almost 80% of all compensated awards by the NVICP come as a “result of a negotiated settlement between the parties in which HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury.”
the NVICP settlements are funded by an excise tax on vaccines
the NVICP cases are published by the U.S. Court of Federal Claims, so all information is disclosed to the public and no safety concerns are hidden
So what does the National Vaccine Injury Compensation Program (VICP) really prove?
One thing to understand when talking about tics and Tourette Syndrome is that tics are not Tourette Syndrome.
Instead, Tourette Syndrome is a type of tic disorder.
What Causes Tics and Tourette Syndrome?
You should also understand that tics are common.
In fact, about 20% of school age kids get tics, although few have them for more than a year. These motor or vocal tics (involuntary eye blinking, head jerking, shoulder shrugging, humming, sniffing, grunting, throat clearing, or yelling out a word or phrase) are most common when kids are between the ages of 10 to 12 years old, but may start as early as age 6 to 7 years.
Not only are these tics common, but they are thought to be normal and very often go away without treatment. About 97% of kids have complete resolution of their tics within a year or so.
The rest might go on to have a persistent motor or vocal tic disorder though.
And some kids with persistent motor and vocal tics might have Tourette Syndrome.
“While environmental factors and illness may influence ticcing, the weight of evidence argues that tic disorders and their comorbidities are inherited/genetic. The inheritance pattern can be subtle and unexpected. In clinic, we often see a parent, while either indicating that they experienced childhood tics that remitted or that no one in the immediate family ever had tics, demonstrating frequent subtle tics.”
Kids and Tics: What’s “Normal” and When to see a Specialist
That’s right. Genetics.
Tics and Tourette Syndrome often run in families.
Do Vaccines Cause Tics or Tourette Syndrome?
As you might suspect, vaccines do not cause tics or Tourette Syndrome.
Neither does thimerosal, which used to be a common preservative in vaccines.
That’s not surprising, as neither tics nor Tourette Syndrome are new conditions.
Why can you find studies that try to link thimerosal and vaccines to tics and Tourette Syndrome? Because they are poorly done studies by folks who routinely do studies that try to make it look like vaccines cause everything from autism and tics to ADHD.
Other studies have found no link between thimerosal and tics, including the study Neuropsychological Performance 10 Years After Immunization in Infancy With Thimerosal-Containing Vaccines.
Even the studies that found some association weren’t very convincing.
“With the possible exception of tics, there was no evidence that thimerosal exposure via DTP/DT vaccines causes neurodevelopmental disorders.”
Andrews et al on Thimerosal exposure in infants and developmental disorders: a retrospective cohort study in the United kingdom does not support a causal association.
One study, for example, did actually find some association between thimerosal and tics.
Infants who received one dose of DTP with thimerosal had a higher rate of tics than infants who didn’t. The strange thing about the study though is that infants who had two or three doses also had a higher rate than getting just one dose and a similar rate as kids who didn’t get any vaccines with thimerosal.
“We did find one statistically significant association between exposure to thimerosal-containing vaccines and the presence of tics among boys, however, this association was not replicated in girls. Previous associations between thimerosal containing vaccines and tics were found by Verstraeten et al. (2003) and Andrews et al. (2004) but the findings were not sex specific. Our tic finding was also consistent with the tic finding reported in the original study (Thompson et al., 2007).”
John Barile et al on Thimerosal Exposure in Early Life and Neuropsychological Outcomes 7–10 Years Later
None of this sounds like evidence that vaccines cause tics, does it?
None of these studies found clinically significant evidence that vaccines cause tics or Tourette Syndrome.
What about other thimerosal-free vaccines? There have been no reports of increased rates of tics or Tourette Syndrome with any thimerosal-free vaccines either.
“There were 17 reports of Tourette’s disorder. Two patients developed movement disorders following 4vHPV with symptoms similar to Tourette’s, but did not have a definitive clinical diagnosis of Tourette’s disorder from a specialist (i.e., a neurologist or psychiatrist). In three additional reports, patients had a Tourette’s diagnosis or displayed symptoms of Tourette’s prior to vaccination. The remaining 12 reports were submitted by one physician who read on internet websites about possible Tourette disorder occurring after vaccines, but he had no firsthand information on any patient. None of these 12 reports could be verified.”
Arana et al on Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2009-2015.
There is no evidence that vaccines cause tics or Tourette Syndrome.
In fact, at the December 2017 meeting of the Advisory Committee on Childhood Vaccines, there was a petition to add tics as a vaccine table injury. After reviewing all available evidence, including the work of William Thompson, the so-called CDC Whistleblower, the committee voted 5-1 for the option to not add tics as an injury to the Table. They also didn’t add asthma or PANDAS to the vaccine injury table, despite some folks petitioning them to do so.
Anti-Vaxxers Should Be Able to Answer These Questions Correctly
Since it is immoral and dangerous to push misinformation that scares parents away from vaccinating and protecting their kids, it would be nice if anti-vaccine folks would answer these questions before they tried to persuade anyone to not get vaccinated:
Name 5 vaccine ingredients that you think are toxic and how exactly they can be toxic at the amounts present in vaccines.
If today’s vaccines already contain far fewer antigens than they did in the old days, what would be the extra benefit of splitting them up even further into separate shots for each vaccine-preventable disease?
For example, while it might sound like there have been a lot of adverse drug reaction reports for the DTaP vaccine, with 179,447 reports in VigiAccess, since those are worldwide reports since 1968, it is likely among many billions of doses of vaccines being given.
Most importantly though, as with VAERS, “The reports in VigiBase result from suspicions of a relationship between a drug and a reaction. No causal relation has been confirmed.”
So how do you put the numbers from VigiBase and VigiAccess in context?
If you consider that reports and safety signals from VigiBase, VigiMatch, VigiRank, and other tools used by the Uppsala Monitoring Centre continue to find that vaccines are safe, then to put the DTaP numbers in context, they help us know that vaccines are being well monitored for safety.
And since we know that these diseases haven’t disappeared, any further context, if you need it, would be that since vaccines are safe and necessary, then you should get yourself and your family vaccinated and protected.
Have you heard about the Cochrane HPV controversy?
Well, yeah, but anti-vaccine folks are crowing about what is essentially a letter that was published in BMJ Evidence-Based Medicine journal.
About the Cochrane HPV Controversy
What’s the controversy?
Seems that the folks at Cochrane Reviews recently published a review, Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors, which concluded that the HPV vaccines work and that they are safe.
That doesn’t sound controversial…
Well, it seems that some other folks, associated with the Nordic Cochrane Center, disagreed. They published an “analysis” in BMJ Evidence-Based Medicine, The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias.
So who do we believe when we have Cochrane vs Cohrane?
Who is the Nordic Cochrane Centre?
Some people will be familiar with the Nordic Cochrane Centre because of their involvement in complaints about the HPV vaccine that were investigated by the European Medicines Agency.
Complaints that were initially triggered by a case series that was published by Dr. Louise Brinth, when she was head of the Danish Syncope Group, but who is now part of the Nordic Cochrane Centre.
Complaints that were not approved by the Cochrane Collaboration and that were not an official Cochrane viewpoint!
“…we highlight here how academic colleagues, under the purported banner of a respected authority, raise concerns about the HPV vaccine but they cite an evidence base of small and poor quality studies and ignore the extensive wealth of global literature that vividly demonstrate the excellent efficacy and safety record of the vaccine.”
Head et al on Inadvisable anti-vaccination sentiment: Human Papilloma Virus immunisation falsely under the microscope
Complaints that had already been investigated and dismissed by the European Medicines Agency.
“In conclusion, in clinical trials conducted in the 9 to 26-year- old age range, vaccination was generally well tolerated with no apparent adverse health impact following completion of the vaccination regimen.”
Block et al Clinical trial and post-licensure safety profile of a prophylactic human papillomavirus (types 6, 11, 16, and 18) l1 virus-like particle vaccine.
Complaints that are also refuted by many other studies.
So we don’t actually have Cochrane vs Cochrane…
The Cochrane HPV Review
Once you read the complaint against the Cochrane HPV review, you realize that this isn’t even just about the Cochrane HPV review.
The main faults that the Nordic Cochrane Centre folks found is that the Cochrane review left out a bunch of what they consider to be eligible HPV vaccine trials, even though “twenty-six randomised trials were identified that contained data on vaccine efficacy and/or safety, which all together enrolled 73,428 women.”
But if this was just about a systemic review which didn’t stick to protocol about which studies to include, then why do the Nordic Cochrane Centre folks go on and on about placebos and active comparators?
“The Cochrane authors mistakenly used the term placebo to describe the active comparators.”
Lars Jørgensen et al. on The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias
Would you be surprised to know that one of Nordic Cochrane Centre’s arguments to the EMA was about placebos?
“In all the vaccine trials apart from a small one, the “placebo” contained aluminium adjuvant, which is suspected of being neurotoxic.”
Cochrane Nordic Complaint to the European Medicines Agency (EMA) over maladministration at the EMA
Why do they talk about placebos?
Most of these folks want pure saline placebos to be used in clinical trials, even though doing so would make it hard to keep the trials blinded.
Placebos don’t have to be inert though. The BMJ and the Nordic Cochrane Centre authors mistakenly corrected the Cochrane authors on their use of the term placebo.
They make plenty of other mistakes too.
“The Cochrane authors did not mention a study from 2017 by the WHO UMC that found serious harms following HPV vaccination overlapping with two syndromes: postural orthostatic tachycardia syndrome (POTS) and complex regional pain syndrome (CRPS).”
Lars Jørgensen et al. on The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias
Jørgensen cites a commentary that describes “a signal based on both spontaneous reports and published case series that is best characterized as a potential association between HPV vaccination and dysfunction of the autonomic nervous system.”
“There is currently no conclusive evidence to support a causal relationship between the HPV vaccine and POTS. It is of utmost importance to recognize that although temporal associations may be observed, conclusions of causality cannot be drawn from case reports and case series due to the small sample size and lack of control population inherent to this type of scientific literature. If POTS does develop after receiving the HPV vaccine, it would appear to do so in a small subset of individuals and would be difficult to distinguish from the normal prevalence and incidence of the disorder.”
Butts et al on Human Papillomavirus Vaccine and Postural Orthostatic Tachycardia Syndrome: A Review of Current Literature
So who do you believe?
Researchers who published a systemic review as part of the Cochrane Review Groups that confirms that the HPV works and that it is safe, or a group who seems to have an axe to grind against the HPV vaccines?
Update on the Cochrane HPV Controversy
Apparently, Cochrane has taken the Nordic Cochrane Centre complaints seriously enough to launch an investigation.
“Our current investigations appear to show that there may be a handful of missed but potentially eligible studies, but that this falls substantially below ‘nearly half of the eligible trials’.”
David Tovey, editor-in-chief of the Cochrane Library
And not surprisingly, Tovey stated that “To date, we also have no reason to believe that the main conclusions of the review relating to benefit and serious adverse effects are unsafe.”
And yet, as with their complaints to the EMA, resources get wasted as the attacks are put down.
Reagan didn’t do much for vaccines, but it isn’t fair to pin this one on him.
It seems that some folks think that the Department of Health and Human Services hasn’t been complying with federal vaccine safety mandates for 30 years.
Did the US Government Lose a Landmark Vaccine Lawsuit?
While anti-vaccine folks are pushing this lawsuit victory (?) to make folks think that HHS has done absolutely nothing to promote vaccine safety in the last 30 years, that is obviously nonsense.
The lawsuit was actually just about the reporting requirements of paragraph (c) of section 2127 of the National Childhood Vaccine Injury Act of 1986.
It should be clear that the HHS has done plenty to promote vaccine safety though.
Even if no formal reports were filed, the HHS secretary did report to and appear before Congress. Come to think of it, they even sent some reports to Congress.
And the Health and Medicine Division (HMD) division (previously known as the Institute of Medicine (IOM) of the National Academies of Sciences, Engineering, and Medicine has published a number of vaccine safety reviews and reports under commission of HRSA, an agency of HHS.
Where do folks think that all of those IOM vaccine safety reports and reviews come from? Were they sent to Congress?
a Task Force on Safer Childhood Vaccines was established and completed a report, “identifying key issues and enhancing collaboration on behalf of vaccine safety” in 1996. Did someone forget to send it to Congress?
the Salk inactivated polio vaccine (IPV) replaced the oral polio vaccine (OPV) in 1996 because of a small risk of vaccine-associated paralytic poliomyelitis (VAPP), beginning with a sequential IPV-OPV vaccine schedule and then going to an all IPV schedule in 2000
the DTaP vaccine, which is supposed to have fewer side effects than DTP is licensed, and replaces DTP for all required doses by 1997, although DTP is never actually shown to have caused seizures or brain damage
RotaShield, the first rotavirus vaccine is licensed in 1998 but is soon withdrawn from the market in 1999 after it is associated with an increased risk of intussusception, a form of bowel obstruction
a new National Vaccine Plan was established in 2010, with the goal to develop new and improved vaccines, enhance the vaccine safety system, support communications to enhance informed vaccine decision-making, ensure a stable supply of, access to, & better use of recommended vaccines in the U.S., and increase global prevention of death & disease through safe & effective vaccination. Was the plan sent to Congress?
They did settle a lawsuit though, a lawsuit which was then dismissed.
So like the CDC whistleblower movie that didn’t include a whistleblower, anti-vaccine folks think that they have a smoking gun about vaccine safety reports, except that it is very obvious that all kinds of reports about vaccine safety have been done over the years.
Although it does seem like HHS didn’t file the required formal reports and keep to the strict letter of the National Childhood Vaccine Injury Act of 1986, there is abundant evidence that they have actually done all of the work required to make sure that our vaccines are safe.
Can a child be fine one day and then die the next?
Tragically, they can.
There is even a name for it – sudden unexplained death in childhood.
Sudden Death in Children
Although 10% of deaths in children over age 12 months are classified as sudden death, most have explanations, such as asthma, epilepsy, or a heart problem (congenital malformations and arrhythmias). Unfortunately, some of these conditions, especially some infections and heart problems, aren’t discovered until after the child dies.
“Most sudden cardiac deaths that remain unexplained after necropsy are probably caused by primary cardiac arrhythmias.”
Sudden death in children and adolescents
About 16% of these sudden deaths don’t have any explanation though.
Surprisingly, these types of sudden, unexplained deaths are the 5th leading cause of death in children between the ages of 1 and 4 years. That adds up to about 400 deaths a year in the United States alone!
“…making general assumptions and drawing conclusions about vaccinations causing deaths based on spontaneous reports to VAERS – some of which might be anecdotal or second-hand – or from case reports in the media, is not a scientifically valid practice.”
Miller et al on Deaths following vaccination: What does the evidence show?
“At the present time there is not enough known about the underlying mechanisms of death in SUDC to allow prediction of which children might die suddenly and unexpectedly. Additionally, there is no way to prevent SUDC since its cause is unknown. Through research, we strive to discover the risk factors and underlying causes of SUDC that will lead to its prevention. In the meantime, optimal pediatric care recommendations, including attending well child visits, maintaining current vaccinations, and obtaining appropriate health care when clinically indicated, should be followed.”
SUDC Foundation on Frequently Asked Questions
And it’s not just SIDS. We also see a “healthy vaccinee effect” in older kids, who have lower mortality rates than the general population, which includes some folks who aren’t vaccinated.
We don’t know what causes sudden unexplained death in children, although with continued research we hopefully soon will, and can then learn to prevent them. Until then, parents should feel confident that it is not caused by the vaccines, which are safe and necessary and work to protect them from many life-threatening vaccine-preventable diseases.
What to Know About Vaccines and Sudden Unexplained Death in Children
Vaccines are not associated with sudden unexplained death in children.
More on Vaccines and Sudden Unexplained Death in Children