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.

 

Del Bigtree misleads his audience over safety of influenza vaccinations

An excellent video published by More Truth © provides a firm evidence based rebuttal to the blatant lies being peddled by Del Bigtree in his promotion of fraudulent anti-vaccine film Vaxxed.

A quick summary of main points raised in this production follows beneath the video.

Lies of Vaxxed: Episode 1 “The Flu Shot”

—————————–

  • The first lie from Del Bigtree is that “mercury” is still in influenza vaccines. “So let’s not kid ourselves”.

Actually the silvery metallic liquid that appears alongside huge needles in images antivaccinationists use to mislead, is elemental mercury. This has never been used in vaccines. The preservative thimerosal is used in multi-dose vials of influenza vaccine only. It is vital multi-dose containers are protected from bacterial infection and thimerosal ensures this.

Once in the body this compound breaks down into 49% ethylmercury which is expelled within approximately one week. A large number of studies confirm its safety for use in childhood vaccines. The mercury in seafood that we consume – methylmercury – is bio-accumulative and a recognised neurotoxin. This is why guidelines exist to ensure safe levels of methylmercury are consumed via seafood.

Of course the anti-vaccine lobby lie just as Bigtree does. Some even counter, bizarrely, that they do not inject fish. Or that ethylmercury is still a form of mercury and crosses the blood brain barrier. Firstly it does not enter the brain. Secondly if one is going to argue ethylmercury is “still mercury” they should apply that flawed logic to table salt; sodium chloride. In that light table salt is “still a form of chlorine”, which is inaccurate.

Thimerosal isn’t used in single shot vials. Finally, to be sure, one can simply ask for an influenza vaccine without thimerosal. There’s more information available here, and also here. So let’s no kid ourselves.

  • Next Del misleads his audience by claiming the influenza vaccine is being given to pregnant women, “and if you read the vaccine insert it’s never been tested on pregnant women”.

There are numerous studies confirming the safety of the influenza vaccine for both mother and fetus. As is clear in the above video this is true for “VAERS reports of pregnant women after the administration of TIV or LAIV”. TIV: Trivalent influenza vaccine. LAIV: Live attenuated influenza vaccine. Also there are significant problems in assuming the content of package inserts is equal to the conclusions of clinical research. Only the latter can be considered evidence.

  • Del continues with, “We now know women are probably miscarrying because of these vaccines, so that’s really horrific”.

Quoting from the video, “There are no studies that show the influenza vaccine can cause miscarriages or stillbirths. An independent study has actually shown that the flu shot can decrease the risk of a miscarriage or stillbirth”. A screenshot [3min 20] from the New England Journal of Medicine, Jan. 24 2013 follows showing an abstract summary of Risk of Fetal Death After Pandemic Influenza Virus Infection of Vaccination. Conclusion as follows:

vaxxed_lies

There are a number of benefits for newborns associated with administering influenza vaccines to pregnant women. Between 2004-2012, 43% of children who died from influenza were healthy with no underlying conditions.

I recommend watching the video which includes evidence of a large number of studies that firmly refute the claims made by Bigtree.

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

 

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

 

“Something has happened in the motorcade route”

“Something has happened in the motorcade route”

Friday November 22, 1963 Sam Pate, a reporter for KBOX Radio describing President Kennedy’s motorcade

——————

I was struck by recent tweets from Australia’s most troublesome, and arguably troubled, antivaccinationist.

In a splendid example of the transcendental world view that conspiracies are everywhere Meryl Dorey retweeted and commented on a pro-chemtrail tweet. Not just any pro-chemtrail tweet. This came from an account so packed with conspiracy tweets it’s almost suffocating to read. Ample antivaccine waffle, false flags, a comment on the strange absence of accents from Orlando shooting witnesses, the Sandy Hook “actors”, GMO, depopulation, etc, etc.

“TheMatrix” hashtag worked overtime and happened to accompany the tweet that caught Ms. Dorey’s eye.

Dorey_chemtrails2

This prompted a number of replies criticising the lack of thinking behind the chemtrail conspiracy theory. Meryl offered one critic:

Dorey_chemtrails

Understanding conspiracy theorists and the role implausible fallacy plays in their thinking is not as simple as accusing them of being crackpots. As individuals, they come from any age, race, socioeconomic status, education level, occupation, gender, political viewpoint. Uscinski and Parent wrote the 2014 book American Conspiracy Theories. They note on page 11 that laboratory experiments that induce loss of control and anxiety prompt subjects to draw conspiratorial explanations and see nonexistent patterns.

Such agenticity and patternicity are intuitive human qualities. Left unchecked they are qualities that steer one toward justifying the world as filled with interconnected events. Events that happen for a reason. Despite the evidence void, intuition can shape transcendental conspiracy thinking to believing the reason behind such events is generally one of malignant control.

Empiricism lacks the intuitive quality of transcendentalism. The empiricist accepts that coincidence and random events are part of reality. Any belief thus requires evidence. In this way skeptics are not prone to conclude based upon unchecked intuition. A simple but worthy example is the well used truism that correlation is not causation. For so many claims of the antivaccination movement (say, so-called vaccine injuries as opposed to genuine injuries) there is no evidence – just a claim based upon correlation.

These claims resonate with intuition. But subject to empirical examination and scientific skepticism we find these injuries (as opposed to genuine injuries) do not exist. The evidence supports another cause. With no evidence to the contrary and the inability to accept reality, we find the antivaccine lobby will cry conspiracy. Indeed there are a great many false claims kept in circulation by this lobby that are defeated with scientific evidence. Rather than accept the consensus the group cries conspiracy.

In March ABC Minefield produced Is the truth still out there? Why do conspiracy theories still exist? It’s an excellent episode. Hosts Waleed Aly and Scott Stephens discuss the persistence of conspiracy theories with guest, Patrick Stokes. Enjoy.

© ABC

Dravet syndrome is not a vaccine induced genetic mutation

Recently I was sent some appallingly misleading nonsense on Twitter regarding Dravet (pron. druh-vay) syndrome and vaccination. Or more specifically that Dravet (a rare intractable form of epilepsy) is a “vaccine induced genetic mutation”.

The phrase appeared on a screen grabbed page (below) full of harmful misinformation. It took advantage of the fact that in around 80% of cases Dravet is linked to a de novo genetic mutation. More specifically the uninherited SCN1A mutation leads to the development of dysfunctional ion channels in the brain.

Seizures develop within the first year of life and infants develop normally until this time. The first seizures infants experience may often be associated with fever. Later seizures can present without heat triggers or illness. Nonetheless the first seizures often occur around six months of age and are associated with vaccination. Although it begins in infancy Dravet syndrome is a lifelong condition. It is also known as Severe Myoclonic Epilepsy of Infancy (SMEI).

A range of health challenges accompany Dravet syndrome including a higher incidence of SUDEP (sudden unexplained death in epilepsy). According to The Dravet Syndrome Foundation other conditions which require proper management and treatment include:

Behavioral and developmental delays, movement and balance issues, orthopedic conditions, delayed language and speech issues, growth and nutrition issues, sleeping difficulties
chronic infections, sensory integration disorders, disruptions of the autonomic nervous system (which regulates things such as body temperature and sweating)

Whilst the screenshot below offers a copious amount of rubbish and does so with absurd confidence, we can see how important facts have been abused to push a fearful message of misinformation. Firstly the presence of a de novo (new, not inherited) genetic mutation. Secondly the association of vaccination with the first seizure.

McIntosh et al (2010) state:

Vaccination might trigger earlier onset of Dravet syndrome in children who, because of an SCN1A mutation, are destined to develop the disease.

That statement is quite unambiguous. Infants are destined to develop the disease because of the genetic mutation. Not because of vaccines. Vaccination may trigger a seizure; the early onset of Dravet syndrome. In what may be considered a firm conclusion that vaccinations do not cause Dravet syndrome, they continue:

However, vaccination should not be withheld from children with SCN1A mutations because we found no evidence that vaccinations before or after disease onset affect outcome.

We’re now in a better position to judge how misleading this insult to evidence is.

P01YN0NYM0U55_2016-May-24

Interestingly I have not been able to source it. Nonetheless it is intellectually offensive to see so much effort go in to falsely accuse the scientific and medical communities of hiding information. Apart from targeting the WebMD page on Dravet syndrome, the piece merely insists “the medical establishment” studied six children “who had previously been diagnosed with vaccine induced Dravet”. Then the children were “re-diagnosed” as not vaccine injured. Keep an eye out and one can see a “pattern of coverups like this…”.

Below is a short audio of Dr. Linda Laux, MD, of Lurie Children’s Hospital speaking on behalf of Dravet Syndrome Foundation [Which can also be accessed here]. She is quite clear in stressing that in Dravet, vaccinations can trigger seizures. “It is not the cause of the epilepsy syndrome. But it may precipitate seizures just the way an illness may precipitate seizures”.

Dr. Laux argues this was first shown by “an Australian group” (McIntosh et al) wherein the authors chased up adults who had previously been compensated for vaccine encephalopathy. They checked for Dravet and found the majority were positive for the SCN1A gene mutation. As we saw above there is good evidence to continue vaccinating. Laux reminds us that vaccine preventable diseases would trigger seizures for such a cohort.

The researchers checked the sample’s seizures as children. They defined the “vaccine proximate group”, who had their first seizure within two days of a vaccine. The second group who had their first seizure not associated with a vaccine, was labelled the “vaccine distant group”. Then the researchers studied subsequent seizures, severity of seizures and development of both groups.

They found no difference in the prognosis of these variables. This suggests that in this study Dravet syndrome seizures initially triggered by vaccination did not lead to a more deleterious prognosis than Dravet syndrome seizures initially triggered by another means.

————————————–

Another study (Pediatrics, 2011) by Reyes et al entitled Alleged Cases of Vaccine Encephalopathy Rediagnosed Years Later As Dravet Syndrome, includes in the abstract:

It was reported recently that a proportion of patients previously diagnosed with alleged vaccine encephalopathy might possess SCN1A mutations and clinical histories that enabled a diagnosis of Dravet syndrome, but these results have not been replicated. We present here the cases of 5 children who presented for epilepsy care with presumed parental diagnoses of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as Dravet syndrome.

Verbeek et al studied data of 23 children with epilepsy onset after vaccination. In October 2014 they published in Pediatrics Etiologies For Seizures Around The Time Of Vaccination. They write in their abstract conclusion:

Our results suggest that in most cases, genetic or structural defects are the underlying cause of epilepsy with onset after vaccination, including both cases with preexistent encephalopathy or benign epilepsy with good outcome. These results have significant added value in counseling of parents of children with vaccination-related first seizures, and they might help to support public faith in vaccination programs.

The constant theme that emerges as one pursues research on vaccination and Dravet syndrome is that the SCN1A mutation underlies Dravet, and as demonstrated by Verbeek et al, “genetic or structural defects are the underlying cause of epilepsy with onset after vaccination”. The valuable work of McIntosh et al, reinforces the importance of maintaining vaccination regimes for these at-risk populations.

As for nonsense claiming Dravet syndrome is a “vaccine induced genetic mutation”, supporters of vaccine programmes should be aware that perpetrators of these lies can distort facts to cause fear and confusion in the unaware. Evidence to confirm vaccination does cause Dravet syndrome has not been forthcoming.

Fortunately the medical establishment has never tried to hide the truth. Vaccines can trigger seizures in infants with the SCN1A mutation at a rate of 1:16,000 – 1:21,000. The reality is that if not a vaccine causing a fever, then another trigger will certainly bring Dravet syndrome to the fore. Evidence suggests there is no difference in prognosis between the vaccine proximate and vaccine distant.

Dravet syndrome remains a very rare condition and there is still no vaccine conspiracy.