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Just like religions, companies have creation stories.  Part fact, part myth, and a lot of hazy memories drive the path of these stories until someone decides to write it down.

At AdverseEvents, our genesis came from a scary situation.  The wife of one of co-founders suffered a serious adverse drug event.  Not knowing what else to do, we turned to Google to search what was going on with her.  What we found was overwhelming – and largely useless.  Millions of records, but none that could actually tell us how many people suffered from a similar event, what their outcomes were, and what the odds were for her condition to worsen or improve.

We ultimately found the FDA’s database of drug side effects – the Adverse Event Reporting System (then AERS, now FAERS).  FDA does not make the data publicly searchable, but it can be downloaded and mined from a relational database.  As certified data geeks it didn’t take us long to download these data and start searching around.

What we found, however, was horrifying.  The database structure and data within were an absolute mess.  It took us weeks to try to make sense of the inconsistent table configurations, the lack of data entry controls, and the ridiculous misspellings that were rife throughout the database.  Many days we alternated between crying and laughing uncontrollably at the scope of the data problems.

Fortunately, our patient recovered well from her ailments, but by then we were in so deep with these data that we didn’t want to give up.  Like Alice going down the rabbit hole, we just found ourselves sucked deeper and deeper into an almost endless abyss of data mismanagement.  It became our driving goal to fix the database and make the underlying data available, accessible, understandable, and actionable.

What we first thought would be a 3 or 4 month project turned into a 2-year saga and was only possible via the creation of some new data scrubbing algorithms that we designed from the ground up.  And we’re proud to say that we did ultimately make the data available and accessible.

It even seems that our efforts haven’t gone unnoticed.   FDA recently launched a reformatted version of their database that attempts to solve some of the same problems we encountered way back in 2010/11.  While we applaud their efforts, the end result is far from perfect.  But that’s OK – it ensures our job security.

As we find ourselves in our third full year at AdverseEvents, we’re officially out of the insular Garden of Eden where we get to run around naked and develop product.  We’ve officially been banished out into the wilds of customers, prospects, and selling product.  The second part of our goal – making the data understandable and actionable is our primary focus now. 

And we’ve got big plans ahead.

Follow the link to read our comprehensive guide to FAERS data. 



Brian Overstreet

Brian Overstreet

President

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Topics: FDA, FAERS, Drug Safety

Brian Overstreet

Written by Brian Overstreet