How Safe is Safe -- False Skeptics and Sheep Scientists

MySocratesNote: I will again take the time to thank Schwartz for his excellent rebuttal to Orac's "It can't be done" fallacy. Schwartz, I think that perhaps we should name a new logical fallacy after Orac, yes? Or, do you think that would be giving him too much credit.

Readers, please enjoy.

I came across an article recently titled: "Enablers of the vaccine-autism manufactroversy" describing how a group of self designated skeptical scientists from various disciplines (including medicine) have gathered together to coordinate their efforts to shout down and dissuade parents from questioning the mainstream medical establishment about vaccines. The commentary was weighted toward the standard personal attacks and name calling generalizations I've grown used to seeing from this group but I'll be gracious and ignore that part in this piece.



Apparently, these people feel that one should not be welcome to question the existing status quo and that everyone must take a hard position for or against vaccines as if the world were black and white. Of course those who dare question the establishment are arbitrarily classified as "anti-vaccine" (sound familiar to anyone here?) and are also deemed illogical and beyond logical reason. To illustrate this, they have crafted 3 questions that they insist no one is able to answer. Let's take a look:



Question 1) You say you want safer vaccines. OK then, please, define "safe enough." What rate of complications for specific vaccines would be "safe enough"? What rates of various infectious diseases against which these vaccines protect would be acceptable in order to balance the risk-benefit ratios?



This question appears reasonable enough upon a quick glance -- which is what I think they feel their audience will give this stuff -- but if you think about it you realize this is gross simplification of a problem akin to something you would see on a high school math exam. The funny part is they didn't even provide the assumptions required for such a question, which is just dishonest -- a false argument commonly utilized among this group of "scientists".



What is safe enough? It depends; that's the catch. Since we're dealing with the real world and not a simplified model, let's review with the critical information we need to know and consider to answer such a question for each individual vaccine:

A) Under what context is the question being asked?

i) i.e. Safe enough to hold a clinical trial is different from safe enough to mandate application to all citizens or children.

ii) This is an often overlooked question, yet this piece of criteria is critical.

B) What are the negative outcomes of contracting the disease where you live?

i) This establishes the background risk of the disease itself, which is important, because the safety of a preventative measure has to be measured against the risk you are being protected against.

ii) The current numbers provided by the CDC are exaggerated in some cases (i.e. influenza deaths -- read http://www.bmj.com/cgi/content/full/333/7574/912) and in other cases they don't apply to the Western World because they are global statistics that are skewed by disease rates in the third world where they often don't even have basic sanitation, let alone medical care. So don't accept at face value any assumptions provided by your skeptic because the simplified assumptions rarely apply to the real world. I have yet to find credible published numbers for many of the diseases that vaccinations protect against.

iii) It is also important to identify the specific outcomes as well. For example, if death or serious permanent damage is very rare for the disease, then any substantial risk of death from the vaccine is probably an unacceptable safety outcome even if it reduces hospitalizations and saves a lot of money. (and yes, some vaccines are justified from a cost basis, not on a reduction of deaths)

C) What is the efficacy of the vaccine against the desired endpoint?

i) Beware here, as published efficacy numbers from regulatory clinical trials are almost always inaccurate. History and outbreaks -- often caused by vaccine failure despite the misinformation these skeptics distribute -- because the efficacy of the vaccine was over-estimated. So ask for details, and don't accept the assumptions provided by your skeptic who wants to simplify the problem.  The CDC and FDA post the vaccine reaction prevalence using data gleaned from the VAERS. Less than 10% of vaccine reactions are reported to this system

ii) Make sure you're getting efficacy against the desired outcomes as the clinical trials sometimes only measure antibody titers. i.e. influenza vaccines are often rated as effective because they measure anti-bodies, but when tested against reduced hospitalizations or deaths, they are found to have no measurable effect (http://www.bmj.com/cgi/content/full/333/7574/912). Another example: Gardasil has never been tested against the goal of reducing deaths from cervical cancer. Don't just accept the assumptions from your skeptic when you're dealing with questions in real life. In reality, a proper clinical trial must be designed to test this (i.e. comparing vaccinated to unvaccinated people)

iii) Beware of the simple graphs showing a significant reduction of disease since vaccination was introduced. These simplified graphs are littered with confounders and are not an acceptable substitute for quantified efficacy. I've seen the same graphs used on both sides of the argument (for and against vaccination)

D) Are there other treatment options to prevent negative outcomes of the disease?

i) This is often overlooked by many people. If there is an alternate treatment/preventative measure that changes the probability of negative outcomes of the disease, and these treatments have lower risks than vaccines, then the acceptable risk from the vaccine drops. i.e. treating children suffering from measles with Vitamin A (as recommended by the WHO) has been shown to reduce negative outcomes.

E) What are the risks of vaccination?

i) Quantify the short term risks with credible scientific evidence - this isn't always properly done. The control groups must consist of a true placebo.

ii) Quantify the long term risks with credible scientific evidence - this is almost never done and it requires the study of vaccinated vs unvaccinated populations -- no problems were suspected with HRT until independent long term large population testing was done. This doesn't mean there will be a problem, but history has shown us that unless we study the problem, the theories are virtually useless.

iii) Vaccination risks include the risks for the recommended schedules (i.e. concomitant vaccine application) -- i.e. they need to test the schedule

F) What is the biological mechanism in the cases of negative vaccine outcomes?

i) This is almost never done as follow-up and extensive documentation of vaccine damage is rare. However, this is critical to understand the mechanisms where harm is caused because it may very well lead to a drastic reduction in negative outcomes if pre-screening for at-risk populations is performed. This definitely impacts the "safe enough" determination. Why this isn't currently done is baffling. Exactly. There is no pre-screening to determine contraindications for the general populace. They give the vaccines anyway, though, despite the possibility that there could be allergies to the components or other conditions that could cause serious adverse reactions (case in point: Hannah Poling)

G) What mechanisms are in place to identify and address unforeseen problems?

i) This is critical to address the inevitable uncertainty and unknowns. Credible tracking and reporting mechanisms are required here. Why is infectious disease reporting compulsory by law while adverse event reporting of vaccines is voluntary and often ignored by doctors?



Of course, some of the more disingenuous skeptics will try use an Argument of Ignorance to turn these questions around and argue that you don't have this data, and therefore you can't state vaccines aren't safe. Unfortunately that's a flawed argument. A lack of data doesn't imply safety at all. Additionally, they omit the fact that vaccines are an unnecessary medical intervention (i.e. there is no immediate medical reason to get a vaccine) that they are trying to impose on everyone. In these cases, it is clearly incumbent to demonstrate safety for the individual, not the opposite, as they would like you to believe.



Let's examine the next Question this group of skeptics would have you answer.



2) You castigate vaccines for having "toxins." ...what "toxins" would you remove? Be specific, and provide evidence that these "toxins" actually cause harm at the levels used in vaccines.



Here we find the fallacious "argument from ignorance" in full display. The implication is that in the absence of proof of specific harm, safety is implied. I would recommend you repeat the logic required by any critical thinker; that in order to justify an unnecessary medical intervention with risks, you have to demonstrate safety, not rely on a lack of evidence of harm as an argument. This is especially true when discussing some of the more questionable vaccine ingredients.



This interaction would be humourous if the topic wasn't so serious. If I ask an expert about the safety of elements that are known to be toxic to the human body under a variety of conditions, I would expect them to demonstrate that the toxic elements under these conditions had been studied and have them explain the mechanisms by which safety is assured (i.e. they studied the pharmacokinetics). Instead, you are asked to provide information even the specialist hasn't tested for? This is akin to NASA telling to you provide specific proof that foam can damage the wings of the shuttle after mentioned that you heard that foam keeps falling off during launches. Fortunately, NASA has real scientists that actually studied the problem and found -- to their own surprise -- that foam traveling at supersonic speeds can indeed damage (i.e. punch big holes through) very strong materials such as the shuttle wing. If you had asked for their opinion prior to the testing, each one would have said the risks were very low and the scenario implausible. This illustrates quite clearly that without testing, the opinions of the good experts must be judged carefully as it is not based on evidence but belief.



Ignoring the disingenuous nature of the question however, we can still give a credible answer.



Any element or chemical used as a preservative, adjuvant, or other ingredient that is known to be toxic to humans should be safety tested against the target population in the form it will take during vaccination (dose and method of application). Of course, this includes, but is not limited to: Mercury, Aluminum Salts and newer experimental adjuvants.



Lets move on to the last question that no one can supposedly answer:

3) What specific evidence would it take for you to accept that vaccines are safe relative to the risk of disease and to vaccinate your children and urge your friends to vaccinate theirs?



This one is easy. A simplified form of our final risk analysis would as follows:

For any individual person for whom a specific vaccine is recommended,

A) The risk of damage or death from disease must be higher than

B) The risk of damage or death from the vaccine (long or short term) AND

C) the reduced risk of disease



A similar risk analysis methodology can and should be made before deciding on ANY medical intervention, whether it is preventative or not. Vaccines and other preventative interventions typically have to meet a higher safety bar because the risk of damage and death is much lower than that of a more immediate treatment intervention (i.e. cancer treatment).



Conclusion

The medical community continues to provide one of the most glaring examples of hypocrisy in any community claiming to be science based. The scientific method requires a measurement of outcomes. That means running a prospective clinical study of vaccinated populations compared to unvaccinated controls. It also means rigorously tracking and following up on adverse outcomes of vaccinations. The medical community continues to make excuses and fight this critical step in any evidence based practice. When it comes to the pseudoscience of vaccines, the scientific method is clearly MIA.

As the critical thinker has already figured out, the answers to our questions from 1 and 2 above will provide the information required to perform a logical analysis and make a logical decision. These are the questions that your skeptical scientist needs to answer before we can determine "safe enough". I welcome a discussion of these topics as these are the questions I've been asking since I started to research vaccines before my children were born. Unfortunately, most of them are still unanswered. Alas, since this group of skeptic scientists are clearly employing simplistic dishonest arguments here, they have no intention of entering a logical or scientific discussion. Consequently you will likely be promptly labeled as "anti-vaccine" for asking the questions required to actually do a proper analysis. From the evidence it appears that they just want to browbeat everyone into the same sheep-like conclusions they've drawn.



Shame on them.



Conflicts of Interest: None