Del Bigtree misleads his audience over vaccine safety testing

In a second episode dealing with the Lies of Vaxxed published by More Truth © an old standard of the anti-vaccine lobby is subject to facts.

The lie Del Bigtree smothers his uncritical audience with is that, “there is not a safe vaccine out there” presumably because as he continues to lie, “there is not a decent safety study on any of the vaccines”.

Lies of Vaxxed: Episode 2 “Vaccine Safety Testing”

What we learn from the video above is that there are six main stages of vaccine development is the US. Including;

  • Exploratory
  • Pre-clinical
  • Clinical development
  • Regulatory review and approval
  • Manufacturing
  • Quality control

During the exploratory stage scientists focus on identifying an antigen that can prevent a specific disease. Without success during this process development goes nowhere. It cannot continue. Nonetheless, the exploratory stage takes years of diligent laboratory research.

When the exploratory stage yields viable results production continues into the pre-clinical stage. Here progress with tissue or cell-culture preparation involves animal testing. This aspect of the pre-clinical stage will assess the safety, or lack thereof, of any potential vaccine. Another aspect of the pre-clinical stage is assessing the ability of the potential vaccine to stimulate an immune response.

Despite the cost and time invested by this point, the majority of potential vaccines do not satisfy the rigour of the pre-clinical stage. In these cases again development cannot continue.

The diligence of the clinical stage can be seen as a three part process.

  • In the quest to ascertain safety, trial vaccines are tested on a small sample of healthy adults.
  • Vaccines are tested on a sample of several hundred adults.
  • Finally the clinical stage involves testing the vaccine on tens of thousands.

With vaccines being developed for children the clinical stage process continues. The age of test subjects is lowered incrementally until the target age is safely reached.

The final stages of clinical development include randomised and double blind trials. The potential vaccine is tested against a placebo. It takes from six to ten years to complete these safety tests. Whilst medications in the USA are subject to the same intense testing it’s worth noting that sample populations are three times smaller than for vaccine studies.

There are six more stages overseen by the FDA for regulatory review and approval of vaccines. This involves safety inspection of manufacturing facilities by the FDA and even more testing.

Safety monitoring, including phase IV trials, continues indefinitely once a vaccine has been approved. In the USA there is the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink – a nationwide set of linked databases.

I certainly recommend watching this video because it is clear that safety is the primary element in vaccine manufacture. Claims to the contrary by Del Bigtree and the Vaxxed cronies are demonstrable lies. Under present manufacturing guidelines and restrictions most potential vaccines do not reach clinical development. As is clear in this video the reason is safety.

Professional anti-vaccinationists like Bigtree, or any who promote Vaxxed in order to consciously profit from their manufactured controversy, are a malignant force in public health. As such they deserve our derision.

 

♣ Despite this reality, in Australia the self appointed “vaccine experts” from the anti-vaccine lobby such as Meryl Dorey, Judy Wilyman and Tasha David insist no randomised double blind trials or testing against placebo has ever been carried out.

♥ Australians may likely remember from 2010, a significant number of AEFI. Febrile seizures in children aged 6-59 months following administration of CSL’s Trivalent Influenza Vaccine. One chid was ultimately compensated. This event resulted in the FDA inspecting CSL laboratories and outlining five “objectionable conditions”. Australia’s TGA reported at length on the event, the FDA inspection and the process of TGA inspection of CSL manufacturing facilities.

Whilst this was an unwanted, unfortunate event, it is also an example of safety and quality control procedures being firmly implemented.

 

Conspiracy Theorists: obsessed and beyond reason

This morning I was met with the news that a train accident in Hoboken, New Jersey had left one person dead and over 100 injured. It was being described as “the worst NJ transit incident in the recent past”.

Moments later I was pondering what conspiracy theorists would be doing with this information. I didn’t expect much but a visit to Prison Planet – a hive of conspiracy paranoia fathered by Alex Jones – yielded some pickings. Comments lay under opening paragraphs from an NBC New York article. One read:

Yet another “accident” hundreds in serious condition, death toll still rising.

Note the press will not identify the train engineer.

Note how the press wont even identify if train was under control of “PTC” positive train control.

PTC prevents this, unless its tampered with. PTC cannot turn the power “up”, in a train, only “down”. That region was one the 1st in the USA to get PTC. Appears Mr. Obama needs a few days to work a narrative.

The author seemed to be “arguing” that the event was executed deliberately. His over confident assessment of “PTC” train control in that region suggested such an accident was unlikely if not impossible. The press, in his mind, were suppressing two vital facts: the driver’s name and the presence/absence of PTC control. President Obama thus, needed “a few days” to mislead the American public.

As it turned out the driver, engineer Thomas Gallagher had spoken to authorities “within hours” of the accident. He had been rescued from his crushed cabin and is reported to be in a critical condition.

Another commenter had worked it out using exclamation marks. This was no accident. It was the “scum Muslims”. He’s quite likely blown his ten bucks – unless the almost certainly American born descendent of Irish-Americans, has converted to Islam:

Can you say Tabotage / Terrorism !!!!!!!!!!!!!!!!!!! The scum Muslims have struck again. This was no accident !!!!!!!!!!!!!!!!. Ten bucks – the engineer was a Muslim.

Someone had posted Beastie Boys Sabotage clip, which was followed by Beastie boyz are enemy jews. Why do you listen to their music?

By this point someone gleaned the rules, summarising them neatly:

RULES FOR POSTING ABOUT THIS STORY:
1. DO NOT WAIT FOR ANY FACTS ABOUT WHAT REALLY HAPPENED. IT IS IMPORTANT THAT YOU IMMEDIATELY POST WHATEVER MINDLESS CONSPIRACY THEORY YOU CAN THINK OF.
2. BLAME THE JEWS

So why was I pondering what these enemies of reason would be thinking? Recently, I’ve been considering the intractability of conspiracy theorist thinking. Or is that lack of thinking? Either way it (the pondering) is likely a constant for those who value the role of evidence in public health and appreciate the harm caused by opportunists who benefit from peddling fear and confusion.

This week I’d enjoyed a discussion in a clinical setting with a physiotherapist about “vitalistic” chiropractic. Whilst familiar and infuriated with the lack of evidence behind treatment claims, she was fascinated to learn of the anti-vaccine slant in chiropractic.

I’ve been as fascinated as disgusted with the antics of David Thrussell who, as artistic director of the Castlemaine Local and International Film Festival, attempted to bring the rankly deceptive anti-vaccine film Vaxxed to Castlemaine. An outstanding conspiracy theorist and blatant liar, Thrussell has played the victim whilst misleading both the media and sponsors of the film festival.

As always the delightfully unstable Judy Wilyman has been showing off her declining grip on reality. Of late she has chosen to bully the Executive Dean of the Faculty of Science, Medicine and Health at the University of Wollongong and also the Minister for Social Services. Wilyman’s ranting is so far from possessing an evidence base or a cogent stream of argument that it beggars belief. Unless of course, one considers it through the eyes of a conspiracy devotee.

Rob Brotherton (@rob_brotherton) authored Suspicious Minds – The Psychology of Conspiracy Theories. He suggests that to the conspiracy theorist their beliefs are unfalsifiable. There is simply no evidence to prove them wrong. In addition, driven by a need for control – a need which they cannot develop when faced with reality – the likes of Thrussell, Wilyman and Meryl Dorey, develop compensatory control.

The misleading film Vaxxed has given compensatory control to so many who lack control. We may consider Dorey’s misappropriation of funds, Wilyman’s feverish ranting about her superior “research” and Thrussell’s manipulation of others as types of compensatory control also.

Suffering from the insignificance that comes with no control over reality, such conspiracy prone personalities fall victim to proportionality bias. Events they desire to control, but can’t, must have a complicated – indeed powerful – cause. We see this also in their propensity toward other conspiracies.

Between 1/4 to 1/3 of Americans believe 9/11 was the result of some type of conspiracy. Usually the Inside Job theory. Within days of Kennedy being assassinated more than half of Americans believed Lee Harvey Oswald did not act alone. Today, according to Brotherton, “the majority of Americans” believe some type of conspiracy led to the Kennedy assassination.

The audio below is from ABC’s All In The Mind and includes an excellent interview with Rob Brotherton. I certainly recommend it.

  • © ABC All In The Mind

 

♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦

 

Vaccines and autism: A thorough review of the evidence

The following post is an exceptionally detailed review of the evidence, and scientific consensus, specific to the persistent claim of a link between vaccination and autism.

Those familiar with the integrity of the scientific method and its value in examining this particular issue will be grateful for both the quality and extent of this review.

Use of the seven tiered Hierarchy of Scientific Evidence provides an excellent device by which to gauge the value of evidence, and as such, introduces one to a reliable tool for similar endeavours.

I trust you find the article a valuable resource.

Hierarchy of Scientific Evidence

© thelogicofscience.com

The Logic of Science

One of the most common concerns that people have about vaccines is that they might cause (or exacerbate) autism. This idea is perpetuated by celebrities and innumerable websites, and it has become one of the cornerstone arguments of the anti-vaccine movement, but is there any truth to it? Perhaps unsurprisingly, both sides claim a superiority of evidence. Indeed, you can find numerous websites presenting lists of papers that they claim provide evidence that autism is caused by vaccines (such as “124 research papers supporting the vaccine/autism link“). Conversely, those who support vaccines also have lists of papers which they present as evidence that vaccines do not cause autism (for example, here and here). So which is correct? The internet is full of misinformation on this topic, so I want to cut through that crap and talk about the actual studies themselves rather than simply tossing lists around…

View original post 17,466 more words

Vaccines contain no aborted fetal cells

One of the most offensive lies peddled about vaccines is that they “contain aborted foetal cells”.

Consider this April 2013 screenshot from AVN Facebook:

Aborted fetal tissue

I noticed an even more absurd take when reading Anti-vaccine chiropractors redux-1, c/o reasonablehank. He was reviewing the anti-vaccine rantings of one “Dr” Koe Davidson who is a chiropractor running Peak Potential Health and Wellness in Mentone, Melbourne. One screenshot includes Davidson addressing vaccine ingredients as listed by the CDC. It includes:

Oh and “egg protein” = fancy word for aborted fetus cells. This wording was changed in mid 2012… Scary stuff.

For a document last updated in February 2012 I’m not sure what he’s trying to convey. The CDC cannot have changed egg protein to aborted “fetus” cells in 2012 as this would be complete nonsense. Thus one must conclude he is either utterly confused on the topic of cell cultures or – as is common with chiropractors aligned with the CAA – misinforming readers.

The CDC write about egg protein as a vaccine additive:

Egg protein is found in yellow fever and most influenza vaccines, which are prepared using chicken eggs. Ordinarily, persons who are able to eat eggs or egg products safely can receive these vaccines.

So how can such confusion on cell cultures come to pass? Today strains of human diploid cell culture are grown in containers in laboratories. In the manufacture of vaccines, viruses that infect humans are grown in these human diploid cell lines. One strain of human diploid cell culture was made in the USA in 1961. Labelled WI-38 this strain came from the lung tissue of an aborted female of three months gestation.

Another human diploid cell culture was produced in the UK in 1966. The tissue came from the lungs of a 14 week old male foetus and the strain is labelled MRC-5. W.I. refers to the Wistar Institute. M.R.C. refers to the Medical Research Council.

The abortions did not take place with the intent of producing human diploid cell culture for use in vaccine manufacture. The biologists who produced the diploid cultures did not induce the abortions. Both abortions were intentional and would have been carried out whether the foetal tissue had that fate or not, post abortion.

These cells used to grow viruses have been reproducing since 1961 (WI-38) and 1966 (MRC-5), respectively. The viruses produced this way are further processed and sterilised in the production of the vaccine. In this way any potential for contamination with foetal material is eliminated. Furthermore, strict quality control measures are employed to examine each vaccine to ensure no foetal material is present.

♣ The USA National Network for Immunization Information state (bold mine):

These two cell strains have been growing under laboratory conditions for more than 35 years. The cells are merely the biological system in which the viruses are grown. These cell strains do not and cannot form a complete organism and do not constitute a potential human being. The cells reproduce themselves, so there is no need to abort additional fetuses to sustain the culture supply. Viruses are collected from the diploid cell cultures and then processed further to produce the vaccine itself. ♣

Vaccines produced using WI-38 and MRC-5 human diploid cell lines include hepatitis A, rabies, rubella, MMR, varicella and Pentacell DTaP-IPV/Hib.

Another abortion was performed on a rubella virus-infected mother in 1968. Both mother and foetus were infected with wild rubella and this posed the risk of major birth defects. Foetal tissues were obtained and wild rubella virus (RA27/3) was isolated. This has been grown in human foetal diploid cell line WI-38. No foetal tissue is present in the vaccine. No further abortions are necessary to produce more vaccines.

Prior to isolation of RA27/3 the USA experienced 800 cases of congenital rubella annually. At the turn of the century only three babies with congenital rubella were born. Research was carried out to study the possibility of using other animal cells to produce the RA27/3 rubella vaccine. However these proved less effective and less safe.

The Vatican accepts the use of human diploid cells in the manufacture of vaccines. A June 9th 2005 Vatican City Statement on Aborted Fetal Vaccines acknowledges this. It notes use of these cell lines is:

…to avoid a serious risk not only for one’s own children but also, and more specifically, for the health conditions of the population as a whole – especially for pregnant women.

For example, the severe epidemic of German measles which affected a huge part of the United States in 1964 thus caused 20,000 cases of congenital rubella2, resulting in 11,250 abortions (spontaneous or surgical), 2,100 neonatal deaths, 11,600 cases of deafness, 3,580 cases of blindness, 1,800 cases of mental retardation. It was this epidemic that pushed for the development and introduction on the market of an effective vaccine against rubella, thus permitting an effective prophylaxis against this infection.

[And observes that]

…the parents who did not accept the vaccination of their own children become responsible for the malformations [due to rubella infection] in question.

Think of an apple orchard. The organic material nourishing the trees includes (say) manure, bird droppings, animal carcases, rotting vegetation and so on. If one eats an apple one is not eating manure or the carcass of an unfortunate passing mammal. To say vaccines contain cellular material is to employ exactly such flawed thinking.

A vaccine initially made using human diploid cells that passed FDA requirements via another production method is the RabAvert rabies vaccine by Chiron Corporation. When safe and effective alternatives can replace the methodology involving human diploid cells we shall begin to see them. It is a fact that the human strains are superior in many ways. However they are not, in any way shape or form, “aborted foetal cells”.

The claim that vaccines contain the cells of aborted foetuses or are contaminated with any organic material is quite simply false.

Of chiropractic tripe and the odd zebra stripe

When we think of chiropractic and Equidae, it’s usually unicorns that come to mind.

The search for the chiropractic subluxation has been as fruitful as the search for the unicorn. In fact perhaps less fruitful, as we know with a high degree of accuracy what the unicorn looks like. Yet with the chiropractic subluxation our fairy tale is limited to conjuring mystical malaise or blaming dastardly disease as the work of this elusive evil.

chiro face palm

Do not be alarmed. This man has not seen a unicorn.

Rather, he had just been told that chiropractic subluxations

involve some type of “static” in the spinal cord.

Doctors (real doctors) report that he made a full recovery

after his palm was removed from his face.

Interestingly enough, whilst chiropractic teaches that areas of subluxation are invisible and can be “detected” only by the presence of symptoms, Simon Floreani, erstwhile president of the Chiropractors Association of Australia, has other ideas.

Check out the Catalyst video below at 1min, 45sec. Using the apparently magical Activator – or the “stick that goes click” – on an infant, Floreani announces:

Areas of subluxation that I can feel there, that are immediately improved after you adjust it like that…

You can read more about the Sonic Screwdriver-like Activator here in The Medical Observer. Just be prepared for some tongue in cheek observations. In September 2011 it was reported in Australian Doctor that the Federal Government had been asked to investigate both the Activator and “the Nervoscope” as they had been reported as having, “no biomechanical or physiological effect and cannot diagnose or treat any health condition”.

Fortunately, whilst new-age chiropractors continue to push their ineffective devices, practices and claims onto an unsuspecting public, genuinely motivated supporters of evidence based medicine are busy exposing their scams.

Check out the videos below to see just how devoid of facts claims made by the resurgent followers of Daniel David Palmer, really are. And keep an eye out for Simon and his zebra.

Catalyst – July 11th 2013


Floreani’s penchant for cutting his own path may help explain why he has chosen the zebra over the unicorn.

zebra floreaniFloreani positions a young subluxee on his treatment table cunningly disguised as a zebra

Lateline – July 6th 2009


Zebra floreani2

Floreani seems to be watched over by a zebra

Today Tonight – December 2011


Today Tonight – March 14th 2013