The Vaccine Debate Part 1: The Legal Aspect of the Feb. 22 Ruling

Preamble  
    Because this blog post is likely to attract new readers to my blog, before I get into the meat of the debate I feel some preamble is in order.  Facebook is a wonderful thing.  It allows us to reconnect and stay in contact with friends to a degree that old skool letter writing simply wouldn't allow.  One interesting derivative of facebook is that we can learn how our own views differ from those of our friends and our friends' friends.  As we progress though life we tend to surround ourselves most closely with people who share our own point of view.  Facebook allows us to observe in real time how our views have changed or are diverging from past peer groups.
     So what's my point?  I guess what I'm getting at is that I think having friends/friends of friends who have divergent views from my own allows me to examine my own beliefs more critically.  For example, politically I have what Americans call a "liberal" bias (in Canada I'd be much closer to the centre) but thanks to facebook I can read articles that my more right leaning friends post.  Having access to these articles allows me to see things from a perspective that I probably might not have otherwise.  Sometimes I discount these countervailing views as malarky but occasionally I will agree with some of the points and modify my position.  The most fruitful reaction is when I respond to the article.  Doing so allows me to clarify my own position to myself and determine whether my position is simply an opinion or whether there are strong arguments and/or evidence which support my position.  Sometimes things get heated but as long as my friends and I stay within boundaries appropriate to our friendship/character the outcome is usually fruitful for the both of us.  Basically, this blog entry the the result of one of those interactions.
       As a caveat, I loves me some sarcasm, it's built into my DNA so I urge you not to take too much offence if I am dismissive of any of your cherished beliefs.  I'll do my best to temper it (Ha!) On the bright side I can take just as well as I can dish it...so give me your best!
     Although I'm but a babe in the woods in academia and I have no specialized knowledge, I would argue that training in philosophy qualifies one quite well in the evaluation of arguments.  The subsequent blog post is about several issues in the vaccine debate.  So, what are my medical credentials you ask?  Well, I'm not a doctor, but I did play one for over 2 years with Chippendales.  If that doesn't convince you of my bonifides, I don't know what will.  Without further ado...


Issue 1:  Government "Protection" of Vaccine Producers


    My good friend Nima posted the following article on his facebook page with a subject line that he knew would bate me (we do this to each other....it's fun!)
http://www.nvic.org/NVIC-Vaccine-News/March-2011/No-Pharma-Liability--No-Vaccine-Mandates-.aspx
 Besides the fact that this article is poorly written with grammatical errors and missing words (see ad hominem attack)  there are so many factual fabrications it reads like fox news (see "ad hominem" again!).  Basically I'm having a hard time deciding where to begin.  Lets try this.  I'll summarize the article, point out the main errors, then give some examples of dishonesty in the article.
    The main points of the articles are as follows:  1. Vaccine producers are protected from civil liability should a vaccine cause injury, 2. a)  'mericans are legally compelled to be vaccinated by government b) and that's a violation of FREEDOM! (chant USA! USA! USA!) 3. Vaccines are baaaaad.


Vaccine Producers are Protected from Civil Liability
      First of all the way this claim is made is disingenuous.  Thoughout the article the claim is made that there is "no liability" and "no accountability" for vaccine producers.  The tacit implication that it is very difficult if not impossible for victims of vaccine side effects to receive compensation.  I commend the writer for not outright lying but his account is misleading.  Here are the actual facts:
1.  In 1986 the US government set up the National Childhood Vaccine Injury Act (NCVI) to provide no-fault compensation to those claiming to be victims of vaccines.  So, children suffering from what may be side effects of vaccines have an avenue by which they can receive compensation.  The threshold for a successful claim to demonstrate a causal link is very weak and the effects need only manifest themselves within a reasonable time frame after the injection.  It is important to note that the causal link between most vaccines and the purported side effects is weak at best.
     In many cases, for compensation to be awarded there need only be a temporal causal link between symptoms and vaccination, not physiological or biochemical.  Basically just because event B occurred after event A does not mean that event A caused event B.  I will get into the science of that later.  With the NCVI Children are provided medical, rehabilitation, counselling, and educational expenses in the case of a successful claim.  
Assessment:  While it is true that vaccine producers are protected from civil liability, it is not true that victims have no recourse for compensation.  In defence of the article writer, they never outright say this but any uninformed person reading the article could easily draw this conclusion.


     So how did this whole ruling come about?  Well, basically there was a case in which a family from Pennsylvania went to the NCVI claims committee looking for compensation and didn't get it.  The condition--residual seizure disorder--which afflicted the daughter had been removed from the schedule of approved reactions that qualify for compensation .  In other words,  there was no evidence indicating or plausible mechanism for a causal link between the vaccine and that particular condition.  Despite this, the plaintiff argued that the vaccine company had knowledge of a safer vaccine and if they had distributed the newer vaccine their daughter would not have had the reaction.  The family did not accept the ruling of the NCVI and eventually their case made it to the supreme court.
     In order to understand the supreme court ruling we need to look at the wording of the key passage in the 1986 NCVI law:
     No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.
The two keys to the case are the phrase "side effects that were unavoidable" and "the vaccine...was accompanied by proper directions and warnings".  Lets look first at the later.  Before a child gets any vaccine it is the law that the parents read and sign a vaccine information statement (VIS):

A VIS must be given with every vaccination, including each dose in a multi-dose series. Each VIS contains a brief description of the disease, as well as the risks and benefits of the vaccine. Each VIS is developed by the CDC and distributed to state and local health departments as well as individual providers.(my italics, thank you wikipedia)

     Basically this amounts to informed consent. The plaintiff wanted to argue that despite the informed consent the vaccine manufacturer knew about a more attenuated vaccine and should have offered it.
The judges ruled that despite this, the informed consent that was for the vaccine at hand, not another version of the vaccine.  Also, despite what the National Vaccine Information Centre NVIC article states, there are state laws that allow for abstention from taking vaccines.  

    So, the family could have refused that vaccine if the known risks which were on the VIS had been unacceptable to them.  That is to say, the family could have declined having the vaccine administered to their daughter if they were concerned about the "side effects that were unavoidable".  (Actually, in the article the NVIC contradicts themselves because in the first part of the article they say that Americans are legally required to get vaccinated, but at the end of the article they ask for donations to continue their support of existing state laws that allow for exemption--go figure).  

    The supreme court noted that if the law were otherwise interpreted it would open the door for very difficult cases.  Here are a couple of analogies I came up with as thought experiments to illustrate the point:  Let say you buy a car the year before they install airbag technology into the model.  You get into an accident and the injuries you sustained could have been prevented if there had been an airbag in the car.  The car company knew about airbag technology and maybe even sold some of your model with airbags in another country (with less stringent testing regulations, for example).  Can you sue the car company?  They knew about a safer modification to the vehicle.   Or lets say that midway production they started adding airbags.  You bought a car from an early production run that didn't have one.  Does the car company now need to pull all non-airbag (safer) cars from the market and junk them?  

    Here's another that maybe isn't so much of an analogy but a similar case.  Lets say you have a headache and decide to take your usual ibuprofen (NSAID) which can cause stomach ulcers with prolonged frequent use.  Meanwhile just 2 days ago that same drug company just concluded a 5 year FDA trial and received FDA approval for a similar drug but the new one is less likely to cause stomach ulcers.  Is the drug company expected to recall all existing stock of ibuprofen and destroy it just because it has produced on innovation that is slightly safer?  I'm not so sure it has this obligation.  

     If we consider these imperfect analogies we can see how it would be difficult for the court to rule in favour of the plaintiff and the difficulties that would arise out of setting such a legal precedent.  The bottom line however is that all this legal stuff is secondary to the science.  The science does not support any causal link between the DTP vaccine and many of the claimed side effects. (Again, I will discuss the science in part 2 which I hope to write over the weekend)

     Anyway, hopefully this fosters some perspicuity on how the ruling came about and why the supreme court ruled the way it did.  One final note.  At this point any careful reader should notice what seems to be a logical inconsistency in my position.  On the one hand I am implying that vaccines are safe but on the other I am saying that there is the NCVI which provides compensation for those experiencing side effects.  If vaccines are so safe why should there be a body which decides on compensation for side effects?  Ah! ha! good question.  I will elaborate on this when I discuss the science of vaccines.

Why Protect Vaccination Producers?

     Although the issues surrounding this particular case are interesting, the more important issue is why the US enacted the NCVI law in 1986 in the first place.  Why should government (once again) protect big bad pharma?  Before I continue I'd like to clarify that I do not think that pharmaceutical companies are particularly ethical actors.  In fact, there are many instances where they have proven to be quite the opposite.  Despite this there are important reasons for which the NCVI law was enacted.

A little background which I have stolen from this article 

http://www.sciencebasedmedicine.org/?p=11127#more-11127

I'll summarize for those of you who are already bored with the topic and don't wish to do any further reading:
In 1982 NBC produced an "expose" of alleged DTP vaccine related injuries.  This began the first major anti-vaccination movement and proliferation of misinformation.  
While in 1979 there was only 1 DTP-related lawsuit, by 1986 there were 255, with a total of over $3 billion sought by claimants. This clearly was not sustainable for the vaccine industry, and in fact manufacturers went out of business. In 1967 there were 26 US manufacturers of vaccines. By 1980 this number had dropped to 15, and by 1986 there were only 3 companies still making vaccines in this country. Vaccine prices skyrocketed, and manufacturers found it difficult to obtain liability insurance.


Basically, the sheer legal costs of defending claims made doing business prohibitive. The alternative was for pharmaceutical companies to stop producing vaccines. I know if I were selling vaccines in that environment I'd close my doors too and stick to selling aspirin.  What rational business person wouldn't?  So, it seems that the CDC and related government agencies were faced with a decision:  offer some protection to vaccine producers, or eliminate the vaccine program all together.  

     Now I know what your thinking.  They should have eliminated the vaccine program.  If people would just think more positive thoughts they wouldn't get sick.  All sickness comes from either negative (quantum?) energy, stress, and poor access to triple rainbows.  I know! But you're preaching to the choir.  All this crap about genetic predispositions, viruses, bacterial infection, different diseases having different aetiologies and pathologies... can all be avoided by simply tapping into the universe's positive energy.  And if you should accidentally unplug yourself from the positive waves of quantum energy, easy solutions are just around the corner.  Got mumps?  Laugh away those bumps....homeopathy will fix it!  Got polio? Just look at my portfolio...super doses of vitamins will have you healthy in no time!  Problem with your spleen?  Easiest thing I've ever seen...Reflexology will do the trick, just massage your foot where it's thick!  I've got hundreds of these folks, but I'll spare you--you get my point.

      I know it sucks to give legal protection to big corporations (and I'm actually being serious here) but I think in this particular instance it is warranted.  

OK folks, what was supposed to be a quick overview of the vaccine issues sprinkled with witty remarks has turned into a full-blown research project.  I have to work over the next few days but over the weekend I'll try to produce a part 2 focusing on the research/science.  Please post your comments and hate mail!