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Immunization Tragedy

January 19, 2011
by Bobbie Byrne
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Why are immunization registeries optional for meaningful use when millions of kids are immunized every year?

When I was a second year resident in pediatrics, I saw an 8-year-old girl in the emergency department for a cold. In many ways she was typical of many kids I saw at that time. The ED was full of non-emergency cases, and access to medical care was a challenge for these families. The emergency room was convenient, and we had the best graham crackers and popsicles.

But if she had really been typical, I probably would not remember her. She had severe developmental delay that her mother shared was from measles encephalitis. Prior to contracting measles, she was a normal healthy kid. She just had the poor fortune of being poor. Her mom said she was “just a little” behind on her immunizations when the measles outbreak in Chicago hit in the late ’80s.

In my mind, this was an immunization tragedy with an n=1 and the cause was access disparity.

For most of my time in an affluent pediatrics practice, I had a lot of immunization conversations. There was a lot in the news about vaccine safety. Some parents requested mercury free vaccines. Some wanted to spread vaccines out over a few visits instead of doing them all at one time. Some parents preferred to have the single component instead of combination vaccines. Some parents delayed brand-new vaccines. I supported all of this. I just could not support complete immunization refusal. There were a few patients who left the practice.

In my mind, this was an immunization tragedy with an n of about 10 and the cause was misplaced but genuine parent concern.

Of course, what I saw in my practice was representative of peds practices all over the world. On February 28, 1998, the Lancet published an article on the link between immunization against Measles-Mumps-Rubella (MMR), gastrointestinal disease, and autism. While we now know that the data was fraudulent, the article outlined case studies of 12 children who received the MMR vaccine and then developed autistic behaviors. This article appropriately caused parents to become interested in vaccine safety, but it did more to increase parental fear than any other single piece of information. On February 2, 2010, the Lancet officially retracted the article.

This week we have learned more about this fraudulent study and how it came to be published despite questionable methodology. It seems clear that Andrew Wakefield and other researchers falsified data to create a link between immunization and autism. Wakefield had plans for a lawsuit against vaccine manufactures and a number of businesses all lined up to profit from parental fear of vaccines, including testing services.

In my mind, this is an immunization tragedy with the n in the millions and the cause was greed.

You may be asking what the heck this all has to do with information technology? It is just the ranting of a really angry pediatrician? (answer: yes, a little…) Millions of kids are immunized every year. Why do we still struggle with immunization registries? Why is it done on a state by state basis? Why is it optional for meaningful use? Could population research help us identify a subset of kids that perhaps should not receive a particular vaccine or combination of vaccines? More and more questions…

It took 12 years for this study to be discredited and that is probably the biggest immunization tragedy of all.

 

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Comments

I've never, ever met a paranoid pediatrician! I'm pretty sure that, like unicorns, the easter bunny and santa claus, a paranoid pediatrician would be a rare find.

My friends, Scott, Helga, and Lois at Westat are currently doing a comprehensive review for AHRQ. It's one of several studies looking hard at the pediatric EHR, in part to better understand what Meaningful Use requires - kids aren't simply little adults :)   Healthcare providers, which includes parents of course, realize that.  Apparently policy makers get it as well!

CHIPRA Model Children's EHR Format (CHIPRA act of 2009)

More here:

http://www.ahrq.gov/about/annualconf10/grace_kahn_finle/grace_kahn_finley.HTM


Bobbie, great post!

I attended the eHI annual meeting this week, complete with an impressive range of stakeholders, including several representing pediatric care providers (directly and otherwise). It became even more clear after discussions that the range of issues specific to newborns and children were far more nuanced than usually discussed. Just look at privacy and confidentially rights around adoption. I hadn't realized that adoption issues were in the range of scope for "The Era of Meaningful Use." Of course they are.

FDAAA
Active drug safety surveillance systems, enabled by electronic data practices, by the Food and Drug Administration through the Sentinel Initiative,  was publicly launched in May 2008. It was a key provision of the recent Food and Drug Administration Amendments Act (FDAAA) of 2007 signed into law on September 27, 2007.   (More information available through eHI.org regarding the collaborating healthcare providers, drug manufacturers, and other stakeholders.)



My reaction to your post takes me back to several of my recent posts on Comparative Effectiveness Research and HIEs, including Part 2 of Blind Spots (cognitive errors), and Charlene Marietti's recent post. See my comments and link about The Observational Medical Outcomes Partnership (OMOP), a public-private partnership designed to help improve the monitoring of drugs for safety.  The connection to immunization surveillance and safety are obvious.  My point is, the available data today, if appropriately managed, is a lot more powerful than we are exploiting.

The skinny is data capture and discovery methods are an evolving competency. We ought to be able to refute studies like the Lancet article you cited by much larger, locally relevant and well policed observations. I am not willing to hold state-level or federal level MU requirements as a significant part of the solution to the Lancet tragedy.

As you clearly and effectively point out, the root cause diagram for the immunization tragedy includes

1) fraud-driven-by-greed,
2) access disparities,
3) complexity of attribution of causation versus association over time compared to base rate (with no current, untreated and randomized control group), and
4) lack of science required "... population research help us identify a subset of kids that perhaps should not receive a particular vaccine or combination of vaccines."


I'm wondering whether inadequate policing of medication and immunization practices, and failure of adequate counter-detailing of the public may be larger, more important issues than requiring immunization registries in Stage One of MU. Those two problems may persist after registry requirements. One analytics firm with effectively complete "registry" data on Vioxx use mentioned at eHI that they were aware of it's safety concerns before [probably long before] it was removed from the market. They apparently had no duty to disclose that to care providers; they also would have certainly had liability issues precluding most commercial organizations from releasing their findings. Registries, while necessary, are no sufficient.

You are so correct. I actually do not actually think that immunization registries would have changed much in this situation and I know that we are not ready to have them be mandatory or national. I am just so bent on this issue. I just have a hard time imagining that it would have taken 12 years if the patients were adults. Pediatricians are often accused of being paranoid-that their patients and their work is not valued as highly as adult medicine. They are not paranoid, because they are right! :)

Bobbie Byrne

Vice President for Health Information Technology at Edward Hospital in Naperville, Ill

Bobbie Byrne M.D. writes about being a community hospital CIO all the while trying to figure out...