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Friday, January 17, 2014

A Community Conversation - Part 10

A Community Conversation About Health and Responsibility: Vaccines and Beyond

Part 10:  Convoluted Policy-Making & Autism

Pure science is a beautiful and complex dance of careful planning and unexpected discoveries. But things get truly convoluted when we throw in money, public agendas, politics, media, and liability law.  Here’s how.

Before 1900, there were no federal regulations of pharmaceuticals and anyone could manufacture vaccines. Then tragedy struck. In what the newspapers later called “criminal carelessness,” contaminated vaccine batches killed at least 23 children. This led to the Biologics Control Act of 1902. 
In addition to setting manufacturing standards for many types of medications, the Biologics Control Act put government in charge of safety enforcement and private industry in charge of manufacturing.

Why can you confidently buy a bottle of ibuprofen, and why are tainted batches found and recalled?  Because of a vaccine tragedy more than a hundred years ago, and how society responded to the problem.

Another incident, in 1955 drew considerable attention when Cutter Laboratories accidentally released an injectable polio vaccine in which the polio virus was not completely killed. There was no negligence involved and all procedures were followed properly. The polio virus was simply tougher than the scientific knowledge of the time understood. 40,000 children got polio, 200 were paralyzed, and 10 died. In response,
the California Supreme Court ruled that Cutter Laboratories was not guilty of negligence, but was still liable for the harm done.

This precedent of “strict liability” would be devastating to the vaccine market. Freed of the necessity of proving negligence, the number of vaccine-related lawsuits skyrocketed. An additional problem was that doctors continued to assure patients that vaccines were absolutely safe, opening the door to lawsuits for “breach of warrantee.”

The truth is that vaccines, like all medical treatments, have risks. There is nothing that can be done to make vaccines absolutely safe. This fact is understood by the scientific and medical communities.  There is no debate.  And, caring for a single child with severe vaccine injuries can cost millions of dollars.  There are 74 million children in the USA.  Even if severe adverse reactions are only one in a million, liability settlements for those 74 kids makes it financially unsustainable to manufacture vaccines.

And so, by the mid 1980's, there were only 3 vaccine manufacturers, and only one manufacturer of the DPT (diptheria, pertussis, tetanus) vaccine. In 1984, there was such a shortage of the DPT vaccine that the CDC recommended pediatricians immediately stop giving DPT boosters, in order to ensure sufficient supplies to vaccinate infants.  Society needed to respond to the problem.

In 1986, Congress passed the National Childhood Vaccine Injury Act (NCVIA), to be funded by a tax of $0.75 per vaccine. The NCVIA was designed to improve informed consent, stabilize vaccine supplies, improve research on vaccine complications, and protect those injured by vaccines.   Additionally, vaccine manufacturers would only be subject to lawsuits for outright negligence. The Vaccine Adverse Event Reporting System (VAERS) was established to improve documentation of vaccine complications, and the Institute of Medicine established a committee to review the literature on vaccine side effects.

But most well-known was the formation of the National Vaccine Injury Compensation Program (NVICP). This program was intended to assist families suffering from a vaccine injury.  Further, the pharmaceutical companies are never involved. The general reasoning is that since our society reaps the benefits of a vaccinated population, we also bear responsibility to those injured by vaccines.

Proving a claim of vaccine damage with the NVICP is extremely difficult and requires meticulous documentation. The US government has no intention of paying damages for anything that could possibly be ascribed to any cause other than vaccine damage! On average, it takes 2-3 years to adjudicate a claim after it is filed and approximately two-thirds of cases are rejected. Despite this, the NVICP has paid damages to 3,456 people since 1989. Total costs have been more than $2.8 billion dollars.

So how does autism fit into the picture? Autism is complicated and virtually undefined.  This lack of understanding has presented challenges to the NVICP.  Here's why. Approximately 15 years ago, there were two hypotheses proposed regarding the cause of autism. One hypothesis involved the MMR, specifically the live measles component. The other hypothesis involved thimerosal, a mercury-containing preservative that was used in vaccines. The media firestorm around these two hypotheses led to a temporary but significant reduction in MMR use, a few measles outbreaks, the removal of thimerosal from most vaccines, and an explosion of research into autism. It also led to nearly 5,000 claims being submitted to the NVICP for vaccine-induced autism.

Most of these claims were grouped together into the Omnibus Autism Proceeding (OAP). In 2009, after 7 years of reviewing the research, the vaccine court ruled that the MMR does not cause autism. In 2010, the vaccine court ruled that thimerosal does not cause autism. All subsequent cases arguing that autism was caused by MMR and/or thimerosal would be summarily dismissed.

Was that the final word on autism? Not exactly. Encephalopathy is a known complication of both the DPT and the MMR vaccines
And there are quite a few children who have received compensation for vaccine-induced neurological damage who also have a diagnosis of autism, further complicating the situation.  To date, the significance of children who have a dual diagnosis of vaccine injury and autism is a subject of heated debate and intensive scientific inquiry.

This matters because appropriate services for autistic children are expensive and when parents are desperately seeking support for their children, the National Vaccine Injury Compensation Program offers a possible solution.  Of course, the NVICP is equally desperate to deny any responsibility for children with autism, because a payout to tens of thousands of children would bankrupt the compensation fund.

When millions of dollars are at stake, human beings tend to have difficulty interpreting science with anything approaching neutrality, even when the science is very clear.  And, regrettably, the science is not clear.  Thus the continued debate, discussion and research.  

Ultimately, the lesson to take away from the past century of vaccine science is this:  When we mix together science, money, public agendas, politics, media, and liability law, things get truly convoluted...and the truth can be almost impossible to find.   

“A Community Conversation About Health and Responsibility: Vaccines and Beyond” is an ongoing series written by two close friends with a passion for improving community cohesion and building respectful relationships in a diverse world.  This article was co-created by Karen Crisalli Winter and March Twisdale.  

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Welcome to the conversation. Knowledge changes. People respond best when this truism is kept in mind. In community, March & Karen