AAP: Vaccine Safety: Examine the Evidence

Even though there has never been any reputable, science-based evidence to support a link between vaccines and autism, the antivaxxer crowd continues to pretend that isn't the case as they push retracted papers from discredited "doctors" and self-proclaimed experts, nutritionists, or 'alternative medicine gurus'.  One tactic I tend to see employed on a regular basis is the famed "link dump" where an antivaxxer will share a website or a blog page (often his or her very own blog or webpage) which lists dozens upon dozens of various studies or papers all of which they claim show vaccines are harmful, or show that vaccines cause autism, or show that vaccines are deadly etc.

So often the problem is that these studies and papers are rarely ever peer-reviewed nor are they published in reputable medical journals (or reputable non-medical journals for that matter).  Those that are peer-reviewed or published will often have little to nothing to do with vaccines, and they surely don't prove that vaccines cause autism.  Sadly, I have even seen cases where these websites and blogs contain studies that actually say the exact opposite of what antivaxxers are claiming, but they lack the ability of understanding the subject matter and simply misunderstood a line of text in the abstract.

The other aspect of these link dumps that I find so peculiar is that often times there is zero context other than a title which says "Proof that Vaccines cause Autism" or "Evidence that Vaccines are Killing Us" or some other outrageous claim.  If one cannot even offer the slightest context around the studies they are listing, does it not suggest they haven't bothered to even read them?  Or is it that they have tried to read them but found the subject matter far too complex?  Either way, I have noticed the same lists appearing on antivaxxer blogs and websites (in one occasion even the same typo in the URL of a study which tells me those copying the list didn't even bother to visit all of the sites) and thus it seems as if in some cases antivaxxers are merely sourcing other antivaxxers without bothering to vet the information.  In theory this could lead to antivaxxer A being cited by antivaxxer B who in turn is cited by antivaxxer C who is then cited by antivaxxer A who never realizes they are actually indirectly using themselves as the supporting evidence to claims they themselves originally made.

Confused yet?  I can't blame you, but keep in mind antivaxxers have also been known to create their own blogs and then cite those blogs as sources within comments as if writing something and then linking to your own words adds credibility.

So what is my point you might ask?  Well, during a recent discussion with some colleagues I commented that even though there haven't been any studies that have successfully linked vaccines to autism, there have been several peer-reviewed AND published studies that have shown no link between vaccines and autism and that these studies were widely known.  The problem it seems is that those searching for real live published science are often overwhelmed because when they do find a study they may not understand what it means or they may not understand what the conclusions of a study actually were.

So inevitably the question was asked... where is the easiest place to find these studies, and unfortunately that answer is rather complex.  You could go directly to the journals which publish the studies, you could search pubmed, or you could try browsing the websites of the CDC or the FDA, but if we are honest with ourselves we must admit most people simply don't have the time, nor the patience, to follow this path.

Wouldn't it be nice if someone (a reputable someone) would put a list together that could be shared with parents or laypersons who have an interest in the subject?  Of course blogs and websites do that sort of thing all the time, but what about an actual organization known for their healthcare advocacy or one which is composed of over 60,000 pediatricians or pediatric specialists (you know... doctors who actually specialize in children)?

If you haven't guessed, I'm referring to the American Academy of Pediatrics which has published a memo detailing around 40 of these studies.  They make occasional updates to the list as new information is published, but even more impressive is that they do an amazing job of offering context!  This means they don't just provide a list of studies or sources but rather they summarize each study as well as providing a brief overview of what the author conclusions were, thereby giving those interested a succinct way of seeing the results without necessarily needing to read through hundreds upon hundreds of pages of medical and technical material.

Of course the list is geared towards parents, but I've found myself referring to it on many occasions and I can state in no uncertain terms that it is a useful list for anyone interested in vaccine safety up to an including pediatricians, researchers, and educators.  Thus, if you ever find yourself wondering if there is a nice package detailing the science behind vaccines... this might be right up your alley.  Click the link below, read the summaries and conclusions, dive into the studies themselves, and make up your own mind.  That isn't so hard is it?

Vaccine Safety: Examine the Evidence

The Impossible Demand for 100% Vaccine Safety

What would you say to someone who makes a demand for you to prove to them that all automobiles are

safe?  Do you think you could use safety data to prove that automobiles are more safe than they have ever been?  Maybe you could explain how there are new innovations like airbags, crumble zones, anti-lock brakes, or traction control systems which all work together to increase safety.

Now what if that same person cited statistics which showed that even in the year 2011 there were still over 32,000 people killed in automobile accidents in the US alone?  Does that suggest that automobiles aren't really that safe after all?

When you really think about it... how do you determine what is "safe"?

Reasonable people will understand that claims about vehicle safety based upon the number of accidents or the number of deaths in a year isn't taking in to account the big picture.  First you need to realize that there are hundreds of millions of miles traveled each and every year and there are million upon millions of drivers.  Next you need to take into account that even if a vehicle has eight airbags and has a five star crash test rating, sometimes things can and do go wrong and it may have nothing to do with the vehicle.

In the end, you would realize that 32,000 deaths may seem like a significant number, but in context of the hundreds of millions of miles driven, and the millions of unique drivers, the millions of different vehicles, the total hours spent in a vehicle throughout the year... well in the end 32,000 deaths is actually a very small number.  You might even show them statistics which prove that we haven't had less traffic fatalities since 1949 when the population and the number of miles traveled were less than half of what we have today.  You might even point out that almost as many people die from accidental poisonings in a given year (more than 33,000 deaths in 2010) than do in automobile accidents.

So perhaps logical people will agree that proving vehicles are safe is based upon certain assumptions.  Number one, you need to define the term "safe" and assume that is based upon historical averages and based upon percentages.  You also need to assume that no vehicle can ever be 100% safe, and you need to accept the fact that there will be accidents, and there will be a certain amount of deaths as a result.

With that in mind, should we ban automobiles because people die every year?  Should we change the laws to only allow them to be sold if they are 100% safe?  Should we demand that the government require automobile companies to be held personally responsible for each and every death that occurs while operating a motor vehicle?  Of course not... that sounds so silly when you put it like that doesn't it?

So with that in mind, why do anti-vaccinationists demand that we prove every vaccine is 100% safe?  Not only do they demand vaccines are 100% safe, but they aren't willing to accept the commonly held definition of the term "safe" (which in this case means involving little or no risk of mishap).

Even though there is overwhelming evidence supporting the efficacy and safety of vaccines, it is doubtful this would appease an antivaxxer because chances are there will always be cases where someone had an allergic reaction to a vaccine or a case where someone suffered a side effect, or cases where someone was fully vaccinated but still contracted the disease they were supposed to be protected against.

In addition to requiring all vaccines to be 100% safe, anti-vaccinationists are quick to point out case where someone was injured by a vaccine over 50 years ago.  They believe that the modern vaccines of today should still be blamed for any problems that existed decades ago, just as we should be blaming modern automobiles for the safety failures of the Chevrolet Corvair or the Ford Pinto.

We can all admit that vaccines have not always been perfect.  There have been cases such as the Rotashield rotavirus vaccine in 1998 and 1999 which was pulled from the market after it was determined it increased the risk of intussusception (a rare type of bowel obstruction) in infants.  There was the "Cutter Incident" back in the 1950s where a live virus was included in a polio vaccine which resulted in 10 deaths, and 200 children suffering from paralysis.

We also know that some polio vaccines were contaminated with Simian vacuolating virus 40 (SV40) which has the potential of leading to tumors.  Granted studies linking SV40 to cancer in humans have been inconclusive, this doesn't remove the negative impact these contaminated vaccines have had.

However, even with these and other failures in mind, is this enough to warrant the elimination of vaccines entirely?  Sadly if you are an antivaxxer the answer is yes.  Antivaxxers are convinced that these failures overshadow any good effects from vaccines, and they believe we would be better off without any vaccinations whatsoever.

They would have us return to the days where polio infected tens of thousands annually and killed as many as 6,000 in the US alone.

They would have us return to the days of millions upon millions of people dying from smallpox and to the time where as many as one out of every seven Russian children would die from the disease.

They would even attempt to convince us that the 18 people that died from measles every hour in 2011 (158,000 deaths total) aren't important.  They would try to claim the 71% reduction in measles deaths due to vaccination is trivial and unimportant.

Whether it be a vaccine used to prevent pertussis (whooping cough) or one which has been shown to prevent rotavirus, antivaxxers seem to believe that no vaccine is a good one, and although vaccines are overwhelmingly safe and effective, even if we could guarantee vaccines were safe 99.97% of the time and effective 99.99% of the time it still wouldn't be enough to convince those in the anti-vaccine crowd, because they will never be satisfied with anything less than 100% effectiveness and 100% safety.

So there is a choice... one one hand you could...

• Refuse to acknowledge the safety and effectiveness of vaccines and believe they cause far more harm than good

Or alternatively you can accept reality and...

• Acknowledge that although vaccines are not perfect, they do an incredible job of reducing and in some cases actually eliminating entirely the risk of contracting disease.  Accept that vaccines safe lives and prevent the spread of disease.  Accept that vaccines are overwhelmingly safe and that we have the historical record to show us not only how safe they are, but how effective they are as well.  Acknowledge that we no longer need to fear death from diseases such as smallpox or polio, acknowledge that vaccines are one of humankind's greatest scientific breakthroughs, and agree that vaccines (although not always 100% safe or 100% effective) are far less risky or damaging than the diseases they prevent (which can, and often do lead to death or long-term complications).

Nobody says we have to be satisfied with our current vaccines, and we can (and should) demand for better vaccines, safer vaccines, and vaccines for diseases which currently have no other cure (such as HIV).  We should always be striving for advancements and we shouldn't be afraid to challenge accepted science or to ask the difficult questions.

However there is a vast difference between wishing for vaccines to improve and wishing vaccines didn't exist.  Antivaxxers don't really care about vaccine safety.  They don't care about the millions of lives lost.  They don't care about people suffering from polio or pertussis or smallpox because they have never suffered from these diseases.  They likely aren't old enough to remember a loved one dying from what we now consider to be vaccine preventable diseases, and as such I can think of no other term to describe antivaxxers than the word selfish.

These people don't care about those who have died, and their only concern is pushing a political agenda based upon something they read about on the Internet or a reaction that their cousin's, boyfriend's, sister's, coworker's daughter's, teacher's, kid had after being vaccinated for tetanus.

Demanding improvements is reasonable, demanding 100% safety and effectiveness quite simply is the exact opposite of reasonable.  Just as we understand there is a risk every time we get into an automobile, we also understand there is a risk with each and every vaccination.  The question that should be asked is whether the level of risk is worth engaging in that particular activity, and the data overwhelmingly proves to us that driving in automobiles as well as being vaccinated is well worth the risk.

The Profit of Vaccinations

The New York Times recently published an article about the flu season which shows that the levels of deaths have officially crossed over into "epidemic" territory.  The full article can be found here:  Flu Season Deaths Reach Epidemic Level but May Be at Peak, C.D.C. Says

This is a well balanced article speaking about the impact of the flu as well as explaining that the flu vaccine isn't nearly as effective as some other vaccines like those for the norovirus (aka: the "stomach flu" or gastroenteritis) or pertussis (aka: whooping cough).  Part of this is obviously due to how quickly flu viruses mutate, but another aspect that could be partly responsible is the simple fact that on any given year only around a third of the population bothers to actually get a vaccine.  This means there is a much greater chance that the virus can spread among those who have no protection from the vaccine, as well as among those who the vaccine wasn't effective.

Clearly there are failures in the system and improvements must be made.  Not only do we need better vaccines, but we need to do a better job informing the public as to the benefits.  The good news is we appear to be making progress on both of these fronts, and the percentage of those who receive flu vaccines is on the rise each year.  There are also new vaccines in development that hope to address some of the problems with the current targeted vaccines although progress is slow, and funding is difficult to obtain.

This latter point is one which I wanted to speak about, because all too often we hear antivaxxers complain that vaccines are merely a profit mechanism for pharmaceutical companies and that there is no true benefit.  As the article explains it could take as much as $1 Billion to actually bring a vaccine to market, which at first glance seems like an insurmountable figure.  If a new vaccine was to be developed which either prevented the flu or even merely significantly reduced the chances of contracting a flu virus and if the usage of that vaccine was on par with vaccines for MMR or Hib, chances are we would see a vaccine acceptance rate somewhere above 90%.

So let's be conservative and use a vaccination rate of only 80% for the "one-time" flu vaccine.  We know not everyone would bother to be vaccinated the first year, but after a few years when people realized they no longer need an annual flu vaccine, they would probably be more willing to get the single vaccine, and since many other vaccines have rates well above 90%, I don't think 80% is that unbelievable.

So if we focus on the United States alone, we know there are around 312,000,000 (312M) people who could potentially be vaccinated.  80% of this is around 250,000,000 people who would likely receive a flu vaccine.  So let's assume the cost of this vaccine is $35.  The current wholesale costs of single year flu vaccines is closer to $10, but a one-time vaccine is likely to be incrementally higher due to the complexity.  For example an adult vaccine for MMR costs around $35 while the vaccine for varicella is over $60.  A childhood vaccine for Hib may be only $12 while rotavirus can be over $70, so it isn't hard to a flu vaccine could cost at least $35 wholesale - at least for the first few years after release.

Ok, so now we have 250,000,000 potential customers each of which will spend $35 for a grand total of $8,750,000,000 ($8.75B).  Even if we assume only a 50% vaccination rate (156M) and an even lower cost of $25 per vaccine, the total is still $3,900,000,000 ($3.9B).

Of course the $1B it takes to bring a vaccine to market does not include the costs to produce, distribute, and market the vaccine, so it isn't as if there will be billions in profit the first year, but the flip side of this equation is that we are only factoring in the population of the US.  Chances are once the vaccine was available it could be submitted for approval in numerous other nations with the potential to sell hundreds of millions of doses to those nations.

The moral of this story is, there would be a lot of money to be made from a one-time flu vaccine, yet to date we haven't seen anything available.  Since antivaxxers seem to feel vaccine manufacturers are only interested in profits, how can they explain that not a single manufacturer has unleashed such a vaccine on the public?  It shouldn't matter if the vaccine is effective or not, because as any good antivaxxer will tell you vaccines don't actually work (and yes I'm being sarcastic).  Antivaxxers are even willing to claim publicly that the polio vaccine and the smallpox vaccine did nothing to prevent those diseases (suggesting the diseases just magically disappeared on their own apparently), and they feel that vaccines are generally ineffective.

These same antivaxxers will tell you that the MMR vaccine does far more harm that good and that there is no evidence that viruses like the Measles have been controlled by the vaccine in any way.  They will also claim that the HPV vaccines don't work at all and that it is merely a method for the manufacturers to collect millions upon millions from insurance companies and the unsuspecting public.

You see this is one of those situations where antivaxxers want to have it both ways.  One one hand they claim vaccine manufacturers are simply in it for the money and that the vaccines themselves don't actually work.  On the other hand, they can't explain why the market hasn't delivered something like a one-time flu vaccine which would quite obviously be a gigantic windfall for the pharmaceutical companies.

So which is it antivaxxers?

It would seem to be the fact we don't have a one-time vaccine for the flu only proves that the system works.  We have clinical trials and data which shows us the effectiveness of vaccines, and if a vaccine is found to be ineffective it wouldn't be approved.  We have a system of checks and balances in place to ensure the public is protected and that vaccines are not only effective but that they are safe.  We have a system which rewards responsibility, and one which puts the safety and health of the public as the priority far head of profit.

We aren't talking about a nutritional supplement or a vitamin that can be sold by anyone trying to make a buck.  Vaccines are subjected to rigorous safety and effectiveness testing which can take years to complete and which requires verifiable proof of efficacy before that vaccine is ever approved for use.  Can we say the same thing about the various supplements and pills sold on antivaxxer websites?

Sort of makes you wonder what type of clinical trial or testing was done on something like the miracle "brain repair" pills sold by a well known anti-vaxxer.  I think we all know the answer, and it rhymes with none.

If vaccines were really all about profit and if the health of the public was an afterthought as so many antivaxxers have suggested, I have no doubt we would have a half dozen one-time flu vaccines on the market this very moment.  Yet we don't - and I've yet to see an antivaxxer who can explain this without contradicting themselves.

HuffPo: Anti-Vaccine Vitriol: Seeking Reason

Dr. David Katz recently published a piece on The Huffington Post in response to some of the anti-vaccination nonsense that gets posted on the HuffPo website on a regular basis.  The amazing thing is HuffPo is known to  be somewhat of a safe haven for antivaxxers, so to witness them being called out for their tactics and lunacy is nothing short of amazing.

I'd love to cite some specific passages from his article, but the truth is if I cited only the parts of the article which make sense and which make very valid points, I'd end up posting the entire piece.  Therefore I encourage you to read the entire article in its entirety over at the HuffPo website.  You can find the article at this link:  Anti-Vaccine Vitriol: Seeking Reason.

Well ok, I do have to list one of my personal favorite quotes that Dr. Katz wrote: "In other words, if you want to offer advice against vaccination that reasonable people can take seriously, try being reasonable".

I dare say the phrase "reasonable antivaxxer" is an oxymoron, but perhaps one day I'll actually come across one.  It is difficult to imagine a world where a reasonable person tosses aside all logic and common sense while ignoring mountains of scientific evidence and historical records, but perhaps there are varying levels of reason.

Of course even after reading the article, the antivaxxers once again come out in full force in the comments section.  Sadly it seems most of them were unable to complete the entire article before posting because many of their comments are using the very tactics discussed in the article itself almost as if they antivaxxers were so enraged after the first paragraph or two they skipped the remainder to cut and paste more anti-vaccine nonsense.

One comment that caught my eye was from an antivaxxer who complained of a lack of "[d]ouble-blind, randomized controlled studies" showing the efficacy of flu vaccinations.  Not only did this particular antivaxxer clearly not read or understand Dr. Katz's article, but she also appears to be very confused about ethically questionable studies.

We of course have discussed this issue in the past, and frankly anyone of average intelligence should understand the moral issues with trying to perform such a study, but even more troubling is how these antivaxxers presume it is possible to prove a negative in the first place.  I just have to wonder if someone did perform a double-blind randomized controlled study on a flu vaccine and those individuals who did not receive the vaccine were six times more likely to contract the flu - would antivaxxers actually suggest the vaccine was functioning as designed?  I think we all know the answer, and that answer is "no", because they would simply claim there was bias, or they would challenge the funding source for the study, or they would make claims about how correlation does not equal causation (even though they are guilty of confusing the two on a continual basis).

The truth is, even if the results did come out as expected it wouldn't change perceptions or the minds of the anti-vaccination crowd, so what benefit would such an unethical study provide, and at what costs?  What if one of the test subjects contracted the flu and died as a result of complications?  What if those study participants who didn't receive the vaccine contracted the flu and spread it to dozens or possibly even hundreds of others?

You see when someone doesn't receive a vaccine, it isn't only them who is impacted.  Potentially it is everyone around them.  It is anyone and everyone who comes into contact with that person which is precisely why I have no problem with calling someone who willfully skips their vaccinations out of ignorance to be nothing short of selfish.  If you want to kill yourself I have zero problem with it, but when you put the lives of others in danger due to your selfishness, then I have a problem with your actions.

We have seen the ramifications of scientific ignorance when antivaxxers refuse to allow their children to receive vaccines, and in some cases it has lead to outbreaks of vaccine preventable diseases such as the measles or pertussis... with the end result being hospitalizations, prolonged illness, and in a few select cases even death.

Therefore antivaxxers can continue to protest that no double-blind randomized and controlled studies on the efficacy of the flu vaccine have been performed, but it won't change anything and is merely a distraction.  As much as we might love to see such a study, it won't be happening anytime soon not only because of the ethical issues, but because anytime a study is performed and the treatment has such profound effects, the study will be interrupted.  It is simply inhumane to continue a study when a sample group shows such a significant benefit over the control group, and any long-term study of a vaccine is most certainly going to show this disparity thus we must look elsewhere for the necessary data.

Granted it isn't like we can't look at actual historical data to know if something works.... say for instance the fact that the CDC reported the incidence of invasive Hib disease dropped from 40-100 per 100,000 children down to 1.3 per 100,000 due to routine usage of the Hib vaccine from 1980 to 1990. Surely that is merely a coincidence.

Then again, Australia found the same thing... which results in this chart showing how the Hib vaccine resulted in over a 90% drop in reported cases in 12 years and actually eliminated all fatalities within 7 years.

It still must just be a coincidence right?  I mean we can't use this type of data because it isn't part of a double-blind randomized and controlled study... so it must be garbage.

Then again, there have never been double-blind randomized and controlled studies proving the efficacy of parachutes either, and there won't be anytime soon.  Does that mean we shouldn't trust the efficacy of parachutes?  Of course not, because we already know they save lives.  We already have more than enough evidence to know that parachutes are a great idea, and we know what the alternative is.  To suggest we need a double-blind study to determine whether parachutes work or not would be unethical (and obviously idiotic), but when you think about it, vaccines are no different.


So the next time an antivaxxer asks for a double-blind study aka: a "vax vs. unvaxxed" study showing the efficacy of vaccines, just ask them if they are willing to participate in a double-blind study for parachutes.  Sure that seems incredibly stupid, but so does the idea of passing on a vaccine because of scientific ignorance or fear.

Now if you need an example that is more in tune with vaccine, simply look no further than shoulder-mounted three point safety belts in automobiles.  We know the usage of such devices has resulted in many lives saved, and we know what the statistics are prior to their usage much in the way we know what the rates of disease were prior to vaccines being developed.  So should automobile manufacturers be required to perform double-blind studies on seat belts prior to installing them in vehicles?  Should they be required to report any findings of shoulder injury or broken arms due to the seat belts even though those same people may have died without the seat belt?

Our world isn't always so black and white, and sometimes the data is impossible to obtain via a perfectly controlled scientific study.  In some cases we need to look at the other sources of evidence such as infection rates or historical data.  It may not always be as clean and concise as a chart listing infection rates of X vs. Y, but unless you are willing to jump out of a plane without a parachute you really have no business complaining about a lack of double-blind studies.

What Do We Really Know About Vaccines?

If you listen to a vaccine conspiracy theorist (aka: an antivaxxer) for long, they will eventually make a comment which resembles one of the following:

• "Vaccines have never even been studied!"
• "There is no science behind vaccines!"
• "The safety of vaccines is unknown!"
• "The efficacy of vaccines has never been proven!"
• "Nobody has ever studied vaccinated vs. unvaccinated children!"  
• "Vaccines don't work at all and aren't even based upon science!"

To that I say... Really?  I can understand someone missing a study or two, but when a five second Google search can provide over 577,000 results it seems antivaxxers are simply going out of their way to ignore what is right in front of them.

Getting more specific, if you want to know about vaccine efficacy the data is available.  If you want to know about vaccine safety the data is available.  Even if you want to know about a specific vaccine such as the Hepatitis B vaccine and you were trying to determine if there was ever a comparison between vaccinated and unvaccinated children, that data is available.

Or perhaps you heard about the Gardasil vaccine and you are curious if the efficacy of that one specific vaccine has ever been examined, the data is available.  Even if you get more specific and are curious if the Gardasil vaccine results in an increased risk of miscarriage (spoiler alert - there is no evidence to support an increased risk) - once again the data is available.  Even if you have some strange desire to know what women in the rural South happen to think about the Gardasil vaccine even if they had never heard of it before being asked... that data is available!

So the next time you hear an antivaxxer claim vaccines have never been studied or that their safety has never been examined it would seem they are either misinformed, they are ignorant to the plethora of scientific available at our fingertips, or they are simply being dishonest.

Perhaps it is true that antivaxxers don't study vaccines, but the scientific community most certainly does.