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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.  

Tuesday, January 14, 2014

Breaking News #2: Evidence That Flu Vaccine Makes H1N1 Worse

Breaking News!
In a nutshell:  
A recent death, and additional hard-core 
science provides evidence that the flu vaccine
 actually makes you more vulnerable to H1N1.

Part of science is a willingness to look at the data, even the data that makes us uncomfortable.  
This data is very discomforting.  

It is especially disturbing because many of us have personally observed a chain of infection where influenza skipped over the vaccinated individuals, or touched them only lightly.  It is clear that sometimes the flu vaccine works as intended for some individuals.  But not always.

In fact, we're starting to see evidence that the flu vaccine may have some unexpected effects - and we are NOT just talking about reactions to the vaccine itself.  This news report begins with the story of a young boy's unexpected death, but what follows has serious ramifications for every person vaccinated by the flu vaccine who then comes into contact with H1N1...which is currently making a resurgence in the USA this flu season! 

This article contains links to multiple well-designed studies, such as:
  • Infectious diseases expert Professor Peter Collignon in Australia
  • Researchers in Hong Kong who conducted a double-blind placebo-controlled trial on children with the trivalent inactivated influenza vaccine with results published in the journal Clinical Infectious Diseases in 2012
  • A study conducted in the U.S. and published in 2013, by microbiologist Dr. Hana Golding of the Center for Biologics Evaluation and Research at Bethesda in Maryland, who conducted a study on piglets vaccinated for H1N2, and then later exposed to H1N1
This is the kind of scientific research we need.
Even when such studies produce unexpected results.  
Because, science does that sometimes.

Link to news report and ongoing research from around the world:

Tuesday, January 7, 2014

Breaking News #1: Herd Immunity Fail - New Study on Pertussis Vaccine

Breaking News!

Acellular pertussis vaccine is shown to prevent symptoms 
in vaccine recipients while NOT preventing transmission 
of the bacterium to other individuals.

AAAS article summary of how the study was set up:  The current study goes a step further and suggests that people who get the newer vaccine may still become infected and spread the germ. Tod Merkel, a microbiologist, and colleagues at the Food and Drug Administration in Bethesda, Maryland, examined response to the acellular vaccine in infant baboons, an animal that responds to the bacterium responsible for pertussis similarly to people. The researchers infected four groups of baboons, each group containing three or four babies, by anesthetizing the animals and dripping a pertussis-containing solution into their noses. One group had already received the standard three doses of the acellular vaccine; a second received the whole-cell vaccine. Members of the third group had previously had whooping cough. Those in the fourth group had not had the disease and received no vaccine before being exposed.

AAAS article summary of vaccine efficacy for the individual:  As expected, the unvaccinated baboons developed severe whooping cough, while the baboons that had been sick previously remained well, the research team reports today in the Proceedings of the National Academy of Sciences. Both groups of vaccinated animals also remained healthy. However, the germ persisted an average of 35 days in the throats of baboons vaccinated with the acellular shot, though it grew less thickly than it did in the throats of the sick, unvaccinated animals. Baboons vaccinated with the whole-cell shot harbored the germ for 18 days, and it did not grow at all in animals that previously had recovered from pertussis.
PNAS article summary of vaccine efficacy for the community:  Pertussis rates in the United States have been rising and reached a 50-y high of 42,000 cases in 2012.  Although pertussis resurgence is not completely understood, we hypothesize that current acellular pertussis (aP) vaccines fail to prevent colonization and transmission. To test our hypothesis, infant baboons were vaccinated at 2, 4, and 6 mo of age with aP or whole-cell pertussis (wP) vaccines and challenged with B. pertussis at 7 mo. Infection was followed by quantifying colonization in nasopharyngeal washes and monitoring leukocytosis and symptoms. Baboons vaccinated with aP were protected from severe pertussis-associated symptoms but not from colonization, did not clear the infection faster than na├»ve animals, and readily transmitted B. pertussis to unvaccinated contacts.
Resources:  All of our resources come from high quality, peer-reviewed, conservative or generally pro-vaccine sources.  We avoid mainstream news articles, which can be poorly summarized, and aim for the best core sources we can find.