of sodium chloride, ≤100 mcg of residual formaldehyde, and 387 ≤100 mcg of polysorbate 80 (Tween 80).
 

Adacel contains: 2.5 mcg detoxified pertussis toxin (PT), 5 mcg filamentous hemagglutinin  (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM). Also dose includes 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, ≤5 mcg residual formaldehyde.
 
 
I would also encourage you to read more about pertussis infection here: CDC Pinkbook Pertussis.




Similar posts:
 
The Perfect Storm - How the increase in pertussis vaccine usage is causing an 'epidemic'