Tag: causation

Why Do Some People Think That Vaccines Cause AFM?

So we know that vaccines don’t cause acute flaccid myelitis.

Consider a five-year-old in Maryland who recently came down with symptoms of AFM.

Was he recently vaccinated?

Nope. It had been some time since his four-year-old vaccines. Almost a year. And he had not gotten a flu vaccine yet.

What he did have were worsening symptoms about two weeks after he had seemed to get over a cold, something he has in common with most other kids with AFM.

“To try to pin a tragic yet uncommon neurological condition caused by enteroviruses on vaccines is dangerous and puts more kids at risk.”

Scott Krugman, MD

As with this case, the CDC reports no correlation with vaccines in the cases that they have investigated.

And remember, some of these kids have been unvaccinated!

That makes you wonder why some folks actually think that vaccines are associated with AFM, doesn’t it?

Why Do Some People Think That Vaccines Cause AFM?

That’s right, as you are likely suspecting, the usual suspects are pushing anti-vaccine propaganda and promoting the idea to scare parents away from vaccinating and protecting their kids.

“…there are many other reasons to suspect vaccine-related mechanisms of causation for AFM in the U.S., a primary one being that the scientific literature has documented paralysis as an adverse reaction to vaccination for decades!”

The Non-Polio Illness That “Looks Just Like Polio” by Lyn Redwood, RN, MSN, President, Children’s Health Defense

If any of these kids had recently gotten the oral polio vaccine, then sure, an adverse reaction to the vaccination would be at the top of the list of possible causes. After all, we know that VAPP can occur after OPV, but that vaccine hasn’t been used in the United States since 2000, when we switched to IPV.

Why do these folks think that they have it all figured out?

Vaccines are not causing AFM because of needle puncture wounds or tonsillectomies.
Vaccines are not causing AFM because of needle puncture wounds or tonsillectomies.

The AFM outbreaks happen at the beginning of the school year, when kids are all getting their shots, right?

Nope. They happen during the summer and early fall, peaking in August. And despite what some folks think, most parents don’t wait until the end of summer, just before school starts, to vaccinate their kids. Plus, most kids don’t even need vaccines before the start of the school year. Kids typically only get vaccines before starting kindergarten and middle school.

But the outbreaks do coincide with the when kids get their flu shots, right?

How many kids get flu shots in June and July?

If it was flu shots, the peak would be in October and November, when most kids get their flu shots and we would continue to see cases through December and January.

Many anti-vaccine websites and Facebook groups are pushing the idea that vaccines cause AFM.
Many anti-vaccine websites and Facebook groups are pushing the idea that vaccines cause AFM.

Of course, there is absolutely no evidence that flu vaccines, or any other vaccines, cause AFM.

What about the journal article that Brandy Vaughan posts as evidence?

“By reviewing vaccine-associated inflammatory diseases of the central nervous system, this study describes the current knowledge on whether the safety signal was coincidental, as in the case of multiple sclerosis with several vaccines, or truly reflected a causal link, as in narcolepsy with cataplexy following pandemic H1N1 influenza virus vaccination.”

Vaccine-associated inflammatory diseases of the central nervous system: from signals to causation

Even if you just read the abstract, as many folks do, you get a good idea where they are going with the article. It talks about how the claims of an association between multiple sclerosis and vaccines were proven to be purely coincidental.

Remember, correlation does not imply causation.

With AFM, you don’t even have much correlation to imply causation though!

Most cases occur just before we start giving flu vaccines and they don’t occur every year or in every state.

But doesn’t the article mention myelitis?

“Most of the published associations are based on individual case reports or small series of patients.”

Vaccine-associated inflammatory diseases of the central nervous system: from signals to causation

It does mention myelitis, just like it mentions MS – where an association has been shown to be purely coincidental.

Remember, case reports are not good evidence.

“…there are many other reasons to suspect vaccine-related mechanisms of causation for AFM in the U.S., a primary one being that the scientific literature has documented paralysis as an adverse reaction to vaccination for decades!”

The Non-Polio Illness That “Looks Just Like Polio” by Lyn Redwood, RN, MSN, President, Children’s Health Defense

But isn’t acute flaccid myelitis listed as a possible side affect in the package inserts for our vaccines?

Uh, TRANSVERSE myelitis and ACUTE DISSEMINATED ENCEPHALOmyelitis are not the same as acute flaccid myeltitis.
Uh, TRANSVERSE myelitis and ACUTE DISSEMINATED ENCEPHALOmyelitis are not the same as acute flaccid myelitis.

While it should be clear that AFM isn’t the same as ADEM and TM, it is very important to understand that even when those other conditions are listed in a package insert, it is in the section that is marked “without regard to causality.”

This isn’t evidence that vaccines cause AFM!

But didn’t the BMJ publish a study about Vaccines and the U.S. Mystery of Acute Flaccid Myelitis?

BMJ seems to allow anyone to publish responses to their articles online...
BMJ seems to allow anyone to publish responses to their articles online…

Nope. What they did is let someone publish what is essentially an online letter to the editor. And anti-vaccine folks are spreading it around like it is an actual BMJ study…

Surprised?

You shouldn’t be.

This is how anti-vaccine propaganda works.

Why are vaccine injury lawyers talking about AFM?
Why are vaccine injury lawyers talking about AFM?

It’s no coincidence that anti-vaccine folks are trying so hard to associate the outbreaks of AFM with vaccines. What better way to scare folks and make them think that vaccines are dangerous?

AFM is all that anti-vaccine folks are talking about these days...
AFM is all that anti-vaccine folks are talking about these days…

How are ‘we’ working on a vaccine for AFM if we don’t even know what causes AFM???

But that’s how many anti-vaccine folks think. Everything is a vaccine injury. Everything is a conspiracy.

Don’t believe them. Vaccines are safe and necessary.

More on Anti-Vaccine Propaganda About AFM

 

VigiAccess Numbers in Context

Most people are familiar with VAERS, the Vaccine Adverse Event Reporting System.

They sometimes forget that it is only the Vaccine Adverse Event Reporting System for the United States.

Other countries have their own vaccine safety systems.

VigiAccess Numbers in Context

One of the biggest is VigiBase, the World Health Organization’s  global database for suspected adverse drug reactions, maintained by the Uppsala Monitoring Centre in Sweden.

“Information on suspected ADR should not be interpreted as meaning that the medicinal product in question, or the active substance(s), generally causes the observed effect or is unsafe to use.”

Not surprisingly, folks misuse VigiBase numbers, just like they misuse VAERS reports.

JB Handley needs help understanding VigiAccess reports.
JB Handley needs help understanding VigiAccess reports.

To look at the VigiBase reports, you can use VigiAccess.

“VigiAccess has a search interface that allows visitors to retrieve summary statistics on suspected adverse reactions to medicines and vaccines.”

Uppsala Monitoring Centre

While VigiBase “is at the heart of UMC’s signal detection and scientific research,” you aren’t going to learn much from VigiAccess.

“Geographically, only continent-level statistics are shown, due to issues relating to patient confidentiality and data protection in individual countries.”

Uppsala Monitoring Centre

The biggest problem?

You don’t know how many vaccines were given to all of those people.

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.

More on VigiBase and VigiAccess

 

Vaccine Injuries vs Coincidences

Believe it or not, some folks don’t think that coincidences are real.

Not believing in coincidences is a well known trope of the anti-vaccine movement.
Not believing in coincidences is a well known trope of the anti-vaccine movement.

Is it a coincidence that these folks are the ones who are the most likely to believe that vaccines cause a lot of injuries and vaccine induced diseases?

Vaccine Injuries vs Coincidences

Thinking about vaccine side effects and coincidences is not new.

“When I undertook the study with the current vaccine strain on my own two triple-negative children and their three playmates, also triple- negatives, I thought: “I am going to do this very carefully now,” and, like Dr. Gear, I set up certain time schedules. I said: “I am going to start to give the vaccine now.” Every time I said “I am going to start to give it” and did not give it, two to three or four days later they came down with either pharyngitis, vomiting and abdominal pain, or a little fever.

I waited for approximately six weeks for those children to stop having some sort of febrile episode. I finally gave up. It so happened that after they got the vaccine they did not have any such episode.”

Albert Sabin on Recent Studies And Field Tests With A Live Attenuated Poliovirus Vaccine

When Albert Sabin was first researching his oral polio vaccine, he understood the problem. How could he really know if any signs or symptoms that occurred after he gave someone his vaccine were really caused by the vaccine, or just a coincidence?

“However, a report later to be given by Dr. Smorodintsev will deal with approximately 7,500 children who had received the vaccine and were carefully followed, as compared with another group, in similar number, who had not, for various types of illnesses which were occurring during the period.”

Albert Sabin on Recent Studies And Field Tests With A Live Attenuated Poliovirus Vaccine

The solution? They studied kids who had not gotten his vaccine.

But you don’t need an unvaccinated group to uncover coincidences.

You can just look at the background rate of a symptom or condition, and compare the periods before and after you start using a vaccine.

For instance, consider this study from Australia about using the HPV vaccine in boys, in which they made some predictions of what would happen after introducing the HPV vaccine.

Assuming an 80% vaccination rate with three doses per person — which equates to about 480 000 boys vaccinated and a total of 1 440 000 doses administered nationally per year in the first 2 years of the program — about 2.4 episodes of Guillain-Barré syndrome would be expected to occur within 6 weeks of vaccination. In addition, about 3.9 seizures and 6.5 acute allergy presentations would be expected to occur within 1 day of vaccination, including 0.3 episodes of anaphylaxis.

Clothier et al. on Human papillomavirus vaccine in boys: background rates of potential adverse events.

Wait. Are they saying that the HPV vaccine is going to cause Guillain-Barré syndrome, seizures, allergic reactions, and anaplylaxis?

Of course not. When the study was done, the kids hadn’t gotten any vaccines yet!

That was the background rate of those conditions.

They happened before the vaccine was given, and you can expect them to continue to happen after these kids start getting vaccinated – at that same rate.

What if they start happening more often after kids get vaccinated?

Then it makes it less likely to be a coincidence and more likely that the vaccine is actually causing an increase in the background rate. And vaccine safety studies look for that, which is how we know that vaccines don’t cause SIDS, transverse myelitis, multiple sclerosis, and many other conditions.

Most of you will have heard the maxim “correlation does not imply causation.” Just because two variables have a statistical relationship with each other does not mean that one is responsible for the other. For instance, ice cream sales and forest fires are correlated because both occur more often in the summer heat. But there is no causation; you don’t light a patch of the Montana brush on fire when you buy a pint of Haagan-Dazs.

Nate Silver on The Signal and the Noise

Of course, when we are talking about coincidences, we are also talking about correlation and causation.

When correlation doesn’t equal causation, then it’s probably a coincidence. Or it’s at least caused by some other factor.

And coincidences happen all of the time.

Is It a Vaccine Injury or a Coincidence?

That something could be a coincidence is not typically want parents want to hear though, especially if their child has gotten sick.

What does it mean that something happens coincidentally?

“Most sudden cardiac deaths that remain unexplained after necropsy are probably caused by primary cardiac arrhythmias.”

Sudden death in children and adolescents

Often it just means that it is unexplained. And that it is chance alone that it occurred as the same time as something else.

“In the absence of a specific etiology for ASDs, and a tendency among parents of children with a disability to feel a strong sense of guilt, it is not surprising that parents attempt to form their own explanations for the disorder in order to cope with the diagnosis.”

Mercer et al on Parental perspectives on the causes of an autism spectrum disorder in their children

Again, when folks blame vaccines, it is often because they have nothing else to blame.

“In some fraction of the American population, however, the belief in a link remains. One reason is a coincidence of timing: children are routinely vaccinated just as parents begin to observe signs of autism. Most vaccines are administered during the first years of life, which is also a period of rapid developmental changes. Many developmental conditions, including autism, don’t become apparent until a child misses a milestone or loses an early skill, a change that in some cases can’t help but be coincident with a recent vaccination.”

Emily Willingham on The Autism-Vaccine Myth

Think that it is too big of a coincidence that some infants develop spasms shortly after their four month vaccines?

Dr. William James West first described these types of infantile spasms in the 1840s!

And the “Fifth Day Fits,” seizures that began when a newborn was five days old, was described in the 1970s, well before we began giving newborns the hepatitis B vaccine.

But SIDS was only discovered after we began vaccinating kids, right?

“But, with millions upon millions of doses given each year to infants in the first 6 months of life across industrialized countries and with sudden infant death syndrome being the most common cause of infant death among infants 1 month or older, the coincidence of SIDS following DTP vaccination just by chance will be relatively frequent. When the two events occur, with SIDS following vaccination, well-meaning and intelligent people will blame the vaccine. They seek order out of randomly occurring events.”

Jacobson et al. on A taxonomy of reasoning flaws in the anti-vaccine movement

Of course not.

Cases of SIDS have been described throughout recorded history and have been well studied to prove that they are not associated with vaccines.

“Some events after immunisation are clearly caused by the vaccine (for example, a sore arm at the injection site). However, others may happen by coincidence around the time of vaccination. It can therefore be difficult to separate those which are clearly caused by a vaccine and those that were going to happen anyway… Scientific method is then used to determine if these events are a coincidence or a result of the vaccine.

Vaccine side effects and adverse reactions

It is easy to blame a vaccine when something happens and a child was recently vaccinated. That is especially true now that anti-vaccine folks turn every story of a child’s death or disability into a vaccine injury story.

“Autism was known well before MMR vaccine became available.”

Chen et al. on Vaccine adverse events: causal or coincidental?

Blaming vaccines when it is clear that vaccines aren’t the cause doesn’t help anyone though. It scares other parents away from vaccinating and protecting their kids. And it doesn’t help parents who need support caring for a sick child or help coping with the loss of a child.

What to Know About Vaccine Injuries vs Coincidences

While all possible adverse events after getting a vaccine should be reported to VAERS and your pediatrician, remember that just because something happened after getting vaccinated, it doesn’t mean that it was caused by the vaccine.

More on Vaccine Injuries vs Coincidences

About the Cochrane HPV Controversy

Have you heard about the Cochrane HPV controversy?

What 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.

Cochrane Nordic has been filing multiple complaints with the EMA about HPV vaccine safety for years.
Cochrane Nordic has been filing multiple complaints with the EMA about HPV vaccine safety for years.

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.

While the Cochrane Collaboration has a very good reputation, you can't really say the same about the Nordic Cochrane Centre.
While the Cochrane Collaboration has a very good reputation, you can’t really say the same about 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

What study?

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.

More on the Nordic Cochrane Centre HPV Attacks

Can Parents Still Sue Vaccine Manufacturers?

Have you heard the myth that vaccine manufacturers have no liability and that you can no longer sue them

Of course, it isn’t true.

After all, isn’t there a class action lawsuit against Merck about the mumps vaccine?

Can Parents Still Sue Vaccine Manufacturers?

The Wisconsin Coalition for Informed Vaccination is pushing myths about the liability of vaccine manufacturers.
The Wisconsin Coalition for Informed Vaccination is pushing myths about the liability of vaccine manufacturers.

Vaccines are safe, but they are not without some risks, so what happens if a child does suffer a vaccine injury? Hopefully, even if it is a rare life-threatening condition, they can get treated and improve, avoiding that particular vaccine in the future.

They can also file a petition with the Vaccine Court and if the reaction is determined to be caused by a vaccine, they can be compensated.

So parents don’t usually sue vaccine manufacturers directly – they go through Vaccine Court.

But that isn’t there only option…

Parents can still sue vaccine manufacturers:

  • if the claim is not related to vaccine injury
  • in state court for vaccine injury, as long as the claim is not of design defect, and as long as they have already gone through Vaccine Court

So it certainly isn’t true that “under no circumstance may you sue a vaccine manufacturer.”

What’s the benefit of going through Vaccine Court, “a no-fault alternative to the traditional legal system for resolving vaccine injury petitions?”

For one thing, the majority of compensated claims in Vaccine Court are settled claims, in which “cannot be characterized as a decision by HHS or by the Court that the vaccine caused an injury.”

etitioners would not get to use the Althen standard if the National Childhood Vaccine Injury Act and NVICP were rescinded.
Petitioners would not get to use the Althen standard if the National Childhood Vaccine Injury Act and NVICP were rescinded.

It is likely that at least some of those claims wouldn’t win if they weren’t in Vaccine Court, where:

  • causation is presumed (you automatically win) if you are claiming a table injury
  • the rules for evidence are relaxed and expert testimony does not necessarily have to meet the  strict requirements of the Daubert standard
  • petitioners must meet a fairly lenient standard to win, the regular standard of proof for a civil trial (more likely than not), but only have to provide a plausible theory for vaccine injury. Instead of providing scientific evidence or proving causation, they simply have to provide a theory that “is ‘logical’ and legally probable, not medically or scientifically certain.”
  • you don’t have to show that the vaccine was defective to make your case

Another benefit of Vaccine Court? All lawyer fees are paid, whether you win or lose, and lawyers do not get part of the award if you win. In traditional court, lawyers might get up to thirty-three percent of your award.

What to Know About Vaccine Manufacturer Liability and Vaccine Court

Although they must usually go through Vaccine Court first, folks can still sue vaccine manufacturers in some cases.

More on Vaccine Manufacturer Liability and Vaccine Court

Correlation and Causation

Some people think vaccines cause autism simply because we are giving more vaccines, and protecting kids against more vaccine-preventable diseases, just as more kids were getting diagnosed with autism.

So it has to be the vaccines. Correlation implies causation, right?

Not really.

The saying is “correlation does not imply causation.”

Nate Silver explains it very well:

Most of you will have heard the maxim “correlation does not imply causation.” Just because two variables have a statistical relationship with each other does not mean that one is responsible for the other. For instance, ice cream sales and forest fires are correlated because both occur more often in the summer heat. But there is no causation; you don’t light a patch of the Montana brush on fire when you buy a pint of Haagan-Dazs.

Correlation does not imply causation.

Just because two things happen at the same time, it doesn’t mean that one caused the other.

And just because we don’t know what causes autism, it doesn’t mean that it is vaccines. That is especially true since so many studies have shown that it is not vaccines.

But, and this is what confuses a lot of people, sometimes correlation does show causation.

When?

When the evidence supports the correlation!

More on Correlation and Causation