Tag: vaccine court

Is It a Vaccine Reaction?

Why do anti-vaccine folks think that there are so many vaccine reactions?

It is mostly because they think that anything bad that happens after someone is vaccinated, even if it is weeks or months later, must have been caused by the vaccine.

“Differentiation between coincidence and causality is of utmost importance in this respect. This is not always easy, especially when an event is rare and background rates are not available.”

Heininger on A risk-benefit analysis of vaccination

Of course, this discounts that fact that most people have a basic risk, often called the background rate, for developing most of these very same conditions, and they can just coincide with getting vaccinated.

Put more simply, the “reaction” would have happened whether or not they had been vaccinated.

“…when a number of well-controlled studies were conducted during the 1980s, the investigators found, nearly unanimously, that the number of SIDS deaths temporally associated with DTP vaccination was within the range expected to occur by chance. In other words, the SIDS deaths would have occurred even if no vaccinations had been given.”

WHO on Six Common Misconceptions About Immunization

That doesn’t mean that everything automatically gets blamed on coincidence though.

Is It a Vaccine Reaction?

Vaccine adverse events can be reported to VAERS online or using a downloadable form.
Vaccine reactions can be reported to VAERS online or using a downloadable form.

When trying to determine if a child has had a vaccine reaction, experts typically go through a series of questions, looking at the evidence for and against :

  • How soon after the vaccine was given did the reaction occur? Was it minutes, hours, days, weeks, months, or years later?
  • Is there any evidence that something else could have caused the reaction?
  • Is there a known causal relation between the reaction and the vaccine?
  • Is the reaction a table injury?
  • Is there evidence that the vaccine does not have a causal association with the reaction?
  • Do any lab tests support the idea that it was a vaccine reaction?

Why is it important to consider these and other questions?

Because most of us are very good at jumping to conclusions, are quick to place blame, and like to know the reasons for why things happen.

We don’t like to think that things are just caused by coincidence.

Post hoc ergo propter hoc (after this, therefore, because of this).

We are especially good at linking events and often automatically assume that one thing caused another simply because it occurred afterwards.

It is incident to physicians, I am afraid, beyond all other men, to mistake subsequence for consequence.

Dr Samuel Johnson

But we also know that correlation does not imply causation. And because of the great benefits of vaccines, it is important to find strong evidence for a correlation before we blame vaccines for a reaction.

Too often though, the opposite happens. Despite strong evidence against a correlation, parents and some pediatricians still blame vaccines for many things, from SIDS and encephalitis to autism.

Background Rates vs Vaccine Reactions

Although anti-vaccine folks are always calling for vaccinated vs unvaccinated studies to further prove that vaccines are indeed safe, much of that work is already done by looking at the observed rate of possible reactions and comparing them to the background rate of reactions and conditions.

We often know how many people are expected to develop certain conditions, from seizures and type 1 diabetes mellitus to acute transverse myelitis and juvenile and rheumatoid arthritis.

“On the basis of the reviewed data, if a cohort of 10 million individuals was vaccinated in the UK, 21.5 cases of Guillain-Barré syndrome and 5.75 cases of sudden death would be expected to occur within 6 weeks of vaccination as coincident background cases. In female vaccinees in the USA, 86.3 cases of optic neuritis per 10 million population would be expected within 6 weeks of vaccination. 397 per 1 million vaccinated pregnant women would be predicted to have a spontaneous abortion within 1 day of vaccination.”

Black et al on Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines

Intussusception is a good example of this.

This might surprise some folks, but we diagnosed and treated kids with intussusception well before the first rotavirus vaccines were ever introduced. And then, it was only after the risk of intussusception after vaccination exceeded the background rate that experts were able to determine that there was an issue.

Background rates also explain why unvaccinated kids develop autism. It’s not a coincidence.

“Knowledge of the background incidence rates of possible adverse events is a crucial part of assessing possible vaccine safety concerns. It allows for a rapid observed vs expected analysis and helps to distinguish legitimate safety concerns from events that are temporally associated with but not necessarily caused by vaccination.”

Gadroen et al on Baseline incidence of intussusception in early childhood before rotavirus vaccine introduction, the Netherlands, January 2008 to December 2012

Fortunately, studies have never found an increased risk above the background rate for SIDS, non-febrile seizures, and other things that anti-vaccine folks often blame on vaccines. So when these things happen on the same day or one or two days after getting vaccinated, it almost certainly truly is a coincidence. It would have happened even if your child had not been vaccinated, just like we see these things happen in the days before a child was due to get their vaccines.

For example, using background incidence rates in Danish children, one study found that if you vaccinated a million children with a new flu vaccine, you could expect that naturally, after seven days, you would see:

  • facial nerve palsy – one case
  • seizures – 36 cases
  • multiple sclerosis – one case
  • type 1 diabetes – three cases
  • juvenile and rheumatoid arthritis – three cases

After six weeks, those numbers of course go up. In addition to 4 kids developing MS, 20 develop diabetes, 19 develop arthritis, and 218 have seizures, and there would have been at least two deaths of unknown cause.

Would you blame the flu shot for these things?

What flu shot?

This was a “hypothetical vaccine cohort” that used 30 years of data from the Danish healthcare system to figure out background rates of each condition.

“In addition, the expected number of deaths in Japan following an estimated 15 million doses of H1N1 vaccine administered would be >8000 deaths during the 20 days following vaccination, based on the crude mortality rate.”

McCarthy et al on Mortality Rates and Cause-of-Death Patterns in a Vaccinated Population

Looking at background rates is especially helpful when folks report about vaccine deaths.

Using the Japan example that McCarthy studied, if they had looked at background rates, then all of a sudden, the 107 deaths they found after 15 million doses of H1N1 vaccine were given in 2009 would not have been so alarming. Background rates would have predicted a much, much higher number of deaths to naturally occur in that time period simply based on crude mortality rates.

Again, none of this means that possible vaccine reactions are dismissed as being coincidences. They just aren’t immediately assumed to have been caused by vaccines, because vaccines are necessary and a lot of research has already gone into demonstrating that vaccines are safe and vaccines continue to go through routine safety monitoring to make sure they stay safe.

What to Know About Evaluating Vaccine Reactions

Vaccines are safe and many of the things that folks think are vaccine reactions can be explained by looking at the background rates for these conditions and understanding that they would have happened anyway.

More on Evaluating Vaccine Reactions

Vaccine Injury Stories That Scare Parents

It is not uncommon to hear about parents having ‘panic attacks’ over the idea of vaccinating their kids.

“…many parents are inundated with horror stories of vaccine dangers, all designed to eat away at them emotionally while the medical and scientific communities have mounted their characteristic response by sharing the facts, the data, and all of the reliable peer-reviewed and well-cited research to show that vaccines are safe and effective.”

Federman on Understanding Vaccines: A Public Imperative

Or simply becoming anxious over an upcoming appointment for routine immunizations or to get caught up on vaccines.

What’s fueling all of this anxiety?

Vaccine Injury Stories That Scare Parents

Some of it is likely from the vaccine injury stories that they read  or videos they watch.

As parents get better at spotting the myths and misinformation behind the anti-vaccine movement, we are seeing more and more vaccine injury stories pop up to scare them.

“…recognizes the importance of examples—testimonials and stories—that are the lifeblood of vaccine-hesitant beliefs.”

Nathan Rodriguez on Vaccine-Hesitant Justifications

Vaccine injury stories aren’t new though.

These types of anecdotal stories were very popular when folks used to think that the DPT vaccine was causing a lot of side effects. It wasn’t though. And it was soon proven that the DPT vaccine didn’t cause SIDS, encephalitis, non-febrile seizures, and many other things it was supposed to have caused.

“Anecdotes – about a new miracle cure, a drug that is not being made available on the NHS, or the side effects of treatment, or some environmental hazard – sell product. Data, on the other hand, which take us towards the truth about these things, are less popular. Anecdotes, however many times they are multiplied, do not point the way to reliable knowledge. As the aphorism says, “The plural of anecdote is not data”.”

Raymond Tallis on Anecdotes, data and the curse of the media case study.

That anecdotes “sell” better than data may be one reason why you see them so often on anti-vaccine websites. Another is that they simply don’t have any good data to use as evidence!

Are Vaccine Injury Stories True?

Vaccines are not 100% safe, so there is no doubt that some vaccine injury stories are true.

There is also no doubt that what many people perceive to be vaccine injuries have actually been proven to not be caused by vaccines, from allergies and eczema to autism and MS.

“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

Also keep in mind that in addition to the many so-called vaccine induced diseases, there are many historical vaccine injury stories that have been shown to be untrue:

  • the first deaf Miss America did not have a vaccine injury
  • Johnnie Kinnear supposedly began having seizures 7 hours after getting a DPT vaccine, when he was 14-months-old, but medical records actually shown that his seizures started 5 months after he received his vaccines
  • Dravet syndrome now explains many severe seizures associated with vaccinations

And at least one of Wakefield’s own followers – a mother who claimed that the MMR vaccine caused her son’s autism, was “dismissed as a manipulative liar” by a court in the UK.

Vaccine Injury Stories are Dangerous

Do vaccine injury stories have a purpose? They might help a parent cope with a diagnosis in the short term, but vaccine injury stories are dangerous in so many ways.

We have seen how they create anxiety for many parents, which can scare them away from vaccinating and protecting their kids from life-threatening vaccine-preventable diseases.

What else can they do?

Driving a wedge between parents and pediatricians does not help autistic kids.
Driving a wedge between parents and pediatricians does not help autistic kids.

They can certainly build up mistrust towards pediatricians and other health professionals. That is one way that the anti-vaccine movement continues to hurt autistic families. They also can lead parents to think that their “vaccine injured” child is “damaged” in some way.

And they push parents towards dangerous, unproven, unnecessary, and expensive alternative treatments. It shouldn’t be a surprise that many of the sites and forums that push vaccine injury stories also promote a lot of dangerous advice.

From recommending goat milk for your baby and skipping your baby’s vitamin K shot to various kinds of detoxing “treatments,” these are not the folks you want to trust with the health of your child.

What to Know About Vaccine Injury Stories

Vaccine injury stories prey on the fears of parents, help drive a wedge between them and their pediatricians, and are considered by many experts to be the lifeblood of the anti-vaccine movement.

More on Vaccine Injury Stories

Who is Julie Gerberding?

Dr, Julie Gerberding was the director of the Centers for Disease Control and Prevention from 2002 to 2009, when she was replaced by Tom Frieden.

Julie Gerberding, MD, MPH

A medical doctor with a Masters in Public Health, who had done a fellowship in clinical pharmacology and infectious diseases, she was well trained for the notable issues she faced during her tenure include anthrax bioterrorism, avian flu, SARS, natural disasters, and concerns about autism and vaccines.

Gerberding's CDC did a lot of work to get autistic kids diagnosed early including the 'Learn the Signs, Act Early' campaign.
Gerberding’s CDC did a lot of work to get autistic kids diagnosed early, including starting the ‘Learn the Signs, Act Early’ campaign.

One thing in particular that anti-vaccine folks continue to bring up is the mistaken idea that Dr. Gerberding actually said that vaccines cause autism on CNN following the Hannah Polling case.

GUPTA: And one of those 4,900 cases was the case of nine-year-old Hannah Polling, which has been making a lot of news lately. Luckily, we have the director of the Centers for Disease Control and Prevention, Dr. Julie Gerberding here.

We’re talking a lot about autism, as you know. I should remind people that the — my understanding is the federal government conceded that vaccines caused her autism like symptoms. First of all, is there a difference? I mean, does she have autism or autism like symptoms? What’s the difference?

JULIE GERBERDING, DR., CDC DIRECTOR: Well, you know, I don’t have all the facts because I still haven’t been able to review the case files myself. But my understanding is that the child has a — what we think is a rare mitochondrial disorder. And children that have this disease, anything that stresses them creates a situation where their cells just can’t make enough energy to keep their brains functioning normally. Now, we all know that vaccines can occasionally cause fevers in kids. So if a child was immunized, got a fever, had other complications from the vaccines. And if you’re predisposed with the mitochondrial disorder, it can certainly set off some damage. Some of the symptoms can be symptoms that have characteristics of autism.

GUPTA: Yes, I have a two-and-a-half-year-old and a one-year-old as you know. And you know, you know, you think about this all the time. Are we ready to say right now as things stand that childhood vaccines do not cause autism?

GERBERDING: What we can say absolutely for sure is that we don’t really understand the causes of autism. We’ve got a long way to go before we get to the bottom of this. But there have been at least 15 very good scientific studies on the Institute of Medicine who have searched this out. And they have concluded that there really is no association between vaccines and autism.

As many people are aware, Hannah Polling was awarded compensated for a table injury in Vaccine Court. She was not awarded compensated because vaccines caused her to be autistic.

And Dr. Gerberding certainly did not admit or say that vaccines cause autism. You can read that into her statements during the CNN interview if you like, but that isn’t what she said.

She also did not resign “in shame from her post under the Obama regime as director of the CDC in 2009 to return to Merck’s vaccine division.”

As often happens when a new president is elected, President Obama simply brought in a new team to the CDC and many other agencies after he was inaugurated on January 2009.

Dr. Gerberding was appointed by President George Bush.

And while she did become the president of Merck’s vaccine division, it wasn’t a return. She had been at the CDC since 1998 and before that, she directed the Prevention Epicenter at the University of California at San Francisco (UCSF).

Dr. Gerberding is currently the Executive Vice President and Chief Patient Officer, Strategic Communications, Global Public Policy, and Population Health at Merck, where she also has responsibility for the Merck for Mothers program and the Merck Foundation.

What To Know About Julie Gerberding

The first woman to lead the CDC, Dr. Julie Gerberding is an infectious disease expert with a Masters in Public Health who is now the the Executive Vice President at Merck. She never said that vaccines could trigger autism while on CNN or anywhere else.

More Information About Julie Gerberding

Vaccine Excise Tax

The Vaccine Injury Compensation Trust Fund was set up by the National Childhood Vaccine Injury Act of 1986 as a source of funds to compensate people found to be injured by certain vaccines by the Vaccine Court.

Vaccine Excise Tax

Money for the Vaccine Injury Compensation Trust Fund comes from a $0.75 excise tax on each vaccine that kids routinely get as recommended by the CDC.

Who pays this vaccine tax?

Is it the drug companies or folks getting the vaccines?

The U.S. Department of the Treasury collects the tax from the vaccine manufacturers.

But like other manufacturing costs, they likely just add it to the price of the vaccine. They are still paying it though.

Vaccine Injury Compensation Trust Fund

How much does the IRS collect?

Between 2009 and 2013, it has averaged about $200 million a year.

The Vaccine Injury Compensation Trust Fund has a balance of over $3 billion, as in addition to the excise tax, it gains interest on investments. That balance has grown because the Fund’s income has outpaced its payments (about $3.5 billion) over the years.

For More Information on the Vaccine Excise Tax