Monday, May 23, 2016

The approval process: Women's Health Devices and Vaccines - Some Similarities

Some residents from Northwestern University recently published a study examining the approval process for various devices commonly used in or on women for various conditions which revealed some serious concerns about the process the FDA uses for new devices

As I read the description of the study's results (I did not have access to a full-text version) I was struck by some similarities in the deficiencies of the approval process between vaccines and the medical devices their study delineates. 

Of note, one device (now being investigated due to patient reports of complications post-approval) was approved on after "short-term evidence". This is similar to vaccines where most surveillance for adverse reactions is collected after short-term follow up. 

Here's an example: 
Hiberix Package Insert - see pages 6&7 (Section 6) where you will find that the longest (reported) follow-up was 31 days. 

Section 14 (starting on page 10) - Immunological studies - the approval was based on a randomized controlled study - though none of this is defined and what is most telling is the lack of blinding and in fact you can read on page 12 that at least one of the studies was open-label. 

Table 3 on page 11 shows antibody response 1 month following administration - the table describes this as "Seroprotection Rate" though I would describe this as an example of "science" (scare quotes deliberate) by proxy - in other words, not real science as science requires direct observation of an effect, not an inference of a desired result (reduced incidence of "x" infection) by indirect measurement of something else (mounting an antibody response). Measurement of an antibody response is not a randomized double-blind controlled trial. 

On page 11 you will see that data regarding race/ethnicity was incomplete (" ... among subjects for whom information on race/ethnicity was available ...") but that most of those were White/Anglo - what factors were "controlled" in this study? The age of children ranged from 12 months to 23 months - a 12 month old infant is far different from a 23 month old toddler immunologically! If age was not controlled, nor was race, and apparently data collection on at least one demographic variable was spotty (race) - just what exactly was "controlled"? 

Here's a pertinent quote: 
“Devices are a huge part of the medical care that we provide women on a daily basis,” said study first author Jessica Walter, MD, a resident in the Department of Obstetrics and Gynecology. “We found that there’s an opportunity to increase the burden of proof required for a device to be approved for public use.” 
I think you could easily substitute "Vaccines" for "Devices" and "people" for "women" in the above quote ... and that there is likewise the same "opportunity" in regards to strengthening the evidence needed for a vaccine's approval prior to use by anyone - child or adult. 

The article by Northwestern University connected the dots between what this study revealed and a law being considered in Congress - the 21rst Century Cures Act, which if passed would reduce regulation of medical devices and "broaden" the definition of scientific evidence used by manufacturers (this includes vaccines). In other words, this bill, if passed, would codify into law post-normal science. 

We all deserve so much better. And researchers are capable of so much more, as are companies making (and profiting) from medications and devices.   

With valid concern about the quality of research undergirding approval of vaccines it is reasonable and prudent for there to be great freedom in personal choice regarding their use. Even if the research were stronger no one should be forced or manipulated into the use of any medical procedure. 

Sunday, May 22, 2016

Vaccination through the generations

The picture shown below gives a visual image of how the number of vaccinations have increased over the years (it is used with permission).  

This is 4 generations of women: great-grandma through great-grandchild. 
From 1rst to 2nd generation vaccines increased 3.5 fold. 
From 2nd to 3rd generation vaccines increased 2 fold. 
From 3rd to the 4th generation they increased 4.9 fold. 
From 1rst to 4th they increased 34.5 fold. 

Please note, 69 vaccines is just what is required for childhood - this does not include the additional doses one would receive if you continue to receive all recommended vaccines throughout your life according to "the schedule". 

What is unknown is how many more vaccines will be added to the "schedule" (there are currently >200 in development). It is no surprise that there was such a large increase between the 3rd and 4th generation as it was since the 3rd generation was born that anything related to vaccines (from manufacturers to those who recommend or require them to those who order/administer them) received blanket immunity from liability related to any adverse reactions that may occur as a result of vaccination (though how that would happen when a product is "safe and effective" is anybody's guess). 

Vaccines are categorized by the FDA as "biologics", and as such, their approval process is different from other drugs. They are not required to undergo randomized, double-blind trials to demonstrate either safety or efficacy. 

Do we know how many are safe or if it is safe to combine vaccine antigens in one shot or if it is safe to give multiple vaccines at one time? No. These questions have never been asked in research. Have vaccines been studied? Oh yes, exhaustively. But science has gone post-modern, and no where more so than when the issue in question is vaccines. The answer is pre-determined and the study is designed to provide the desired answer. We have yet to do the type of study that would provide some very interesting and very important answers - namely, a long-term study comparing health outcomes in vaccinated individuals with unvaccinated individuals. Unvaccinated defined as having never received any vaccine - not having not received the vaccine in question!! Vaccinated being defined as having received >0 vaccines. In these studies health needs to be defined more broadly than not getting "x" disease or infection. 

The number of vaccines that are necessary should be determined by the person receiving them (or the minor child's parents) - not by government, not by a school system, nor an employer. 

Saturday, May 21, 2016

If you think vaccines are the "bomb", you just might be right!

There are many who believe vaccines are one of the greatest public health "wins" ever - practically the best thing since sliced bread, or "the bomb" in more recent linguistic slang might glowingly (as in nuclear?!) describe them. 

As we continue to (finally) learn the intricacies of how our immune system works there is reason to believe that perhaps vaccination is, quite literally, an immunological bomb. The manner in which it is done bypasses the typical route by which we are exposed to proteins or antigens (typically the respiratory tract or the GI tract - in other words, mucous membranes) as they are generally injected into a muscle giving direct access to the circulatory system via the capillary bed. 

What's more, virtually all vaccines have adjuvents (aluminum or squalene are examples) in order to potentiate the immune response to obtain the "desired" effect - an antibody response. Indeed, without the adjuvent many vaccines won't "work".

As written by Celeste McGovern (© [May 17, 2016] GreenMedInfo LLC. This work is reproduced and distributed with the permission of GreenMedInfo LLC. Want to learn more fromGreenMedInfo? Sign up for the newsletter here

Imagine the immune system as a border guard. If a guard at the Canada-US border pulled every vehicle that drove up to his checkpoint aside, emptied the suitcases, called in the sniffer dogs, strip-searched the occupants and called for the SWAT team, things would get ugly pretty fast. Most of the time, border guards are alert but passive. Our immune system is the same way with foreign proteins.

So vaccine manufacturers pepper vaccines with adjuvants -- crude extracts of mycobacteria, toxins such as mercury, aluminum salts, or mineral oils to force the reluctant immune system to go into attack mode - from passive border guard to hypervigilant nutter pulling a gun on a granny.  Celebrated Yale immunologist Charles Janeway called this “immunologist’s dirty little secret” underlying vaccination.

 “Adjuvants expand, potentiate, and increase immune responses,” explains Kanduc. “Such hyperactivation has a price: the loss of specificity. The hyper-stimulated immune system does not discriminate any more between foreign proteins and self-proteins…Adjuvants render the immune system blind. Human proteins that share peptide sequences will be attacked.”Kanduc likens immunotolerance to a protective wall. “The dam is demolished by the adjuvants and the cross-reactivity flood can crush and alter human proteins.” This might also cause numerous cross-reactions, manifested as a wide variety of autoimmune attacks.

Western, conventional medicine has a long history of going to far, even if the motive was right (and there is so much COI embedded in vaccination that there is plenty of reason to doubt motives!) - this is why it is so important for all to be free to make their own decisions regarding what interventions they do or do not accept, including vaccinations. 

Sunday, May 15, 2016

Pitiful, Pathetic Pan - A gold in the Olympics of truth avoidance

Like so many politicians, California State Senator Richard Pan is a flaming, stinking hypocrite - and a coward to boot! He imposes responsibility on citizens (SB277) while running from it. 

On Mon May 9, Del Bigtree (Producer of Vaxxed) and Polly Tommey (mother, featured in Vaxxed) went to Sacramento California in an attempt to engage California State Senator Richard Pan in a debate. Crazy hijinks ensued: 

I am quite sorry that those who made this video associated Pan with the Pink Panther - that 
character has hallowed place in my family and I hate to see it linked with the likes of Pan, but I'll try to consider that no more than a nit pik in the bigger picture. 

If he is so certain of the validity and rightness of the vaccine mandates his legislation imposed upon the people of California, why would he sprint from a conversation with a citizen of California? What, exactly, is he afraid of? 

He should change his name - to Peter (as in the perpetual child)! 

Wakefield: His story isn't complete

This brief (22 minutes) video is of Andrew Wakefield discussing various issues that have dogged him since a paper of which he was one of 13 authors was published in 1998 in the Lancet (since retracted). Here he defends himself (as well as in the movie Vaxxed, though he is not the subject of the documentary - it is about allegations of fraud within the CDC) - but others have also defended him (Dr. David Lewis, in his book "Science For Sale" (not an affiliate link). 

Watch for yourself: 

I think he, and many others who do not toe the line to the conventional wisdom concerning vaccination, have suffered from the "Semmelweis Effect" - see also "Is Dr. Andrew Wakefield a Victim of Sham Peer Review?"  

For everyones sake, let us hope that truth will prevail, not agendas driven by conflict of interest. 

Podcast Notes: The Vaccine Myth: An Issue of Trust May 1, 2016

One of the podcasts to which I listen (when I can) is Shawn Siegel's "The Vaccine Myth: An Issue of Trust" - broadcast on The Logos Radio Network as a live radio show and available (delayed) as a podcast. This post is raw notes of the May 1, 2016 show. 

He begins with a review of the Innate and Adaptive Immune Systems, noting that vaccination bypasses the Innate Immune System which is found in the mucosa. The Innate Immune System is supposed to control the Adaptive Immune System and that our primary defense (immunologically) resides in the mucosa because that is where exposure to disease or pathogens ordinarily takes place (skin, mouth, nose, lungs, eyes, gut, vagina, etc); 

During the first half of the show he is interrupted by noise he can hear but the listener cannot - he isn't sure if the show is on air but he handles this relatively well, though there are stretches of silence long enough to make one wonder what happened. 

He reads excerpts from three journal articles - it would have been helpful if he had also read the PMID for the articles. This information would have been easier and quicker to jot down rather than having to write out the journal name and article title (he does not name the authors). 

He cites "Cell Surface Environment for Pathogen Recognition and Entry" in Clinical and Translational Immunology

He briefly mentions findings of the Human Microbiome Project - that pathogens were found to be co-existing without disease symptoms ... the Beauchamp vs Pasteur argument about host vs pathogen - personally I doubt it's all one or the other. 

Another excerpt was from Immunological Reviews and the last was from International Immunology

It is worth noting that not all publishers are legit - there is a growing issue with illegitimate journals. - the home page for Scholarly Open Access where predatory journals are exposed. I am not insinuating that any of the journals he mentioned are predatory or publish junk science - full disclosure, I did not check as I am typing this up late at night. I just mention this as a resource. Verify, then trust - and that applies to me as well - I do not expect my readers to uncritically accept the opinions I express in this blog. 
The Retraction Watch blog is another good resource, though they are unabashedly pro-vaccine and bizarrely suspend critical thinking where vaccines are concerned. 

He discussed vaccine-induced antibodies and that these seem to be qualitatively and quantitatively different than those produced by natural, spontaneous disease (gives examples: Measles, Pertussis, Chickenpox). 

He reviews awards for various vaccine induced injuries - themes of demylinating conditions of various kinds being typical diagnoses and Flu/TDap the most common offenders. 

Of note, at 56m30sec he discusses ITP or Idiopathic Thrombocytopenic Purpura and describes this (inaccurately) as a problem affecting White Blood Cells. This is incorrect. 
ITP is a problem affecting platlets (a blood cell involved in clotting). "Idiopathic" means the cause is unknown.  I don't know how he made this mistake as during the discussion of settlements for vaccine injuries he disclosed he was reading from various medical websites to get accurate information about what he was reviewing. 

The second hour of the show is devoted to interviewing a mother of a 3 month old baby 
who allegedly died as a result of receiving 8 vaccines in one visit. Given the bias in vaccine research stories like this highlight questions that are left begging to be answered. The only way to answer these questions is to do the research - longitudinal (long-term) studies comparing vaccinated and unvaccinated populations, along with double-blind placebo controlled trials of vaccines with long-term follow up (years, not days) - in other words, epidemiological research and clinical research - preferably done by researchers free of conflicts of interest. We could do this - it is just a matter of will. 

Saturday, May 07, 2016

While waiting to see Vaxxed, watch Suzanne Humphries for free!

Vaxxed is making its way around the country - and that's fabulous - it needs to be screened far and wide. It has an important message regarding vaccination. 

But if you are looking for more information I encourage you to read anything written by Suzanne Humphries, MD. Like me, she is a medical professional who used to be totally on-board with vaccination, but now, not so much. Her website can be found at She also has a number of pieces at The International Medical Council on Vaccination. The video below is a 10 minute trailer of a lecture in Denmark (Nov 2015) she gave titled "Manufactured Consent". I respect her. 

If you get a vaccine you will likely be given a "VIS" or "Vaccine Information Sheet" - this is the official, approved talking points about the vaccine you are receiving that day. Reading or
receiving this is not informed consent. If you watch her lectures you will be far closer to informed consent - basically, you must "do the work" - if you want to be informed do not blindly accept what you are told by "professionals" ... they may not be as well educated as they should be, certainly not about vaccines. I know I wasn't. I'm far closer now than before.