Tag Archives: vaccine

Root Cause Analysis

Autism & the MMR Vaccine

By ThinkReliability Staff

During most of human history, families and communities feared diseases such as small pox, influenza, tuberculosis.  And rightly so – these scourges were responsible for the deaths of millions.  So with the advent of vaccinations, humanity should have finally been relieved from the worries of these horrible, yet now preventable, diseases.  Unfortunately, despite the widespread acceptance of vaccinations, notable events have set back progress against one particular disease – measles.

Measles, once considered conquered in most of the developed world, is now making resurgence in the United Kingdom.  Why?  Parents fear vaccinating their children.  The Measles, Mumps, and Rubella (MMR) vaccination rate nationwide dropped as low as 84% during the last decade.  Following the drop, measles became more prevalent, infecting thousands after a decade of steep declines.  In fact, measles infection rates are at their highest rates in well over a decade.  Unfortunately, this also coincided with multiple deaths stemming from measles – deaths that were all preventable.

Why the drop in vaccinations?  In this instance, there is clear reason.  A widely-publicized study in 1998 found a correlation between the MMR vaccination, autism and bowel disease.  Any rational parent would fear causing autism in their child, especially when the perceived risk of catching measles was at an all-time low.

What makes this especially disturbing is that the chance of developing autism from receiving an MMR vaccination is…none.  The original study was recently deemed fraudulent and formally retracted.  To create this “study” the lead researcher, Andrew Wakefield, is accused of grossly manipulating data.  One of the longest medical board investigations in UK history found that all 12 cases included in the original study were altered.  Multiple studies which followed showed absolutely no link between the MMR vaccination and autism.  In short, he fabricated the story completely.

Why do such a thing?  To start, Wakefield accepted over £435,000 in compensation.  This pay, provided by a national legal aid fund for the poor, came at the behest of litigators looking to build a case against the makers of the MMR vaccine.  Moreover, Wakefield had various business ventures which would benefit greatly from such a linkage, to the tune of at least £28M per year.

Yet despite overwhelming evidence that the MMR vaccine doesn’t cause autism, perpetually low vaccination rates remain in the UK.  Performing a root cause analysis of the measles epidemic in the UK and building a Cause Map reveals the causes contributing to the problem, including the role Wakefield’s bogus study played.   Medical studies are complex and rely on the integrity and analytic skills of the researchers involved.  Inaccurate conclusions, sensationalism and fraud all can lead to unintended and dangerous consequences.

Click on “Download PDF” to see the Cause Map detailing the drop in UK vaccination rates due to the Wakefield Autism & MMR Study.

(Details of this case were recently published in the British Medical Journal.)

Root Cause

Developing a Meningitis Vaccine Program to Prevent Epidemics in Africa

By ThinkReliability Staff

Meningitis epidemics occur on a regular basis in Africa. Last year, there were more than 88,000 reported cases.  In 1996-1997, during the largest reported epidemic, more than 250,000 cases were reported.  Meningitis is highly contagious and approximately one in ten cases are fatal.  Disability occurs in approximately one in five cases.

The vaccine that was previously available in Africa was a polysaccharide vaccine, which did not prevent transmission of the disease. Understanding that the current situation was dire, the Meningitis Vaccine Project was formed.  With funding from various donors including The Gates Foundation and money raised in Africa, a vaccine that protects against the group A meningitis strain – responsible for more than eight out of ten infections in Africa – has been developed at a cost of less than $.50 (US) a dose.  More funding is still needed to meet the goal of vaccinating 300 million people across 25 nations.    However, the steps that have already been made are remarkable and represent a huge step forward in helping fight this dreadful disease.

Click on “Download PDF” to see the outline and Cause Map of the 1996-1997 meningitis epidemic and the timeline of the progress of the Meningitis Vaccine Project.  To learn more, see the Meningitis Vaccine Project.

Root Cause Analysis

The Downside of Preparedness?

By Kim Smiley

The U.S. Government has announced that 40 million doses of swine flu vaccine have expired and must be disposed of.   In addition, 30 million more doses are about to expire and will also be disposed of (unless there is a sudden need for swine flu vaccine).  The vaccine doses are worth $260-$450 million.  We can capture this information in a problem definition outline.

Then the question is: is this a bad thing (a problem) or a good thing (a success)?  Like a lot of things, it doesn’t necessarily have to be one or the other.  There’s an aspect of success – swine flu did NOT turn out to be a deadly global epidemic, as was predicted – and an aspect of failure – up to $450 million of vaccines were tossed out.

The question that remains for the analysis is: how do we maximize the successes (preventing epidemics) and minimize the not-so-good stuff (wasting vaccines and money)?  A detailed root cause analysis can draw out the successes and problems associated with any event, including this one.  We can use it to look at the planning process used for an epidemic to look for places where the estimation of the need for vaccines can be improved.  We can even look at the use of and expiration dates of the vaccine to determine if, in the future, a backup plan might allow us to get some secondary use out of the vaccines.  Opportunities for improvement are limited only by the brainstorming capability of your organization!